chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Fatigue, Injection site swelling, Oral discomfort, Pain
Clinical narrative: on 11/18 patient had swelling at the injection site 30 minutes after vaccination while she was in the store. she proceeded home and continued having other reactions such as tiredness, body aches, itchy skin and eyes, hot lips and mouth and swelling continued to increase to up to 4 inches at the injection site. on 11/19 at 3am  patient reported taking Benadryl and at 2:30pm when reaction was reported to us she said symptoms had subsided
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: on 11/18 patient had swelling at the injection site 30 minutes after vaccination while she was in the store. she proceeded home and continued having other reactions such as tiredness, body aches, itchy skin and eyes, hot lips and mouth and swelling continued to increase to up to 4 inches at the injection site. on 11/19 at 3am  patient reported taking Benadryl and at 2:30pm when reaction was reported to us she said symptoms had subsided
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Autism spectrum disorder, Autonomic nervous system imbalance, Borrelia test positive, Dizziness
Clinical narrative: Patient became ill with severe headache,  shortness of breath, fatigue,  faint,  dizzy,  shaky hands,  nausea,  stomach pain.  we canceled family plans.  The connection to the vaccine did not occur to me.  Patient never fully recovered and the symptoms continued.  A few months later she was hearing voices and seeing shadows and prescribed anti psychotic med.  Months later she was self harming.  She was evaluated and diagnosed with autism although it had been ruled out 3 years earlier.  Then  attempted to end her life by overdosing on pills.  Patient spent the following 18 months in treatment for mental health.  upon returning to home on July 31, 2023, I immediately noticed her symptoms had worsened and she more ill.  Her pediatrician administered tests ruling out Mono, Celiac, Thyroid and Anemia.  Pediatrician referred patient to Hospital GI, Neurology and Cardiology  where she was diagnosed with dysautonomia.  It was suggested that it was very likely she has POTS and referred to the POTS clinic with a 5 month wait.  She was tested for Lyme disease with her pediatrician looking for antibodies in the blood stream.   And,  DNA Connexions lab separately which which tested positive for 4 confections of Lyme disease.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Fatigue, Hallucinations, mixed, Headache, Intentional overdose
Clinical narrative: Patient became ill with severe headache,  shortness of breath, fatigue,  faint,  dizzy,  shaky hands,  nausea,  stomach pain.  we canceled family plans.  The connection to the vaccine did not occur to me.  Patient never fully recovered and the symptoms continued.  A few months later she was hearing voices and seeing shadows and prescribed anti psychotic med.  Months later she was self harming.  She was evaluated and diagnosed with autism although it had been ruled out 3 years earlier.  Then  attempted to end her life by overdosing on pills.  Patient spent the following 18 months in treatment for mental health.  upon returning to home on July 31, 2023, I immediately noticed her symptoms had worsened and she more ill.  Her pediatrician administered tests ruling out Mono, Celiac, Thyroid and Anemia.  Pediatrician referred patient to Hospital GI, Neurology and Cardiology  where she was diagnosed with dysautonomia.  It was suggested that it was very likely she has POTS and referred to the POTS clinic with a 5 month wait.  She was tested for Lyme disease with her pediatrician looking for antibodies in the blood stream.   And,  DNA Connexions lab separately which which tested positive for 4 confections of Lyme disease.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Intentional self-injury, Laboratory test normal, Loss of personal independence in daily activities, Lyme disease, Malaise
Clinical narrative: Patient became ill with severe headache,  shortness of breath, fatigue,  faint,  dizzy,  shaky hands,  nausea,  stomach pain.  we canceled family plans.  The connection to the vaccine did not occur to me.  Patient never fully recovered and the symptoms continued.  A few months later she was hearing voices and seeing shadows and prescribed anti psychotic med.  Months later she was self harming.  She was evaluated and diagnosed with autism although it had been ruled out 3 years earlier.  Then  attempted to end her life by overdosing on pills.  Patient spent the following 18 months in treatment for mental health.  upon returning to home on July 31, 2023, I immediately noticed her symptoms had worsened and she more ill.  Her pediatrician administered tests ruling out Mono, Celiac, Thyroid and Anemia.  Pediatrician referred patient to Hospital GI, Neurology and Cardiology  where she was diagnosed with dysautonomia.  It was suggested that it was very likely she has POTS and referred to the POTS clinic with a 5 month wait.  She was tested for Lyme disease with her pediatrician looking for antibodies in the blood stream.   And,  DNA Connexions lab separately which which tested positive for 4 confections of Lyme disease.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Mononucleosis heterophile test negative, Nausea, Postural orthostatic tachycardia syndrome, Suicide attempt, Syncope
