chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUC3
Symptoms: Coagulopathy, Immediate post-injection reaction, Injection site reaction, Local reaction, Thrombosis
Clinical narrative: Blood clot/clotting disorder; Local reaction on her left deltoid; This spontaneous case was received on 05-Dec-2023 from a physician (reference number: SEQW23-04692) and concerned a 67-year-old (discrepantly reported also as 65-year-old) patient.  The patient had no relevant medical history and was not taking any concomitant medications. It was reported that the patient was healthy with no diseases, no previous traumas or medical history, not smoking.  On an unspecified date in Nov-2023, reported as about two weeks ago, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: not reported and anatomical location: left deltoid) for active immunization against influenza disease. The batch number reported was 944471 and expiry date was 30-Jun-2024.  On an unspecified date in Nov-2023, immediately after receiving Fluad Quadrivalent, the patient experienced a local reaction on left deltoid.   On an unspecified date in Nov-2023, 48 hours later, the patient was diagnosed with clotting disorder. The patient was treated with Eliquis (apixaban) due to a blood clot.  At a time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment for the event of 'local reaction'. The reporter assessed the events of clotting disorder to be related to Flucelvax Quadrivalent vaccine. It was reported that, since the patient was healthy and with no history of blood clotting, the doctor believed it could be due to the vaccine.  The events of clotting disorder and 'local reaction' were considered as serious due to the seriousness criteria of medical significance.  Company comment: A 67-year-old patient developed local reaction on left deltoid immediately after receiving the suspect product Fluad Quadrivalent. The patient was diagnosed with coagulopathy 48 hours after vaccination. Based on suggestive temporal relationship and the absence of confounders, causality for the event of local reaction is assessed as probably related. Causality for coagulopathy is assessed as not related due to biological implausibility.; Reporter's Comments: Since the patient was healthy and with no history of blood clotting, the doctor believed it could be due to the vaccine.; Sender's Comments: A 67-year-old patient developed local reaction on left deltoid immediately after receiving the suspect product Fluad Quadrivalent. The patient was diagnosed with coagulopathy 48 hours after vaccination. Based on suggestive temporal relationship and the absence of confounders, causality for the event of local reaction is assessed as probably related. Causality for coagulopathy is assessed as not related due to biological implausibility.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Urticaria
Clinical narrative: I received the shot and my body broke out in hives and I feel a burning sensation throughout my body.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Expired Rotavirus Vaccine administered to patient. Provider named in form notified.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen abnormal, Dysstasia, Fall, Femur fracture, Fractured sacrum
Clinical narrative: Date of Admission: 11/25/2023     Medical Diagnosis: Femur and sacral fracture     Date of Surgery/Procedure:  RIGHT INTERTROCHANTERIC FEMUR FX, DISPL INIT 11/26/23 CT Abdomen and Pelvis:  Acute comminuted and mildly displaced right intertrochanteric fracture with fracture lines extending from the greater trochanter to the lesser trochanter.     Acute nondisplaced zone1/2 right sacral fracture.     Age indeterminate likely nonacute L3 compression deformity.     No acute solid organ injury. No free air or free fluid.       Precautions: Fall risk, Hard of hearing, right lower extremity weight bearing as tolerated    PPE Worn:  Provider: N95 Patient masked? No   Covid-19 Testing: No results found for: "CORONAVIRUS"     Current History: Per Dr HPI reports , " Patient is a 91 year old female with a history of HTN and HLD who presented with a fall and right leg pain. She lives alone and reports that last pm around 9 she stood up from her chair and then fell.  She denies any dizziness, palpitations, lightheadedness, CP, SOB, palpitations, presyncope, nausea, vomiting, abdominal pain.  She landed on her right hip and top of her head but did not lose consciousness.  She was unable to get up and spent the night on the floor on laying on her left arm.  Her neighbor found her on the
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Spinal compression fracture
Clinical narrative: Date of Admission: 11/25/2023     Medical Diagnosis: Femur and sacral fracture     Date of Surgery/Procedure:  RIGHT INTERTROCHANTERIC FEMUR FX, DISPL INIT 11/26/23 CT Abdomen and Pelvis:  Acute comminuted and mildly displaced right intertrochanteric fracture with fracture lines extending from the greater trochanter to the lesser trochanter.     Acute nondisplaced zone1/2 right sacral fracture.     Age indeterminate likely nonacute L3 compression deformity.     No acute solid organ injury. No free air or free fluid.       Precautions: Fall risk, Hard of hearing, right lower extremity weight bearing as tolerated    PPE Worn:  Provider: N95 Patient masked? No   Covid-19 Testing: No results found for: "CORONAVIRUS"     Current History: Per Dr HPI reports , " Patient is a 91 year old female with a history of HTN and HLD who presented with a fall and right leg pain. She lives alone and reports that last pm around 9 she stood up from her chair and then fell.  She denies any dizziness, palpitations, lightheadedness, CP, SOB, palpitations, presyncope, nausea, vomiting, abdominal pain.  She landed on her right hip and top of her head but did not lose consciousness.  She was unable to get up and spent the night on the floor on laying on her left arm.  Her neighbor found her on the
