chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received a 2nd dose on 01/14/2025. First dose was on 01/09/2024. Patient has not had any adverse effects.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Headache, Hypoaesthesia
Clinical narrative: Patient said he couldn?t feel his arm. It felt numb. But he wanted to go home. He started walking to the front of the office, felt dizzy and passed out almost immediately. He fell and hit his head. His head hurts but no  other lasting symptoms.  Afterwards he said before he felt dizzy his legs felt tingly, he felt like he was shrinking, and he felt like he was being pushed down.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Paraesthesia, Sensory disturbance
Clinical narrative: Patient said he couldn?t feel his arm. It felt numb. But he wanted to go home. He started walking to the front of the office, felt dizzy and passed out almost immediately. He fell and hit his head. His head hurts but no  other lasting symptoms.  Afterwards he said before he felt dizzy his legs felt tingly, he felt like he was shrinking, and he felt like he was being pushed down.
Sex: F
Vaccine: UNK
Symptoms: Blood bilirubin increased, Hyperbilirubinaemia, Jaundice
Clinical narrative: Hyperbilirubinemia, jaundice, on the verge of getting readmitted to hospital for phototherapy treatment
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Severe fatigue, headache, light headed, arthralgia,myalgia, total loss of appetite. Unable to go about any daily activities. Bed ridden for 24 hours
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: Severe fatigue, headache, light headed, arthralgia,myalgia, total loss of appetite. Unable to go about any daily activities. Bed ridden for 24 hours
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC20
Symptoms: Electroencephalogram normal, Febrile convulsion, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Complex febrile seizure. Patient had two short seizure episodes lasting less than 1 minute on 1/15/25 associated with fever. He had a third febrile seizure episode on 1/16.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC20
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Complex febrile seizure. Patient had two short seizure episodes lasting less than 1 minute on 1/15/25 associated with fever. He had a third febrile seizure episode on 1/16.
Age: 75.0
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects noted, patient had received a prior dose in 2023
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: My son?s arm was very red and swollen from the shoulder to half-way down his upper arm. It was very red in color and itchy. I have pictures
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Donor received the Rabies vaccination. A minute after the shot, the Donor stated that she was going to be sick. (the RN) gave her the garbage can. The Donor vomited 240 mL in the garbage can. The RN asked if this was from the vaccination, The Donor stated that she felt sick half way through her plasma donation & that it was her second time getting sick during plasma donation. RN informed the Donor that had she known that the donor was not feeling well, she would not have given the Donor the Rabies vaccine. Donor stated, "That makes sense."
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient said he never received previous dose of RSV, and was even counseled on his age and underlying conditions and this is a single dose vaccine.  Before receiving the vaccine, he was again counseled on this being a single dose.  After giving the vaccine and dropping the Admin Record on his profile, I saw he received an initial dose in March 2024
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing
Clinical narrative: Flush (redness) in patients face, arms and chest
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Borrelia test, Feeling abnormal, Laboratory test, Mental impairment, Muscular weakness
Clinical narrative: see prior pages
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nephrectomy, Tremor
Clinical narrative: see prior pages
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fluid intake reduced, Headache, Nausea, Pyrexia
Clinical narrative: mild fever at 100f, tiredness, headache, worsening nausea that prevents fluid intake
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pain, hard knot, redness and swelling at injection site for at least five days. Pain with even light pressure for four days.
