chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; The office manager reports the inadvertent administration of a pediatric dose of VAQTA for a 19 year old patient; Information has been received from an office manager regarding a 19-year-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 18-MAY-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis, lot number S032055 with expiration date in 09-NOV-2020 (dose, route of administration, strength and anatomical location not reported) (product administered to patient of inappropriate age).  No additional adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, RV5
Symptoms: Product storage error
Clinical narrative: multiple unspecified patients were administered a dose of improperly stored GARDASIL 9 or ROTATEQ; No adverse symptoms were reported; This spontaneous report was received from a certified medical assistant reporting about multiple patients of unknown age and gender. Information about the patient's medical istory, concurrent conditions or concomitant medications was not reported.     On unknown dates, the patients were vaccinated with a dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # 1621934 and expiration date 29-JAN-2022 (dose, route of administration, and anatomical location were not reported) for prophylaxis.  The patients were also vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot number: S017631, expiration date: 08-DEC-2020 (dose, and anatomical location were not reported). These vaccines were improperly stored at a temperature above 47-degree Fahrenheit for 3 minutes and a temperature below 36-degree Fahrenheit for 5 minutes. These findings were discovered with a digital data logger and the vaccines had previous temperature excursions. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events; 14 old month patient was inadvertently administered PROQUAD and VARIVAX; This spontaneous report was received from a Registered Nurse referring to a 14 month old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not provided.     On 18-MAY-2020, the patient was inadvertently vaccinated with varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003176, expiration date:30-JUL-2020) (strength, dose number, dose, frequency, route or location were not provided) and with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S002874, expiration date:29-JAN-2021) (strength, dose number, dose, frequency, route or location were not provided) for prophylaxis. No additional adverse events and no additional information were reported.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 68 years old received adacel inadvertantly/no AE; Based on information previously received on 13-MAY-2020, the following information [case classification upgraded from Non-case to a Valid case and updated all the relevant fields appropriately] has been amended  Initial information received on 13-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 68 years old male patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age) via  intramuscular route in the left deltoid on an unknown date for prophylactic vaccination [batch number U6272AA; expiry date 26-apr-2021; dosing details 0.5 ml]  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used. Nurse thought the consumer was 62 years old.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with expired IPOL, no AE; Initial information received on 05-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a patient who received an expired 0.5 ml fourth dose of vaccine IPV (VERO) [IPOL] (lot: P1A25, expiry date: 02-May-2020) via subcutaneous route in the left thigh for prophylactic vaccination on 04-May-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation.  It was an actual medication error due to expired vaccine used.  The patient did not experience any adverse event at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Patient received Pneumococcal 23 when he was supposed to receive  the HPV vaccine.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Cold sweat, Dizziness, Feeling cold, Feeling hot
Clinical narrative: Around 2pm mom called and said that the patient came to her pale, dizzy, clammy, "freezing," and legs were weak. Patient was told to take some Tylenol and take a warm bath. Patient temp was 99 degrees. Mom called again at 4pm and stated that patient now has a temp of 100.2 and is feeling hot. Can moves leg well but they still "feel funny". Encouraged her to elevate legs, increase fluid intake, give Tylenol every 4-6 hours. If symptoms get worse to go to the ER. Spoke to mother on 5/19/2020 and patient was doing much better. Symptoms had improved later in the evening on 5/18/2020.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Muscular weakness, Pallor
Clinical narrative: Around 2pm mom called and said that the patient came to her pale, dizzy, clammy, "freezing," and legs were weak. Patient was told to take some Tylenol and take a warm bath. Patient temp was 99 degrees. Mom called again at 4pm and stated that patient now has a temp of 100.2 and is feeling hot. Can moves leg well but they still "feel funny". Encouraged her to elevate legs, increase fluid intake, give Tylenol every 4-6 hours. If symptoms get worse to go to the ER. Spoke to mother on 5/19/2020 and patient was doing much better. Symptoms had improved later in the evening on 5/18/2020.