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Product administered at inappropriate site
Clinical narrative: Patient called into pharmacy  yesterday, a couple of days after getting her covid vaccine and indicated she has been experiencing severe shoulder soreness after getting both her flu shot and covid vaccine coadministered. After seeing a prescriber, they mentioend the vaccine was administered too high in the shoulder. Patient provided a photo to the pharmacy indicating the placement of the bandaid after vaccine administration.  Patient wanted to lodge a complaint about the administration and I was able to take down the details of the administration and what happened during the event. after taking all the information, I had advised the patient on how to mitigate the adverse event of sorness and pain with OTC analgesics and cold compress. Patient took the advise and will report back to the pharmacy if her condition worsens.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: NOTE FROM THE ER The right arm does appear to have a post injection inflammatory reaction. You may use ice pack over the area, Tylenol and ibuprofen for pain relief. Today, we marked the red area with a skin pen. Please watch the area to ensure the redness is decreasing and does not expand be on the area marked off. If the redness expands beyond the marker, please start the antibiotics. Otherwise, anticipate this will resolve spontaneously without the need for antibiotic.  MOC TOOK CHILD TO ED 12/14/2023. CHILD HAD NO SX.  PATIENT  ASKED FOR A BAND-AID WHEN HE GOT UP 12/14/2023. (PATIENT SAYS SWELLING  STARTED  12/13/2023 AT BEDTIME) WHEN MOM LOOKED AT THE ARM ON THAT MORNING SHE COULD SEE THE SWELLING FROM RIGHT SHOULDER TO ELBOW.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy
Clinical narrative: Patient reporting swollen lymph nodes on right side of neck.  Patient saw primary care doctor 12/11/23 and was prescribed an antibiotic as unsure if related to vaccine.  Patient stating today 12/15/23 most of swelling has subsided
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event reported by patient. Patient had requested COVID Spikevax, but was given Fluzone quad. Patient previously received Fluzone quad in August of 2023. This dose on 12/15/23 would be her second dose this season . Patient was counseled to monitor any adverse effects. Patient will be contacted in coming days for any reactions.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Skin discolouration
Clinical narrative: We have not received any complaint from the patient at all.  We received a call from her daughter.  She stated that her mother never mentioned that her arm was hurting, or any concerns after the vaccine.  However, she saw a mark on her arm, and witnessed her mother not being as mobile as normal.  She stated that this was not an adverse event, but more of an issue with the administration.  Family member (pharmacist) mentioned that maybe the vaccine was given too high, and close to the shoulder, as opposed to in the deltoid. And, the daughter called the pharmacy to address.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Feeling hot, Hyperhidrosis, Injection site erythema, Loss of consciousness
Clinical narrative: ADVERSE REACTIONS: Redness on right deltoid after Gardasil administered. PT felt soreness on both arms after all 3 vaccines administered. PT passed out for about 15-20 seconds. PT felt hot, sweaty, weak and nauseous TREATMENT: PT had cool packs to the neck, sipped water slowly, sat down w/ feet elevated above heart and gave crackers to eat. OUTCOME: PT no longer had redness to the vaccination sites, Pt no longer felt soressness, nauseous, hot, sweaty, and weak. PT bp was normal range   -1st assessment bp - 100/70 @ 1400   -2nd assessment bp - 103/72 @1405   -3rd assessment bp  -  103/72 @1410 PT left between 14:20 - 14:30
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Pain in extremity
Clinical narrative: ADVERSE REACTIONS: Redness on right deltoid after Gardasil administered. PT felt soreness on both arms after all 3 vaccines administered. PT passed out for about 15-20 seconds. PT felt hot, sweaty, weak and nauseous TREATMENT: PT had cool packs to the neck, sipped water slowly, sat down w/ feet elevated above heart and gave crackers to eat. OUTCOME: PT no longer had redness to the vaccination sites, Pt no longer felt soressness, nauseous, hot, sweaty, and weak. PT bp was normal range   -1st assessment bp - 100/70 @ 1400   -2nd assessment bp - 103/72 @1405   -3rd assessment bp  -  103/72 @1410 PT left between 14:20 - 14:30
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: For above question: FLUAD 65 + PF INJ 2023-24 0.5 ML.   Regarding adverse event, painful on insertion. Painful that night. Couldn?t lay on left arm. Continued on next day(didn?t resolve like usual) and continuing  to present. Kept thinking it would go away . Did not. Pain in left shoulder, down arm,and to left of neck and top of back. Feels heavy and weak.mostly a constant ache and throbbing.can?t sleep, can?t roll over onto my left. Painful to reach over and pull up quilt to cover myself. Can?t reach back to put on my seatbelt, have to use my right hand and then hurts my left side to reach back. Difficulty dressing, can?t hook my bra in the back, must pull around to front to put on and take off. After waiting over a month to get better looked up on Internet ?shoulder pain after flu shot ?found SIRVA ,  (shoulder injury related to vaccine administration). On October 26, 2023 went to see Dr. orthopedic clinic shoulder x-rays were done no fractures or arthritis diagnosis made rotator cuff tendinitis left shoulder. Advised to take one Aleve twice a day for 10 days and ice my shoulder. Was hesitant at first as I don?t take NSAIDs. I did take 10 days from November 13, 2023 through November 22, 2023. Found no relief as the doctor walked out the door he said three months three months as if I should wait three months.  Left arm continues to be painful heavy and weak. Unable to hold a water bottle with my left hand, have to use both hands. Feel I can?t lift things safely for example emptying dishwasher can?t hold a phone book or magazine while reclined in bed. Continuing to sleep poorly. If I accidentally roll over in my sleep to my left side I am awake and in pain. Difficulty lifting arm such as showering doing my hair putting on deodorant. Pretty much every move hurts. Many movements cause a ?snap? . Finally on December 7, 2023 I saw NP, At family medicine. She recommended an MRI. And to start taking a medicine calledMeloxicam on 7.5 mg tab daily,   Had the MRI yesterday on December 14, 2023
