chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Electrocardiogram normal, Hypotonia, Pallor
Clinical narrative: He cried after his shots and then got very pale and limp shortly after. He was evaluated by Dr. who when she arived to the room placed him on the exam table from moms arms and he immediately cried and pinked up VS. normal. EKG done in office and was read as normal. He was admitted to local hospital for over night observation. He was sent home the next day.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Feeling abnormal, Flushing, Mental fatigue
Clinical narrative: Flushed, pink cheeks with distinct sensation of weakness in the very center of my chest developing within 1 to 2 hours after vaccination and lasting all day.  Mild sore throat, mental fogginess, generalized fatigue and weakness during the day of vaccination.  I did not feel like myself all day on the day of vaccination.  Localized pain and swelling vaccine site lasting several days, right arm.  Overall, I have felt fatigued and with less physical and mental stamina since I was vaccinated on March 3rd, 2020.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Flushed, pink cheeks with distinct sensation of weakness in the very center of my chest developing within 1 to 2 hours after vaccination and lasting all day.  Mild sore throat, mental fogginess, generalized fatigue and weakness during the day of vaccination.  I did not feel like myself all day on the day of vaccination.  Localized pain and swelling vaccine site lasting several days, right arm.  Overall, I have felt fatigued and with less physical and mental stamina since I was vaccinated on March 3rd, 2020.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: Muscle aches, fever 100.5 was the highest, headache and nausea, lasted a day and a half. Took Tylenol for fever and pains which did break my fever. Last night, 6/18/2020 I noticed a rash on my chest just between my breasts. Still there today 6/19/2020                      l
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Corneal reflex decreased, Fall, Petit mal epilepsy
Clinical narrative: within 24-hours of vaccine series, parents noted child begging to blink eyes and then fall over.  At first it was only occasional and they did not think anything about it.  He did not have any illness symptoms and no fever.  He was eating, sleeping and playing normally and his usually happy self.  By the time I saw him on 6/19/202, he was having 5-6 episodes daily.  They were able to catch one video.  He is having classic absence seizures.  At no point since this started has he had a fever THIS IS NOT FEBRILE SEIZURES.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Muscle aches and muscle weakness, slight fever with headache, lack of energy. Felt better by the second day after the shot.
Age: 1.0
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: Exact date vaccines failed to seroconvert; Both VARIVAX and MMR titers showed "negative" titer results/titers draw; Second dose of MMR was administered 11/8/2002; This spontaneous report was received from a pharmacist  referring to a 21-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 31-AUG-1999, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, route of administration, lot number and expiration date were not reported). Other suspect vaccines included the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent for prophylaxis (dose, route of administration, lot number and expiration date were not reported), on the same date.  On an unknown date in 2020, the patient had titers draw for varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and both showed "negative" titer results (antibody test negative). Exact date vaccines failed to seroconvert (vaccination failure)  was unknown by reporter. Furthermore, pharmacist reports that first dose of both live vaccines varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) were administered on 31-AUG-1999, rather than one month before or after administration of other live viral vaccines as per PI. Second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was administered on 8-NOV-2002). The patient did not have any symptoms. It was reported that no laboratory was performed, but it was stated that unspecified studies for the negative titers were performed. The patient sought unspecified medical attention. No treatment was given for the adverse events.  At the time of reporting, the outcome of antibody test negative an vaccination failure was unknown.    The causal relationship between varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and antibody test negative and vaccination failure was unknown.