Clinical narrative: Patient became ill with severe headache,  shortness of breath, fatigue,  faint,  dizzy,  shaky hands,  nausea,  stomach pain.  we canceled family plans.  The connection to the vaccine did not occur to me.  Patient never fully recovered and the symptoms continued.  A few months later she was hearing voices and seeing shadows and prescribed anti psychotic med.  Months later she was self harming.  She was evaluated and diagnosed with autism although it had been ruled out 3 years earlier.  Then  attempted to end her life by overdosing on pills.  Patient spent the following 18 months in treatment for mental health.  upon returning to home on July 31, 2023, I immediately noticed her symptoms had worsened and she more ill.  Her pediatrician administered tests ruling out Mono, Celiac, Thyroid and Anemia.  Pediatrician referred patient to Hospital GI, Neurology and Cardiology  where she was diagnosed with dysautonomia.  It was suggested that it was very likely she has POTS and referred to the POTS clinic with a 5 month wait.  She was tested for Lyme disease with her pediatrician looking for antibodies in the blood stream.   And,  DNA Connexions lab separately which which tested positive for 4 confections of Lyme disease.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Thyroid function test normal, Tremor
Clinical narrative: Patient became ill with severe headache,  shortness of breath, fatigue,  faint,  dizzy,  shaky hands,  nausea,  stomach pain.  we canceled family plans.  The connection to the vaccine did not occur to me.  Patient never fully recovered and the symptoms continued.  A few months later she was hearing voices and seeing shadows and prescribed anti psychotic med.  Months later she was self harming.  She was evaluated and diagnosed with autism although it had been ruled out 3 years earlier.  Then  attempted to end her life by overdosing on pills.  Patient spent the following 18 months in treatment for mental health.  upon returning to home on July 31, 2023, I immediately noticed her symptoms had worsened and she more ill.  Her pediatrician administered tests ruling out Mono, Celiac, Thyroid and Anemia.  Pediatrician referred patient to Hospital GI, Neurology and Cardiology  where she was diagnosed with dysautonomia.  It was suggested that it was very likely she has POTS and referred to the POTS clinic with a 5 month wait.  She was tested for Lyme disease with her pediatrician looking for antibodies in the blood stream.   And,  DNA Connexions lab separately which which tested positive for 4 confections of Lyme disease.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Insomnia, Myalgia, Pyrexia
Clinical narrative: Symptoms lasted for 3 days - chronic  Extreme and persistent muscles and joint aches, mostly upper body  Mild fever difficulty sleeping fatigue  took an ibuprofen once a day - lessened but never took away the aches and pain
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow abnormal, Biopsy kidney, Dialysis, General physical health deterioration, Malaise
Clinical narrative: The second dose was given on March 28 2021..  Two weeks later a rash developed on the torso, this would not go away even with prescription steroids. Patient's health declined through april and May.  In June he went to his doctor but since he had taken steroids he was told to come back in two weeks and have labs done. He was so sick and ended up in the ER on July 5 2021. He was in kidney failure. A bone marrow biopsy resulted in a diagnosis of Waldenstrom macrglobulinemia which caused kidney failure. He was put on emergency dialysis and transferred from hospital to Cancer Center.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Renal failure, Waldenstrom's macroglobulinaemia
Clinical narrative: The second dose was given on March 28 2021..  Two weeks later a rash developed on the torso, this would not go away even with prescription steroids. Patient's health declined through april and May.  In June he went to his doctor but since he had taken steroids he was told to come back in two weeks and have labs done. He was so sick and ended up in the ER on July 5 2021. He was in kidney failure. A bone marrow biopsy resulted in a diagnosis of Waldenstrom macrglobulinemia which caused kidney failure. He was put on emergency dialysis and transferred from hospital to Cancer Center.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: PATIENT CALLED ON 11/15/23 STATED THAT HE MIGHT HAD A DELAYED ALLERGIC REACTION TO THE MODERNA VACCINE AS HE GOT HIS DOSE 11/06/23 ALONG WITH OTHER 2 VACCINES WHICH HE HAD BEFORE AND NEVER CAUSED HIM A PROBLEM ( 2ND DOSE OF SHINGLES AND A FLU SHOT )  I ASKED HIM IF  HE HAD ANY REACTIONS RIGHT AFTER THEM HE SAID HE FELT LITTLE TIRED THE DAY AFTER AND THAT WAS IT SO I ADVISED HIM TO GO TO THE DR THEN I FOLLOWED UP WITH HIM TODAY 11/19/23 AND HE STATED THAT HE USED BENADRYL AND THE RASH DISAPPEARD SO HE CANCELED HIS OPP WITH THE DR AND HE STATED THAT HE DOESN'T THINK THAT WAS BECAUSE OF THE VACCINE
