chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, C-reactive protein, Cardiac flutter, Cardiolipin antibody, Complement factor C3
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Complement factor C4, Computerised tomogram abdomen, Contusion, Differential white blood cell count, Double stranded DNA antibody
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Electrocardiogram, Faecal calprotectin, Faecal elastase test, Fatigue
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Full blood count, Gene mutation identification test, Glycosylated haemoglobin, Head discomfort
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heavy metal test, Helicobacter test, Hepatobiliary scan, Hyperhidrosis
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Iron binding capacity total, Iron binding capacity unsaturated, Lipase, Lipids
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance cholangiopancreatography, Metabolic function test, Musculoskeletal pain, Oesophagogastroduodenoscopy, Pain in extremity
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Pelvic pain, Pregnancy test urine, Pyrexia
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Red blood cell sedimentation rate, Rheumatoid factor, SARS-CoV-2 antibody test, Sensory disturbance
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, Thyroxine free, Transferrin, Treponema test, Ultrasound abdomen
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina, Urine analysis, Visual snow syndrome, Vitamin B12, Vitamin D
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters, Weight decreased
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 3.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pain started immediately after injection and increasing became worse. Significant redness and swelling.  DDX: ( severe vaccine reaction, cellulitis, hematoma, combination of these). Treat with prednisolone and keflex to cover for possible cellulitis. Completely resolved with 48-72hrs.
Age: 3.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Pain started immediately after injection and increasing became worse. Significant redness and swelling.  DDX: ( severe vaccine reaction, cellulitis, hematoma, combination of these). Treat with prednisolone and keflex to cover for possible cellulitis. Completely resolved with 48-72hrs.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer calling to report temperature excursion. She states that the product was administered on 11/6/2024. No additional AE, no PQC. No additional information.          ?    Names of vaccines involved (including lot/exp) PROQUAD Y011215 12/18/202; This spontaneous report was received from an Other Health Professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 06-NOV-2024, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, lot #Y011215, expiration date: 18-DEC-2025, administered for prophylaxis (strength, dose and route of administration were not provided).  It was reported that the suspect vaccine was underwent temperature excursions of 18.4 degree Fahrenheit (F) (the time frame was 360 hours) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Syringe issue
Clinical narrative: no AE; liquid leaked out; there was pressure in the syringe; accidental underdose; poor quality device used; This spontaneous report was received from a nurse and refers to a child patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-DEC-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (therapy type: rHA) lot #Y004114, expiration date: 12-FEB-2026, administered for prophylaxis (strength, dose and route of administration were not provided) which was reconstituted with sterile diluent (STERILE DILUENT) solution for injection/infusion (strength, dose, lot #, expiry date, route of administration, and indication were not provided). During the administration, the reporter heard a popping noise during injection and states there was pressure in the syringe as if it was "carbonated ", as a result liquid leaked out from an unspecified area (product leakage, device issue, accidental underdose, poor quality device used). No adverse event was reported.
Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: plunger wasn't working when they tried to inject it in a patient; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (plunger wasn't working when they tried to inject it in a patient) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (plunger wasn't working when they tried to inject it in a patient) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (plunger wasn't working when they tried to inject it in a patient) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. No concomitant medication was reported.   No treatment information was reported.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, VARCEL
Symptoms: Seizure
Clinical narrative: Seizure, sudden onset, ~1 minute. No treatment needed.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Red itchy Papular rash on sides of waist and forearm
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Pts 4th dose resulted in a rash on his next. His 5th dose resulted in the same rash on his neck in addition to rashes on the flexor portions of his arms, legs, and sides of abdomen.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Arthralgia, Nausea, Vomiting
Clinical narrative: Extreme shoulder and hip pain worsening hours after the injections.  Nausea resulting in vomiting 12hrs after the injections
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel bad; This non-serious case was reported by a consumer and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose receive don an unknown date).   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 feeling bad (Verbatim: feel bad). The outcome of the feeling bad was not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The reporter stated to be aware as the shingles vaccine were 2 separate shots and the second one will make feel so bad. The patient went to the emergency room twice in four days thinking patient had covid or something worse. It was the vaccine and no one warned me beforehand. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Expired product administered
Clinical narrative: Recevied expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Rotavirus vaccine (expiry date 19-SEP-2024) for prophylaxis.   On 31-OCT-2024, the patient received Rotavirus vaccine. On 31-OCT-2024, an unknown time after receiving Rotavirus vaccine, the patient experienced expired vaccine used (Verbatim: Recevied expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-NOV-2024 The reporter reported that patients received a dose of Rotarix which had expired which led to expired vaccine used. The reporter wants to know if the patient needs to have another dose of Rotarix since the dose he received had expired. Also any adverse effects that might occur given that the vaccine was expired.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got first dose of Shingrix on September 26th 2024 and they accidentally gave the second dose 2 weeks later on October 10th 2024; 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 61-year-old male patient who received Herpes zoster (Shingrix) (batch number D5AP5, expiry date 10-AUG-2026) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 10-OCT-2024, the patient received the 2nd dose of Shingrix. On 10-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient got first dose of Shingrix on September 26th 2024 and they accidentally gave the second dose 2 weeks later on October 10th 2024). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 15-NOV-2024 Pharmacist explained that a patient got first dose of Shingrix and second dose was accidentally given 2 weeks later. The patient received second dose of Shingrix earlier than the recommended internal, which led to shortening of vaccine schedule. Medical information specialist did not ask for consent to follow up with safety.
