chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: she states that she is calling about a patient who received two flu shots a month with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient and the reporter reports she states that she is calling about a patient who received two flu shots influenza quadrival A-B vaccine [fluzone QIV]. a month with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, lot number, expiry date, route, administration site: unknown) for Prophylactic Vaccination (immunization) and she states that she is calling about a patient who received two flu shots a month with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Reportedly, She states that she is calling about a patient who received two flu shots a month or so apart and she would like to know if there are any side effects to watch out for. The caller was asked what flu shot the patient received and if both were Fluzone Quadrivalent but it was unclear and she states that they had a message about a patient who was seen today who received a flu shot and they are in a group home and they received a flu shot in the last month or so.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: 8 patients received the expired tenivac with no reported adverse event; Initial information received from on 14-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received the expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jun-2023, the patient received an expired dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No preservative Adult Suspension for injection (lot U7092AA, Expiry date: 24-Jun-2023, with unknown strength and dose) via unknown route in unknown administration site as prophylactic vaccination with no reported adverse event (expired product administered) (Latency: same day).  It was reported "Caller clarified that a total of 8 patients received the expired Tenivac, but she does not have any patient information at this time."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: Patient reported redness and swelling at the site starting on 10/31/23 up until 11/17. As well as pain and a bad burning sensation in the arm occasionally going up to the shoulder.  Also, her legs are experiencing severe trolly horses especially at night involving my entire legs. It is both of them sometimes a burning.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cerebrovascular accident, Disturbance in attention, Eyelid ptosis, Fatigue
Clinical narrative: SEREVE STROKE, SPENT 4 DAYS IN THE HOSPITAL, IM VERY TIRED ALL THE TIME , CANT CONCENTRATE ON THINGS, CANT REMEMEBER ANYTHING, RIGHT EYE IS DROOPY
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: SEREVE STROKE, SPENT 4 DAYS IN THE HOSPITAL, IM VERY TIRED ALL THE TIME , CANT CONCENTRATE ON THINGS, CANT REMEMEBER ANYTHING, RIGHT EYE IS DROOPY
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No symptoms as of yet
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: Patient was given a dose of Kinrex (combination of Dtap and Polio) and a separate dose of Polio.  Vaccine staff thought Kinrex vaccine contained only Dtap.  Patient received 2 doses of Polio vaccine. No reaction observed or reported.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Vaccine error: An MA accidentally administered a Pfizer COVID vaccine 6M- 4Y (a multiple dose vial, which makes 3 doses after dilution) to a 5-year-old patient.
Age: 62.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Pain in extremity, Sciatica, Therapy non-responder
Clinical narrative: Severe sciatic nerve pain in right leg within 24 hours of vaccine. Doctor had no answer other than physical therapy, which was ineffective. Symptoms continued for 18 months, then went away within a few days.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: NO SYMPTOMS AS OF YET
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: small red welts on outside of arm pits, on breast bone and inside of elbows and very itchy on scrotum
Age: 5.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: Patient received vaccine Kinrix (combination of Dtap and Polio) and a separate IPOL (Polio) vaccine.  Staff thought Kinrix vaccine only contained vaccine for Dtap.  Patient received 2 doses of Polio.  No reaction was observed or reported.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Death
Clinical narrative: Patient's wife came into the pharmacy on 11/20/23 between 2:30-3:00pm and stated that her husband received the covid vaccine on 10/27/23. The next morning 10/28/23 blisters started forming on his hands and feet. They went to the clinic then to the hospital to receive treatment. Patient died on 10/31/23.
Age: 68.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse events to report. Thought patient request the flu and RSV vaccines, but actually wanted COVID and RSV vaccines. Patient had previously gotten the flu shot at doctor's office.
Age: 63.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received Jynneos vaccine IM instead of SQ.
Age: 62.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Asthenia, Fatigue, Headache, Mobility decreased, Pain
Clinical narrative: I woke with a high fever (101) at midnight after getting the vaccinations at about 11 am. I ached all over so badly I could hardly lie down. I couldn't sit up longer than to urinate. The body aches felt like I had shingles all over my body. I also had a headache. I took Tylenol and my pain was reduced enough to go back to sleep for 5 hours. I repeated Tylenol every 6 hours through midnight of day two. My fever and severe body aches persisted through the next 32 hours. My fever broke and body aches subsided on day 3 at noon after the vaccinations. I still feel weak and wrung out but I'm on the mend. I had no treatment. I expected moderate to severe side effects.