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Magnetic resonance imaging, Muscular weakness, Neck pain
Clinical narrative: For above question: FLUAD 65 + PF INJ 2023-24 0.5 ML.   Regarding adverse event, painful on insertion. Painful that night. Couldn?t lay on left arm. Continued on next day(didn?t resolve like usual) and continuing  to present. Kept thinking it would go away . Did not. Pain in left shoulder, down arm,and to left of neck and top of back. Feels heavy and weak.mostly a constant ache and throbbing.can?t sleep, can?t roll over onto my left. Painful to reach over and pull up quilt to cover myself. Can?t reach back to put on my seatbelt, have to use my right hand and then hurts my left side to reach back. Difficulty dressing, can?t hook my bra in the back, must pull around to front to put on and take off. After waiting over a month to get better looked up on Internet ?shoulder pain after flu shot ?found SIRVA ,  (shoulder injury related to vaccine administration). On October 26, 2023 went to see Dr. orthopedic clinic shoulder x-rays were done no fractures or arthritis diagnosis made rotator cuff tendinitis left shoulder. Advised to take one Aleve twice a day for 10 days and ice my shoulder. Was hesitant at first as I don?t take NSAIDs. I did take 10 days from November 13, 2023 through November 22, 2023. Found no relief as the doctor walked out the door he said three months three months as if I should wait three months.  Left arm continues to be painful heavy and weak. Unable to hold a water bottle with my left hand, have to use both hands. Feel I can?t lift things safely for example emptying dishwasher can?t hold a phone book or magazine while reclined in bed. Continuing to sleep poorly. If I accidentally roll over in my sleep to my left side I am awake and in pain. Difficulty lifting arm such as showering doing my hair putting on deodorant. Pretty much every move hurts. Many movements cause a ?snap? . Finally on December 7, 2023 I saw NP, At family medicine. She recommended an MRI. And to start taking a medicine calledMeloxicam on 7.5 mg tab daily,   Had the MRI yesterday on December 14, 2023
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Pain in extremity, Poor quality sleep, Rotator cuff syndrome, Sleep disorder
Clinical narrative: For above question: FLUAD 65 + PF INJ 2023-24 0.5 ML.   Regarding adverse event, painful on insertion. Painful that night. Couldn?t lay on left arm. Continued on next day(didn?t resolve like usual) and continuing  to present. Kept thinking it would go away . Did not. Pain in left shoulder, down arm,and to left of neck and top of back. Feels heavy and weak.mostly a constant ache and throbbing.can?t sleep, can?t roll over onto my left. Painful to reach over and pull up quilt to cover myself. Can?t reach back to put on my seatbelt, have to use my right hand and then hurts my left side to reach back. Difficulty dressing, can?t hook my bra in the back, must pull around to front to put on and take off. After waiting over a month to get better looked up on Internet ?shoulder pain after flu shot ?found SIRVA ,  (shoulder injury related to vaccine administration). On October 26, 2023 went to see Dr. orthopedic clinic shoulder x-rays were done no fractures or arthritis diagnosis made rotator cuff tendinitis left shoulder. Advised to take one Aleve twice a day for 10 days and ice my shoulder. Was hesitant at first as I don?t take NSAIDs. I did take 10 days from November 13, 2023 through November 22, 2023. Found no relief as the doctor walked out the door he said three months three months as if I should wait three months.  Left arm continues to be painful heavy and weak. Unable to hold a water bottle with my left hand, have to use both hands. Feel I can?t lift things safely for example emptying dishwasher can?t hold a phone book or magazine while reclined in bed. Continuing to sleep poorly. If I accidentally roll over in my sleep to my left side I am awake and in pain. Difficulty lifting arm such as showering doing my hair putting on deodorant. Pretty much every move hurts. Many movements cause a ?snap? . Finally on December 7, 2023 I saw NP, At family medicine. She recommended an MRI. And to start taking a medicine calledMeloxicam on 7.5 mg tab daily,   Had the MRI yesterday on December 14, 2023
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: X-ray limb abnormal