Age: 18.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Syncope
Clinical narrative: The Patient fainted in  front of the pharmacy after receiving the vaccines. We offered emergency assistant and observed    him and he recovered soon and was able to leave with his parents.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Getting admitted to ICU for suspected (not confirmed) Guillain-Barré syndrome 6 days after flu shot.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, and painful site of injection
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: headache, redness, swelling, itching, sorenessat injection site, later bruising, redness (10 days later)
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: headache, redness, swelling, itching, sorenessat injection site, later bruising, redness (10 days later)
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Back pain, Computerised tomogram, Computerised tomogram abdomen, Computerised tomogram head, Diaphragmatic disorder
Clinical narrative: Injury symptoms began on 10/5 - 3 days post injection with tingling in both feet and both hands and decreased ability to use hands.  Progressed, being masked by back pain/possible spinal compression he'd been having trouble with. He was brought to ER by ambulance 10/20/23 having lost ability to stand up. MRI showed severe compression, so Dr looked no further & did spine surgery 10/24. Woke with no feeling or movement in either leg, bilateral hands, which continued in days following - ascending up arms & trunk to diaphragm and swallowing resulting in emergency vent, then trach & g-tube. Countless tests, MRIs, spinal tap showed no physical reason. Dx is severe Guillain Barre. 11/15 sudden ITP, & platelet transfusions aren't helping. Currently in ICU with trach/vent and g-tube, and no functional movement in his body.
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Dysphagia, Dysstasia, Gastrostomy, Guillain-Barre syndrome, Immune thrombocytopenia
Clinical narrative: Injury symptoms began on 10/5 - 3 days post injection with tingling in both feet and both hands and decreased ability to use hands.  Progressed, being masked by back pain/possible spinal compression he'd been having trouble with. He was brought to ER by ambulance 10/20/23 having lost ability to stand up. MRI showed severe compression, so Dr looked no further & did spine surgery 10/24. Woke with no feeling or movement in either leg, bilateral hands, which continued in days following - ascending up arms & trunk to diaphragm and swallowing resulting in emergency vent, then trach & g-tube. Countless tests, MRIs, spinal tap showed no physical reason. Dx is severe Guillain Barre. 11/15 sudden ITP, & platelet transfusions aren't helping. Currently in ICU with trach/vent and g-tube, and no functional movement in his body.
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Intensive care, Lumbar puncture, Magnetic resonance imaging spinal abnormal, Mechanical ventilation, Movement disorder
Clinical narrative: Injury symptoms began on 10/5 - 3 days post injection with tingling in both feet and both hands and decreased ability to use hands.  Progressed, being masked by back pain/possible spinal compression he'd been having trouble with. He was brought to ER by ambulance 10/20/23 having lost ability to stand up. MRI showed severe compression, so Dr looked no further & did spine surgery 10/24. Woke with no feeling or movement in either leg, bilateral hands, which continued in days following - ascending up arms & trunk to diaphragm and swallowing resulting in emergency vent, then trach & g-tube. Countless tests, MRIs, spinal tap showed no physical reason. Dx is severe Guillain Barre. 11/15 sudden ITP, & platelet transfusions aren't helping. Currently in ICU with trach/vent and g-tube, and no functional movement in his body.
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Musculoskeletal disorder, Nerve conduction studies, Paraesthesia, Platelet transfusion, Spinal cord compression
Clinical narrative: Injury symptoms began on 10/5 - 3 days post injection with tingling in both feet and both hands and decreased ability to use hands.  Progressed, being masked by back pain/possible spinal compression he'd been having trouble with. He was brought to ER by ambulance 10/20/23 having lost ability to stand up. MRI showed severe compression, so Dr looked no further & did spine surgery 10/24. Woke with no feeling or movement in either leg, bilateral hands, which continued in days following - ascending up arms & trunk to diaphragm and swallowing resulting in emergency vent, then trach & g-tube. Countless tests, MRIs, spinal tap showed no physical reason. Dx is severe Guillain Barre. 11/15 sudden ITP, & platelet transfusions aren't helping. Currently in ICU with trach/vent and g-tube, and no functional movement in his body.