Age: 62.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pyrexia
Clinical narrative: I woke with a high fever (101) at midnight after getting the vaccinations at about 11 am. I ached all over so badly I could hardly lie down. I couldn't sit up longer than to urinate. The body aches felt like I had shingles all over my body. I also had a headache. I took Tylenol and my pain was reduced enough to go back to sleep for 5 hours. I repeated Tylenol every 6 hours through midnight of day two. My fever and severe body aches persisted through the next 32 hours. My fever broke and body aches subsided on day 3 at noon after the vaccinations. I still feel weak and wrung out but I'm on the mend. I had no treatment. I expected moderate to severe side effects.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Poor quality product administered, Product preparation error
Clinical narrative: vial was found in box of priorix but the sterile diluent was only administered to patient. Patient mother was informed a month after since child had received an other live vaccine. Explain the situation to mother that child is not fully immunized since he did not get the medication mix. Mother is going to bring child back to immunized.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Swelling
Clinical narrative: Localized swelling and redness at the injection site starting 11/18/23, no better or worse on 11/19/23. Patient went to urgent care and was given Bactrim DS for injection site infection.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site induration
Clinical narrative: Severe headache lasting over 2 full days, severe body aches, fever of over 99.8 degrees, chills, minor temporary nausea, SEVERE, HOT, RED, PAINFUL LARGE HARDENED RASH measuring approx. 2.5" long by 3" wide at injection site.  Rash and related injection site symptoms continue presently over 4 days after vaccine. Headache and other symptoms were so severe that absolute bedrest was necessary for 2.5 days.  No appetite and no thirst.  Also, tech at Pharmacy did not provide me with the specific information form showing lot number or other required information.  She also dropped the vaccine on the floor. When asked if she was going to get a new one she did not comment and injected my arm with the vaccine.  On 11/19/23 I contacted the pharmacist at this facility and spoke to person and advised her of my adverse reaction as well as experience with tech and not receiving required paperwork.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Nausea, Pain
Clinical narrative: Severe headache lasting over 2 full days, severe body aches, fever of over 99.8 degrees, chills, minor temporary nausea, SEVERE, HOT, RED, PAINFUL LARGE HARDENED RASH measuring approx. 2.5" long by 3" wide at injection site.  Rash and related injection site symptoms continue presently over 4 days after vaccine. Headache and other symptoms were so severe that absolute bedrest was necessary for 2.5 days.  No appetite and no thirst.  Also, tech at Pharmacy did not provide me with the specific information form showing lot number or other required information.  She also dropped the vaccine on the floor. When asked if she was going to get a new one she did not comment and injected my arm with the vaccine.  On 11/19/23 I contacted the pharmacist at this facility and spoke to person and advised her of my adverse reaction as well as experience with tech and not receiving required paperwork.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst decreased, Wrong technique in product usage process
Clinical narrative: Severe headache lasting over 2 full days, severe body aches, fever of over 99.8 degrees, chills, minor temporary nausea, SEVERE, HOT, RED, PAINFUL LARGE HARDENED RASH measuring approx. 2.5" long by 3" wide at injection site.  Rash and related injection site symptoms continue presently over 4 days after vaccine. Headache and other symptoms were so severe that absolute bedrest was necessary for 2.5 days.  No appetite and no thirst.  Also, tech at Pharmacy did not provide me with the specific information form showing lot number or other required information.  She also dropped the vaccine on the floor. When asked if she was going to get a new one she did not comment and injected my arm with the vaccine.  On 11/19/23 I contacted the pharmacist at this facility and spoke to person and advised her of my adverse reaction as well as experience with tech and not receiving required paperwork.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Feeling abnormal, Influenza like illness, Pruritus, Pyrexia
