chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Staphylococcus test positive, Status epilepticus, White blood cell count increased
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received more than 1 dose or RSV vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Fall, Impaired work ability, Vertigo
Clinical narrative: I always get really sick after COVID vaccines, run a high fever and weak muscles for about 3 days. This time, 4 hours after receiving the COVID and senior double Flu vaccine, while standing in front of my bathroom sink, I had a very violent and sudden vertigo attack. I lost all equilibrium, my body slammed into the wall between my bathtub and bathroom sink and both feet went out from under me. I was suddenly on my bathroom floor in full vertigo. I stayed there for several hours before moving to my couch. The vertigo attacks almost daily and every other days. I had to stay home from work and lost weeks of sick and annual leave time. I could not function during vertigo attacks. I have never experienced vertigo after a COVID or Flu vaccine. I read where in rare incidents patients with Meniere's and VM, can have vertigo triggered. I believe that is what happened to me with this Pfizer-BioN CIVID vaccine. I reached out to both my GP, Dr. and Neurologist Dr. for any help to stop the cluster of vertigo attacks. Dr. put me on Prednisone and that seems to have lessen the attacks but it caused me to experience severe dizziness whenever standing and walking. After having a vertigo attack at work two weeks ago, HR, my supervisor and Vaccination clinic Dr., have put me on medical work leave to telework at home, so I won't lose all my leave. This has been a medical nightmare and has me scared about future COVID vaccines.
Age: 50.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Abdominal discomfort, Chills, Pain, Pyrexia
Clinical narrative: My PCP asked me to report. We both work for healthcare- Full body rigors for 12 hours and fever, apap did little to help. Chills, body aches, upset stomach. 2 days off of work. The injectionist tried to warn me, but I don?t usually get sick like this. Worst illness I?ve ever had to any illness or vaccine reaction.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Mobility decreased
Clinical narrative: Sharp, excruciating pain  on the lower back, making impossible to move freely (sit, lay down, walk). It stayed for 2 whole days and continues less aggressive. I took ibuprofen to calm it but it didn?t work. To move at bed at night was a nightmare. Weird thing! Previos vaccines gave me adverse reactions but didn?t last like this time.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Ocular hyperaemia, Vision blurred
Clinical narrative: Patient was not really sure when exactly symptoms started, stated 1-3 days after vaccination started experiencing red eyes/blurred vision.  Few days after that she started experience pain in alternating eyes, some days it was in both eyes.  As of today patient is still experiencing eye pain
Age: 30.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood glucose normal, Loss of consciousness, Pallor, Vomiting
Clinical narrative: After the patient received both vaccines she passed out. After a few minutes she came to but was pale and threw up. After EMT checked her out she started to fell better and got the clear to go home by EMT because all vitals were normal
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Double dose. No adverse effects.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient reports feeling itchy all over her body.  There is no redness/swelling or itching specifically at the injection site.  Also reports no fever or body aches. Patient took Benadryl  and Tylenol OTC on day of vaccine and again this morning.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dehydration, Hyperhidrosis, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: High fever, nausea, fainting.  Sweating caused dehydration.  Fainting and being unconscious for half hour prompted trip to ER
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Syncope
Clinical narrative: High fever, nausea, fainting.  Sweating caused dehydration.  Fainting and being unconscious for half hour prompted trip to ER
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Contusion, Erythema, Feeling hot, Limb mass, Swelling
Clinical narrative: large red swollen area very soon after vaccine, has persisted for one month since vaccination 9/18, has seen follow up with physician who said to use ibuprofen and manage swelling. came back for vaccine follow up 2nd dose for a gardasil on the other arm, and noticed her arm was still hot, bruised, and a large lump underneath the skin. told her to follow up with provider and gave vaccine on 10/18 on other arm which seemed fine today.
