chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Insomnia, Middle insomnia, Muscle tightness, Nausea, Paraesthesia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 736168), concerns a 34-year-old, adult female patient. The patient had history of influenza vaccination (about 3 years ago) with adverse reactions like burning sensation down the left arm where vaccine was administered and tingling. The patient was allergic to sulfonamide antibiotics. The patient's concomitant medication included ORTHO TRI-CYCLEN for an unknown indication. On 03-Feb-2018, at around 4:50 pm, the patient was administered FLUVIRIN (dose: 0.5 ml, (frequency reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (03-Feb-2018), about 1-2 hours after vaccination, the patient experienced tingling, numbness in the middle, ring and little finger. Soon after, the patient also experienced shortness of breath and chest heaviness. Around 7 pm, the patient took BENADRYL. At around 8:45 pm, the patient called the doctor and reported the symptoms. The doctor advised to seek medical help the next day if the symptoms worsened. The patient also experienced headache and nausea, tingling feeling that moved into the palm of the left hand, increased chest tightness throughout the night leading to trouble in sleeping. On 04-Feb-2018 (in midnight of 03-Feb-2018, reported as around 12.00 am), the patient woke when tingling, numbness, burning and constricted feeling began in the left foot around the toes and sole of the foot. Subsequently, the symptoms progressed to the leg into the calf area, knee and some in thigh area. The patient's left hand started to improve by morning, however the left leg was still affected. The patient sought medical assistance at health-care walk-in care. The patient made an office visit. At the time of this report, the patient was recovering from the events (tingling and numbness) and had not recovered from other events. The reporter assessed the case as non-serious. This case (201803143) was linked to the case: 201803144 (same patient).
Age: 34.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 736168), concerns a 34-year-old, adult female patient. The patient had history of influenza vaccination (about 3 years ago) with adverse reactions like burning sensation down the left arm where vaccine was administered and tingling. The patient was allergic to sulfonamide antibiotics. The patient's concomitant medication included ORTHO TRI-CYCLEN for an unknown indication. On 03-Feb-2018, at around 4:50 pm, the patient was administered FLUVIRIN (dose: 0.5 ml, (frequency reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (03-Feb-2018), about 1-2 hours after vaccination, the patient experienced tingling, numbness in the middle, ring and little finger. Soon after, the patient also experienced shortness of breath and chest heaviness. Around 7 pm, the patient took BENADRYL. At around 8:45 pm, the patient called the doctor and reported the symptoms. The doctor advised to seek medical help the next day if the symptoms worsened. The patient also experienced headache and nausea, tingling feeling that moved into the palm of the left hand, increased chest tightness throughout the night leading to trouble in sleeping. On 04-Feb-2018 (in midnight of 03-Feb-2018, reported as around 12.00 am), the patient woke when tingling, numbness, burning and constricted feeling began in the left foot around the toes and sole of the foot. Subsequently, the symptoms progressed to the leg into the calf area, knee and some in thigh area. The patient's left hand started to improve by morning, however the left leg was still affected. The patient sought medical assistance at health-care walk-in care. The patient made an office visit. At the time of this report, the patient was recovering from the events (tingling and numbness) and had not recovered from other events. The reporter assessed the case as non-serious. This case (201803143) was linked to the case: 201803144 (same patient).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 736230), concerns a 50-year-old, adult, female patient. On 09-Oct-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, batch number 1720701, anatomical location: unknown, expiry date; date not reported). On an unspecified date in Oct-2017, after vaccination, the patient developed Guillain-Barre syndrome and was subsequently hospitalized. On 14-Jan-2018, the patient reported the event. At the time of this report, the patient was still hospitalized and had not yet recovered from the event 'Guillain-Barre syndrome'. The reporter assessed this case as serious due to hospitalization.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 736254), concerning a 10-year-old, female child. The patient had no relevant medical history and current illness. On 31-Jan-2018, the patient was administered FLUVIRIN (dose: 0.5 ml [unk as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 179904P and expiry date: not reported). On the same day after vaccination, the patient experienced dizziness and fainting which resolved immediately without treatment. On the same day (31-Jan-2018), the patient had recovered from the events (dizziness and fainting). The reporter assessed this case as non-serious.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactate dehydrogenase normal
