chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: dose of expired Pentacel was given to a patient with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 months old female patient who had dose of expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past vaccination(s) included VAXELIS with previous three doses in the series against DTaP, IPV, and hib. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation.  On 26-Oct-2023, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ791AA, expiry date- 10-OCT-2023) via unknown route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, reporter asked, What information do you have for a Pentacel dose that was expired at the time of administration. This was the fourth dose in the series for the patient's vaccination against DTaP, IPV, and hib. The patient received Vaxelis for the previous three doses in the series. The dose was administered by a nurse.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: I had delayed urticaria (no itch) on my neck, arms & back. It appeared on the 2nd day after my vaccine was administered. This was despite taking benadryl after I received my shot. I took benadryl each day after as a preventative and the rash still came.  I have developed this type of rash every time I get a covid vaccine, usually on the 2nd day. It usually takes about 3 or 4 days to recede.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: patient received spikevax on 11/4/2023 and she reports having a red round rash around the injection site about 2-2.5 inches in diameter. she reports that the rash has not grown in size, does not feel warm to the touch, has not changed colors since appearing, and is itchy but does not cause pain/discomfort
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This is the spikevax  50  - Within a few hours, sore arm.  By the next morning (+14 hours) injection site is inflamed, hot to touch, red  and itchy.  Area is 4"x4" and spreading.  Took acetaminophen 1000mg morning and 6 hours later for minor decrease in redness, pain, and itchiness.  Area is sore, red, itchy for 4 days.  5th day and redness has diminished.  Still slightly itchy and sore.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is the spikevax  50  - Within a few hours, sore arm.  By the next morning (+14 hours) injection site is inflamed, hot to touch, red  and itchy.  Area is 4"x4" and spreading.  Took acetaminophen 1000mg morning and 6 hours later for minor decrease in redness, pain, and itchiness.  Area is sore, red, itchy for 4 days.  5th day and redness has diminished.  Still slightly itchy and sore.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: her arm started swelling; her arm became red/arm is very red; her arm is very red, and has red dots, like a rash; the patient has pain, and her arm is still very sore today; the patient has itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-OCT-2023, the patient received Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: the patient has pain, and her arm is still very sore today), itchy upper limbs (Verbatim: the patient has itching) and red rash (Verbatim: her arm is very red, and has red dots, like a rash). On 25-OCT-2023, the patient experienced swelling arm (Verbatim: her arm started swelling) and erythema of extremities (Verbatim: her arm became red/arm is very red). The outcome of the pain in arm, itchy upper limbs, swelling arm, erythema of extremities and red rash were not resolved.   It was unknown if the reporter considered the pain in arm, itchy upper limbs, swelling arm, erythema of extremities and red rash to be related to Arexvy.     It was unknown if the company considered the pain in arm, itchy upper limbs, swelling arm, erythema of extremities and red rash to be related to Arexvy.  Additional Information: GSK Receipt Date: 31-OCT-2023 The reporter was the husband calling on behalf of his wife who was a patient, and was also on the phone, and reported that she received her Arexvy vaccine and her arm started swelling and became red. The reporter stated that the patient's arm was bright, bright, red about 6 to 8 inches, the patient had itching and pain, and her arm was still very sore today (till the time of reporting). The patient reports that her arm was very red, and has red dots, like a rash, still today (till the time of reporting). The patient did not have any lot/expiry information or route of administration. The patient reports her arm was feeling better yesterday, 30-OCT-2023, but it came back today on 31-OCT-2023. Consent to follow up with HCP was not obtained.  The reporter did not consent to follow-up.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: hardness in the injection site; swelling in the injection site; Redness in the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE NODULE (hardness in the injection site), INJECTION SITE SWELLING (swelling in the injection site) and INJECTION SITE ERYTHEMA (Redness in the injection site) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 03-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE NODULE (hardness in the injection site), INJECTION SITE SWELLING (swelling in the injection site) and INJECTION SITE ERYTHEMA (Redness in the injection site). At the time of the report, INJECTION SITE NODULE (hardness in the injection site), INJECTION SITE SWELLING (swelling in the injection site) and INJECTION SITE ERYTHEMA (Redness in the injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the 2nd dose of Shingrix 30 days after receiving the 1st one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received the 2nd dose of Shingrix 30 days after receiving the 1st one). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date-31-OCT-2023 The pharmacist reported that the patient received the 2nd dose of Shingrix 30 days after receiving the 1st dose, which led to shortening of vaccine schedule. The pharmacist consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 2nd dose of Shingrix on 31-Oct-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) (batch number HT7XM, expiry date 15-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix in 2021).   On 31-OCT-2023, the patient received the 2nd dose of Shingrix. On 31-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received 2nd dose of Shingrix on 31-Oct-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 1-Nov-2023 The pharmacist did not want to provide patient's date of birth or initials. Did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None occured
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Fatigue, Herpes zoster, Injection site pain, Pain
Clinical narrative: bruising / extreme fatigue/ soreness at injection site/ body aches / shingles symptoms started within 36 hours of injection
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Hypersomnia, Vertigo
Clinical narrative: Vertigo from 1:00 AM to 6:00 PM Extreme fatigue - slept roughly 20/24 hours from 1:00 AM on
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Herpes zoster, Hypoaesthesia, Mobility decreased, Swelling face
Clinical narrative: Got a Pfizer covid vaccine and flu vaccine at pharmacy. Face swelled up and got Shingles! Loss of movement and numbness in fingertips and arm. Had to go to emergency room. Now have lifetime shingles! I am only 38
Sex: U
Vaccine: COVID19
Symptoms: Colitis
Clinical narrative: Pt. reports about a week after getting the Pfizer covid vaccine, pt developed colitis which is still an ongoing problem.
