chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Foot fracture, Infection, Swelling
Clinical narrative: swelling; infection; fractured left foot; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  This 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fractured left foot (medically significant) on 11Apr2021 with outcome of recovering, swelling on an unspecified date with outcome of recovering, infection on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the events included 500mg prior to second shot. She asked can she get the second dose on 29Apr2021 since she has an injury for fractured leg, swelling and infection. Is taking Naproxen for it. The patient stated that the swelling has gone down. Has been Naproxen taking it for 14 days and tomorrow will be the 15 day. Stated that she will go to the doctor and is not sure if she will get another prescription for it. Stated that the pills are for pain, swelling and potential infection. Clarified that it is for her fractured left foot. Stated that it is a closed fracture.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Throat irritation
Clinical narrative: itching in my throat and then I started scratching after that; started having the bruises like very dark red bruises after I scratch up my throat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 (Lot Number: ER8729) as 1st dose, single in left arm for COVID-19 immunisation. There were no medical history and no concomitant medications. The patient had a vaccine on 12Apr2021 after one week on 18Apr2021 he started having side effect of like itching in his throat and then he started scratching after that. Then the itching was better but however he started having the bruises like very dark red bruises on an unspecified date in Apr2021 after he scratch up his throat. So he didn't know what's that if the concern because the patient had read in heard lot about bruises and hemorrhage maybe bleeding. So he didn't know if something is the concern. The patient needed to do a testing because he had another appointment for the second shot on 03May2021. There was no treatment for the events. The outcome of event itching in my throat and then I started scratching after that was recovering, and of the other event was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ruptured cerebral aneurysm
Clinical narrative: Ruptured Brain aneurysm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in the right arm, on 07Apr2021 10:00, as 2nd dose, single, for COVID-19 immunisation, at a hospital. The patient medical history was not reported. The patient was not pregnant at the time of vaccination and has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) received at age 69 years, administered in the right arm, on 05Mar2021 10:00, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 20Apr2021 at 11:00, the patient experienced ruptured brain aneurysm. This resulted to physician's office and emergency room visits, hospitalization for 14 days (dates not reported), and disability or permanent damage. The event was reported as a life-threatening illness (immediate risk of death from the event). Treatment included surgery. The outcome of the event was not resolved.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died 3 weeks later after getting the vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse  reported that a patient (unknown age and gender) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient died 3 weeks later after getting the vaccine.  It was unknown if autopsy was performed or not.; Sender's Comments: The causal relationship between BNT162B2 and the fatal event cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died 3 weeks later after getting the vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Ear pain, Ear, nose and throat examination
Clinical narrative: ear pain in left ear; Pain worsened over 6 weeks; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular, administered in left arm on 11Jan2021 (at age of 25 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine, also not received other medications within 2 weeks of vaccination. The patient not diagnosed with COVID-19 prior to vaccination also not tested for COVID-19 since the vaccination. The patient experienced ear pain in left ear and pain worsened over 6 weeks on 11Jan2021 after 1st vaccine.  Have been seen by ENT. The events result Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events was serious, seriousness criteria is Life threatening. The outcome of the events was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events "ear and pain worsened over 6 weeks" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Computerised tomogram, Facial paralysis, Magnetic resonance imaging, Salivary gland neoplasm
Clinical narrative: Parotid tumor; Left sided Facial droop; This is a spontaneous report received from a contactable other HCP (patient). A 25-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 01Feb2021 (at 25 years old, not pregnant) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had her first dose of bnt162b2 vaccine on 11Jan2021 on left arm, intramuscular at 25years old for Covid-19 immunization and experienced ear pain. On 18Feb2021, 17 days after second dose, patient experienced left sided Facial droop. Have been seen by ENT and had MRI and CT done along with Biopsy of what appeared to be a parotid tumor however may not be a tumor and further testing will be done. Treatment was given for the events. The outcome of the events was not recovered. The events was assessed as life-threatening. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: myopericarditis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 28Apr2021 at 13:00 (at 21 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. No other medical history and no known allergies. The patient not had Covid prior vaccination. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 07Apr2021 at 13:00 (at 21 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's concomitant medications were not reported. The patient was ended up in the hospital with myopericarditis on 02May2021 at 06:45AM. Patient was a health 21 years old who had no heart problems before. Also had no heart problems in the family. The event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalized 1 day. Prescribed colchicine and metoprolol for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 02May2021. The outcome of the event was recovering.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient got infected with covid; patient got infected with covid; This is spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified dates (Batch/Lot number was not reported) at 1st dose, single and 2nd dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. While visiting abroad, patient got infected with covid and died on an unspecified date. Apparently, the patient received two Pfizer vaccines shots prior to his travel. It was unknown if an autopsy was performed.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: patient got infected with covid