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 29-Jun-2018 by Seqirus from VAERS (VAERS ID: 736825), concerns 11-year-old child of unspecified gender. The patient's historical condition included urticaria [unspecified date]. At the age of 14 months an ophthalmologic exam was done, and results were found to be normal. The patient's concomitant medications included Cetirizine, ranitidine, montelukast, prednisolone, and Hydroxychloroquine for unknown indications. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed sporadic outbreak of hives (recurrence of urticaria). On an unspecified date, the patient visited emergency room for the event and consulted the physician. The lab investigations performed included urinalysis, lactate dehydrogenase, uric acid, vitamin B12, lactase dehydrogenase (reported as LDH), immunoglobulin A, G, M and E and serum immunoglobulins and the results were found to be within normal limits. Treatment medications were not reported. At the time of this report, the patient had recovered from the event.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Blood uric acid normal, Ophthalmological examination normal, Urine analysis normal, Urticaria, Vitamin B12 normal
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 29-Jun-2018 by Seqirus from VAERS (VAERS ID: 736825), concerns 11-year-old child of unspecified gender. The patient's historical condition included urticaria [unspecified date]. At the age of 14 months an ophthalmologic exam was done, and results were found to be normal. The patient's concomitant medications included Cetirizine, ranitidine, montelukast, prednisolone, and Hydroxychloroquine for unknown indications. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed sporadic outbreak of hives (recurrence of urticaria). On an unspecified date, the patient visited emergency room for the event and consulted the physician. The lab investigations performed included urinalysis, lactate dehydrogenase, uric acid, vitamin B12, lactase dehydrogenase (reported as LDH), immunoglobulin A, G, M and E and serum immunoglobulins and the results were found to be within normal limits. Treatment medications were not reported. At the time of this report, the patient had recovered from the event.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Condition aggravated, Fall, Pallor, Syncope
Clinical narrative: This spontaneous case, reported by other Healthcare Professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 736917), concerns a 49-year-old, adult female patient. The patient had no known allergies. It was reported that the patient was not feeling well, was pale and shivering, when she came to pharmacy for administration of flu shot. The patient was suggested to wait until complete recovery to get the flu shot, but patient and her daughter insisted to administer the shot. On 26-Jan-2018, around 3 pm, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, frequency: reported as 1, route of administration: Intramuscular, anatomical location: right arm, batch no: 1720701, expiry date: not reported). On the same day approximately 10 minutes after vaccination, the patient was shivering more, turned more pallor, and finally fainted (facing down the floor). The ambulance was called until paramedic arrived, the patient lie still on floor facing up and legs on the chair. The patient was responsive at the whole time of the incident. The patient visited emergency room. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dehydration, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: This is a serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 29-Jun-2018 by Seqirus from VAERS (VAERS ID: 737217), concerns a 47-year-old adult female patient. The patient's historical condition included stroke (one and half year prior to vaccination). The patient had no known allergies. The patient had no current illness however the patient's concomitant medications were reported as hydralazine, losartan, chlorthalidone, triamterene, aripiprazole, levothyroxine, atorvastatin. On 29-OCT-2017, the patient was administered with influenza vaccine (dose: unknown, route of administration: injection [SYR as reported], anatomical location: unknown, batch number, trade number and manufacturer: not reported). On 13-Nov-2017, 16 days after vaccination, the patient experienced short of breath, dizziness and became weak. The patient was taken to a doctor, who said that, the patient probably had a spot on her lung. The patient was taken to the emergency room, where it was noticed that the patient had nothing on lungs, but she was dehydrated. The patient was sent to home. On the following day, the patient had diarrhoea. The patient called a doctor and said it was flu. On an unspecified date the patient was hospitalized, and unspecified lab test were performed (results were not reported). The patient was in hospital for 6 days. It was reported that the patient would be fine in a couple of days. At the time of this report, the patient had not recovered from the events asthenia, dehydration, diarrhoea, dizziness and dyspnoea, influenza. The reporter assessed this case as serious due to hospitalisation.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Laboratory test