Clinical narrative: For above question: FLUAD 65 + PF INJ 2023-24 0.5 ML.   Regarding adverse event, painful on insertion. Painful that night. Couldn?t lay on left arm. Continued on next day(didn?t resolve like usual) and continuing  to present. Kept thinking it would go away . Did not. Pain in left shoulder, down arm,and to left of neck and top of back. Feels heavy and weak.mostly a constant ache and throbbing.can?t sleep, can?t roll over onto my left. Painful to reach over and pull up quilt to cover myself. Can?t reach back to put on my seatbelt, have to use my right hand and then hurts my left side to reach back. Difficulty dressing, can?t hook my bra in the back, must pull around to front to put on and take off. After waiting over a month to get better looked up on Internet ?shoulder pain after flu shot ?found SIRVA ,  (shoulder injury related to vaccine administration). On October 26, 2023 went to see Dr. orthopedic clinic shoulder x-rays were done no fractures or arthritis diagnosis made rotator cuff tendinitis left shoulder. Advised to take one Aleve twice a day for 10 days and ice my shoulder. Was hesitant at first as I don?t take NSAIDs. I did take 10 days from November 13, 2023 through November 22, 2023. Found no relief as the doctor walked out the door he said three months three months as if I should wait three months.  Left arm continues to be painful heavy and weak. Unable to hold a water bottle with my left hand, have to use both hands. Feel I can?t lift things safely for example emptying dishwasher can?t hold a phone book or magazine while reclined in bed. Continuing to sleep poorly. If I accidentally roll over in my sleep to my left side I am awake and in pain. Difficulty lifting arm such as showering doing my hair putting on deodorant. Pretty much every move hurts. Many movements cause a ?snap? . Finally on December 7, 2023 I saw NP, At family medicine. She recommended an MRI. And to start taking a medicine calledMeloxicam on 7.5 mg tab daily,   Had the MRI yesterday on December 14, 2023
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient experienced itchiness, redness, and soreness at site of administration later the same night (12/4/2023) and was recommended by outside source  of pharmacy/medical personnel to take oral Benadryl OTC to help alleviate persisting symptoms sometime a week later (12/11/23).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Decreased appetite, Gait inability, Laboratory test normal
Clinical narrative: Vomiting, fever muscle spasms muscle and joint pain Loss of consciousness, can?t walk due to pain and muscle rigidity, loss of weight and appetite, loss of taste
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle rigidity, Muscle spasms, Myalgia, Pain
Clinical narrative: Vomiting, fever muscle spasms muscle and joint pain Loss of consciousness, can?t walk due to pain and muscle rigidity, loss of weight and appetite, loss of taste
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting, Weight decreased
Clinical narrative: Vomiting, fever muscle spasms muscle and joint pain Loss of consciousness, can?t walk due to pain and muscle rigidity, loss of weight and appetite, loss of taste
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Erythema, Hypoaesthesia, Pruritus
Clinical narrative: Itching to entire body, redness of chest, numbness of face, burning sensation in in ankles, numbness in hands, burning sensation on right lower extremity.  Itching and redness of chest subsided after first day however, I continue to have a burning sensation in the right lower extremity without it easing and starting to travel to upper right extremity.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: patient received the vaccine and immediately after started to experience a seizure.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Abnormal behaviour, Abnormal sensation in eye, Blood thyroid stimulating hormone increased, Borrelia test negative, C-reactive protein normal
Clinical narrative: Swelling in hands ? November 2022 through January 2023 ? Altered feelings and discomfort with items at home ? started subtly in November 2022, progressed slowly until later in February and into beginning of March, then became intense ? Bilateral sciatica pain ? January 2023-beginning subtly in upper left gluteal area, spreading down left leg into foot and then right side, with spreading down right leg into foot by early March ? Open wound behind left knee ? February 2023- did not heal until early April  ? Fainted  March 2023 ? In late February and through March, Pt also began having focal seizures with her pupils dilated during the episodes. She believed she was in another location and called out to her parents without realizing we were with her. The episodes usually lasted about a minute.  ? Swollen feet with pitting edema ? late March 2023 ? Lymphadenopathy- early March 2023 ? Bilateral peripheral neuropathy ? late March 2023 to present day ? Motor tremors in both hands and legs/feet ? March-May 2023  ? Persistent headache ? March 2023  Incontinence ? late March 2023 ? Feeling of coldness behind left eye ? April 2023  Dizziness ? February 2023 to current day  Fatigue ? July 2023 to current day  ? Obsessive compulsive disorder (fear of contamination from school of items at home, compulsive and ritualistic hand washing and showering, inability to walk in certain areas of home or touch certain objects) ? January 2023 to current day. Condition has improved after 3 month stay in residential mental health facility, but condition still exists and patient continues outpatient therapy for OCD.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Compulsive handwashing, Discomfort, Dizziness, Fatigue, Fear
Clinical narrative: Swelling in hands ? November 2022 through January 2023 ? Altered feelings and discomfort with items at home ? started subtly in November 2022, progressed slowly until later in February and into beginning of March, then became intense ? Bilateral sciatica pain ? January 2023-beginning subtly in upper left gluteal area, spreading down left leg into foot and then right side, with spreading down right leg into foot by early March ? Open wound behind left knee ? February 2023- did not heal until early April  ? Fainted  March 2023 ? In late February and through March, Pt also began having focal seizures with her pupils dilated during the episodes. She believed she was in another location and called out to her parents without realizing we were with her. The episodes usually lasted about a minute.  ? Swollen feet with pitting edema ? late March 2023 ? Lymphadenopathy- early March 2023 ? Bilateral peripheral neuropathy ? late March 2023 to present day ? Motor tremors in both hands and legs/feet ? March-May 2023  ? Persistent headache ? March 2023  Incontinence ? late March 2023 ? Feeling of coldness behind left eye ? April 2023  Dizziness ? February 2023 to current day  Fatigue ? July 2023 to current day  ? Obsessive compulsive disorder (fear of contamination from school of items at home, compulsive and ritualistic hand washing and showering, inability to walk in certain areas of home or touch certain objects) ? January 2023 to current day. Condition has improved after 3 month stay in residential mental health facility, but condition still exists and patient continues outpatient therapy for OCD.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Feeling abnormal, Full blood count normal, Gait disturbance, Headache, Impaired healing