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: the patient's Papanicolaou test came back positive for HPV disease; This spontaneous report was received from a medical assistant and refers to a 26-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-SEP-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, dose 1 (strength, frequency, route of administration, lot # and expiration date were not reported) for prevention from human papilloma virus (HPV) disease. On an unknown date, the patient experienced papilloma viral infection. The patient's Papanicolaou test came back positive for HPV disease. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the outcome of the event were not reported.  Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Otorrhoea, Skin warm
Clinical narrative: ear pain; warm ear; she feels like it has some liquid; This case was reported by a consumer via call center representative and described the occurrence of ear pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2020, the patient received the 2nd dose of Shingrix. On 9th May 2020, less than a day after receiving Shingrix and less than a week after starting Sudafed Expectorant, the patient experienced ear pain, skin warm and ear discharge. The patient was treated with pseudoephedrine, guaiphenesin (Sudafed Expectorant). On an unknown date, the outcome of the ear pain, skin warm and ear discharge were not recovered/not resolved.   It was unknown if the reporter considered the ear pain, skin warm and ear discharge to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 50 or 51 year. The patient reported that she had the second dose of Shingrix on Saturday.  That same day at night she started experiencing ear pain. The patient said  that she took Sudafed and felt better.  On Monday she had two doses of Sudafed instead of 3 and hear ear pain came back. The patient said that the first day it was a piercing ear pain.  Patient also said that her ear was also warm sometimes and she feels like it had some liquid. The patient did not want to share any information. In the source document the outcome of the events were reported as recovering but as per narrative it was captured as not recovered.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No negative symptoms reported. This vaccination was expired when it was given. Provider, supervisor, and pts mom was notified of this. Pt will return in 1 month of the given date to receive another varicella vaccination.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Headache, Pain, Pyrexia
Clinical narrative: body aches; abdominal pain; fever of 102.4; headache; This spontaneous report was received from a physician assistant (also the patient's mother) and refers to a 13-year-old non-pregnant female patient with an allergy to amoxicillin. She had no pertinent medical history or concomitant medications. On 18-MAY-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot number and expiration date were not reported) intramuscularly for routine vaccination. On 19-MAY-2020, the patient woke up in the morning with a fever of 102.4 (unit not provided), a headache, body aches and abdominal pain. She was given ibuprofen as treatment for the events and did not seek medical attention. No lab diagnostics or studies were performed. On 19-MAY-2020, the patient recovered from the events. The relatedness between the events and the suspect therapy was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: received one dose of improperly stored VARIVAX; No additional adverse effects reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On 01-MAY-2020, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot # R020654, expiration date 18-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted in properly stored sterile diluent. The dose of the vaccine was exposed to temperature excursion at 5.7 Fahrenheit (F) degrees (-14.6 Celsius degrees) for 18 minutes. There were previous temperature excursions at -13.3 Celsius degrees for 18 minutes and -13.2 Celsius degrees for 18 minutes. The call was due to digital data logger. No additional adverse effects reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: was really sick w first dose; was due for 2nd dose of vaccine in January; This case was reported by a consumer via call center representative and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise and incomplete course of vaccination. On an unknown date, the outcome of the malaise and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for this report for the 2nd dose. The age group was not reported but it was selected as adult as per the vaccine indication. The patient was sick with 1st dose and was due for 2nd dose of vaccine in January, which led to incomplete course of vaccination. The reporter wanted to know  was it too late to get on at the time of reporting. The reporter asked would it affect patient ability immune system to fight off Covid.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal distension, Influenza like illness