Age: 40.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Pregnant woman (35 weeks) was given wrong RSV vaccine. Instead of Abrysvo she received Arexvy. Before giving the shot pharmacist looked up vaccine information and the only information was found is that the RSV (not specific name) was just recently approved for pregnant women bw weeks 32-36. Then pharmacist looked up the difference b/w Abrysvo and Arexvy and the information found was only difference in strain protection. At the time pharmacist did not find any information indicating that one vaccine is for pregnant women and another (Arexvy) for people 60 years and older. With that information vaccine was given to the patient.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Blood test abnormal, Malaise
Clinical narrative: After receiving the vaccine a few months later I began getting sick for no reason and in extreme pain in my joints. The pain has gotten worse and worse since. I went to the doctor to see what's going on and now my blood work shows I have a autoimmune desease that was never there before! This seems to be happening to alot of people!
Age: 80.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Contusion, Sleep disorder, Swelling face
Clinical narrative: Went to Pharmacy and got a COVID and Flu shot. The next day he had a large bruise on the arm he had the Covid shot in. The right arm had a bruise and the right side of his face swelled. The reaction made it hard for him to sleep. He takes multiple medications.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Patient complaint of nausea/vomiting for 2 days since the vaccine was administered. Pt is not able to keep anything down including ice chips
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: I took the Shingrix vaccine around 2:00 PM. Then I had chills all throughout the night. Then I developed a 101 fever. I'm currently enduring these side effects as I write.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Exercise tolerance decreased, Fatigue, Headache
Clinical narrative: Had my COVID booster (Pfizer) at clinic on 10/14/23. On 10/15/23 I felt headache, muscle aches, and fatigue. None of which seemed out of the ordinary. On 10/18/23 I started to feel heart palpitations and irregular heart beat. Shortness of breath and extreme fatigue on exertion. Continuing as of present 11/3/23. Have visited acute care and seen a cardiologist. Had an echocardiogram performed and result show trace mitral and tricuspid valve regurgitation. I am a 67 year old female. I exercise everyday and work in my garden also everyday. I have felt in excellent health until immediately after the COVID booster vaccine. I have had to stop my exercise regime as I am unable to do any exercise due to the onset of fatigue and palpitations whenever I try.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Immediate post-injection reaction, Mitral valve incompetence, Myalgia, Palpitations
Clinical narrative: Had my COVID booster (Pfizer) at clinic on 10/14/23. On 10/15/23 I felt headache, muscle aches, and fatigue. None of which seemed out of the ordinary. On 10/18/23 I started to feel heart palpitations and irregular heart beat. Shortness of breath and extreme fatigue on exertion. Continuing as of present 11/3/23. Have visited acute care and seen a cardiologist. Had an echocardiogram performed and result show trace mitral and tricuspid valve regurgitation. I am a 67 year old female. I exercise everyday and work in my garden also everyday. I have felt in excellent health until immediately after the COVID booster vaccine. I have had to stop my exercise regime as I am unable to do any exercise due to the onset of fatigue and palpitations whenever I try.