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: high dose influenza vaccine given to 60 year old patient - no adverse events
Age: 49.0
Sex: F
Vaccine: COVID19, FLU3, PNC21
Symptoms: Injection site rash
Clinical narrative: Patient had rash on her left arm near vaccine injection site. Patient stopped at our pharmacy and reported rash on 10/22/2024.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: pt potentially got duplicate shot two months apart
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pallor
Clinical narrative: Pt had difficulty breathing after getting the vaccine and a bit pale. NO history of adverse reaction in the past. Pt was given benadryl 25mg by the immunizer (nurse). Pt was fine after few minutes
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Electrocardiogram, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Vaccines administered by Pharmacy Intern. Patient felt lightheaded and experienced blurry vision shortly after receiving vaccines. Passed out ~4 min after administration. Pharmacist notified. Laid patient down, took vitals (BP 119/68, HR 41, RR 14). Patient non responsive for a few seconds, began to arouse. Felt sweaty and nauseous after regaining consciousness. Technician had called EMS while pharmacist was assessing situation. EMS arrived at pharmacy at around 10:11 am and took over patient care. EMS performed orthostatic vitals. Sitting at 1013 BP 93/54; HR 60; RR 16; SPO2 98; Standing at 1016 BP 59/39; HR 45; RR 16; SPO2 97; Sitting at 1025 BP 95/64; HR 60; RR 16; SPO2 97. Given IV Bolus of fluids. Patient was taken to emergency dept at 10:32 am.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Unresponsive to stimuli, Vision blurred
Clinical narrative: Vaccines administered by Pharmacy Intern. Patient felt lightheaded and experienced blurry vision shortly after receiving vaccines. Passed out ~4 min after administration. Pharmacist notified. Laid patient down, took vitals (BP 119/68, HR 41, RR 14). Patient non responsive for a few seconds, began to arouse. Felt sweaty and nauseous after regaining consciousness. Technician had called EMS while pharmacist was assessing situation. EMS arrived at pharmacy at around 10:11 am and took over patient care. EMS performed orthostatic vitals. Sitting at 1013 BP 93/54; HR 60; RR 16; SPO2 98; Standing at 1016 BP 59/39; HR 45; RR 16; SPO2 97; Sitting at 1025 BP 95/64; HR 60; RR 16; SPO2 97. Given IV Bolus of fluids. Patient was taken to emergency dept at 10:32 am.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vertigo
Clinical narrative: Vertigo for 3-weeks
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Dysstasia, Electromyogram, Gait disturbance
Clinical narrative: Within two days of receiving the vaccine I started losing feeling in my feet, legs, and stomach. I contacted my doctor who referred me to neurology. While waiting for my neurologist appointment, I started losing strenth & muscle function in my legs. I went to the ER where I was admitted for 4 days & left barely able to walk with a walker. My symptoms got worse when I got home & the next morning I couldn't stand or walk on my own. I went to a different hospital where I was admitted for approximately 2 weeks until I entered into inpatient rehabilitation. I lost function in my legs, feet, hands, feeling from my feet to my breasts, lost feeling in half of both hands, & suffered horribly with neuropathy during this time and even still have neuropathy today. I was diagnosed with Guillain-Barre syndrome.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Within two days of receiving the vaccine I started losing feeling in my feet, legs, and stomach. I contacted my doctor who referred me to neurology. While waiting for my neurologist appointment, I started losing strenth & muscle function in my legs. I went to the ER where I was admitted for 4 days & left barely able to walk with a walker. My symptoms got worse when I got home & the next morning I couldn't stand or walk on my own. I went to a different hospital where I was admitted for approximately 2 weeks until I entered into inpatient rehabilitation. I lost function in my legs, feet, hands, feeling from my feet to my breasts, lost feeling in half of both hands, & suffered horribly with neuropathy during this time and even still have neuropathy today. I was diagnosed with Guillain-Barre syndrome.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Neuropathy peripheral, Walking aid user