Clinical narrative: He woke up the morning after getting the shot with a fever, flu like symptoms, and a few hives on his body. As the day went on, the hives got worse. On Thursday, 11/16, I called the dr. and took him back in because the hives were getting worse and really starting to itch. I gave him a dose of Benadryl before calling the doctor. Dr. did a strep test and sent us for a chest X-ray but didn't think the hives were a reaction to the flu shot. She called in 3 days of Prednisone 20mg Tab and he started taking those + Benadryl for the rest of the day. By 11:30 that night, the hives and itching were unbearable and my husband took him to the ER and he was given an IV with more Benadryl, more steroids, and Pepcid. On Friday 11/15, he was still miserable so we did a telemedicine visit with another doctor who prescribed another 2 days of steroids and said it would just need to run its course. We started adding another allergy medicine - xyzal - the the Benadryl and Pepcid and that seemed to help with some of the itching. On Sunday, 11/17, we did a on-call dermatologist appointment because the itching was still not getting any better and was prescribed Triamcinolon 0.1% Cream. We are now almost a week after the flu vaccine and the hives are still all over his body - neck, legs, back, arm pits, face, etc.  He is getting some relief from the Triamcinolon 0.1% Cream and we are still giving him Benadryl, Pepcid, and xyzal as directed.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Streptococcus test, Urticaria
Clinical narrative: He woke up the morning after getting the shot with a fever, flu like symptoms, and a few hives on his body. As the day went on, the hives got worse. On Thursday, 11/16, I called the dr. and took him back in because the hives were getting worse and really starting to itch. I gave him a dose of Benadryl before calling the doctor. Dr. did a strep test and sent us for a chest X-ray but didn't think the hives were a reaction to the flu shot. She called in 3 days of Prednisone 20mg Tab and he started taking those + Benadryl for the rest of the day. By 11:30 that night, the hives and itching were unbearable and my husband took him to the ER and he was given an IV with more Benadryl, more steroids, and Pepcid. On Friday 11/15, he was still miserable so we did a telemedicine visit with another doctor who prescribed another 2 days of steroids and said it would just need to run its course. We started adding another allergy medicine - xyzal - the the Benadryl and Pepcid and that seemed to help with some of the itching. On Sunday, 11/17, we did a on-call dermatologist appointment because the itching was still not getting any better and was prescribed Triamcinolon 0.1% Cream. We are now almost a week after the flu vaccine and the hives are still all over his body - neck, legs, back, arm pits, face, etc.  He is getting some relief from the Triamcinolon 0.1% Cream and we are still giving him Benadryl, Pepcid, and xyzal as directed.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: The patient scheduled an appointment for the meningococcal vaccine and requested the tdap prior to arriving at the pharmacy.  Mom stated that the patient would climb under the table and use to be very afraid of vaccines which I believe made him nervous. The patient reported that he had eggs a 1 and 1/2 prior to his vaccination. After the vaccination the patient stood up from a seated position and reported that he felt like he was dizzy. The patient was asked to sit in a chair with his head between his legs for a few minutes. The patient was provided cookies and water and checked on multiple times during his visit. The patient felt well at 1:30 and left with his mother to grab a bite to eat. I reviewed the package insert to verify that both vaccines may be administered together.
Age: 87.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received 2 vaccines around 2:40pm , after 2-3 hours she was shopping at store and felt like she was going to faint. She fainted at the register and the ambulance took her to the hospital. She informed us of this on Sunday and said her blood pressure was 77/___.  She couldn't remember the entire blood pressure. Per the patient, they gave her a bolus of saline. She told us the medical personnel thought she was dehydrated. She also informed us that she had only eaten 2 cookies that morning.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm very sore . hurt to lift up about 6 hours post vaccination and continues today (11/20/23) minor improvement but affected sleep. hurts to raise arm upwards still
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injected limb mobility decreased, Muscular weakness, Pain
Clinical narrative: Right shoulder pain x3 weeks, do not have full range of motion. Pain when lifting my arm. Slight weakness in that arm now.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine administered to adolescent patient during a well child child. Patient was supposed to receive seasonal influenza, HPV, and meningococcal vaccines but was administered hepatitis A, hepatitis B, and varicella as they were showing overdue in system. Medical assistant failed to reconcile with the patient's vaccine history in computer, which contributed to the error. Medical provider contacted family to explain the situation, and there are no further concerns from the family or the care team at this time.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received two Fluzone HD doses instead of just one.  Pt was aware, ok and showed no symptoms
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Electrocardiogram normal, Heart rate increased, Painful respiration, Sleep disorder
Clinical narrative: Rapid heart rate (160+ bpm), sharp pain when breathing, heart pounding in ears, (Woke up at 5 am with these symptoms.)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Rapid heart rate (160+ bpm), sharp pain when breathing, heart pounding in ears, (Woke up at 5 am with these symptoms.)
