chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin disorder, Skin warm
Clinical narrative: Patient had pain in her arm, red, hot swelling in the right arm the next morning at 8am.  Shot was descriibed as irritating, raised and hot to the touch x 36 hours.   Patient noticed two spots under left breast that looked like bug bites beginning two days ago on 9/19/2020.  She believes it is shingles.  Patient states she has had shingles twice in the past.
Age: 85.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema
Clinical narrative: LARGE (SIZE OF A TEACUP PER PT'S DAUGHTER WHO REPORTED IT) ROUND RED SPOT WHERE PT WAS INJECTED ON RIGHT ARM
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort
Clinical narrative: Patient received the vaccination, then reported back in about 10 minutes that she was feeling tightness in her chest, I administered an oral dose of diphenhydramine (50mg) and strongly recommended that the patient follow up with the local emergency department. the patient left following the diphenhydramine dose and stated that she would probably go to the ED.  I followed up with the patient about a half hour later and she said she was feeling better and no longer was experiencing  any chest tightness and had decided not to go to the ED after she was feeling better.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: RASH/ HIVES
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Malaise, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: swollen arm, red blotchy itchy.  Felt ill for 24 hours approx.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: shoulder pain, difficulty raising arm
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Hyperhidrosis, Insomnia, Tachycardia
Clinical narrative: Tachycardia (over 100 beats/minute), sweating, headache, insomnia
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient immediately experienced dizziness upon fluarix administration into the left arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site pruritus
Clinical narrative: Under eye swollen, large itchy patch at injection site which has increased in size on day 3, long ulcer on inside cheek, itchy eyes
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient received Pneumovax23 Saturday morning, but her left arm (distal from the injection site to the crease of the elbow, wrapping around the whole upper arm) started to feel warm to the touch and become very red and swollen. Patient experienced feeling warm, but did not take her temperature. She took Tylenol to help with the pain and potential fever; patient stated this did not change much from before. Patient presented arm Monday morning to the pharmacist. She stated it slightly improved, but overall it had not changed much since Saturday evening. Patient related it hurt to move her arm, but was not physically unable to move it. Pharmacist recommended taking Benadryl to help with the swelling and redness and to take ibuprofen for the swelling, pain, and fever; pt was also counseled to use cold compresses to help with swelling. Patient was also referred to Urgent Care or PCP if does not improve by tomorrow (Tuesday).
Age: 52.0
Sex: M
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Arthralgia, Body temperature increased, Headache, Myalgia, Pain in extremity
Clinical narrative: temperature over 100 extreme pain in both arms extreme muscle aches headache joint pain
Age: 37.0
Sex: M
Vaccine: PNC13
Symptoms: Influenza like illness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Sore arm with trouble sleeping the night of the vaccine followed by aching/flu-like symptoms the next day.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient had swelling of her left arm from shoulder to elbow the next day.  Patient visited an ED.  They were unsure if it was caused by the injection or and infection had occurred.  I was unable to get any medications that were prescribed for this.  Patient states swelling has decrease since then.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Facial pain, Herpes zoster
Clinical narrative: Patient states approximately five days after vaccination developed red painful spot about 1" diameter on right upper forehead; has not progressed or worsened in severity; does not report any itch.  Spot examined at time of report (13 days after immunization) appears consistent with very mild manifestation of Shingles
Age: 76.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Injection site warmth, Pain in extremity, Swelling
Clinical narrative: Patient reports warn at injection site, burning down entire arm, very sore arm for 4 to 5 days. Swelling also occured for 5 days.