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: I had a very early miscarriage; This is a spontaneous report from a contactable consumer reporting for herself.  This pregnant female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date after the first vaccine shot the patient had a very early miscarriage. The outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administered on 14Apr2021, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Covid 19 Vaccine on 14Apr2021, then tested positive for the Covid 19 Virus on 21Apr2021. Her Second dose of the Covid 19 Vaccine is scheduled for 05May2021. Patient asks what happens next, if she still had her second dose or what. The outcome of the event was unknown.  Information about Lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She was exposed to a Covid positive patient and she tested positive for Covid-19; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history included ongoing exposure to COVID. Concomitant medications were not reported. The patient called in to know why one would be tested positive after getting the vaccine. Patient was exposed to a Covid positive patient and she tested positive for Covid-19 (in 2021). She got her first dose last 27Apr2021 and scheduled to have her second dose on 18May2021. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, Product administered to patient of inappropriate age
Clinical narrative: Patient received expired Tenivac vaccine with no AE; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case from physician.  This case involves a 7-year-old male patient who received expired 0.5 mL dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6265AA, expiry date: not reported] via an intramuscular route in the right arm for prophylactic vaccination on 20-Apr-2021 [expired product administered].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL); HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B); and HEPATITIS A VACCINE INACT (HAVRIX).  It was also a case of actual mediation error due to expired vaccine used administered (latency: on the same day).  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 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: 35.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 35 year old patient received IPOL/no AE; received intradermal, 0.1ml IPOL instead of Tubersol by mistake with no AE; Initial information received on 28-Apr-2021 and additional information was received on 29-Apr-2021, regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2021SA148354 and 2021SA148624 (same reporter).  This case involves a 35-year-old female patient who received intradermal 0.1 ml dose of IPV (VERO) [IPOL] (in the left forearm, lot R1F801M, expiry date-28-Sep-2021) by mistake instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test on 19-Apr-2021 (product administered to patient of inappropriate age) and (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (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 the 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: 3.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: patient received QUADRACEL vaccine who was 3 year old having 9 days short of turning 4 years old/ NO AE; Initial information received on 30-Apr-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional (administrative assistant of a physician's office) via email through sales representative.  This case involves a 3 year old patient who was 9 days short of turning 4 year old (unknown gender) who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number and expiry date not reported) before 4-year of age (product administered to patient of inappropriate age) on 06-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  Reporter would that vaccine need to be repeated.  At the time of reporting, no adverse event was reported.  No additional information was provided.  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 by Regulatory Authority. 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: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Maternal exposure before pregnancy
Clinical narrative: Injection site soreness; Maternal exposure during pregnancy - 21 weeks, 2 days gestation at time of injection; This prospective spontaneous pregnancy case received on 23-Sep-2020 from other non-health professional (consumer) with additional information received on the same day (being processed together) and concerned a 34-year-old female patient.  The patient's medical history was not reported. The patient's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) and Vitamin D 5000 IU (colecalciferol), both used for unreported indications.  The patient's obstetrical history included one previous pregnancy with abortion at eight weeks in 2007. Th patient had no family history of major congenital malformation (MCM). The patient's last menstrual period (LMP) date was 16-Apr-2020 and estimated delivery date (EDD) was 21-Jan-2021.  On 19-Sep-2020, at gestational age of 21 weeks and two days, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, indication: not reported) (explicitly coded as vaccine exposure during pregnancy'). The batch number was 276547 and expiry date was 27-Jun-2021.   On 20-Sep-2020, one day after receiving Flucelvax QIV, the patient experienced mild injection site soreness.  On 22-Sep-2020, the patient recovered from event of 'vaccination site pain'.  Additional information received on 13-Oct-2020 from other non-health professional (consumer): Patient's LMP and EDD provided. Patient's obstetrical history provided. It was confirmed that the patient had no family history of MCM. Route of administration, anatomical location, batch number and expiration date of Flucelvax QIV provided. Two concomitant medications added. Event 'vaccination site pain' added. Case outcome updated from 'not reported' to 'resolved'. Narrative amended accordingly.  Company comment: The event of 'vaccination site pain' is assessed as related, while the event of 'vaccine exposure during pregnancy' is assessed as not related to Flucelvax QIV.; Sender's Comments: The event of 'vaccination site pain' is assessed as related, while the event of 'vaccine exposure during pregnancy' is assessed as not related to Flucelvax QIV.