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Congenital pyelocaliectasis, Cytogenetic abnormality, Foetal exposure during pregnancy
Clinical narrative: fetal pyelectasis; genetic testing ? showed caries of several; Ashkenazi genetic caries traits; Feotal exposure during pregnancy; This spontaneous report was received from a nurse practitioner referring to a currently 36 days old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. The patient's mother was 33 years old. The patient's mother' last menstrual period (LMP) was assumed as 31-JUL-2019, date of conception was assumed as 14-AUG-2019. The patient's mother' medical histories included depression and treatments were given with bupropion hydrochloride (WELLBUTRIN) and citalopram.  On an unknown date, the patient's mother had a genetic testing during pregnancy which showed the patient had caries of several and had Ashkenazi genetic caries traits, and the patient had fetal pyelectasis.   On 26-FEB-2020, the patient's mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date was reported as 16-AUG-2021, but upon internal validation established as 16-AUG-2021 in deltoid; strength and dose were not reported) and transplacental and diphtheria toxoid (+) pertussis acellular vaccine (unspecified (+) tetanus toxoid (TDAP) (1 ml, intramuscular; strength and dose were not reported) for prophylaxis (exposure during pregnancy, wrong product administered, product dispensing error, product administered to patient of inappropriate age and foetal exposure during pregnancy). The patient's mother' estimated due date (EDD) was 06-MAY-2020. On 07-MAY-2020, the patient's mother delivered a normal female baby at 40 weeks gestation.  The outcome of congenital pyelocaliectasis and dental caries was unknown. The outcome of foetal exposure during pregnancy was recovered. The causality assessment was not reported.   Upon internal review, congenital pyelocaliectasis was determined to be medically significant.  This case is crossed-referencing to 2003USA000105 (maternal case). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602283; expirationdate: 18-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA000105:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: experiencing tinnitus / residual ringing; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number C5JL7 ?, expiry date 30th November 2021) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, 2 days after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and after 2 days experienced tinnitus, till the time of reporting experiencing residual ringing.  Reporter consented to follow. This case has been linked with case US2020098378, reported by same reporter. Note:lot corresponds to Boostrix lot however it was reconfirmed that the reporter mentioned it as Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020098378:same reporter
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: experiencing tinnitus / residual ringing; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number C5JL7 ?, expiry date 30th November 2021) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, 2 days after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were reported as follows: The patient received Boostrix and after 2 days experienced tinnitus and till the time of reporting experiencing residual ringing.  Reporter consented to follow up. This case has been linked with case US2020098380, reported by same reporter. Note:lot corresponds to Boostrix lot however it was reconfirmed that the reporter mentioned it as Shingrix; Sender's Comments:  US-GLAXOSMITHKLINE-US2020098380:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain in arm. On an unknown date, the outcome of the vaccination failure, shingles and pain in arm were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient got shingles in year 2019 and also experianced sore arm. The reporter did not consented to follow up. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for herpes zoster were not provided. This case was linked with case US2020101579, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020101579:same reporter
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Gene mutation identification test, Injection site cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Erythema and edema of left thigh at the site of the DTAP vaccination cellulitis (VS). Allergic reaction (local) child was seen for follow up on 06/12/2020 it has resolved after antibiotic treatment.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Prothrombin time normal
Clinical narrative: Erythema and edema of left thigh at the site of the DTAP vaccination cellulitis (VS). Allergic reaction (local) child was seen for follow up on 06/12/2020 it has resolved after antibiotic treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Contusion, Headache, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Immediate pain, bruising, huge swelling in arm covering approx 4" circle, raised welt, edema, joint pain in same arm, hard to lift arm. Headache about 3 hrs after for 2+ days, with stiff neck and major eye sensitivity to light for 2+ days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Oedema, Pain, Peripheral swelling, Photophobia
