chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Dyskinesia, Paralysis
Clinical narrative: Patient received both RSV and COVID19 vaccine around 1pm on 12/27/23. Around 11pm that night she starting experiencing uncontrollably jerking movements with also bouts of paralysis of certain limbs. Patient has no history of seizure and had not experienced these symptoms previously. Patient husband reports this happening over the course of several hours. Husband took her to emergency room - they ruled out stroke and could not confirm seizure. Husband reports ER did tests (unsure which ones). Since that night patient has had no further symptoms.
Age: 97.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: This patient requested a flu shot on 12/27/23, so we went to her room in the long term care facility to administer the shot on 12/28/23. I logged on to immPRINT on 12/29/23 to check that our submission went through. When checking her profile, I noticed she had already received the flu shot by her PCP in September. I am submitting this report as she received two flu shots this season.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Condition aggravated, Impaired work ability, Pain in extremity
Clinical narrative: Severe arthritis pain in left leg starting from the left hip down to the foot making it difficult for me to work after taking second dose of MMR vaccine
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Lipoma, Neuralgia
Clinical narrative: On 12/29/23, the pt made me aware of her right bicep having nerve pain.  Starting at some point after the injection she started having pain about 4" below the shoulder capsule and a small lump forming parallel to the injection site on the outer edge of the bicep.  upon examination of the right arm there is a small lipoma on the outer aspect of the bicep parallel to the injection site (approximately 4 inches below the shoulder capsule centered on the deltoid.)  patient states it feels like a nerve pain you would take gabapentin for.
Age: 16.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix  administered to 16 year old patient . Pediarix not approved for patients over 7 years old.
Age: 14.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix administered to 14 year old patient . Pediarix is not approved for patients over 6 years old.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Patient states that she received the new COVID shot (Spikevax) at 10am and at midnight that night was woken up by her upper body jerking. She said it lasted about 10 minutes then stopped. She has not noticed it since and was advised to seek medical attention if anything happened again or worsened.  Patient advised to call on-call provider to see if they want her to seek medical attention, she did not lose consciousness or have any muscle stiffness per her account.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Next morning, 12/19, work up with rash; hives itching on inner forearms at first. Over following days progressed to biceps and under arms;  showing on chest; upper inner thighs and outer thighs. On a scale of 1 (low) to 10 (severe), I'd say it is a 6 to 7. Using Aveeno 1% hydrocortisone a few times a day and using generic Benadryl pink pill before bedtime. Not sure anything has changed as it has progressed, not diminished. I may have skipped the vaccine had I known this would have  for sure occurred for me. Using Lever soap for shower.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram normal, Headache, Hypertension
Clinical narrative: 4 days post vaccine administration I experienced increasing pain on sternum, neck, jaw and headache. I was told to immediately go to the emergency department at the hospital. A heart infarction was immediately ruled out by EKG which was normal. My blood pressure was found to be excessively high. I saw as much as 197/91 on the cuff monitor. My blood pressure is normally in the low range. It was found that this was causing some of the symptoms I was experiencing. Blood pressure lowering med was administered via IV along with a liter of saline solution. Blood and x-rays were taken.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Neck pain, Pain in jaw, X-ray
Clinical narrative: 4 days post vaccine administration I experienced increasing pain on sternum, neck, jaw and headache. I was told to immediately go to the emergency department at the hospital. A heart infarction was immediately ruled out by EKG which was normal. My blood pressure was found to be excessively high. I saw as much as 197/91 on the cuff monitor. My blood pressure is normally in the low range. It was found that this was causing some of the symptoms I was experiencing. Blood pressure lowering med was administered via IV along with a liter of saline solution. Blood and x-rays were taken.
