chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Ipol was inadvertently administered/No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves female patient of an unknown age who inadvertently received expired dose of vaccine IPV (VERO) [IPOL].   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 05-May-2020, the patient received third 0.5 mL dose of suspect IPV (VERO) lot number not reported expiry date- 26-Apr-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There was no information available on the lot number.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Missed day 3 dose of vaccine imovax rabies and back to day for the next dose, No Ae; Initial information received on 06-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 66 year old male patient who missed day 3 dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and back to day for the next dose (inappropriate schedule of product administration) which was started on 29-Apr-2020 for post exposure immunization.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a actual medication error due to inappropriate schedule of product administration.   At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information on the batch number for this case.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: I had the vaccine on the afternoon of Friday, May 8.  At 3:00 am on Saturday morning, May 9, I woke up with a fever.  I checked my temperature and it was 101.4.  I was shivering.  I stayed in bed most of the day.  When I checked my temperature at 10:00 pm on Saturday it was normal 98.0.  I stayed in bed most of the day on Sunday too.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Pain in shoulder, and arm radiating to elbow
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-APR-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status: rHA, lot # S006048, expiration date 27-FEB-2021 (dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine underwent the temperature excursion of 47.3 degrees Fahrenheit for 14 minutes. Data logger was involved. There was no previous excursion.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; the patient was administered an improperly stored dose of Pneumovax; Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies, and concomitant therapies were not reported.  On 26-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (therapy type: digital data logger) (strength, dose, frequency, route of administration, or anatomical location was reported) with lot # S004548 which was confirmed to be valid for pneumococcal vaccine, polyvalent (23-valent) with an expiration date reported and established as 12-AUG-2020, for prophylaxis.  Temperature excursion (product storage error) was reported as follows: temperature 47.3 degrees Fahrenheit and the timeframe was 20 minutes. No previous temperature excursion was reported. The product storage error was identified via a data logger. No additional adverse event information provided. No product quality complaint was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; 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-009507513-2005USA000302: US-009507513-2005USA000310: US-009507513-2005USA000352: US-009507513-2005USA000356: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000415: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000614: US-009507513-2005USA000624: US-009507513-2005USA000735:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a patient was administered with a properly stored expired MMR II; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 05-MAY-2020, the patient was vaccinated with properly stored dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R025335 with expiry date 06-APR-2020, therapy type: RHA; 1 dosage form) (strength was not reported) via subcutaneous route for prophylaxis (expired product administered). The expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. No additional adverse effect reported (no adverse event). No product quality complaint (PQC) was involved.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: I am having the common reactions; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and had common reaction. The reporter asked how long do these typically last. Any over the counter medication to mitigate the symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: fatigue; chills; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fatigue and chills. On an unknown date, the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the fatigue and chills to be related to Shingrix.  Additional information was provided as follows: The reporter reported for her brother in-law.  The age at vaccination was not reported. Batch number details were not available. The received Shingrix year ago and experienced fatigue, chills, the symptoms resolved within 48 hours. The reporter did not consent to follow up. Medical doctor follow up was not provided. This case linked with US2020075689, reported by same reporter.
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Neck pain, Paraesthesia
Clinical narrative: Pain in her arm (injection site); Pain in her arm then her neck all the way down to the feet on left site; Pain in her arm then her neck all the way down to the feet on left site; Numbness and tingling and weakness in arm; Numbness and tingling and weakness in arm; Numbness and tingling and weakness in arm; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in the arm, on an unspecified date, in 2015, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2015, 6h after the vaccination, she experienced pain in her arm (injection site) then her neck all the way down to the feet on left site. Also had numbness and tingling and weakness in arm. Chiropractic treatment was performed. The patient did not recover from the adverse events.   No follow-up attempts are needed, information about batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Fatigue, Hypersomnia, Nausea, Pain
Clinical narrative: 1/31 Nauseous, Achy, tired, almost passed out, stayed in bed & slept entire day. 2/1 Sick all day 2/2 Still tired but began feeling better I took Advil & Tylenol to relieve body aches.  The 1st dose of Shingrix caused similar but much less severe symptoms. *I have never had any side effects from vaccines except local pain on any other vaccines
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Urticaria
Clinical narrative: My son broke out in hives all over his body and had a low grade fever.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Medication was 1 month out of date when given to patient.
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC
Symptoms: Electroencephalogram normal, Seizure like phenomena
Clinical narrative: On 4/16, patient experienced brief seizure-like activity that resulted in ER visit. Discharged to home same day. EEG WNL
Age: 57.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: Severe Pain in right upper arm. Upper Biceps, (Swollen, Pain radiated down, upper Arm to wrist-to soulder, down to Front wrist, can't raise Arm up sense this, vaccine.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first dose of GARDASIL 9 on 08/15/2017 and second dose of GARDASIL 9 12/20/2018; This spontaneous report has been received from a medical assistant referring to a 19 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 15-AUG-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis. On 20-DEC-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; Pain at the site; My daughter is sick from your medication; This is a spontaneous report from a contactable consumer.  A female patient (reporter's daughter) of an unspecified age received meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, fatigue, pain at the site and the reporter also specified that his/her daughter was sick from medication. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Thyroidectomy
Clinical narrative: My thyroid had to be cut out.
Age: 1.17
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: At 8pm the same night of receiving vaccinations, he was warmer than normal at bed time. The next morning he had a fever of 102; he seemed unusually cranky though the day, and the leg that received the injection was sensitive. His fever rose to 103 by 4pm; we gave him a warm bath at 4:30pm in hopes of helping his body manage the fever better. Immediately after the bath his temp had dropped a degree. He still had a fever of 102 at bed time that night (4/30; 8pm). The next morning his temp was 100, and was normal by lunch time.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Bone marrow oedema, Electromyogram abnormal, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: Injection placed immediately below right shoulder joint. Within 2 hours right arm pain uncharacteristic of usual postvaccination symptoms. Gradual loss of use of right arm due to weakness, stiffness and pain. Numbness in medial forearm and 4th and 5th fingers of right hand along with sensation of pulling and abduction of those same fingers. Right sided neck and occipital pain and stiffness developed over the course of the next few weeks along with decreased and interrupted sleep due to right sided shoulder pain. MRI of right shoulder performed on 02/12/2019 Impression: adhesive capsulitis, bone marrow edema of the posterior lateral humeral head, edema in the overlying teres minor tendon and deep fibers of the deltoid muscle and resultant partial tears of the supraspinatus and infraspinatus tendons.  Steroid injections into R shoulder and elbow joints. Ongoing physical therapy treatments to right shoulder and neck  and possibly further steroid injections.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Insomnia, Joint injection, Magnetic resonance imaging abnormal, Mononeuropathy
Clinical narrative: Injection placed immediately below right shoulder joint. Within 2 hours right arm pain uncharacteristic of usual postvaccination symptoms. Gradual loss of use of right arm due to weakness, stiffness and pain. Numbness in medial forearm and 4th and 5th fingers of right hand along with sensation of pulling and abduction of those same fingers. Right sided neck and occipital pain and stiffness developed over the course of the next few weeks along with decreased and interrupted sleep due to right sided shoulder pain. MRI of right shoulder performed on 02/12/2019 Impression: adhesive capsulitis, bone marrow edema of the posterior lateral humeral head, edema in the overlying teres minor tendon and deep fibers of the deltoid muscle and resultant partial tears of the supraspinatus and infraspinatus tendons.  Steroid injections into R shoulder and elbow joints. Ongoing physical therapy treatments to right shoulder and neck  and possibly further steroid injections.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle oedema, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness, Myopathy
Clinical narrative: Injection placed immediately below right shoulder joint. Within 2 hours right arm pain uncharacteristic of usual postvaccination symptoms. Gradual loss of use of right arm due to weakness, stiffness and pain. Numbness in medial forearm and 4th and 5th fingers of right hand along with sensation of pulling and abduction of those same fingers. Right sided neck and occipital pain and stiffness developed over the course of the next few weeks along with decreased and interrupted sleep due to right sided shoulder pain. MRI of right shoulder performed on 02/12/2019 Impression: adhesive capsulitis, bone marrow edema of the posterior lateral humeral head, edema in the overlying teres minor tendon and deep fibers of the deltoid muscle and resultant partial tears of the supraspinatus and infraspinatus tendons.  Steroid injections into R shoulder and elbow joints. Ongoing physical therapy treatments to right shoulder and neck  and possibly further steroid injections.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Nerve conduction studies abnormal, Pain in extremity, Periarthritis, Rotator cuff syndrome
Clinical narrative: Injection placed immediately below right shoulder joint. Within 2 hours right arm pain uncharacteristic of usual postvaccination symptoms. Gradual loss of use of right arm due to weakness, stiffness and pain. Numbness in medial forearm and 4th and 5th fingers of right hand along with sensation of pulling and abduction of those same fingers. Right sided neck and occipital pain and stiffness developed over the course of the next few weeks along with decreased and interrupted sleep due to right sided shoulder pain. MRI of right shoulder performed on 02/12/2019 Impression: adhesive capsulitis, bone marrow edema of the posterior lateral humeral head, edema in the overlying teres minor tendon and deep fibers of the deltoid muscle and resultant partial tears of the supraspinatus and infraspinatus tendons.  Steroid injections into R shoulder and elbow joints. Ongoing physical therapy treatments to right shoulder and neck  and possibly further steroid injections.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory disturbance, Sleep disorder, Tendon disorder, Tendon rupture
Clinical narrative: Injection placed immediately below right shoulder joint. Within 2 hours right arm pain uncharacteristic of usual postvaccination symptoms. Gradual loss of use of right arm due to weakness, stiffness and pain. Numbness in medial forearm and 4th and 5th fingers of right hand along with sensation of pulling and abduction of those same fingers. Right sided neck and occipital pain and stiffness developed over the course of the next few weeks along with decreased and interrupted sleep due to right sided shoulder pain. MRI of right shoulder performed on 02/12/2019 Impression: adhesive capsulitis, bone marrow edema of the posterior lateral humeral head, edema in the overlying teres minor tendon and deep fibers of the deltoid muscle and resultant partial tears of the supraspinatus and infraspinatus tendons.  Steroid injections into R shoulder and elbow joints. Ongoing physical therapy treatments to right shoulder and neck  and possibly further steroid injections.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: arm is swollen, red and warm to the touch.  patient is also experiencing pain
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Constipation
Clinical narrative: Patient states that almost immediately after vaccine injection she became constipated and had little to no bowel movement for over a month. Patient states that if she did have a bowel movement then it would be very little and it would be about 1 1/2  weeks apart from each other. Patient stated that she tried drinking laxative and that didn't work.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Large Swelling/Cellulitis at injection site. Started pt on  Cephalexin 250 mg/5 ml. 10 mls TID x 10 days
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain
Clinical narrative: patient returned for 1 month dose of engerix b. stated roughly a few days to a week after patient noticed shoulder pains when rotating shoulder in certain ways. patient also stated has a history of carpal tunnel that radiated up to elbow and has tennis elbow in the arm the vaccine was administered.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain
Clinical narrative: Right shoulder pain immediately after injection that has persisted for 11 days without significant improvement. Pain with shoulder abduction.  Evidence of subacromial bursitis (nonseptic) on exam.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed severe pain @ site of injection, large swelling & redness approx. 7 hrs after administration.
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Rash morbilliform
Clinical narrative: -diarrhea & rash (mild morbiliform)
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. has a small 1" red raised circle on right thigh. It is itchy to the patient. Pt. mom instructed to give oral benedryl or can apply topical benedryl/topical 1 % hydrocortisone ointment. Pt. mom told that She should be seen if she develops a fever or if it spreads.
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Blindness unilateral, Optic neuritis
Clinical narrative: Pt states losing vision in one eye and has optic nerve inflammation This was reported to pharmacy on 5/11/20
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Anti-cyclic citrullinated peptide antibody, Anti-thyroid antibody, Antibody test, Antinuclear antibody, Antinuclear antibody positive
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Back pain, Blood 25-hydroxycholecalciferol, Blood creatine phosphokinase MB, Blood immunoglobulin G
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Blood thyroid stimulating hormone, Borrelia test, C-reactive protein, Cardiolipin antibody, Complement factor C3
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Complement factor C4, Differential white blood cell count, Fatigue, Full blood count, Grip strength decreased
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Immunology test, Injection site warmth, Insomnia, Joint range of motion decreased, Lipids
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Metabolic function test, Mycobacterium tuberculosis complex test, Neck pain, Pain, Pain in extremity
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Platelet count, Red blood cell sedimentation rate, Rheumatoid factor, Sarcoidosis, Sjogren's syndrome
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Spinal X-ray, Thyroid disorder, Thyroid function test, Thyroxine free, Ultrasound Doppler
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Urine analysis, X-ray limb, X-ray of pelvis and hip
Clinical narrative: Location of shot hot to touch, radiating pain in elbow, difficulty grabbing or holding on to anything with moderate weight within 5 days.  Within 6 weeks, difficulty in ability to bend knees among other joints. Ankle pain, neck pain, wrist pain, back pain,  stabbing pains in upper thighs, arms. Inability to sleep. Extreme fatigue. Received diagnosis of Sjogrens Autoimmune disorder, thyroid imbalance, saccrolosis.