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Injection site bruising, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, red rash, hot to touch, fever, aches, chills, bruising at injection site
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Pain, Pyrexia, Rash erythematous
Clinical narrative: Swelling, red rash, hot to touch, fever, aches, chills, bruising at injection site
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain of skin
Clinical narrative: Chills, site soreness, felt like my skin hurt
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: 1/15/2025, 9:10 am - Covid vaccine at pharmacy, vaccines for multiple patients loaded in syringes and stored in ziplock bags with name and prescription information on them (filled before our arrival, no idea of how long they were out).  1/16/2025, 1-4 am, woke up feeling like I had something similar to the flu - hot/cold, sweating/chills, exhausted, aches, queasy.  1/16/25 8 am-3 pm continued queasy feeling, exhaustion, hot/cold.  1/16/25 3 pm ate Salisbury steak and mashed potatoes.  1/16/25 started to feel faint, saw bright white light, passed out and started vomiting at the same time, lost control of bladder, convulsions..  Struggled to wake back up.  Finally did (getting close to calling for an ambulance but didn?t).  Ever since through today 1/18/25 at 2 pm, continued queasy, , diarrhea, exhaustion, sleeping a lot more than normal, feel lousy in general, not much interest in trying to eat (eating small amounts, followed by diarrhea).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hyperhidrosis, Hypersomnia, Influenza like illness, Loss of consciousness
Clinical narrative: 1/15/2025, 9:10 am - Covid vaccine at pharmacy, vaccines for multiple patients loaded in syringes and stored in ziplock bags with name and prescription information on them (filled before our arrival, no idea of how long they were out).  1/16/2025, 1-4 am, woke up feeling like I had something similar to the flu - hot/cold, sweating/chills, exhausted, aches, queasy.  1/16/25 8 am-3 pm continued queasy feeling, exhaustion, hot/cold.  1/16/25 3 pm ate Salisbury steak and mashed potatoes.  1/16/25 started to feel faint, saw bright white light, passed out and started vomiting at the same time, lost control of bladder, convulsions..  Struggled to wake back up.  Finally did (getting close to calling for an ambulance but didn?t).  Ever since through today 1/18/25 at 2 pm, continued queasy, , diarrhea, exhaustion, sleeping a lot more than normal, feel lousy in general, not much interest in trying to eat (eating small amounts, followed by diarrhea).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Seizure, Urinary incontinence
Clinical narrative: 1/15/2025, 9:10 am - Covid vaccine at pharmacy, vaccines for multiple patients loaded in syringes and stored in ziplock bags with name and prescription information on them (filled before our arrival, no idea of how long they were out).  1/16/2025, 1-4 am, woke up feeling like I had something similar to the flu - hot/cold, sweating/chills, exhausted, aches, queasy.  1/16/25 8 am-3 pm continued queasy feeling, exhaustion, hot/cold.  1/16/25 3 pm ate Salisbury steak and mashed potatoes.  1/16/25 started to feel faint, saw bright white light, passed out and started vomiting at the same time, lost control of bladder, convulsions..  Struggled to wake back up.  Finally did (getting close to calling for an ambulance but didn?t).  Ever since through today 1/18/25 at 2 pm, continued queasy, , diarrhea, exhaustion, sleeping a lot more than normal, feel lousy in general, not much interest in trying to eat (eating small amounts, followed by diarrhea).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 1/15/2025, 9:10 am - Covid vaccine at pharmacy, vaccines for multiple patients loaded in syringes and stored in ziplock bags with name and prescription information on them (filled before our arrival, no idea of how long they were out).  1/16/2025, 1-4 am, woke up feeling like I had something similar to the flu - hot/cold, sweating/chills, exhausted, aches, queasy.  1/16/25 8 am-3 pm continued queasy feeling, exhaustion, hot/cold.  1/16/25 3 pm ate Salisbury steak and mashed potatoes.  1/16/25 started to feel faint, saw bright white light, passed out and started vomiting at the same time, lost control of bladder, convulsions..  Struggled to wake back up.  Finally did (getting close to calling for an ambulance but didn?t).  Ever since through today 1/18/25 at 2 pm, continued queasy, , diarrhea, exhaustion, sleeping a lot more than normal, feel lousy in general, not much interest in trying to eat (eating small amounts, followed by diarrhea).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever and headache