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Electroencephalogram, Magnetic resonance imaging, Pyrexia, Seizure
Clinical narrative: Seizure 2-3 minutes on night of vaccine 12/21 suspected due to  fever. Followed by second seizure unprovoked in 12/28.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Felt dizzy, fell down
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Dizziness, Dyspnoea, Immunisation reaction, Nausea
Clinical narrative: SHORTNESS OF BREATH, SEIZURES, EXTREME DIZZINESS, NAUSEA, AMBULANCE TO ER, 5 HOURS IN EMERGENCY ROOM, RECEIVED OXYGEN AND IVs
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Seizure, Urine analysis normal, X-ray normal
Clinical narrative: SHORTNESS OF BREATH, SEIZURES, EXTREME DIZZINESS, NAUSEA, AMBULANCE TO ER, 5 HOURS IN EMERGENCY ROOM, RECEIVED OXYGEN AND IVs
Age: 53.0
Sex: F
Vaccine: COVID19-2, PPV
Symptoms: Arthralgia, Blister, Cellulitis, Injection site discharge, Injection site reaction
Clinical narrative: The pharmacy employee administered both vaccines in the left arm. The injections should have been given in separate arms.  The injection was given about 12 cm below the acromion process instead of 5 cm. So the injections were NOT given in the deltoid muscle but in an area where muscle is deep under the skin.  Within 24 hours I experienced typical malaise symptoms, muscle aches and joint pain. Cellulitis developed measuring 20 cm by 8 cm on the anterior of the left arm. This was incredibly painful and by 12/10/2023 a blister developed that burst spontaneously. I started Cephalexin 500 mg taken 4 times per day. After finishing this course, I started a second course of same antibiotic due to redness around the wound with yellow drainage. On 12/30/2023 the wound is 25 cm by 4 cm; it is so deep that the subcutaneous tissue with fat layer, is exposed.
Age: 53.0
Sex: F
Vaccine: COVID19-2, PPV
Symptoms: Malaise, Myalgia, Pain in extremity, Product administered at inappropriate site, Wound
Clinical narrative: The pharmacy employee administered both vaccines in the left arm. The injections should have been given in separate arms.  The injection was given about 12 cm below the acromion process instead of 5 cm. So the injections were NOT given in the deltoid muscle but in an area where muscle is deep under the skin.  Within 24 hours I experienced typical malaise symptoms, muscle aches and joint pain. Cellulitis developed measuring 20 cm by 8 cm on the anterior of the left arm. This was incredibly painful and by 12/10/2023 a blister developed that burst spontaneously. I started Cephalexin 500 mg taken 4 times per day. After finishing this course, I started a second course of same antibiotic due to redness around the wound with yellow drainage. On 12/30/2023 the wound is 25 cm by 4 cm; it is so deep that the subcutaneous tissue with fat layer, is exposed.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Coccidioidomycosis, Cough, Immunisation reaction, Mobility decreased
Clinical narrative: Severe chest pain, inability to lay on back, cough, low grade fever, body aches.  This was determined to be pericarditis due to the vaccine.  I can not take NSAIDs due to a severe sensitivity to them (gastritis and peptic ulcers) and so I was started on prednisone, 25mg with a tapered dose each day.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pericarditis, Pneumonia, Pyrexia
Clinical narrative: Severe chest pain, inability to lay on back, cough, low grade fever, body aches.  This was determined to be pericarditis due to the vaccine.  I can not take NSAIDs due to a severe sensitivity to them (gastritis and peptic ulcers) and so I was started on prednisone, 25mg with a tapered dose each day.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Bronchoscopy, Computerised tomogram, Hypoaesthesia
Clinical narrative: As a healthcare worker, I was vaccinated 5 times. Initially with Pfizer EJ1685 on 12/24/20, Again with Pfizer Ej1685 on 01/12/2021, again on 4/28/22 with Pfizer EW0187 on 04/28/2022 and 3/28/23 with (I believe Moderna), no lot # available.  I began to have acute back pain in 2021 but as a SR Director, I attributed this to long work hours and a previous car accident. The sought chiropractic care in May of 2022 because the pain was becoming unbearable and keeping me from sleeping. After that was unsuccessful, my primary care provider ordered physical therapy which seemed to be helping so no imaging was ordered. In June my body went partially numb from the shoulders down and I was diagnosed with Transverse myelitis and eventually Neuro sarcoidosis. As I look back, I see this aligned with the pain I experienced but didn't consider back/shoulder pain to be vaccine related.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging, Myelitis transverse, Neurosarcoidosis
