chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Malaise, Tachycardia, Tachypnoea
Clinical narrative: At about 20:15 after getting the flu shot an hour prior shortness of breath was noted. Then I became tachycardic as well as tachypneic with general malaise. Symptoms lasted for roughly 1hr before resolving themselves.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PT HAD FEVER OF 102 F FOR 3 DAYS AFTER VACCINATION
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: severe headache, muscle soreness, fatigue, restlessness, insomnia, arm very warm and red
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Restlessness, Skin warm
Clinical narrative: severe headache, muscle soreness, fatigue, restlessness, insomnia, arm very warm and red
Sex: M
Vaccine: FLUN4
Symptoms: Fatigue, Hyperhidrosis, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: EXCESS SWEATING; FATIGUE; RUNNY NOSE; SORE THROAT; SNEEZING; A spontaneous report has been received from a consumer via the regulatory authority in regulatory authority concerning a 2 year old male patient with height of 96 centimetres and with weight of 13 kilograms.    No medical history was reported. No concomitant products were reported.    On 13-Nov-2020, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal), via nasal route, for influenza immunisation.     On 14-Nov-2020, the patient experienced sore throat (preferred term: Oropharyngeal pain), sneezing (preferred term: Sneezing), fatigue (preferred term: Fatigue) and runny nose (preferred term: Rhinorrhoea). On 15-Nov-2020, the patient experienced excess sweating (preferred term: Hyperhidrosis).     At the time of reporting, the event of sore throat, sneezing and fatigue was ongoing. At the time of reporting, the event of excess sweating and runny nose was improving.     The events were considered serious (important medical event) by the reporter.; Sender's Comments: Oropharyngeal pain, sneezing and hyperhidrosis are not listed in the company core datasheet of Q/LAIV. Underlying rhinorrhoea could be contributory to the event of sneezing. Due to limited information on the circumstance leading to the events, clinical course of treatment given, relevant medical history, concurrent conditions, concomitant medications, other risk factors (underlying infections), detailed etiological and diagnostic workup, imaging studies, it is not possible to make conclusive assessment of the causal relationship of the events and the suspect drug.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-JAN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently after receiving zoster vaccine live (ZOSTAVAX), the patient was diagnosed with shingles. As a result of these symptoms, the patient was seen and treated by a physician. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: body aches; fever; This is a spontaneous report from a contactable physician and non-contactable consumer (patient's parent) via Pfizer sales representative. A patient of unspecified age and gender received second dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, fever on an unspecified date with outcome of unknown. Patients parent called doctor's office to report after second dose patient had body aches and fever.  No follow up attempts are needed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Underdose
Clinical narrative: Jerked arm; Patient did not receive full dose; This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in arm on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced jerked arm when receiving injection on an unspecified date. Patient did not receive full dose. The outcome of event was unknown.  No Follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; fatigue; muscle pain; This is a spontaneous report from a contactable other health professional via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  Reporter stated that she had seen patient experienced headache, fatigue and muscle pain when given meningococcal group b rlp2086 on an unspecified date.  Outcome of events were unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu shot last year and still got the flu a few months later; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who got the flu shot last year and still got the flu (influenza) a few months later, while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route in administration site unknown) for prophylactic vaccination.  On an unknown date, the patient developed still got the flu a few months later (influenza), Unknown latency, following the administration of INFLUENZA VACCINE.  No laboratory test was reported.  It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arms are sore; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (MI) via call-center (Reference number- 00342347) and transmitted to Sanofi on 02-Nov-2020.  Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2020SA320485 and 2020SA307661 (same reporter).  This case involves a 36-years-old male patient who experienced arms are sore (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot number LUT7007NA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arms are sore (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: ill; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) .  This case involves patient (unknown demographics) who experienced ill (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Nasopharyngitis
Clinical narrative: bronchitis; terrible cold; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient [age unspecified] who experienced bronchitis with symptoms terrible cold (nasopharyngitis), while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bronchitis and terrible cold (nasopharyngitis) for 2 months unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient used the expired formula  (2019-2020) which was expired on 29 May 2020 /no AE; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unspecified age and gender) who were vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number not reported and expiry date: 29 May 2020) via unknown route in unknown administration site in 2019-2020 for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided  This was an actual medication error case due to expired vaccine used (latency was same day).  Patient used the 2019-2020 formula which was expired on 29 May 2020 of Fluzone Quadrivalent prefilled syringe.  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.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: This was the second follow up shot.....no reaction to first injection.  fatigue, headache, shivering, fever and vomiting all night.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: During vaccine appointment, 17 yo client was given Fluzone shot mistakenly when vaccine was not indicated. Client had already received Fluzone vaccine earlier in the season and was up to date. Guardian was notified by phone. Father and client had no concerns at time of call.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Acne, Hyperhidrosis, Injection site reaction, Parosmia, Seizure
Clinical narrative: Patient described a small "pimple like white head" to the injection site, and then having "uncontrolled shaking" for approximately 4 hours that he thought was a "mild seizure."  Patient never lost consciousness, did not lose control of his bowel/bladder, did not have a post ictal period, and was "aware" of his shaking for the entire 4 hour period.  He also reported that his "excessive" sweat on his pillow smelled like "vinegar."