Sex: U
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: Flucelvax Quadrivalent dose administered to a patient with the expiration date 30-Jun-2020; This spontaneous case was received on 30-Sep-2020 from a health care professionl via Health Authority (reference number: SEQW20-02634) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unreported date, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported, expiry date: 30-Jun-2020.(explicitly coded as 'Expired vaccine used')  At the time of initial reporting on 30-Sep-2020, it was not reported if the patient experienced any adverse event after Flucelvax QIV administration.  The reporter assessed the case as non-serious.  Company comment: The patient was vaccinated with Flucelvax QIV. Reportedly, vaccine expiry date was 30-Jun-2020.    (explicitly coded as 'Expired vaccine used') . It was not reported if the patient experienced any adverse event after Flucelvax QIV administration. Causality is assessed as not related per company's conventions.; Sender's Comments: The patient was vaccinated with Flucelvax QIV. Reportedly, vaccine expiry date was 30-Jun-2020.    (explicitly coded as 'Expired vaccine used') . It was not reported if the patient experienced any adverse event after Flucelvax QIV administration. Causality is assessed as not related per company's conventions.
Sex: U
Vaccine: FLUC4
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   The outcome of events was not reported.   The reporter did not provide a causality assessment.  This case is linked to 202004882, 202004883, 202004884 and 202004885 (the same reporter).  Company comment:The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for 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 warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscular weakness, Neck pain, Pain, Pain in extremity
Clinical narrative: Extreme pain radiating to her neck; Extreme pain radiating to her neck; Left arm weakness and pain; Left arm weakness and pain; This spontaneous case was received on 01-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-02728) and concerned a 42-year-old, female patient.  The patient had no relevant medical history and was not taking concomitant medications.  On 31-Aug-2020, the patient was vaccinated with Flucelvax QIV (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 279827, expiry date: 18-Jun-2021.   On the same day, two hours after receiving Flucelvax QIV, the patient developed left arm weakness and pain.   On 01-Sep-2020, within 24 hours, the patient experienced extreme pain radiating to her neck.   On 03-Sep-2020, the patient came to pharmacy and it was noted there was no redness, swelling or sign of infection at the injection site and the site appeared to be fine.   On an unspecified date in 2020, at a later time (as reported), she was seen at an Urgent Care and given a high dose of steroids and Advil (ibuprofen).   On an unspecified date in 2020, all cleared up and the patient recovered from left arm pain, 'neck pain' and 'radiating pain', except the weakness in left arm.    At the time of initial reporting on 01-Oct-2020, the patient had not recovered from weakness in left arm.   The reporter did not provide a causality assessment.  The reporter did not provide a seriousness assessment.  Company comment: The patient developed pain in extremity, muscular weakness, pain and neck pain within one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain in extremity, muscular weakness, pain and neck pain within one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: The site of injection is a little bit red; HCP administered Flucelvax Quad PFS in the fat and not in the muscle; This spontaneous case was received on 01-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-02713) and concerned a 59-year old female patient.  The patient's concurrent conditions included diabetes type 2, hypertension, hypercholesterol, thyroid disease and mild asthma. The patient's concomitant medications included lisinopril, Lipitor (atorvastatin calcium), Januvia (sitagliptin phosphate), metformin, Baby aspirin (acetylsalicylic acid), Synthroid (levothyroxine sodium), calcium, vitamin D (colecalciferol) and insulin pump, all used for unreported indications.  On 01-Oct-2020 the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: reported as 'in the fat') for influenza prophylaxis. The batch number reported was 276554 and expiry date was 30-Jun-2021. HCP (helth care professional) administered Flucelvax Quad PFS in the fat and not in the muscle (explicitly coded as 'inappropriate route of vaccination'). The HCP pinched the skin so the fat could stick out of the arm and injected the syringe.  On the same day, after receiving Flucelvax QIV, the site of injection was a little bit red.   The outcome of 'vaccination site erythema' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: The event of 'vaccination site erythema' is assessed as related, while the event of 'inappropriate route of vaccination' is assessed as not related to Flucelvax QIV.; Sender's Comments: The event of 'vaccination site erythema' is assessed as related, while the event of 'inappropriate route of vaccination' is assessed as not related to Flucelvax QIV.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Strange skin reaction; Looked like red thread from the injection site and down to his elbow/ like a straight line; This spontaneous case was received on 02-Oct-2020 from a pharmacist via Health Authority (reference number: SEQW20-02779) and concerned a 56-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On 01-Oct-2020, the patient was vaccinated with Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml; route of administration: intramuscular; anatomical location: deltoid] for influenza prophylaxis. The batch number reported was P100240258 and expiry date was 26-May-2021.  