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Spinal operation, Tracheostomy, X-ray
Clinical narrative: Injury symptoms began on 10/5 - 3 days post injection with tingling in both feet and both hands and decreased ability to use hands.  Progressed, being masked by back pain/possible spinal compression he'd been having trouble with. He was brought to ER by ambulance 10/20/23 having lost ability to stand up. MRI showed severe compression, so Dr looked no further & did spine surgery 10/24. Woke with no feeling or movement in either leg, bilateral hands, which continued in days following - ascending up arms & trunk to diaphragm and swallowing resulting in emergency vent, then trach & g-tube. Countless tests, MRIs, spinal tap showed no physical reason. Dx is severe Guillain Barre. 11/15 sudden ITP, & platelet transfusions aren't helping. Currently in ICU with trach/vent and g-tube, and no functional movement in his body.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Exercise tolerance decreased, Fatigue
Clinical narrative: Brain fog, Fatigue, and  extra difficulty with cardio exercise
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram, Seizure, Stress echocardiogram, Syncope
Clinical narrative: She has VVS.  Fainting periodically. Convulsions  During her episodes.     2/16/23 Dr patient was taken to hospital for fainting/syncope   2/27/23 Hospital. Dr. Patient was taken there for syncope. EKG. Echo gram stress test
Age: 43.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Paraesthesia, Syncope
Clinical narrative: Patient was sitting in waiting room after she received the 2 vaccines. Shortly after, patient's  friend screamed for help bc patient fainted. I rushed out; patient was conscious again by the time I got to patient. Pt denied SOB . Just the tips of her fingers were slightly tingling,  but resolved shortly after. Patient denied for us to call the ambulance.  Drank water and waited until she felt better and back to " normal" before she left.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood magnesium, Dizziness, Electrocardiogram, Full blood count, Hypertension
Clinical narrative: Dizzy, lightheaded, hypertension and sinus tachycardia
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus tachycardia
Clinical narrative: Dizzy, lightheaded, hypertension and sinus tachycardia
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Amnesia, Anxiety, Arthralgia, Asthenia
Clinical narrative: Minutes after vaccination, experienced a tingling in the brain that increased until it spread causing a tingling sensation all over the "brain" leading to cognitive difficulties such as impaired thinking, memory loss, trouble with memory recall, personality changes, depression, and anxiety, and physical difficulties such as lack of energy, chronic headache, trouble breathing, bone pain/loss, hair loss, extreme food sensitivities, chronic fatigue, excessive sleeping, unrestful sleep, dark gums (oral), aged skin, joint pain, etc. The tinkling in the brain felt like my brain was frying until eventually my brain felt numb and no longer noticeably tingly simply because the entire brain was damaged.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Bone loss, Bone pain, Brain injury, Cognitive disorder, Depression
Clinical narrative: Minutes after vaccination, experienced a tingling in the brain that increased until it spread causing a tingling sensation all over the "brain" leading to cognitive difficulties such as impaired thinking, memory loss, trouble with memory recall, personality changes, depression, and anxiety, and physical difficulties such as lack of energy, chronic headache, trouble breathing, bone pain/loss, hair loss, extreme food sensitivities, chronic fatigue, excessive sleeping, unrestful sleep, dark gums (oral), aged skin, joint pain, etc. The tinkling in the brain felt like my brain was frying until eventually my brain felt numb and no longer noticeably tingly simply because the entire brain was damaged.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Food allergy, Gingival discolouration, Headache