Clinical narrative: Within two days of receiving the vaccine I started losing feeling in my feet, legs, and stomach. I contacted my doctor who referred me to neurology. While waiting for my neurologist appointment, I started losing strenth & muscle function in my legs. I went to the ER where I was admitted for 4 days & left barely able to walk with a walker. My symptoms got worse when I got home & the next morning I couldn't stand or walk on my own. I went to a different hospital where I was admitted for approximately 2 weeks until I entered into inpatient rehabilitation. I lost function in my legs, feet, hands, feeling from my feet to my breasts, lost feeling in half of both hands, & suffered horribly with neuropathy during this time and even still have neuropathy today. I was diagnosed with Guillain-Barre syndrome.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate doses of Fluad and Covid vaccine
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient reported feeling very dizzy, and she was visibly sweaty. She was given a couple of bottles of water and some sugar. She sat for a while until she felt better and the left.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Immediate post-injection reaction, X-ray of pelvis and hip
Clinical narrative: I don?t know that it was an adverse event, directlyrelated to vaccination, but I started having severe left hip pain immediately afterwards, could?ve been exacerbated by inflammation from the vaccine, but I also had right big toe surgery a few months before, and which caused me to walk unevenly because of the heel shoe I had to wear on my right foot, and I have had some left hip pain ever since then, but it got much worse after the vaccination
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: First let me say I appreciate having a vaccine for Covid. I know sometimes vaccines have side effects and those are expected. My adverse reaction doesn?t make me regretful about getting the vaccine and I will continue to receive Moderna Covid vaccines. I just wanted to let you know on day 2 my arm is red and swollen at the injection site. It?s tolerable and not life altering.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: DUPLICATE FLU VACCINE
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Condition aggravated, Feeding disorder, Impaired gastric emptying
Clinical narrative: 1) Loss of taste and smell the day after the vaccination. Lasted for 2 days. 2) Flareup of gastroparesis 6 days after the vaccine. Could not eat anything for one day. Mostly improved after 3 days. Still having problems eating enough at a meal. I contacted my gastroenterologist via the portal for advice. He is investigating increasing the frequency of the Motlilium I take to 4 times a day.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lip pruritus, Lip swelling, Pruritus, Urticaria
Clinical narrative: Itchy Hives. Itchy swollen lips.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Hypoaesthesia, Paraesthesia
Clinical narrative: after received Flu injection, patient experiences numbness, tingling feeling from head down to her arm. Pt went to ER, then referred to neurologist. Currently was prescribe anxiety mediation to reduce anxiety
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cholecystectomy, Cholelithiasis, Computerised tomogram, Ultrasound scan
Clinical narrative: I don?t think the gallbladder stone and surgery were related to COVID-19 Vaccine
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills
Clinical narrative: Chills for 90 min 12 hrs after.
Age: 0.33
Sex: F
Vaccine: DTAP, FLU3, HIBV, IPV, PNC20, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Pt only 4 months old and too young for flu vaccine. However, flu vaccine accidentally given in error.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was given Flumist on 10/11/24 at our drive up clinic with mom. Today 10/22/24 he was given Flu shot listed above while with his aunt (who had permission). Only 11 days between dose. Adverse event: Unnecessarily give flu shot today - 11 days after Flumist. No current symptoms of concern.