On 02-Oct-2020, one day after vaccination, in the morning, the patient observed a strange skin reaction. It looked like a red thread from the injection site and down to his elbow and it looked like a straight line. No corrective treatment was applied for events.  At the time of initial reporting on 02-Oct-2020, the patient had not recovered from events.   The reporter assessed events as non-serious.  The reporter did not provide a causality assessment.  Company comment: A 56-year old, male patient was administered Afluria Quadrivalent vaccine. The patient developed skin reaction and erythema (reported as red thread from the injection site and down to his elbow and it looked like a straight line) one day after receiving vaccine. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology and location of the event.; Sender's Comments: A 56-year old, male patient was administered Afluria Quadrivalent vaccine. The patient developed skin reaction and erythema (reported as red thread from the injection site and down to his elbow and it looked like a straight line) one day after receiving vaccine. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology and location of the event.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Choking sensation, Pharyngeal swelling
Clinical narrative: Throat swelling; Felt she was being chocked; This spontaneous case was received on 02-Oct-2020, from pharmacist via Health Authority (reference number: SEQW20-02845) and concerned a 41-year-old, female patient.     The patient's medical history and concomitant medications were not reported.  On 02-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 276535 and expiry date was 07-Jun-2021.  On the same date, after receiving Flucelvax QIV, the patient experienced throat swelling and felt she was being choked. The patient was hospitalized and was treated with Benadryl (diphenhydramine hydrochloride), orally and Solumedrol (methylprednisolone sodium succinate). The symptoms were getting better. Reporter stated that did not know if it was fully resolved. The patient was discharged from hospital on the same day.   At the time of initial reporting on 02-Oct-2020, the patient was recovering from the events throat swelling and 'choking sensation'.  The reporter assessed events as non-serious.  The reporter did not provide causality assessment.  This case is linked with 202005024 due to same reporter.  Company comment: The patient developed pharyngeal swelling and choking sensation on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient was hospitalized, was treated with Benadryl orally and Solumedrol, and the symptoms were getting better. The patient was discharged from hospital on the same day. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pharyngeal swelling and choking sensation on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient was hospitalized, was treated with Benadryl orally and Solumedrol, and the symptoms were getting better. The patient was discharged from hospital on the same day. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Sex: U
Vaccine: FLUC4
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   At the time of initial reporting on 30-Sep-2020, the outcome of events was not reported.   The reporter did not provide a causality assessment.  This case is linked to cases 202004826, 202004883, 202004884 and 202004885 (the same reporter).  Company comment:The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for 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 warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Paraesthesia, Vaccination site bruising
Clinical narrative: Bruising and it was in black and blue; Tingling; This spontaneous case was received on 05-Oct-2020 from a pharmacist via Health Authority (reference number: SEQW20-02859) and concerned a 49-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included vitamin D and gabapentine, both used for unreported indications. The patient experienced tingling after all the vaccines she received in the past.   On 28-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for flu prophylaxis. The batch number reported was 276532, expiry date: 03-Jun-2021.    On the same date, immediately after receiving Flucelvax QIV, the patient felt tingling. Shortly after, she noticed bruising and she said that it was in black and blue. The patient applied ice to the bruising.   On 03-Oct-2020, reported as Saturday, the patient came to the pharmacy and the bruising was still there.  At the time of initial reporting on 05-Oct-2020, the patient had not recovered from the event of 'vaccination site bruising'.  The outcome of event tingling was not reported.   The reporter did not provide a causality assessment   The reporter assessed the case as non-serious.  Case updated on 02-Dec-2020: Correction made to information received on 05-Oct-2020: Coding for event bruising and it was in black and blue changed from LLT 'Bruising' to LLT "Vaccination site bruising'. Narrative amended accordingly. Company comment amended accordingly.  Company comment: The patient developed vaccination site bruising and paraesthesia on the same day after vaccination with the suspect product, Flucelvax QIV.  Chronology seems highly suggestive for both events. The patient's medical history was not reported while concomitant medications included vitamin D and gabapentine, both used for unreported indications. The patient experienced tingling after all the vaccines she received in the past. Causality is assessed as possibly related for both events.; Sender's Comments: The patient developed vaccination site bruising and paraesthesia on the same day after vaccination with the suspect product, Flucelvax QIV.  