Age: 85.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Chest pain
Clinical narrative: roughly within 10mins post vaccine - patient was having severe back pain described as (someone hitting me with a sledgehammer on my back) - ambulance was called by store staff because patient did say she was having chest pain. After being checked by medics - she requested to be released. Store asset protection leader on duty reported to pharmacy the patient incident that happened because she had just received her vaccine.  After talking to patient later that evening, she reported to feeling much better and no pain was indicated.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Administration site erythema, Dyspnoea, Injection site pain, Pain
Clinical narrative: Per patient's mother, patient endorsed minor pain later that night on the day of vaccine administration 9/20/2020, however, no noticeable signs. Today after school, 9/21/2020, patient endorsed consistent pain and patient's mother noticed erthymea around site of administration and slight tenderness. Per patient's mother, no fever, difficulty breathing, or known drug allergy.  Patient's mother was recommended to try children's APAP or Ibuprofen and apply a cold compress if swelling and warmth as well as contact pediatrician as soon as possible.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Seconds after administering the vaccines, some blood starting coming out of the injection site, followed by swelling of the surrounding area of the arm.  The skin around the injection site of the left arm rose noticeably, and bulged out.  Gave patient ice pack for swelling and had patient sit for 15 minutes.  Patient reported no systemic symptoms.  After 15 minutes, patient informed they were feeling better and left the pharmacy.  Patient informs he would check in with his doctor regarding this adverse reaction and get it looked at.  Unable to currently contact patient regarding if he made and appointment.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Pain, Pain in extremity, Pruritus, Skin warm, Urticaria
Clinical narrative: Patient came to pharmacy on 09-21-20. she complaiend that her left arm has been itching with trobing pain and felt warm to touch. left are was shown hives. she said today a little better. but still bothering her. I recommended to consult with her doctor.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: This vaccination was given to me at my workplace by my nursing supervisor. The injection itself was very painful locally. By the end of my shift (4-6hrs later) I was unable to lift my right arm over my head due to severe joint pain and limited range of motion. This pain persisted for 3-4 months before slowly healing and impacted my ability to exercise and perform activities of daily living.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: 2-3 weeks after receiving a second varicella vaccine, I broke out in a full body rash that appeared identical to one associated with varicella infection. The rash persisted for several days. I did not experience pruritis at any time.
Age: 1.25
Sex: M
Vaccine: FLU4, HIBV, VARCEL
Symptoms: Chills, Cyanosis, Irritability, Nasal congestion, Pyrexia
Clinical narrative: 9/14 cranky maybe low grade fever - motrin  9/15 totally fine  9/16 Fever 102-104, shaking chills, peripheral cyanosis mom called EMS concerned seszure. Was NOT a seszure child alert whole time. Intermittent fever 9/17 + 9/18 with development nasal congestion.
Age: 1.25
Sex: M
Vaccine: FLU4, HIBV, VARCEL
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 9/14 cranky maybe low grade fever - motrin  9/15 totally fine  9/16 Fever 102-104, shaking chills, peripheral cyanosis mom called EMS concerned seszure. Was NOT a seszure child alert whole time. Intermittent fever 9/17 + 9/18 with development nasal congestion.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain
Clinical narrative: Patient has reported persistent soreness that has improved but not gone away on the right side (pneumovax side). No redness, no discharge, no other symptoms beyond soreness
Age: 93.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Nausea
Clinical narrative: SEVERE NAUSEA AND FATIGUE LASTING 14 HOURS.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt received DTAP + Proquad on 9-16-2020. Started with swelling and redness of Right knee + Thigh that evening. Pain with standing. Subjective Fever. Pain, Swelling and redness increased by Day 2 after vaccine. Significant Swelling of (R) knee but right thigh Felt tight. would not bear weight. No redness or swelling noted @ injection site. Seen by Provider on 9/18/2020. Advised to elevate Leg, and us heat over the week end. To F/U in office in 2days (Monday). I spoke with mom today 9/21/20. She said the swelling, redness and pain were gong by the morning of 9-19-20. Pt running around and No problems noted. 0 Fever
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Injection site swelling, Neck pain
Clinical narrative: I felt my arm swelling were shot was put in my arm returned to store and was told to put ice on it now my arm is all bruised and pain in the left side of my neck same side the shot was done on. The shot was in my left arm.
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left arm / shoulder pain past 10-14 day
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discharge, Injection site rash, Injection site vesicles
Clinical narrative: Pt had rash on back of shoulder+ described the injection site as "oozy" next day said looked Blistered around site told pt to call oncall MD since weekend. Went to urgent care told pt to use Bacitracin oint over weekend seems to be healing 9/18
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: Patient was seen during Telemedicine. There was some swelling, redness, and blisters on the site the vaccine was administered. Per mom, Benadryl ointment was applied to the site, was better during the telemedicine visit.