Clinical narrative: it is a weird bloat/stomach is hanging.; flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included laparoscopy (had a laparoscopic procedure and could always see the small incision scars).   On 11th May 2020, the patient received the 1st dose of Shingrix. On 13th May 2020, 2 days after receiving Shingrix, the patient experienced abdominal bloating. In May 2020, the patient experienced influenza-like symptoms. On 16th May 2020, the outcome of the abdominal bloating was recovering/resolving. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and abdominal bloating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had flu like symptoms for about a day and a half which was told could happen. The patient when getting dressed after gardening noticed the stomach looked funny and only way could describe it was a weird bloat and the lower part of my stomach was hanging. The patient had a laparoscopic procedure and could always see the small incision scars. But now patient cant see them. The reporter stated it's a little better but could you tell what's going on.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Lower Back Issue; This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number HE2P5, expiry date 22nd February 2022) for prophylaxis.   On 3rd January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced back pain. The patient was treated with prednisone. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and started with a Prednisone therapy for a lower back issue. The pharmacist was not sure of the patient´s clinical condition. He also clarified to the second line agent that the therapy consisted on 60 mg of Prednisone for 3 days, 40 mg for 3 days, 20 mg for 3 days and 10 mg for 3 days. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain
Clinical narrative: flu like symptoms; fatigue; injection site pain in her left arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia. Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included pregabalin (Lyrica).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain and fatigue. On an unknown date, the outcome of the influenza-like symptoms and fatigue were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced flu like symptoms consisting of fatigue.   The patient also reported that the injection site pain in her left arm that lasted about a week and had resolved.  The reporter did not consent to follow up. This case linked with US2020AMR084981, US2020AMR084982 and US2020AMR084983, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chills, Nausea, Neck pain, Pyrexia
Clinical narrative: Neck pain; Back [and neck] pain; Chills; Fever of 101.7 F; Nausea; Vomiting; This is a non-serious spontaneous case initially received from other health professional on 19-March-2019, concerning a 70-year-old, elderly, female patient.  On 12-Oct-2018, the patient was administered Afluria QIV (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication and on 11-Mar-2019, at 3:30 pm, the patient was also administered non-company drug glatiramer acetate.  On 11-Mar-2019, 4 months and 27 days after vaccination, at around 08:00 pm, the patient was administered glatiramer acetate and eventually experienced chills, fever of 101.7 F, nausea, vomiting, back pain and neck pain. The symptoms lasted for around 2 hours and then resolved.  The outcome of the events was recovered on 11-Mar-2019.; Reporter's Comments: A 70-year-old female patient experienced neck pain, back pain, chills, fever, nausea and vomiting, four months twenty-seven days after administration of Afluria QIV. The company assessed the causality of the events as not related to the suspect vaccine as there is no plausible temporal relationship between the events and the suspect vaccine.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Neck pain; Back [and neck] pain; Chills; Fever of 101.7 F; Nausea; Vomiting; This is a non-serious spontaneous case initially received from other health professional on 19-March-2019, concerning a 70-year-old, elderly, female patient.  On 12-Oct-2018, the patient was administered Afluria QIV (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication and on 11-Mar-2019, at 3:30 pm, the patient was also administered non-company drug glatiramer acetate.  On 11-Mar-2019, 4 months and 27 days after vaccination, at around 08:00 pm, the patient was administered glatiramer acetate and eventually experienced chills, fever of 101.7 F, nausea, vomiting, back pain and neck pain. The symptoms lasted for around 2 hours and then resolved.  The outcome of the events was recovered on 11-Mar-2019.; Reporter's Comments: A 70-year-old female patient experienced neck pain, back pain, chills, fever, nausea and vomiting, four months twenty-seven days after administration of Afluria QIV. The company assessed the causality of the events as not related to the suspect vaccine as there is no plausible temporal relationship between the events and the suspect vaccine.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Product quality issue, Vaccination failure
Clinical narrative: Vaccination failure; Flu; This is a spontaneous case from, initially reported by other health professional on 11-Apr-2019, concerning a 46-year-old, adult male patient.  On 29-Sep-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose:  0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019] for active immunization against influenza.  On 11-Apr-2019, 6 months and 13 days after vaccination, the patient was diagnosed with flu (considered as vaccination failure). It was reported that, the patient was not hospitalized, and the symptoms were not very strong or long. The patient was treated with unspecified antiviral drug which shortened the length of her symptoms to about 4 days. The patient felt better.   This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAIR reference number was 1039510. Based on the investigation performed, it can be concluded that Flucelvax 252664 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the Fill Finish or Bulk manufacturing process at the facility and no trend was identified for the batch. Therefore, no internal root cause could be confirmed.   