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: per patient wife patient received fluzone HD and spikevax at same time he became very fatgued unable to function developsd a fever and the second day after he had to go to hospital felt so poor was in hospital for 1 week then in rahab facility for another week then recovered
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia
Clinical narrative: PATIENT STATES SHE HAS MILD LEFT SHOULDER PAIN
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Pruritus, Swelling
Clinical narrative: Patient got the vaccine and had arm pain after the vaccine. The next day, extreme itching occurred and inflammation. They applied triamcinolone cream and the swelling and itching as gone down starting today.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Chills Fever 102.1 degrees lasted 12 hours Fatigue Headache Dizziness  Red @ Swollen around injection site. A border of 2 inches Took aspirin and drank fluids
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Chills Fever 102.1 degrees lasted 12 hours Fatigue Headache Dizziness  Red @ Swollen around injection site. A border of 2 inches Took aspirin and drank fluids
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: The patient stated that the most recent vaccine she received was Shingrix from her primary pharmacy in March.  She requested the RSV (Arexvy) vaccine.  She was then immunized.  The claim for the vaccination rejected by the patient's primary insurance.  The insurance company informed us that the patient had received Abrysbo on October 19, 2023 at her primary pharmacy.  Upon calling the patient, she informed us that she had no recollection of receiving a vaccination for anything when she went to her pharmacy on that day.  She did remember being told that she was not yet due for her second dose of the Shingrix vaccine, but seemed quite sure she had not received any vaccinations that day.  I called the pharmacy that had provided the vaccination, and the pharmacist verified that the vaccine had been administered.  I then called the patient's primary care physician and explained the situation.  The doctor's nurse returned my call and stated she would inform the prescriber.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe hives lasting several days over large portions of legs, trunk,arms,  feet.  Urgent care prescribed Prednisone.  Saw PCP.  Started Zyrtec 2x/day with Pepcid.  Have since weaned to 1 Zyrtec/day but unable to wean off due to intense itching when dose is not taken.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient came in with their partner to receive the Moderna Covid-19 Spikevax vaccination. Both patients wanted to get vaccinated together so both came into the vaccination room. After verifying DOB, the names, and what vaccine the patients were receiving- I prepared to give the vaccine to the first patient. While doing so, the patient started a discussion, and it distracted me from what I was doing. I then accidentally gave the patient a second dose of the vaccine (her partner's vaccine). Immediately after, I notified the staff pharmacist who consulted with the patient and had them stay for extra observation. Followed up with the patient same day and the next day to check on them and said they were doing well.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Ischaemic stroke, Nausea, Vomiting
Clinical narrative: Ischemic stroke, preceded by nasaua and vomiting and belly issues 1-2 days prior
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bell?s Palsy, given steroids and antiviral pills
Age: 68.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray normal, Condition aggravated, Electrocardiogram abnormal, Laboratory test normal
Clinical narrative: Episode of Afibrillation
Age: 68.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray, Condition aggravated, Electrocardiogram
Clinical narrative: Episode of Afibrillation
Age: 58.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: Patient bled after the vaccine and a bruise was visible right away within a minute, Pt stayed for 15 min after the vaccine and reported brief pain down the elbow after the shot, pain did not reoccur. The injection site was elevated, patient was advised to ice the injection site, and went home. Pt reported the swelling went down within an hour after icing. Injection site was still bruised on 11/20/2023. Patient denied limited range of motion, or pain.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Menstrual disorder
Clinical narrative: Menstruation on day 3 after vaccination
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle spasms, Pain
Clinical narrative: 12 hours after receiving the vaccine all of my joints ached horribly. It hurt beyond a normal flu pain. I could not do anything but lay perfectly still. Any movement I made was excruciating. This lasted for approximately 18 hours. The following night I had terrible leg cramps in my right leg all over from my ankle to my knee. I have never experienced anything like this before.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute macular neuroretinopathy, Fluorescence angiogram abnormal, Imaging procedure, Retinal disorder, Visual impairment
Clinical narrative: acute macular neuroretinopathy I woke up on the morning of 2/11/21 with a very small blind spot in my right eye. I went to the eye doctor and received a diagnosis of AMN with an unknown cause. Fluorescein angiography was performed and they could not discern a cause. In my retina, there was a very small portion of the layer of the photoreceptor cells that was simply missing with no cause able to be seen. The blind spot itself has been stable, and maybe a little better as I write this today. Retinal imaging as of today shows stability/slight improvement in the affected area of the retina.
