chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, FLUC3
Symptoms: Product administration error, Vaccination site pain
Clinical narrative: Sore arm at injection site; Got Flucelvax in the same left arm at the same time as Comirnaty; This spontaneous case was received on 26-Oct-2023 from Seqirus via Pfizer (reference number: 202300322326), reported by other non-healthcare professional (consumer) and concerned a patient of an unreported age and gender.   The patient's concurrent conditions included penicillin allergy. The patient's concomitant medications were not reported.    On 08-Oct-2023 at 10:30 am, the patient was vaccinated with the fifth dose of a non-company, co-suspect Comirnaty vaccine (tozinameran; anatomical location: left arm, dose, route of administration and indication: not reported). The batch number was not reported.  On the same date, at the same time as reported, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm, dose, route of administration and indication: not reported) (explicitly coded as 'Product administration error'). The batch number was not reported.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Comirnaty, the patient experienced a sore arm at the injection site.   At the time of initial reporting, the patient was recovering from the event of 'vaccination site pain'.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine.; Sender's Comments: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction; Rash in arm, legs, trunk, face and hair; This spontaneous case from was received on 02-Nov-2023 from other non-healthcare professional via Agency (reference number SEQW23-03981) and concernes a 76-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 11-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 mL, route of administration and anatomical location: not reported) for influenza immunization. The batch number reported was 371635.  On the same date, the patient was also vaccinated with non-company co-suspect Covid-19 vaccine (manufacturer unknown; dose, route of administration and indication: not reported). The batch number was not reported.  On an unspecified date (15-Oct-2023 or 16-Oct-2023), four or five days after receiving the vaccines, as reported, the patient developed a rash in the arm, legs, trunk, face, and hair. The patient also reported that she thought she might have had an allergic reaction to Fluad vaccine. The patient used calamine lotion and Benadryl (diphenhydramine hydrochloride) as a treatment.  The outcome of the events 'allergic reaction' and 'rash all over' was not reported.   The reporter considered the event 'allergic reaction' as related to Fluad Quadrivalent. The reporter did not provide a causality assessment for the event 'rash all over'.   The case was assessed as non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Large intestine perforation, White blood cell count increased
Clinical narrative: SUMMARY OF PATIENT PROGRESS:   STATUS: Progressing as expected towards goals - continuing present plan   Primary Problem: DIVERTICULITIS OF SIGMOID W PERFORATION   Key findings related to primary problem: T 99.3, WBC 12.4, IV Ceftriaxone & Metronidazole, maintenance IVF.  NPO x meds, denies N/V/abd pain at this time.  Abdomen soft, tender to touch, guarded, bowel sounds hypoactive.  ERAS interventions, CHG wipe.   Other key findings: Patient seen at least every hour by nursing staff (or assigned designees) throughout the shift.   Covid detected, notified Dr., implemented Enhanced Respiratory & Contact Precautions.           Note Details  Author (R.N.) File Time 10/29/2023  7:54 PM Author Type REGISTERED NURSE Status Signed Last Editor (R.N.) Specialty GENERAL, OTHER Admit Date 10/29/2023 ED to Hosp-Admission (Discharged) on 10/29/2023     ED to Hosp-Admission (Discharged) on 10/29/2023       Detailed Report     Note shared with patient
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Swelling and redness measuring up to approximately 4 inches in diameter, excessive itching and pain on right arm. Swelling and redness measuring up to 3 inches in diameter. excessive itching and pain.  Onset of symptoms were about 24 hrs after receiving vaccines.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient developed muscle pain on the right side of her hip. Patient went to urgent care and is prescribed Cyclobenzaprine.