Age: 1.0
Sex: M
Vaccine: MEN, MMR
Symptoms: Hypotonic-hyporesponsive episode, Screaming, Unresponsive to stimuli
Clinical narrative: Screaming then unresponsive for 30 minutes - no seizure activity or colour change; Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 1 year old male patient. Primary reporter is a physician. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 13-DEC-2018, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dose unspecified; strength, route, lot # and expiration date were unknown) for vaccination.  On the same day, the patient was also vaccinated with meningococcal acyw conj vaccine (tet toxoid) (NIMENRIX) (1 dose unspecified; strength, route, lot# and expire date unknown) for vaccination.      On the same day after vaccinations, the patient was screaming then unresponsive for 30 minutes- no seizure activity or colour change (hypotonic-hyporesponsive episode). The management of the event was hospital admission. The patient recovered from the event on 13-DEC-2018. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was assessed as possible related by Agency.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, lot # S025609, expiration date 18-AUG-2021 (exact dose and route of administration were not reported) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted in a properly stored sterile diluent. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion of 15 Fahrenheit (F) degrees to 46 F degrees for 7 hours. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported.; 59 years old patient was inadvertently administered VARIVAX instead if Shingrix.; This spontaneous report was received from a nurse prescriber referring to a 59-year-old patient, of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 04-MAY-2020, the patient was "inadvertently" vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, vaccination scheme and anatomical site of vaccination were not reported; lot number S032353, expiration date 14-OCT-2021) as prophylaxis; instead of dose of Shingrix (wrong product administered). The nurse confirmed this was not a vaccine confusion. The use of a sterile diluent (MERCK STERILE DILUENT) to reconstituted the vaccine was reported. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The concurrent conditions, medical history and concomitant medications were not reported. On or about 06-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) as prescribed and/or administered by a healthcare provider in a clinic, for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the patient was treated by a healthcare provider at a clinic for herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Hypogammaglobulinaemia, Pain, Post herpetic neuralgia
Clinical narrative: Postherpetic neuralgia; Hypogammaglobulinemia; Herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. The patient's medical history, historical drugs and concomitant therapies were not reported.   On or about 07-MAR-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prevention of shingles (herpes zoster) (dose, route, lot number and expiration date were not reported).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)), she suffered from vesicular rash on the left side of her back along with chronic fatigue and pain. She was diagnosed with herpes zoster, postherpetic neuralgia and hypogammaglobulinemia. The patient suffered symptoms that resulted in physical limitations. Also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, and sustained severe and permanent personal injuries. The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live(ZOSTAVAX) was related.   The events were considered to be disabling events and the event of hypogammaglobulinaemia was considered medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Postherpetic neuralgia; Hypogammaglobulinemia; Herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. The patient's medical history, historical drugs and concomitant therapies were not reported.   On or about 07-MAR-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prevention of shingles (herpes zoster) (dose, route, lot number and expiration date were not reported).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)), she suffered from vesicular rash on the left side of her back along with chronic fatigue and pain. She was diagnosed with herpes zoster, postherpetic neuralgia and hypogammaglobulinemia. The patient suffered symptoms that resulted in physical limitations. Also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, and sustained severe and permanent personal injuries. The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live(ZOSTAVAX) was related.   The events were considered to be disabling events and the event of hypogammaglobulinaemia was considered medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's, concurrent condition, medical history, concomitant medications, drug reactions or allergies were not reported. In 2009, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) at a health center for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to inoculation with Zoster Vaccine Live (ZOSTAVAX), the patient was treated by a health care provider at a health center for shingles. As a direct an proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to mental and physical pain and suffering; 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered the event of shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's, concurrent condition, medical history, concomitant medications, drug reactions or allergies were not reported. In 2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) at the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to vaccination with Zoster Vaccine Live (ZOSTAVAX), the patient was treated by a health care provider at a medical office for shingles. As a direct an proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to mental and physical pain and suffering; 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered the event of shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: one dose of PROQUAD was administered. Temperature 12.2F; This spontaneous report was received from a medical assistant concerning a currently 4 year old patient of unknown gender. Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included sterile diluent.  On 05-MAY-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously (dose, dose number, and location of administration were not reported) (lot # S021234, expiration date 05-JAN-2021), administered for immunization for measles, mumps, rubella and varicella.   The vaccine was exposed to a temperature of 12.2 degrees Fahrenheit (F) for a time frame of 26 minutes as recorded by a digital data logger. There were no previous temperature excursions.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site mass, Irritability, Pyrexia, Rash