Clinical narrative: Minutes after vaccination, experienced a tingling in the brain that increased until it spread causing a tingling sensation all over the "brain" leading to cognitive difficulties such as impaired thinking, memory loss, trouble with memory recall, personality changes, depression, and anxiety, and physical difficulties such as lack of energy, chronic headache, trouble breathing, bone pain/loss, hair loss, extreme food sensitivities, chronic fatigue, excessive sleeping, unrestful sleep, dark gums (oral), aged skin, joint pain, etc. The tinkling in the brain felt like my brain was frying until eventually my brain felt numb and no longer noticeably tingly simply because the entire brain was damaged.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Memory impairment, Paraesthesia, Personality change, Poor quality sleep
Clinical narrative: Minutes after vaccination, experienced a tingling in the brain that increased until it spread causing a tingling sensation all over the "brain" leading to cognitive difficulties such as impaired thinking, memory loss, trouble with memory recall, personality changes, depression, and anxiety, and physical difficulties such as lack of energy, chronic headache, trouble breathing, bone pain/loss, hair loss, extreme food sensitivities, chronic fatigue, excessive sleeping, unrestful sleep, dark gums (oral), aged skin, joint pain, etc. The tinkling in the brain felt like my brain was frying until eventually my brain felt numb and no longer noticeably tingly simply because the entire brain was damaged.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Skin disorder, Thinking abnormal
Clinical narrative: Minutes after vaccination, experienced a tingling in the brain that increased until it spread causing a tingling sensation all over the "brain" leading to cognitive difficulties such as impaired thinking, memory loss, trouble with memory recall, personality changes, depression, and anxiety, and physical difficulties such as lack of energy, chronic headache, trouble breathing, bone pain/loss, hair loss, extreme food sensitivities, chronic fatigue, excessive sleeping, unrestful sleep, dark gums (oral), aged skin, joint pain, etc. The tinkling in the brain felt like my brain was frying until eventually my brain felt numb and no longer noticeably tingly simply because the entire brain was damaged.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Libido disorder, Magnetic resonance imaging normal
Clinical narrative: Two days after receiving booster, my headaches began, and have not stopped.  Also, this negative side effect is also affecting my labido.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Laboratory test, Peripheral swelling, Rash, Vision blurred
Clinical narrative: 11/11/23  8:30 am Rash + red swelling both feet  11/11/23  430pm Vision in left eye circle cloudy hazy vision in center and kept moving around - vision still blurry 11/13/23  Appt with eye doctor                 did all test they can do in office 11/14 woke up with body rash - still have rash.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Pyrexia
Clinical narrative: Shortness of breath, weakness, subjective fevers/chills, and cough
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, RSV
Symptoms: Asthenia, Dysphonia, Somnolence, Throat irritation
Clinical narrative: Raspy voice, weakness, no energy, feeling tired and sleepy. Symptoms started next day after vaccines and have not resolved even one month later. Patient states he still  has symptoms as of today 11/20/23.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, RSV
Symptoms: Asthenia, Dysphonia, Somnolence
Clinical narrative: Raspy voice, weakness, no energy, feeling tired and sleepy. Symptoms started next day after vaccines and have not resolved even one month later. Patient states he still  has symptoms as of today 11/20/23.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HBP calling to report the administration of an expired dose of GARDASIL 9 to a patient on 10/17/2023.   Caller confirmed no previous temperature excursions for this product and stored in the recommended range.  HBP states there are no symptoms or fur; This spontaneous report was received from other health professional and referred to a 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 17-OCT-2023, the patient received an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection (valid lot #U008899 with reported expiration date: 12-AUG-2023) (strength, dose description, and route of administration not provided) for prophylaxis by a health professional. There were no previous temperature excursions for this product and stored in the recommended range, and there were no symptoms reported (no adverse event).
