chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Lumbar puncture, Lymphocyte percentage, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Metabolic function test
Clinical narrative: Over the weekend of 10/19 Patient developed congestion and rhinorrhea. Monday (10/21) reported headache and was subsequently sent home from school. Otherwise at neurologic baseline. Had PCP appointment on Tuesday at which time he still had some headache and congestion but was well appearing otherwise and received vaccines (Meng ACWY, TDAP, flu). Wednesday he was sent home from school again, this time because of fever (reportedly around 101F). Given fever and congestion parents gave regular Nyquil and Dayquil but otherwise no concern and remained at neurologic baseline. Patient was kept home from school on Thursday but well enough to participate in football practice that night. During the practice he had a helmet to helmet collision but no LOC, vomiting or concern for seizure activity. Jumped right back up and no reported concern for concussion. Reportedly more fatigued on Friday and Saturday but no obvious concerns for parents. Sunday morning mom heard him fumbling around in the bathroom. When she went to check on him he reported that he couldn't see. On further questioning he reported double vision and when cover his left eye reported blurry vision. Mother noticed that while right eye was looking ahead, left eye appeared to deviate inward and upward. This prompted attendance to University Center where he was admitted for further work up.   While sedated for his LP at University Center had episode of lip smacking and, separately during rounds at University Center, he had episode of rhythmic right upper extremity jerking. For this reason University Center planned for EEG but not available at their center so transferred to Hospital. At the Hospital, MRI obtained showing Abnormal T2/FLAIR signal involving bilateral dorsal and medial thalami, as well as the periaqueductal gray matter. Patient remains hospitalized in the pediatric ICU at the time of report submission; leading differential diagnosis is ADEM secondary to vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Neisseria test negative, Platelet count increased, Procalcitonin increased, Protein albumin ratio decreased, Protein total normal
Clinical narrative: Over the weekend of 10/19 Patient developed congestion and rhinorrhea. Monday (10/21) reported headache and was subsequently sent home from school. Otherwise at neurologic baseline. Had PCP appointment on Tuesday at which time he still had some headache and congestion but was well appearing otherwise and received vaccines (Meng ACWY, TDAP, flu). Wednesday he was sent home from school again, this time because of fever (reportedly around 101F). Given fever and congestion parents gave regular Nyquil and Dayquil but otherwise no concern and remained at neurologic baseline. Patient was kept home from school on Thursday but well enough to participate in football practice that night. During the practice he had a helmet to helmet collision but no LOC, vomiting or concern for seizure activity. Jumped right back up and no reported concern for concussion. Reportedly more fatigued on Friday and Saturday but no obvious concerns for parents. Sunday morning mom heard him fumbling around in the bathroom. When she went to check on him he reported that he couldn't see. On further questioning he reported double vision and when cover his left eye reported blurry vision. Mother noticed that while right eye was looking ahead, left eye appeared to deviate inward and upward. This prompted attendance to University Center where he was admitted for further work up.   While sedated for his LP at University Center had episode of lip smacking and, separately during rounds at University Center, he had episode of rhythmic right upper extremity jerking. For this reason University Center planned for EEG but not available at their center so transferred to Hospital. At the Hospital, MRI obtained showing Abnormal T2/FLAIR signal involving bilateral dorsal and medial thalami, as well as the periaqueductal gray matter. Patient remains hospitalized in the pediatric ICU at the time of report submission; leading differential diagnosis is ADEM secondary to vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Respiratory viral panel, SARS-CoV-2 test negative, Scan with contrast abnormal
Clinical narrative: Over the weekend of 10/19 Patient developed congestion and rhinorrhea. Monday (10/21) reported headache and was subsequently sent home from school. Otherwise at neurologic baseline. Had PCP appointment on Tuesday at which time he still had some headache and congestion but was well appearing otherwise and received vaccines (Meng ACWY, TDAP, flu). Wednesday he was sent home from school again, this time because of fever (reportedly around 101F). Given fever and congestion parents gave regular Nyquil and Dayquil but otherwise no concern and remained at neurologic baseline. Patient was kept home from school on Thursday but well enough to participate in football practice that night. During the practice he had a helmet to helmet collision but no LOC, vomiting or concern for seizure activity. Jumped right back up and no reported concern for concussion. Reportedly more fatigued on Friday and Saturday but no obvious concerns for parents. Sunday morning mom heard him fumbling around in the bathroom. When she went to check on him he reported that he couldn't see. On further questioning he reported double vision and when cover his left eye reported blurry vision. Mother noticed that while right eye was looking ahead, left eye appeared to deviate inward and upward. This prompted attendance to University Center where he was admitted for further work up.   While sedated for his LP at University Center had episode of lip smacking and, separately during rounds at University Center, he had episode of rhythmic right upper extremity jerking. For this reason University Center planned for EEG but not available at their center so transferred to Hospital. At the Hospital, MRI obtained showing Abnormal T2/FLAIR signal involving bilateral dorsal and medial thalami, as well as the periaqueductal gray matter. Patient remains hospitalized in the pediatric ICU at the time of report submission; leading differential diagnosis is ADEM secondary to vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Serum ferritin normal, Streptococcus test negative, Tardive dyskinesia, Varicella virus test negative, Viral test negative