Age: 2.25
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: While reviewing COVID vaccine information, realized that vaccine had been past 12 hour limit when it was given (was reconstituted 10/21/24 at 3:05 PM). Patient with no symptoms.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Eating disorder, Gastric varices, Hepatic cirrhosis, Papule
Clinical narrative: I became autoimmune; thrombosis; Cirrhosis of the liver; varacies in my esophagus and stomach; psoriasis; They day after receiving it I got VREPP; They day after receiving it I got VREPP; not making enough platelets in my blood; varacies in my esophagus and stomach; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I became autoimmune"; THROMBOSIS (medically significant), outcome "unknown"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "Cirrhosis of the liver"; GASTRIC VARICES (medically significant), VARICES OESOPHAGEAL (non-serious), outcome "unknown" and all described as "varacies in my esophagus and stomach"; PSORIASIS (non-serious), outcome "unknown"; PAPULE (non-serious), SKIN PLAQUE (non-serious), outcome "unknown" and all described as "They day after receiving it I got VREPP"; PLATELET DISORDER (non-serious), outcome "unknown", described as "not making enough platelets in my blood"; SLEEP DISORDER (non-serious), EATING DISORDER (non-serious), TEMPERATURE REGULATION DISORDER (non-serious), outcome "unknown" and all described as "message center no longer tells my body to sleep, eat, or how to adjust to temperature change". Clinical course was reported as follows: patient stated that covid19 vaccine ruined his life, the day after receiving it patient got VREPP, within months patient became autoimmune, resulting in cirrhosis of the liver, psoriasis, thrombosis, varices in esophagus and stomach, and not making enough platelets. Patient stated vaccine made message center no longer tells the body to sleep, eat, or how to adjust to temperature change.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Platelet disorder, Psoriasis, Skin plaque, Sleep disorder, Temperature regulation disorder
Clinical narrative: I became autoimmune; thrombosis; Cirrhosis of the liver; varacies in my esophagus and stomach; psoriasis; They day after receiving it I got VREPP; They day after receiving it I got VREPP; not making enough platelets in my blood; varacies in my esophagus and stomach; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I became autoimmune"; THROMBOSIS (medically significant), outcome "unknown"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "Cirrhosis of the liver"; GASTRIC VARICES (medically significant), VARICES OESOPHAGEAL (non-serious), outcome "unknown" and all described as "varacies in my esophagus and stomach"; PSORIASIS (non-serious), outcome "unknown"; PAPULE (non-serious), SKIN PLAQUE (non-serious), outcome "unknown" and all described as "They day after receiving it I got VREPP"; PLATELET DISORDER (non-serious), outcome "unknown", described as "not making enough platelets in my blood"; SLEEP DISORDER (non-serious), EATING DISORDER (non-serious), TEMPERATURE REGULATION DISORDER (non-serious), outcome "unknown" and all described as "message center no longer tells my body to sleep, eat, or how to adjust to temperature change". Clinical course was reported as follows: patient stated that covid19 vaccine ruined his life, the day after receiving it patient got VREPP, within months patient became autoimmune, resulting in cirrhosis of the liver, psoriasis, thrombosis, varices in esophagus and stomach, and not making enough platelets. Patient stated vaccine made message center no longer tells the body to sleep, eat, or how to adjust to temperature change.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Varices oesophageal
Clinical narrative: I became autoimmune; thrombosis; Cirrhosis of the liver; varacies in my esophagus and stomach; psoriasis; They day after receiving it I got VREPP; They day after receiving it I got VREPP; not making enough platelets in my blood; varacies in my esophagus and stomach; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I became autoimmune"; THROMBOSIS (medically significant), outcome "unknown"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "Cirrhosis of the liver"; GASTRIC VARICES (medically significant), VARICES OESOPHAGEAL (non-serious), outcome "unknown" and all described as "varacies in my esophagus and stomach"; PSORIASIS (non-serious), outcome "unknown"; PAPULE (non-serious), SKIN PLAQUE (non-serious), outcome "unknown" and all described as "They day after receiving it I got VREPP"; PLATELET DISORDER (non-serious), outcome "unknown", described as "not making enough platelets in my blood"; SLEEP DISORDER (non-serious), EATING DISORDER (non-serious), TEMPERATURE REGULATION DISORDER (non-serious), outcome "unknown" and all described as "message center no longer tells my body to sleep, eat, or how to adjust to temperature change". Clinical course was reported as follows: patient stated that covid19 vaccine ruined his life, the day after receiving it patient got VREPP, within months patient became autoimmune, resulting in cirrhosis of the liver, psoriasis, thrombosis, varices in esophagus and stomach, and not making enough platelets. Patient stated vaccine made message center no longer tells the body to sleep, eat, or how to adjust to temperature change.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Gastric varices, Hepatic cirrhosis, Insomnia, Nasopharyngitis