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: administration of Boostrix to a 30 week pregnant patient; 30 week pregnant patient 2 weeks apart/1st dose on 23OCT2023 and 2nd dose 08NOV2023; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 324B2, expiry date 30-JAN-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 08-NOV-2023, the patient received the 2nd dose of Boostrix. On 23-OCT-2023, the patient received the 1st dose of Boostrix. On 08-NOV-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: 30 week pregnant patient 2 weeks apart/1st dose on 23OCT2023 and 2nd dose 08NOV2023). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administration of Boostrix to a 30 week pregnant patient). The outcome of the vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   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: 09-NOV-2023 The medical assistant requested data on potential effects of administration of 2 doses of Boostrix to a 30 weeks pregnant patient 2 weeks apart, which led to vaccine exposure during pregnancy and extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: an incomplete dose was administered to the patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number TY2Y) for prophylaxis.   On 31-MAR-2023, the patient received Shingrix. On 31-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: an incomplete dose was administered to the patient). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt date: 09-NOV-2023 A pharmacist reported that while administering shingrix one or two drops leaked out and an incomplete dose was administered to the patient which led to incomplete dose administered.  The reporter consented to follow up by email.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant administered Infanrix to a 8year old female patient; 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 8-year-old female patient who received DTPa (Infanrix) (batch number YA259, expiry date 03-MAR-2024) for prophylaxis.   Previously administered products included Dtap vaccine (on an unknown date receive 1st dose) and Dtap vaccine (on an unknown date receive 2nd dose).   On 08-NOV-2023, the patient received Infanrix. On 08-NOV-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Medical Assistant administered Infanrix to a 8year old female patient). The outcome of the inappropriate age at vaccine administration 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: 09-NOV-2023 A registered nurse reported that one of her medical assistant administered Infanrix to a patient. 8 years old patient received Infanrix which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on November 2019 received 1st dose.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 10-NOV-2023 The patient was self-reported.  The patient received the first dose of Shingrix November 2019, and had not yet received the second dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The vaccine administration facility is same as primary reporter for 1st dose.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Somnolence
Clinical narrative: He has pain; really sleepy; lot of fatigue in his legs and joints/he is tired; had chills; some nausea but no vomiting; This spontaneous case was reported by a patient and describes the occurrence of PAIN (He has pain), SOMNOLENCE (really sleepy), FATIGUE (lot of fatigue in his legs and joints/he is tired), CHILLS (had chills) and NAUSEA (some nausea but no vomiting) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032472) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (He has pain), SOMNOLENCE (really sleepy), FATIGUE (lot of fatigue in his legs and joints/he is tired), CHILLS (had chills) and NAUSEA (some nausea but no vomiting). At the time of the report, PAIN (He has pain), SOMNOLENCE (really sleepy), FATIGUE (lot of fatigue in his legs and joints/he is tired), CHILLS (had chills) and NAUSEA (some nausea but no vomiting) had not resolved.            Patient did not provide any information about previous COVID-19 vaccination doses.  No concomitant medications were provided.  Patient wanted the turn around time for the side effects of the Moderna vaccine. He has a lot of fatigue in his legs and joints. He has pain, he was tired. He wanted to know how long the side effects last, or it depend on the individual. He had some nausea but no vomiting. He had chills. He wanted to know when people report side effects how long it usually last. The side effects he was still having that he was really sleepy and fatigue.   No treatment information was provided
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Heart rate, Heart rate increased, Heart rate variability decreased, Heart rate variability test
Clinical narrative: low heart rate variability; Heart rate has been high; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Heart rate has been high) and HEART RATE VARIABILITY DECREASED (low heart rate variability) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced HEART RATE INCREASED (Heart rate has been high). On an unknown date, the patient experienced HEART RATE VARIABILITY DECREASED (low heart rate variability). At the time of the report, HEART RATE INCREASED (Heart rate has been high) and HEART RATE VARIABILITY DECREASED (low heart rate variability) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: High. On an unknown date, Heart rate variability test: decreased.         Concomitant and treatment medications were not reported.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Postmenopausal haemorrhage
Clinical narrative: low heart rate variability; Heart rate has been high; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Heart rate has been high) and HEART RATE VARIABILITY DECREASED (low heart rate variability) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced HEART RATE INCREASED (Heart rate has been high). On an unknown date, the patient experienced HEART RATE VARIABILITY DECREASED (low heart rate variability). At the time of the report, HEART RATE INCREASED (Heart rate has been high) and HEART RATE VARIABILITY DECREASED (low heart rate variability) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: High. On an unknown date, Heart rate variability test: decreased.         Concomitant and treatment medications were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Loss of consciousness