Clinical narrative: Immediate pain, bruising, huge swelling in arm covering approx 4" circle, raised welt, edema, joint pain in same arm, hard to lift arm. Headache about 3 hrs after for 2+ days, with stiff neck and major eye sensitivity to light for 2+ days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Immediate pain, bruising, huge swelling in arm covering approx 4" circle, raised welt, edema, joint pain in same arm, hard to lift arm. Headache about 3 hrs after for 2+ days, with stiff neck and major eye sensitivity to light for 2+ days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient calls, reports that he received his pneumococcal immunization  in his right arm. He shares that the shot itself was not painful. He said he noticed a burning sensation when the fluid was pushed in only.  By Friday night, his right arm was "throbbing" and was very painful.  By Saturday night, it was improving and is less painful. He is able to move his arm without issues.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In or around December of 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided), at a medical center for routine health maintenance and for its intended purpose: the prevention of shingles. In or around January of 2016, the patient was diagnosed by a physician with shingles (herpes zoster); the rash lasted several weeks and caused severe pain. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had incurred and will continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome for herpes zoster was not recovered. The herpes zoster was considered a disabling event.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: stroke; heart attack; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 03-DEC-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) inoculation: heart attack (Myocardial infarction) and stroke (Cerebrovascular accident). Outcome of the events was not provided.  Upon internal review, cerebrovascular accident and myocardial infarction were determined to be medically significant events.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness, Dysarthria, Echocardiogram abnormal, Facial paralysis
Clinical narrative: stroke/cerebral vascular accident; cerebral infarction, unspecified; Cerebral infarction due to thrombosis of right middle cerebral artery; left facial droop; slurred speech; hemiparesis affecting left side as late effect of stroke (HCC); chronic microvascular ischemic changes with mild cerebellar atrophy; hemiplegia; acute-subacute lacunar infarct; right-sided lacunar stroke; left side numbness; dizziness; This case was reported by a lawyer and described the occurrence of hemiparesis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 14 August 2018 the patient received suspect Shingrix vial kit. As per medical record, the patient reports few days prior to hospital presentation on 16 August 2018 had received vaccine for shingles was not feeling well, generalized weakness, tiredness 2-3 days later he went to meet his friend at his work, friend noticed that his speech was slurred and was taken to the hospital for evaluation. The patient was weak in his left arm and left leg and patient's friend has noticed left facial droop. He was admitted to for stroke. He was noted to have left facial droop and slurred speech. The patient reports his symptoms have started to resolve within 8 hours of Admission and within 2-3 weeks most of his symptoms have resolved. He had MRI (Magnetic resonance imaging) of the brain which showed acute-subacute lacunar infarct in the subependymal white matter of the right cerebral hemisphere within the corona radiata, chronic microvascular ischemic changes with mild cerebellar atrophy. On 16 August 2018, the patient states he continues to had symptoms of left side numbness, difficulty walking, complains of not being able to grasp for long periods of time with left hand and states he feels slow and disconnected. The patient was admitted on 21 August 2018 and discharge on date 19 September 2018 for cerebral infarction, unspecified (admission diagnoses and final diagnoses). The patent diagnosis included right-sided lacunar stroke (HCC), hemiparesis affecting left side as late effect of stroke (HCC), hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side. As per record, the patient positive for chest pain (described as burning mid-sternal discomfort), gait problem , dizziness and weakness. On 14 September 2018, the patient had echocardiogram 2d complete with contrast showed positive agitated saline bubble study for right to left shunting, likely at the pulmonary level. The patient was admitted on 27 September 2018 and discharge on date 27 September 2018 for Cerebral infarction due to thrombosis of right middle cerebral artery (admission diagnoses and final diagnoses). On 27 September 2018, the patient encounter diagnosis was Cerebral infarction due to thrombosis of right middle cerebral/ CVA (cerebral vascular accident) (HCC) (primary), Hemiparesis affecting left side as late effect of stroke (HCC).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Grip strength decreased, Hemiparesis