Clinical narrative: I became autoimmune; thrombosis; Cirrhosis of the liver; varacies in my esophagus and stomach; psoriasis; They day after receiving it I got VREPP; They day after receiving it I got VREPP; not making enough platelets in my blood; varacies in my esophagus and stomach; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I became autoimmune"; THROMBOSIS (medically significant), outcome "unknown"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "Cirrhosis of the liver"; GASTRIC VARICES (medically significant), VARICES OESOPHAGEAL (non-serious), outcome "unknown" and all described as "varacies in my esophagus and stomach"; PSORIASIS (non-serious), outcome "unknown"; PAPULE (non-serious), SKIN PLAQUE (non-serious), outcome "unknown" and all described as "They day after receiving it I got VREPP"; PLATELET DISORDER (non-serious), outcome "unknown", described as "not making enough platelets in my blood"; SLEEP DISORDER (non-serious), EATING DISORDER (non-serious), TEMPERATURE REGULATION DISORDER (non-serious), outcome "unknown" and all described as "message center no longer tells my body to sleep, eat, or how to adjust to temperature change". Clinical course was reported as follows: patient stated that covid19 vaccine ruined his life, the day after receiving it patient got VREPP, within months patient became autoimmune, resulting in cirrhosis of the liver, psoriasis, thrombosis, varices in esophagus and stomach, and not making enough platelets. Patient stated vaccine made message center no longer tells the body to sleep, eat, or how to adjust to temperature change.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Papule, Platelet count, Platelet count decreased, Psoriasis, Spider vein
Clinical narrative: I became autoimmune; thrombosis; Cirrhosis of the liver; varacies in my esophagus and stomach; psoriasis; They day after receiving it I got VREPP; They day after receiving it I got VREPP; not making enough platelets in my blood; varacies in my esophagus and stomach; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I became autoimmune"; THROMBOSIS (medically significant), outcome "unknown"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "Cirrhosis of the liver"; GASTRIC VARICES (medically significant), VARICES OESOPHAGEAL (non-serious), outcome "unknown" and all described as "varacies in my esophagus and stomach"; PSORIASIS (non-serious), outcome "unknown"; PAPULE (non-serious), SKIN PLAQUE (non-serious), outcome "unknown" and all described as "They day after receiving it I got VREPP"; PLATELET DISORDER (non-serious), outcome "unknown", described as "not making enough platelets in my blood"; SLEEP DISORDER (non-serious), EATING DISORDER (non-serious), TEMPERATURE REGULATION DISORDER (non-serious), outcome "unknown" and all described as "message center no longer tells my body to sleep, eat, or how to adjust to temperature change". Clinical course was reported as follows: patient stated that covid19 vaccine ruined his life, the day after receiving it patient got VREPP, within months patient became autoimmune, resulting in cirrhosis of the liver, psoriasis, thrombosis, varices in esophagus and stomach, and not making enough platelets. Patient stated vaccine made message center no longer tells the body to sleep, eat, or how to adjust to temperature change.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Temperature regulation disorder, Thrombosis, Varices oesophageal, Weight
Clinical narrative: I became autoimmune; thrombosis; Cirrhosis of the liver; varacies in my esophagus and stomach; psoriasis; They day after receiving it I got VREPP; They day after receiving it I got VREPP; not making enough platelets in my blood; varacies in my esophagus and stomach; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; message center no longer tells my body to sleep, eat, or how to adjust to temperature change; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I became autoimmune"; THROMBOSIS (medically significant), outcome "unknown"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "Cirrhosis of the liver"; GASTRIC VARICES (medically significant), VARICES OESOPHAGEAL (non-serious), outcome "unknown" and all described as "varacies in my esophagus and stomach"; PSORIASIS (non-serious), outcome "unknown"; PAPULE (non-serious), SKIN PLAQUE (non-serious), outcome "unknown" and all described as "They day after receiving it I got VREPP"; PLATELET DISORDER (non-serious), outcome "unknown", described as "not making enough platelets in my blood"; SLEEP DISORDER (non-serious), EATING DISORDER (non-serious), TEMPERATURE REGULATION DISORDER (non-serious), outcome "unknown" and all described as "message center no longer tells my body to sleep, eat, or how to adjust to temperature change". Clinical course was reported as follows: patient stated that covid19 vaccine ruined his life, the day after receiving it patient got VREPP, within months patient became autoimmune, resulting in cirrhosis of the liver, psoriasis, thrombosis, varices in esophagus and stomach, and not making enough platelets. Patient stated vaccine made message center no longer tells the body to sleep, eat, or how to adjust to temperature change.