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: red itchy bumps on belly and chest.  No reation on arm or injection site.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt was seen in clinic to get influenza and COVID vaccine. MA drew up COVID vaccine from a SDV that was labeled as 0.25ml which was the appropriate dose for her age. COVID and flu vaccine was administered. Later, RN was drawing up 2 move COVID vaccines for 2 other pts under ages 12years and found that there was more that 0.25ml in SDV labeled as 0.25ml. RN called Moderna the manufacturer and representative did confirm that they are overfilling this SDV more that 0.25ml to ensure that when drawing up, pt gets the full amount of 0.25ml. Representative was not able to tell RN the exact amount that each vial contains but did start a case on this. Pts mom and dad contacted communicated that pt could have received more than 0.25ml appropriate dose. RN had mom and dad observe pt injection site and there were no issues noted at this time. RN educated mom and dad to come into clinic for any concerns to local site reaction such as redness, heat or hardening to site. Educated to take pt to ER for evaluation for any systemic reaction to include; trouble breathing, swelling to throat, tongue, eyes, trouble swallowing, hives etc. Mom and dad verbalized understanding. RN communicated that RN will f/u with mom and dad on Monday to check on pt status.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site pain, Oedema peripheral
Clinical narrative: Vaccine was given in the right arm. Patient reports onset of posterior right shoulder pain the evening of the vaccination and the next day woke up with right hand edema and numbness.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pleural effusion
Clinical narrative: PT REPORTS TROUBLE BREATHING, CHEST TIGHTNES, FLUID IN THE LUNGS
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: Shingrix 1st dose given 9/29/23; Pt 2nd dose supposed to be on or after 11/29/23 (2 months after 1st dose). However, 2nd dose was given on 11/2/23 instead. When administering RPH check system for vaccination history, RPH wrote down 1st vaccination date incorrectly as 8/29/23 instead of 9/29/23.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Feeling hot, Injection site bruising, Injection site discolouration, Injection site erythema
Clinical narrative: I received the flu shot of Sunday morning at pharmacy  and on Monday afternoon on the left arm to the right of and well below the injection site an initially small and later larger red area appeared. In addition, tiredness ensued all the subsequent days and today I have felt feverish and with general body malaise despite not having a temperature. The actual injection site is still bruised looking and the red area is , despite application of otc cortisone cream, still discolored. My concern is that it would appear in all I have read that the side effects should go away in 2-3 days.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Malaise
Clinical narrative: I received the flu shot of Sunday morning at pharmacy  and on Monday afternoon on the left arm to the right of and well below the injection site an initially small and later larger red area appeared. In addition, tiredness ensued all the subsequent days and today I have felt feverish and with general body malaise despite not having a temperature. The actual injection site is still bruised looking and the red area is , despite application of otc cortisone cream, still discolored. My concern is that it would appear in all I have read that the side effects should go away in 2-3 days.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angioedema, Urticaria
Clinical narrative: Urticaria, angioedema High dose antihistamines (Allegra), Pepcid, steroids Outcome is TBD
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient stated she developed a rash on her neck 48 hours after receiving spikevax with no other symptoms
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue
Clinical narrative: I have been feeling fatigue and faint since receiving the vaccine. I feel like I am going to pass out. I feel this way sitting, standing, and laying .  It?s been 11 days and I?m still not feeling better.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received moderna instead of Pfizer as recommended.