Clinical narrative: As a healthcare worker, I was vaccinated 5 times. Initially with Pfizer EJ1685 on 12/24/20, Again with Pfizer Ej1685 on 01/12/2021, again on 4/28/22 with Pfizer EW0187 on 04/28/2022 and 3/28/23 with (I believe Moderna), no lot # available.  I began to have acute back pain in 2021 but as a SR Director, I attributed this to long work hours and a previous car accident. The sought chiropractic care in May of 2022 because the pain was becoming unbearable and keeping me from sleeping. After that was unsuccessful, my primary care provider ordered physical therapy which seemed to be helping so no imaging was ordered. In June my body went partially numb from the shoulders down and I was diagnosed with Transverse myelitis and eventually Neuro sarcoidosis. As I look back, I see this aligned with the pain I experienced but didn't consider back/shoulder pain to be vaccine related.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Positron emission tomogram, Sleep disorder
Clinical narrative: As a healthcare worker, I was vaccinated 5 times. Initially with Pfizer EJ1685 on 12/24/20, Again with Pfizer Ej1685 on 01/12/2021, again on 4/28/22 with Pfizer EW0187 on 04/28/2022 and 3/28/23 with (I believe Moderna), no lot # available.  I began to have acute back pain in 2021 but as a SR Director, I attributed this to long work hours and a previous car accident. The sought chiropractic care in May of 2022 because the pain was becoming unbearable and keeping me from sleeping. After that was unsuccessful, my primary care provider ordered physical therapy which seemed to be helping so no imaging was ordered. In June my body went partially numb from the shoulders down and I was diagnosed with Transverse myelitis and eventually Neuro sarcoidosis. As I look back, I see this aligned with the pain I experienced but didn't consider back/shoulder pain to be vaccine related.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Chills, Decreased appetite, Erythema, Nausea
Clinical narrative: about 30 minutes after injection - pain, itching, large red spot and lump,  around bedtime got chills, nauseous, in morning pause 115-110, no appetite, ear noise, itchy, no energy, slept most of day
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pruritus, Skin mass, Somnolence, Tinnitus
Clinical narrative: about 30 minutes after injection - pain, itching, large red spot and lump,  around bedtime got chills, nauseous, in morning pause 115-110, no appetite, ear noise, itchy, no energy, slept most of day
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient describes swelling in his left arm and hand, tenderness to the touch and increased temperature in the left arm.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient was vague and said that "passed out the day after his vaccine". We assumed it was the one that we gave but unsure. He was also asking about interactions with alcohol
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Rash, Urticaria
Clinical narrative: Hives/rash along neck, both front and back. Mild pressure against throat.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Extreme head pain, nausea, shivers, fever, extreme fatigue, loss of appetite, dizzy
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Extreme head pain, nausea, shivers, fever, extreme fatigue, loss of appetite, dizzy
Age: 19.0
Sex: F
Vaccine: FLUR4, HEP, TDAP
Symptoms: Cold sweat, Dizziness, Fall, Hyperhidrosis, Mydriasis
Clinical narrative: Patient received 3 vaccinations as stated above. Once complete, I urged customer to sit for 15 minutes outside the pharmacy to monitor for side effects. She stated she felt lightheaded at that time, so I placed her feet up in a chair as well and told her to let us know if symptoms persist or worsen. After a few minutes, her friend sitting beside her called to pharmacy personnel for help. The customer was slouched down on the bench, unresponsive, eyes open, pale, and diaphoretic. Her entire body was shaking, though minimally, and she was posturing with her hands drawn inward to her chest. We called a code white at our location. Within a few moments after coming to her side, the customer aroused without additional rescue medication. When asked questions about orientation, she was able to answer all of them. She was provided a cool compress and water. She stated she felt like she had "just gone to sleep". Her friend described her posturing in the same manner and explained her eyes "were dilated and open in a crazy way." The customer quickly returned to "normal" but remained pale and clammy. She refused an ambulance. She was able to walk away from the pharmacy with her friend unassisted about 20 minutes after the event. I gathered pertinent information for reporting and told the customer to please call us with any other concerns. She stated she did not have a history of seizures, nor prior reactions to any vaccinations.