Age: 27.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Abdominal pain, Diarrhoea, Nausea, Paraesthesia oral, Throat tightness
Clinical narrative: Employee had to administer their epi-pen  Additional information: Possible anaphylactic rxn after COVID and flu vax in vax clinic
Age: 27.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Employee had to administer their epi-pen  Additional information: Possible anaphylactic rxn after COVID and flu vax in vax clinic
Age: 75.0
Sex: M
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Back pain, Chest discomfort, Dyspnoea, Groin pain, Immediate post-injection reaction
Clinical narrative: Back pain; chest pressure/discomfort; Dyspnoea; Groin pain; Immediate post-injection reaction; Palpitations; This spontaneous case from United States, initially received on 08-Oct-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2791126-1), and concerns an elderly male patient.  Past medical history included hypertension, hyperlipidemia.  Administration of company suspect drug: On 16-Sep-2024, the patient received Fluad Quadrivalent for not reported, Dose regimen: not reported, Route of administration: Intramuscular, Anatomical location: Left arm. Lot number: 388478. CSL Seqirus Batch number unable to be matched.  Non-company suspect drugs: Abrysvo (RSV vaccine prot. subunit PreF 2v), Indication: not reported, Dose regimen: not reported, Route of administration: Intramuscular, Anatomical location: Left arm, Lot number: LN5485.  Adverse reactions/events and outcomes: On 16-Sep-2024, the patient experienced Back pain (outcome: Recovered / Resolved), chest pressure/discomfort (outcome: Recovered / Resolved), Dyspnoea (outcome: Recovered / Resolved), Groin pain (outcome: Recovered / Resolved), Immediate post-injection reaction (outcome: Recovered / Resolved), Palpitations (outcome: Recovered / Resolved). Patient reported having palpitations immediately after receiving both vaccines. He also reported having chest pressure/discomfort with radiation to back pain and groin, In addition to dyspnea. We had patient sit down and we were going to call Emergency Medical Services (EMS) for an ambulance. Patient stated he felt better, symptoms Improved. He refused medical care and left against medical advice.  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: All events were considered related.
Age: 75.0
Sex: M
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Palpitations
Clinical narrative: Back pain; chest pressure/discomfort; Dyspnoea; Groin pain; Immediate post-injection reaction; Palpitations; This spontaneous case from United States, initially received on 08-Oct-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2791126-1), and concerns an elderly male patient.  Past medical history included hypertension, hyperlipidemia.  Administration of company suspect drug: On 16-Sep-2024, the patient received Fluad Quadrivalent for not reported, Dose regimen: not reported, Route of administration: Intramuscular, Anatomical location: Left arm. Lot number: 388478. CSL Seqirus Batch number unable to be matched.  Non-company suspect drugs: Abrysvo (RSV vaccine prot. subunit PreF 2v), Indication: not reported, Dose regimen: not reported, Route of administration: Intramuscular, Anatomical location: Left arm, Lot number: LN5485.  Adverse reactions/events and outcomes: On 16-Sep-2024, the patient experienced Back pain (outcome: Recovered / Resolved), chest pressure/discomfort (outcome: Recovered / Resolved), Dyspnoea (outcome: Recovered / Resolved), Groin pain (outcome: Recovered / Resolved), Immediate post-injection reaction (outcome: Recovered / Resolved), Palpitations (outcome: Recovered / Resolved). Patient reported having palpitations immediately after receiving both vaccines. He also reported having chest pressure/discomfort with radiation to back pain and groin, In addition to dyspnea. We had patient sit down and we were going to call Emergency Medical Services (EMS) for an ambulance. Patient stated he felt better, symptoms Improved. He refused medical care and left against medical advice.  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: All events were considered related.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Confusional state
Clinical narrative: confusion, tremulousness, weakness
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Asthenia, Confusional state, Full blood count, Metabolic function test, Tremor
Clinical narrative: confusion, tremulousness, weakness
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Urine analysis
Clinical narrative: confusion, tremulousness, weakness
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3, UNK
Symptoms: Blood pressure decreased, Bone pain, Dyspnoea, Flushing, Hypersensitivity