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Lethargy, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Patient had vaccine several weeks ago but came in today to tell me she had what she considered to be a bad reaction. Her arm was swollen for two weeks and still itches. It began at midnight the day she got. For 16 hours she was extremely lethargic. She had a fever of 102.8 for 1 day following vaccine. Did not seek medical attention for symptoms.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis, Pyrexia, Renal pain
Clinical narrative: Kidney stone pain and fever
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: PATIENT REPORTED THAT FOLLOWING VACCINATION WITH THE FLUZONE HIGH DOSE VACCINE ON 12/21/2024 HAVING "MUSCLE PAIN BUT I WOULD SAY FROM  0-10 IT WAS 7" . "I TYHINK I TOOK NAPROXEN SODIUM" AND THAT "DID HELP" . ACCORDING TO THE PATIENT, THE PAIN LASTED APPROXIMATELY "2 DAYS" .  PATIENT STATED THAT THERE WAS "MUSCLE PAIN" AND "SORENESS" , AND THAT IT WOULD GO "REALLY DEEP".  PATINET REPORTED THAT SHE HAD TO GO THROUGH CHEMO[THERAPY]  AND THAT SHE HAD SIMILAR SYUMPTOMS TO THOSE FOLLOWING THE VACCINE. THE PATIENT ALSO REPORTED THAT SHE WAS "ACHY" . PATIENT ALSO REPORTED THAT SHE WAS ON ANTIBIOTICS IN THE PRECEDING WEEKS BEFORE THE INFLUENZA VACCINE (SHE COULD NOT RECALL THE EXACT ANTIBIOTIC REGIMEN AT THE TIME OF THIS WRITING). ALSO, THE PATIENT STATED THAT THE ADVERSE EVENTS RESOLVED AFTER SEVERAL DAYS.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache, body aches, extreme fatigue
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Brain stem syndrome, Central nervous system lesion, Chest X-ray normal, Clinically isolated syndrome
Clinical narrative: I came into the hospital in the beginning of November with face numbness. Almost the entirety of the right side of my face was numb and when I would touch it I could not feel it. The doctors decided to give me a CT scan of my head, after that I had an MRI (no contrast,) that?s where they found a lesion on my brain stem. There was another lesion but it was very very small closer to the top of my head. They weren't sure if it was a tumor at first or something else so I had to go back and get an MRI with contrast this time and they saw that it was in fact a lesion. I was then admitted to the hospital over a period of 5 days in the middle of November. They had me hooked up to an IV over those 5 days with a heavy dose of steroids. (I believe it was 1,000 mg but I could be wrong.) Later they did another MRI on my neck to make sure there were no lesions there (I was clear.) I got a chest x-ray done just as a precaution (nothing was found there.) They took about 30 vials of blood in total during that month of me in and out of the hospital (it all looked normal.) They ended up diagnosing me with Isolated Case Syndrome, but they are talking about treating me for Multiple Sclerosis. They can?t say that it is Multiple Sclerosis due to the fact that there were not enough lesions to pinpoint it on that. My face numbness went away after the steroids and I was released from the hospital. It?s been a couple months since November and I have been nauseous most days and I have migraines most days. They gave me medicine to subside that and it helps and it has been a lot more manageable since then. I am not sure if this is related to the COVID-19 Pfizer shot but seeing that nothing in my life has changed before I had the shot or after it?s safe to assume that this could have definitely been the cause of what I may have. I also have permanent brain damage on my brain stem from this lesion. I forgot to mention I also had a spinal tap done.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck normal
Clinical narrative: I came into the hospital in the beginning of November with face numbness. Almost the entirety of the right side of my face was numb and when I would touch it I could not feel it. The doctors decided to give me a CT scan of my head, after that I had an MRI (no contrast,) that?s where they found a lesion on my brain stem. There was another lesion but it was very very small closer to the top of my head. They weren't sure if it was a tumor at first or something else so I had to go back and get an MRI with contrast this time and they saw that it was in fact a lesion. I was then admitted to the hospital over a period of 5 days in the middle of November. They had me hooked up to an IV over those 5 days with a heavy dose of steroids. (I believe it was 1,000 mg but I could be wrong.) Later they did another MRI on my neck to make sure there were no lesions there (I was clear.) I got a chest x-ray done just as a precaution (nothing was found there.) They took about 30 vials of blood in total during that month of me in and out of the hospital (it all looked normal.) They ended up diagnosing me with Isolated Case Syndrome, but they are talking about treating me for Multiple Sclerosis. They can?t say that it is Multiple Sclerosis due to the fact that there were not enough lesions to pinpoint it on that. My face numbness went away after the steroids and I was released from the hospital. It?s been a couple months since November and I have been nauseous most days and I have migraines most days. They gave me medicine to subside that and it helps and it has been a lot more manageable since then. I am not sure if this is related to the COVID-19 Pfizer shot but seeing that nothing in my life has changed before I had the shot or after it?s safe to assume that this could have definitely been the cause of what I may have. I also have permanent brain damage on my brain stem from this lesion. I forgot to mention I also had a spinal tap done.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Scan with contrast abnormal