Sex: F
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence
Clinical narrative: Had my COVID booster (Pfizer) at clinic on 10/14/23. On 10/15/23 I felt headache, muscle aches, and fatigue. None of which seemed out of the ordinary. On 10/18/23 I started to feel heart palpitations and irregular heart beat. Shortness of breath and extreme fatigue on exertion. Continuing as of present 11/3/23. Have visited acute care and seen a cardiologist. Had an echocardiogram performed and result show trace mitral and tricuspid valve regurgitation. I am a 67 year old female. I exercise everyday and work in my garden also everyday. I have felt in excellent health until immediately after the COVID booster vaccine. I have had to stop my exercise regime as I am unable to do any exercise due to the onset of fatigue and palpitations whenever I try.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity, Restlessness
Clinical narrative: Patient experienced being fidgety the following day after administration, then the day after experienced neck pain that progressed to the shoulder of the opposite arm that he received the vaccine. Patient stated since the, the pain keeps alternating from the right to the left side of his neck that shoots down to the same side of shoulder/arm, but not the same side daily, either one or the other side.
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Pt reports she fainted and was transported to the ER.
Sex: U
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Rash
Clinical narrative: pt reports getting rashes, eczema all over body, bottom of ankles, front and back, elbows, all over legs, parts of torso, went up legs around 3 months after 1st covid-19 vaccine, extreme itching
Sex: M
Vaccine: COVID19
Symptoms: Alcohol poisoning, Blood creatinine increased, Fall, Femoral neck fracture, Gait disturbance
Clinical narrative: Left Femoral Neck Fracture. On 11/3/2023, patient notes as mildly intoxicated at home. Patient tripped and fell while putting on pants, landing directly on his left hip. Patient presented to the ED 11/3/2023 with concern of fall and left leg pain. Patient denied striking head of loss of consciousness. At time of admission, patient denied any symptoms prior to the fall including chest pain, shortness of breath, dizziness, or lightheadedness. X-ray of hip showed left femoral neck fracture. On 11/4/2023, patient underwent uncomplicated left hip hemiarthroplasty. Patient is attending physical therapy and in admission with concern of fall risk. Admission is ongoing at time of this report. Barriers to Discharge Home: Safety concerns, Fall risk, Current functional status, Inaccessible home environment, Limited caregiver availability Pain limiting progress at this time. On 07/19/2022, subject received the Janssen Ad26.CoV2.S vaccine for a research study.
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hip arthroplasty, International normalised ratio normal, Joint injury
Clinical narrative: Left Femoral Neck Fracture. On 11/3/2023, patient notes as mildly intoxicated at home. Patient tripped and fell while putting on pants, landing directly on his left hip. Patient presented to the ED 11/3/2023 with concern of fall and left leg pain. Patient denied striking head of loss of consciousness. At time of admission, patient denied any symptoms prior to the fall including chest pain, shortness of breath, dizziness, or lightheadedness. X-ray of hip showed left femoral neck fracture. On 11/4/2023, patient underwent uncomplicated left hip hemiarthroplasty. Patient is attending physical therapy and in admission with concern of fall risk. Admission is ongoing at time of this report. Barriers to Discharge Home: Safety concerns, Fall risk, Current functional status, Inaccessible home environment, Limited caregiver availability Pain limiting progress at this time. On 07/19/2022, subject received the Janssen Ad26.CoV2.S vaccine for a research study.
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain in extremity, Platelet count increased, Vascular calcification, White blood cell count decreased
Clinical narrative: Left Femoral Neck Fracture. On 11/3/2023, patient notes as mildly intoxicated at home. Patient tripped and fell while putting on pants, landing directly on his left hip. Patient presented to the ED 11/3/2023 with concern of fall and left leg pain. Patient denied striking head of loss of consciousness. At time of admission, patient denied any symptoms prior to the fall including chest pain, shortness of breath, dizziness, or lightheadedness. X-ray of hip showed left femoral neck fracture. On 11/4/2023, patient underwent uncomplicated left hip hemiarthroplasty. Patient is attending physical therapy and in admission with concern of fall risk. Admission is ongoing at time of this report. Barriers to Discharge Home: Safety concerns, Fall risk, Current functional status, Inaccessible home environment, Limited caregiver availability Pain limiting progress at this time. On 07/19/2022, subject received the Janssen Ad26.CoV2.S vaccine for a research study.
Sex: M
Vaccine: COVID19
Symptoms: X-ray of pelvis and hip abnormal
Clinical narrative: Left Femoral Neck Fracture. On 11/3/2023, patient notes as mildly intoxicated at home. Patient tripped and fell while putting on pants, landing directly on his left hip. Patient presented to the ED 11/3/2023 with concern of fall and left leg pain. Patient denied striking head of loss of consciousness. At time of admission, patient denied any symptoms prior to the fall including chest pain, shortness of breath, dizziness, or lightheadedness. X-ray of hip showed left femoral neck fracture. On 11/4/2023, patient underwent uncomplicated left hip hemiarthroplasty. Patient is attending physical therapy and in admission with concern of fall risk. Admission is ongoing at time of this report. Barriers to Discharge Home: Safety concerns, Fall risk, Current functional status, Inaccessible home environment, Limited caregiver availability Pain limiting progress at this time. On 07/19/2022, subject received the Janssen Ad26.CoV2.S vaccine for a research study.