Clinical narrative: stroke/cerebral vascular accident; cerebral infarction, unspecified; Cerebral infarction due to thrombosis of right middle cerebral artery; left facial droop; slurred speech; hemiparesis affecting left side as late effect of stroke (HCC); chronic microvascular ischemic changes with mild cerebellar atrophy; hemiplegia; acute-subacute lacunar infarct; right-sided lacunar stroke; left side numbness; dizziness; This case was reported by a lawyer and described the occurrence of hemiparesis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 14 August 2018 the patient received suspect Shingrix vial kit. As per medical record, the patient reports few days prior to hospital presentation on 16 August 2018 had received vaccine for shingles was not feeling well, generalized weakness, tiredness 2-3 days later he went to meet his friend at his work, friend noticed that his speech was slurred and was taken to the hospital for evaluation. The patient was weak in his left arm and left leg and patient's friend has noticed left facial droop. He was admitted to for stroke. He was noted to have left facial droop and slurred speech. The patient reports his symptoms have started to resolve within 8 hours of Admission and within 2-3 weeks most of his symptoms have resolved. He had MRI (Magnetic resonance imaging) of the brain which showed acute-subacute lacunar infarct in the subependymal white matter of the right cerebral hemisphere within the corona radiata, chronic microvascular ischemic changes with mild cerebellar atrophy. On 16 August 2018, the patient states he continues to had symptoms of left side numbness, difficulty walking, complains of not being able to grasp for long periods of time with left hand and states he feels slow and disconnected. The patient was admitted on 21 August 2018 and discharge on date 19 September 2018 for cerebral infarction, unspecified (admission diagnoses and final diagnoses). The patent diagnosis included right-sided lacunar stroke (HCC), hemiparesis affecting left side as late effect of stroke (HCC), hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side. As per record, the patient positive for chest pain (described as burning mid-sternal discomfort), gait problem , dizziness and weakness. On 14 September 2018, the patient had echocardiogram 2d complete with contrast showed positive agitated saline bubble study for right to left shunting, likely at the pulmonary level. The patient was admitted on 27 September 2018 and discharge on date 27 September 2018 for Cerebral infarction due to thrombosis of right middle cerebral artery (admission diagnoses and final diagnoses). On 27 September 2018, the patient encounter diagnosis was Cerebral infarction due to thrombosis of right middle cerebral/ CVA (cerebral vascular accident) (HCC) (primary), Hemiparesis affecting left side as late effect of stroke (HCC).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: stroke/cerebral vascular accident; cerebral infarction, unspecified; Cerebral infarction due to thrombosis of right middle cerebral artery; left facial droop; slurred speech; hemiparesis affecting left side as late effect of stroke (HCC); chronic microvascular ischemic changes with mild cerebellar atrophy; hemiplegia; acute-subacute lacunar infarct; right-sided lacunar stroke; left side numbness; dizziness; This case was reported by a lawyer and described the occurrence of hemiparesis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 14 August 2018 the patient received suspect Shingrix vial kit. As per medical record, the patient reports few days prior to hospital presentation on 16 August 2018 had received vaccine for shingles was not feeling well, generalized weakness, tiredness 2-3 days later he went to meet his friend at his work, friend noticed that his speech was slurred and was taken to the hospital for evaluation. The patient was weak in his left arm and left leg and patient's friend has noticed left facial droop. He was admitted to for stroke. He was noted to have left facial droop and slurred speech. The patient reports his symptoms have started to resolve within 8 hours of Admission and within 2-3 weeks most of his symptoms have resolved. He had MRI (Magnetic resonance imaging) of the brain which showed acute-subacute lacunar infarct in the subependymal white matter of the right cerebral hemisphere within the corona radiata, chronic microvascular ischemic changes with mild cerebellar atrophy. On 16 August 2018, the patient states he continues to had symptoms of left side numbness, difficulty walking, complains of not being able to grasp for long periods of time with left hand and states he feels slow and disconnected. The patient was admitted on 21 August 2018 and discharge on date 19 September 2018 for cerebral infarction, unspecified (admission diagnoses and final diagnoses). The patent diagnosis included right-sided lacunar stroke (HCC), hemiparesis affecting left side as late effect of stroke (HCC), hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side. As per record, the patient positive for chest pain (described as burning mid-sternal discomfort), gait problem , dizziness and weakness. On 14 September 2018, the patient had echocardiogram 2d complete with contrast showed positive agitated saline bubble study for right to left shunting, likely at the pulmonary level. The patient was admitted on 27 September 2018 and discharge on date 27 September 2018 for Cerebral infarction due to thrombosis of right middle cerebral artery (admission diagnoses and final diagnoses). On 27 September 2018, the patient encounter diagnosis was Cerebral infarction due to thrombosis of right middle cerebral/ CVA (cerebral vascular accident) (HCC) (primary), Hemiparesis affecting left side as late effect of stroke (HCC).