Age: 19.0
Sex: F
Vaccine: FLUR4, HEP, TDAP
Symptoms: Pallor, Posturing, Tremor, Unresponsive to stimuli
Clinical narrative: Patient received 3 vaccinations as stated above. Once complete, I urged customer to sit for 15 minutes outside the pharmacy to monitor for side effects. She stated she felt lightheaded at that time, so I placed her feet up in a chair as well and told her to let us know if symptoms persist or worsen. After a few minutes, her friend sitting beside her called to pharmacy personnel for help. The customer was slouched down on the bench, unresponsive, eyes open, pale, and diaphoretic. Her entire body was shaking, though minimally, and she was posturing with her hands drawn inward to her chest. We called a code white at our location. Within a few moments after coming to her side, the customer aroused without additional rescue medication. When asked questions about orientation, she was able to answer all of them. She was provided a cool compress and water. She stated she felt like she had "just gone to sleep". Her friend described her posturing in the same manner and explained her eyes "were dilated and open in a crazy way." The customer quickly returned to "normal" but remained pale and clammy. She refused an ambulance. She was able to walk away from the pharmacy with her friend unassisted about 20 minutes after the event. I gathered pertinent information for reporting and told the customer to please call us with any other concerns. She stated she did not have a history of seizures, nor prior reactions to any vaccinations.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Erythema, Injection site swelling, Lethargy, Mobility decreased
Clinical narrative: Itching, hives, very swollen site, lethargic, crying, red, hot, very painful when moving the arm, could not pick up anything with that arm for 3-5 days. 9 days after the vaccine, it started all over again with swelling and hives. Itching and hives started again dec. 23nd and there is still a big knot under the skin and hurts when pressing on it.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Skin mass, Skin warm, Tenderness
Clinical narrative: Itching, hives, very swollen site, lethargic, crying, red, hot, very painful when moving the arm, could not pick up anything with that arm for 3-5 days. 9 days after the vaccine, it started all over again with swelling and hives. Itching and hives started again dec. 23nd and there is still a big knot under the skin and hurts when pressing on it.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Itching, hives, very swollen site, lethargic, crying, red, hot, very painful when moving the arm, could not pick up anything with that arm for 3-5 days. 9 days after the vaccine, it started all over again with swelling and hives. Itching and hives started again dec. 23nd and there is still a big knot under the skin and hurts when pressing on it.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills, headache, muscle ache, low-grade fever; lasted 1 day, treated with Tylenol, extra strength 1 tablet, took 2 doses
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: The injection site swelled to five times is normal size, patient would not move arm, swollen lump was incredibly painful, redness spread to entire upper arm and forearm
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: pain left neck, shoulder, arm, elbow down to wrist.  3000 mg Tylenol for 10 days 12/5 - 12/20, with heating pad.  Obtained prescription Gabapentin 12/15 taken 3x's per day to 12/29 day.  Did not need Gabapentin today 12/30/23.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac failure congestive, Cardiomegaly, Chest pain, Death
Clinical narrative: Shortness of breath, swelling, chest pains, low energy, weakness, rapid heart rate 130 plus at all times, loss of appetite, extremely enlarged heart leading to shrunken lung and fluid around all organs, DEATH, started about a year ago and gradually and steadily got worse last 6 months was rapid deterioration
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dyspnoea, Effusion, General physical health deterioration, Heart rate increased
Clinical narrative: Shortness of breath, swelling, chest pains, low energy, weakness, rapid heart rate 130 plus at all times, loss of appetite, extremely enlarged heart leading to shrunken lung and fluid around all organs, DEATH, started about a year ago and gradually and steadily got worse last 6 months was rapid deterioration
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatic failure, Hepatomegaly, Laboratory test, Lung disorder, Pericardial effusion
Clinical narrative: Shortness of breath, swelling, chest pains, low energy, weakness, rapid heart rate 130 plus at all times, loss of appetite, extremely enlarged heart leading to shrunken lung and fluid around all organs, DEATH, started about a year ago and gradually and steadily got worse last 6 months was rapid deterioration
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Shortness of breath, swelling, chest pains, low energy, weakness, rapid heart rate 130 plus at all times, loss of appetite, extremely enlarged heart leading to shrunken lung and fluid around all organs, DEATH, started about a year ago and gradually and steadily got worse last 6 months was rapid deterioration
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Immobile, Immunisation reaction, Impaired work ability