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient received Arexvy (RSV vaccine) and Afluria (flu shot) in one arm and the patient had reddness and swelling from the injectionsite all the ay down to elbow. Patient is also having some pain in the arm.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Onset of (L) shoulder pain/heaviness day following vaccine. Persistent pain in (L) arm, exam findings of impingement in (L) shoulder 1 month after vaccine.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Headache, Influenza like illness, Lethargy, Pain
Clinical narrative: Flu like symptoms, headache, temperature, aching body and lethargy.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given.  Expiration date is 10/10/2023.  Patient will receive a new dose in 1 month.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: RED BUMPY RASH ON VACCINATION AREA
Age: 56.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus, Sensitive skin
Clinical narrative: He received both the flu and Moderna COVID vaccine on Thursday morning 10/26, and woke up on Saturday morning 10/28 with symmetrical reaction starting at palms with erythema, swelling, and itching, then spreading to the back of his bil hands and wrists. They were very heat sensitive from hot water when he was taking a shower, which is how he first noticed it. He states the worst day was Saturday, when he couldn?t even close his hands. He tried Zyrtec and Benadryl which made him sleepy and he was unsure how much it helped. Sunday morning the reaction spread to his the tops and bottoms of both feet, with slight swelling, erythema and itching. His feet were never as bad as his hands. It really improved 10/30, and 10/31 there was slight redness around wrists and some itching, but overall better.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site induration, Injection site warmth
Clinical narrative: Feeling of being "hot," firm lump at site of injection, head feels "strange."
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Inflammation immediately upon vaccination.  Numbness in hands and feet, especially outside toes and fingers.  Acute inflammation in shoulders in the joint areas of each side.  Numbness in heels of feet.   Doctors were consulted and said the symptoms would go away in a few days.  They did not.  Subsequent visits to doctors produced no diagnosis or remedy to numbness and inflammation.  Symptoms have persisted for the last 2 years and have appeared to worsen.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Pt avoids vaccines in R arm d/t severe lymphadenopathy that began after the initial COVID vaccine and continued with subsequent vaccines in R arm (physician recommended she no longer receive vax in R arm). After injection on 10/9/23, felt immediate pain. Later took ibuprofen which helped. On 10/10, she developed shoulder pain. She has been taking ibuprofen around the clock, but pain has progressed to becoming worse at night, keeping her awake, and has limited ROM in L arm with feelings of stiffness and numbness. Employee is left hand dominant. Trialed range of motion exercises. Trialed 5d course of prednisone 20 mg which did not help. Received a cortisone injection at orthopedist in shoulder on 11/2/23.   Pt stated she had emailed yesterday, and when told her manager, the manager advised she open an incident. Pt states he numbness is in her deltoid/upper arm which goes away with movement. Pt states that it is worse in the morning after sleeping on it. She puts heat packs on it which seem to help.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Sleep disorder
Clinical narrative: Pt avoids vaccines in R arm d/t severe lymphadenopathy that began after the initial COVID vaccine and continued with subsequent vaccines in R arm (physician recommended she no longer receive vax in R arm). After injection on 10/9/23, felt immediate pain. Later took ibuprofen which helped. On 10/10, she developed shoulder pain. She has been taking ibuprofen around the clock, but pain has progressed to becoming worse at night, keeping her awake, and has limited ROM in L arm with feelings of stiffness and numbness. Employee is left hand dominant. Trialed range of motion exercises. Trialed 5d course of prednisone 20 mg which did not help. Received a cortisone injection at orthopedist in shoulder on 11/2/23.   Pt stated she had emailed yesterday, and when told her manager, the manager advised she open an incident. Pt states he numbness is in her deltoid/upper arm which goes away with movement. Pt states that it is worse in the morning after sleeping on it. She puts heat packs on it which seem to help.