Age: 68.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles appeaRed a few day following the vaccinations weRe given. No oRal medication was given - he use acycloviR cReam
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chest discomfort
Clinical narrative: 09/19/20- VAERS - Patient was given Flucelvax Flu Vaccine around 1:20 pm and experienced tightness in the chest and a generalized weakness a few minutes after administration. Patient was seated in the waiting area and was asked if she wanted an ambulance, and  she declined. Pharmacist kept an eye on her she was able to communicate without any difficulty to the pharmacist. After a approximately 3 minutes pharmacist went to check up on her and she said she wanted us to call an ambulence. She stated she just had tightness in the chest but was able to talk and her physical demeanor did not change. The pharmacist called 911 and an ambulance arrived . Patient was awake, alert, and responsive when paramedics took her to the hospital around 1:35-1:40m. The pharmacist called her at 4:35 pm for a check up call and she was doing well and did not have any problems with tightness in the chest. She stated she did go to the hospital where she was offered treatment with prednisone but the patient stated she declined treatment and was discharged.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Gait inability, Swelling, Weight bearing difficulty
Clinical narrative: Patient "Ballooned up" on side of injection to the point he was unable to walk or put weight on that side
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab, Skin lesion
Clinical narrative: came in approx. 2 months later & described mild rash on neck lesion on upper lip and in the cleavage of breast. They itch and the lesion is crusty
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: After a few minutes of receiving the shot, the patient felt dizzy and looked like she was going to faint. Within a minute she said she felt hive. Paramedics arrived and all the vitals were normal. Called 911 rightaway. Paramedics arrived immediately and checked all the vitals. Patient was doing fine. Everything was normal. Paramedics advised the parents to take her to the doctor just to get checked out.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted after the administration of vaccine. Pt woke up a few seconds after. Pt sat for a few minutes until she felt better. Pt parents stated she has fainted in the past due to low blood pressure but has never fainted after a vaccine. Follow call was made on 9/16/20 - mom stated pt was ok and feeling fine.
Age: 1.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I gave patient the kinrix instead of giving #4 dose of Dtap only
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Joint swelling
Clinical narrative: States swelling and pain on injection site area (half sized tennis ball) when she gets home from the vaccination. Consulted patient to take benadryl
Sex: U
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: in-valid Fluzone Quad and Adacel that was given to 6 patients which are exposed to 30 Fahrenheit, no AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to case 2020SA209916 (same reporter).  This case involves six patients with unknown demographic who were vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date which was exposed to 30 Fahrenheit.  The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event 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.  There will be no information available on batch number for this case.
Age: 52.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52-years-old patient was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake, No AE; 52-years-old patient was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake, No AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA242185, 2020SA242184 and 2020SA242187 (same reporter).  This case involves a 52-year-old patient (gender unknown) who was mistakenly vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose (unclear whether 0.5 mL or 0.7 mL) of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] by mistake (Lot number: UJ450AB and expiration date:30-Jun-2021) via unknown route in an unknown administration site as prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency same day).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 year old patient was given Fluone HD Quadrivalent by mistake, no AE; 13 year old patient was given Fluone HD Quadrivalent by mistake, no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a 13-year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] by mistake (product administered to patient of inappropriate age and overdose).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included a dose of HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) via unknown route and site of administration for prophylactic vaccination.  On 27-Aug-2020, the patient was vaccinated with 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number:UJ450AB and expiration date:30-Jun-2021) by mistake via intramuscular route in the left deltoid as prophylactic vaccination, it was a case of actual medication error due to inappropriate age at vaccine administration and overdose (latency same day).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow up information received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  The dose of the suspect product was updated.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Intensive care, Magnetic resonance imaging brain normal, Muscular weakness, Sensory disturbance, Vaccination complication
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angina pectoris, Arthralgia, Asthenia, Axillary pain, Back pain
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood pressure increased, Blood test, Breast pain, Breast swelling, Cardiac disorder
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Cardiac monitoring, Cardiac stress test, Cerebrovascular accident, Chest X-ray, Chest pain
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Clumsiness, Computerised tomogram head, Computerised tomogram neck, Condition aggravated, Cough
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Diarrhoea, Differential white blood cell count, Dysphagia, Dyspnoea, Echocardiogram normal
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Essential hypertension, Exercise electrocardiogram, Fatigue, Full blood count, Gait disturbance
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Inflammation, Insomnia, Intensive care, Lactic acidosis, Lymphadenopathy
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Magnetic resonance imaging brain, Magnetic resonance imaging normal, Mammogram abnormal, Muscle spasms, Muscular weakness
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Myalgia, Nasal congestion, Ocular hyperaemia, Oedema peripheral, Pain in extremity
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Product storage error, Pruritus, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Scan with contrast, Somnolence, Sputum discoloured, Swelling, Tachycardia
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.