Clinical narrative: The injection was injected into my left Deltoid.  Immediately, it felt sore like a normal injection. The soreness continued and became increasingly more painful  within 48 hours and I began to lose mobility in my left arm. It was painful to get dressed, shower, sleep, work. I had to stop exercising and have my husband help dress/undress me. I was unable to sleep due to the discomfort.  During this time we took a family vacation.  I woke up the second morning there and was unable to move my left arm. It had become completely imobolized. I immediately made and appointment with an ortho group in the area. After an x-ray and an exam I was diagnosed with a frozen shoulder from the flu shot.  The XRay looked great. I had no broken bones or visible injury to my shoulder. I was given a steroid injection under ultrasound. This immediately improved by mobility but not the pain.  I have been doing physical therapy and massage therapy since November-about 2 weeks after the steroid injection under ultrasound.  My mobility has improved, but the pain is still constant.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain, Periarthritis, Sleep disorder
Clinical narrative: The injection was injected into my left Deltoid.  Immediately, it felt sore like a normal injection. The soreness continued and became increasingly more painful  within 48 hours and I began to lose mobility in my left arm. It was painful to get dressed, shower, sleep, work. I had to stop exercising and have my husband help dress/undress me. I was unable to sleep due to the discomfort.  During this time we took a family vacation.  I woke up the second morning there and was unable to move my left arm. It had become completely imobolized. I immediately made and appointment with an ortho group in the area. After an x-ray and an exam I was diagnosed with a frozen shoulder from the flu shot.  The XRay looked great. I had no broken bones or visible injury to my shoulder. I was given a steroid injection under ultrasound. This immediately improved by mobility but not the pain.  I have been doing physical therapy and massage therapy since November-about 2 weeks after the steroid injection under ultrasound.  My mobility has improved, but the pain is still constant.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan, X-ray limb normal
Clinical narrative: The injection was injected into my left Deltoid.  Immediately, it felt sore like a normal injection. The soreness continued and became increasingly more painful  within 48 hours and I began to lose mobility in my left arm. It was painful to get dressed, shower, sleep, work. I had to stop exercising and have my husband help dress/undress me. I was unable to sleep due to the discomfort.  During this time we took a family vacation.  I woke up the second morning there and was unable to move my left arm. It had become completely imobolized. I immediately made and appointment with an ortho group in the area. After an x-ray and an exam I was diagnosed with a frozen shoulder from the flu shot.  The XRay looked great. I had no broken bones or visible injury to my shoulder. I was given a steroid injection under ultrasound. This immediately improved by mobility but not the pain.  I have been doing physical therapy and massage therapy since November-about 2 weeks after the steroid injection under ultrasound.  My mobility has improved, but the pain is still constant.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 2" diameter red lump on injection site, painful, persisting into day 2.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: soreness, swelling, redness, warmth, 4 small red dots, all at injection site.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Blood calcium, Blood magnesium, Full blood count, Laboratory test, Liver function test
Clinical narrative: Tingling of left hand, left foot, left face
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia
Clinical narrative: Tingling of left hand, left foot, left face
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Respiratory symptom, SARS-CoV-2 test negative, Sinusitis
Clinical narrative: My wife and I both received the RSV vaccine and a day later had upper respiratory and sinusitis symptoms which we still have 3 days later. These side effects were not listed in the description of the vaccine. It is too much of a coincidence that both my wife and I would have these symptoms and be the result of other exposure to pathogens.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, COVID-19
Clinical narrative: Tested positive for Covid twice in 5 months and became frequently ill with common colds way above average for an adult. 12 illnesses within 12 months and it has continued. CBC trends showed decreasing WBC count from time of vaccination to present.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Differential white blood cell count, Malaise, Nasopharyngitis, Red blood cell nucleated morphology, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid twice in 5 months and became frequently ill with common colds way above average for an adult. 12 illnesses within 12 months and it has continued. CBC trends showed decreasing WBC count from time of vaccination to present.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Tested positive for Covid twice in 5 months and became frequently ill with common colds way above average for an adult. 12 illnesses within 12 months and it has continued. CBC trends showed decreasing WBC count from time of vaccination to present.