Clinical narrative: Swelling in hands ? November 2022 through January 2023 ? Altered feelings and discomfort with items at home ? started subtly in November 2022, progressed slowly until later in February and into beginning of March, then became intense ? Bilateral sciatica pain ? January 2023-beginning subtly in upper left gluteal area, spreading down left leg into foot and then right side, with spreading down right leg into foot by early March ? Open wound behind left knee ? February 2023- did not heal until early April  ? Fainted  March 2023 ? In late February and through March, Pt also began having focal seizures with her pupils dilated during the episodes. She believed she was in another location and called out to her parents without realizing we were with her. The episodes usually lasted about a minute.  ? Swollen feet with pitting edema ? late March 2023 ? Lymphadenopathy- early March 2023 ? Bilateral peripheral neuropathy ? late March 2023 to present day ? Motor tremors in both hands and legs/feet ? March-May 2023  ? Persistent headache ? March 2023  Incontinence ? late March 2023 ? Feeling of coldness behind left eye ? April 2023  Dizziness ? February 2023 to current day  Fatigue ? July 2023 to current day  ? Obsessive compulsive disorder (fear of contamination from school of items at home, compulsive and ritualistic hand washing and showering, inability to walk in certain areas of home or touch certain objects) ? January 2023 to current day. Condition has improved after 3 month stay in residential mental health facility, but condition still exists and patient continues outpatient therapy for OCD.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Incontinence, Laboratory test normal, Limb injury, Lymphadenopathy, Magnetic resonance imaging head normal
Clinical narrative: Swelling in hands ? November 2022 through January 2023 ? Altered feelings and discomfort with items at home ? started subtly in November 2022, progressed slowly until later in February and into beginning of March, then became intense ? Bilateral sciatica pain ? January 2023-beginning subtly in upper left gluteal area, spreading down left leg into foot and then right side, with spreading down right leg into foot by early March ? Open wound behind left knee ? February 2023- did not heal until early April  ? Fainted  March 2023 ? In late February and through March, Pt also began having focal seizures with her pupils dilated during the episodes. She believed she was in another location and called out to her parents without realizing we were with her. The episodes usually lasted about a minute.  ? Swollen feet with pitting edema ? late March 2023 ? Lymphadenopathy- early March 2023 ? Bilateral peripheral neuropathy ? late March 2023 to present day ? Motor tremors in both hands and legs/feet ? March-May 2023  ? Persistent headache ? March 2023  Incontinence ? late March 2023 ? Feeling of coldness behind left eye ? April 2023  Dizziness ? February 2023 to current day  Fatigue ? July 2023 to current day  ? Obsessive compulsive disorder (fear of contamination from school of items at home, compulsive and ritualistic hand washing and showering, inability to walk in certain areas of home or touch certain objects) ? January 2023 to current day. Condition has improved after 3 month stay in residential mental health facility, but condition still exists and patient continues outpatient therapy for OCD.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Magnetic resonance imaging spinal normal, Metabolic function test, Mydriasis, Neuropathy peripheral, Obsessive-compulsive disorder
Clinical narrative: Swelling in hands ? November 2022 through January 2023 ? Altered feelings and discomfort with items at home ? started subtly in November 2022, progressed slowly until later in February and into beginning of March, then became intense ? Bilateral sciatica pain ? January 2023-beginning subtly in upper left gluteal area, spreading down left leg into foot and then right side, with spreading down right leg into foot by early March ? Open wound behind left knee ? February 2023- did not heal until early April  ? Fainted  March 2023 ? In late February and through March, Pt also began having focal seizures with her pupils dilated during the episodes. She believed she was in another location and called out to her parents without realizing we were with her. The episodes usually lasted about a minute.  ? Swollen feet with pitting edema ? late March 2023 ? Lymphadenopathy- early March 2023 ? Bilateral peripheral neuropathy ? late March 2023 to present day ? Motor tremors in both hands and legs/feet ? March-May 2023  ? Persistent headache ? March 2023  Incontinence ? late March 2023 ? Feeling of coldness behind left eye ? April 2023  Dizziness ? February 2023 to current day  Fatigue ? July 2023 to current day  ? Obsessive compulsive disorder (fear of contamination from school of items at home, compulsive and ritualistic hand washing and showering, inability to walk in certain areas of home or touch certain objects) ? January 2023 to current day. Condition has improved after 3 month stay in residential mental health facility, but condition still exists and patient continues outpatient therapy for OCD.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Oedema, Partial seizures, Peripheral swelling, Red blood cell sedimentation rate normal, Sciatica