Age: 83.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Confusional state
Clinical narrative: Patient got confused...received RSV 08-28-2023...counseled on typical vaccination reactions
Age: 91.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal discomfort, Product preparation issue
Clinical narrative: The RSV vaccine was supposed to be administered but only the diluent was given, patient was not experiencing any symptoms but the wife mentioned he had stomach upset yesterday 11/19/23
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Pruritus
Clinical narrative: Very Itchy, slightly burning spots started on my back and progressed around my whole torso.   Nothing was noticed on my extremities. The itching was the worst and the burning was still very uncomfortable. No Redness or splotching was visible. The symptoms lated 5 weeks and then slowly disappeared over the next 2 weeks. No treatment was used except scratching.
Age: 43.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo, lightheadedness.  Turning my head can bring on symptoms. Turning over in bed at night at times leads to vertigo.
Age: 75.0
Sex: F
Vaccine: COVID19, PPV, RSV
Symptoms: Chest pain, Chills, Chromaturia, Decreased appetite, Dyspnoea
Clinical narrative: 10-29-23 Headache Body ache Chills Nausea Extremely tired Dark Urine No appetite  11-7-23 Still have: Tiredness Nausea Dark Urine No appetite
Age: 75.0
Sex: F
Vaccine: COVID19, PPV, RSV
Symptoms: Fatigue, Headache, Hypersensitivity, Laboratory test normal, Nausea
Clinical narrative: 10-29-23 Headache Body ache Chills Nausea Extremely tired Dark Urine No appetite  11-7-23 Still have: Tiredness Nausea Dark Urine No appetite
Age: 75.0
Sex: F
Vaccine: COVID19, PPV, RSV
Symptoms: Pain, Urine analysis normal
Clinical narrative: 10-29-23 Headache Body ache Chills Nausea Extremely tired Dark Urine No appetite  11-7-23 Still have: Tiredness Nausea Dark Urine No appetite
Age: 42.0
Sex: M
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: Arm pain including pain at injection site. Numbness and tingling down arm through elbow
Age: 42.0
Sex: M
Vaccine: FLUR4
Symptoms: Paraesthesia
Clinical narrative: Arm pain including pain at injection site. Numbness and tingling down arm through elbow
Age: 1.25
Sex: F
Vaccine: COVID19, DTAPIPVHIB, FLUC4, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling (no warmth or tenderness) after flu and pentacel
Age: 47.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Inflammation, Pain in extremity, Tenderness
Clinical narrative: Client states approx 4 AM on 10/19 she experienced a sore right arm that lasted a few days. Client states she also experienced left leg pain near the knee that was painful to the touch and inflamed. This leg pain continues. No other symptoms reported. Client states she has taken ibuprofen and uses heat for comfort measures. Client states leg pain is a little better but concerned about the continuing leg pain. Advised client to seek care for an assessment from a provider and will contact the client in a few days to assess status. 10/30/23 TC to client. Client states she did not see a provider but that the left leg pain has resolved. No further follow-up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, General physical health deterioration, Injury, Mobility decreased
Clinical narrative: I am so damaged I haven't been able to report this until now. I got the 1st covid 19 shot in my upper arm and thought I was going to be fine. Then my energy & cognition overall state of health began to decline continuously and severely This decline had had me laying in bed or a couch most of the day Still to this day (11/11/2023).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, General physical health deterioration, Mobility decreased
Clinical narrative: I am so damaged I haven't been able to report this until now. I got this 2nd shot in the covid 19 pfizer series and my health continued to plummet (along w/the 1st shot) my energy, cognition, and state of health had, and still has me laying in bed or in a couch most days (11/12/2023)
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Impaired driving ability
Clinical narrative: The worst excrutiatingly horrible pain I have ever experienced in my 88 years began on the evening of 10 November 2023. It ocurred about 33 hours after the high dose flu shot was administered.  The pain was so bad in my neck, back, and shoulders, I could not sleep in any position for five consecutive nights. The adverse reaction has left me with risidual neck and shoulder pain, and headaches.  Additionally, it has caused me to have limited range of motion (very painful to raise or lower head and/or turn head left or right.  Driving a vehicle safely has become both difficult and challenging. To this day (nine days later), my sleep is constantly interrupted by pain at night and my daily chores are curtailed by fatigue.   A Orthopedist took x-rays, and prescribed both muscle relaxers and physical therapy. I have had only one of twenty physical therapy sessions allowed. However, it's far to early to determine a benefit.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Mobility decreased, Neck pain, Pain
