chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: I may have received a vaccination similar to this before; I may have received a vaccination similar to this before; No adverse effect reported; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reactions were not provided. On an unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and on 02-OCT-2019, the patient vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient stated that "she might had received a vaccination similar to that before" (circumstance or information capable of leading to medication error and inappropriate schedule of product administration). No adverse effects reported. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event, Product confusion
Clinical narrative: No adverse effects; accidenlally given a third dose or VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 12-NOV-2019 the patient was accidentally vaccinated with third dose of hepatitis a vaccine, inactivated (VAQTA) vial (25/0.5 unit not specified) via intramuscular route for prophylaxis (dose, lot # and expiry date were not reported) (extra dose administered). It was confirmed that, the dose was not given due to product confusion. The patient did not experience any adverse effects. Product quality complaint was not involved.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient received improperly stored ROTATEQ; This spontaneous report was received from a medical assistant refers to a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, drug reactions/allergies and concomitant medications were not reported. On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S005874 and expiration date 31-OCT-2020 (strength, dose and route not reported) for prophylaxis (product storage error). The storage temperature of vaccine included 33.8 Fahrenheit (F) for the time frame of 4 hours and 5 minutes. There was no previous temperature excursion. The call was made because of data logger. No adverse effects reported. No product quality complaint (PQC) present.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: NO adverse effect; imrpoerly stored vaccine administered; This spontaneous report as received from a medical assistant refers to a 11-week-old patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # S005874, expiry date:31-OCT-2020, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (product storage error).  It was reported that the vaccine was exposed to a temperature of 33.8 fahrenheit for a time frame of 4 hours and 5 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report. No adverse effects reported. No additional information. The outcome of product storage error and no adverse event was unknown.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; no adverse effect; This spontaneous report was received from a medical assistant refers to a 4 months old patient of unknown gender.    The patient's medical history, concurrent conditions and concomitant medications were unknown. On 11-NOV-2019, the patient was vaccinated with improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (therapy type: digital data logger) (lot # S005874 exp.date: 31-OCT-2020) for prophylaxis. The vaccine was under went at a temperature of 33.8 Fahrenheit for a time frame of 4 hours and 5 minutes. There is no previous temperature excursion. No adverse events were reported. No product quality compliant was reported.  The outcome of product storage error and no adverse event was unknown.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; received improperly stored ROTATEQ; This spontaneous report as received from a medical assistant refers to a 6 month old Infant. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 12-NOV-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # S005874, expiry date : 31-OCT-2020) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of 33.8 Fahrenheit for 4 hours and 5 minutes (product storage error). There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Sex: U
Vaccine: RV5
Symptoms: Combined immunodeficiency, Rotavirus infection, Rotavirus test positive, Stem cell transplant
Clinical narrative: This triggered the diagnosis of severe combined immunodeficiency; two cases of infants who were vaccinated with RotaTeq and subsequently developed strain rotavirus (identified by CDC lab); This spontaneous report was received from a physician referring to a pediatric patient (infant) of unknown age and gender. The patients' concurrent conditions, medical history, concomitant therapies and drug allergies or reactions were not reported. On an unspecified date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, lot number and expiration date were not reported) route: defaulted to oral for prophylaxis. Subsequently, the patient developed vaccine strain rotavirus (identified by centers for disease control and prevention (CDC) lab). This triggered the diagnosis of severe combined immunodeficiency, and the patient was subsequently treated with stem cell transplants. Post-transplant, the patient continued to have rotavirus (detected by routine lab, presumed to be persistent vaccine strain) and received additional experimental treatment in attempt to clear rotavirus. The outcome of the events was unknown. The causality between severe combined immunodeficiency and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported. The reporter considered that rotavirus infection to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  Upon internal review, severe combined immunodeficiency syndrome was determined to be medically significant.  As of 12-NOV-2019, all telephone attempts to obtain follow-up information have been unsuccessful.  This is one of the two reports received from the same reporter (2 valid linked cases, identified as 2 pediatric patients).; Sender's Comments:  US-009507513-1908USA004390:
Sex: F
Vaccine: HEPA
Symptoms: Injection site irritation
Clinical narrative: possible irritation at the injection site; VAQTA that was adrninistered Subcutaneous as opposed to Intramuscular; This spontaneous report as received from a pharmacist refers to a 23 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 08-NOV-2019, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated(VAQTA) Intramuscular Injection, at a dose of 0.5 milliliter once, subcutaneously (Lot # and expiry date was not reported) for prophylaxis (incorrect route of product administration). The pharmacist reported that the patient may have experienced "possible irritation at the injection site" (injection site irritation). The outcome of injection site irritation was unknown (it was reported as "no harm"). The relatedness between the event and the suspect therapy was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; was administered an improperly stored dose of PROQUAD; Information has been received from a nurse referring to an unknown gender patient of unknown age. The patient's historical condition and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.  On 12-NOV-2019, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(lot # S012470, expiration date:20-OCT-2020, dose, frequency and route were not reported) for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) experienced a temperature excursion at  -9°C to 8°C (0.9C) for 6 hours and 1 min; No previous temperature excursions. The temperature excursions were detected by a data logger. (Product storage error). No adverse effects were reported.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Fatigue
Clinical narrative: Tiredness; Chills; Stayed in bed a day; This case was reported by a consumer and described the occurrence of tiredness in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced tiredness, chills and bedridden. On an unknown date, the outcome of the tiredness, chills and bedridden were unknown.   It was unknown if the reporter considered the tiredness, chills and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix few months ago and had tiredness for reaction and had some chills and stayed in bed a day. The patient asked should 1 get a second shot and how far apart can I get the 2nd shot without having to start again. The patient asked should 2nd dose be administered between 2-6 months following the 1st dose. The reporter not able to provide an answer to that questions.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Left arm is sore; This case was reported by a consumer and described the occurrence of pain in arm in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and asked could I exercise. The reported stated that there are no contraindications to exercising after receiving the Shingrix vaccine. The patient stated that even though the patient left arm was sore at the time of reporting, and can work out with arm weights. The reporter stated they did not had any contraindications to exercise as I said but it was always good to check with your healthcare provider as we are unable to give medical advice
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Irritability
Clinical narrative: couldn't sleep; head feels bad; irritable; sluggish and slow; hand feels weak; pain; muscle pain; dragging and tired; She felt like she was moving in slow motion all day/she did not usually feel like this; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received Shingrix. On 4th November 2019, less than a day after receiving Shingrix, the patient experienced sleeplessness. In November 2019, the patient experienced headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness. On an unknown date, the outcome of the sleeplessness, headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness were unknown.   It was unknown if the reporter considered the sleeplessness, headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she could not sleep last night. Her head on the left side was not feeling that bad anymore but she received the vaccination on her left side. She was very irritable, sluggish and slow. She felt like she was moving in slow motion all day. Her entire left arm and hand feels weak to the bottom of her arm pit and was bothering her. She has pain, muscle pain and feels like she was dragging and tired. She was always on the go so she did not usually feel like this.  The reporter did not consent to follow up. The patient refused to provide any additional information and hung up.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Pain, Sluggishness
Clinical narrative: couldn't sleep; head feels bad; irritable; sluggish and slow; hand feels weak; pain; muscle pain; dragging and tired; She felt like she was moving in slow motion all day/she did not usually feel like this; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received Shingrix. On 4th November 2019, less than a day after receiving Shingrix, the patient experienced sleeplessness. In November 2019, the patient experienced headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness. On an unknown date, the outcome of the sleeplessness, headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness were unknown.   It was unknown if the reporter considered the sleeplessness, headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she could not sleep last night. Her head on the left side was not feeling that bad anymore but she received the vaccination on her left side. She was very irritable, sluggish and slow. She felt like she was moving in slow motion all day. Her entire left arm and hand feels weak to the bottom of her arm pit and was bothering her. She has pain, muscle pain and feels like she was dragging and tired. She was always on the go so she did not usually feel like this.  The reporter did not consent to follow up. The patient refused to provide any additional information and hung up.