Clinical narrative: Over the weekend of 10/19 Patient developed congestion and rhinorrhea. Monday (10/21) reported headache and was subsequently sent home from school. Otherwise at neurologic baseline. Had PCP appointment on Tuesday at which time he still had some headache and congestion but was well appearing otherwise and received vaccines (Meng ACWY, TDAP, flu). Wednesday he was sent home from school again, this time because of fever (reportedly around 101F). Given fever and congestion parents gave regular Nyquil and Dayquil but otherwise no concern and remained at neurologic baseline. Patient was kept home from school on Thursday but well enough to participate in football practice that night. During the practice he had a helmet to helmet collision but no LOC, vomiting or concern for seizure activity. Jumped right back up and no reported concern for concussion. Reportedly more fatigued on Friday and Saturday but no obvious concerns for parents. Sunday morning mom heard him fumbling around in the bathroom. When she went to check on him he reported that he couldn't see. On further questioning he reported double vision and when cover his left eye reported blurry vision. Mother noticed that while right eye was looking ahead, left eye appeared to deviate inward and upward. This prompted attendance to University Center where he was admitted for further work up.   While sedated for his LP at University Center had episode of lip smacking and, separately during rounds at University Center, he had episode of rhythmic right upper extremity jerking. For this reason University Center planned for EEG but not available at their center so transferred to Hospital. At the Hospital, MRI obtained showing Abnormal T2/FLAIR signal involving bilateral dorsal and medial thalami, as well as the periaqueductal gray matter. Patient remains hospitalized in the pediatric ICU at the time of report submission; leading differential diagnosis is ADEM secondary to vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Vision blurred, White blood cell count increased
Clinical narrative: Over the weekend of 10/19 Patient developed congestion and rhinorrhea. Monday (10/21) reported headache and was subsequently sent home from school. Otherwise at neurologic baseline. Had PCP appointment on Tuesday at which time he still had some headache and congestion but was well appearing otherwise and received vaccines (Meng ACWY, TDAP, flu). Wednesday he was sent home from school again, this time because of fever (reportedly around 101F). Given fever and congestion parents gave regular Nyquil and Dayquil but otherwise no concern and remained at neurologic baseline. Patient was kept home from school on Thursday but well enough to participate in football practice that night. During the practice he had a helmet to helmet collision but no LOC, vomiting or concern for seizure activity. Jumped right back up and no reported concern for concussion. Reportedly more fatigued on Friday and Saturday but no obvious concerns for parents. Sunday morning mom heard him fumbling around in the bathroom. When she went to check on him he reported that he couldn't see. On further questioning he reported double vision and when cover his left eye reported blurry vision. Mother noticed that while right eye was looking ahead, left eye appeared to deviate inward and upward. This prompted attendance to University Center where he was admitted for further work up.   While sedated for his LP at University Center had episode of lip smacking and, separately during rounds at University Center, he had episode of rhythmic right upper extremity jerking. For this reason University Center planned for EEG but not available at their center so transferred to Hospital. At the Hospital, MRI obtained showing Abnormal T2/FLAIR signal involving bilateral dorsal and medial thalami, as well as the periaqueductal gray matter. Patient remains hospitalized in the pediatric ICU at the time of report submission; leading differential diagnosis is ADEM secondary to vaccination.
Age: 92.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: During an offsite vaccine clinic for flu and covid vaccines, the patient requested and received an RSV vaccine. When processing the paperwork after the clinic it was discovered that the patient received a dose on 10/04/23. The patient was contacted and reported no adverse effects.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Fall, Malaise, Pallor, Presyncope
Clinical narrative: Pt received both vaccines and tolerated well during. Was able to step off of exam table and stand to the side of the room as he waited for mom and brother to get vaccines. Around 3-4 minutes after vaccine placement, pt became pale and had a likely vasovagal response. Pt fell, sliding down the wall to the floor. Pt arousable in seconds after fall. Alert and oriented. Pt remained light headed and feeling "unwell" for 8-10 minutes. Pt felt better with lying flat and his color returned. Vital signs were acquired and an assessment for injury was performed. Pt able to walk out of room on his own.