The outcome of the event was recovering.  The reporter assessed the case as serious (medically significant).  Follow up report received from other non-health professional on 06-May-2019: It was reported that the patient's symptoms were not very strong or long. The patient was treated with unspecified antiviral drug which shortened the length of her symptoms to about 4 days. The outcome of the event was updated from not recovered to recovering in the event tab. The patient confirmed that she could not recall the exact dates. The narrative was amended accordingly.  Non-significant follow-up received from the reporter on 07-May-2019: Info Number (SEQ19-01470) was added in additional information tab. No new information received, hence no changes were made in the narrative.; Reporter's Comments: A 46-year-old male patient was diagnosed with Flu (influenza), 6 months 13 days after receipt of Flucelvax QIVc (considered as vaccination failure). Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the event influenza cannot be ruled out. Hence, company assessed the events influenza and vaccination failure as related to suspect vaccine.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Diarrhoea
Clinical narrative: The patient developed body chills after injection; The patient developed body diarrhea after injection; This is a spontaneous case from initially received from a pharmacist (case ID: SEQ19-01740) on 09-Aug-2019, concerning an 89-year-old, female patient (race and ethnic group were not provided).   It was not reported whether the patient had relevant medical history and drug reactions or allergies.  On 07-Aug-2019, the patient was administered intramuscularly Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit) egg-derived, MF59, batch number: 260382, expiration date: 30-Apr-2020, in deltoid] for influenza prophylaxis.   On the same day, the patient developed diarrhea and body chills after injection.   On 09-Aug-2019, the patient's daughter reported that they were at urgent care and the patient was hospitalised, but details were not specified.  At the time of reporting, the events of diarrhea and chills were resolved.  The reporter assessed the case as serious. Causality to Fluad was not reported.  Company comment: The patient developed chills and diarrhoea on the same day after administration of Fluad (influenza vaccine, inactivated influenza virus surface antigen (subunit) egg-derived). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Reportedly, the patient was hospitalised, and the events resolved. Based on this information, causal relationship between the suspect product and both events is assessed as possibly related.   Follow up received from the initial reporter on 27-Aug-2019: Seriousness criteria hospitalization was provided for both events and case was upgraded from non-serious to serious. Date of hospitalization was added. The outcome for diarrhea and chills was changed from not reported to resolved. The narrative was amended accordingly.; Reporter's Comments: The patient developed chills and diarrhoea on the same day after administration of Fluad (influenza vaccine, inactivated influenza virus surface antigen (subunit) egg-derived). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Reportedly, the patient was hospitalised, and the events resolved. Based on this information, causal relationship between the suspect product and both events is assessed as possibly related.
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Hypersensitivity, Injection site pain, Pruritus, Swelling
Clinical narrative: Allergic reaction; Pain in left arm at injection site; This is a spontaneous case from reported by a physician to agency (reference number: SEQ19-02156), initially received on 29-Aug-2019 and processed together with follow up received on 30-Aug-2019, concerning a 62-year-old, adult female patient.  The patient's medical history included: allergy to vancomycin, allergic reaction due to administered Flucelvax vaccine last year and possible egg allergy. The patient concomitant medications included: simvastatin, Ventolin (salbutamol), Symbicort (budesonide, formoterole fumarate), losartan, hydrochlorothiazide, amlodipine, Anapril (enalapril maleate) and Lasix (furosemide).   On 27-Aug-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261208, expiration date: Jun-2020, route of administration, anatomical location: not reported] for influenza prophylaxis.  On 28-Aug-2019, 1 day after vaccination, the patient developed allergic reaction, with symptoms of redness, swelling and itching. The patient also experienced pain in left arm at injection site. Since it was reported that for 2019 and 2020, all 4 vaccine strains for Flucelvax would be cell derived and therefore Flucelvax would not contain any egg protein, egg allergy was excluded as cause for the allergic reaction. The patient was treated with Tylenol (paracetamol), Medrol dose pack (methylprednisolone) and Vistaril (hydroxyzine hydrochloride) for the events.  The outcome of the events was not reported and it was confirmed that no further information would be provided.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax.  Non-significant follow up received by the physician on 10-Sep-2019: It was reported that the physician had no further information to provide regarding outcomes of the events. Narrative was amended accordingly.  Company comment: All events are considered related to Flucelvax.; Reporter's Comments: All events are considered related to Flucelvax.
