chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; she received her first dose of GARDASIL 9, and second dose of GARDASIL 9 on unspecified dates in 2016. The consumer reports that she is "now in the pharmacy to receive the third dose of GARDASIL 9 late"; This spontaneous report was received from a female patient of unknown age and refers to herself. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date in 2016, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # L023230, expiration date 28-JUL-2017 and lot # L044475, expiration date 12-MAY-2017, accordingly (exact dose and route of administration were not reported) for prophylaxis.  On 30-JUL-2019 (reported as now), the consumer reports that she was in the pharmacy to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) late. No adverse effects reported.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site urticaria
Clinical narrative: inappropriate schedule; Injection site welt 3 inch wide half inch tall; This case was reported by a nurse via call center representative and described the occurrence of injection site wheal in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th October 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that a patient was late for their second dose of Shingrix after receiving the first dose, which led to lengthening of vaccination schedule.  The reason for the late dose was unknown. The reporter had consented to follow up.   Follow up information was received from the nurse on 16th July 2019: The patient's demographic details were updated. On 19th October 2018, the patient received the 1st dose of Shingrix (intramuscular) and less than a day after receiving 1st dose of Shingrix, the patient experienced injection site wheal. On 1st April 2019, the outcome of the injection site wheal was recovered. The reporter considered the injection site wheal to be almost certainly related to Shingrix. On 6th May 2019, the patient received the 2nd dose of Shingrix and not cause any side effect or adverse event. 2nd dose was given by the same nurse and no side effect noted or reported by nurse or patient. The patient was not allergic to the Shingrix vaccine but the technique of administration as well as the intensity of the vaccine itself may have been compromised. The reporter stated that the office did not stored the documentation of specific vial of Shingrix used on 19th October 2018. Reason for delayed in receiving 2nd dose was unknown and probably a fault of administration. The reporter was asking about how to complete information and if it was necessary. The reporter explained reason for follow up. The reporter encouraged completion of healthcare professional information on adverse event reported. The reporter reported no documentation of lot number was done at healthcare professional office.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Patient states extreme pain in arm, cant move or lift arm at all, pain to the point of nausea
Age: 18.0
Sex: F
Vaccine: HEP, MENB
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: Approximately 2 hours after receiving the vaccines, developed a headache, shaking, and fever to 102.5.  Fever came down by the evening.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis bacterial, Aspiration joint abnormal, Bursa disorder, Electrocardiogram, Full blood count
Clinical narrative: Approximate 4 hours after receiving his vaccine the patient developed extremely painful right shoulder pain.  He initially was able to move his arm above his head that progress to the point where he could not lift it against gravity.  Any movement worsened the pain was passive or active.  The patient was brought to the emergency department and was evaluated by orthopedics.  The patient had a right shoulder aspiration that was grossly abnormal, consistent with septic arthritis.  He was then brought to the operating room for washout where they found pus in the sub deltoid bursa.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Joint irrigation, Metabolic function test, Neutrophil percentage increased
Clinical narrative: Approximate 4 hours after receiving his vaccine the patient developed extremely painful right shoulder pain.  He initially was able to move his arm above his head that progress to the point where he could not lift it against gravity.  Any movement worsened the pain was passive or active.  The patient was brought to the emergency department and was evaluated by orthopedics.  The patient had a right shoulder aspiration that was grossly abnormal, consistent with septic arthritis.  He was then brought to the operating room for washout where they found pus in the sub deltoid bursa.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Osteoarthropathy, Pain, Purulent discharge, Synovial fluid crystal, Synovial fluid white blood cells positive
Clinical narrative: Approximate 4 hours after receiving his vaccine the patient developed extremely painful right shoulder pain.  He initially was able to move his arm above his head that progress to the point where he could not lift it against gravity.  Any movement worsened the pain was passive or active.  The patient was brought to the emergency department and was evaluated by orthopedics.  The patient had a right shoulder aspiration that was grossly abnormal, consistent with septic arthritis.  He was then brought to the operating room for washout where they found pus in the sub deltoid bursa.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray limb abnormal
Clinical narrative: Approximate 4 hours after receiving his vaccine the patient developed extremely painful right shoulder pain.  He initially was able to move his arm above his head that progress to the point where he could not lift it against gravity.  Any movement worsened the pain was passive or active.  The patient was brought to the emergency department and was evaluated by orthopedics.  The patient had a right shoulder aspiration that was grossly abnormal, consistent with septic arthritis.  He was then brought to the operating room for washout where they found pus in the sub deltoid bursa.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose normal, Chest discomfort, Dizziness, Nausea, Syncope
Clinical narrative: the pneumovax was ordered. All appropriate screening questions were reviewed with the pt. the injection was given at 12:10 pm. At 12:20 pm the patient c/o feeling dizzy, faint. Pt was lowered to the floor. BP 110/70 P-60. Pt c/o nausea. Vomited several sm amts. Dr was in attendance and pt was transported to the Hospital Emergency room since she then starting to c/o of tightness in chest. SPO2=96%. was seen at the Hospital ER -given SoluMedrol 125 mg IV, Benadryl 50 mg IV and Zofran 4 mg IV. pt also received DuoNeb treatment.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: the pneumovax was ordered. All appropriate screening questions were reviewed with the pt. the injection was given at 12:10 pm. At 12:20 pm the patient c/o feeling dizzy, faint. Pt was lowered to the floor. BP 110/70 P-60. Pt c/o nausea. Vomited several sm amts. Dr was in attendance and pt was transported to the Hospital Emergency room since she then starting to c/o of tightness in chest. SPO2=96%. was seen at the Hospital ER -given SoluMedrol 125 mg IV, Benadryl 50 mg IV and Zofran 4 mg IV. pt also received DuoNeb treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia, Vaccination complication
Clinical narrative: patient reported feeling malaise and low grade fever starting about 4-5 hours after being given the vaccination. The fever escalated up to 105 F. Leading the patient to go to the Medical Center ER on 07/19/2019. Patient was told  by medical stafff at the hospital that is was likely due to the vaccine. According to the patient IV fluids were administered, but no medication was given. The patient stayed for observation for less than 1 day.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: fever of 100-103 degrees Fahrenheit lasting 48 hours, measles-like rash predominantly on forehead and cheeks. spread slightly to chest, back, and stomach.
Sex: F
Vaccine: FLU4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Gestational age at outcome 35.9 weeks/Preterm birth; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 23-Jul-2019, concerning a female neonate patient.   The patient's mother was a 26-year-old, female who had no previous pregnancies. The patient's mother had no history of offspring with major congenital malformation. The patient's mother used tobacco during pregnancy and consumed 10 cigarettes per day. The patient's mother did not have a prior history of use of alcohol or illicit drugs during pregnancy. The patient's mother had no maternal or paternal history with major congenital malformations.  The current conditions of the patient's mother included polycystic ovaries and RhD negative. The patient mother's concomitant medication included prenatal vitamins (minerals NOS, vitamins NOS) as supplement.  The patient's mother's last menstrual period (LMP) date was 22-Oct-2018 and type of pregnancy was singleton.   On 21-Dec-2018, at gestational age of 8 weeks, the patient was exposed to Afluria Quadrivalent [influenza vaccine, batch number: YF42609, route of administration: transplacental, dose, anatomical location and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, the patient's mother underwent ultrasound test and no major congenital malformation was noted.  On 25-Jan-2019, the patient's mother underwent nuchal translucency and inheri test, no major congenital malformation was noted. On 15-Mar-2019 and 12-Apr-2019, the patient's mother underwent ultrasound test and no major congenital malformation was noted.  On 03-Jul-2019, at gestational age of 35.9 weeks, the patient's mother gave a live birth to a female neonate (reported as preterm birth) (coded as premature birth) by vaginal method. The characteristics of neonate included birth weight: 3090 grams, head circumference: no data, body length: no data, appearance, pulse, grimace, activity and respiration (APGAR) scores 8 at one minute, 9 at five minutes and for ten minutes: no data. There were no major congenital malformations identified at birth.  The patient's mother estimated date of delivery (EDD) was reported as 29-Jul-2019 and corrected estimated date of delivery (CEDD) was reported as 01-Aug-2019.  This case is linked to the case 201904218 (the correspond ding maternal pregnancy report).; Reporter's Comments: A female neonate experienced premature birth at 35.9 weeks of gestation, 6 months 12 days after maternal receipt of Afluria Quadrivalent vaccine (considered as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event premature birth assessed as not related. Maternal use of tobacco (10 cigarettes per day) is considered as known risk factor. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: extreme pain at injection site - could not move arm  911 called
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, Swelling to (L) arm Spoke with MOC swelling has gone down, redness is going away.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Rash vesicular
Clinical narrative: On 7/31 I noticed two bright red spots on my upper thigh.On 8/1 I noticed about a dozen bright red spots some with white raised pimply spots in the middle. They looked just like pictures of chicken pox and if memory serves like the ones my kids had
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dyskinesia, Hyperhidrosis, Mobility decreased, Mydriasis
Clinical narrative: HPV vaccine was given at 0947. When this RN was in the room after administration, the patient fell forward on the seat and leaned over.  The patient began to jerk and was responsive to this RN's voice.  Pupils were dilated and patient was pale. blood pressures were taken. Initial blood pressure upon triage prior to immunization was 100/53. when patient began syncope episode, 0950, blood pressure was 78/45 with a pulse of 66. blood pressure was continued to be taken q5mintues. 0955 81/47 pulse of 64, patient began to sweat heavily and was hot to touch. temperature taken and was 97.7.  blood pressure at 1000 87/54 pulse of 55. patient requested to sit up and blood pressure was taken and was 93/60 with pulse of 63.  patient was given cracker and Gatorade to sip. Color improved to patient's lips and cheeks. they began to pink up. Patient complained of not being able to move feet. Shoes and socks were taken off and feet were cold and clammy. Patient was able to feel this rn squeezing feet and could move toes. patient stated she felt better when she was sitting up at this time. Patient began to get shaky again and this RN and mother laid patient back slowly. patient laid down for approximately 5 minutes and then was able to sit up with her back against the wall. patient color remained pink with no paleness to lips or cheeks. This rn asked patient to move feet and she was able to move them. Dr. came in the room several times between episode of syncope and prior to patient leaving with parents.  Patient blood pressure was taken again prior to standing and it was 93/61.  The patient was able to get up and walk down the hall without difficulty with this RN, father, and mother at side. No further concerns were noted. patient stated she was fine. Patient ambulated out of the office with both parents at side.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Peripheral coldness, Posture abnormal, Skin warm, Syncope
Clinical narrative: HPV vaccine was given at 0947. When this RN was in the room after administration, the patient fell forward on the seat and leaned over.  The patient began to jerk and was responsive to this RN's voice.  Pupils were dilated and patient was pale. blood pressures were taken. Initial blood pressure upon triage prior to immunization was 100/53. when patient began syncope episode, 0950, blood pressure was 78/45 with a pulse of 66. blood pressure was continued to be taken q5mintues. 0955 81/47 pulse of 64, patient began to sweat heavily and was hot to touch. temperature taken and was 97.7.  blood pressure at 1000 87/54 pulse of 55. patient requested to sit up and blood pressure was taken and was 93/60 with pulse of 63.  patient was given cracker and Gatorade to sip. Color improved to patient's lips and cheeks. they began to pink up. Patient complained of not being able to move feet. Shoes and socks were taken off and feet were cold and clammy. Patient was able to feel this rn squeezing feet and could move toes. patient stated she felt better when she was sitting up at this time. Patient began to get shaky again and this RN and mother laid patient back slowly. patient laid down for approximately 5 minutes and then was able to sit up with her back against the wall. patient color remained pink with no paleness to lips or cheeks. This rn asked patient to move feet and she was able to move them. Dr. came in the room several times between episode of syncope and prior to patient leaving with parents.  Patient blood pressure was taken again prior to standing and it was 93/61.  The patient was able to get up and walk down the hall without difficulty with this RN, father, and mother at side. No further concerns were noted. patient stated she was fine. Patient ambulated out of the office with both parents at side.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: HPV vaccine was given at 0947. When this RN was in the room after administration, the patient fell forward on the seat and leaned over.  The patient began to jerk and was responsive to this RN's voice.  Pupils were dilated and patient was pale. blood pressures were taken. Initial blood pressure upon triage prior to immunization was 100/53. when patient began syncope episode, 0950, blood pressure was 78/45 with a pulse of 66. blood pressure was continued to be taken q5mintues. 0955 81/47 pulse of 64, patient began to sweat heavily and was hot to touch. temperature taken and was 97.7.  blood pressure at 1000 87/54 pulse of 55. patient requested to sit up and blood pressure was taken and was 93/60 with pulse of 63.  patient was given cracker and Gatorade to sip. Color improved to patient's lips and cheeks. they began to pink up. Patient complained of not being able to move feet. Shoes and socks were taken off and feet were cold and clammy. Patient was able to feel this rn squeezing feet and could move toes. patient stated she felt better when she was sitting up at this time. Patient began to get shaky again and this RN and mother laid patient back slowly. patient laid down for approximately 5 minutes and then was able to sit up with her back against the wall. patient color remained pink with no paleness to lips or cheeks. This rn asked patient to move feet and she was able to move them. Dr. came in the room several times between episode of syncope and prior to patient leaving with parents.  Patient blood pressure was taken again prior to standing and it was 93/61.  The patient was able to get up and walk down the hall without difficulty with this RN, father, and mother at side. No further concerns were noted. patient stated she was fine. Patient ambulated out of the office with both parents at side.
Age: 17.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Subq area of rt arm red, itchy, swollen, and warm to touch.  Reaction started 11 hrs after vaccine given.  Father stated he had given pt   one ibuprofen tablet and some benadryl  on 7/31/2019.  Parent was advised by FNP to continue with ibuprofen and benadryl and to use cold compresses and to seek medical attention of mouth/throat swelling occurs or if pt has reaction in other areas of body.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swelling,  painful, Erythema. 8/1/19 diagnosed with cellulitis of LUE.  Keflex 500mg presribed. ICE, motrin, mark swelling, RTC as needed.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: patient developed nausea, vomiting, headache, fatigue and chills approximately 12 hours after receiving Tdap
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: Local erythema, tenderness, fever Required hospitalization, antibiotics for possible cellulitis
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Feeling hot, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Woke up feeling achey, flu like symptoms, temp to 100 and arm hurting-sore and felt warm Advised on rest, hydration and Motrin as needed.  48 hrs later-feeling better, arm still achey but otherwise better
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Gait disturbance, Loss of consciousness, Vomiting
Clinical narrative: Patient's mother called stating that her son stated that he passed out after receiving the vaccination; none of the staff had witnessed the patient falling nor did the patient bring it to the attention of the staff while he was at our facility. Upon reviewing the cameras, it can be seen that the patient stumbles to his knees then immediately sits in the chair adjacent to the location of his stumble while the staff had turned and faced away from the waiting area, when staff had turned around the patient was already seated in the chair. The mother also stated that the patient had vomited at the residence. The mother was advised that the patient should seek medical attention since he had already left the facility. Upon follow-up with the patient, they did not seek medical attention but that the symptoms had resolved.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effect reported; the 4 year old patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from  a nurse prescriber referring to 4 year-old patient of unknown gender.       The patient's medical history, concurrent conditions and concomitant therapies were not provided.           The nurse reported that on 30-JUL-2019, the patient was inadvertently administered an adult dose of Hepatitis A Vaccine, Inactivated(VAQTA) 50/1.0 U/ml (lot # S010726, expiration date; 06-MAR-2020, dose, route and anatomical location were not reported) for prophylaxis. No adverse effect was reported. No further information was provided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Bedridden, Feeling cold, Lethargy
Clinical narrative: Freezing Cold; Shaking; Weak; Upset Stomach; Lethargic; Not feel well; being in bed; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019 15:00, the patient received the 1st dose of Shingrix. In July 2019, 3 days after receiving Shingrix, the patient experienced feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden. On an unknown date, the outcome of the feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden were unknown.   It was unknown if the reporter considered the feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient felt fine on saturday and sunday.  On 22nd July 2019, at around 8:00am, 2 days 17 hrs. after vaccination when the patient woke up, she did not feel well. The patient was freezing cold, shaking, felt weak, and had a mild upset stomach. She got back into bed and has been there ever since.  At the time of reporting the patient was feeling better but still in the bed and felt lethargic. Unable to obtain additional information. The reporter gave permission to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Tremor
Clinical narrative: Freezing Cold; Shaking; Weak; Upset Stomach; Lethargic; Not feel well; being in bed; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019 15:00, the patient received the 1st dose of Shingrix. In July 2019, 3 days after receiving Shingrix, the patient experienced feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden. On an unknown date, the outcome of the feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden were unknown.   It was unknown if the reporter considered the feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient felt fine on saturday and sunday.  On 22nd July 2019, at around 8:00am, 2 days 17 hrs. after vaccination when the patient woke up, she did not feel well. The patient was freezing cold, shaking, felt weak, and had a mild upset stomach. She got back into bed and has been there ever since.  At the time of reporting the patient was feeling better but still in the bed and felt lethargic. Unable to obtain additional information. The reporter gave permission to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: numbness in his arm; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves male patient (age not reported) who experienced numbness in his arm, while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In June 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious numbness in his arm (hypoaesthesia) with unknown latency following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  Final diagnosis was numbness in his arm.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for numbness in his arm.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: Temp 101.9; injection site redness; Initial information received on 18-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient who experienced pyrexia and vaccination site erythema, while he received 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.   On an unknown date, (at the age of 15 months old) the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious temp 101.9 (pyrexia) and injection site redness (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Final diagnosis was vaccination site erythema and pyrexia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site erythema and pyrexia.  Information on the batch number was requested.  List of document held by sender: none.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Patient received vaccine that was expired; Patient is on a three dose regimen for the Trumenb/ Instead of getting two doses he will get three; Initial information received on 24-Jul-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer) on 24-Jul-2019.  This case involves patient of unknown demographics who was vaccinated with 0.5 ml dose of TRUMENBA (Batch number: S26985 and expiry date: 01-Jan-2019)  via intramuscular route in the left deltoid on 18-Jul-2019 and 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number: U6220AA and expiry date: 31-May-2020)  via intramuscular route in the left deltoid on an unknown date.  The patient's past medical history included Myasthenia gravis.   It was a case of actual medication error due to expired vaccine used and extra dose administered.  It was unknown if any adverse event occurred or not following the vaccination.  No Lab data was reported.  The patient was treated with ECULIZUMAB (SOLIRIS) as a corrective treatment.  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: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: 4 patients was administered open Ipol that reached 11.3 degrees Celsius for 6 hours and 32 minutes because a mobile vaccine truck had a temperature excursion in their refrigerator; Initial information received on 25-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 4 patients who was administered open IPV (VERO) [IPOL] that reached 11.3 degrees celsius for 6 hours and 32 minutes because a mobile vaccine truck had a temperature excursion in their refrigerator lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch; arm was itchy; arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch and itchy; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 4 years, 5 month old male patient who experienced arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch and itchy, while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patients past medical history, concomitant medication and family history were not provided.   On 24-Jul-2019, the patient received a first dose 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA, expiry date 09-Oct-2020 via intramuscular route in the right arm.  On 26-Jul-2019, the patient developed a non-serious arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch (inflammation) (pruritus) (vaccination site reaction) 2 days following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  On 26-Jul-2019, the patient visited doctor. HCP instructs mother to continue benadryl and monitor for worsening symptoms.  Lab data was not provided.  Final diagnosis was arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch and itchy.   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Recovering / Resolving for all the events. Mother states that benadryl was helpful with itching.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 year old received Quadracel Vaccine / no adverse event; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who vaccinated with 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C55532AA (Expiry date 09-Oct-2020) via intramuscular route in the left thigh.  It was a actual medication error case due to Inappropriate age at vaccine administration. It was reported that 3 year old received Quadracel Vaccine  At the time of reporting no adverse reactions were 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: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 year old received Quadracel Vaccine; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who vaccinated with0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C55532AA (Expiry date 09-Oct-2020) via intramuscular route in the left thigh.  It was a actual medication error case due to Inappropriate age at vaccine administration. It was reported that 3 year old received Quadracel Vaccine  At the time of reporting no adverse reactions were 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: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: nurse not mix the Pentacel correctly and only gave a portion (acthib) to their patient; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient of an unknown age who received only ActHib portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique. Had a nurse not mix the Pentacel correctly and only gave a portion (acthib) to their patient.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  Information on the batch number was requested  Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: gave Menactra SQ by mistake instead of IM/no AE; inappropriate age at vaccine administration/no AE; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist with live follow-up on same date.  This case involves a 66 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that gave Menactra SQ by mistake instead of IM/no AE and inappropriate age at vaccine administration/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot 46365AA and expiry date: 20-Sep-2024 via subcutaneous route in the right arm.  It was a case of actual medication error due to inappropriate route of vaccination and inappropriate age at vaccine administration.  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: U
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: a patient received Menactra Subcutaneously instead of IM; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a office staff in.  This case involves a patient of unknown demography who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that a patient received Menactra subcutaneously instead of intramuscular route.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA and expiry date: 20-Mar-2020 via subcutaneous route in unknown administration site.  It was a case of actual medication error due to inappropriate route of vaccination.  It was not reported if any adverse event occurred or not.  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: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired Menactra vaccine/ No AE; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient of an unknown age who received 0.5 mL dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5948AB, expiry date- 03-Jul-2019 via intramuscular route in the arm nos.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  The patient has not reported any symptoms.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Hematoma following 30 seconds after injection. Ice pack and follow up if symptoms prolong. 8/5/19
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: administered the vaccine subcutaneously instead of intramuscularly; a 66-year-old female was administered Menactra; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 66-year-old female patient who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via subcutaneous route in unknown administration site on an unspecified date.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to inappropriate route of vaccination and Inappropriate age at vaccine administration. It was reported that they administered it subcutaneously instead of intramuscularly.  It was not reported whether the patient had any adverse event or not.  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.  Information on the batch number was requested  List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: child was administered ActHIB using sterile water instead of the diluent; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Child patient (age and gender unknown) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history, concomitant medication and family history were not provided.   On 24-Jul-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was an actual medication error due to wrong solution used in drug reconstitution.  It was reported that child was administered ActHIB using sterile water instead of the diluent.  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 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.  Information on batch number was requested for this case
Sex: U
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; headache; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old patient (gender not reported) who experienced dizziness and headache, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB via unknown route in unknown administration site.  On an unknown date, the patient developed dizziness and headache following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of lab data not reported.  Final diagnosis was headache and dizziness.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: 13-year-old male patient received an expired Menactra/No AE; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 13 years old male patient who received a 0.5ml booster dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot US835AB, expiry date: 27-Feb-2019 via intramuscular route in the right deltoid on 19-Jul-2019.  The patient also received a dose of HPV vaccine in his left deltoid during this visit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  No symptoms or treatment were 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. List of documents held by sender: none.  List of documents held by sender: none.