Clinical narrative: anaphylaxis; facial swelling; mouth swelling; bone pain; Initial information received on 04-Oct-2024 regarding an unsolicited valid serious case received from patient.  This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 Vaccine for Immunisation.  On 10-Sep-2024, the patient received unknown dose of suspect influenza trivalent recombinant vaccine (Solution for injection) (Frequency: once), (Strength: standard) (lot number and expiry date not reported) via unknown route in the right arm for immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 10-Sep-2024, 2 and half hours later the patient developed a serious anaphylaxis (anaphylactic reaction) following the administration of influenza trivalent recombinant vaccine.   In Sep-2024, the patient developed symptoms of facial swelling (swelling face), mouth swelling and bone pain following the administration of influenza trivalent recombinant vaccine.  Reportedly, patient went to the ER (emergency room) and they treated her for suspected allergic reaction. And the next day, patient had another anaphylaxis episode and got admitted to the hospital and for like the two weeks after that, she got discharged from the hospital then a few days later, patient had to go to the ER again because her face and mouth were swelling. Since then she been to the ER four times. She was working with an Allergist to try to calm down the inflammation.   Action taken was not applicable.  The patient was treated with 60mg of Prednisone per day, four Zyrtec and two Famotidine for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.  Seriousness criteria: The event was assessed as medically significant. The patient was hospitalized.; Sender's Comments: Sanofi company comment dated 21-Oct-2024: This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV]. The patient information regarding underlying conditions, past medical treatment(s), past vaccination(s), family history would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3, UNK
Symptoms: Pain in jaw, Pharyngeal swelling, Sinus pain, Swelling face, Wheezing
Clinical narrative: anaphylaxis; facial swelling; mouth swelling; bone pain; Initial information received on 04-Oct-2024 regarding an unsolicited valid serious case received from patient.  This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 Vaccine for Immunisation.  On 10-Sep-2024, the patient received unknown dose of suspect influenza trivalent recombinant vaccine (Solution for injection) (Frequency: once), (Strength: standard) (lot number and expiry date not reported) via unknown route in the right arm for immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 10-Sep-2024, 2 and half hours later the patient developed a serious anaphylaxis (anaphylactic reaction) following the administration of influenza trivalent recombinant vaccine.   In Sep-2024, the patient developed symptoms of facial swelling (swelling face), mouth swelling and bone pain following the administration of influenza trivalent recombinant vaccine.  Reportedly, patient went to the ER (emergency room) and they treated her for suspected allergic reaction. And the next day, patient had another anaphylaxis episode and got admitted to the hospital and for like the two weeks after that, she got discharged from the hospital then a few days later, patient had to go to the ER again because her face and mouth were swelling. Since then she been to the ER four times. She was working with an Allergist to try to calm down the inflammation.   Action taken was not applicable.  The patient was treated with 60mg of Prednisone per day, four Zyrtec and two Famotidine for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.  Seriousness criteria: The event was assessed as medically significant. The patient was hospitalized.; Sender's Comments: Sanofi company comment dated 21-Oct-2024: This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV]. The patient information regarding underlying conditions, past medical treatment(s), past vaccination(s), family history would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3, UNK
Symptoms: Anaphylactic reaction, Bone pain, Hypersensitivity, Inflammation, Mouth swelling