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Fatigue, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: Vomiting, fever, dizziness & fatigue
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pyrexia, Urine analysis, Vomiting
Clinical narrative: Vomiting, fever, dizziness & fatigue
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: She initially had localized arm pain for the first couple of days. She states she was sick around the same time as the COVID vaccine and felt achy on Friday, so it took her a little bit of time to realize it was just in her shoulder.  Since she filed the incident report on 10/30/23, she states her shoulder is exactly the same. She filed the incident on day 4 of 4 shifts in a row, and works in the ICU. She has been off the last few days, starts her week again on Sat for 4 shifts in a row.  Patient states it hurts to raise her arm above the level of shoulder in any direction ? laterally, in front, behind. She states it is the worst when crossing her arms in front of her as if she is taking off a sweatshirt. Over the 10/28 weekend, it now hurts when her arm is hanging down from her shoulder, when pulling the joint downward. She states that sleeping is okay.  She has applied heat, which feels better than ice. She has tried to do stretching, but painful to do ROM with rotation. Provided ROM exercises. Referred to Physical Therapy.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This child was given an adult dose of covid-19 vaccine instead of the child dosing.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid irritation, Headache, Ocular discomfort, Swelling of eyelid
Clinical narrative: Approximately 5 hours after vaccination patient developed a mild headache with right temple and right eye discomfort alleviated by Children's Motrin. The next day upon awakening around 7am, patient had right upper eyelid swelling and discomfort.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This child was given an adult dose of covid-19 vaccine instead of the child dose.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Panic attack, Rash, Raynaud's phenomenon, Sjogren's syndrome
Clinical narrative: Severe hives and rash all over body that did not go away for 4 full weeks of prescription steroids. Also began having panic attacks / full blown anxiety, which has never been my nature and within the year was diagnosed with Sjogrens, Lupus and Raynauds Syndrome.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus, Urticaria
Clinical narrative: Severe hives and rash all over body that did not go away for 4 full weeks of prescription steroids. Also began having panic attacks / full blown anxiety, which has never been my nature and within the year was diagnosed with Sjogrens, Lupus and Raynauds Syndrome.
Age: 1.67
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pyrexia, Rash, Serum sickness, Skin discolouration, Urticaria
Clinical narrative: Abrupt hive like rash starting on 11/6.  Discrete separated hives clustered around L lateral chest wall/axillary region and more diffuse on back and abdomen. confluent at posterior neck and diaper line. no facial, palmar, oral or perineal involvement  progressed and spread  on 11/7, involving face, majority of trunk. became more purple in color with central clearing and surrounding erythema. developed fever 100.5. seen in ED and by dermatology econsult. differential diagnosis was serum sickness versus acute urticaria versus urticaria multiforme. treated with antihistamines and topical steroids
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Brain fog, Headache, Migraine
Clinical narrative: Headache and migraine, constant headaches, general brain fog. Migraine was sudden onset Saturday night at 9:00 pm. Tylenol lessens pain. Headaches and migraines are still ongoing.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient is a 17 y.o. year old female patient who presents for Arm Pain (Acc by dad) received Men B 10/30/23 Right upper arm, started that night complains of soreness, red, swollen, burning, hot to touch, itchy.)
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Anaphylactic reaction, Blood test, Dizziness, Dyspnoea
Clinical narrative: swelling of neck, tongue, ears, face, throat - anaphylactic reaction. Shortness of breath. Generalized pain and swelling of both hands. Dizziness, blurred vision. Face was red. Called 911 taken to hospital and admitted for 24 hrs. Epinephrine given, steroids, heparin. ENT consult, numerous blood test. seen by allergist 2 days after discharge. Tested for everything for 8 hrs (medications, foods and environmental).
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Ear swelling, Electrocardiogram, Erythema, Pain, Peripheral swelling
Clinical narrative: swelling of neck, tongue, ears, face, throat - anaphylactic reaction. Shortness of breath. Generalized pain and swelling of both hands. Dizziness, blurred vision. Face was red. Called 911 taken to hospital and admitted for 24 hrs. Epinephrine given, steroids, heparin. ENT consult, numerous blood test. seen by allergist 2 days after discharge. Tested for everything for 8 hrs (medications, foods and environmental).