Age: 14.0
Sex: M
Vaccine: MNQ, UNK, VARCEL
Symptoms: Asthenia, Blood test normal, CSF test normal, Central nervous system lesion, Cough
Clinical narrative: ?After the vaccines?: cough, muscle aches that resolved.  10/17: headache (in back of head), neck pain with flexion, subjective fever, decreased appetite. No photophobia/phonophobia. 10/19: Inabiity to urinate, abdominal pressure.  10/20: One episode of emesis, nonbloody, non-bilious. Bilateral leg weakness, difficulty standing, generalized weakness and dizziness. Blurry vision in left eye. Presented to emergency department, febrile, admitted to general pediatrics service for presumed meningitis.  10/21: Transferred to pediatric ICU for progressive focal weakness (Right arm and leg) and sensory loss. Brain MRI was normal. Spine MRI with multiple independent T2 hyperintense spinal cord lesions (C1-C6, T1-T3, T11-T12, conus), hence potential concerns for post-vaccination, immune-mediated rapidly progressive myelopathy.
Age: 14.0
Sex: M
Vaccine: MNQ, UNK, VARCEL
Symptoms: Decreased appetite, Discomfort, Dizziness, Dysstasia, Headache
Clinical narrative: ?After the vaccines?: cough, muscle aches that resolved.  10/17: headache (in back of head), neck pain with flexion, subjective fever, decreased appetite. No photophobia/phonophobia. 10/19: Inabiity to urinate, abdominal pressure.  10/20: One episode of emesis, nonbloody, non-bilious. Bilateral leg weakness, difficulty standing, generalized weakness and dizziness. Blurry vision in left eye. Presented to emergency department, febrile, admitted to general pediatrics service for presumed meningitis.  10/21: Transferred to pediatric ICU for progressive focal weakness (Right arm and leg) and sensory loss. Brain MRI was normal. Spine MRI with multiple independent T2 hyperintense spinal cord lesions (C1-C6, T1-T3, T11-T12, conus), hence potential concerns for post-vaccination, immune-mediated rapidly progressive myelopathy.
Age: 14.0
Sex: M
Vaccine: MNQ, UNK, VARCEL
Symptoms: Intensive care, Magnetic resonance imaging head abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Meningitis
Clinical narrative: ?After the vaccines?: cough, muscle aches that resolved.  10/17: headache (in back of head), neck pain with flexion, subjective fever, decreased appetite. No photophobia/phonophobia. 10/19: Inabiity to urinate, abdominal pressure.  10/20: One episode of emesis, nonbloody, non-bilious. Bilateral leg weakness, difficulty standing, generalized weakness and dizziness. Blurry vision in left eye. Presented to emergency department, febrile, admitted to general pediatrics service for presumed meningitis.  10/21: Transferred to pediatric ICU for progressive focal weakness (Right arm and leg) and sensory loss. Brain MRI was normal. Spine MRI with multiple independent T2 hyperintense spinal cord lesions (C1-C6, T1-T3, T11-T12, conus), hence potential concerns for post-vaccination, immune-mediated rapidly progressive myelopathy.
Age: 14.0
Sex: M
Vaccine: MNQ, UNK, VARCEL
Symptoms: Muscular weakness, Myalgia, Neck pain, Optic nerve disorder, Pain
Clinical narrative: ?After the vaccines?: cough, muscle aches that resolved.  10/17: headache (in back of head), neck pain with flexion, subjective fever, decreased appetite. No photophobia/phonophobia. 10/19: Inabiity to urinate, abdominal pressure.  10/20: One episode of emesis, nonbloody, non-bilious. Bilateral leg weakness, difficulty standing, generalized weakness and dizziness. Blurry vision in left eye. Presented to emergency department, febrile, admitted to general pediatrics service for presumed meningitis.  10/21: Transferred to pediatric ICU for progressive focal weakness (Right arm and leg) and sensory loss. Brain MRI was normal. Spine MRI with multiple independent T2 hyperintense spinal cord lesions (C1-C6, T1-T3, T11-T12, conus), hence potential concerns for post-vaccination, immune-mediated rapidly progressive myelopathy.