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: was given subcutaneously; Redness at site of injection; Swelling at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10th December 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   On 3rd June 2020, the patient received Shingrix .5 ml and Boostrix .5 ml. On 3rd June 2020, unknown after receiving Shingrix and Boostrix, the patient experienced intramuscular formulation administered by other route. In June 2020, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix and Boostrix.  Additional details were provided as follows: The patient received Shingrix and boostrix in the left arm. The reporter stated that, the patient received Shingrix and Boostrix on the same day. The reporter stated that, one vaccine was given intramuscular and one was given subcutaneously, but It was not known which one was given at which site, which led to intramuscular formulation administered by other route. The reporter stated that, the patient experienced injection site redness and injection site swelling on the subcutaneous site which resolved on 8th June 2020. No other details were provided.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Antibody test negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: nonreactive antibody test; 'Drug dose administration interval too long; 'Drug dose administration interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 51-year-old female patient who received HBV (Engerix B) (batch number 29ZB7, expiry date 29th June 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 54A32, expiry date 12th November 2021) for prophylaxis and HBV (Engerix B) (batch number L5C49, expiry date 17th May 2022) for prophylaxis.   On 29th June 2019, the patient received the 1st dose of Engerix B. On 7th August 2019, the patient received the 2nd dose of Engerix B. On 8th March 2020, the patient received the 3rd dose of Engerix B. In August 2019, not applicable after receiving Engerix B and Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. In March 2020, the patient experienced drug dose administration interval too long. On 3rd June 2020, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received the complete 3-dose series of Engerix-B but had a nonreactive antibody test on 3rd June 2020. The patient received 2nd and 3rd dose late which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: redness at the injection site; 25 month old patient was vaccinated Kinrix; 4th dose of DTaP; the patient was suppose to received DTaP and Hib.; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On 10th June 2020, the patient received Kinrix (intramuscular) .5 ml. On 10th June 2020, 3 min after receiving Kinrix, the patient experienced injection site erythema, inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the injection site erythema, inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Kinrix.  Additional details were provided asa follows: The patient received dose of Kinrix in the left thigh. The medical assistant reported that, the 25 months old patient received dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter stated that, the patient received 4th dose of DTaP, which led to inappropriate schedule vaccine administered. The reporter clarified that, the patient was suppose to received DTaP and Hib instead of Kinrix, which led to  wrong vaccine administered. The reporter stated that, 3 to 5 minuites after vaccination, the patient experienced redness at the injection site. No other details were provided.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Eczema, Pyrexia, Rash
Clinical narrative: WHOLE BODY WAS COVERED WITH SEVERE ECZEMA AND RASH INCLUDING THE PENIS AREA. THE CHILD CRIED NON-STOP, CONTINOUSLY AND HAD A HIGH FEVER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Vomiting
Clinical narrative: Patient calls, reports that on 6/15/20 she received a pneumonia vaccine. She reports that she reacted to this vaccine as follows:   Patient began experiencing severe left arm pain in the arm she received the pneumococcal 23 vaccine in, along with being unable to lift it.  Patient stated she began to ache all over her body and began to vomit.    The GI symptoms have subsided.  Her arm pain is much improved and she is able to lift it again.   She is home resting.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Fatigue, Migraine, Nausea
Clinical narrative: Migraine headaches, nausea, weakness, fatigue
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash along the left flank consistent with shingles outbreak starting approximately 8 hours after vaccination.