Sex: U
Vaccine: FLUC4
Symptoms: Malaise
Clinical narrative: Got deathly ill; This is a spontaneous case initially reported by other health professional (nurse) to Agency (reference number: SEQ19-02296) on 04-Sep-2019, concerning a patient of unknown age and gender.   The patient's medical history and concomitant medications were not provided.  On an unspecified date in 2018, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mg, route of administration, anatomical location, batch number and expiration date: not reported] for protection against seasonal influenza.   On an unspecified date, after vaccination the patient got deathly ill. No further information was reported.  On an unreported date, the patient recovered from the event of 'got deathly ill'.  Reporter assessed this case as non-serious and possibly related to Flucelvax. The reporting nurse was concerned that potential preservative from the vaccine caused the event.  Company Comment: The event of 'got deathly ill' is considered related to Flucelvax.; Reporter's Comments: The event of 'got deathly ill' is considered related to Flucelvax.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site extravasation, Injection site pain, Underdose, Vaccination site pain
Clinical narrative: Upon withdrawing the needle some of the vaccine leaked out; Shot hurt; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-02429) on 09-Sep-2019, concerning a 73-year-old, female patient.   The patient's medical history included unspecified cardiac issues.   The patient's concomitant medications included: oxygen, diltiazem, water pill, potassium, warfarin, propranolol and Albuterol (salbutamol); all for unknown indication.   On 03-Sep-2019, the patient was administered Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number: 260389, expiration date: 31-May-2020] for influenza prophylaxis. The patient stated that the shot hurt. The patient was treated with ice.  As reported, while administering the vaccine, the reporter stated that she might have backed out a little bit (also reported that half of it came out), but still administered the full dose. Upon withdrawing the needle, some of the vaccine leaked out (explicitly coded as Inappropriate dose of vaccine administered'. The reporter wanted to know if the patient should be re-vaccinated.   On 05-Sep-2019, the patient recovered from the vaccination site pain.  The reporter assessed the case as non-serious and did not provide causality assessment.  The reporter gave consent to be contacted for further follow up.  Follow up received by pharmacist on 18-Sep-2019: Reporter did not give us permission to contact the patient therefore there would be no additional information provided.  Company comment :The patient developed vaccination site pain on the same day after vaccination with the suspect product, Fluad. Chronology is plausible. Reportedly, upon withdrawing the needle some of the vaccine leaked out, which suggests incorrect dose administration. The patient recovered from the vaccination site pain two days after, as reported. Based on this information, causal relationship between the suspect product and the event vaccination site pain is assessed as related, while for incorrect dose administered as not related.; Reporter's Comments: The patient developed vaccination site pain on the same day after vaccination with the suspect product, Fluad. Chronology is plausible. Reportedly, upon withdrawing the needle some of the vaccine leaked out, which suggests incorrect dose administration. The patient recovered from the vaccination site pain two days after, as reported. Based on this information, causal relationship between the suspect product and the event vaccination site pain is assessed as related, while for incorrect dose administered as not related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Very big bruise on upper arm on the site of injection; This is a spontaneous, reported by pharmacist to Med Communications (reference number: SEQ19-02669), and initially received on 13-Sep-2019, concerning a female patient.   The patient's medical history and concomitant medication were not provided.  On 08-Sep-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, batch number: P100115959, expiration date: 17-Jun-2020, anatomical location: upper arm, route of administration: not reported] for influenza prophylaxis.   On 09-Sep-2019, one day after vaccination, the patient developed a very big bruise on her upper arm at the site of injection. It was not reported whether the patient received any corrective treatment for the event.  On 13-Sep-2019, the patient recovered from the event.  The reporter assessed the case as non-serious, while the causality assessment was not provided.  Company comment: A female patient has experienced injection site bruising associated with Afluria Quadrivalent. Chronology seems plausible. The patient's medical history and concomitant medications were not provided. Route of administration was also not reported. The cause of the event could be attributed to the way the needle was inserted into the muscle of the patient and/or to the expertise of the qualified personnel. Also medical history of the patient could provide more reasonable casualty for the event. With information provided causality is assessed as not related to the product.; Reporter's Comments: Company comment: A female patient has experienced injection site bruising associated with Afluria Quadrivalent. Chronology seems plausible. The patient's medical history and concomitant medications were not provided. Route of administration was also not reported. The cause of the event could be attributed to the way the needle was inserted into the muscle of the patient and/or to the expertise of the qualified personnel. Also medical history of the patient could provide more reasonable casualty for the event. With information provided causality is assessed as not related to the product.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy; This is a spontaneous case, initially reported by other non-health professional to agency (reference number: SEQ19-02746) on 16-Sep-2019, concerning a pregnant, female patient of unspecified age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date in 2019, the patient was administered Afluria Quadrivalent [Influenza Vaccine; dose, route of administration, batch number, expiry date and anatomical location: not reported] for unknown indication (explicitly coded as 'Vaccine exposure during pregnancy').  No adverse event was reported.   The reporter did not provide information about seriousness or causality.  Company comment: The event of 'Vaccine exposure during pregnancy' is considered not related to Afluria Quad.; Reporter's Comments: The event of 'Vaccine exposure during pregnancy' is considered not related to Afluria Quad.