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Patient described a small "pimple like white head" to the injection site, and then having "uncontrolled shaking" for approximately 4 hours that he thought was a "mild seizure."  Patient never lost consciousness, did not lose control of his bowel/bladder, did not have a post ictal period, and was "aware" of his shaking for the entire 4 hour period.  He also reported that his "excessive" sweat on his pillow smelled like "vinegar."
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient says she is still experiencing pain in her upper Left arm after almost 3 month.  States she can not lift arm or sleep on that arm.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash macular
Clinical narrative: Large long red spot about 6 inches long spreading.
Age: 73.0
Sex: F
Vaccine: FLUR4, PNC13, VARZOS
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: The next day she felt fevered and was having difficulty breathing.  She was hospitalized for 3 days.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Hemianaesthesia
Clinical narrative: Pt has numbness on Left side
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Patient had trouble breathing - 911 was called - epipen administered, blood pressure taken 159/109 pulse 106
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient received flu vaccine at clinic through Health Department.  Patient called to day to report that she has pain at the site and when she raises arm overhead.  In am, upon rising, has to do ROM exercises to get the arm functioning.  Does not take OTC medication of any kind so tried heat with no improvement.  Has not discussed symptoms with physician.  Instructed to follow up with physician and provide update after visit.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Magnetic resonance imaging abnormal, Oedema peripheral, Osteoarthritis
Clinical narrative: Persistent pain and limitation of range of movement (now for more than  10 weeks) in left shoulder on raising arm since receiving vaccination. Ibuprofen 400 mg three times a day 25 mg Benadryl at night for sleep. Consulted with Dr. on October 13, 2020 and November 6, 2020. Referred to Orthopedic Surgeon on November 10 and November 17. Had x-rays of shoulder on November 10 and MRI of shoulder on November 12.  Received corticosteroid injection in left shoulder by Dr. on November 17.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, Tendon disorder, X-ray limb
Clinical narrative: Persistent pain and limitation of range of movement (now for more than  10 weeks) in left shoulder on raising arm since receiving vaccination. Ibuprofen 400 mg three times a day 25 mg Benadryl at night for sleep. Consulted with Dr. on October 13, 2020 and November 6, 2020. Referred to Orthopedic Surgeon on November 10 and November 17. Had x-rays of shoulder on November 10 and MRI of shoulder on November 12.  Received corticosteroid injection in left shoulder by Dr. on November 17.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Caller had fever and chills
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Hyperaesthesia, Skin lesion
Clinical narrative: Extreme sensitivity to touch in left torso from front to back. Extreme pain in affected area. Sores in affected area. Effects have lessened but still exist as of today.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Fatigue, Injection site pruritus, Malaise
Clinical narrative: About a few hours after vaccination, patient reported itching all over the body, swelling at the injection site. Her arm was sore. We followed up with patient and patient felt sick and achy up to today after almost 3 days. Patient used Benadryl cream to help with the itching and Ibuprofen to help with the soreness. However, no signs of fever, difficulty breathing. After almost 3 days, the itching at injection site is described as "a ball size"; other areas itching has gone away. Patient is still tired and feels sick.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: About a few hours after vaccination, patient reported itching all over the body, swelling at the injection site. Her arm was sore. We followed up with patient and patient felt sick and achy up to today after almost 3 days. Patient used Benadryl cream to help with the itching and Ibuprofen to help with the soreness. However, no signs of fever, difficulty breathing. After almost 3 days, the itching at injection site is described as "a ball size"; other areas itching has gone away. Patient is still tired and feels sick.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site pruritus, Injection site swelling, Peripheral coldness
Clinical narrative: Patient developed fever and chills, had cold hands all of Friday night and then on Saturday the injection site was swollen with purple bruising.  Currently the whole arm is tender and patient has itching at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: Patient developed fever and chills, had cold hands all of Friday night and then on Saturday the injection site was swollen with purple bruising.  Currently the whole arm is tender and patient has itching at injection site.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: The patient developed a rash on her scalp and on her cheeks. She had an itchy scalp and back of neck.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Pain in extremity, X-ray
Clinical narrative: Patient received the Fluzone HD shot on 10/23/2020. A few days later, pt was complaining that her arm was hurting. Her son took her to the doctor's office on 12/04/2020 since she wasn't getting any better. Dr's office called the pharmacy on 12/04/2020 saying the pt had a reaction to the Flu shot.  Dr gave the patient Lidocaine patches and arm pain cream.  They did an x-ray and are awaiting the results as of today when we spoke to the dr's office.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia, Tremor