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: product was administered on 07Nov2024 to a 6 month old male after being stored at inappropriate temperature; product was administered to a patient less than the approved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received MMR (Priorix) for prophylaxis.   On 07-NOV-2024, the patient received Priorix. On 07-NOV-2024, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: product was administered to a patient less than the approved age). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: product was administered on 07Nov2024 to a 6 month old male after being stored at inappropriate temperature). The outcome of the inappropriate age at vaccine administration and incorrect storage of drug were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-NOV-2024 Nurse Manager reports their facility received 2 boxes of Priorix and did not realize they should be refrigerated, so the boxes were stored in the freezer for about a month. They were exposed to a low of minus 23 degree celsius.  The product was administered to a 6 month old male after been stored at inappropriate temperature, which led inappropriate age at vaccine administration and incorrect storage of drug. The reporter states the product was administered to a patient less than the approved age because the patient would be traveling outside of the country.  The reporter consented to follow up. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024144734:Same reporter/different patient US-GSK-US2024144736:Same reporter/different patient US-GSK-US2024144738:Same reporter/different patient
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site warmth, Neuralgia
Clinical narrative: had redness to Rt del. warmth to touch She was then later dx with shingles. Redness and pain at injection site. received vaccine 10/22. was seen 11/8 with nerve pain in this arm 11/12/24 Dx with shingles in this arm
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Post herpetic neuralgia
Clinical narrative: had redness to Rt del. warmth to touch She was then later dx with shingles. Redness and pain at injection site. received vaccine 10/22. was seen 11/8 with nerve pain in this arm 11/12/24 Dx with shingles in this arm
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Incorrect dose administered
Clinical narrative: I mistakenly gave an 18 year old patient an adult dose of Hepatitis A Vaccine, Inactivated Adult Formation instead of giving the correct dose of Hepatitis A Vaccine, Inactivated Pediatric/Adolescent Formulation.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: While at skilled rehab unit on 12/9/24 at 1442 resident was given a Moderna Spikevax vaccine to right deltoid. Resident has never received a prior dose of Covid-19 vaccines. At approximately 10pm when doing her shift assessment the nurse noted hives on the residents back, chest and arms, no other symptoms noted resident alert answering questions, no SOB, Benadryl 25mg ordered every 4 hours and monitoring every 2 hours for resp complications. No complications rash improved no resp concerns. On 12/11/24 resident d/c back to nursing facility. Rash much improved.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Urticaria
Clinical narrative: Child received flulaval 2024-2025 trivalent vaccine in office 12/9/24. Child presented to urgent care 12/10/2024 with crying and urticaria to R arm and face. Denied SOB, DI, vomiting, fever. The child had flu vaccine on 10/06/2021, 10/25/2022, and 10/26/2023 without adverse reaction.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: large left cervical lymphadenopathy; lymph node on left side of neck (same side that the vaccine was administered on) became enlarged two days after receiving the vaccine. It still hasn't gone down.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Injection site erythema, Nausea
Clinical narrative: flushing, nausea, redness at site about 4 hours after vaccination
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Myalgia, Nausea, Sleep disorder
Clinical narrative: I had been to restaurant for dinner and dancing. In bed 10 pm. Was very unusually tired.  Woke up at 1AM feeling very nauseous, hot (maybe fever, I didn't ck).  Very sore hurting muscles, in ways not normal to me. Throwing up some, but very little, and very weak. Almost like symptoms of food. I only had soup and one beer for dinner. Not gonna play pickle all today as I am still feeling so tired muscles  aching.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: I had been to restaurant for dinner and dancing. In bed 10 pm. Was very unusually tired.  Woke up at 1AM feeling very nauseous, hot (maybe fever, I didn't ck).  Very sore hurting muscles, in ways not normal to me. Throwing up some, but very little, and very weak. Almost like symptoms of food. I only had soup and one beer for dinner. Not gonna play pickle all today as I am still feeling so tired muscles  aching.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: patient developed a rash
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Product storage error
Clinical narrative: The patient received the FluMist Vaccine @3:31PM on 12/10.  This vaccine was exposed to a temperature excursion (brief, approx 3 or so minutes), lowest temp 1.94C earlier that same day. Unknown at time of admin that there was a previous excursion.  Fridge temperatures quickly returned to normal range. Patient's mother notified of this incident. Patients PCP also aware.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Eosinophil count increased, Injection site pruritus, Lymphocyte percentage decreased, Pruritus
Clinical narrative: Itching beginning at injection site and spreading over torso.  No rash.  Intense in nature, it lasted two weeks and two days, subsiding after I took a couple days' worth of Benadryl antihistamine caplets.  Possibly notable at this time, my ABS Eosinophils level was 1,763.  I will have a follow-up blood test soon.  Lymphocyte levels went from 7.5% on Sept. 30, to 16.6% on Dec. 2.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Dose for 4y-11y given to 12 year ola patient. Patient was under dosed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Tinnitus
Clinical narrative: I woke up at 4:00 A.M. with a bad headache and tinnitus. The tinnitus has not gone away.
Age: 5.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Underdose
Clinical narrative: Client was presented by his father. Client received 0.3 mL Covid Pfizer lot LN6739 (6m-4YO). This vaccine is the 2nd dose in his scheduled series. Client was under dosed. Client did not exhibit any signs or symptoms of difficulty.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Confusional state, Crying, Cyanosis, Dizziness, Fatigue
Clinical narrative: Within 2 minutes of receiving the vaccines, patient stopped breathing, became pale and lips cyanotic, she then lost consciousness and began posturing in seizure with arms stiff and straight out, eyes rolling back and tense. Episode lasted about 1 minute. Able to touch her face, talk with her and when she came out of the episode she was confused, looking around the room, then began to cry, sweat profusely and was very dizzy. She was then dizzy, tired, and with nausea and headache for 1 hour. Gave her cool water, pedialyte, bites of granola bar and eventually zofran dissolvable.  She felt better about 20 min after zofran but was still tired and slightly dizzy. About 2 hours after administration of the vaccines she was home, ate a small amount of food and then fell asleep for a few hours. Per mom after she woke up she was feeling better and hungry. Follow up the following day, mom states that she ate really well the previous night, slept well, no fever or residual symptoms. Was feeling back to normal this morning and is going to school. No further questions
Age: 13.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Gaze palsy, Haemoglobin normal, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Within 2 minutes of receiving the vaccines, patient stopped breathing, became pale and lips cyanotic, she then lost consciousness and began posturing in seizure with arms stiff and straight out, eyes rolling back and tense. Episode lasted about 1 minute. Able to touch her face, talk with her and when she came out of the episode she was confused, looking around the room, then began to cry, sweat profusely and was very dizzy. She was then dizzy, tired, and with nausea and headache for 1 hour. Gave her cool water, pedialyte, bites of granola bar and eventually zofran dissolvable.  She felt better about 20 min after zofran but was still tired and slightly dizzy. About 2 hours after administration of the vaccines she was home, ate a small amount of food and then fell asleep for a few hours. Per mom after she woke up she was feeling better and hungry. Follow up the following day, mom states that she ate really well the previous night, slept well, no fever or residual symptoms. Was feeling back to normal this morning and is going to school. No further questions
Age: 13.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Musculoskeletal stiffness, Nausea, Pallor, Respiratory arrest, Seizure
Clinical narrative: Within 2 minutes of receiving the vaccines, patient stopped breathing, became pale and lips cyanotic, she then lost consciousness and began posturing in seizure with arms stiff and straight out, eyes rolling back and tense. Episode lasted about 1 minute. Able to touch her face, talk with her and when she came out of the episode she was confused, looking around the room, then began to cry, sweat profusely and was very dizzy. She was then dizzy, tired, and with nausea and headache for 1 hour. Gave her cool water, pedialyte, bites of granola bar and eventually zofran dissolvable.  She felt better about 20 min after zofran but was still tired and slightly dizzy. About 2 hours after administration of the vaccines she was home, ate a small amount of food and then fell asleep for a few hours. Per mom after she woke up she was feeling better and hungry. Follow up the following day, mom states that she ate really well the previous night, slept well, no fever or residual symptoms. Was feeling back to normal this morning and is going to school. No further questions