Clinical narrative: This is a serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 29-Jun-2018 by Seqirus from VAERS (VAERS ID: 737217), concerns a 47-year-old adult female patient. The patient's historical condition included stroke (one and half year prior to vaccination). The patient had no known allergies. The patient had no current illness however the patient's concomitant medications were reported as hydralazine, losartan, chlorthalidone, triamterene, aripiprazole, levothyroxine, atorvastatin. On 29-OCT-2017, the patient was administered with influenza vaccine (dose: unknown, route of administration: injection [SYR as reported], anatomical location: unknown, batch number, trade number and manufacturer: not reported). On 13-Nov-2017, 16 days after vaccination, the patient experienced short of breath, dizziness and became weak. The patient was taken to a doctor, who said that, the patient probably had a spot on her lung. The patient was taken to the emergency room, where it was noticed that the patient had nothing on lungs, but she was dehydrated. The patient was sent to home. On the following day, the patient had diarrhoea. The patient called a doctor and said it was flu. On an unspecified date the patient was hospitalized, and unspecified lab test were performed (results were not reported). The patient was in hospital for 6 days. It was reported that the patient would be fine in a couple of days. At the time of this report, the patient had not recovered from the events asthenia, dehydration, diarrhoea, dizziness and dyspnoea, influenza. The reporter assessed this case as serious due to hospitalisation.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 737943), concerns a 14-year-old, adolescent female patient. The patient had no relevant medical history and current illnesses. The patient had not received any concomitant medications. On 10-Feb-2018, the patient was administered FLUVIRIN (dose: 0.5 ml (reported as unk), anatomical location: left arm, route of administration: unknown, batch number: 179803P, expiry date: not reported). On the same day (10-Feb-2018), approximately 10-15 minutes after vaccination, the patient fainted while walking out the front door. However, the patient had no injury, was placed on ground and she regained consciousness. The patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Tremor
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 738281), concerns a 40-year-old, adult, male patient. The patient stated that, he had reaction to vaccination or needles before. It was reported that, the patient had passed out after vaccination (unspecified). The patient had no current illnesses. On 15-Feb-2018, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, batch number: 1721401, anatomical location: unknown, expiry date: not reported). On the same day (15-Feb-2018) after vaccination, the patient was instructed to take rest for 15 minutes after vaccination. When the reporter checked the patient after 5 minutes, he was unconscious with mild tremors and emergency medical team (EMT) was called. Within a couple of minutes, the patient was able to regain consciousness and left with the emergency medical team. On 15-Feb-2018, the patient was discharged from the emergency room. On 16-Feb-2018, the patient was contacted and he stated that, he had recovered from the events. The reporter assessed this case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Loss of personal independence in daily activities, Lumbar puncture, Muscle injury
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 738945), concerns a 54-year-old, adult female patient. The patient's historical condition included: breast cancer. On 03-Jan-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, [frequency reported as 1], route of administration: injection [reported as SYR], anatomical location: left arm, batch number, expiry date: not reported). On an unspecified day after the receipt of flu shot, the patient had muscle and severe nerve damage, could barely walk and do any normal day to day functions. The patient underwent X-ray, magnetic resonance imaging (MRI) and spinal tap but the results were not reported. On 18-Jan-2018, 15 days after vaccination, the patient was diagnosed with Guillain-Barre syndrome. It was reported that, the patient visited office. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as serious (permanent disability).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve injury, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 738945), concerns a 54-year-old, adult female patient. The patient's historical condition included: breast cancer. On 03-Jan-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, [frequency reported as 1], route of administration: injection [reported as SYR], anatomical location: left arm, batch number, expiry date: not reported). On an unspecified day after the receipt of flu shot, the patient had muscle and severe nerve damage, could barely walk and do any normal day to day functions. The patient underwent X-ray, magnetic resonance imaging (MRI) and spinal tap but the results were not reported. On 18-Jan-2018, 15 days after vaccination, the patient was diagnosed with Guillain-Barre syndrome. It was reported that, the patient visited office. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as serious (permanent disability).