Clinical narrative: Uncontrollable shaking, fever up to 101.6, some nausea and muscle pain in place of shot. Started around 11:00pm and took Tylenol to lower temperature. This worked over night, lowering temperature back to normal, 98.6.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Immunology test, Polymerase chain reaction positive, Rash, Rash papular
Clinical narrative: On 11/14/20 developed a rash over the face, upper and lower extremities, and trunk.  The rash was papular with some vesicles as well.  The rash was not itchy.  There was no associated fever.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: On 11/14/20 developed a rash over the face, upper and lower extremities, and trunk.  The rash was papular with some vesicles as well.  The rash was not itchy.  There was no associated fever.
Age: 50.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Hypoaesthesia, Loss of personal independence in daily activities, Muscular weakness, Pain
Clinical narrative: The day following vaccine administration he began to develop acute diffuse pain in the shoulder region radiation both up toward the neck and down toward the elbow associated with limb weakness/numbness. Describes pain as persistent and weakness sufficient so as to not be able to hold a cup of coffee.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on right side of torso in two areas.  Dr. treated symptoms that were resolved within 9 days.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Small rash, circular around site of injection; itchy, red in color
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: No adverse event
Clinical narrative: no adverse affect at time of dosage
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Patient experiencing numbness in fingertips at time of vaccine. She is still having numbness/tingling in shoulder/neck as well.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: patient came in on 12/6 saying he has been having a swollen arm where injection was given. the arm in his arm is a little swollen and hard. it is also warm to touch. he reports no pain moving the arm and has no fever or other symptoms.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Grip strength decreased, Oedema peripheral, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: No symptoms including pain, redness or swelling were seen or reported at the time of vaccine and patient was in clinic well over 15 minutes once vaccine was given. After vaccine patient was in clinic for a well woman exam with pap smear. Patient had a virtual visit with Dr. 11/13/2020 reporting right arm & hand swelling but the arm swelling had gone down and at that point was only the right hand. Patient was prescribed ibuprofen 600mg and urged to follow up if swelling persisted past 3-5 days. Patient was seen again on 11/19/2020 for right hand edema by Dr. - per note: Reports having swelling on top of right hand  with decreased strength. Denies any current redness at injection site, fever, nausea, vomiting. Pain is worse when making a fist, no pain or swelling of smaller joints of the right hand. Patient was given diclofenac topical for pain. Advised to use moist heat and ice and follow up in 3 weeks with possible occupational therapy referral. Patient then had a virtual visit with PCM on 12/7/2020 for right hand pain and was referred to occupational therapy and PMR for evaluation of nerve testing as well as  x-ray of right hand. Patient was prescribed Gabapentin 100mg for nerve pain with advice to taper up to 300mg if needed. Patient was advised to follow up if needed.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood test, Chest X-ray, Cough, Fatigue, Malaise
Clinical narrative: fever; significant arm swelling; feeling ill; dry cough; extreme fatigue; This spontaneous report has been received from a 72 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 03-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) 0.5 milliliter for prophylaxis. Other suspect therapies included influenza virus split virion 4v vaccine inactivated (FLUZONE) (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided).On the same date, the patient experienced fever, significant arm swelling, especially on the vaccination side, dry cough, extreme fatigue and "feeling ill". On 30-NOV-2020, the patient went to visit a clinic where a chest ray and a bloodwork were drawn, however, no result had been received yet. The patient sought for medical attention, but no treatment was given. At the reporting time, the outcome of pyrexia, fatigue, cough, malaise and peripheral swelling was reported as not resolved. The causality assessment was not provided.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: fever; significant arm swelling; feeling ill; dry cough; extreme fatigue; This spontaneous report has been received from a 72 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 03-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) 0.5 milliliter for prophylaxis. Other suspect therapies included influenza virus split virion 4v vaccine inactivated (FLUZONE) (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided).On the same date, the patient experienced fever, significant arm swelling, especially on the vaccination side, dry cough, extreme fatigue and "feeling ill". On 30-NOV-2020, the patient went to visit a clinic where a chest ray and a bloodwork were drawn, however, no result had been received yet. The patient sought for medical attention, but no treatment was given. At the reporting time, the outcome of pyrexia, fatigue, cough, malaise and peripheral swelling was reported as not resolved. The causality assessment was not provided.
Sex: M
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: suffer on his death bed for almost a year after taking a flu vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was recovering/resolving.   It was unknown if the reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at the vaccination was not reported. The reporter watched her husband suffer on his death bed for almost a year after taking a flu vaccine. The patient was better now.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu shot and got flu; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from non-healthcare professional via social media.  This case is linked with 2020SA293945 and 2020SA293953.  This case involves a male patient of unknown age who had the INFLUENZA VACCINE (flu shot) and got the flu (influenza).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for the event.  There will be no information available for the batch number.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: so sick; Initial information received on 24-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced so sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient developed a non-serious so sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient recieved fluzone quadrivalent instead of fluzone high dose, no AE; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA312206 (same reporter).  This case involves a 77 years old female patient who recieved  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020 (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered (Same day latency).  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.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome, Wheelchair user
Clinical narrative: patient got Guillian-Barre / patient died from it/ passed away; wound up in a wheel chair suffered; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case from a non-health care professional (Patient's Friend) via social media.  This case involved female patient of unknown age who developed Guillian-Barre/ died from it /passed away (Guillain-Barre syndrome) and wound up in a wheel chair (wheelchair user) , after receiving INFLUENZA VACCINE.  The patient's past vaccinations included flu shot.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious events of Guillian-Barre/ died from it/ passed away (Guillain-Barre syndrome) and wound up in a wheel chair (wheelchair user) unknown latency, following the vaccination. These events were assessed as medically significant and were leading to disability. It was reported that patient suffered for about 4 years.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was fatal for the event Guillain-Barre syndrome and died on an unknown date. It was unknown if an autopsy was done. The cause of death was reported as Guillain-Barre syndrome.  Information on the batch number to be requested for this case; Sender's Comments: This poorly documented social media involves a female patient of unknown age who presented Guillain-Barre syndrome, wounded up in a wheel chair and died after vaccination with an INFLUENZA VACCINE. Time to onset is unknown. The cause of death was unspecified. Moreover, additional information regarding their relevant medical history, health condition at time of vaccination and Laboratory tests, autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Guillain Barre syndrome
Sex: M
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: patient died after getting the shot from what it was to prevent; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional.  This case involves a male patient (age not reported) who died after getting the INFLUENZA VACCINE from what it was to prevent (influenza).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer batch number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (unknown latency) following the administration of INFLUENZA VACCINE from what it was to prevent (influenza).   No laboratories details reported.  It was not reported if the patient received any corrective treatment before he died.  It was unknown if an autopsy was done.   Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a male patient who had influenza infection and died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient died after getting the shot from what it was to prevent
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received Fluzone Quadrivalent vaccine subcutaneously instead of intramuscular route, no AE; Initial information regarding an unsolicited valid non-serious case received from pharmacist via The Agency (Reference number- 00325597) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 57-years-old female patient who was received 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe, lot number and expiry date not reported) via subcutaneous route at back arm for prophylactic vaccination (incorrect route of product administration).  Medical history, past medical treatment, vaccination and family history were not provided.   Patient did not received any other vaccine.  This was a case of an actual medication error case due to incorrect route of product administration (latency same day).  It was reported that pharmacist who was also a patient states that she received either a Fluzone Quadrivalent or a Flublok vaccine (she was not sure which). The patient received her dose in the back of the arm. Because of this, she believes it was a subcutaneous injection. She asks if the vaccine was just as effective if it was given subcutaneously.  The patient had not experienced any adverse event.  Reporter relationship: Self, Product used: Used, First time product used: Yes, Still using product: No and Was Device Used: Yes.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the lot number for this case.
Age: 36.0
Sex: M
Vaccine: FLUR4
Symptoms: Chest X-ray, Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches; severe headache; Bodytemperature of 102 -105 Fahrenheit; chills; Initial information regarding an unsolicited valid non-serious case was received from a consumer (Reference number- 00335714) and transmitted to Sanofi on 28-Oct-2020.   This case involves a 36 years old male patient who experienced body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills, while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 21-Oct-2020, the patient received a dose  of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number not reported) via intramuscular route in the right arm.  On 24-Oct-2020, the patient developed a non-serious body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills 3 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test results included: Body temperature - On 24-Oct-2020: 102 Fahrenheit ; on 26-Oct-2020: 104 Fahrenheit ; on an unknown date: 105 Fahrenheit   Chest X-ray - On 26-Oct-2020:  (Unknown result)  SARS-CoV-2 test (COVID test)- On 24-Oct-2020: Negative  Final diagnosis was body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills.  The patient was treated with PARACETAMOL (TYLENOL) and IBUPROFEN (IBUPROFEN).  The patient was not recovered from the events at the time of this report.  There will be no information on the batch number for this case.
Age: 36.0
Sex: M
Vaccine: FLUR4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Body aches; severe headache; Bodytemperature of 102 -105 Fahrenheit; chills; Initial information regarding an unsolicited valid non-serious case was received from a consumer (Reference number- 00335714) and transmitted to Sanofi on 28-Oct-2020.   This case involves a 36 years old male patient who experienced body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills, while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 21-Oct-2020, the patient received a dose  of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number not reported) via intramuscular route in the right arm.  On 24-Oct-2020, the patient developed a non-serious body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills 3 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test results included: Body temperature - On 24-Oct-2020: 102 Fahrenheit ; on 26-Oct-2020: 104 Fahrenheit ; on an unknown date: 105 Fahrenheit   Chest X-ray - On 26-Oct-2020:  (Unknown result)  SARS-CoV-2 test (COVID test)- On 24-Oct-2020: Negative  Final diagnosis was body aches (pain), severe headache (headache), body temperature of 102 -105 Fahrenheit (Fever) and chills.  The patient was treated with PARACETAMOL (TYLENOL) and IBUPROFEN (IBUPROFEN).  The patient was not recovered from the events at the time of this report.  There will be no information on the batch number for this case.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia, Rash
Clinical narrative: Patient exhibited fever, myalgia, chills, and  a rash in the upper torso, arm, and thigh that spread from one side to another. This occurred over a period of 2 days since the vaccination. Upon timing of call to facility, patient reported that rash was improving but not fully resolved while the other adverse effects fully resolved.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: right sided face numbness developed on 12/5 at 9am, continued through 12/7 when evaluated by CNP
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Eye infection, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Shingrix given 7/8/2020. Fluarix given 9/21/2020. Shingrix given 10/28/2020. Eye infections 9/28/20, 10/7/20, 10/23/20 Back pain, joint pain Hip pain 11/2/20 Toe pain 11/10/20 Pt is seeing multiple doctors about sudden onset of pains and infections. Doctors think it may be related to Shingrix vaccinations and told pt to call Pharmacist to report.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injury associated with device
Clinical narrative: rph received needle stick after administering flu shot to patient
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Colonoscopy, Computerised tomogram, Face oedema, Fatigue
Clinical narrative: Facial edema started on 5/22/2019 - continues intermittently to date ER visits Referral to dermatologist Abdominal pain started in Aug-Sept 2019 - continues to date Visit to OBGYN abdominal ultrasound CT scan at Hospital  Referral to GI doctor - colonoscopy performed Allergy doctor and allergy testing Multiple visits to ER OBGYN visit Primary care visit Back to GI  Since receiving this vaccine, my daughter has experienced numerous episodes of facial swelling and abdominal pain and the conditions continue to worsen.  Currently, we are in our longest episode.  It started on 11/10/20 and is still occurring (4 weeks) - symptoms include abdominal pain, fever, facial swelling, and fatigue.  We have been to 7 doctors who have run numerous tests and have not found anything to contribute symptoms to.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pyrexia, Swelling face, Ultrasound scan