Clinical narrative: I came into the hospital in the beginning of November with face numbness. Almost the entirety of the right side of my face was numb and when I would touch it I could not feel it. The doctors decided to give me a CT scan of my head, after that I had an MRI (no contrast,) that?s where they found a lesion on my brain stem. There was another lesion but it was very very small closer to the top of my head. They weren't sure if it was a tumor at first or something else so I had to go back and get an MRI with contrast this time and they saw that it was in fact a lesion. I was then admitted to the hospital over a period of 5 days in the middle of November. They had me hooked up to an IV over those 5 days with a heavy dose of steroids. (I believe it was 1,000 mg but I could be wrong.) Later they did another MRI on my neck to make sure there were no lesions there (I was clear.) I got a chest x-ray done just as a precaution (nothing was found there.) They took about 30 vials of blood in total during that month of me in and out of the hospital (it all looked normal.) They ended up diagnosing me with Isolated Case Syndrome, but they are talking about treating me for Multiple Sclerosis. They can?t say that it is Multiple Sclerosis due to the fact that there were not enough lesions to pinpoint it on that. My face numbness went away after the steroids and I was released from the hospital. It?s been a couple months since November and I have been nauseous most days and I have migraines most days. They gave me medicine to subside that and it helps and it has been a lot more manageable since then. I am not sure if this is related to the COVID-19 Pfizer shot but seeing that nothing in my life has changed before I had the shot or after it?s safe to assume that this could have definitely been the cause of what I may have. I also have permanent brain damage on my brain stem from this lesion. I forgot to mention I also had a spinal tap done.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Upon entering the vaccine administration information on the registry, we noticed the patient was previously vaccinated with an RSV vaccine in 2023. Currently, the guidelines recommend only one dose of the RSV vaccine. The patient was contacted upon discovering this issue at 5:01 pm 1/18/2025 and we informed her that we will report this incident. Patient states that she is feeling fine but was instructed to contact the pharmacy or her doctor if she does not feel well or has any concerns.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Complex regional pain syndrome, Pain in extremity, Uterine haemorrhage, Vaginal haemorrhage
Clinical narrative: I received the COVID-19 injection. The shot was mandatory for some jobs; with that being said I was the Front Gate Runner at the time. While receiving the Janssen COVID  19 injection I felt normal as if this shot would be like a flu injections as describe by injection medical staff.  April 2020 not even more than twenty-four hours later; I began to feel pain and soreness. I requested to see the doctor, and I was told the side effects of pain as well as soreness would be accepted, and I was prescribed some Ibuprofen 800mg at pill time. I still have extreme pain in left shoulder and arm I was diagnosed with CRPS(central regional pain syndrome).  While dealing with the pain from the vaccination; I started bleeding from my vaginal area, not to mention that to this date and year of 2025 I am still experiencing vaginal bleeding, that recently has been diagnosed as Hemorrhaging of the uterus.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Myalgia
Clinical narrative: Patient received a second dose of Arexvy on 1/16/25 after already receiving the vaccine on 12/16/23. Muscle pain/soreness after vaccination that is better now a couple days after vaccination. He used ibuprofen to treat the symptoms and reported that the symptoms did not significantly affect his day-to-day activities.
Age: 76.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Middle insomnia, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient was waking up in the middle of the night initially with itching  however itching never got to the point where it was severe.  The itching then spread over the next few weeks including a breakout around the patients entire waist with itchy red rash that was inflamed looking with no bleeding. Patient never got to the point where she took anything  or went to seek medical attention and describes it more as an irritation.
