chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received first dose of Covid Vaccine on 22Mar. Husband and daughter came down with Covid; Received first dose of Covid Vaccine on 22Mar. Husband and daughter came down with Covid; This is a spontaneous report from a contactable consumer (parent; mother) and a physician via a Pfizer-sponsored program. This consumer (mother) reported same events for two patients. This is the second of 2 reports.  A female patient (daughter) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, unknown lot number and expiration), via an unknown route of administration on 22Mar2021 at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother reported that the patient received first dose of COVID vaccine on 22Mar. Husband and daughter came down with COVID on unspecified date. Patient came down with COVID as she was in quarantine and will miss her second dose. As of 27Apr2021, it was confirmed that the husband (patient's father) and daughter tested positive for COVID. The patient underwent lab test and procedure which included: COVID-19 PCR test: positive on unspecified date.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: The event coded to Missed dose in error was deleted. Verbatim term "Received first dose of Covid Vaccine on 22Mar. Husband and daughter came down with Covid" was also coded to Drug ineffective and was upgraded to serious (medically significant). Case is now serious. New information received from a physician includes: course details.; Sender's Comments: Linked Report(s) : PFIZER INC-2021481080 Same reporter, product, event; different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Blood test, Burning sensation, Diarrhoea
Clinical narrative: burning between her belly button and breasts; sharp pain in her belly; arm felt like someone punched her; Severe Stomach Pain; stomach pain was unbelievable; So Much Diarrhea; Peeing out of her butt; This is a spontaneous report from a contactable nurse reporting for herself.    A 72-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Apr2021 11:30 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced severe stomach pain; stomach pain was unbelievable on 13Apr2021 with outcome of recovering , so much diarrhea; peeing out of her butt on 13Apr2021 with outcome of recovered on 17Apr2021 , sharp pain in her belly  on 14Apr2021 with outcome of recovering , burning between her belly button and breasts  on 15Apr2021 with outcome of recovered on 17Apr2021 , arm felt like someone punched her on 13Apr2021 with outcome of recovered on 15Apr2021.  The patient underwent lab tests and procedures which included blood test: unknown   on 26Apr2021. All the reported events were considered Important Medical Events.  Causality: Caller stated yes, it is related to the vaccine. Stated she doesnt get diarrhea. Stated she eats healthy and doesnt ever get diarrhea, well maybe once in a blue moon. Caller states she thinks it is totally related to the vaccine.  Follow up information has been requested. Lot number was already provided.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: burning between her belly button and breasts; sharp pain in her belly; arm felt like someone punched her; Severe Stomach Pain; stomach pain was unbelievable; So Much Diarrhea; Peeing out of her butt; This is a spontaneous report from a contactable nurse reporting for herself.    A 72-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Apr2021 11:30 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced severe stomach pain; stomach pain was unbelievable on 13Apr2021 with outcome of recovering , so much diarrhea; peeing out of her butt on 13Apr2021 with outcome of recovered on 17Apr2021 , sharp pain in her belly  on 14Apr2021 with outcome of recovering , burning between her belly button and breasts  on 15Apr2021 with outcome of recovered on 17Apr2021 , arm felt like someone punched her on 13Apr2021 with outcome of recovered on 15Apr2021.  The patient underwent lab tests and procedures which included blood test: unknown   on 26Apr2021. All the reported events were considered Important Medical Events.  Causality: Caller stated yes, it is related to the vaccine. Stated she doesnt get diarrhea. Stated she eats healthy and doesnt ever get diarrhea, well maybe once in a blue moon. Caller states she thinks it is totally related to the vaccine.  Follow up information has been requested. Lot number was already provided.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Left arm weakness; Unable to flex wrist or fingers; This is a spontaneous report from a contactable physician. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 71 years of age),  intramuscular, administered in arm left on 20Apr2021 (Batch/Lot Number: ER8731) as 1st dose, single for COVID-19 immunisation.  Medical history included anxiety, hyperlipidaemia, depression and hypertension, all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had not received any other vaccine within four weeks prior covid-19 vaccine. He had no covid-19 prior to vaccination. He had not been tested for covid-19 post vaccination. The patient was taking Legendz, Powerful enhanced energy, and Horny goat weed. On 21Apr2021, the patient experienced left arm weakness, unable to flex wrist or fingers. The events resulted to doctor or other healthcare professional office/clinic visit. The patient was admitted to the hospital for the events. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysarthria, Muscular weakness, Pyrexia, Transient ischaemic attack