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PT IS 7 MONTHS OLD AND WAS GIVEN KINRIX INTSTEAD OF PEDIRIX. NO ADVERSE REACTION
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Circumoral swelling, Injection site urticaria, Swelling of eyelid, Throat irritation
Clinical narrative: Hives around injection site only, swelling of eyelids and around mouth, itching in throat Given benadrul 50mg PO x1, vitals checked eveyr 15 min for 1 hour Symptoms improved 20 min after benadryl, only residual throat itching at 1 hour mark Never had swelling lips/tongue, difficulty breathing, abdominal pain, or widespread rash
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Syncope
Clinical narrative: Patient experienced syncope the morning following administration of the Shingrix and Pneumovax 23 vaccines. The patient experienced a contusion to the head and was taken to the ED for assessment where he was later admitted. He is currently being further assessed to determine other potential causes for the syncope.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site injury, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 0.5mm area at injection site where the top layer of the skin appears to have been scratched off. 3.5mm x 4.0mm red, warm to touch area circled with a pen by patient's mother when she first noticed the reaction at approx 6:30 pm on 6/18/2020.  Mother states she gave the child benadryl at approx 6:30pm. Mother states child c/o mild pain at the site and itching. 6.0mm x 7.5mm red, warm to touch area circled by mother with pen at approx 11:00am 6/19/2020. Child denies pain while in clinic today @ 2:00pm 6/19/2020 for us to look at the reaction.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Administered an HPV vaccine on patient on her left arm. Gave apple juice prior to giving vaccine. Patient drank all of the apple juice. Once vaccine was administered, patient got up too quickly and asked if she can remain seated. She sat back down on the bed table, said she was okay. Once I walked out of the room her brother came out and she fainted and we elevated her legs. Took her blood pressure right away, and it was 131/65 Once patient laid down for a few minutes, we retook blood pressure, and it was 100/65, 88/50, 96/61. Patient was feeling nauseous and was pale, but never vomited. Mom brought her something to eat, and after she ate she felt better. Patient was able to get up and walk, felt better and left with mom. Dr said it was okay for patient to leave and will follow up with patient.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Urinary incontinence
Clinical narrative: patient reported severe dizziness, couldn't stand up and urinated in the bed. Symptoms started around 10:00pm on day of vaccination. Said they seem to be improving  when he notified us the next day 6/19/2020 at 4:40pm
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Varicella zoster virus infection
Clinical narrative: Pt's wife has reported a significant reaction of an all-over body rash that is suspected to be varicella zoster. Awaiting confirmation with physician, however the office seems to believe this to be the diagnosis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 7X5 ERYTHEMATOUS RAISED PATCH ON LEFT UPPER THIGH FOR 2 DAYS AS OF TODAY 06/19/2020 PT COMPLAINS OF LEFT LEG PAIN.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever/lassitude started approximately 14 hours post injection  with climbing temperature until  Day 1 peak temperature 101.1 was reached approximately 18 hours post injection??-compared to baseline 96.6 - 97.6 (7 am/9pm readouts)  With Tylenol temperature reduced,  but only to 100.1 Day 2 temperature 99.0 most of the day  First dose (3 months prior) more modest effects (slight fever approximately 26 hours post injection), not reported
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dyspepsia, Fatigue, Headache
Clinical narrative: I got a headache, sour stomach, some neck stiffness about 6 h. after the injection. Headache and stomach upset were worse the following morning (about 18 h. post-injection), also felt slightly chilled.  The headache and stomach upset began to improve around late morning (about 22 h. post-injection) but by then I felt very fatigued.  I dozed for perhaps an hour on the lawn, then went to bed and slept solidly for an hour and a half.  I woke feeling very groggy, but the headache and upset stomach were mild (26 h. post-injection).  By the following morning I felt well.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Somnolence
Clinical narrative: I got a headache, sour stomach, some neck stiffness about 6 h. after the injection. Headache and stomach upset were worse the following morning (about 18 h. post-injection), also felt slightly chilled.  The headache and stomach upset began to improve around late morning (about 22 h. post-injection) but by then I felt very fatigued.  I dozed for perhaps an hour on the lawn, then went to bed and slept solidly for an hour and a half.  I woke feeling very groggy, but the headache and upset stomach were mild (26 h. post-injection).  By the following morning I felt well.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Pain, Vision blurred, Visual impairment
Clinical narrative: Patient woke with blurred vision in one eye and terrible pain at temple. Throughout the day today patient's vision decreased and he could no longer see out of eye.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Developed intense pain in the right deltoid to the point cannot move the shoulder much.  Pain extends to the scapula and down the arm.  Some numbness down the arm and into hand as well.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash
Clinical narrative: Patient got a low grade fever several weeks after getting the vaccine and wouldn't eat for a couple days then she got a rash all over her body (starting on her trunk) that has lasted for two days so far.