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 740484), concerns a 36-year-old, adult, male patient. The patient did not have any medical history and allergies. The patient's current illness was not reported. On 28-Jan-2018, the patient was administered FLUVIRIN [dose: 0.5 ml, (frequency: 1), route of administration: intramuscular, batch number: 170105P, anatomical location: unknown, expiry date: not reported]. On 29-Jan-2018, 1 day after vaccination, the patient woke up with half of the face paralyzed. The patient had emergency/office visit to consult primary care physician (PCP) and was diagnosed with Bell's palsy. On 09-Mar-2018, the patient went to store and reported about adverse reaction to the flu shot. MD (Doctor of medicine) was contacted who stated, the event was unrelated to the vaccine. At the time of report, the patient had recovered from Bell's palsy. The reporter assessed this case as non-serious.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Areflexia, Electromyogram abnormal, Gait inability, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 740783), concerns an 84-year-old, elderly, female patient. On 29-Sep-2017, the patient was administered with influenza vaccine (dose: reported as unknown, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). The patient reported after vaccination, she was unable to walk, when she left the hospital. The patient was taken to rehabilitation centre for 2 and a half weeks, but there was no improvement. The patient developed subacute weakness in lower extremities, sensory loss and had no reflexes. Hence, on 21-Nov-2017, the patient consulted a neurologist. Nerve conduction studies and electromyogram of lower extremities were performed, which showed abnormal results consistent with Guillain-Barre syndrome (GBS). Subsequently, the patient was admitted to the hospital. It was reported that, if the creatinine level was normal, the patient could be initiated with intravenous immunoglobulin (IVIG) 4 gm/kg intravenous daily (qd) for 5 days. The patient was hospitalized for 5 days. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as serious due to hospitalization.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Nerve conduction studies abnormal, Sensory loss
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 740783), concerns an 84-year-old, elderly, female patient. On 29-Sep-2017, the patient was administered with influenza vaccine (dose: reported as unknown, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). The patient reported after vaccination, she was unable to walk, when she left the hospital. The patient was taken to rehabilitation centre for 2 and a half weeks, but there was no improvement. The patient developed subacute weakness in lower extremities, sensory loss and had no reflexes. Hence, on 21-Nov-2017, the patient consulted a neurologist. Nerve conduction studies and electromyogram of lower extremities were performed, which showed abnormal results consistent with Guillain-Barre syndrome (GBS). Subsequently, the patient was admitted to the hospital. It was reported that, if the creatinine level was normal, the patient could be initiated with intravenous immunoglobulin (IVIG) 4 gm/kg intravenous daily (qd) for 5 days. The patient was hospitalized for 5 days. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as serious due to hospitalization.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 741835), concerns a 68-year-old, elderly, male patient. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, following the vaccination, the patient experienced Guillain-Barre syndrome. The lab test and corrective treatment for the event were not reported. At the time of this report, the outcome of the event was not reported.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV9, MENB, MNQ
Symptoms: Blood glucose normal, Electrocardiogram normal, Syncope
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 743065), concerns a 16-year-old, male adolescent. The patient had no relevant medical history, no known allergies and current illnesses. The patient was not taking any concomitant medications at the time of vaccination. On 03-Apr-2018, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 1721401, expiry date: not reported). On the same day, the patient also received non-company suspect products GARDASIL 9 (frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: N019103, dose, expiry date: not reported), BEXSERO (frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 165801, dose, expiry date: not reported) and MENVEO (route of administration: intramuscular, anatomical location: right arm, batch number: M17031, dose, expiry date: not reported). On the same day after vaccination, the patient fainted and was guided to the floor by the medical assistants. The patient woke up within few seconds with ammonia. The patient was helped onto a bed in the closest exam room and the vitals were checked by the doctor. The patient was provided oxygen. The patient's electrocardiogram (EKG) was found to be normal. The glucose level was 88 (units unspecified) low and the patient was given sweet snacks. The patient was discharged in a stable condition. It was reported that, the patient had office visit. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, PNC13
Symptoms: Seizure