Clinical narrative: anaphylaxis; facial swelling; mouth swelling; bone pain; Initial information received on 04-Oct-2024 regarding an unsolicited valid serious case received from patient.  This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 Vaccine for Immunisation.  On 10-Sep-2024, the patient received unknown dose of suspect influenza trivalent recombinant vaccine (Solution for injection) (Frequency: once), (Strength: standard) (lot number and expiry date not reported) via unknown route in the right arm for immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 10-Sep-2024, 2 and half hours later the patient developed a serious anaphylaxis (anaphylactic reaction) following the administration of influenza trivalent recombinant vaccine.   In Sep-2024, the patient developed symptoms of facial swelling (swelling face), mouth swelling and bone pain following the administration of influenza trivalent recombinant vaccine.  Reportedly, patient went to the ER (emergency room) and they treated her for suspected allergic reaction. And the next day, patient had another anaphylaxis episode and got admitted to the hospital and for like the two weeks after that, she got discharged from the hospital then a few days later, patient had to go to the ER again because her face and mouth were swelling. Since then she been to the ER four times. She was working with an Allergist to try to calm down the inflammation.   Action taken was not applicable.  The patient was treated with 60mg of Prednisone per day, four Zyrtec and two Famotidine for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.  Seriousness criteria: The event was assessed as medically significant. The patient was hospitalized.; Sender's Comments: Sanofi company comment dated 21-Oct-2024: This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV]. The patient information regarding underlying conditions, past medical treatment(s), past vaccination(s), family history would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3, UNK
Symptoms: Swelling face
Clinical narrative: anaphylaxis; facial swelling; mouth swelling; bone pain; Initial information received on 04-Oct-2024 regarding an unsolicited valid serious case received from patient.  This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 Vaccine for Immunisation.  On 10-Sep-2024, the patient received unknown dose of suspect influenza trivalent recombinant vaccine (Solution for injection) (Frequency: once), (Strength: standard) (lot number and expiry date not reported) via unknown route in the right arm for immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 10-Sep-2024, 2 and half hours later the patient developed a serious anaphylaxis (anaphylactic reaction) following the administration of influenza trivalent recombinant vaccine.   In Sep-2024, the patient developed symptoms of facial swelling (swelling face), mouth swelling and bone pain following the administration of influenza trivalent recombinant vaccine.  Reportedly, patient went to the ER (emergency room) and they treated her for suspected allergic reaction. And the next day, patient had another anaphylaxis episode and got admitted to the hospital and for like the two weeks after that, she got discharged from the hospital then a few days later, patient had to go to the ER again because her face and mouth were swelling. Since then she been to the ER four times. She was working with an Allergist to try to calm down the inflammation.   Action taken was not applicable.  The patient was treated with 60mg of Prednisone per day, four Zyrtec and two Famotidine for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.  Seriousness criteria: The event was assessed as medically significant. The patient was hospitalized.; Sender's Comments: Sanofi company comment dated 21-Oct-2024: This case involves a 24 years old female patient who experienced anaphylaxis after receiving influenza trivalent recombinant vaccine [Flublok TIV]. The patient information regarding underlying conditions, past medical treatment(s), past vaccination(s), family history would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/ No PQC."; HCP called to report TE where products were administered after stored improperly.; This spontaneous report was received from a licensed practical nurse referring to a 8 year old patient of unknown gender. The patient's historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On 26-SEP-2024, the patient was vaccinated with improperly stored dose (Product storage error) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter,  lot # Y012074, expiration date 05-JAN-2026 (also reported as: 02-FEB-2026, conflicting information) (strength, dose number, route and anatomical location were not provided) for prophylaxis.  The temperature excursion of the vaccines was: 0 hours 44 minutes 0 seconds in -8.25°C (current)  and it was reported the following temperature excursion as prior:  0 hours 30 minutes 0 seconds in -11.25°C 0 hours 30 minutes 0 seconds in -11.63°C 0 hours 44 minutes 0 seconds in -8.69°C 0 hours 36 minutes 0 seconds in -9.63°C  No adverse event was reported.; Sender's Comments:  US-009507513-2410USA003525:MSD US-009507513-2410USA003178: US-009507513-2410USA003188: