chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional (medical assistant) refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 22-JUN-2017, the patient was vaccinated with GARDASIL 9 dose 1 (strength, lot#, expiry date, dose, frequency, route of administration, anatomical location were unknown) for prophylaxis and On 19-NOV-2018, the patient was vaccinated with GARDASIL 9 dose 2 (strength, lot#, expiry date, dose, frequency, route of administration, anatomical location were unknown) for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported. The outcome of inappropriate schedule of product administration was unknown. No product quality complaint (PQC) reported for this case.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional referring to an adolescent patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 30-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9, lot # N000326 and expiration date: 14-OCT-2019, intramuscularly for prophylaxis at 13 years of age (strength, dose, unit and anatomical location were not reported). On 17-APR-2019, the patient was vaccinated with second dose of GARDASIL 9, lot # R004689 and expiration date: 29-NOV-2020, intramuscularly for prophylaxis at 15 years of age (strength, dose, unit and anatomical location were not reported) (inappropriate schedule of product administration) (onset date: 31-MAY-2018). No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 22-year's old Adult patient of unknown gender. There was no information regarding concurrent condition, pertinent medical history, concomitant medication and drug allergies or reactions. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1 and after 2 weeks patient was vaccinated with Dose 2 of the vaccine for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Limb mass
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date in April 2019 (reported as last week), the patient received her first dose of GARDASIL 9 injection via subcutaneous route (incorrect route of product administration) for prophylaxis (lot number, expiry date unspecified). The dose of GARDASIL 9 was not administered into her deltoid muscle, it was administered into subcutaneous area in the back her arm. On an unknown date in April 2019 (reported as 4 days later), the patient developed a lump on her arm (limb mass). No product quality complaint (PQC) was involved. The outcome of lump on her arm was unknown. Reporter causality was not provided. No additional information provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Patient was inadvertently administered one expired dose of PROQUAD; This spontaneous report as received from a physician refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent (DILUENT MRK INJ).  On 16-APR-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # N028443, expiry date: 09-APR-2019) (dose and frequency were not reported) subcutaneous for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received a dose of pneumovax 23 under 65 y. o. in AUG 2018 and recently received the prevenar 13 at (65 y.o.); This spontaneous report was received from a pharmacist via Pfizer refers to a patient of currently 65 years of age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in August 2018, when the patient was under 65 years of age, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (dose, strength, route of administration, lot number and expiration date not reported) for prophylaxis. On an unknown date, approximately in April 2019, when the patient was at 65 years of age, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). It was reported that the time gap of at least 1 year was not maintained to administer pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (inappropriate schedule of vaccine administered).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever of 101.6 in the afternoon on the first day after, also chills, headache.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patiet did not experience any reaction; his son (the patient)was administered his first MMR-II shot"five months ago at 15 months of age and was accidently given another shot today 4/17/2019; This spontaneous report as received from a consumer (patient's father) regarding to a 20 month old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter described that, on an unspecified date in (approximately) November 2018, five months ago at 15 months of age, his son was administered his first measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and was accidentally given another dose today on 17-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose 2 (strength, dose, frequency, route lot# and expiry were not reported) for prophylaxis (inappropriate schedule of product administration). The patient father stated that his son did not experience any reaction (no adverse event). The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Erythema, Fatigue, Headache
Clinical narrative: I got a headache, fever/shivering, body/muscle aches and really really tired that lasted for around 36 hours. It just ran it course. I also had bruising from the shot and was red/swollen/sore and warm to the touch from the top of my shoulder clear down about 2 inches from elbow--this is still red/sore/bruised 4 days later. Hopefully won't get this reaction after 2nd shot...wonder if I got this reaction because I've never had the Chick Pox??
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: I got a headache, fever/shivering, body/muscle aches and really really tired that lasted for around 36 hours. It just ran it course. I also had bruising from the shot and was red/swollen/sore and warm to the touch from the top of my shoulder clear down about 2 inches from elbow--this is still red/sore/bruised 4 days later. Hopefully won't get this reaction after 2nd shot...wonder if I got this reaction because I've never had the Chick Pox??
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: DTaP (Daptacel) given, custodian (grandmother) notified directly after (with in 15 min) of exp date. Provider and supervisor notified. CDC notified. Received consent from grandmother to give additional/corrected DTaP with Infanrix. Child monitored another 15 min after Infanrix. No distress noted in child after 15 min. and  Grandmother has VIS and number to clinic to call as needed.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram normal, Cyanosis, Electrocardiogram normal, Electroencephalogram normal, Hypotonia
Clinical narrative: My child turn cyanotic, was not responding and was completely limb. We went through 911 to emergency. After doing research found that this is called HHE (hypotonic hyporesponsive episode) and its a rare but an adverse event from this and other vaccines.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Hypotonic-hyporesponsive episode, Lumbar puncture normal, Unresponsive to stimuli, Urine analysis normal, X-ray normal
Clinical narrative: My child turn cyanotic, was not responding and was completely limb. We went through 911 to emergency. After doing research found that this is called HHE (hypotonic hyporesponsive episode) and its a rare but an adverse event from this and other vaccines.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Crying, Decreased eye contact, Injected limb mobility decreased, Injection site discomfort, Pyrexia
Clinical narrative: She had a low grade fever, would not/could not smile for 2 days, cried most of those two days, she would not look at us in our eyes or even our faces, she would stare off, did not use her right arm for most of those two days, and her legs were very sore. No site redness and not hot to the touch.  I lost trust in her doctors office so I did not take her into the office!
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Gave both vaccines, 1 minute after giving vaccines patient turned pale and expressed feeling dizzy. Immediately had patient lie down. Monitoring patient in exam room, he expressed starting to feel better after 10 minutes. Had him slowly sit up but lost color and felt dizzy again so had him lie down again. Nurse come in to exam room to assess patient came in and again offered water and ice pack. Patient did take water but again declined ice pack. Stayed another 5 minutes and then color returned to patient's face and he no longer felt dizzy. Walked out of office on his own. Mom aware to call office if any further reactions or concerns. Made Provider Dr. aware.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Hypoaesthesia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Shortness of breath, Left arm pain, Numbness and tingling, " Unable to move my body".
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Cardiac arrest, Death, Diarrhoea, Resuscitation
Clinical narrative: The child had seen his pediatric provider 2 days prior to presentation to emergency department and had immunizations. The day prior to presentation, the child was seen for loose stools. He was described as nontoxic in appearance and feeding okay with normal urinary output. Presented to the emergency department via ambulance with CPR in progress after suffering an in-home arrest.  Resuscitation was terminated after patient's arrival and patient was pronounced as deceased.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: redness, pain and swelling at site of injection; pain in left arm; fatigue; muscle pain; generalized aches.  Took 2000 mg of extra strength acetaminophen on day one; 2000 mg on day 2; 2000 mg day 3.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: redness, pain and swelling at site of injection; pain in left arm; fatigue; muscle pain; generalized aches.  Took 2000 mg of extra strength acetaminophen on day one; 2000 mg on day 2; 2000 mg day 3.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Had SHINGRIX shot and had soreness at injection site but have severe nerve pain in the upper and lower teeth on left side.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Blindness transient, Blindness unilateral, Blood test, Cardiac monitoring, Chest X-ray
Clinical narrative: Sudden blindness in left eye. Like a black curtain descended and vision faded to black. After about 15 to 20 minutes, vision slowly returned, like the curtain way drawn upward. Vision had returned to normal by the time I could get to my ophthalmologist. Eye exam was completely normal and vision 20/20 in both eyes. He sent me to emergency room for possible TIA. At hospital admission, had mild fever, pain in both shoulders, pain in neck. By late that night (4/9/19) neck pain was bad enough that I could hardly turn my head, couldn't sleep with pillow under my head. Next day to my knowledge, no one made note of this. During the day the pain slowly diminished. Although I repeatedly told personnel about the vaccination, no one took any interest in that. After getting back home I did some research and found that a facility reported an adverse reaction to Tdap. My pharmacist said I should report my experience.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram, Injection site pain, Mobility decreased
Clinical narrative: Sudden blindness in left eye. Like a black curtain descended and vision faded to black. After about 15 to 20 minutes, vision slowly returned, like the curtain way drawn upward. Vision had returned to normal by the time I could get to my ophthalmologist. Eye exam was completely normal and vision 20/20 in both eyes. He sent me to emergency room for possible TIA. At hospital admission, had mild fever, pain in both shoulders, pain in neck. By late that night (4/9/19) neck pain was bad enough that I could hardly turn my head, couldn't sleep with pillow under my head. Next day to my knowledge, no one made note of this. During the day the pain slowly diminished. Although I repeatedly told personnel about the vaccination, no one took any interest in that. After getting back home I did some research and found that a facility reported an adverse reaction to Tdap. My pharmacist said I should report my experience.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging, Ophthalmological examination normal, Pyrexia
Clinical narrative: Sudden blindness in left eye. Like a black curtain descended and vision faded to black. After about 15 to 20 minutes, vision slowly returned, like the curtain way drawn upward. Vision had returned to normal by the time I could get to my ophthalmologist. Eye exam was completely normal and vision 20/20 in both eyes. He sent me to emergency room for possible TIA. At hospital admission, had mild fever, pain in both shoulders, pain in neck. By late that night (4/9/19) neck pain was bad enough that I could hardly turn my head, couldn't sleep with pillow under my head. Next day to my knowledge, no one made note of this. During the day the pain slowly diminished. Although I repeatedly told personnel about the vaccination, no one took any interest in that. After getting back home I did some research and found that a facility reported an adverse reaction to Tdap. My pharmacist said I should report my experience.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Visual acuity tests normal
Clinical narrative: Sudden blindness in left eye. Like a black curtain descended and vision faded to black. After about 15 to 20 minutes, vision slowly returned, like the curtain way drawn upward. Vision had returned to normal by the time I could get to my ophthalmologist. Eye exam was completely normal and vision 20/20 in both eyes. He sent me to emergency room for possible TIA. At hospital admission, had mild fever, pain in both shoulders, pain in neck. By late that night (4/9/19) neck pain was bad enough that I could hardly turn my head, couldn't sleep with pillow under my head. Next day to my knowledge, no one made note of this. During the day the pain slowly diminished. Although I repeatedly told personnel about the vaccination, no one took any interest in that. After getting back home I did some research and found that a facility reported an adverse reaction to Tdap. My pharmacist said I should report my experience.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Back pain, Chills, Headache
Clinical narrative: Received SHINGRIX Vaccine dose 1, on 04/17/2019, and developed fever to 101.3F, severe myalgias and weakness, shivering, back pain, headache, intestinal distress for the following 24 hours. Symptoms started 17 hours after receiving vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Received SHINGRIX Vaccine dose 1, on 04/17/2019, and developed fever to 101.3F, severe myalgias and weakness, shivering, back pain, headache, intestinal distress for the following 24 hours. Symptoms started 17 hours after receiving vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Injection site pain
Clinical narrative: I received the SHINGRIX vaccine on 4/18/19. Within 12 hours, I was vomiting, feverish greater than 100 degrees Fahrenheit, chills, muscle aches, headache, and tiredness (I took 4 naps today), in addition to the usual and expected pain at injection site. All of this caused me to miss work. I had no known exposure to anyone ill, and received my flu shot for this season. I am an otherwise healthy individual who exercises 4 times per week, and runs half marathons etc.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: I received the SHINGRIX vaccine on 4/18/19. Within 12 hours, I was vomiting, feverish greater than 100 degrees Fahrenheit, chills, muscle aches, headache, and tiredness (I took 4 naps today), in addition to the usual and expected pain at injection site. All of this caused me to miss work. I had no known exposure to anyone ill, and received my flu shot for this season. I am an otherwise healthy individual who exercises 4 times per week, and runs half marathons etc.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received his first pre-exposure prophylactic immunization with Imovax 53 days ago; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 years old male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history, concomitant medication and family history were not provided.   On 26-Feb-2019, the patient received a 0.5ml dose of suspect RABIES (HDC) VACCINE lot N1L132M, expiry date 26-Feb-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to Inappropriate schedule of vaccine administered.  It was reported that patient received his first pre-exposure prophylactic immunization with Imovax 53 days ago.  It was unknown whether patient experienced any adverse reaction after the injection.   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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: she was giving the pentacel vaccine and realized that she only gave the diluent; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who received only gave the diluent portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without ActHIb portion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccines were Prevnar 13 and Rotavirus.   On 10-Apr-2019, the patient received a 0.5 ml second primary dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5576AB via intramuscular route in the left thigh.  It was of actual medication error due to inappropriate reconstitution technique.  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.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering an expired dose of Fluzone HD; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from  a consumer/non-hcp.  This case involves a 65 years old female patient who received expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 16-Apr-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI995AB (expiry date 01-Apr-2019) via intramuscular route in the right arm.  It was of actual medication error case due to  Expired vaccine used..  