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 743564), concerns a 1-year-old, male infant patient. The patient's historical conditions included gastrooesophageal reflux disease (GERD) and neonatal jaundice. The patient's current condition included delayed milestones (reported as medical history) and respiratory syncytial virus infection (RSV) (since an unspecified date). On 05-Jan-2018, the patient was administered influenza vaccine (dose, route of administration and anatomical location: unknown, batch number and expiry date: not reported, trade name, manufacturer: not reported). On the same day, the patient was administered non-company suspect product Hepatitis A vaccine (dose, route of administration and anatomical location: unknown, batch number and expiry date: not reported), MMR (dose, route of administration and anatomical location: unknown, batch number and expiry date: not reported) and PREVNAR (dose, route of administration and anatomical location: unknown, batch number and expiry date: not reported). On the same day (05-Jan-2018) night [as reported], the patient developed seizures and went to emergency room (ER). The patient had an appointment for electroencephalogram (EEG) but did not show up. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RV5
Symptoms: Pyrexia, Seizure
Clinical narrative: This is spontaneous case, reported by Physician via Pfizer sales representative to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 753071), concerns a 07-months male infant patient. The patient's medical history and concomitant medications were not reported. On 31-Jan-2018, the patient received influenza vaccine [dose: frequency reported as 1, route of administration: unknown, anatomical location: unknown, batch number and manufacturer, trade name and expiry date: not reported]. On the same day, the patient also received non-company suspect Hepatitis B vaccine [dose: frequency reported as 3, route of administration and anatomical location: unknown, manufacturer, batch number and expiry date: not reported], PENTACEL [dose: frequency reported as 3, route of administration and anatomical location: unknown, batch number and expiry date: not reported], PREVNAR 13 [dose: frequency reported as 3, route of administration and anatomical location: unknown, batch number: S58703 and expiry date: 31-Oct-2019] and ROTATEQ [dose: frequency reported as 3, route of administration: unknown, anatomical location: oral, batch number and expiry date: not reported]. On the same day, after vaccination in the evening, the patient developed a fever and had a seizure. Two days later, the patient's mother called to report but did not seek any medical attention for the patient. It was reported that, the patient had only one episode of seizure. On an unspecified date, the patient made a physician office visit. On an unspecified date, the patient recovered from the event seizure and the outcome for the event fever was unknown. The reporter assessed the case as non-serious. Update received on 21-Sep-2018: Non-significant case correction (IRD: 02-Aug-2018): The sentence in the narrative was changed from 'concerns a 07-months-infant patient' to 'concerns a 07-months male infant patient'. The indication (immunization) for suspect vaccine was added in narrative. The age at vaccination (7 months) was added in the patient tab.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case, reported by other healthcare professional (pharmacist) to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 754115), concerning a male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported] and PREVNAR 13 [dose (reported as single dose), route of administration, anatomical location, batch number and expiry date: not reported]. On an unspecified date (reported as few months ago), after the vaccination, the patient experienced flu like symptoms and was subsequently hospitalized. At the time of the report, the outcome of the event was unknown. The reporter assessed this case as serious due to hospitalization.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-AUG-2015, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 01-APR-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Seizure
Clinical narrative: Seizures, high fever.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was administered an improperly stored PNEUMOVAX 23 (strength, dose and route were not reported, lot # R018735, expiration date 06-APR-2020, therapy type digital data logger) for prophylaxis (product storage error). The vaccines experienced temperature excursion from 32 Fahrenheit degrees to 35 (34.9) Fahrenheit degrees for 1 hour and 30 minutes. There was no previous temperature excursion. No adverse events were reported. A data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker and refers to a 4 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 05-DEC-2018, the patient was vaccinated with ROTATEQ orally  (dose, lot number, expiration date were not provided) for prophylaxis. At that time, the patient was 4 months old and did not receive any prior doses (inappropriate schedule of product administration). No known adverse effects.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about September 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about December 2015, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 12-MAR-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about March 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Lymphadenopathy, Neck mass, Pain
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (lot # R023607, expiration date: 06-MAY-2021, dose was not provided) for prevention of HPV. On 28-DEC-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly into left arm (lot # R023607, expiration date: 06-MAY-2021, dose was not provided) for prevention of HPV and with a dose of FLULAVAL. On 30-DEC-2018, the patient experienced achiness in an unspecified part of the body. On 02-JAN-2019, the patient experienced a lump on the left side of the neck. On 04-JAN-2019, the patient was examined in the physician's office and the second lymph node was noted on the left side of the neck and one lymph node was noted on the right side of the neck. No inguinal or axillary nodes were involved. An unspecified lab work was performed and results were unremarkable. No treatment was given for the events. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 11-NOV-2011, the patient was vaccinated with the 1st dose of VAQTA and on 04-MAY-2012, the patient was vaccinated with the 2nd dose of VAQTA (route, anatomical location, lot # and expiration date were for both doses not provided) for prophylaxis. It was stated that this was shorter than the recommended interval. No adverse effects were reported.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case ID 2019SA010539 (same reporter, patient received TUBERSOL). This case involves a 13 years old male patient who was administered MENACTRA, (Single dose prefilled syringe) lot U6152A and Exp. Date 20-Mar-2019 via unknown route in the left deltoid on 07-Jan-2019. The patient's medical history and concomitant medications were not reported. No concomitant vaccines were given. It was as actual medication error case due to incorrect product storage. It was reported that reporter called about stability of MENACTRA, TENIVAC (Td) and TUBERSOL MDV (1 each opened/unopened) and FLUZONE 0.5 ml single dose. Temp 33.6 and below 32 F from 1100 to 1230 reaching a min of 26.8 F for 1.5 hours. 2 people received vaccines with medication that was outside of the recommend stability standard guideline: one person received a TB test and one received MENACTRA. No adverse reaction 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 Directive and Module VI of the 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient who was received vaccine ADACEL, lot number not reported via unknown route in unknown administration site after the excursion and this case also involves vaccines temp excursion of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Incorrect product storage as temp excursion with ADACEL and FLUZONE Quad, at 29.0F for 21 hours, unopened product. She also stated that the ADACEL had been given after the excursion It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Apnoea, Blood test, Chest X-ray, Conversion disorder, Crying
Clinical narrative: 5 days after the vaccines, Patient was eating in his high chair when his eyes rolled into his head and his arms and legs pulled up in spasm...this continued over and over for a few minutes as he cried hysterically. 911 was called and we went to the emergency room. After a spinal and x-ray we were told he MIGHT have a start of pneumonia with a tiny fever so they put an IV in with antibiotics and kept him for a couple days. I never left his side and he continued these spasms and would stop breathing. They finally agreed to do an EEG and refer us to a neurologist who didn't get him in for a total of 12 days...Patient suffered 100 of these each day until seen. Then another EEG was done and he was diagnosed with Infantile Spasms and given a script for ACTH which he was on for 9 weeks...attempted to eventually ween him off of it and then put him back on it for 6 more weeks before weening to DEPAKOTE.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Electroencephalogram, Eye movement disorder, Infantile spasms, Lumbar puncture, Muscle spasms
Clinical narrative: 5 days after the vaccines, Patient was eating in his high chair when his eyes rolled into his head and his arms and legs pulled up in spasm...this continued over and over for a few minutes as he cried hysterically. 911 was called and we went to the emergency room. After a spinal and x-ray we were told he MIGHT have a start of pneumonia with a tiny fever so they put an IV in with antibiotics and kept him for a couple days. I never left his side and he continued these spasms and would stop breathing. They finally agreed to do an EEG and refer us to a neurologist who didn't get him in for a total of 12 days...Patient suffered 100 of these each day until seen. Then another EEG was done and he was diagnosed with Infantile Spasms and given a script for ACTH which he was on for 9 weeks...attempted to eventually ween him off of it and then put him back on it for 6 more weeks before weening to DEPAKOTE.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: 5 days after the vaccines, Patient was eating in his high chair when his eyes rolled into his head and his arms and legs pulled up in spasm...this continued over and over for a few minutes as he cried hysterically. 911 was called and we went to the emergency room. After a spinal and x-ray we were told he MIGHT have a start of pneumonia with a tiny fever so they put an IV in with antibiotics and kept him for a couple days. I never left his side and he continued these spasms and would stop breathing. They finally agreed to do an EEG and refer us to a neurologist who didn't get him in for a total of 12 days...Patient suffered 100 of these each day until seen. Then another EEG was done and he was diagnosed with Infantile Spasms and given a script for ACTH which he was on for 9 weeks...attempted to eventually ween him off of it and then put him back on it for 6 more weeks before weening to DEPAKOTE.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 11 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 02-JAN-2019, the patient was vaccinated with VAQTA 50/1.0 units per millilitre (U/ml) (lot # R022982, expiration date 09-AUG-2019; dose and frequency were not reported) intramuscularly for prophylaxis (inappropriate dose of drug administered and adult product administered to child). No adverse effect was reported.