Clinical narrative: The worst excrutiatingly horrible pain I have ever experienced in my 88 years began on the evening of 10 November 2023. It ocurred about 33 hours after the high dose flu shot was administered.  The pain was so bad in my neck, back, and shoulders, I could not sleep in any position for five consecutive nights. The adverse reaction has left me with risidual neck and shoulder pain, and headaches.  Additionally, it has caused me to have limited range of motion (very painful to raise or lower head and/or turn head left or right.  Driving a vehicle safely has become both difficult and challenging. To this day (nine days later), my sleep is constantly interrupted by pain at night and my daily chores are curtailed by fatigue.   A Orthopedist took x-rays, and prescribed both muscle relaxers and physical therapy. I have had only one of twenty physical therapy sessions allowed. However, it's far to early to determine a benefit.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder, Spinal X-ray abnormal, Spondylitis
Clinical narrative: The worst excrutiatingly horrible pain I have ever experienced in my 88 years began on the evening of 10 November 2023. It ocurred about 33 hours after the high dose flu shot was administered.  The pain was so bad in my neck, back, and shoulders, I could not sleep in any position for five consecutive nights. The adverse reaction has left me with risidual neck and shoulder pain, and headaches.  Additionally, it has caused me to have limited range of motion (very painful to raise or lower head and/or turn head left or right.  Driving a vehicle safely has become both difficult and challenging. To this day (nine days later), my sleep is constantly interrupted by pain at night and my daily chores are curtailed by fatigue.   A Orthopedist took x-rays, and prescribed both muscle relaxers and physical therapy. I have had only one of twenty physical therapy sessions allowed. However, it's far to early to determine a benefit.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Consciousness fluctuating, Hyperhidrosis, Pallor, Syncope
Clinical narrative: About 10 mins after receiving Pfizer Covid booster, and after walking around the store, came to counter to pick up RX and fainted. Her daughter caught her midfall. Did not hit head. We sat her down, raised her feet, made sure ABC and alert, but pt was sweating, getting pale looking and intermittently losing consciousness. EMS called. Gave one dose Epi 0.3mg. Waited for EMS
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chronic obstructive pulmonary disease, Death, Mental status changes
Clinical narrative: Patient received her covid vaccine booster dose 11-13-23. Pharmacist came to facility to administer vaccine to residents and staff. Patient noted with change in her mental sttaus 11-14-23 at the facility, EMS activated, 11-15-23 the facility staff received a call that patient expired at the hospital on 1-14-23
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Rash, Rash erythematous
Clinical narrative: 11/14/23 11pm Rash on Left Heel worse on Left & Right Heel And Started to Reduce Red Bumps & Burns Responded to Hydrocortisone Cream
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She was very sick with the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She was very sick with the 1st dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 prophylaxis.     The patient's past medical history included Respiratory infection.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She was very sick with the 1st dose). At the time of the report, ILLNESS (She was very sick with the 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided. The patient received 2nd Dose on 10FEB2021 , Lot no. 013L20A, 3rd Dose on 4NOV2021 , Lot No. 022C21A and 4th Dose on 05MAY2022, Lot No. 059M21A. The patient was very sick with the 1st dose, but did not had a fever.   This case was linked to US-MODERNATX, INC.-MOD-2023-750042 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750042:Master case for dose 6 (Spikevax 2023-2024)
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Deafness, Ear discomfort, Magnetic resonance imaging
Clinical narrative: left ear to plug; I developed Bells Palsy; permanent hearing loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 (BNT162B2), on 13Jan2022 as dose 3 (booster), single (Lot number: F08757) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6201, Anatomical location: Arm Left), administration date: 24Feb2021, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6205, Anatomical location: Arm Left), administration date: 19Mar2021, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (disability) with onset 31Jul2022, outcome "not recovered", described as "I developed Bells Palsy"; DEAFNESS (disability) with onset 31Jul2022, outcome "not recovered", described as "permanent hearing loss"; EAR DISCOMFORT (disability), outcome "not recovered", described as "left ear to plug". The events "i developed bells palsy", "permanent hearing loss" and "left ear to plug" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: unknown results; Magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of bell's palsy, deafness, ear discomfort. Clinical course: Patient reported after his third vaccination that he developed Bells Palsy. It affected his hearing as it caused his left ear to plug. In more than a year of having this problem and seeing two ENT specialists, it had been determined that It caused permanent hearing loss. No COVID prior vaccination. COVID not tested prior vaccination. No other vaccine in four weeks.