Age: 1.0
Sex: U
Vaccine: HIBV, MMR, MMRV, PNC13
Symptoms: Developmental regression, Intentional self-injury, Speech disorder developmental
Clinical narrative: 3 days after the vaccination was given patient's speech drastically reduced. She went from saying short phrases to no words at all and also, that same day began the habit of smacking herself in the head. I was hoping these issues would clear up on their own but now it has been almost 3 months and has not gotten better. The only word she can say now is "mamma" when prior to the shot she could say "what's that" "who is that" "Dog" "Dad" "sissy" "no" "hi" and "I love you". This is a huge regression in speech. Patient is still hitting herself in the head too, it seems to out of frustration. I believe she is now disabled from this vaccine.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Eczema, Irritability, Rash
Clinical narrative: Rash on arms, legs, torso, and back that lasted over a month. Child also became fussy after vaccinations when previously had not bed and still has issues with fussiness at 14 months old.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Computerised tomogram normal, Dizziness, Feeling abnormal, Headache, Pain
Clinical narrative: Extreme headache, dizziness, feeling of disconnection from limbs, unexplained body pain, all within hours of receiving vaccine. Reported to EAP and told vaccine did not and would not cause these issues so soon. Referral sent to neurology and cat scan preformed. Midrin prescribed for headaches and pain. Never had headaches or issues before vaccine. Still have issues with all symptoms nearly 7 years later.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Lethargy
Clinical narrative: Mild headache, lethargy, mild temperature (99.1 degrees Fahrenheit)
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Joint stiffness, Nausea, Vomiting
Clinical narrative: chills, nausea, vomiting, stiffness in joints (achy)
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Tired, aches
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headache and chills.
Age: 57.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Breast swelling, Chills, Computerised tomogram normal, Headache, Impaired work ability
Clinical narrative: The Tdap was in the right arm, there was no reaction at all. The Varicella (shingrix) was given in the left arm. The arm got heavy and I got the chills as the first vaccination. But a headache started also. The next morning the chills were gone but my arm was swollen down under the arm into the breast. The left breast and lymph nodes were swollen and very sore. My headache keep increasing in severity. I tried my imitrex and it did little good.  I tried to get into the clinic but they would not let me come in because the symptoms "may" be something else. I ended up in the ER on June 15th six days after receiving the shot because my headache had still not gone away and I could not control the pain. The pain was lessened with the ER visit but I am still battling a major headache. I am not able to work or go about normal activities.  This is not like any headache I have experienced before. It has been eleven days of misery. Unless I get some answers and help I will be telling everyone I know not to get the vaccination. Nothing is worth going through this pain.