Clinical narrative: covid 19; tiredness; Her husband found her passed out again during this diagnosis; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Her husband found her passed out again during this diagnosis) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced LOSS OF CONSCIOUSNESS (Her husband found her passed out again during this diagnosis) (seriousness criterion medically significant) and FATIGUE (tiredness). On 15-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). At the time of the report, LOSS OF CONSCIOUSNESS (Her husband found her passed out again during this diagnosis) outcome was unknown and COVID-19 (covid 19) and FATIGUE (tiredness) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. Patient did not take any medications or treatments, though she was offered Paxlovid.  Company comment:  This is a Spontaneous case concerning a 74-year-old, female patient with no reported medical history, previously vaccinated with other Moderna vaccines, who experienced the unexpected serious (medically significant) event of loss of consciousness, and non serios events of COVID-19 and fatigue. The patient had COVID-19 about 10 months after the administration of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine, used as a fifth dose. During this diagnosis, her husband found her passed out. She has had passed out after the second dose as well.  No further information on clinical course, investigations and treatment received was available in the report. Loss of consciousness is assessed as not related to vaccination due to lack of temporal association (latency too long) and since there is a better explanation, COVID-19 disease.  The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.   This case was linked to MOD-2023-749467 (Patient Link).   Reporter did not allow further contact.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Device malfunction, Productive cough
Clinical narrative: developed a cough with a lot of phlegm the day after the flu shot; developed a cough with a lot of phlegm the day after the flu shot; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA350650(CLUSTER).  This case involves a 33 years old female patient who developed a cough with a lot of phlegm the day after the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SARILUMAB (KEVZARA).  On an unknown date, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date the patient developed a cough with a lot of phlegm the day after the flu shot (productive cough) and (cough)(unknown latency).  It was reported that "Consumer reports that she uses 200mg KEVZARA and the last injection that she attempted the pen malfunctioned. Consumer states that she does not know what happened, when she was pressing, it would not go and when she removed the injection away from her skin the medication deployed. Could Kevzara have a role in me developing a cough the day after I got a flu shot last week? Additional Description of event Adverse events :On Thursday, 02Nov2023, the caller was attempting to inject a Kevzara 200 mg PEN in her thigh when it would not deploy. She does not remember if the device made any click/s. It would not push. The button never when down. She held it to her thigh and it would not do anything. When she removed it from her leg, the medication then came out of the pen. She did not miss a dose because the used the other pen from the carton. The other pen had no problems. The lot and expiry were unknown because she was not at home during the call, and the Kevzara pen is at her home. She had a flu shot on Friday or Saturday last week. she developed a cough with a lot of phlegm the day after the flu shot. She had not been sick or had a cough in 5 years, therefore this cough is unusual for her. She confirmed that the flu vaccination was an injection."  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both the events.    At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Age: 0.17
Sex: U
Vaccine: DTPPVHBHPB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: nurse that administered VAXELIS and IPOL at the same day and at the same time (with no reported adverse event); Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA341553(CLUSTER).  This case involves a 2 months old and unknown gender patient who's nurse administered VAXELIS and IPV (VERO) [IPOL] at the same day and at the same time (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of both the suspect IPV (VERO) (Suspension for injection) (lot V1B902M and expiry date: 02-Jun-2024) and VAXELIS not produced by Sanofi Pasteur (lot number and expiry not reported) at the same day and at the same time (with no reported adverse event) (extra dose administered) (latency: same day) with an unknown route and unknown administration site for prophylactic vaccination (Immunization).    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: the dose was given due to timing error with no reported adverse event; once the extra doses were already given with no adverse event; Initial information was received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA351280(CLUSTER).  This case involves a 16 years old male patient to whom dose was given due to timing error and once the extra doses were already given with no adverse event after receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3v (vero) (ipol), hepatitis b vaccine, measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunisation; and hpv vaccine (hpv vaccine) for immunisation.  On 19-Mar-2023, the patient received an unknown (Dose 1) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot number (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunisation.  On an unknown date in September 2023, the patient also received 0.5 mL dose 2 of same vaccine.  On 01-Nov-2023, received (extra dose, dose 3), 0.5 ml (Frequency: twice), of the same vaccine (lot U7745AA, expiry date: 20-May-2025, strength: standard) via intramuscular route in the right deltoid for Immunization.  On 01-Nov-2023, patient was given due to timing error and once the extra doses were already given with no adverse event (inappropriate schedule of product administration) and (extra dose administered) (Latency: same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of PENTACEL on 06Nov2023 with no adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA352579.  This case involves a 15-month-old male patient who had received an expired dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(VERO)/ HIB(PRP/T) vaccine [Pentacel (Vero)] on 06nov2023 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2023, the patient received 0.5 mL expired dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Frequency: once; Strength: standard) (lot: UJ804AA; expiry date: 07-Oct-2023) via intramuscular route in the right thigh for Immunization with no adverse event (expired product administered) (same day latency). Treatment: unknown  No additional information available at the time of the report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: products been administered post excursion with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 years old female patient who has been administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine [ADACEL] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/TETANUS/5 AC Pertussis vaccine Suspension for injection of lot U7929AA and expiry: 14-Nov-2025 via unknown route in unknown administration site for immunization.  On an unknown date, the patient has been administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine post excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA353755:01836321, 01836324  US-SA-2023SA353804:01836321