Clinical narrative: slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability.  Information on lot/batch number was available. Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: flu; Based on information previously received, the following information [Delete Non-Valid classification and the justification product not otherwise specified (NOS) and Influenza Vaccine to be recoded] has been amended.  Initial and additional information regarding an unsolicited non-valid non-serious case received from a consumer (patient) from via social media on 12-Oct-2020 and 17-Oct-2020 respectively (both processed together).  This case is linked to case 2020SA289533(CLUSTER).  This case involves patient (unknown demographics) who experienced flu (influenza), while receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was also reported that Only had the flu one time. The year patient took the Flu shot.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event influenza was reported as unknown.   There will be no information available on the batch number for this case.  Follow-up information regarding an unsolicited non-valid non-serious case received from a consumer (patient) from via social media on 17-Oct-2020 transmitted to Sanofi on 17-Mar-2021.  Action taken changed unknown to not applicable. Corresponding field and narrative were updated accordingly.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Vaccine was reconstituted the hib with sterile water, instead of the diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00585910) and transmitted to Sanofi on 03-May-2021.  This case involves a two-month-old female patient who received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiry date: 29-Oct-2021) via an unknown route in the left thigh for prophylactic vaccination, which was reconstituted the hib part with sterile water, instead of the diluent on 03-May-2021 (product preparation issue).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  The reporter wanted to know that the revaccination should be needed or not.  This was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good 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: YF
Symptoms: Yellow fever
Clinical narrative: yellow fever; Initial information received on 03-May-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare Professional.  This case involves a adult patient (unspecified gender and age) who had yellow fever while receiving YELLOW FEVER VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious yellow fever (unknown latency) following the administration of YELLOW FEVER VACCINE. This event was assessed as medically significant.  Medication Details and reason for taking the medicine: prophylactic vaccination It is unknown if the patient had any medical history, concomitant disease or risk factor.  It was unknown if there were lab data/results available. causality not reported  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a patients (unspecified age and gender) who had yellow fever after vaccination with YELLOW FEVER VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Apr-2021 regarding an unsolicited valid non-serious case from other health professionals via Agency (inquiry number 00582945).  This case involves a patient with unknown demography who was administered with an expired 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number was not reported and expiry date: 19-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 20-Apr-2021.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   The reporter asked if it counts as a valid dose.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, 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 the Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: vaccine was mixed with a sterile diluent but not the one that comes with the vaccine, no AE; Initial information was received on 30-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional in.  This case involves a patient (demographics unknown) who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] mixed with a sterile diluent but not the one that came with the vaccine, (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Wrong diluent used (latency same day).  At the time of report, no adverse event was reported.  The caller stated that they administered a dose of Pentacel and that the vaccine was mixed with a sterile diluent but not the one that comes with the vaccine. She had questions about side effects and re-administering the vaccine. she would like to know when they can give another Pentacel dose since it is not considered a valid dose. She would like to know if they can give it as soon as possible or do they have to wait. She said they were planning on giving another Pentacel dose to the patient not until the week of the 10th. The Caller had questions about side effects and re-administering the vaccine. She was referred to the Pentacel Reconstitution Guide. She was asked for additional information for the adverse event (AE) report and she said that she does not know if she would give accurate information. She said she does not believe it was reconstituted the way that it should have been. This is all the information she provided at the time of her call.  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 Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 3.0
Sex: M
Vaccine: DTAP, FLUX, HIBV, IPV
Symptoms: Expired product administered, Medication error, Product storage error
Clinical narrative: patient received expired IPOL/ NO AE; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 months old male patient who received expired dose of 0.5 mL IPV (VERO) [IPOL] (strength: standard, frequency: once, batch number: R1B251M, expiry date: 13-Mar-2021 via subcutaneous route in left arm) (expired product administered) on 30-Apr-2021 for prophylactic vaccination  The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (HIBERIX); INFLUENZA VACCINE (INFLUENZA VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic Vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, 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 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: F
Vaccine: DTAPIPVHIB
Symptoms: Seizure
Clinical narrative: seizures; Initial information received on 04-May-2021 regarding an unsolicited valid serious case received from a consumer.  This case involves a 8 month old female patient who experienced seizure, while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Past vaccination included PENTACEL (October and January) with no problems.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, concomitant medication and family history were not provided.  On an unknown date (March), the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) (Suspension for injection) (Frequency once) via an intramuscular route in the leg for prophylactic vaccination.  On an unknown date, the patient developed a serious seizure (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  It was also reported that Caller is requesting information on ingredients of PENTACEL, and also asks if the ingredients change from lot to lot because his daughter received two PENTACEL vaccines with no problems, but the third one she received resulted in adverse event. He wonders if the third one had any different ingredients.   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.   Corrective treatment: anti-seizure medication.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a 8 month old female patient who had seizure, after receiving PENTACEL. The time to onset is unknown. Past vaccination included PENTACEL. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Underdose
Clinical narrative: Afluria Quad pediatric dose 0.25 mg administered to adult pregnant woman; Afluria Quad pediatric dose 0.25 mg administered to adult pregnant woman; This spontaneous case was received on 02-Sep-2020 from physician via agency (reference number SEQW20-01174) and concerned an adult, pregnant female patient.  The patient's medical history and concomitant medications were not reported.  The patient's last menstrual period and estimated due date were not provided.   On unknown date, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.25 ml, indication, route of administration, anatomical location: not reported) (explicitly coded as 'Underdose' and 'Vaccine exposure during pregnancy').   The batch number was not reported.   At the time of initial reporting on 02-Sep-2020, the patient had no adverse reactions since administration.  This case is linked to cases 202004294, 202004295 and 202004296 (due to the same reporters).  Company comment:Reportedly, Afluria Quad pediatric dose 0.25 mg was administered to adult pregnant woman (explicitly coded as 'Underdose' and 'Vaccine exposure during pregnancy'). No information about medical history and concomitant medications was provided. The patient had no adverse reactions since administration. Causality for the events of underdose and vaccine exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: Reportedly, Afluria Quad pediatric dose 0.25 mg was administered to adult pregnant woman (explicitly coded as Underdose' and Vaccine exposure during pregnancy'). No information about medical history and concomitant medications was provided. The patient had no adverse reactions since administration. Causality for the events of underdose and vaccine exposure during pregnancy is assessed as not related per company conventions.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Cough, Erythema of eyelid, Immediate post-injection reaction, Myalgia
Clinical narrative: Left eyelid swollen and red; Burning sensation; Left eyelid swollen and red; Dry cough; Uncomfortable feeling in body; Myalgia from shoulder to elbow; This case was received on 02-Sep-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-01159) and concerned a 59-year-old, female patient.  The patient's concurrent conditions included unspecified thyroid disorder and alpha gal allergy.  The patient's concomitant medications included levothyroxine for unreported indication.   On 31-Aug-2020, the patient was vaccinated with Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route od administration: intramuscular and anatomical location: not reported] for influenza prophylaxis. The batch number reported was 276533, the expiration date reported was 05-Jun-2021.  On the same day, immediate after receiving Flucelvax QIV, the patient developed myalgia from shoulder to elbow, uncomfortable feeling in body and burning sensation. Her left eyelid was swollen and red and she developed dry cough at night.  On an unspecified date in 2020, the patient was treated with Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting, on 02-Sep-2020, the patient was recovering. She was better that the previous day, but still was very red.  The reporter assessed the events to be related to Flucelvax QIV. The patient stated this is the first time she has a reaction to a flu shot.  Company comment: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: This is the first time she has a reaction to a flu shot.; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness over the entire shoulder; The injection site was hot; Injection site had swelling; This spontaneous case was received on 03-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01221) and concerned a 33-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   The patient received multiple vaccines of all types in the past, and no adverse events were reported.  On 27-Aug-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mg (as reported), route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279827 and expiry date was 18-Jun-2021.   On 28-Aug-2020, 24 hours after receiving Flucelvax QIV, the patient's injection site had swelling. The patient experienced redness over the entire shoulder and the injection site was hot.   The patient was treated with Medrol Dosepak (methylprednisolone).   On an unspecified date in Aug-2020, the patient recovered from the events.  The reporter assessed the events to be related to Flucelvax QIV.  The reporter assessed the events as non-serious.  Company comment: The patient developed erythema, vaccination site warmth and vaccination site swelling one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed erythema, vaccination site warmth and vaccination site swelling one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: M
Vaccine: FLUC4
Symptoms: Haematoma, Haemorrhage, Injection site haemorrhage
Clinical narrative: A small hematoma; A small drop of blood was noted when the needle was withdrawn; This spontaneous case was received on 05-Sep-2020 from pharmacist via agency (reference number: SEQW20-01289) and concerned a male patient of an unspecified age.  The patient's medical history was not reported. The patient's concomitant medication included unspecified anticoagulant for unreported indication.  On 05-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 276531 and expiry date was 02-Jun-2021.  On the same day, when the needle was withdrawn after receiving Flucelvax Quadrivalent, a small drop of blood was noted, and a band aid was placed on the site. The patient left.  On the same day, about 10 minutes later, the patient returned with a small hematoma and in questioning if the vaccine was administered subcutaneously. The pharmacist used a 25-gauge (G) 1-inch needle and felt the vaccine was injected intramuscularly. The patient did not receive any treatment measures associated with event.   At the time of initial reporting on 05-Sep-2020, the patient had not recovered from the event of hematoma.   The outcome of 'vaccination site bleeding' was not reported.   The reporter did not provide a causality assessment.  The reporter assessed events as non-serious.  Company comment: The patient developed hematoma and vaccination site hemorrhage on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to ''relate'' in the safety database for reporting purposes).; Sender's Comments: The patient developed hematoma and vaccination site hemorrhage on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: U
Vaccine: FLU4
Symptoms: Chills, Headache, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Pain; Stiffness; Swelling around shoulder joint; Unable to move left arm; Headache; Chills; Vaccine was given too high stating it was 1/4 inch below the shoulder bone; This spontaneous case, was received on 07-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01292) and concerned a patient of unknown age and gender.   The patient's medical history and concomitant medications were not reported.  On 06-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) for influenza prophylaxis. The patient reported the vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as 'Product administration error'). The batch number reported was P100227879, expiry date: 28-May-2021.  On the same day, after receiving Afluria Quadrivalent, the patient was unable to move left arm and had swelling around shoulder joint, pain, stiffness, headache and chills.  At the time of this report, the patient did not receive any treatment for the events.   At the time of initial reporting on 07-Sep-2020, the patient did not recover from the events.   The reporter did not provide causality assessment.    The reporter assessed the events as non-serious.  Company comment:The patient developed all events on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as 'Product administration error'). No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and the event of product administration error is assessed as not related per company conventions, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as Product administration error'). No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and the event of product administration error is assessed as not related per company conventions, while for all other events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: U
Vaccine: FLU4
Symptoms: Product administration error, Swelling
Clinical narrative: Pain; Stiffness; Swelling around shoulder joint; Unable to move left arm; Headache; Chills; Vaccine was given too high stating it was 1/4 inch below the shoulder bone; This spontaneous case, was received on 07-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01292) and concerned a patient of unknown age and gender.   The patient's medical history and concomitant medications were not reported.  On 06-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) for influenza prophylaxis. The patient reported the vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as 'Product administration error'). The batch number reported was P100227879, expiry date: 28-May-2021.  On the same day, after receiving Afluria Quadrivalent, the patient was unable to move left arm and had swelling around shoulder joint, pain, stiffness, headache and chills.  At the time of this report, the patient did not receive any treatment for the events.   At the time of initial reporting on 07-Sep-2020, the patient did not recover from the events.   The reporter did not provide causality assessment.    The reporter assessed the events as non-serious.  Company comment:The patient developed all events on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as 'Product administration error'). No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and the event of product administration error is assessed as not related per company conventions, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as Product administration error'). No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and the event of product administration error is assessed as not related per company conventions, while for all other events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Diarrhoea, Nausea
Clinical narrative: Confused; Diarrhea; Nausea; This spontaneous case was received on 14-Sep-2020 from other non-health care professional (consumer) to agency (reference number: SEQW20-01634) and concerned a 64-year-old, female patient.  The patient's concurrent conditions included hypothyroidism and high cholesterol. The patient's concomitant medications included levothyroxine and pravastatin both for an unreported indication.  On 13-Sep-2020 at 12 am, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml) for influenza prophylaxis. The batch number reported was P100251765 and expiry date was 30-Jun-2021.  On the same day at 7:00 pm, 5 hours after receiving Afluria Quadrivalent, the patient started to experience nausea and diarrhea.   On 14-Sep-2020, the pharmacist was called and confirmed the narrative above. The pharmacist reported that the patient seemed confused. At 2:00 am, the patient took one Tylenol (paracetamol) as treatment.  On the same day, the patient recovered from the event of nausea.  