Age: 14.0
Sex: M
Vaccine: MNQ, UNK, VARCEL
Symptoms: Pyrexia, Sensory loss, Urinary retention, Vision blurred, Vomiting
Clinical narrative: ?After the vaccines?: cough, muscle aches that resolved.  10/17: headache (in back of head), neck pain with flexion, subjective fever, decreased appetite. No photophobia/phonophobia. 10/19: Inabiity to urinate, abdominal pressure.  10/20: One episode of emesis, nonbloody, non-bilious. Bilateral leg weakness, difficulty standing, generalized weakness and dizziness. Blurry vision in left eye. Presented to emergency department, febrile, admitted to general pediatrics service for presumed meningitis.  10/21: Transferred to pediatric ICU for progressive focal weakness (Right arm and leg) and sensory loss. Brain MRI was normal. Spine MRI with multiple independent T2 hyperintense spinal cord lesions (C1-C6, T1-T3, T11-T12, conus), hence potential concerns for post-vaccination, immune-mediated rapidly progressive myelopathy.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse event, but unneeded vaccine given.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath- Given in ER Epinephrine, Dipeenhydramine HCI, Methylprednisolone 10/25/2024 @8:45am
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Vaccination site erythema
Clinical narrative: Rapid spread of erythema and swelling surrounding the vaccination site, covering most of the upper outer arm. No mucosal swelling, lip swelling, cough/wheezing, or hives.  Likely a localized cutaneous reaction. Given antibiotics for possible cellulitis.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Arthritis, Mobility decreased, Pain, Pain in extremity
Clinical narrative: intense pain in  left arm/shoulder region.  Decreased range of motion/pain lifting arm/putting pressure on arm/rotating arm
Age: 64.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Injection site pain
Clinical narrative: intense pain in  left arm/shoulder region.  Decreased range of motion/pain lifting arm/putting pressure on arm/rotating arm
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Feeling abnormal, Head injury, Headache
Clinical narrative: PATIENT WAS ADMINISTERED VACCINE AND AMBULATED OUT OF EXAM ROOM; PATIENT STATED HE "FELT LIKE SOMETHING IS IN MY ARM" PER ADMINISTERING LPN. WHILE CHECKING OUT OF THE CLINIC APROX. 10 MINUTES AFTER THE VACCINE, THE MOTHER CALLED FOR HELP.  PATIENT RECALLS THAT HE FELT "FUZZY" AND STARTED TO PASS OUT.  MOTHER GRABBED THE PATIENT'S FACE, SHE TRIED TO GRAB HIS TORSO BUT HIS LEGS BUCKLED AND HE PASSSED OUT, LOOSING CONCIOUSNESS AND HITTING HIS HEAD ON THE WALL WHILE FALLING TO THE GROUND.  ALMOST IMMEDIATELY MEDICAL STAFF WAS AT THE PATIENTS SIDE AND ASSESSED HIM.  PATIENT WAS DIAPHORETIC AND PALE; RESUME CONSIOUSNESS AND REPORTED NAUSEA AND HEAD PAIN. "GOOSE EGG" APROX 2CM NOTED ON POSTERIOR SKULL BUT NO LACERATIONS. PATIENT WAS ALLOWED TIME TO REST AND ATTEMPTED TO SIT BUT HAD RETURN OF PALLOR AND DIAPHORESIS. THIS CONEINUED FOR 2 HOURS BEFORE THE PATIENT WAS ABLE TO SIT WITHOUTH FEEDING DIZZY, NAUSEATED, OR TURING PALE IN COLOR.  PT WAS THEN ABLE TO TOLERATE CRACKERS AND PO HYDRATION AND AMBULATED OUT OF THE OFFICE OF HIS OWN WILL 2.5 HRS AFTER VACCINATION.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: PATIENT WAS ADMINISTERED VACCINE AND AMBULATED OUT OF EXAM ROOM; PATIENT STATED HE "FELT LIKE SOMETHING IS IN MY ARM" PER ADMINISTERING LPN. WHILE CHECKING OUT OF THE CLINIC APROX. 10 MINUTES AFTER THE VACCINE, THE MOTHER CALLED FOR HELP.  PATIENT RECALLS THAT HE FELT "FUZZY" AND STARTED TO PASS OUT.  MOTHER GRABBED THE PATIENT'S FACE, SHE TRIED TO GRAB HIS TORSO BUT HIS LEGS BUCKLED AND HE PASSSED OUT, LOOSING CONCIOUSNESS AND HITTING HIS HEAD ON THE WALL WHILE FALLING TO THE GROUND.  ALMOST IMMEDIATELY MEDICAL STAFF WAS AT THE PATIENTS SIDE AND ASSESSED HIM.  PATIENT WAS DIAPHORETIC AND PALE; RESUME CONSIOUSNESS AND REPORTED NAUSEA AND HEAD PAIN. "GOOSE EGG" APROX 2CM NOTED ON POSTERIOR SKULL BUT NO LACERATIONS. PATIENT WAS ALLOWED TIME TO REST AND ATTEMPTED TO SIT BUT HAD RETURN OF PALLOR AND DIAPHORESIS. THIS CONEINUED FOR 2 HOURS BEFORE THE PATIENT WAS ABLE TO SIT WITHOUTH FEEDING DIZZY, NAUSEATED, OR TURING PALE IN COLOR.  PT WAS THEN ABLE TO TOLERATE CRACKERS AND PO HYDRATION AND AMBULATED OUT OF THE OFFICE OF HIS OWN WILL 2.5 HRS AFTER VACCINATION.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient has had no Adverse reactions to Vaccine