Age: 76.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Skin irritation
Clinical narrative: Patient was waking up in the middle of the night initially with itching  however itching never got to the point where it was severe.  The itching then spread over the next few weeks including a breakout around the patients entire waist with itchy red rash that was inflamed looking with no bleeding. Patient never got to the point where she took anything  or went to seek medical attention and describes it more as an irritation.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: this vaccine was given twice (11/23 and 1/25). no adverse event reported by patient
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Cerebrovascular accident, Computerised tomogram, Lymphadenopathy, Rash
Clinical narrative: Broke out in a rash with swollen lymph nodes on chest and under armpits. After second shot on 04-01-2021 at 10:30 a.m. Moderna 020B21A I had a stroke on June 5, 2021.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Sore arm.
Age: 76.0
Sex: F
Vaccine: DT, DT, DT, RSV, VARZOS
Symptoms: Chills, Cough, Headache, Myalgia, Nausea
Clinical narrative: Headache chills, cough nauseous body aches and muscles
Age: 76.0
Sex: F
Vaccine: DT, DT, DT, RSV, VARZOS
Symptoms: Pain
Clinical narrative: Headache chills, cough nauseous body aches and muscles
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: redness/swelling the day of vaccination. Diagnosed with cellulitis on 1/17/2025 (4 days after vaccination)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site induration, Injection site warmth, Pain
Clinical narrative: Swelling the size of a golf ball, blood red like a sunburn, excruciating pain, headache that hasn?t yet gone away.  Arm where shot was given is hard as a rock and hot to the touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling the size of a golf ball, blood red like a sunburn, excruciating pain, headache that hasn?t yet gone away.  Arm where shot was given is hard as a rock and hot to the touch.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Pericardial effusion, Ultrasound scan
Clinical narrative: Developed fluid around the heart resulting in hospitalization for AFIB. Pulse of 180.  Meds reduced fluid.
Age: 7.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Fall, Head injury, Somnolence
Clinical narrative: Patient came into clinic for vaccine only appointment. He tolerated the vaccines well and then, when leaving, he fell by the elevator and hit the side of his head. He was groggy, but responsive. Observed closely in clinic and vital signs remained stable. Patient needed no other assistive care.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: The vaccine is listed in my insurance as: COMIRNATY 2024-25 (Rx #: 000007490038) I had no immediate reaction to the vaccine on Dec 1, but after a week or two I started getting itchy rashes over large parts of my torso. These have spread from one part to another part of my body, mostly on my upper half. As one area returns to normal, the rash spreads to another area. As of right now, the affected area is my breasts and buttocks, though the rash seems to be subsiding somewhat in those areas. I have experienced some level of rash each time I take a COVID vaccine, but the reaction this year is far worse, covering a larger area, and has lasted noticeably longer than previous years. At this point I intend to discontinue any future COVID vaccinations unless a safer alternative can be found.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: I did get tired and didn't feel well. Did report.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: SHE SAYS SHE CAN'T LIFT ARM AND HAS SEVERE PAIN FROM VACCCINATION ON 11/24. SHE SAID SHE WILL BE GETTING PHYSICAL THERAPY DUE TO INCIDENT.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: My upper left arm is very red and swollen. It's bit itchy as well and warm to the touch. I've never had a reaction to a flu shot before and feel this should be jnoted
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cardiac failure congestive, Computerised tomogram heart abnormal, Coronary arterial stent insertion, Mammogram
Clinical narrative: Heart Attack- 2 Stents. First  issue was pain under left arm in breast area. radiology did Mammo, then Mamo sonogram, was negative but no other referral or indication. This was Jan 12 or approx. Feb 24 went to hospital with similar pains. Sent home. Next day went to hospital, Admitted and tested for 4 days. On 5 day, heart scan with contrast revealed congestive heart failure l. Surgery performed March 1 . released March 3.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Scan with contrast abnormal, Ultrasound breast normal
Clinical narrative: Heart Attack- 2 Stents. First  issue was pain under left arm in breast area. radiology did Mammo, then Mamo sonogram, was negative but no other referral or indication. This was Jan 12 or approx. Feb 24 went to hospital with similar pains. Sent home. Next day went to hospital, Admitted and tested for 4 days. On 5 day, heart scan with contrast revealed congestive heart failure l. Surgery performed March 1 . released March 3.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Arthropathy, Fall, Induration, Joint swelling
Clinical narrative: Swelling, hardness, and pain in left shoulder where vaccination was given.  When I got up the next morning, my entire left leg, ankle, and foot were swollen and they are still swollen six weeks later.  I have had two total left knee replacements, with the revision surgery requiring a titanium rod to be placed inside the entire left femur in 2018 at the main campus of the Clinic.  Since receiving the RSV vaccination, I have nearly fallen several times because of my left knee .