Clinical narrative: Swelling in hands ? November 2022 through January 2023 ? Altered feelings and discomfort with items at home ? started subtly in November 2022, progressed slowly until later in February and into beginning of March, then became intense ? Bilateral sciatica pain ? January 2023-beginning subtly in upper left gluteal area, spreading down left leg into foot and then right side, with spreading down right leg into foot by early March ? Open wound behind left knee ? February 2023- did not heal until early April  ? Fainted  March 2023 ? In late February and through March, Pt also began having focal seizures with her pupils dilated during the episodes. She believed she was in another location and called out to her parents without realizing we were with her. The episodes usually lasted about a minute.  ? Swollen feet with pitting edema ? late March 2023 ? Lymphadenopathy- early March 2023 ? Bilateral peripheral neuropathy ? late March 2023 to present day ? Motor tremors in both hands and legs/feet ? March-May 2023  ? Persistent headache ? March 2023  Incontinence ? late March 2023 ? Feeling of coldness behind left eye ? April 2023  Dizziness ? February 2023 to current day  Fatigue ? July 2023 to current day  ? Obsessive compulsive disorder (fear of contamination from school of items at home, compulsive and ritualistic hand washing and showering, inability to walk in certain areas of home or touch certain objects) ? January 2023 to current day. Condition has improved after 3 month stay in residential mental health facility, but condition still exists and patient continues outpatient therapy for OCD.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Syncope, Thyroxine free normal, Tremor, Ultrasound scan normal, Wound
Clinical narrative: Swelling in hands ? November 2022 through January 2023 ? Altered feelings and discomfort with items at home ? started subtly in November 2022, progressed slowly until later in February and into beginning of March, then became intense ? Bilateral sciatica pain ? January 2023-beginning subtly in upper left gluteal area, spreading down left leg into foot and then right side, with spreading down right leg into foot by early March ? Open wound behind left knee ? February 2023- did not heal until early April  ? Fainted  March 2023 ? In late February and through March, Pt also began having focal seizures with her pupils dilated during the episodes. She believed she was in another location and called out to her parents without realizing we were with her. The episodes usually lasted about a minute.  ? Swollen feet with pitting edema ? late March 2023 ? Lymphadenopathy- early March 2023 ? Bilateral peripheral neuropathy ? late March 2023 to present day ? Motor tremors in both hands and legs/feet ? March-May 2023  ? Persistent headache ? March 2023  Incontinence ? late March 2023 ? Feeling of coldness behind left eye ? April 2023  Dizziness ? February 2023 to current day  Fatigue ? July 2023 to current day  ? Obsessive compulsive disorder (fear of contamination from school of items at home, compulsive and ritualistic hand washing and showering, inability to walk in certain areas of home or touch certain objects) ? January 2023 to current day. Condition has improved after 3 month stay in residential mental health facility, but condition still exists and patient continues outpatient therapy for OCD.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient has no known adverse events - Believed to have gotten two COVID-19 boosters when only 1 was appropriate. This was identified on 12/15/23. They are believed to be given on 12-01-23 (Moderna) and 10-2-23 (Pfizer)
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fundoscopy normal, Hallucination, visual
Clinical narrative: By the evening of 12/13/2023, I was having geometrical hallucinations. They took the form of surfaces looking textured or being covered with tiny moving dots (all the same color, different colors against different colored surfaces), or of tiny bubbles rising in transparent liquids. Driving after dark the evening of 12/13/2023, it looked like swirling snow outside. The hallucinations started the evening I got my shot, were strongest the next morning, were less prominent as the day progressed, and have since vanished. They were strong enough the morning of 12/14/2023 that I called Dr.'s cellphone to ask to be seen stat. She did a full work up and found nothing wrong with my eyes physically.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Electrocardiogram normal, Exposure during pregnancy
Clinical narrative: Pregnant 16w 6d (due date 5/24/2024): left chest pain when walking after 15 minutes and continued for 2 hours (12/14/2023 2 pm adverse event) Pregnant 17w 0d: left chest pain when walking after 15 minutes and continued for 3 hours (12/15/2023 8 am adverse event) Patient went to hospital emergency department @ 9 am on 12/15/2023 for evaluation of symptoms
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Laboratory test
Clinical narrative: CHRONIC COUGH
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Headache, Influenza virus test
Clinical narrative: Stuffy head, sinus pressure, headache, cough, chest pressure, chest tightness, fatigue.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Respiratory syncytial virus test, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Stuffy head, sinus pressure, headache, cough, chest pressure, chest tightness, fatigue.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Body temperature increased, Chest X-ray normal, Diarrhoea, Frequent bowel movements, Influenza A virus test negative