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Malaise, Nausea, Posture abnormal, Retching, Unresponsive to stimuli
Clinical narrative: At the end of todays visit the patient was given his COVID and FLU shot. Within  seconds he was feeling unwell/nauseous. his head dropped and he became  unresponsive. he began to slouch over to the left and was spitting up sputum. He  appeared to be gagging on the sputum. I was unable to get help because I was  having to hold him upright. after about 45 seconds his condition improved and he  looked at me in the eyes. A rapid response was called. we laid him down and  gave him food and water and he slowly felt better. no evidence of post ictal sx.  We drew his labs in the room. the patient felt near his baseline and appeared  appropriate to drive himself home.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Vomiting
Clinical narrative: At the end of todays visit the patient was given his COVID and FLU shot. Within  seconds he was feeling unwell/nauseous. his head dropped and he became  unresponsive. he began to slouch over to the left and was spitting up sputum. He  appeared to be gagging on the sputum. I was unable to get help because I was  having to hold him upright. after about 45 seconds his condition improved and he  looked at me in the eyes. A rapid response was called. we laid him down and  gave him food and water and he slowly felt better. no evidence of post ictal sx.  We drew his labs in the room. the patient felt near his baseline and appeared  appropriate to drive himself home.
Age: 33.0
Sex: F
Vaccine: COVID19, HEPAB, TDAP
Symptoms: Pain
Clinical narrative: PAIN
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: The Pedvax Hib was mistakenly given with a Diluent dose.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Patient uncooperative, Underdose
Clinical narrative: The child flinched and half of the dose went out into the air surrounding her once the needle was forced out of her skin.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was mistakenly administered them Moderna Spikevax Covid vaccine for ages 12 and over, instead of the Moderna Covid vaccine for 6 months - 11 y ears. No adverse reaction noticed immediately while patient was in clinic. Provider and family were informed, and will contact the clinic if there are any reactions or further concerns related to this event.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 7 years old, but was mistakenly ordered for and received the adult Spikevax/Moderna COVID-19 vaccine. Patient received a 50 mcg/0.5 mL dose instead of the 25 mcg/0.25 mL doses that is intended for children between the ages of 6 months to 11 years. No adverse events have been reported as of yet. Submitting VAERS report due to use of this vaccine being under an EUA for this age group.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: PT was given vaccine and fainted. PT was back to baseline after 5 mins.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Fatigue, SARS-CoV-2 test
Clinical narrative: Cough, fatigue
Age: 24.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: 34 weeks pregnant, contact patient for more information I am unsure
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Back pain, Blood pressure abnormal, Hypoaesthesia, Injection site swelling
Clinical narrative: Extreme swelling at vaccine site.  Neuropathy. Numbness tingling. In feet. Hands   Extreme back pain.  Muscle pain. Weakness in legs. Whole body. Blood pressure instability.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Muscular weakness, Myalgia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Extreme swelling at vaccine site.  Neuropathy. Numbness tingling. In feet. Hands   Extreme back pain.  Muscle pain. Weakness in legs. Whole body. Blood pressure instability.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events. Provider ordered Proquad and Medical Assistant administered MMR erroneously.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered to a 5 year old.  Indication for use is for 12 years and older
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient recieved Influenza Flucelvax on 8/27/2024 and then requested and recieved Influenza Fluad on 12/11/2024
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Age 12+ Spikevax given to 6 year old
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID about one month after my most recent booster. Paxlovid was prescribed. Symptoms were minimal. I isolated for 10 days. Masked at home mostly.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric Moderna Covid Vaccine had a Beyond Use Date of 11/16/2024 and was erroneously administered on 12/3/2024.