Age: 57.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Lymph node pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: The Tdap was in the right arm, there was no reaction at all. The Varicella (shingrix) was given in the left arm. The arm got heavy and I got the chills as the first vaccination. But a headache started also. The next morning the chills were gone but my arm was swollen down under the arm into the breast. The left breast and lymph nodes were swollen and very sore. My headache keep increasing in severity. I tried my imitrex and it did little good.  I tried to get into the clinic but they would not let me come in because the symptoms "may" be something else. I ended up in the ER on June 15th six days after receiving the shot because my headache had still not gone away and I could not control the pain. The pain was lessened with the ER visit but I am still battling a major headache. I am not able to work or go about normal activities.  This is not like any headache I have experienced before. It has been eleven days of misery. Unless I get some answers and help I will be telling everyone I know not to get the vaccination. Nothing is worth going through this pain.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Sudden death, Sudden infant death syndrome
Clinical narrative: Pt was taken to ED with sudden unexplained infant death
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Musculoskeletal pain, Oedema peripheral, Ultrasound Doppler abnormal
Clinical narrative: pt was fine upon leaving the pharmacy, developed shoulder pain late at night along with some numbness in arm which prompted a visit to the emergency room. US right upper extremity venous duplex Doppler was performed and showed a 7.2x5.2x5.6cm fluid collection in the subcutaneous soft tissues of the lateral upper arm. Pt was given rx for Norco for pain relief.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: adverse event(s): Myalgia, Grade 3; Fatigue, Grade 3; Headache, Grade 3;Shivering, Grade 3; Fever,  Grade 3 (101.5 degree F); GI (slight nausea)  treatment: 4 200mg advil and 5 hours sleep/rest  outcome: complete recovery
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: adverse event(s): Myalgia, Grade 3; Fatigue, Grade 3; Headache, Grade 3;Shivering, Grade 3; Fever,  Grade 3 (101.5 degree F); GI (slight nausea)  treatment: 4 200mg advil and 5 hours sleep/rest  outcome: complete recovery
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, shivering, soreness left arm, aches and pains throughout body
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, muscle aches, pain at site of injection. These began 9 hours post injection, lasted in full strength for 24 hours, tapered off for the next 12. All symptoms except pain at site of injection gone within 48 hours.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Headache, Insomnia, Nausea
Clinical narrative: Exactly 10 hours after the vaccination, I developed a slight headache with some back body ache.  About 12 hours later I had to bed with a pounding headache, body aches, chills, and a temperature of 100.4 degrees.  Took 2 IBU to help with body aches.  Several hours later, temp was up to 101.4 degrees and I had a severe headache, body chills, ache all over, eyes hurt, nausea, took 2 aspirin.. and used ice pack to deal wIth head ache.  Hardly any sleep due to headache and body pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Temperature intolerance
Clinical narrative: Exactly 10 hours after the vaccination, I developed a slight headache with some back body ache.  About 12 hours later I had to bed with a pounding headache, body aches, chills, and a temperature of 100.4 degrees.  Took 2 IBU to help with body aches.  Several hours later, temp was up to 101.4 degrees and I had a severe headache, body chills, ache all over, eyes hurt, nausea, took 2 aspirin.. and used ice pack to deal wIth head ache.  Hardly any sleep due to headache and body pain.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: Got shingles on left side, on back,shoulder, down left arm and onto hand.  Pain in arm and hand, strong pain in thumb.  Took three and a half months to get over pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Breast pain, Burning sensation, Discomfort, Injection site pain
Clinical narrative: The patient states that about one week following her second shingrix vaccination, she started to have pain on her left side, including left upper arm (underside), left breast and left clavicle. She has been following with her PCP to rule out other causes. She continues to have pain and discomfort in these areas, as well as tingling and burning in her left clavicle area and down into her left upper arm and axilla area.  Has been taking oral anti-inflammatory medication with some relief. Her PCP has discussed with her that this could be due to the shingrix vaccine. The patient has had shingles in the past. Her PCP discussed the option of treatment with Elavil to help with nerve pain. This treatment has not been started yet. The patient has had symptoms now for about one month. The patient suspects that she may be  currently dealing with shingles.