Clinical narrative: Diarrhea (at 4:00 pm), 4-5 movements (took Imodium), took Covid test - was negative.  Then I fell asleep (fatigue?), awoke for small dinner, back to sleep, around 10:00 pm diarrhea recurred, 4 or so movements, vomited twice, went to Emergency Room (spent $ on copay!), where I was re-hydrated and underwent numerous tests.  My ER doctor.  Temperature spiked at about 101.5 .  Then gradually came down, symptoms have abated since, but I've been on a clear liquid diet for the whole of today until now (8:30 PM), so not certain that I'm over all symptoms yet.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Influenza B virus test, Influenza virus test negative, Nucleic acid test, Platelet count decreased, Polymerase chain reaction negative
Clinical narrative: Diarrhea (at 4:00 pm), 4-5 movements (took Imodium), took Covid test - was negative.  Then I fell asleep (fatigue?), awoke for small dinner, back to sleep, around 10:00 pm diarrhea recurred, 4 or so movements, vomited twice, went to Emergency Room (spent $ on copay!), where I was re-hydrated and underwent numerous tests.  My ER doctor.  Temperature spiked at about 101.5 .  Then gradually came down, symptoms have abated since, but I've been on a clear liquid diet for the whole of today until now (8:30 PM), so not certain that I'm over all symptoms yet.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Somnolence, Urine analysis normal, Vomiting
Clinical narrative: Diarrhea (at 4:00 pm), 4-5 movements (took Imodium), took Covid test - was negative.  Then I fell asleep (fatigue?), awoke for small dinner, back to sleep, around 10:00 pm diarrhea recurred, 4 or so movements, vomited twice, went to Emergency Room (spent $ on copay!), where I was re-hydrated and underwent numerous tests.  My ER doctor.  Temperature spiked at about 101.5 .  Then gradually came down, symptoms have abated since, but I've been on a clear liquid diet for the whole of today until now (8:30 PM), so not certain that I'm over all symptoms yet.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus (ringing in ears) in both ears that isn't going away.
Age: 83.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Reported Symptoms: 10029436:NO DVERSE EFFECT;    Narrative: The expiration date of the Tenivac vaccine led to nursing inadvertently administering and expired vaccine. The format is 24SEP23 (expired 9/24/2023) and the vaccine was administered on 9/25/2023. Sanofi was contacted and they couldn't recommend administering the vaccine after expired but they didn't expect a loss of immune response one day after expiration. They stated that if a repeated dose was given to wait 28 days after the expired vaccine was given. Nursing discussed it with the patient's provider and they decided that a repeat dose was not necessary for the patient. Nursing educated their staff on the vaccine format and Sanofi filed a report on the confusing format of the expiration date.  Other Relevant HX:  Other: No Adverse Effects Noted
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Therapeutic product ineffective
Clinical narrative: Reported Symptoms: 10037887:PRURITUS; Narrative: Per care note 9/7/23: "He reports itching since getting covid vaccines. last vaccine 10/2022. He notes that he has used multiple creams, benadryl without help. did not try clobetasol cream as prescribed because of side effects he read about." Other Relevant HX: Other:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac telemetry, Hypotension, Hypoxia
Clinical narrative: Reported Symptoms: 10021143:HYPOXIA; 10035664:PNEUMONIA; Narrative: The patient was admitted to the medical floor, maintained on supplemental oxygen, and monitored on telemetry. He was started on remdesivir for symptomatic COVID-19 infection. He was initially hypotensive; with concerns for acute adrenal insufficiency due to abrupt discontinuation of steroids at nursing facility, he was started on stress dose hydrocortisone with rapid improvement in hemodynamic stability. Once blood pressures were stabilized, patient was transitioned to previous home dose of dexamethasone. He completed a 5-day course of remdesivir with resolution of hypoxia and respiratory symptoms. Other Relevant HX: The patient was admitted to the medical floor, maintained on supplemental oxygen, and monitored on telemetry. He was stated on remdesivir for symptomatic COVID-19 infection. He was initially hypotensive; with concerns for acute adrenal insufficiency due to abrupt discontinuation of steroids at nursing facility, he was started on stress dose hydrocortisone with rapid improvement in hemodynamic stability. Once blood pressures were stabilized, patient was transitioned to previous home dose of dexamethasone. He completed a 5-day course of remdesivir with resolution of hypoxia and respiratory symptoms. Other: PNA, Acute hypoxic respiratory failure
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Respiratory symptom
Clinical narrative: Reported Symptoms: 10021143:HYPOXIA; 10035664:PNEUMONIA; Narrative: The patient was admitted to the medical floor, maintained on supplemental oxygen, and monitored on telemetry. He was started on remdesivir for symptomatic COVID-19 infection. He was initially hypotensive; with concerns for acute adrenal insufficiency due to abrupt discontinuation of steroids at nursing facility, he was started on stress dose hydrocortisone with rapid improvement in hemodynamic stability. Once blood pressures were stabilized, patient was transitioned to previous home dose of dexamethasone. He completed a 5-day course of remdesivir with resolution of hypoxia and respiratory symptoms. Other Relevant HX: The patient was admitted to the medical floor, maintained on supplemental oxygen, and monitored on telemetry. He was stated on remdesivir for symptomatic COVID-19 infection. He was initially hypotensive; with concerns for acute adrenal insufficiency due to abrupt discontinuation of steroids at nursing facility, he was started on stress dose hydrocortisone with rapid improvement in hemodynamic stability. Once blood pressures were stabilized, patient was transitioned to previous home dose of dexamethasone. He completed a 5-day course of remdesivir with resolution of hypoxia and respiratory symptoms. Other: PNA, Acute hypoxic respiratory failure