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: This is a spontaneous case initially received from other health professional on 10-Apr-2019, concerning a male neonate patient. The patient's mother did not have any history of offspring (3 previous full-term live births reported) with major congenital malformation. The patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The patient's mother risk factor included advanced maternal age. The patient's mother's last menstrual period (LMP) date was 08-Apr-2018. The patient's mother had singleton type of pregnancy. On 01-Jun-2018, patient's mother underwent ultrasound examination and no congenital malformation was noted. On 25-Jun-2018, a repeat ultrasound was performed, and no congenital malformation was noted. On 16-Jul-2018, Materni-T 21 genetic test and nuchal translucency test was performed, and no congenital malformation was noted. On 19-Oct-2018, at gestational age of 26 weeks, the foetus was exposed to AFLURIA QUADRIVALENT    (batch number: YF40208, route of administration: transplacental, dose, expiry date and anatomical location: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication. The patient's mother's estimated date of delivery (EDD) was reported as 13-Jan-2018 and corrected EDD was reported as 22-Jan-2019. 3 months and 6 days after vaccination (at the gestational age of 39 weeks), a male patient was born with large for gestational age, body weight 3670 g, head circumference: no data and length: no data, Apgar score at one minute was 8 and at 5 minutes was 9 and no data at 10 minutes and delivery method: caesarean. The patient's mother pregnancy complication included large for gestational age. On an unspecified date in 2018, patient's mother's early 1-hour glucose test was performed which showed elevated values. The outcome of the event large for gestational age was not reported. This case is linked to case 201805222 (mother case).; Reporter's Comments: A male neonate born with large for gestational age (body weight 3670 g), 3 months and 6 days after receipt of AFLURIA QUADRIVALENT vaccine administered to mother at approximately 26 weeks of gestation. Considering the risk factors (advanced maternal age, multigravida, gestation age at birth-39 weeks and elevated early 1-hour glucose test) and no evidence for a biological mechanism that could cause the event, the event was assessed as not related to the suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine.The company assessed the case as serious (medically significant).
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Injection site erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph nodes on back of neck. Fatigue. Red splotch at injection site
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Patient reported having fevers as high as 102 F starting same day as receiving injection along with muscle aches and cramping that resolved the following day.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash generalised, Rash morbilliform, Vaccination complication
Clinical narrative: Child started having a rash all over on Saturday 4-20-19, child was seen in office on 4-22-19 by Dr and was diagnosed with a reaction to the MMRV vaccine. Child had "classis measles rash". Child was well appearing in clinic other than rash.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: arm swelling, fever, redness, local pain, rigors
Sex: U
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: An unspecified number of improperly stored doses of VAQTA and PROQUAD were administered to unspecified patients on unspecified dates.; No adverse effect reported; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On an unknown date, the patients were vaccinated with an unspecified number of improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # R027431, expiration date 08-SEP-2019 for prophylaxis (dose and route of administration were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R021232, expiration date 21-JAN-2020 for prophylaxis (dose and route of administration were not reported) (product storage error). The sterile diluent (lot # and expiration date were not reported) that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly. The administered dose of the vaccine hepatitis a vaccine, inactivated (VAQTA) experienced a temperature excursion above 9° C degrees Celsius (12.3C) for 5 hours and 21 minutes, as recorded by a data logger. The administered dose of the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion above -9° C degrees Celsius to 8° C  (-2.4C) for 7 hours and 59 minutes, as recorded by a data logger. The administered doses of both vaccines did not experience previous temperature excursion. No adverse effect reported. This is a non-valid case since there's no patient identifiers.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse efect reported; patients received improperly stored dose of varivax; This spontaneous report was received from a Medical assistant regarding to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 03-APR-2019 the patient was vaccinated improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (product storage error) lot # N027618 and expiry date reported 04-OCT-2019 (strength, dose, frequency, route were not provided) for prophylaxis. No adverse effects reported (no adverse event). The medical assistant was described temperature and time frame details about varicella virus vaccine live (oka/merck)(VARIVAX).  Temperature total time in the range 6 degree Fahrenheit to 14 degree Fahrenheit (-14 degree Celsius) multiple excursions. Time frame cumulative 1 hour 3 minutes. It was also reported that temperature total time in the range 15 degree Fahrenheit to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) and time frame 32 minutes. Temperature total time in the range 47 degree Fahrenheit to 77 degree Fahrenheit (9 degree Celsius to 25 degree Celsius) total time frame 2 hours 39 minutes. The temperature excursion details was reported.  Temperature and time frame: -14 degree Celsius to -10 degree Celsius at 1 hour 3 minutes. Temperature and time frame: -9 degree Celsius to 8 degree Celsius at 1.3 Celsius 3 hours 11 minutes. It was reported that there was no product quality complaint. Digital data logger was involved. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no known adverse effects; On 17-APR-2019, a patient received a dose of proquad and a dose of varivax; This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 17-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) via subcutaneous route (strength, dose, lot# and expiry date not reported) for prophylaxis. On the same day, other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiry date not reported) for prophylaxis (inappropriate schedule of product administration). No known adverse effects (no adverse event). Product quality complaint was not involved.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blister, Pain, Pruritus, Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of systemic lupus erythematosus in a 80-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, 2 days after receiving SHINGRIX, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), widespread rash, skin plaque, blister, pruritus and pain. On an unknown date, the outcome of the systemic lupus erythematosus, widespread rash, skin plaque, blister, pruritus and pain were unknown. It was unknown if the reporter considered the systemic lupus erythematosus, widespread rash, skin plaque, blister, pruritus and pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX and 2 days later she experienced rash which began on left arm and spread to right arm and back. The patient visited physician's office on 9th April 2019, presented with scaly plaques with occasional blisters on her arms, chest, face and upper back associated with itching and pain. The biopsy was performed on same day and results showed subcutaneous lupus. No further details were provided.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin plaque, Systemic lupus erythematosus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of systemic lupus erythematosus in a 80-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, 2 days after receiving SHINGRIX, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), widespread rash, skin plaque, blister, pruritus and pain. On an unknown date, the outcome of the systemic lupus erythematosus, widespread rash, skin plaque, blister, pruritus and pain were unknown. It was unknown if the reporter considered the systemic lupus erythematosus, widespread rash, skin plaque, blister, pruritus and pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX and 2 days later she experienced rash which began on left arm and spread to right arm and back. The patient visited physician's office on 9th April 2019, presented with scaly plaques with occasional blisters on her arms, chest, face and upper back associated with itching and pain. The biopsy was performed on same day and results showed subcutaneous lupus. No further details were provided.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a staff member gave a 6 month old Adacel instead of Pentacel; a staff member gave a 6 month old Adacel instead of Pentacel; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 6 months old patient (gender not reported) who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Adacel was administered on 11Apr2019 and expired on 05Apr2019; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone.  This case involves 36-years old male patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U5626AA and expiry date: 05-Apr-2019) in the left arm on 11-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: gave the DTaP-IPV only portion of Pentacel; Initial information received on 18-Apr-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a four months old male patient who received only Dtap-IPV portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 17-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number U6397AA via intramuscular route in the right thigh. (Package portion: lot- UJ122AAA expiration date: 29-Sep-2020; DTaP portion-Lot number: U6397AA expiration date: -29-Sep-2020; ACTHIB portion- lot number: UJ122AA expiration date: 29-Sep-2020)  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported whether the patient experienced any adverse events following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Extreme tiredness, aches and pains over entire body. Headache, ear aches, and throat soreness. Worse I felt in my life. After 12 hours aches and pains subsided; however, tiredness did not.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Autism spectrum disorder, Developmental regression
Clinical narrative: A few months after administration of the vaccine my daughter developed signs of autism. She started to regress by the age of 2. Diagnosed at age 7 with autism.
Age: 88.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Angiogram, Chest X-ray normal, Computerised tomogram head normal, Electroencephalogram normal, Mental status changes
Clinical narrative: Pt given vaccine at pharmacy 3/20/19. Was admitted to medical center 3/27/2019 for altered mental status and seizure.
Age: 88.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Seizure
Clinical narrative: Pt given vaccine at pharmacy 3/20/19. Was admitted to medical center 3/27/2019 for altered mental status and seizure.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 29-SEP-2017, the patient was inoculated with the ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number, dosage and route of administration not provided). "Shortly after" receiving ZOSTAVAX, the patient suffered from shingles and extreme mid-thoracic pain. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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 of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the shingles and extreme mid-thoracic pain was considered to be not recovered. Shingles and extreme mid-thoracic pain were considered to be disabling. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Muscle swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: severe muscle & arm soreness-unable to lift arm more than 40' Lasted about 2 days- I took aleve and lots of ice because of swelling of shoulder, bicep+muscle and a little into back.