Clinical narrative: lump under skin on leg where vaccine was administered/1 month later still has a lump under skin on leg where vaccine (not sure which one) was administered; irritability; Fever; rash on belly; This spontaneous report was received from a physician via company representative and refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose, frequency, duration and indication were not provided), for prophylaxis.  Other suspect therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, frequency, duration and indication were not provided), for prophylaxis.  On an unknown date, seven days after vaccination,  the patient experienced irritability,  rash  on belly and  fever (pyrexia).  On an unknown date, the patient experienced a lump under skin on leg where vaccine was administered (vaccination site mass) which one month after the patient still had.  At the time of reporting, the outcome of irritability, rash and pyrexia was unknown.  The reporter did not provide a causality assessment between the suspect therapies and the events.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms or adverse effects reported; patient received first dose GARDASIL 9 at age 23 on 1/1/2018. Patient tben received second dose in GARDASIL 9 immunization series on 1/30/2020.; This spontaneous report was received from a nurse referring to a 24 years old female patient. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On 01-JAN-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, dose detail, lot# and expiration date were not provided) for prophylaxis. On 30-JAN-2020, the patient received the second dose in hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, dose detail, lot# and expiration date were not provided) immunization series (inappropriate schedule of product administration). No symptoms or adverse effects were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: an unspecified number of unspecified patients received a dose of improperly stored PEDVAX HIB or ROTATEQ; No additional adverse effect reported; This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On unknown dates, the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # r036178, expiration date 09-OCT-2021; vaccine dosage detail and route of administration were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # r029818, expiration date 09-JUL-2020; vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was above 47 Fahrenheit degrees (56.8 Fahrenheit degrees) for 2 hours and 15 minutes. Previous temperature excursion was above 47 Fahrenheit degrees (51.4 Fahrenheit degrees) for 1 hours and 45 minutes. No additional adverse effect reported (no adverse event). Data logger was involved.  This is a non-valid case as no identifiable patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Concussion, Fall, Head injury, Injury, Loss of consciousness
Clinical narrative: Approx 2 minutes after vaccine admin , my daughter fainted, lost consciousness and fell off exam table hitting her head on the floor sustaining numerous injuries and a concussion.  Six stitches to upper eye
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Suture insertion, Syncope
Clinical narrative: Approx 2 minutes after vaccine admin , my daughter fainted, lost consciousness and fell off exam table hitting her head on the floor sustaining numerous injuries and a concussion.  Six stitches to upper eye
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2S7, expiry date unknown) for prophylaxis.   The patient's past medical history included shingles.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st January 2020, 118 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). Shingrix was continued with no change. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: On 21st January 2020, the patient received Valtrex for an outbreak. The patient was also given another Valtrex prescription on 1st March for 10 days. On 18th March 2020, the pharmacist noted that patient had cleared of the event and received her 2nd dose  in her left deltoid via intramuscular. On 16th April 2020, the patient had to receive another Valtrex prescription given 1gm total of 20 tablets. And then her doctor also placed her on 500mg  daily for suppression.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2S7, expiry date unknown) for prophylaxis.   The patient's past medical history included shingles.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st January 2020, 118 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). Shingrix was continued with no change. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: On 21st January 2020, the patient received Valtrex for an outbreak. The patient was also given another Valtrex prescription on 1st March for 10 days. On 18th March 2020, the pharmacist noted that patient had cleared of the event and received her 2nd dose  in her left deltoid via intramuscular. On 16th April 2020, the patient had to receive another Valtrex prescription given 1gm total of 20 tablets. And then her doctor also placed her on 500mg  daily for suppression.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: back pain; This case was reported by a other health professional via interactive digital media and described the occurrence of back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had back pain.