Age: 81.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Dysphagia, Secretion discharge
Clinical narrative: Dropping oxygen saturation to 83%; Due to dysphagia, she is unable to clear; Excessive mucous secretions/After clearing mucous builds up again/4 to 5 clearings at night; This spontaneous case was retrieved on 07-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2692398-1) reported by other healthcare professional and concerned a 81-year-old, female patient.   The patient's current condition included right CVA (Cerebrovascular accident) MCA (Middle cerebral artery), mostly paralyzed left side, spasticity, lactose allergy and fentynal allergy. The patient's concomitant medications were not reported. The patient's historical vaccinations included Shingrix anti-viral medicine (Varicella zoster vaccine rgE (CHO))) on 15-Jul-2023, used for unreported indication, after which the patient experienced unspecified adverse event.   On 03-Oct-2023, the patient was vaccinated with influenza vaccine (brand not specified; route of administration: injection (reported as 'SYR'), anatomical location: right arm, dose: reported as '1' and indication: not reported). The batch number was not reported.   On 04-Oct-2023, after receiving influenza vaccine, the patient experinced excessive mucous secretions at times dropping oxygen saturation to 83%. Due to dysphagia, she was unable to clear. The patient had to turn onside of bed to drain the mucous secretions. After clearing mucous, oxygen level rised, but slow build up again. The patinet had four to five clearings at night.  On 05-Oct-2023, The blood oxygen saturation was 83%.  On 06-Oct-2023, The blood oxygen saturation was 83%.  On an unspecified date in Oct-2023, the patient recovered from the events.  The reporter did not provide a causality assessment.   The event of 'oxygen saturation decreased' was considered to be medically significant by Physician within CSL Department.  Company comment: An 81-year-old patient developed dysphagia, mucous discharge, and decreased oxygen saturation one day after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: An 81-year-old patient developed dysphagia, mucous discharge, and decreased oxygen saturation one day after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 81.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Dysphagia, Oxygen saturation decreased, Secretion discharge, Sputum retention
Clinical narrative: Dropping oxygen saturation to 83%; Due to dysphagia, she is unable to clear; Excessive mucous secretions/After clearing mucous builds up again/4 to 5 clearings at night; This spontaneous case was retrieved on 07-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2692398-1) reported by other healthcare professional and concerned a 81-year-old, female patient.   The patient's current condition included right CVA (Cerebrovascular accident) MCA (Middle cerebral artery), mostly paralyzed left side, spasticity, lactose allergy and fentynal allergy. The patient's concomitant medications were not reported. The patient's historical vaccinations included Shingrix anti-viral medicine (Varicella zoster vaccine rgE (CHO))) on 15-Jul-2023, used for unreported indication, after which the patient experienced unspecified adverse event.   On 03-Oct-2023, the patient was vaccinated with influenza vaccine (brand not specified; route of administration: injection (reported as 'SYR'), anatomical location: right arm, dose: reported as '1' and indication: not reported). The batch number was not reported.   On 04-Oct-2023, after receiving influenza vaccine, the patient experinced excessive mucous secretions at times dropping oxygen saturation to 83%. Due to dysphagia, she was unable to clear. The patient had to turn onside of bed to drain the mucous secretions. After clearing mucous, oxygen level rised, but slow build up again. The patinet had four to five clearings at night.  On 05-Oct-2023, The blood oxygen saturation was 83%.  On 06-Oct-2023, The blood oxygen saturation was 83%.  On an unspecified date in Oct-2023, the patient recovered from the events.  The reporter did not provide a causality assessment.   The event of 'oxygen saturation decreased' was considered to be medically significant by Physician within CSL Department.  Company comment: An 81-year-old patient developed dysphagia, mucous discharge, and decreased oxygen saturation one day after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: An 81-year-old patient developed dysphagia, mucous discharge, and decreased oxygen saturation one day after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 67.0
Sex: M
Vaccine: FLUC4, FLUA4
Symptoms: Thermal burn