Clinical narrative: Facial edema started on 5/22/2019 - continues intermittently to date ER visits Referral to dermatologist Abdominal pain started in Aug-Sept 2019 - continues to date Visit to OBGYN abdominal ultrasound CT scan at Hospital  Referral to GI doctor - colonoscopy performed Allergy doctor and allergy testing Multiple visits to ER OBGYN visit Primary care visit Back to GI  Since receiving this vaccine, my daughter has experienced numerous episodes of facial swelling and abdominal pain and the conditions continue to worsen.  Currently, we are in our longest episode.  It started on 11/10/20 and is still occurring (4 weeks) - symptoms include abdominal pain, fever, facial swelling, and fatigue.  We have been to 7 doctors who have run numerous tests and have not found anything to contribute symptoms to.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Allergy test negative, Colonoscopy normal, Computerised tomogram normal, Eye swelling
Clinical narrative: Facial edema started on 5/22/2019 - continues intermittently to date ER visits Referral to dermatologist Abdominal pain started in Aug-Sept 2019 - continues to date Visit to OBGYN abdominal ultrasound CT scan at Hospital  Referral to GI doctor - colonoscopy performed Allergy doctor and allergy testing Multiple visits to ER OBGYN visit Primary care visit Back to GI  Since receiving this vaccine, my daughter has experienced numerous episodes of facial swelling and abdominal pain and the conditions continue to worsen.  Currently, we are in our longest episode.  It started on 11/10/20 and is still occurring (4 weeks) - symptoms include abdominal pain, fever, facial swelling, and fatigue.  We have been to 7 doctors who have run numerous tests and have not found anything to contribute symptoms to.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Intussusception, Lip swelling, Pyrexia, Swelling face, Ultrasound abdomen
Clinical narrative: Facial edema started on 5/22/2019 - continues intermittently to date ER visits Referral to dermatologist Abdominal pain started in Aug-Sept 2019 - continues to date Visit to OBGYN abdominal ultrasound CT scan at Hospital  Referral to GI doctor - colonoscopy performed Allergy doctor and allergy testing Multiple visits to ER OBGYN visit Primary care visit Back to GI  Since receiving this vaccine, my daughter has experienced numerous episodes of facial swelling and abdominal pain and the conditions continue to worsen.  Currently, we are in our longest episode.  It started on 11/10/20 and is still occurring (4 weeks) - symptoms include abdominal pain, fever, facial swelling, and fatigue.  We have been to 7 doctors who have run numerous tests and have not found anything to contribute symptoms to.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site induration, Injection site mass, Nervousness
Clinical narrative: Immediately after injection, a small hard lump formed at injection site. Had patient sit for ~20min, patient started to feel a little dizzy, unsure whether it is from the vaccine itself or nervousness from the lump. Lump softened in ~20min but was still there, patient was feeling okay after some rest and went home. Patient did not want ambulance to be called.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema
Clinical narrative: red, rectangular area just under the site of injection for 3-5 days, really tired on 11/21 (the day after immuinization), then progressively better over next 2 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm, shivering
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: patient developed low grade fever the day following his vaccines. on or near 11/8/2020, patient developed red marks at vaccine site as well as down the arm
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Rheumatoid arthritis, X-ray abnormal
Clinical narrative: Severe shoulder pain
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: She felt pain at time of injection that did not resolve with continued swelling 3 to 4 days later. On 11/23 arm was stiff and on 11/26 it was painful to raise her arm.  She saw her PCP on 11/27/2020 and was given a Medrol Dose Pak. Since completing the steroid it has been less painful but still has reduced range of motion. Will follow up with provider.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt was inadvertently given MenB instead of MenactraACWY -- no adverse reactions.