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Lethargy, Malaise, Nausea
Clinical narrative: Nauseousness, lethargy, stomach pain, general ill feeling
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: presnted with raised  red/itchy skin around the injection site
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Tinnitus
Clinical narrative: Patient started to complain about a ringing in the ear after patient got home.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: On 10-17-24 around 9PM, started developing body aches, fevers, and tenderness at injection site.  Had fevers overnight and into the next day, so I missed a full day of work.  The next AM I developed a large erythematous raised area below the site of injection that last approximately 5 days.  I have had fevers with every COVID injection that I have received; I have never had a reaction to previous flu shots.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia
Clinical narrative: On 10-17-24 around 9PM, started developing body aches, fevers, and tenderness at injection site.  Had fevers overnight and into the next day, so I missed a full day of work.  The next AM I developed a large erythematous raised area below the site of injection that last approximately 5 days.  I have had fevers with every COVID injection that I have received; I have never had a reaction to previous flu shots.
Age: 23.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Injection site erythema, Pain, Pyrexia
Clinical narrative: Developed fatigue, body aches and fevers overnight and into the next day; had minimal erythema below COVID injection site.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: FATIGUE, FEVER, NAUSEA AND VOMITING
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event reported. patient received 2 seasonal flu vaccines. 2 months apart
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; patient received a dose of VARIVAX after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's medical history, concurrent condition, concomitant therapies were not reported.  On an unknown day, vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was temperature excursion to 10.2 degree Fahrenheit for 1 hour and 30 minutes. There was no Previous temperature excursion. On 10-SEP-2024, the patient was vaccinated with temperature excursion varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #y003891, expiration date: 06-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). It was confirmed no other adverse event occurred (no adverse event).; Sender's Comments:  US-009507513-2410USA001590: US-009507513-2410USA001596:MSD US-009507513-2410USA001407:MSD US-009507513-2410USA001417:MSD
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report vaccines were administered after experiencing a temperature excursion.; This spontaneous report was received from a physician, referring to a 1-year-old male patient. The patient's pertinent medical histories, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported.   On 23-JUL-2024, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X026666, expiration date: 29-MAY-2025, administered intramuscularly at right thigh for prophylaxis (strength and dose was not provided).  The vaccine was administered after a temperature excursion of 8.8.1 degree Celsius (C) during a time frame of 4 minutes and 45 seconds (product storage error). No previous temperature excursion was reported. No additional adverse event (AE) was reported (no adverse event).  This is one of the several reports received from the same reporter. ; Sender's Comments:  US-009507513-2410USA001631: US-009507513-2410USA001607: US-009507513-2408USA009052:
Age: 1.42
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; was inadvertently administered to a 17-month-old male; This spontaneous report was received from nurse and refers to a 17-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-OCT-2024, the patient was inadvertently administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (0.5 milliliter/once, lot #X019196 was valid for formulation pre-filled syringe, expiration date: 25-APR-2025, route of administration and anatomical location were not provided) for prophylaxis (Product administered to patient of inappropriate age). There were no other adverse issues or side effects noted with the administered dose. No additional AE (No adverse event). No PQC.
Sex: F
Vaccine: MMRV
Symptoms: Conjunctivitis, Ear infection, Oropharyngeal discolouration, Pyrexia, Rash
Clinical narrative: possible strep; double ear infection; respiratory infection/fever/She also has a fever of 102 for almost 7 days while on the antibiotics the doctor prescribed to battle her symptoms.; pinkeye/conjunctivitis; white spots on her throat; thrombocytopenia; It dried out looking similar to eczema, was itching, then started oozing.; Now it looks similar to a bruise and it has still not healed; a spot on her leg the size of a nickel, similar to bee sting, by the next morning it grew to a silver dollar and became about 5-7 red, bumpy spots.; This spontaneous report was received from a consumer and refers to her a daugther, a child female patient of unknown age.  The patient's medical history included abnormally high B12 levels. The patient's concurrent conditions and concomitant therapies were not reported.  On 16-SEP-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, lot #, expiry date, and route of administration were not provided).  On 19-SEP-2024, by that Thursday, the patient had developed pinkeye (conjunctivitis). On 18-SEP-2024, by that Saturday, she developed white spots on her throat (throat lesion). By 20-SEP-2024, she had developed conjunctivitis, possible Streptococcal (strep), fever, double ear infection, and a respiratory infection (Streptococcal infection; ear infection; respiratory tract infection). She also has a fever of 102 for almost 7 days while on the antibiotics the doctor prescribed to battle her symptoms. After that, on an unspecified date in 2024, she started getting a spot on her leg the size of a nickel, similar to bee sting, by the next morning it grew to a silver dollar and became about 5-7 red, bumpy spots (rash macular). It dried out looking similar to eczema, was itching, and then started oozing (eczema weeping). On an unspecified date in 2024 (reported as now), it looked similar to a bruise and it had still not healed (skin lesion). The mother believed the child may be experiencing thrombocytopenia. No additional adverse event (AE) and no product quality complaint (PQC) was noted. The consumer was calling with questions about the side effects. The outcome of the reported adverse events was reported as not recovered.  The causal relationship between the adverse events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was considered to be related. It was reported that the reporter's child has been experiencing side effects for 6 weeks now that she believed was related to the vaccine.  Upon internal review, the event of thrombocytopenia was considered to be medically significant.
Sex: F
Vaccine: MMRV
Symptoms: Rash macular, Rash pruritic, Respiratory tract infection, Skin lesion, Skin weeping
Clinical narrative: possible strep; double ear infection; respiratory infection/fever/She also has a fever of 102 for almost 7 days while on the antibiotics the doctor prescribed to battle her symptoms.; pinkeye/conjunctivitis; white spots on her throat; thrombocytopenia; It dried out looking similar to eczema, was itching, then started oozing.; Now it looks similar to a bruise and it has still not healed; a spot on her leg the size of a nickel, similar to bee sting, by the next morning it grew to a silver dollar and became about 5-7 red, bumpy spots.; This spontaneous report was received from a consumer and refers to her a daugther, a child female patient of unknown age.  The patient's medical history included abnormally high B12 levels. The patient's concurrent conditions and concomitant therapies were not reported.  On 16-SEP-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, lot #, expiry date, and route of administration were not provided).  On 19-SEP-2024, by that Thursday, the patient had developed pinkeye (conjunctivitis). On 18-SEP-2024, by that Saturday, she developed white spots on her throat (throat lesion). By 20-SEP-2024, she had developed conjunctivitis, possible Streptococcal (strep), fever, double ear infection, and a respiratory infection (Streptococcal infection; ear infection; respiratory tract infection). She also has a fever of 102 for almost 7 days while on the antibiotics the doctor prescribed to battle her symptoms. After that, on an unspecified date in 2024, she started getting a spot on her leg the size of a nickel, similar to bee sting, by the next morning it grew to a silver dollar and became about 5-7 red, bumpy spots (rash macular). It dried out looking similar to eczema, was itching, and then started oozing (eczema weeping). On an unspecified date in 2024 (reported as now), it looked similar to a bruise and it had still not healed (skin lesion). The mother believed the child may be experiencing thrombocytopenia. No additional adverse event (AE) and no product quality complaint (PQC) was noted. The consumer was calling with questions about the side effects. The outcome of the reported adverse events was reported as not recovered.  The causal relationship between the adverse events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was considered to be related. It was reported that the reporter's child has been experiencing side effects for 6 weeks now that she believed was related to the vaccine.  Upon internal review, the event of thrombocytopenia was considered to be medically significant.
Sex: F
Vaccine: MMRV
Symptoms: Throat lesion, Thrombocytopenia
Clinical narrative: possible strep; double ear infection; respiratory infection/fever/She also has a fever of 102 for almost 7 days while on the antibiotics the doctor prescribed to battle her symptoms.; pinkeye/conjunctivitis; white spots on her throat; thrombocytopenia; It dried out looking similar to eczema, was itching, then started oozing.; Now it looks similar to a bruise and it has still not healed; a spot on her leg the size of a nickel, similar to bee sting, by the next morning it grew to a silver dollar and became about 5-7 red, bumpy spots.; This spontaneous report was received from a consumer and refers to her a daugther, a child female patient of unknown age.  The patient's medical history included abnormally high B12 levels. The patient's concurrent conditions and concomitant therapies were not reported.  On 16-SEP-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, lot #, expiry date, and route of administration were not provided).  On 19-SEP-2024, by that Thursday, the patient had developed pinkeye (conjunctivitis). On 18-SEP-2024, by that Saturday, she developed white spots on her throat (throat lesion). By 20-SEP-2024, she had developed conjunctivitis, possible Streptococcal (strep), fever, double ear infection, and a respiratory infection (Streptococcal infection; ear infection; respiratory tract infection). She also has a fever of 102 for almost 7 days while on the antibiotics the doctor prescribed to battle her symptoms. After that, on an unspecified date in 2024, she started getting a spot on her leg the size of a nickel, similar to bee sting, by the next morning it grew to a silver dollar and became about 5-7 red, bumpy spots (rash macular). It dried out looking similar to eczema, was itching, and then started oozing (eczema weeping). On an unspecified date in 2024 (reported as now), it looked similar to a bruise and it had still not healed (skin lesion). The mother believed the child may be experiencing thrombocytopenia. No additional adverse event (AE) and no product quality complaint (PQC) was noted. The consumer was calling with questions about the side effects. The outcome of the reported adverse events was reported as not recovered.  The causal relationship between the adverse events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was considered to be related. It was reported that the reporter's child has been experiencing side effects for 6 weeks now that she believed was related to the vaccine.  Upon internal review, the event of thrombocytopenia was considered to be medically significant.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain-Barre; partially paralyzed; This serious case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for prophylaxis.   On an unknown date, the patient received Shingrix and PFIZER BIONTECH COVID-19 VACCINE. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre) (serious criteria GSK medically significant) and paralysis (Verbatim: partially paralyzed) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingrix.     The company considered the guillain barre syndrome and paralysis to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 23-OCT-2024 The reporter reported that she was trying to find out if any ingredient from Shingrix vaccines to the covid vaccine. The reporter just had his/her Pfizer covid vaccine and had a rough reaction from it.  All her covid vaccines had been Pfizer.  She was asking because she had a reaction with Pfizer covid vaccine which was similar to the reaction she had with Shingrix vaccine, Guillain-Barre reaction where she was partially paralyzed.  The reporter asked guess what she was asking was if she can continue to get the Pfizer covid vaccines or should she not. The response received to the reporter was Pfizer MI had no comparison information to the Shingrix vaccine. Provided response from attached document regarding risks, CDC rare adverse events.  Shared contraindications for use of Comirnaty from PI and referred to HCP for recommendations.  As Pfizer was unable to make treatment recommendations to individual patients. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Pfizer-BioNTech COVID-19 Vaccine.; Sender's Comments: Guillain-Barre syndrome and Paralysis  are unlisted events which are considered unrelated GSK vaccine Shingrix.
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain, Anal incontinence
Clinical narrative: fecal incontinence; severe abdominal pain; This non-serious case was reported by a consumer and described the occurrence of fecal incontinence in a 24-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   On 29-SEP-2024, the patient received Fluarix 2024-2025 season .5 ml. On 30-SEP-2024, 1 days after receiving Fluarix 2024-2025 season, the patient experienced fecal incontinence (Verbatim: fecal incontinence) and abdominal pain (Verbatim: severe abdominal pain). The outcome of the fecal incontinence and abdominal pain were resolving.   It was unknown if the reporter considered the fecal incontinence and abdominal pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the fecal incontinence and abdominal pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-OCT-2024 The patient was the reporter. The patient received Fluarix vaccine and experienced fecal incontinence and severe abdominal pain.
Sex: U
Vaccine: DTAPHEPBIP, DTAPHEPBIP, DTAPHEPBIP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; breakthrough pertussis cases; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Pediarix, the 2nd dose of Pediarix and the 1st dose of Pediarix. On an unknown date, 2 months after receiving Pediarix and an unknown time after receiving Pediarix and Pediarix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: breakthrough pertussis cases) (serious criteria GSK medically significant). The outcome of the vaccination failure and pertussis were not reported.   The reporter considered the vaccination failure and pertussis to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device.     The company considered the vaccination failure and pertussis to be unrelated to Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2024  The nurse reported that she had several patients with breakthrough pertussis cases 2 months after completing pertussis (DTaP). This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient  details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding measles) is considered unrelated to GSK vaccine Pediarix and Pediarix PRE-FILLED SYRINGE DEVICE (Dose 1, 2 and 3).  Pertussis is an unlisted event  which is considered unrelated to GSK vaccine  Pediarix and Pediarix PRE-FILLED SYRINGE DEVICE (Dose 1, 2 and 3).
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site rash, Pain, Pruritus, Rash erythematous
Clinical narrative: Experienced extreme pain; Rash from elbow to injection site; red raised rash; raised rash; hives; itching; Product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   Previously administered products included Covid vaccine (Covid 19  vaccine was received on unknown date). Concurrent medical conditions included allergy to vaccine (had an allergy of tetanus).   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, immediately after receiving Fluarix 2024-2025 season, the patient experienced injection site pain (Verbatim: Experienced extreme pain), rash (Verbatim: Rash from elbow to injection site), red rash (Verbatim: red raised rash), raised rash (Verbatim: raised rash), hives (Verbatim: hives), pruritus (Verbatim: itching) and pharmaceutical product complaint (Verbatim: Product complaint). The patient was treated with methylprednisolone (Medrol). The outcome of the injection site pain, rash, red rash, raised rash, hives and pruritus were not reported and the outcome of the pharmaceutical product complaint was unknown.   The reporter considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the reporter considered the rash, red rash, raised rash, hives and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the rash, red rash, raised rash, hives and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-OCT-2024 The Pharmacist stated that 5 Healthcare professionals who received Fluarix and experienced extreme pain upon administration. Patient developed a red raised rash with hives and itching, for which they were treated with Medrol and an antibiotic.  Patient experienced extreme pain and rash was from elbow to injection site which occurred within 24 hours.  This patient had allergic reactions with Tetanus and COVID vaccine in past. This case was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR121802:
Sex: F
Vaccine: UNK
Symptoms: Rash papular, Urticaria
Clinical narrative: Experienced extreme pain; Rash from elbow to injection site; red raised rash; raised rash; hives; itching; Product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   Previously administered products included Covid vaccine (Covid 19  vaccine was received on unknown date). Concurrent medical conditions included allergy to vaccine (had an allergy of tetanus).   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, immediately after receiving Fluarix 2024-2025 season, the patient experienced injection site pain (Verbatim: Experienced extreme pain), rash (Verbatim: Rash from elbow to injection site), red rash (Verbatim: red raised rash), raised rash (Verbatim: raised rash), hives (Verbatim: hives), pruritus (Verbatim: itching) and pharmaceutical product complaint (Verbatim: Product complaint). The patient was treated with methylprednisolone (Medrol). The outcome of the injection site pain, rash, red rash, raised rash, hives and pruritus were not reported and the outcome of the pharmaceutical product complaint was unknown.   The reporter considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the reporter considered the rash, red rash, raised rash, hives and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the rash, red rash, raised rash, hives and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-OCT-2024 The Pharmacist stated that 5 Healthcare professionals who received Fluarix and experienced extreme pain upon administration. Patient developed a red raised rash with hives and itching, for which they were treated with Medrol and an antibiotic.  Patient experienced extreme pain and rash was from elbow to injection site which occurred within 24 hours.  This patient had allergic reactions with Tetanus and COVID vaccine in past. This case was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR121802:
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest pain, Pericarditis
Clinical narrative: diagnosed with pericarditis; chest pain; This serious case was reported by a consumer via other manufacturer and described the occurrence of pericarditis in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number DJ22N) for prophylaxis.   Co-suspect products included Tozinameran (Comirnaty) (batch number LM7786) for prophylaxis.   Concurrent medical conditions included penicillin allergy. Concomitant products included calcium citrate.   On 01-OCT-2024, the patient received the 1st dose of FluLaval 2024-2025 season (left arm). On 01-OCT-2024 12:00, the patient received the 1st dose of Comirnaty (right deltoid). On 05-OCT-2024 16:00, 4 days after receiving FluLaval 2024-2025 season, the patient experienced pericarditis (Verbatim: diagnosed with pericarditis) (serious criteria hospitalization and GSK medically significant) and chest pain (Verbatim: chest pain) (serious criteria hospitalization). The patient was treated with ketorolac tromethamine (Toradol), morphine, colchicine and ibuprofen. The outcome of the pericarditis and chest pain were resolving.   It was unknown if the reporter considered the pericarditis and chest pain to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     The company considered the pericarditis and chest pain to be unrelated to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-OCT-2024 The reporter reported that the patient had received FluLaval vaccine. On 01st October 2024 12:00 PM patient received Comirnaty vaccine in facility where vaccine was administered. The reporter reported that after vaccination patient experienced with severe chest pain and diagnosed with pericarditis. The reporter mentioned that no other vaccines within 4 weeks prior to the vaccine in pharmacy or drug store did the patient receive. The patient was taken other medications within 2 weeks of the event starting. The patient received treatment for chest pain and pericarditis as Toradol then IV Morphine, colchicine 0.6 and IBU (Ibuprofen) 600mg. The reporter mentioned that the device date was 23rd October 2024. It was unknown if the reporter considered the pericarditis and chest pain to be related to Comirnaty vaccine.; Sender's Comments: Pericarditis,chest pain are unlisted events which are considered unrelated to GSK vaccine INFLUENZA VIRUS VACCINE POLYVALENT and Flu Seasonal TIV Quebec PRE-FILLED SYRINGE DEVICE