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient had a quarter sized purplish bruise on her upper arm at injection site. The pain was only to the touch. This was 6 days after the injection.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: In the early morning hours of 12/28 I began to experience diarrhea. Throughout that day (12/28) I had an unsettled stomach, diarrhea, serious chills, nausea, aching joints and muscles, fatigue and a mild headache. I had no fever. The next day ((12/29) was better but I still had an unsettled stomach, diarrhea, and a mild headache. By 12/30, I was feeling pretty well again. I have never had a reaction to a flu, Covid or other vaccine. I have no ideas if this was a result of the vaccine but it was a very unusual event for me. I am in pretty good health and I have no idea where this may have come from. I am pretty certain it didn't come from any food I had.  I realize this is probably unusual since it was several days after the vaccination. I leave it up to your experience and knowledge of other reports but, I thought it was worth reporting.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: In the early morning hours of 12/28 I began to experience diarrhea. Throughout that day (12/28) I had an unsettled stomach, diarrhea, serious chills, nausea, aching joints and muscles, fatigue and a mild headache. I had no fever. The next day ((12/29) was better but I still had an unsettled stomach, diarrhea, and a mild headache. By 12/30, I was feeling pretty well again. I have never had a reaction to a flu, Covid or other vaccine. I have no ideas if this was a result of the vaccine but it was a very unusual event for me. I am in pretty good health and I have no idea where this may have come from. I am pretty certain it didn't come from any food I had.  I realize this is probably unusual since it was several days after the vaccination. I leave it up to your experience and knowledge of other reports but, I thought it was worth reporting.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: PERSISTANT UPPER ARM SORENESS SINCE VACCINE ADMINISTRATION, ESPECIALLY AT BEDTIME. NO IMPROVEMENT WITH OTC PAIN RELIEVERS. PATIENT SUSPENTS IMMUNIZER INJECTED TOO HIGH, MISSING THE DELTOID AND INTO THE BURSA.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Condition aggravated, Cough, Dyspnoea, Nasal congestion
Clinical narrative: At 4 a.m. after taking the vaccination the previous evening I woke up experiencing symptoms of asthma, including coughing, not able to breathe, vomiting, two welts raised on my face, one on the left cheek, the other beneath my right eye, Both nostrils were full of phelgm so I could not breathe out of my nose. I tried my asthma inhaler, Claritin, neti pot, saline gargle, Nasonex. MyO2 dropped to 93. Using compressed oxygen, I was able to get the level up to 98. The entire incident last about 90 minutes.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oxygen saturation decreased, Urticaria, Vomiting
Clinical narrative: At 4 a.m. after taking the vaccination the previous evening I woke up experiencing symptoms of asthma, including coughing, not able to breathe, vomiting, two welts raised on my face, one on the left cheek, the other beneath my right eye, Both nostrils were full of phelgm so I could not breathe out of my nose. I tried my asthma inhaler, Claritin, neti pot, saline gargle, Nasonex. MyO2 dropped to 93. Using compressed oxygen, I was able to get the level up to 98. The entire incident last about 90 minutes.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Caesarean section, Discomfort, Exposure during pregnancy, Gait disturbance
Clinical narrative: 2 days after vaccination, I experienced severe myalgias and arthralgias. Due to this discomfort I was not able to walk much. 3 days into this reaction, I started to experience hand and wrist weakness, so much so that I could not open jars. I also developed a rash on my abdomen. I was vaccinated at 31 weeks gestation; my pregnancy was medically uncomplicated. I delivered at 38 weeks via planned repeat c-section, birth weight was 6 lb 15 oz (female). No complications during delivery. My daughter was recently diagnosed with cerebral palsy (per MRI brain) that is thought to be due to a white matter injury occurring between weeks 30-34 of gestation (according to neuroradiology and neurology at Hospital, which is a world renowned hospital). Oligodendrocyte precursors (which make myelin / white matter) are particularly vulnerable during this time of gestation, and there has been a question of whether they may have been injured during the inflammatory response I mounted after vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Myalgia, Pain, Rash
Clinical narrative: 2 days after vaccination, I experienced severe myalgias and arthralgias. Due to this discomfort I was not able to walk much. 3 days into this reaction, I started to experience hand and wrist weakness, so much so that I could not open jars. I also developed a rash on my abdomen. I was vaccinated at 31 weeks gestation; my pregnancy was medically uncomplicated. I delivered at 38 weeks via planned repeat c-section, birth weight was 6 lb 15 oz (female). No complications during delivery. My daughter was recently diagnosed with cerebral palsy (per MRI brain) that is thought to be due to a white matter injury occurring between weeks 30-34 of gestation (according to neuroradiology and neurology at Hospital, which is a world renowned hospital). Oligodendrocyte precursors (which make myelin / white matter) are particularly vulnerable during this time of gestation, and there has been a question of whether they may have been injured during the inflammatory response I mounted after vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exercise tolerance decreased, Headache