Age: 31.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Vasovagal syncope post vaccination (Tdap, Hep A- 1, TY- IM). Pt responded well to Vx administration in clinic room prior to walking out to waiting area. In waiting area Pt felt lightheaded so I had her sit in a chair, then I got her a cold pack. She sat there for another minute and I coached her to take slow, deep breaths. She then went limp while seated in the chair and was briefly nonresponsive. I called for help and 2 people came to the waiting area to assist. When 1 arrived the pt was already recovering and she brought her a juice to drink. I stayed with the pt for several more minutes to ensure her stability and check HR and RR (both WNL). I had the pt stay in the waiting area another 15 minutes rechecking her several times before walking she and her husband out of the dept. The pt stated after the fact that she has had syncopal episodes previously with Vx administration. (Her screening Dx was checked no for serious vaccine reactions and when asked prior to Vx administration pt stated that there were no previous issues with Vx.)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: I had had this before with the first vaccine in my arm so I have to do it in my leg now but I think it's important you log people have this issue as it's extremely hard to find a pharmacy or doctor that will inject in the thigh for an adult and this is the only place I can get it. My injection site becomes inflamed so much so I can see the tissue bulking. The actual injection spot has no issues, it's just the tissue under has very strong reaction. Previously when this happened in my arm, it caused so much Inflammation that I couldn't lift my arm for over 6 months, had to get an MRI, and finally got a steroid injection that countered it. So, this vaccine does cause severe inflammation but when given in my leg it can be tolerated and is just painful,  bulky, and hot to touch but I'm confident it will go away unlike if given in my arm where causes a chain reaction of inflammation.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Transient global amnesia
Clinical narrative: on 10-11-23 patient was hospitalized in the Emergency room and was diagnosed with "transient global amnesia". patient had short term memory loss for duration of 2 hours. For reference the patient got comirnaty pfizer covid shot for the first time on 10-4-23. patient reports no drug allergies and no other side-effects to durgs/ vaccines in the past. The patient's wife reported her husband's side-effects to the pharmacist who then reported event in vaers.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram ambulatory, Eye injury, Fatigue
Clinical narrative: BRAO-branch retinal artery occlusion - October 4, 2022 Event history:  while on vacation in October 2022, I noticed an issue with my left eye.  At first I thought I had something IN my eye, then on the second day, when it was still there I thought maybe I had scratched my eye.  I called my dr. office, described my symptoms to see if flying home was a safe idea.  I knew the symptoms for a detached retina and it was not those.  I was advised that they felt it was safe to fly home on the Wednesday and attend their office on the Friday of that same week for an exam.  When I got up Thursday a.m., I called my optometrist as I assumed I would be referred there for an appointment after the dr. appointment on Friday.  They requested I come in right after lunch, which I did.  I experienced no headache, no blurred vision or other symptoms while on this trip.  We did leave VERY early on our flight out, and had written off any ill-feeling to just being tired.  When I returned home I saw my optometrist on the Thursday, gp on the Friday.  It turns out I?d had a ?stroke? in my left eye and it has left me with some permanent damage ? causing partial blindness.  It may get worse, nobody knows.  I?ve been checking in with my ophthalmologist regularly and have been advised there is no pill, surgery or hope of fixing the damage that has happened.  Apparently, this condition is something they usually see in males - 80 year olds.  It is called BRAO ? Branch Retinal Artery Occlusion.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise, Retinal artery occlusion, Visual impairment, X-ray
Clinical narrative: BRAO-branch retinal artery occlusion - October 4, 2022 Event history:  while on vacation in October 2022, I noticed an issue with my left eye.  At first I thought I had something IN my eye, then on the second day, when it was still there I thought maybe I had scratched my eye.  I called my dr. office, described my symptoms to see if flying home was a safe idea.  I knew the symptoms for a detached retina and it was not those.  I was advised that they felt it was safe to fly home on the Wednesday and attend their office on the Friday of that same week for an exam.  When I got up Thursday a.m., I called my optometrist as I assumed I would be referred there for an appointment after the dr. appointment on Friday.  They requested I come in right after lunch, which I did.  I experienced no headache, no blurred vision or other symptoms while on this trip.  We did leave VERY early on our flight out, and had written off any ill-feeling to just being tired.  When I returned home I saw my optometrist on the Thursday, gp on the Friday.  It turns out I?d had a ?stroke? in my left eye and it has left me with some permanent damage ? causing partial blindness.  It may get worse, nobody knows.  I?ve been checking in with my ophthalmologist regularly and have been advised there is no pill, surgery or hope of fixing the damage that has happened.  Apparently, this condition is something they usually see in males - 80 year olds.  It is called BRAO ? Branch Retinal Artery Occlusion.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Device malfunction, Exposure via skin contact, No adverse event, Underdose