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Reported Symptoms: 10037844:RASH; 10040604:SHORTNESS OF BREATH; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA, mild SOB
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood creatine phosphokinase increased, COVID-19, Fall, Liver function test increased
Clinical narrative: Reported Symptoms: 10024409:LFTS RAISED; 10028411:MYALGIA; 10047862:WEAKNESS; 10084268:COVID-19; Narrative: Patient received five doses of Pfizer COVID 19 Vaccine (Feb/Mar/Sep 2021) and (Apr/Dec 2022). The patient presented to the ED on 10 August 2023 with generalized weakness, falls, and congestion. The patient tested positive for COVID 19 on 10 August 23. The patient was admitted with elevated CPK and mild rhabdomyolysis and COVID 19 with severe weakness. The patient was treated with fluids and supportive care and was discharged on 14 August 2023 with severe muscle weakness to the lower extremities with consult to physical therapy. Reported per EUA. Other Relevant HX: Other: COVID 19 severe weakness
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Respiratory tract congestion, Rhabdomyolysis, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10024409:LFTS RAISED; 10028411:MYALGIA; 10047862:WEAKNESS; 10084268:COVID-19; Narrative: Patient received five doses of Pfizer COVID 19 Vaccine (Feb/Mar/Sep 2021) and (Apr/Dec 2022). The patient presented to the ED on 10 August 2023 with generalized weakness, falls, and congestion. The patient tested positive for COVID 19 on 10 August 23. The patient was admitted with elevated CPK and mild rhabdomyolysis and COVID 19 with severe weakness. The patient was treated with fluids and supportive care and was discharged on 14 August 2023 with severe muscle weakness to the lower extremities with consult to physical therapy. Reported per EUA. Other Relevant HX: Other: COVID 19 severe weakness
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: RASH
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash erythematous, Rash macular, Rash papular
Clinical narrative: Received shots ~ 10:30AM on 12/14/23. Spiked fever of 103 and broke out in blotchy red, raised rash on arms & buttock. Recommended Tylenol, ibuprofen, Zyrtec.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: RASH
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary abnormal, Asthenia, COVID-19, Erythema, Fall
Clinical narrative: Reported Symptoms: 10028735:NASAL CONGESTION; 10047862:WEAKNESS; Narrative: Patient was treated with 5 days course of remdesivir and Dexamethasone and was stable and symptoms resolved. Other Relevant HX: Patient presented to ED 7/11/23. Reports over the last few days he has felt very weak, culminating in a fall yesterday. He denies fever, chills, cough, sputum, nausea, diarrhea. He is fully vaccinated/boosted for COVID19 and has no known exposure, but ntoes his wife has had a bit of cough as well. He mainly presented today for evaluation of continued RLE edema and erythema as well as for the generalized weakness, but in the ED was noted to be hypoxic to the mid80s%. He tested positive for COVID19 and CTA showed pulmonary embolism. Treated with 5 days course of remdesivir and Dexamethasone - currently stable, hypoxia resolved and symptoms resolved Other: Weakness, congestion
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia, Nasal congestion, Oedema peripheral, Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10028735:NASAL CONGESTION; 10047862:WEAKNESS; Narrative: Patient was treated with 5 days course of remdesivir and Dexamethasone and was stable and symptoms resolved. Other Relevant HX: Patient presented to ED 7/11/23. Reports over the last few days he has felt very weak, culminating in a fall yesterday. He denies fever, chills, cough, sputum, nausea, diarrhea. He is fully vaccinated/boosted for COVID19 and has no known exposure, but ntoes his wife has had a bit of cough as well. He mainly presented today for evaluation of continued RLE edema and erythema as well as for the generalized weakness, but in the ED was noted to be hypoxic to the mid80s%. He tested positive for COVID19 and CTA showed pulmonary embolism. Treated with 5 days course of remdesivir and Dexamethasone - currently stable, hypoxia resolved and symptoms resolved Other: Weakness, congestion
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradycardia, COVID-19, Hypoglycaemia, Presyncope
Clinical narrative: Reported Symptoms: 10021005:HYPOGLYCEMIA; 10042772:SYNCOPE; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: See above under Event 2. Patient was treated with Remdesivir x 3 dose and was about to be d/c home. Other Relevant HX: Patient is an 81 yo MALE with was going to his podiatry appt and noted he was having syncope, weakness, and hypoglycemia. Patient then presented to ED and was tested and found to be positive for COVID 19. PMHx most notable for CAD sp PCI, pAF s/p ablation, DM w/ neuropathy, chronic pain, glaucoma, visual impairment, and chronic lower extremity wounds who presented with weakness and presyncopal symptoms during an outpatient podiatry visit with finding of COVID-19 infection on admission. The patient's presyncopal symptoms were presumed to be from COVID 19 infection and medication related bradycardia. The patient was treated with 3 days of remdesivir with minimal symptoms at the time of my initial evaluation. Given the pt's bradycardia the patient was evaluated by cardiology with his sotalol dose reduced to 40 mg BID with the patient to be discharged with an event monitor. The pt's presyncopal symptoms resolved at the time of DC. Other: Weakness.