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Difficulty moving the affected arm; Redness (and swelling) at the injection site; (Redness and) swelling at the injection site; A large knot distal to the injection site above the elbow; This is a spontaneous case, reported by pharmacist to Agency (Case ID: SEQ19-02900) and initially received on 18-Sep-2019, concerning a female patient of unknown age.  The patient's relevant medical history and concomitant medications were not provided.  On 17-Sep-2019, in the morning, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, batch number: 260395, expiration date: 30-Jun-2020, anatomical location: left deltoid, route of administration: intramuscular (IM)] for protection against seasonal influenza.  On the same day, after vaccination, the patient developed redness and swelling at he injection site, a large knot distal to the injection site above the elbow and difficulty moving the affected arm. The patient did not received any treatment measures.  At the time of reporting, the outcome of the events was ongoing.  The reporter assessed the case as non serious and did not provided causality criteria.  The reporter did not give the permission to be contacted for further information.  Company Comment: The patient experienced injected limb mobility decreased, injection site erythema, injection site swelling and vaccination site induration on the same day, after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal relationship between the suspect product and all the events is assessed as related.; Reporter's Comments: The patient experienced injected limb mobility decreased, injection site erythema, injection site swelling and vaccination site induration on the same day, after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal relationship between the suspect product and all the events is assessed as related.
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Immediate post-injection reaction, Peripheral swelling, Pruritus
Clinical narrative: Left arm felt scratchy; Left arm started immediately to swell up/arm has swelled to the size of a golf ball; Fever; This is a spontaneous case from reported by a pharmacist to agency (reference number: SEQ19-02940) and initially received on 19-Sep-2019, concerning a 54-year-old, female adult patient.  The patient's relevant medical history and concomitant medications were not provided.  On 18-Sep-2019, the patient was administered Flucelvax (QIV) [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 261207 and expiration date: 30-Jun-2020] for protection of influenza.  On the same day, after vaccination, the patient's left arm started immediately to swell up. Also, her arm felt scratchy and the band aid came off. The patient applied an ice pack and has taken Benadryl. As well, the patient mentioned that she may have had fever on the same day after injection. In addition, her left arm swelled to the size of a golf ball. Arm was bruised further the day after.  The outcome of the events was reported as unknown.  The case was assessed as non-serious and reporter did not provide causality to Flucelvax.  Follow up received on 02-Oct-2019: Patient's initials and information regarding patient's medical history and concomitant medications confirmed, outcome of the events updated. The narrative was updated accordingly.; Sender's Comments: Temporal relationship between administration of Flucelvax vaccine and development of adverse events is plausible. Combination of adverse events and its treatment with Benadryl may suggest hypersensitivity reaction. Based on the available information all adverse events were assessed as related to the suspect product.