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling
Clinical narrative: Swelling, hardness, and pain in left shoulder where vaccination was given.  When I got up the next morning, my entire left leg, ankle, and foot were swollen and they are still swollen six weeks later.  I have had two total left knee replacements, with the revision surgery requiring a titanium rod to be placed inside the entire left femur in 2018 at the main campus of the Clinic.  Since receiving the RSV vaccination, I have nearly fallen several times because of my left knee .
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Amnesia, Blood glucose, Dizziness, Fall, Head injury
Clinical narrative: fainted about a min after getting  the shots. Fell hit her head. Was awake but can't remember fainting  from chair to floor. Took about 15-20 minutes to recover. Was given water and evaluated by paramedic. Has another dizzy and shaking spell after returned to chair from fall before paramedic arrived. Lasted a min or so, lots of sweating and blurry vision. Hands shaking but not any other sign that would indicate seizure versus recovery from syncope event. patient left on own accord, when friend arrived to take them home and monitor.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hyperhidrosis, Syncope, Tremor, Vision blurred
Clinical narrative: fainted about a min after getting  the shots. Fell hit her head. Was awake but can't remember fainting  from chair to floor. Took about 15-20 minutes to recover. Was given water and evaluated by paramedic. Has another dizzy and shaking spell after returned to chair from fall before paramedic arrived. Lasted a min or so, lots of sweating and blurry vision. Hands shaking but not any other sign that would indicate seizure versus recovery from syncope event. patient left on own accord, when friend arrived to take them home and monitor.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had previously received the dose on 12/03/23 and received a shot again on 01/18/25. Health agency recommendations is just one dose and complete. He was not experiencing any side effects as of 01/19/25. Patient was educated on possible side effects.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of RSV vaccine. First dose was 12/19/2023 and second dose was 1/19/2025. First dose was discovered after pt was administered the second dose and it was reported into the vaccine database. Patient states first dose would have been given at this pharmacy (no record here) or the dr's clinic.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, Pain, Pain in extremity
Clinical narrative: Pt received the RSV vaccine in 2023 and again on 1/18/25. Followed up with pt and she said she felt like she was hit by a truck last night and her arm was sore. She stated that she is doing okay now
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Second dose of RSV was administered inappropriately. Patient did not suffer from any adverse effects.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT REPORTED REDNESS & SWELLING AT THE INJECTION SITE, HEADACHE, SHIVERING, AND NAUSEA.  ALSO HAD ITCHING AT THE INJECTION SITE THAT SPREAD TO THE ABDOMINAL AREA.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus
Clinical narrative: PATIENT REPORTED REDNESS & SWELLING AT THE INJECTION SITE, HEADACHE, SHIVERING, AND NAUSEA.  ALSO HAD ITCHING AT THE INJECTION SITE THAT SPREAD TO THE ABDOMINAL AREA.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Injection site reaction, Neuralgia
Clinical narrative: PATIENT STATES THAT SHE IS EXSPERIENCING PAIN IN THE UPPER LEFT ARM. THERE IS NERVE PAIN AND BURNING IN THAT AREA. DIFFICULTY LIFTING ARM; SHE DIDNT HAVE ANY SWELLING, REDNESS, OR PAIN UNTIL A FEW DAYS AFTER THE VACCINE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: PATIENT STATES THAT SHE IS EXSPERIENCING PAIN IN THE UPPER LEFT ARM. THERE IS NERVE PAIN AND BURNING IN THAT AREA. DIFFICULTY LIFTING ARM; SHE DIDNT HAVE ANY SWELLING, REDNESS, OR PAIN UNTIL A FEW DAYS AFTER THE VACCINE.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Not known.  Unable to reach patient
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF AREXVY ONE YEAR AFTER THE FIRST DOSE. ONLY ONE DOSE INDICATED.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF AREXVY ONE YEAR AFTER THE FIRST DOSE. ONLY ONE DOSE INDICATED.