Clinical narrative: Looked like burn mark size of half dollar; This spontaneous case retrieved on 09-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2693393-1), reported by other healthcare professional and concerned a 67-year-old, male patient.      The patient's medical history included Parkinson's disease and allergy to statins. The patient's concomitant medications included tamsulosin and carbidopa/levodopa, both used for unreported indication.  On 25-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v, dose: reported as 'dose 1', route of administration: intramuscular (IM), anatomical location: left arm (LA), and indication: not reported). The batch number reported was 371607.   On 26-Sep-2023, one day after receiving Fluad Quadrivalent, the patient had a burn mark size of half dollar, as reported.   On an unspecified date in 2023, the patient recovered from the event.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: One day after receiving Fluad Quadrivalent, the patient had a burn mark size of half dollar, as reported. Causal role of the vaccine is assessed as not related for the event of thermal burn, based on biological implausibility.; Sender's Comments: One day after receiving Fluad Quadrivalent, the patient had a burn mark size of half dollar, as reported. Causal role of the vaccine is assessed as not related for the event of thermal burn, based on biological implausibility.
Age: 67.0
Sex: M
Vaccine: FLUC4, FLUA4
Symptoms: Injection site discolouration
Clinical narrative: Looked like burn mark size of half dollar; This spontaneous case retrieved on 09-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2693393-1), reported by other healthcare professional and concerned a 67-year-old, male patient.      The patient's medical history included Parkinson's disease and allergy to statins. The patient's concomitant medications included tamsulosin and carbidopa/levodopa, both used for unreported indication.  On 25-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v, dose: reported as 'dose 1', route of administration: intramuscular (IM), anatomical location: left arm (LA), and indication: not reported). The batch number reported was 371607.   On 26-Sep-2023, one day after receiving Fluad Quadrivalent, the patient had a burn mark size of half dollar, as reported.   On an unspecified date in 2023, the patient recovered from the event.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: One day after receiving Fluad Quadrivalent, the patient had a burn mark size of half dollar, as reported. Causal role of the vaccine is assessed as not related for the event of thermal burn, based on biological implausibility.; Sender's Comments: One day after receiving Fluad Quadrivalent, the patient had a burn mark size of half dollar, as reported. Causal role of the vaccine is assessed as not related for the event of thermal burn, based on biological implausibility.
Age: 75.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Cough, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Cough; Dizziness; Nausea; Emesis; Fever; This spontaneous case was retrieved on 10-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2694958-1), reported by the other healthcare professional, and concerned a 75-year-old male patient.  The patient's concurrent conditions included insulin dependent diabetes, hypertension, hyperlipidemia, chronic kidney disease, osteoarthritis, benign prostate hypertrophy, and obesity. The patient's concomitant medications included Asparin (acetylsalicylate lysin), Coreg (carvedilol), Trulicity (dulaglutide), Trelegy Ellipta (fluticasone furoate, umeclidinium bromide, vilanterol trifenatate), Lantus (insulin glargine), Humalog (insulin lispro), losartan, Crestor (rosuvastatin calcium), torsemide, alfuzosin, glipizide, and Myrbetriq (mirabegron). The patient did not have any known allergies.  It was reported that on 04-Oct-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular (IM), anatomical location: right arm (RA), dose and indication: not reported). The batch number reported was 371609. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On 06-Oct-2023, two days after receiving Fluad Quadrivalent, the patient experienced nausea, emesis, fever, dizziness, and cough.   On 11-Oct-2023, after five days, the patient recovered from the events. It was reported that all events lasted for five days and were self-resolving.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 75-year-old patient experienced cough, dizziness, nausea, vomiting, and fever two days after receiving the suspect product Fluad Quadrivalent. Causality is confounded by therapy with multiple concomitant drugs. Nevertheless, based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 75-year-old patient experienced cough, dizziness, nausea, vomiting, and fever two days after receiving the suspect product Fluad Quadrivalent. Causality is confounded by therapy with multiple concomitant drugs. Nevertheless, based on plausible temporal relationship, causality for the reported events is assessed as possibly related.