Clinical narrative: NO ADVERSE EVENT OCCURED.  DOSE WAS DRAWN UP CORRECTLY (0.5ML.)  THERE WAS A MALFUNCTION OF THE SYRINGE/NEEDLE.  MOST OF THE DOSE WAS EXPELLED DOWN THE ARM OF PATIENT.  THE NEEDLE DID PENETRATE THE ARM.  THERE WAS NO WAY OF KNOWING HOW MUCH ACTUALLY WENT INTO THE PATIENTS RIGHT DELTOID.   MY RECOMMENDATION WAS THAT MOST DID NOT GET IN THE MUSCLE.  MOM DID NOT WANT US TO REDOSE UNTIL SHE HAD A CHANCE TO DISCUSS WITH PEDIATRICIAN.  SHE WILL BE IN CONTACT WITH ME ON MONDAY 11/6/2023 TO GIVE ME A NAME OF A PEDIATRICIAN TO CONTACT AT HOSPITAL.  PATIENT WAS VERY NERVOUS AND TENSE BEFORE GIVING THE VACCINE AND BOTH PARENTS WERE ATTEMPTING TO HOLD PATIENT WHILE THE SHOT WAS ADMINISTERED.  THE ISSUE SEEMED TO BE A FAULTY SYRINGE/NEEDLE.  WE WERE NOT AWARE OF HOW MUCH OF THE VACCINE WAS ACTUALLY GIVEN THROUGH THE IM NEEDLE.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Eczema, Rash
Clinical narrative: Eczema got inflamed, rashes appeared on both forearms days 2 to 4. Rashes appeared on back days 4 to 7. Rashes appeared on shoulders and legs days 5 to 7. Rashes are continuing on shoulders, leg, and back.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Intensive care, Pharyngeal swelling
Clinical narrative: Pt was driving and was having a hard time swallowing, took some benadryl while waiting for husband then went to ER.  Ended up in ICU for 24 hours with severe reaction of throat swelling.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Patient claimed that after receiving the Spikevax  Moderna vaccine on October 19, 2023, 8 days later he experienced facial paralysis ("per patient Bell's palsy") and when to see an MD for treatment.  Patient is currently taking Acyclovir and Prednisone for 5 days. Will follow-up with primary care MD afterwards.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: I've had a sudden onset of tachycardia, with dizziness, difficulty breathing, and pain in my chest. So far after going to the doctor, they have not been able to find the cause. It was at one of these appointments that I was talking to a nurse at let me know other women have been through with similar problems and it might be do to the vaccine. In the case that it is caused by the vaccine I wanted to report it in some way. From the experience I've had not be taken seriously about my symptoms, I could understand that it may be something that is under reported in women in particular.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Tachycardia
Clinical narrative: I've had a sudden onset of tachycardia, with dizziness, difficulty breathing, and pain in my chest. So far after going to the doctor, they have not been able to find the cause. It was at one of these appointments that I was talking to a nurse at let me know other women have been through with similar problems and it might be do to the vaccine. In the case that it is caused by the vaccine I wanted to report it in some way. From the experience I've had not be taken seriously about my symptoms, I could understand that it may be something that is under reported in women in particular.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU4, PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Overnight the night after vaccination, patient reports the site of Spikevax (covid-19) vaccination became locally red, swollen, and itchy.  She tried Advil which provided marginal relief.  Over the following two days she reports that the swelling has slowly improved but the red area somewhat spread, on 11/3 appears roughly the diameter of a tennis ball.  Counseled patient to continue to montior and symptomatically treat; that this is not unheard of.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Patient reports loss of taste and smell shortly after vaccination. As of 11/3/23, he still has not recovered taste or smell.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: No pain at injection time, raised bump and sore arm have now continued a week affecting sleep and some day to day movements
Age: 21.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse    I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Patient came in on 11/02/2023 saying her shoulder has been hurting since the vaccine and is not getting any better over time. She was advised to go to her local doctor for evaluation. She said she had been taking Motrin but it is not helping.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse  I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse   I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUA4, VARZOS
Symptoms: Contusion, Inflammation, Peripheral swelling, Wrong product administered
Clinical narrative: patient accidentally received a moderna(spikevax) vaccine. called pharmacy and wanted to talk to manager. I was not in work until 11/2/23 and called patient that day and patient stated that she had a swollen/inflammation to arm last week, but now it is just bruised.