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Swelling, Swelling face, Swollen tongue, Vision blurred
Clinical narrative: swelling of neck, tongue, ears, face, throat - anaphylactic reaction. Shortness of breath. Generalized pain and swelling of both hands. Dizziness, blurred vision. Face was red. Called 911 taken to hospital and admitted for 24 hrs. Epinephrine given, steroids, heparin. ENT consult, numerous blood test. seen by allergist 2 days after discharge. Tested for everything for 8 hrs (medications, foods and environmental).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Gastrointestinal disorder, Influenza, Infrequent bowel movements, Pyrexia
Clinical narrative: Extreme GI issues (started pooping every 9-10 days instead of 3-5 times in one single day), Rib breathing for at least 1 month very consistently especially at night time, came down with fever and flu symptoms within a day after, and started scream crying consistently during day and night for no reason and was inconsolable (which had never happened before and with no other lifestyle changes)
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Respiration abnormal, Screaming
Clinical narrative: Extreme GI issues (started pooping every 9-10 days instead of 3-5 times in one single day), Rib breathing for at least 1 month very consistently especially at night time, came down with fever and flu symptoms within a day after, and started scream crying consistently during day and night for no reason and was inconsolable (which had never happened before and with no other lifestyle changes)
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Back pain, Chest pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Hour 0-24: Marked L arm pain into left anterior chest wall Hour 30-Day 11: Symmetrical, migratory musculoskeletal pain in back, abdomen, pelvis, proximal lower extremity.  Associated with L iliac crest and R anterior intercostal (between ribs 8 and 9) point tenderness.. Severe for days 2-6 Day 18: Recurrence of symmetrical, migratory pain same as above plus extending higher into back and into abdominal wall. Point tenderness recurrent in left iliac crest and right anterior intercostal space (between ribs 8 and 9). Severe for 4 hours Day 23: (date of report): Recurrent pain in back with same areas of point tenderness. Progression history not yet available.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pelvic pain, Tenderness
Clinical narrative: Hour 0-24: Marked L arm pain into left anterior chest wall Hour 30-Day 11: Symmetrical, migratory musculoskeletal pain in back, abdomen, pelvis, proximal lower extremity.  Associated with L iliac crest and R anterior intercostal (between ribs 8 and 9) point tenderness.. Severe for days 2-6 Day 18: Recurrence of symmetrical, migratory pain same as above plus extending higher into back and into abdominal wall. Point tenderness recurrent in left iliac crest and right anterior intercostal space (between ribs 8 and 9). Severe for 4 hours Day 23: (date of report): Recurrent pain in back with same areas of point tenderness. Progression history not yet available.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID VACCINE SERIES
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Erythema, Lethargy, Pain, Rash
Clinical narrative: RASH PAIN LETHARGY REDNESS HIVES SEEN IN OFFICE BENADRYL SENT ALLERGY LAB SENT WILL F/U AFTER RESULTS ARE IN
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: RASH PAIN LETHARGY REDNESS HIVES SEEN IN OFFICE BENADRYL SENT ALLERGY LAB SENT WILL F/U AFTER RESULTS ARE IN
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: hives
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID VACCINE SERIES
Age: 10.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Musculoskeletal pain, Pain, Rash, Rash erythematous, Rash macular
Clinical narrative: Mother of client reported that 1 day after vaccine the client reported right buttock pain. The following day on 10/28/23 she noted to have a rash on left stomach.  This rash is still present and has progressively spread to chest, back, and groin area.  Denied anything around injection sites but did report soreness post vaccination. Denied fevers, N/VD, s.s. of anaphlaxisis. Did report the rash is occasionally itchy, is red splotched, with bumps but not blister like.
Age: 10.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Rash pruritic
Clinical narrative: Mother of client reported that 1 day after vaccine the client reported right buttock pain. The following day on 10/28/23 she noted to have a rash on left stomach.  This rash is still present and has progressively spread to chest, back, and groin area.  Denied anything around injection sites but did report soreness post vaccination. Denied fevers, N/VD, s.s. of anaphlaxisis. Did report the rash is occasionally itchy, is red splotched, with bumps but not blister like.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Day after vaccine pt swelling swelling and redness in left arm.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Defaecation urgency, Fatigue, Nausea, Pain in extremity