Chronology seems highly suggestive for both events. The patient's medical history was not reported while concomitant medications included vitamin D and gabapentine, both used for unreported indications. The patient experienced tingling after all the vaccines she received in the past. Causality is assessed as possibly related for both events.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Redness around the injection site area and swelling; Redness around the injection site area and swelling; This spontaneous case was received on 06-Oct-2020 from pharmacist via Health Authority (reference number: SEQW20-03030) and concerned a 7-year-old, male patient.  The patient had no relevant medical history and was not taking any concomitant medications.   On 03-Oct-2020, on Saturday, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: no reported) for an influenza prophylaxis. The batch number reported was 276578.   On 04-Oct-2020, on Sunday, one day after vaccination, the patient experienced an injection site reaction that was described as some redness around the injection site area and swelling. The patient had no hives and allergy. It was reported that the patient had no any corrective treatment.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: The events of 'vaccination site erythema' and 'vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of 'vaccination site erythema' and 'vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was received on 06-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-02974) and concerned a 58-year-old female patient.  The patient had no medical history and was not taking any concomitant medications.  On 02-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was 276575, expiration date: 30-Jun-2021.  On the same day, 3-4 hours after vaccination, the patient experienced vertigo.  On an unspecified date in Oct-2020, the patient took a dose of diphenhydramine (by her own).  At the time of initial reporting on 06-Oct-2020, the outcome of the event was resolving, as the patient was feeling better and reported no other ill effects.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: The patient developed vertigo 3-4 hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vertigo 3-4 hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal distension, Joint swelling, Pruritus, Swelling face
Clinical narrative: Swelling of the face, stomach and hip; Swelling of the face, stomach and hip; Swelling of the face, stomach and hip; Itching; This spontaneous case was received on 02-Oct-2020, from pharmacist via Health Authority (reference number: SEQW20-02810) and concerned a 45-year-old, male patient.     The patient's medical history and concomitant medications were not reported.  On 28-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 276535 and expiry date was 07-Jun-2021.  On the same date, after receiving Flucelvax QIV, the patient experienced itching, swelling of the face, stomach and hip and was treated with Benadryl (diphenhydramine hydrochloride) orally.  On 01-Oct-2020, the patient recovered from the events.  The reporter assessed events as non-serious.  The reporter did not provide causality assessment.  The case is linked to case 202004781 due to same reporter.  Company comment: A 45-year-old patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed pruritus, face swelling, joint swelling and abdominal distension. The patient was treated with Benadryl (diphenhydramine hydrochloride) orally. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.; Sender's Comments: A 45-year-old patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed pruritus, face swelling, joint swelling and abdominal distension. The patient was treated with Benadryl (diphenhydramine hydrochloride) orally. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Sore arm; Trouble sleeping; This spontaneous case was received on 07-Oct-2020 from a pharmacist via Health Authority (reference number: SEQW20-03135) and concerned a 57-year old, female patient.  The patient's medical history and concomitant medications were not provided.  On 24-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 276576 and expiration date 30-Jun-2021.  On an unspecified date in 2020, after receiving Flucelvax QIV, the patient experienced sore arm, and had trouble with sleeping. The patient took Tylenol (paracetamol) and ibuprofen as treatment medications.   At the time of initial reporting on 07-Oct-2020, the patient had not recovered from events of 'pain in arm' and 'sleep difficult'. As reported, the patient was not improving.   The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 57-year-old, female patient, was vaccinated with Flucelvax QIV vaccine. On an unspecified date in 2020, after receiving Flucelvax QIV, the patient experienced pain in extremity and insomnia. The patient's medical history and concomitant medications were not provided. Causality is assessed as possibly related for pain in extremity and unlikely related for insomnia. (defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 57-year-old, female patient, was vaccinated with Flucelvax QIV vaccine. On an unspecified date in 2020, after receiving Flucelvax QIV, the patient experienced pain in extremity and insomnia. The patient's medical history and concomitant medications were not provided. Causality is assessed as possibly related for pain in extremity and unlikely related for insomnia. (defaults to "related" in the safety database for reporting purposes)