Age: 48.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Blood test, Cardiac monitoring, Chest X-ray, Chills
Clinical narrative: Heart pounded, chills, sweats, nausea, aches, shaky,  muscle weakness, shortness of breath, felt like someone was squeezing my upper body, increased blood pressure. Started first night, heart pounding lessened over next few days. Five days after injection heart wouldn't quit pounding. Went to ER
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Hyperhidrosis, Muscular weakness, Nausea, Nervousness
Clinical narrative: Heart pounded, chills, sweats, nausea, aches, shaky,  muscle weakness, shortness of breath, felt like someone was squeezing my upper body, increased blood pressure. Started first night, heart pounding lessened over next few days. Five days after injection heart wouldn't quit pounding. Went to ER
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Palpitations, Sensory disturbance, Urine analysis
Clinical narrative: Heart pounded, chills, sweats, nausea, aches, shaky,  muscle weakness, shortness of breath, felt like someone was squeezing my upper body, increased blood pressure. Started first night, heart pounding lessened over next few days. Five days after injection heart wouldn't quit pounding. Went to ER
Age: 31.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
Age: 42.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Canalith repositioning procedure, Therapy non-responder, Vertigo
Clinical narrative: I got the moderna spikevax and my seasonal flu shot at the same time in my arm. I woke up with vertigo at 3:22 am the next day and it has not gone away almost three days later. I have never had vertigo.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: PATIENT STARTED EXPERIENCING EXCESSIVE SWEATING /FEVER THE 2ND DAY AFTER GETTING VACCINE, GENERALIZED BODY ACHES, CHILLS AND EXTREME TIREDNESS- SHE ALSO EXPERIENCED NUMBNESS IN HER LEGS . SHE IS FEELING BETTER TODAY BUT STILL VERY TIRED
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: PATIENT STARTED EXPERIENCING EXCESSIVE SWEATING /FEVER THE 2ND DAY AFTER GETTING VACCINE, GENERALIZED BODY ACHES, CHILLS AND EXTREME TIREDNESS- SHE ALSO EXPERIENCED NUMBNESS IN HER LEGS . SHE IS FEELING BETTER TODAY BUT STILL VERY TIRED
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Headache, Pyrexia
Clinical narrative: fever: Tmax= 103.3 F  chills, rigors disorientation headache
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: From no pain, gradually to severe bilateral shoulder pain, a few hours after injection.  Vaccine administered in L deltoid, which became increasingly sore with increased limited range of motion.  R shoulder more painful (7 or 8 on scale of 1 to 10) both at rest and with movement, normal range of motion not possible without severe pain (8 or 9), and difficulty getting comfortable or sleeping.  This is the most my tendinosis has ever hurt throughout the night and most of the next day.  Pain at rest has improved to about a 3 level.  But currently, raising arm forward above 20 degrees without changing movement pattern or assistance is not tolerated.  I had been looking forward to completing a long-held physical goal next week (on my birthday), which I had been working toward for most of the year, but now will be impossible, so I am also extremely disappointed.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: From no pain, gradually to severe bilateral shoulder pain, a few hours after injection.  Vaccine administered in L deltoid, which became increasingly sore with increased limited range of motion.  R shoulder more painful (7 or 8 on scale of 1 to 10) both at rest and with movement, normal range of motion not possible without severe pain (8 or 9), and difficulty getting comfortable or sleeping.  This is the most my tendinosis has ever hurt throughout the night and most of the next day.  Pain at rest has improved to about a 3 level.  But currently, raising arm forward above 20 degrees without changing movement pattern or assistance is not tolerated.  I had been looking forward to completing a long-held physical goal next week (on my birthday), which I had been working toward for most of the year, but now will be impossible, so I am also extremely disappointed.