Clinical narrative: Quite tired for 24 hours, nauseated and felt urge to defecate continually but didn't. Felt chills but temp stayed below average. Arm soreness as expected.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Discharge provider MD   Primary care physican DO Admission date 5/31/2023 Discharge date Jun 2, 2023   Discharge diagnosis 1. Sepsis due to covid 19, sepsis resolved 2. Acute hypoxic respiratory failure, resolved  3. Hypokalemia, resolved 4. Hypomagnesemia, resolved  5. Persistent atrial fibrillation 6. S/P TAVR 7. Fabry disease 8. COPD 9. ILD 10. Obesity 11. Type 2 diabetes with diabetic neuropathy  12. Dysphagia, unspecified  13. Essential hypertension     Hospital Course He was admitted with sepsis due to covid 19 with tachycardia, fever, hypoxia, lactic acidosis. He was initially requiring 2L oxygen by nasal canula. He had hypokalemia and hypomagnesemia that resolved after being replaced. He was given IV fluids and his lactic acidosis resolved. His covid infection was treated with Decadron and remdesivir. No antibiotics were given because there was no bacterial infection identified in additional to his viral infection. The following morning, he was weaned off oxygen supplementation and was saturating normally on room air. He was seen by physical therapy and occupational therapy who recommended home health care at discharge however, he declined this. The remainder of his chronic medical conditions were stable. He was prescribed 3 additional days of decadron to complete a total of 5 days. Remdesivir was stopped.    Patient was discharged home in stable condition
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diabetic neuropathy, Dysphagia, Essential hypertension, Fabry's disease, Hypokalaemia
Clinical narrative: Discharge provider MD   Primary care physican DO Admission date 5/31/2023 Discharge date Jun 2, 2023   Discharge diagnosis 1. Sepsis due to covid 19, sepsis resolved 2. Acute hypoxic respiratory failure, resolved  3. Hypokalemia, resolved 4. Hypomagnesemia, resolved  5. Persistent atrial fibrillation 6. S/P TAVR 7. Fabry disease 8. COPD 9. ILD 10. Obesity 11. Type 2 diabetes with diabetic neuropathy  12. Dysphagia, unspecified  13. Essential hypertension     Hospital Course He was admitted with sepsis due to covid 19 with tachycardia, fever, hypoxia, lactic acidosis. He was initially requiring 2L oxygen by nasal canula. He had hypokalemia and hypomagnesemia that resolved after being replaced. He was given IV fluids and his lactic acidosis resolved. His covid infection was treated with Decadron and remdesivir. No antibiotics were given because there was no bacterial infection identified in additional to his viral infection. The following morning, he was weaned off oxygen supplementation and was saturating normally on room air. He was seen by physical therapy and occupational therapy who recommended home health care at discharge however, he declined this. The remainder of his chronic medical conditions were stable. He was prescribed 3 additional days of decadron to complete a total of 5 days. Remdesivir was stopped.    Patient was discharged home in stable condition
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypomagnesaemia, Hypoxia, Interstitial lung disease, Intra-aortic balloon placement, Lactic acidosis
Clinical narrative: Discharge provider MD   Primary care physican DO Admission date 5/31/2023 Discharge date Jun 2, 2023   Discharge diagnosis 1. Sepsis due to covid 19, sepsis resolved 2. Acute hypoxic respiratory failure, resolved  3. Hypokalemia, resolved 4. Hypomagnesemia, resolved  5. Persistent atrial fibrillation 6. S/P TAVR 7. Fabry disease 8. COPD 9. ILD 10. Obesity 11. Type 2 diabetes with diabetic neuropathy  12. Dysphagia, unspecified  13. Essential hypertension     Hospital Course He was admitted with sepsis due to covid 19 with tachycardia, fever, hypoxia, lactic acidosis. He was initially requiring 2L oxygen by nasal canula. He had hypokalemia and hypomagnesemia that resolved after being replaced. He was given IV fluids and his lactic acidosis resolved. His covid infection was treated with Decadron and remdesivir. No antibiotics were given because there was no bacterial infection identified in additional to his viral infection. The following morning, he was weaned off oxygen supplementation and was saturating normally on room air. He was seen by physical therapy and occupational therapy who recommended home health care at discharge however, he declined this. The remainder of his chronic medical conditions were stable. He was prescribed 3 additional days of decadron to complete a total of 5 days. Remdesivir was stopped.    Patient was discharged home in stable condition
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obesity, Pyrexia, Sepsis, Tachycardia, Type 2 diabetes mellitus
Clinical narrative: Discharge provider MD   Primary care physican DO Admission date 5/31/2023 Discharge date Jun 2, 2023   Discharge diagnosis 1. Sepsis due to covid 19, sepsis resolved 2. Acute hypoxic respiratory failure, resolved  3. Hypokalemia, resolved 4. Hypomagnesemia, resolved  5. Persistent atrial fibrillation 6. S/P TAVR 7. Fabry disease 8. COPD 9. ILD 10. Obesity 11. Type 2 diabetes with diabetic neuropathy  12. Dysphagia, unspecified  13. Essential hypertension     Hospital Course He was admitted with sepsis due to covid 19 with tachycardia, fever, hypoxia, lactic acidosis. He was initially requiring 2L oxygen by nasal canula. He had hypokalemia and hypomagnesemia that resolved after being replaced. He was given IV fluids and his lactic acidosis resolved. His covid infection was treated with Decadron and remdesivir. No antibiotics were given because there was no bacterial infection identified in additional to his viral infection. The following morning, he was weaned off oxygen supplementation and was saturating normally on room air. He was seen by physical therapy and occupational therapy who recommended home health care at discharge however, he declined this. The remainder of his chronic medical conditions were stable. He was prescribed 3 additional days of decadron to complete a total of 5 days. Remdesivir was stopped.    Patient was discharged home in stable condition