Age: 85.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received Prevnar 20 on 06/26/2022 then received a second dose of Prevnar 20 on 01/14/2025. Patient is doing ok.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: duplicate dose of arexy was originally given 05/25/24
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red, warm and painful - started a day after vaccine -
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling face
Clinical narrative: Patient claims 2 days later she had a red face and a little swelling of the face.  Mouth and Tongue were not affected.  She took an antihistamine and applied cool compresses and the next day she said she was doing better.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Patient called pharmacy informed pharmacist of a small raised 3 inch diameter red circle on her left arm. She said it was hot and tender to the touch. Recommended to take some ibuprofen or tylenol for the pain. Told her this is a known but rare side effect. She waited until 1/19/2025 to report because the swelling had not gone down. Will follow up with her for improvement of symptoms and told her to call back to inform us if it got worse.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Sluggishness
Clinical narrative: The morning after receiving the vaccine (Jan 18, 2025) at 11AM patient woke up with headache, fever (up to 102degrees F), chills, feeling tired and sluggish.  As a result she took ER650mg of tylenol and 400mg of advil. She feels better today Jan 19, 2025.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received first dose of arexvy 12/1/2023 and this wasn't realized until after patient received a second dose 1/16/25. This is a one shot series. No second shot is needed.
Age: 86.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Prevnar20 on 1/17/25. On 1/18/25, it was discovered that patient got Prevnar 20 on 6/19/24.  I was able to reach the patient on 1/19/25 and told her that she got a duplicate vaccine. She was not experiencing any adverse effects.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Impaired work ability
Clinical narrative: PT RETURNED TO THE PHARMACY  REPORTING SYMPOMS LIST ON THE VIS INFORMATION SHEET
Age: 36.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Urticaria
Clinical narrative: Urticaria of arms, legs, back w/ onset 48 hours after vaccine administration
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Nurse practitioner reported that a patient received an expired MMR II vaccine on 1/6/2025.; This spontaneous report was received from a nurse practitioner and referred to a patient with unknown age or gender on 06-JAN-2025.  Information about concurrent condition, concomitant medication and medical history was not provided.  On 06-JAN-2025, the patient was vaccinated with the expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, lot #X000178, expiration date: 02-JAN-2025 (Albumin status recombinant Human albumin (rHA)), administered for prophylaxis (strength and route of administration were not provided). No additional adverse events (AEs) were reported.
Sex: F
Vaccine: HPV9
Symptoms: Antibody test negative
Clinical narrative: Antibody test negative; This spontaneous report was received from Pharmacist and refers to a female of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date (reported as patient as a child), the patient was vaccinated with 3 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown day, the reporter was calling inquiring regarding hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Would like to know if there would be a presence of antibodies detected via blood work. The patient who was told by her HCP that she no longer has immunity to  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and they want to revaccinate her, despite getting the 3 required doses as a child (Antibody test negative).The outcome of the event was unknown.  The causal relationship between Antibody test negative and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired VARIVAX inadvertently administered to a patient; no adverse event; This spontaneous report was received from Other Health Professional and refers to a 12-month-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-JAN-2025, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dosage form, lot #X001000, expiration date: 09-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 15-JAN-2025, the patient experienced expired VARIVAX inadvertently administered to a patient, the patient experienced no adverse event. At the time of reporting, the outcome of the event expired VARIVAX inadvertently administered to a patient was not known, the outcome of the event no adverse event was not known. The action taken with VARIVAX regarding expired VARIVAX inadvertently administered to a patient was reported as Not Applicable. The action taken with VARIVAX regarding no adverse event was reported as Not Applicable.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse called and reported that a consumer received the 1st dose of GARDASIL-9 as a teenager. The consumer is now an adult and has not received any additional doses of GARDASIL-9 at this time. No additional AE reported. No PQC reported.  ; Nurse called and reported that a consumer received the 1st dose of GARDASIL-9 as a teenager. The consumer is now an adult and has not received any additional doses of GARDASIL-9 at this time. No additional AE reported. No PQC reported.  ; This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions concomitant therapies were not reported.  On an unknown date, the patient received the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) as a teenager and had not received any additional doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at that time (Inappropriate schedule of product administration). No additional adverse event (AE) reported (No adverse event).  Lot number is being requested and will be submitted if received.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; i had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included covid vaccine with an associated reaction of herpes zoster (same with covid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i had the shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JAN-2025 This case was reported by a patient via interactive digital media. The patient was about 72 when they got shingles vaccine and 2 months later he/she had the shingles, same with covid, he/she mentioned that through with our vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Rash, Rash pruritic