Age: 4.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient lost conciousness for 2 seconds after covid & flu vaccine administration
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Pain
Clinical narrative: Sudden, extreme diarrhea and headache starting 6 hours after vaccine was given. I have body aches and overall feel absolutely terrible. It all came on super suddenly.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pt. reported extreme pain and difficulty range of motion less than 2 weeks after being vaccinated.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: the patient was given the covid vaccine. when mixing the diluent 2.2ml was used instead of the new protocol that indicates to use 1.1ml diluent to be used to mix.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Henoch-Schonlein purpura, Laboratory test normal
Clinical narrative: rash, swelling in joint and muscles, pain in abdomen, terrible pain in his legs causing him to not be able to do simple tasks like walking, swollen hands and feet, swelling on face, dx with HSP, ongoing symptoms for almost a month
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abdominal pain, Blood test, Gait inability, Henoch-Schonlein purpura, Joint swelling
Clinical narrative: rash, swelling in joint and muscles, pain in abdomen, terrible pain in his legs causing him to not be able to do simple tasks like walking, swollen hands and feet, swelling on face, dx with HSP, ongoing symptoms for almost a month
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Loss of personal independence in daily activities, Muscle swelling, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: rash, swelling in joint and muscles, pain in abdomen, terrible pain in his legs causing him to not be able to do simple tasks like walking, swollen hands and feet, swelling on face, dx with HSP, ongoing symptoms for almost a month
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Swelling face, Urine analysis
Clinical narrative: rash, swelling in joint and muscles, pain in abdomen, terrible pain in his legs causing him to not be able to do simple tasks like walking, swollen hands and feet, swelling on face, dx with HSP, ongoing symptoms for almost a month
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Oropharyngeal pain, Product administered to patient of inappropriate age
Clinical narrative: I CAN DEAL WITH A SORE THROAT, STATEMENT NOT FURTHER CLARIFIED; POTENTIAL OFF LABEL USE,  PATIENT STATED HE IS 74 YEARS OLD AND IT WAS NOT CLARIFIED IF PATIENT HAS RECEIVED FLUMIST; A spontaneous report has been received from a consumer. The report concerns a male patient of Unknown ethnic origin (age 74 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Male    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on an unknown date. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.   No malfunction has been reported for FLUMIST QUADRIVALENT.    The report described off-label use for Flumist Quadrivalent and Flumist Quadrivalent. The reported term was potential off label use,  patient stated he is 74 years old and it was not clarified if patient has received flumist (Preferred term: Off label use). On an unknown date, the patient experienced i can deal with a sore throat, statement not further clarified (preferred term: Oropharyngeal pain).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v) and Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of i can deal with a sore throat, statement not further clarified and potential off label use,  patient stated he is 74 years old and it was not clarified if patient has received flumist was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 03-Nov-2023: Applicable null flavors added for both events. valid null flavors to State field for Reporter 7 added. Narrative amended.
Sex: M
Vaccine: TYP
Symptoms: Foreign body in throat
Clinical narrative: Second dose of Vivotif got stuck in throat; A spontaneous report was received from a male patient of unknown age on 03OCT2023 whose "second dose of Vivotif got stuck in throat" (PT: Foreign body in throat). The patient took oral Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for typhoid prophylaxis.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the first dose of Vivotif and read that it was not supposed to be taken with alcohol for two hours. Further, the second dose of Vivotif got stuck in the throat of the patient for the first hour and then when the patient had food the medication went down. Reportedly, the patient completed the typhoid fever pills course.  The patient recovered from the reported event on an unknown date.  No action was taken with Vivotif with respect to the reported event.  No additional information was reported.  Company comment: It was reported that a consumer's second dose of Vivotif got stuck in throat (foreign body in throat) for the first hour and then when the patient had food the medication went down. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of foreign body in throat is assessed as possible. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer's second dose of Vivotif got stuck in throat (foreign body in throat) for the first hour and then when the patient had food the medication went down. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of foreign body in throat is assessed as possible. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Vomiting; A spontaneous report was received from a nurse on 18OCT2023 regarding a female patient of unknown age who had "vomiting" (PT: Vomiting) following the administration of Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003850) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 14OCT2023, the patient took the first dose of Vivotif followed by the second dose on 16OCT2023. Reportedly, the patient did not have any side effects with either of the first two doses. However, on 18OCT2023, the morning when the patient woke up, she had an episode of vomiting and later she felt better. A while later, on the same date, the patient took the third dose of Vivotif and after 45 minutes she again had an episode of vomiting. The patient did not see the capsule and did not look for it either as there was a 45-minute interval between her taking the capsule and the episode of vomiting. Further, the patient was advised to take the fourth capsule on 20OCT2023.  The outcome of the reported event was unknown, at the time of this report.  No action was taken with Vivotif with respect to the reported event.  No additional information was reported.  Company comment: It was reported that a patient took a second dose of Vivotif on 16OCT2023 and had vomiting on the morning of 18OCT2023 when the patient woke up. Further on 18OCT2023, the patient again had an episode of vomiting after 45 minutes of taking the third dose of Vivotif. Considering a temporal association (between the onset of the event and Vivotif intake) and a known potential of Vivotif to cause vomiting, the causality for the above event is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took a second dose of Vivotif on 16OCT2023 and had vomiting on the morning of 18OCT2023 when the patient woke up. Further on 18OCT2023, the patient again had an episode of vomiting after 45 minutes of taking the third dose of Vivotif. Considering a temporal association (between the onset of the event and Vivotif intake) and a known potential of Vivotif to cause vomiting, the causality for the above event is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site pain
Clinical narrative: Upper left arm (injection site) very sore; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 24Oct2023 at 16:15 as dose 1, single (Lot number: HG4664) at the age of 48 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEXAPRO. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 24Oct2023 at 20:00, outcome "not recovered", described as "Upper left arm (injection site) very sore"; HEADACHE (non-serious) with onset 24Oct2023 at 20:00, outcome "not recovered". Therapeutic measures were not taken as a result of injection site pain, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: stuffed up head/my head is like I have a very bad cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "stuffed up head/my head is like I have a very bad cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Facial pain, Injection site erythema, Injection site swelling
Clinical narrative: fever 100.3F; chills; facial/jaw/teeth pain; facial/jaw/teeth pain; facial/jaw/teeth pain; arm pain; injection site redness and swelling; injection site redness and swelling; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Atopic dermatitis/Eczema" (unspecified if ongoing); "Atopic dermatitis/Eczema" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing); "known allergies:  Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious) with onset 26Oct2023 at 15:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 26Oct2023 at 18:00, outcome "recovering", described as "arm pain"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 26Oct2023 at 18:00, outcome "recovering" and all described as "injection site redness and swelling"; FACIAL PAIN (non-serious), PAIN IN JAW (non-serious), TOOTHACHE (non-serious) all with onset 26Oct2023 at 22:30, outcome "recovering" and all described as "facial/jaw/teeth pain"; CHILLS (non-serious) with onset 26Oct2023 at 23:30, outcome "recovering"; PYREXIA (non-serious) with onset 27Oct2023 at 16:00, outcome "unknown", described as "fever 100.3F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pyrexia. Therapeutic measures were not taken as a result of injection site erythema, injection site swelling, facial pain, pain in jaw, toothache, chills.  Additional information: the patient did not receive any other vaccine in four weeks. Other medications in two weeks included Natures medicine multivitamin. The patient used Tylenol for pain and fever management.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pain in jaw, Pyrexia, Toothache
Clinical narrative: fever 100.3F; chills; facial/jaw/teeth pain; facial/jaw/teeth pain; facial/jaw/teeth pain; arm pain; injection site redness and swelling; injection site redness and swelling; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Atopic dermatitis/Eczema" (unspecified if ongoing); "Atopic dermatitis/Eczema" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing); "known allergies:  Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious) with onset 26Oct2023 at 15:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 26Oct2023 at 18:00, outcome "recovering", described as "arm pain"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 26Oct2023 at 18:00, outcome "recovering" and all described as "injection site redness and swelling"; FACIAL PAIN (non-serious), PAIN IN JAW (non-serious), TOOTHACHE (non-serious) all with onset 26Oct2023 at 22:30, outcome "recovering" and all described as "facial/jaw/teeth pain"; CHILLS (non-serious) with onset 26Oct2023 at 23:30, outcome "recovering"; PYREXIA (non-serious) with onset 27Oct2023 at 16:00, outcome "unknown", described as "fever 100.3F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pyrexia. Therapeutic measures were not taken as a result of injection site erythema, injection site swelling, facial pain, pain in jaw, toothache, chills.  Additional information: the patient did not receive any other vaccine in four weeks. Other medications in two weeks included Natures medicine multivitamin. The patient used Tylenol for pain and fever management.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid from 20Oct2023 to 25Oct2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350855 Same patient, different drug/AE;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 16Oct2023 to 21Oct2023. Clinical Course: Patient had recovered from covid was testing negative. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350751 same patient, different drug/event;
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: SERTRALINE, start date: 01Jan2010, stop date: 30Oct2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 21Oct2023 to 25Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352131 Same reporter/patient, different drug, different event.;