Clinical narrative: Same day developed a horrible throbbing headache  mostly in forehead area that pulsed with every heartbeat.  Very painful and constant for first 2 weeks.  It gets worse with physical activity when I try to work out.  Somedays it is worse than others, but it still has not gone away.  I NEVER experienced headaches like this in my whole life.  It's horrible. I wish I had never gotten this shot.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Sore arm, Redness around injection site, chills, body aches, slight headache.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: First 24 hours: headache, fever, chills. Severe headache for next 10 days
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Pt received RSV vaccine on 12/15/2023 from immunizer. Pt states immunizer pinched skin and injected vaccine but was not in correct location. Immunizer pinched too much skin and ended up injecting pt lower and inward toward tricep. Pt states that injection site was initially red, swollen, painful, and bump appeared under skin. Pt states injections site is still painful and bump still present today 12/31/23 though redness and swelling has subsided. Confirmed pt did not have a fever or any other side effects after vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: One day after the Shingles vaccine, patient report redness, itchiness at the injection site. Radius of about 3-4inches. Pt did not use any product/drug. Resolved on its own within 1 day.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, tenderness, redness to left upper arm that continued spreading rather than decreasing/abating over the subsequent days following the vaccination.  Patient seen for this event on 12/30/23.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral infarction, Cerebrovascular accident, Computerised tomogram head abnormal, Deaf mutism, Death
Clinical narrative: Apparently experienced stroke on evening of 2/18/21. Lived alone. Discovered on floor in her apartment morning of 2-20-21 on a wellness check by building staff. Taken to hospital. Was deaf/mute so complete workup done including CT scan. CT results were "multiple small infarcts" scattered throughout brain. Significant neural deficits noted as well as dysphagia. Began eating small amounts about 2/24. Transferred to rehabilitation center on 2/28.  Not found to meet criteria for rehab in about 2-3 days. Reclassifed as long term care. Appeared to be stable for several days. Was found unresponsive on March 7 and died shortly after on the same day.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Neurological symptom, Unresponsive to stimuli
Clinical narrative: Apparently experienced stroke on evening of 2/18/21. Lived alone. Discovered on floor in her apartment morning of 2-20-21 on a wellness check by building staff. Taken to hospital. Was deaf/mute so complete workup done including CT scan. CT results were "multiple small infarcts" scattered throughout brain. Significant neural deficits noted as well as dysphagia. Began eating small amounts about 2/24. Transferred to rehabilitation center on 2/28.  Not found to meet criteria for rehab in about 2-3 days. Reclassifed as long term care. Appeared to be stable for several days. Was found unresponsive on March 7 and died shortly after on the same day.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Blepharospasm, Laziness, Lethargy
Clinical narrative: Eye twitching and lethargy/laziness.
Age: 67.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Tinnitus
Clinical narrative: Customer said she has had ringing in the ears since the vaccine was given
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Condition aggravated, Dizziness, Fatigue
Clinical narrative: unsure if RSV (abrysvo or other)-given at Facility. This will be in my electronic health record.After not hav ing any Atrial Fibrillation events for 11 months, I had an event 3 days after RSV vaccination.   I could not identify any triggering events ( the only triggering event I determined in the past was alcohol- as little as a glass of wine).  My heart rate went from 60 to 188 quickly, necessitated taking Diltiazem & Flecainide to bring rate & rhythm back to normal range (80's).  I felt dizzy/lightheaded and unusually tired for 2-3 days after.
Age: 75.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Patient states that since she received the vaccine she has been experiencing blurry vision and dizziness. She also experienced nausea the day after receiving the vaccines. Patient was advised to follow up with her physician.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Moderate tinnitus increased substantially in left ear and onset of tinnitus in right ear
Age: 81.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Aphasia, Brain fog
Clinical narrative: I could not put two syllables together to make any sense, although I knew what I wanted to say to my friends. It lasted at least ten minutes. I did not have any other adverse effect that I am aware of, although I think that there was lingering "brain fog". My husband drove me to primary care office where we were told to drive directly to hospital in next town because that would be faster than waiting for ambulance (agreed).