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Valvuloplasty cardiac, Viral infection
Clinical narrative: Discharge provider MD   Primary care physican DO Admission date 5/31/2023 Discharge date Jun 2, 2023   Discharge diagnosis 1. Sepsis due to covid 19, sepsis resolved 2. Acute hypoxic respiratory failure, resolved  3. Hypokalemia, resolved 4. Hypomagnesemia, resolved  5. Persistent atrial fibrillation 6. S/P TAVR 7. Fabry disease 8. COPD 9. ILD 10. Obesity 11. Type 2 diabetes with diabetic neuropathy  12. Dysphagia, unspecified  13. Essential hypertension     Hospital Course He was admitted with sepsis due to covid 19 with tachycardia, fever, hypoxia, lactic acidosis. He was initially requiring 2L oxygen by nasal canula. He had hypokalemia and hypomagnesemia that resolved after being replaced. He was given IV fluids and his lactic acidosis resolved. His covid infection was treated with Decadron and remdesivir. No antibiotics were given because there was no bacterial infection identified in additional to his viral infection. The following morning, he was weaned off oxygen supplementation and was saturating normally on room air. He was seen by physical therapy and occupational therapy who recommended home health care at discharge however, he declined this. The remainder of his chronic medical conditions were stable. He was prescribed 3 additional days of decadron to complete a total of 5 days. Remdesivir was stopped.    Patient was discharged home in stable condition
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID VACCINE SERIES
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Basically I got dizzy. The dizziness lasted for 6 weeks. I kept eating and forcing myself to walk and eat. Gradually the dizziness went away after 6 weeks of it.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Pain
Clinical narrative: Unable to lift arm 5 hours after vaccination, took NSAID and symptoms improved the next day, still having some decreased range of motion, she is unable to lift her left hand to her face without pain. TM denies any rashes, numbness or tingling to her left upper extremity.  Will follow up with Occupational Health.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling hot, Throat tightness, Vomiting
Clinical narrative: Client presents for Flu vaccine per her Employer. Client states she has a severe egg allergy. Components of Flucelvax printed and reviewed by Client and her mother, education provided. Client states that she has until the 15th to receive her flu vaccine, otherwise she will face corrective action by her employer. Client states her employer refused her medical exemption. Client reviewed and signed HIPAA and Vaccine Consent. Client was insistent to receive Flu vaccine. Flu vaccine administered at 9:39. Client complained of throat warmth at 9:44. Client complained of throat tightness at 9:51. EMS contacted at 9:52. Benadryl 1mg IM administered at 09:56. Client able to speak in full sentences and did not complain of SOB. Minimal emesis by client. Client remained alert and oriented, in an upright position. EMS arrived shortly after and began assessment/symptomatic treatment. Client independently got onto gurney and was transported.  Spoke with Nurse Hotline a few times during appointment.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dry skin, Pruritus, Skin texture abnormal, Urticaria
Clinical narrative: MESSAGE FROM PT REAGRDING A REACTION SHE'S HAVING WITH FLU SHOT. PT WANTED TO DISCUSS POTENTIAL CAUSES. SHE REPORTED SHE HAD THE FLU SHOT ON 10/30 AND ABOUT 2 DAYS LATER HAD SOME ITCHINESS ON HER ARMS. SHE THOUGHT IT WAS SOME DRY SKIN SO SOME LOTION TOOK CARE OF THE ISSUE A BIT. BUT LATER NOTICED SMALL PRICKLY HEAT HIVES ON BOTH ARMS THAT WERE SUPER ITCHY. SHE STILL HAVE SOME ITCHINESS FROM IT BUT IT HAS GOTTEN BETTER AND HER SKIN IS STILL TEXTURED BUT NO MORE RASH IS VISIBLE.
Age: 25.0
Sex: F
Vaccine: FLU4, HEP, HEP, MMR, TDAP, VARCEL
Symptoms: Immunisation, No adverse event, Underdose
Clinical narrative: Inadvertent administration of Hepatitis B pediatric formulation. Notified patient and administered correct dose of Hepatitis B adult formulation, patient tolerated well.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: SHOULDER STIFFNESS OVER 10 DAYS
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, X-ray limb normal
Clinical narrative: Immunization was given on 10/21.  Symptoms started out as a sore arm, within 2 days patient could not lift arm.  Visited Doctor office a few days later, after using ibuprofen and salonpas.  Dr took x-ray of arm and shoulder with no findings.  Patient has a return appt later.  She said symptoms are letting up as of today (november 8).