Sex: M
Vaccine: FLUC4
Symptoms: Discomfort, Dizziness, Fatigue, Heart rate increased, Hyperhidrosis
Clinical narrative: Pulse increased; Feeling discomfort; Dizziness; Fever like symptoms/ aprox 37-38C; Fatigue; This is a spontaneous case, reported by other non-health professional (consumer) to Agency (Case ID: SEQ19-03067) and initially received on 23-Sep-2019, concerning a 33-year-old, adult, male patient.   The patient had no relevant medical history, drug reactions or allergies, and concomitant medications provided.  On 19-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: arm, batch number, expiration date: not reported] for influenza prophylaxis.  On 23-Sep-2019, at 8 am, the patient developed a fever-like symptoms, approximately 37-38 C. Pulse increased and the patient felt discomfort, dizziness and fatigue. During night fever got to 38.1 C (106 F). Corrective treatment has not been applied yet.  On 24-Sep-2019 in the morning, the fever stopped, the patient had no more temperature.  On 26-Sep-2019, dizziness and sweating went away as reported.  On 29-Sep-2019, the patient was feeling fatigued.  On 30-Sep-2019, the patient was better than the day before. And reported he was 80% recovered.  The outcome of the events fever-like symptoms, approximately 37-38 C and dizziness was recovered on 26-Sep-2019.  The outcome of the events pulse increased, feeling discomfort and fatigue was recovering, at the time of this report.  The reporter assessed the case as non serious and did not provide causality assessment to Flucelvax.  Follow up received on 30-Sep-2019: It was provided the outcome and stop dates of the events. Dizziness was added. The narrative was amended accordingly.; Sender's Comments: The patient experienced heart rate increased, discomfort, dizziness, pyrexia and fatigue four days after receipt of Flucelvax QIV. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Pulse increased; Feeling discomfort; Dizziness; Fever like symptoms/ aprox 37-38C; Fatigue; This is a spontaneous case, reported by other non-health professional (consumer) to Agency (Case ID: SEQ19-03067) and initially received on 23-Sep-2019, concerning a 33-year-old, adult, male patient.   The patient had no relevant medical history, drug reactions or allergies, and concomitant medications provided.  On 19-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: arm, batch number, expiration date: not reported] for influenza prophylaxis.  On 23-Sep-2019, at 8 am, the patient developed a fever-like symptoms, approximately 37-38 C. Pulse increased and the patient felt discomfort, dizziness and fatigue. During night fever got to 38.1 C (106 F). Corrective treatment has not been applied yet.  On 24-Sep-2019 in the morning, the fever stopped, the patient had no more temperature.  On 26-Sep-2019, dizziness and sweating went away as reported.  On 29-Sep-2019, the patient was feeling fatigued.  On 30-Sep-2019, the patient was better than the day before. And reported he was 80% recovered.  The outcome of the events fever-like symptoms, approximately 37-38 C and dizziness was recovered on 26-Sep-2019.  The outcome of the events pulse increased, feeling discomfort and fatigue was recovering, at the time of this report.  The reporter assessed the case as non serious and did not provide causality assessment to Flucelvax.  Follow up received on 30-Sep-2019: It was provided the outcome and stop dates of the events. Dizziness was added. The narrative was amended accordingly.; Sender's Comments: The patient experienced heart rate increased, discomfort, dizziness, pyrexia and fatigue four days after receipt of Flucelvax QIV. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Rash on neck; This is a spontaneous case, initially received from other health professional via e-mail on 26-Sep-2019 and follow up received on the same day (being processed together), concerning a 46-year-old, female patient.   The patient's relevant medical history, drug reactions or allergies and concomitant medications were not reported.  On 25-Sep-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: right upper arm, dose, batch number and expiration date: not reported] for an unknown indication.   On the same day, six hours later, the patient developed a mild rash on neck.  The outcome for the event of neck rash' was recovered.  The reporter did not provide seriousness and causality assessment to Flucelvax.  Company Comment: Event's causality was assessed as related to the suspect product per company.  Follow up was received from other non health professional on 04-Oct-2019: Patient age, route of administration and anatomical location for the vaccine, as well as outcome for the event of neck rash' was provided.  Non-significant case correction performed on 26-Nov-2019: Severity removed from the verbatim of the event and added to structure field. Medically confirmed by healthcare professional (HCP) ticked as 'yes' in general and event tab.  Significant case correction performed on 30-Apr-2020: Suspect vaccine recoded from Flucelvax TIV to Flucelvax QIV. No changes in narrative.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.