Age: 57.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: chicken pox; This spontaneous report as was received from a medical assistant referring to a 57 year old male patient, with no pertinent medical history, no drug reactions/allergies and no concomitant medications.    On 02-FEB-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously for vaccination (dose, vaccination site, lot number and expiration date were not reported).         On 28-FEB-2019 (also reported as on "02-MAR-2019"), the patient developed chicken pox (varicella).  The patient saw the physician who recommended unspecified labs, but the patient declined to have them performed due to cost.  An unspecified treatment was given for the event.  The patient was seen a t the office on 08-MAR-2019, and was determined to have recovered.  The reporter did not assess the causal relationship between therapy with varicella virus vaccine live (oka/merck) (VARIVAX)and the event.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swollen and warm to touch. Treatment: steroid shot and prednisone tablets.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: Redness, swollen and warm to touch. Treatment: steroid shot and prednisone tablets.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Nausea, Pain
Clinical narrative: Redness, swollen and warm to touch. Treatment: steroid shot and prednisone tablets.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pallor, Peripheral swelling, Thinking abnormal, Vaccination complication, Visual impairment
Clinical narrative: Redness, swollen and warm to touch. Treatment: steroid shot and prednisone tablets.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: raised bump, red, bruise- patient refused benadryl, follow up patient states he is fine, pharmacist reported it with patients doctor
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed a case of shingles.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Hyperhidrosis, Pallor, Syncope, Tremor
Clinical narrative: When standing at the front desk after the appointment was over she fainted and fell to the floor.  Patient was sweaty and pale on examination and her one hand did shake for a few seconds. The episode did not last long and patient was able to walk out of the clinic with her father after laying down for a while with cold rags and water. Patient was assessed by the nurse and provider during this episode. We are unsure if this was truly from the vaccinations or if there was some anxiousness.
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Chills, body aches, tender swollen lymph nodes in underarm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Received the second dose of the vaccine on Friday 19Apr2019 and developed significant muscle and joint pain, nausea on 20Apr2019 and a golf ball size lymph node enlargement above my left clavicle that wore very red and tender on 21Apr2019.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Received the second dose of the vaccine on Friday 19Apr2019 and developed significant muscle and joint pain, nausea on 20Apr2019 and a golf ball size lymph node enlargement above my left clavicle that wore very red and tender on 21Apr2019.
Age: 7.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Breath holding, Eyelid function disorder, Headache, Pallor, Presyncope
Clinical narrative: Patient got pale and started closing his eyes right after vaccines were finished being administered.  Patient seemed to be holding his breath during vaccine administration.  This RN encouraged patient to take some deep breaths while vaccines were being administered.  When patient got pale and started closing his eyes, patient's head was placed between knees.  Vitals were taken and were BP: 90/64; Resp:24; Pulse 74, Temp 98.6.  Pt  c/o of headache so 911 was called.  Paramedics arrived within 5 minutes.  EMS stated it was most likely a vaso-vagal response.  EMS gave the parent the option to go to ER to be evaluated.  Parent chose to have child transported to ER for further evaluation.
Age: 7.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Vital signs measurement
Clinical narrative: Patient got pale and started closing his eyes right after vaccines were finished being administered.  Patient seemed to be holding his breath during vaccine administration.  This RN encouraged patient to take some deep breaths while vaccines were being administered.  When patient got pale and started closing his eyes, patient's head was placed between knees.  Vitals were taken and were BP: 90/64; Resp:24; Pulse 74, Temp 98.6.  Pt  c/o of headache so 911 was called.  Paramedics arrived within 5 minutes.  EMS stated it was most likely a vaso-vagal response.  EMS gave the parent the option to go to ER to be evaluated.  Parent chose to have child transported to ER for further evaluation.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: Following morning woke with a temperature of 101.2 F. Accompanying chills with fever. Treated with ADVIL with reduction in fever and no reoccurrence.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Patient states fever of 101. arm warm to touch, redness, state swelling size of egg. States she took ibuprofen and BENADRYL. Advised patient to check with MD's office to see if needs to be seen.  Spoke with patient again on 4/22/19 states somewhat better still red and raised.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Trigeminal neuralgia
Clinical narrative: Patient experience a pain in face similar to trigeminal neuralgia. His son is an EENT specialist and he said that could have experienced a slight case of the shingles. Patient said he wanted this reported.