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Chills, Decreased appetite, Fatigue, Malaise
Clinical narrative: mild chest pain; tiredness; fever; chills; decreased appetite; feeling unwell
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: mild chest pain; tiredness; fever; chills; decreased appetite; feeling unwell
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient reports that approximately 48 hours post-HD influenza immunization, she started experiencing an itchy rash/redness on various parts of her body. She reports that it moves to different areas of her body - she has been using Zyrtec and hydrocortisone cream (unsure if it is OTC or Rx) since rash appeared. Patient reports that she is contemplating seeing a dermatologist as this has persisted daily since the first appearance.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Oedema, Pain, Urticaria
Clinical narrative: Localized erythema, edemitis, urticaria, painful, hardened area of approximately an inch wide and half and inch tall
Age: 56.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Tinnitus, Vertigo
Clinical narrative: 1. Tinnitus, ringing in both ears: Starting ~ 10/14/2023, currently ongoing; no change.   2. Vertigo/spinning, only immediately after lying down and sitting up from lying down, and sometimes when turning head while lying down. Vertigo started 10/14/2023 and is currently on-going and consistently occurs, however, the intensity/length in time of spinning changes each time and I cannot pinpoint a factor that effects the intensity. The changes are random, and it is not as though it was more intense near the start of it occurring and less now. The spinning lasts about 10 seconds at the longest and typically about 5 seconds.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Immunisation reaction
Clinical narrative: We talked to the patient's dad on 12/31/23 and he states there was no adverse effects besides the normal side effects that patient had experienced previously with the previous pfizer covid vaccines. Dad states patient only felt that way for the first day and since has been doing well with no other complaints. The vaccine has a manufacturer's expiration date of 4/31/24 with a beyond use date of 12/20/23.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: We called mom today on 12/31/23 to see how patient is doing and explained to mom that we had administered the vaccine 2 days after the "beyond use date" for the vaccine. Mom states that patient is currently potty training and has been going to restroom more often with no sign of diarrhea. This may or may not be an adverse effect of the vaccine since potty training may cause a child to experience changes in their bathroom activities and might not correlate to the vaccine. Mom states patient experience symptoms of arm sore with the vaccine, similarly to what he got from a previous covid vaccine. Mom states that patient is currently doing well with no complaints.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, Laboratory test, Muscle spasms, Pulseless electrical activity, Vocal cord dysfunction
Clinical narrative: Severe muscle spasms and cramps. Vocal cord dysfunction. Respiratory arrest to cardiac arrest. All happening from April 11th- P.E.A. Arrest 7-4-2021
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Patient got COVID in September 2022. Tinnitus began and has not ceased since the onset of COVID
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: 5days of severe HA, cough, sob, fatigue, that suddenly stopped, then 3d of diarrhea, nausea, no vomting.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Nausea
Clinical narrative: 5days of severe HA, cough, sob, fatigue, that suddenly stopped, then 3d of diarrhea, nausea, no vomting.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, TDAP, UNK
Symptoms: Biopsy skin, Rash
Clinical narrative: Broke out in a rash under both of my arms and the rash lasted 1-2 weeks cleared up and came back a month later and it was worst then the first time it happens every time I take a shot
Age: 14.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: fluzone qiv hd administered to a minor patient with no reported adverse event; patient was supposed to receive the Flumist Nasal Spray but she grabbed the FLUZONE QIV HD and inadvertently gave it to intranasally with no reported adverse event; patient was supposed to receive the Flumist Nasal Spray but she grabbed the FLUZONE QIV HD and inadvertently gave it to intranasally with no reported adverse event; Initial information received from Regulatory Authority on 18-Dec-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 14 years old male patient to whom influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] was administered who was supposed to receive the Influenza Vaccine Live Reassort 3v (Flumist) nasal Spary but she grabbed the Fluzone QIV HD and inadvertently gave it to intranasally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the minor patient received (dose 1) of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine, (lot 370679: formulation, strength and expiry date; unknown) via nasal route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (unknown latency).  On an unknown date the was supposed to receive the flumist nasal spray but she grabbed the fluzone qiv hd and inadvertently gave it to intranasally with no reported adverse event (wrong product administered) (incorrect route of product administration) (unknown latency).    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: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administering vaccines subcutaneously to patients; Reason for deletion: No GSK suspect
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Gait inability
Clinical narrative: extreme joint pain; Unable to walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: extreme joint pain) and unable to walk (Verbatim: Unable to walk). The outcome of the joint pain and unable to walk were not reported.   It was unknown if the reporter considered the joint pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the joint pain and unable to walk to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-DEC-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media.  The patient reported that got extreme joint pain of almost unable to walk The reported that all symptoms except injection site pain. The patient reported that he/she scared badly.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: was due to have 2nd when everything shut down for pandemic; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: was due to have 2nd when everything shut down for pandemic). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 27-DEC-2023  The patient was due to have 2nd dose of Shingrix when everything shut down for pandemic (pandemic shutdown caused her to miss 2nd vaccine). The patient asked if she could still get 2nd shot or she should start series over? There was no information about having the 2nd shot years later There was no information regarding this gap. The patient stated that length of a gap was surprised by this because she could not be the only one affected that way. The patient stated that one pharmacist told her 2nd shot was not worthwhile, primary physician did not  know what to advise. The patient asked, what is GlaxoSmithKline (GSK) advising to people with years since 1st vaccine? The patient thought that GSK needs to address this issue As the CDC had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients do not need to restart the vaccine series. The patient stated that, more than 6 months was very different than almost 4 years.  The patient look forward to hearing more from the safety department.