At the time of initial reporting on 14-Sep-2020, the patient had not recovered from the event of diarrhea.  The outcome of the event confused was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The patient developed confusional state, nausea and diarrhoea on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Considering above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed confusional state, nausea and diarrhoea on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Considering above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Golf ball size knot at the injection site; Pain and swelling at the injection site; Pain and swelling at the injection site; This spontaneous case was received on 14-Sep-2020 from other health professional via agency (reference number: SEQW20-01616) and concerned a female patient, of unreported age.   The patient's medical history and concomitant medications were not reported.  On 05-Sep-2020, the patient was vaccinated with Flucelvax QIV vaccine (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was 283847, expiration date reported was 20-Jun-2021.  On the same day, about an hour after receiving Flucelvax QIV, the patient developed pain and swelling at the injection site. Later, in the evening, she developed a golf ball size knot at the injection site. The patient was treated with ice packs to site and it helped to reduce the size of the knot to size of small boil which was still painful.   At the time of initial reporting, on 14-Sep-2020, the patient had not recovered from the event 'vaccination site pain', and was resolving from the event 'vaccination site lump' .  The outcome of event 'vaccination site swelling' was not reported.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.   The case is linked to 202004443 (same reporter).  Company comment: The patient developed vaccination site mass, vaccination site pain and vaccination site swelling on the same day after vaccination with the suspect product, Flucelvax QIV vaccine. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site mass, vaccination site pain and vaccination site swelling on the same day after vaccination with the suspect product, Flucelvax QIV vaccine. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: M
Vaccine: FLUC4
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: The injection site became swollen and painful; The injection site became swollen and painful; This spontaneous case was received on 14-Sep-2020 from other health professional via agency (reference number: SEQW20-01606) and concerned a male patient of unknown age.  The patient's medical history and concomitant medication were not reported.  On 05-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) for influenza prophylaxis. The batch number reported was 283847 and expiry date was 20-Jun-2021.  On the same day, about an hour after receiving Flucelvax Quadrivalent, the injection site became swollen and painful. The treatment included ice packs to the injection site and this helped with the pain and swelling.  At the time of initial reporting on 14-Sep-2020, the patient was recovering from the events 'vaccination site pain' and 'vaccination site swelling'. The reporter stated, the patient was better, but still not resolved completely.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to case 202004442  due to the same reporter.  Company comment: The events of 'vaccination site pain' and 'vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of vaccination site pain' and vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: The patient was vaccinated in right arm and that night the pain started; The patient rubbed her arm against something, and the pain came back; Barely lift arm due to pain; This spontaneous case was received on 14-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01618) with additional document received the same day from pharmacist (being processed together) and concerned a 64-year-old, female patient.  The patient's concurrent condition included arthritis in left shoulder diagnosed several years ago. The patient was always getting pain after unspecified vaccines in the past which would go away after 2 days. The patient reported that the pain was in muscle.   On 03-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, anatomical location: right arm, route of administration and dose: not reported) for influenza prophylaxis. The batch number reported was P100242856 and expiry date was 20-Jun-2021.  On the same day, that night after receiving Afluria Quadrivalent, the patient started experiencing pain in right arm.   On 05-Sep-2020, the pain went away.   On an unspecified date in Sep-2020, the patient rubbed her arm against something, and the pain came back. The patient could barely lift her arm due to pain that was off and on. The patient connected this pain with the past pain from vaccines.  At the time of this report, no treatment was used. The patient was still sore form the vaccine.  At the time of initial reporting on 14-Sep-2020, the patient had not recovered form events.   The reporter assessed all events as related to Afluria Quadrivalent vaccine.   The case was assessed as non-serious.  Company comment: The patient developed pain in extremity on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, on an unspecified date within same month, the patient rubbed her arm against something and the event of pain in extremity reoccurred, along with injected limb mobility decreased. No alternative aetilogy was provided. Considering all above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: The patient stated that she was still sore from the vaccine.; Sender's Comments: The patient developed pain in extremity on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, on an unspecified date within same month, the patient rubbed her arm against something and the event of pain in extremity reoccurred, along with injected limb mobility decreased. No alternative aetilogy was provided. Considering all above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).