Sex: M
Vaccine: HEP, HEP, HEP, HEP, HIBV, HIBV
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Male patient was tested and found to have no hepatitis B antibodies, despite having a full vaccination series of Hepatitis B as a child; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis and Hib UNK (Hib vaccine) for prophylaxis.   The patient's past medical history included crohn's disease.   On 8th May 2002, the patient received the 1st dose of Hepatitis B vaccine. On 30th July 2002, the patient received the 2nd dose of Hepatitis B vaccine. On 27th September 2002, the patient received the 3rd dose of Hepatitis B vaccine. On 22nd May 2003, the patient received the 4th dose of Hepatitis B vaccine. On an unknown date, the patient received Hib vaccine at an unknown dose and Hib vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hib vaccine and Hib vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hib vaccine and Hib vaccine.      Lab Comments: lab test done on an unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had sore arms.  No other details were provided. This case linked with US2019AMR206161, US2019AMR206160 and US2019205719, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: Vaccine supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, an unknown time after receiving Shingrix, the patient experienced product supply issue. The action taken with Shingrix was unknown. On an unknown date, the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the product supply issue to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable. A Pharmacist stated that most of the patients who received the first dose of Shingrix are now outside of the six month time-frame due to supply. The reporter consented to follow up. The reporter declined to give the number of patients at the time of the call.  No specific patient data given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: flu-like symptoms; body aches and pains; fatigue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix (intramuscular). On 1st November 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and fatigue. On an unknown date, the outcome of the influenza-like symptoms, general body pain and fatigue were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient experienced influenza-like symptoms, general body pain and fatigue. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Swelling; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (received 1st dose on an unknown date and experienced severe pain).   On 12th November 2019, the patient received the 2nd dose of Shingrix. On 12th November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and swelling at the injection site after vaccination. The patient also reported similar but more severe reaction following first dose at an undisclosed date or time frame. The reporter declined to provide further demographic information. There is a discrepancy with respect to the primary reporter type, whether the primary reporter is a pharmacist or a consumer, the clarification was raised to confirm the type, however no clear information available for the same hence the clarification has been raised to seek more information regarding that the primary reporter type.
Sex: M
Vaccine: VARZOS
Symptoms: Keratitis, Musculoskeletal pain
Clinical narrative: cornea inflammation; shoulder pain that was strong and bad; This case was reported by a consumer via call center representative and described the occurrence of corneal inflammation in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced corneal inflammation and shoulder pain. On an unknown date, the outcome of the corneal inflammation was unknown and the outcome of the shoulder pain was recovered/resolved.   The reporter considered the corneal inflammation to be related to Shingrix. It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had pain for one week in his shoulder that was strong and bad after vaccination. The patient also reported that his physician recommended that he have surgery for his cornea inflammation around his eyes. The patient did not consent to follow up.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: patient had a small deltoid surface area and was given the subcutaneous injection in the posterior aspect of the upper arm, no AE.; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient was received IPV (VERO) [IPOL] vaccine lot P1A251M, expiry date: 02-May-2020, via subcutaneous route in the posterior upper right arm instead of deltoid surface area on 03-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) in the left deltoid for Immunisation; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) in the right deltoid for Immunisation.  It was an actual medication error case due to Vaccine administered at inappropriate site .  No adverse event reported at the time of reporting.  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.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product prescribing error
Clinical narrative: Per pt request (due to previous reactions), a split dose was ordered at 1 week apart, no ae; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a patient (age and gender not reported) for whom a split dose was ordered at 1 week apart, (PT: Product prescribing error), for 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. Note: the patient had previous reactions.  Concomitant treatment was not reported.  This case involves actual medication error due product prescribing error. It was reported that a split dose was ordered at 1 week apart, no ae (PT: Product prescribing error). It was not reported if the vaccine was administered or not.  At the time of reporting, the patient had no adverse event  Action taken was not applicable.  Outcome was not applicable.  Information about batch no requested.  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.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pain from the heel to the groin; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a Other Health Professional.  This case involves male patient who experienced pain from the heel to the groin (PT: Pain in extremity), while he received vaccine influenza usp trival a-b high dose subvirion vaccine (fluzone high dose).  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient was treated with gemcitabine (gemcitabine) and carboplatin (carboplatin).  On an unknown date, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine lot number UJ242AA and expiry 15-May-2020 via intramuscular route in the upper arm.  On an unknown date, the patient developed a non-serious pain from the heel to the groin (PT: Pain in extremity), following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Other relevant tests included no lab data.  Action taken was not applicable with respect to event.  Corrective treatment was provided.  At the time of reporting, event outcome was unknown.  No further relevant information was reported.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: headache; mild fever; nausea; chills; body aches; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 26 years old male patient who experienced headache (headache), mild fever (pyrexia), nausea (nausea), chills (chills) and body aches (pain), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. There were no concomitant treatments.   On 08-Oct-2019, the patient received dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Injection lot number not reported via unknown route in unknown administration site.  On 09-Oct-2019, patient developed a non-serious mild headache (headache), fever (pyrexia), nausea (nausea), chills (chills) and body aches (pain) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 09-Oct-2019, patient outcome for events body aches, chills, nausea, mild fever and headache reported as recovered.   No lab data was reported.  Final diagnosis was body aches, chills, nausea, mild fever and headache.   It was not reported if the patient received a corrective treatment.  Information on the batch number was requested.
Age: 8.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an eight year old patient received Flublok Quadrivalent with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an eight year old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot, expiry date: unknown via unknown route on 10-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the vaccine administered to patient of inappropriate age.  It was not reported whether the patient experienced 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 batch number requested
Sex: F
Vaccine: FLU4
Symptoms: Dark circles under eyes, Hypoacusis, Ocular hyperaemia, Peripheral swelling, Swelling face
Clinical narrative: right side of face affected as well as her hearing; right eye redness; dark under the right eye; vision in right eye impaired; right side of face affected as well as her hearing; extensive swelling of right arm; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional  This case involves a female patient of an unknown age who experienced extensive swelling of right arm, (PT Peripheral swelling), right side of face affected as well as her hearing (PT Swelling face), right side of face affected as well as her hearing (PT hypoacusis), right eye redness (PT Ocular hyperaemia), dark under the right eye (PT Dark circles under eyes) and vision in right eye impaired (PT Visual impairment), while she was immunized with influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2019, the patient was immunized with influenza quadrival a-b vaccine at a dose of 0.5 ml (batch number unknown).  On an unknown date, latency unknown, it was reported that there was extensive swelling of right arm, right side of face affected as well as her hearing, right eye redness, dark under the right eye, and vision in right eye impaired.  Action taken was not applicable.   It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of events were not resolved.  Batch number was requested.  No further information was reported.
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: right side of face affected as well as her hearing; right eye redness; dark under the right eye; vision in right eye impaired; right side of face affected as well as her hearing; extensive swelling of right arm; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional  This case involves a female patient of an unknown age who experienced extensive swelling of right arm, (PT Peripheral swelling), right side of face affected as well as her hearing (PT Swelling face), right side of face affected as well as her hearing (PT hypoacusis), right eye redness (PT Ocular hyperaemia), dark under the right eye (PT Dark circles under eyes) and vision in right eye impaired (PT Visual impairment), while she was immunized with influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2019, the patient was immunized with influenza quadrival a-b vaccine at a dose of 0.5 ml (batch number unknown).  On an unknown date, latency unknown, it was reported that there was extensive swelling of right arm, right side of face affected as well as her hearing, right eye redness, dark under the right eye, and vision in right eye impaired.  Action taken was not applicable.   It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of events were not resolved.  Batch number was requested.  No further information was reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone high dose vaccine that was given to a 60 years old patient, no AE; Fluzone high dose vaccine that was given to a 60 years old patient, no AE; Initial information received on 21-Oct -2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 60 years old female  patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: uj288aa, expiry date: 02-Jun-2020) via intramuscular route in the left  arm on 21-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration and overdose.   At the time of reporting, the patient had no 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.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 55 year old female was administered Fluzone High Dose, no adverse event; 55 year old female was administered Fluzone High Dose, no adverse event; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 years old female patient who was vaccinated with a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ285AA, expiry date: 02-Jun-2020), via unknown route in the right arm, on 21-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose.   At the time of reporting, the patient had no 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.
Age: 20.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High-Dose which was given to a 20 year old /no AE; patient who was 20 years old was given Fluzone High-Dose/no AE; Initial information received on 22-OCT-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 20 years old patient who received unknown dose of vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], via unknown route, on unknown date (Batch number not reported).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Inappropriate age at vaccine administration. Fluzone High-Dose which was given to a 20 year old/no AE.  At the time of reporting, the patient had no 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.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 48 year old received Fluzone HD/ no AE; 48 year old received Fluzone HD/ no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a Other Health Professional.  Linked case Number: 2019SA295850, 2019SA295848, 2019SA295846, 2019SA295847, 2019SA295849 and 2019SA295851 (same reporter).  This case involves a 48 year old male patient who received a 0.5 ml dose of vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] (lot: UJ2858A, expiry date: 02-Jun-2020), via intramuscular route in the left arm on 21-Oct-2019.  The patients past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration and overdose.   At the time of reporting, the patient had no 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.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 36 year old patient received Fluzone High Dose, no AE; 36 year old patient received Fluzone High Dose, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health care professional.  Linked case Number: 2019SA295789, 2019SA295846, 2019SA295848, 2019SA295849, 2019SA295850, 2019SA295851 (same reporter).  This case involves a 36 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Prefilled Syringe (lot: UJ285AA, expiry date: 02-Jun-2020), via intramuscular route in the left arm accidentally, on 21-Oct-2019  The patient's past medical history, medical treatments, vaccinations and family history were not provided. Pregnancy test was given- to the patient and was found to be Negative.   It was an actual medication error due to product administered to patient of inappropriate age and overdose.   At the time of reporting, the patient had no 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.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patient received a dose of Flublok / no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a non health care professional (office staff).  This case involves a 16 years old male patient who received vaccine of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QJAA1911, expiry date: 27-Jun-2020 via intramuscular route in the right deltoid, on 11-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had no 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.
Age: 8.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an 8 year old patient recieve a dose of Flublok / no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a non health care professional.  This case involves an eight years old female patient who received vaccine of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QJAA1911, expiry date: 27-Jun-2020 via intramuscular route in the right arm, on 11-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Inappropriate age at vaccine administration.  It was not reported 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.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was accidentally administered to a patient 15 years of age, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Nurse on 29-Oct-2019.  This case involves a 15 years old patient (unknown gender) for whom it was reported that Flublok (influenza quadrivalent recombinant vaccine [Flublok Qiv] (Batch No:Unknown, Expiration date: Unknown)  was accidentally administered to a patient 15 years of age (Inappropriate age at vaccine administration).  The patient s past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  Information on the batch number was requested.  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.
Age: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patiend received a dose of Flublok QIV / no AE; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist via Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304580, 2019SA304586, 2019SA304587, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced 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.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient was administered with Flublok with no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old female patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1931, expiry date: 30-Jun-2020 via intramuscular route in the left arm on 13-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had no 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.