Clinical narrative: injection site pain; injection site swelling; itchy rash on chest and back; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a 16-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: injection site pain), injection site swelling (Verbatim: injection site swelling) and itchy rash (Verbatim: itchy rash on chest and back). The outcome of the injection site pain, injection site swelling and itchy rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and itchy rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site swelling and itchy rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JAN-2025 Physician gave first dose of Bexsero to a 16 year old who developed injection sight pain/ swelling and an itchy rash on chest and back.  Patient almost went to emergency room because it was so bad. Physician was hesitant to gave the 2nd dose in 6 months because of this reaction.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: it actually expired 03Nov2024. So 15 days pass expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number G7749, expiry date 03-NOV-2024) for prophylaxis.   On 18-NOV-2024, the patient received Boostrix. On 18-NOV-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: it actually expired 03Nov2024. So 15 days pass expiration date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JAN-2025 The nurse practitioner reported that they had a nurse who gave an expired dose of Boostrix injection and realized it actually 15 days passed expiration date, which led to expired vaccine used. The reporter was just wondering was there a protocol for that. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypertension, Laboratory test, Renal failure, Vertigo
Clinical narrative: difficult to walk; high blood pressure; had bad vertigo for first month; KIDNEY FAILURE; This spontaneous report received from a consumer concerned a male patient of unspecified age. via social media. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose and frequency not reported, administered on Aug-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers No concomitant medications were reported.  On an unspecified date, the patient experienced kidney failure, high blood pressure, and had bad vertigo for first month. On an unspecified date, the patient experienced difficult to walk and was hospitalized on an unspecified date.dose series 1  On 2022, laboratory data included: nerve conduction exam (NR: not provided) results not reported.  It was reported that 10 days later ankles would not work , he moved maybe the vibration, knees will not lock almost to his diagram (dose series 1). Done nerve conduction testing that was in 2022. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of kidney failure, difficult to walk, high blood pressure and had bad vertigo for first month was not reported.  This report was serious (caused/prolonged hospitalization and other medically important condition).; Sender's Comments: V0; Renal failure and Gait disturbance; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Completed suicide, Depression
Clinical narrative: Depression leading to suicide
Age: 71.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness and itchiness around injection site; redness and itchiness around injection site; This spontaneous report was received from a pharmacist and refers to a 71-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JAN-2025, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  On 14-JAN-2025, the patient experienced redness and itchiness around injection site (Vaccination site erythema, Vaccination site pruritus). The patient came back to speak to pharmacist. At the time of reporting, the patient had not recovered from the events. No additional information was known by reporter. The action taken with the suspect vaccine regarding both events was not applicable.   The causal relationship between both events and pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) was not provided.   Lot# is being requested and will be submitted if received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Fall, Intervertebral disc degeneration, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: patient admitted for #Recurring Mechanical Ground-Level Falls #Severe multilevel lumbar degenerative disc disease #Covid 19+ bronchitis discharged home Other Relevant HX: discharged to home Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: patient admitted for #Recurring Mechanical Ground-Level Falls #Severe multilevel lumbar degenerative disc disease #Covid 19+ bronchitis discharged home Other Relevant HX: discharged to home Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Breakthrough COVID-19, COVID-19 pneumonia, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted for COVID pneumonia with acute on chronic hypoxic respiratory failure and discharged home after treatment. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination