chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site swelling
Clinical narrative: Extreme fatigue in the evening; next morning severe muscle pain throughout the whole body; shivering; headache; fever; stomach pain; nausea; extreme fatigue; goose egg sized swelling at injection site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Extreme fatigue in the evening; next morning severe muscle pain throughout the whole body; shivering; headache; fever; stomach pain; nausea; extreme fatigue; goose egg sized swelling at injection site
Age: 2.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Very red , hot to touch , very hard and tight around injection site , keeps getting bigger
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Injection site and muscle pain. Gradually, left arm movement became limited, and muscle strength weak and stiff.   it lasts from Oct 3, 2020 till now.  It is more than two months, my left arm movement is still limited. .
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Back pain, Blood urine present, Eye discharge, Hordeolum
Clinical narrative: Two styes in my eyes, treated twice by eye doctor. Bubbles in my urine,blood in urine, more back pain and more stomach pain
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Urine abnormality, Urine analysis normal, pH urine normal
Clinical narrative: Two styes in my eyes, treated twice by eye doctor. Bubbles in my urine,blood in urine, more back pain and more stomach pain
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Hypophagia, Lethargy, Pyrexia, Rash
Clinical narrative: Patient had onset of low grade fever, decreased oral intake and rash for 2 days prior to er visit. Pt presented to the er with after febrile seizure, high fever (104) and inconsolable/lethargic approx. 2 hours after the seizure. Pt was examined by ems immediately after seizure. Patient was treated with ibuprofen/Tylenol and IV fluids and had comprehensive workup. Patient improved significantly and was cleared for d/c home with close f/u with PCP.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Rash, SARS-CoV-2 test negative
Clinical narrative: Pain in upper back began evening of 11/27 and persisted. Feared a heart attack so went to the ER 11/29.  Ruled out heart attack and treated for other GI symptoms, tested negative for COVID.  Later that week tested positive for COVID (exposure at hospital?).  Burning and pain started on chest, opposing side of the back pain.  On 12/5 a rash developed on the irritated chest area below the breast.  Shingles suspected.  Had phone appointment with Dr on 12/7 and he ordered Valtrex.  Symptoms improved therefore Shingles outbreak was a positive diagnosis per Dr office.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pain in upper back began evening of 11/27 and persisted. Feared a heart attack so went to the ER 11/29.  Ruled out heart attack and treated for other GI symptoms, tested negative for COVID.  Later that week tested positive for COVID (exposure at hospital?).  Burning and pain started on chest, opposing side of the back pain.  On 12/5 a rash developed on the irritated chest area below the breast.  Shingles suspected.  Had phone appointment with Dr on 12/7 and he ordered Valtrex.  Symptoms improved therefore Shingles outbreak was a positive diagnosis per Dr office.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore left arm, nausea, headache, brief fever, about 36 hours, took aspirin
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis acneiform, Rash
Clinical narrative: Patient developed a rash over chest, arms, and neck approximately 1-2 hours after vaccination. Vital signs remained stable, BP 122/70, HR 62. Patient returned to vaccination site and was administered 50mg diphenhydramine. Rash resolved within an hour.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Aspiration bone marrow, Blood test, Coagulopathy, Contusion, Haemorrhage
Clinical narrative: I almost died.  I contracted ITP.  My body started attacking it's own white blood cells.    My white platelet count went to zero.  I could not fight off infections.  I was covered with bruises.  Any where I got injured, my cuts would not coagulate and I almost bled to death on multiple occasions.  I could not do anything for risk of opening my flesh or having internal bleeding.  Internal bleeding would result in certain death.   They tested for leukemia.  They took marrow out of my spine.  I was in Hospital for 3 days.  They took blood every week for a year until levels returned to normal.  Too this day I have a deathly fear of hospitals, needles, blood, iodine, bandages, bruising, injury etc.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Immune thrombocytopenia, Platelet count decreased
Clinical narrative: I almost died.  I contracted ITP.  My body started attacking it's own white blood cells.    My white platelet count went to zero.  I could not fight off infections.  I was covered with bruises.  Any where I got injured, my cuts would not coagulate and I almost bled to death on multiple occasions.  I could not do anything for risk of opening my flesh or having internal bleeding.  Internal bleeding would result in certain death.   They tested for leukemia.  They took marrow out of my spine.  I was in Hospital for 3 days.  They took blood every week for a year until levels returned to normal.  Too this day I have a deathly fear of hospitals, needles, blood, iodine, bandages, bruising, injury etc.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Diplopia, Hypoaesthesia, Hyponatraemia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Patient started experiencing nausea, vomiting, diplopia, numbness in lower extremities on November 4. Also weakness in LE Then on Nov 8 she was admitted to hospital for symptoms, worked up and diagnosed with Guillain-Barre Miller Fisher variant Hospital stay Nov 8 - 29th Patient had a lengthy hospital stay. While being diagnosed with Guillain Barre she developed severe hyponatremia and orthostatic hypotension due to Guillain Barre. Patient improved with IVIG. Following with specialists.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Magnetic resonance imaging, Miller Fisher syndrome, Muscular weakness, Nausea, Nerve conduction studies
Clinical narrative: Patient started experiencing nausea, vomiting, diplopia, numbness in lower extremities on November 4. Also weakness in LE Then on Nov 8 she was admitted to hospital for symptoms, worked up and diagnosed with Guillain-Barre Miller Fisher variant Hospital stay Nov 8 - 29th Patient had a lengthy hospital stay. While being diagnosed with Guillain Barre she developed severe hyponatremia and orthostatic hypotension due to Guillain Barre. Patient improved with IVIG. Following with specialists.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Orthostatic hypotension, Vomiting
Clinical narrative: Patient started experiencing nausea, vomiting, diplopia, numbness in lower extremities on November 4. Also weakness in LE Then on Nov 8 she was admitted to hospital for symptoms, worked up and diagnosed with Guillain-Barre Miller Fisher variant Hospital stay Nov 8 - 29th Patient had a lengthy hospital stay. While being diagnosed with Guillain Barre she developed severe hyponatremia and orthostatic hypotension due to Guillain Barre. Patient improved with IVIG. Following with specialists.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Severe pain to arm throbbing, can't move up/down unrelieved by pain meds.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Rash papular
Clinical narrative: Pink circular, upraised rash around site of injection. Denies fever. Diameter was about 3/4 an inch.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Angina pectoris, Heart rate increased, Spinal pain
Clinical narrative: Few minutes after giving the shot, patient returned in severe pain ,  starting from lower spine and going up to the heart.  Also had fast HR and high BP (EMS - 196/90).  Pt. sat down in chair , given cold water , while called 911 for check-up.  EMS recommended she see cardiologist , offered to drive her , but pt refused & went home.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Allergy to vaccine, Muscle injury, Nerve injury
Clinical narrative: severe reaction of nerve and muscle damage; severe reaction of nerve and muscle damage; now allergic to any flu shot; Initial information regarding an unsolicited valid non-serious courtesy case received from a non-healthcare professional (patient) via Pfizer(reference number: 2020481186) on 07-Dec-2020.  This case involved a 67-year old patient of an unknown gender (age at vaccination: 66-years) who experienced severe reaction of nerve (Nerve injury) and muscle damage (Muscle injury), and was now allergic to any flu shot (Allergy to vaccine), after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (FLUZONE HIGH DOSE).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient had ongoing lung disease.  On an unknown date in Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient developed severe reaction of nerve (Nerve injury) and muscle damage (Muscle damage) and was now allergic to any flu shot (Allergy to vaccine). The patient was now wondering the safety about receiving coronavirus infectious disease (COVID) vaccine shot and asked about the dangers needed to consider before receiving the shot.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of all the events was reported as unknown.  There will be no information available on the batch number for this case.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, SMALL, TYP, TYP, ANTH, JEV1, SMALL, TYP
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin increased, Human chorionic gonadotropin negative
Clinical narrative: FOLLOW-UP to VAERS, Pregnancy: G1.  Pregnant.  LMP: 06 Feb 2020.  EDD: 17 Nov 2020. Date Basis: Ultrasound.  . PREGANCY OUTCOME:  Delivered healthy infant girl, at 38 weeks, 6 days. APGARS 8/9. Birth weight 3270 grams. Elevated bilirubin while hospitalized; treated with phototherapy. Had 2 week follow-up: screening normal, breastfeeding, small umb hernia noted
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, SMALL, TYP, TYP, ANTH, JEV1, SMALL, TYP
Symptoms: Delivery, Pregnancy
Clinical narrative: FOLLOW-UP to VAERS, Pregnancy: G1.  Pregnant.  LMP: 06 Feb 2020.  EDD: 17 Nov 2020. Date Basis: Ultrasound.  . PREGANCY OUTCOME:  Delivered healthy infant girl, at 38 weeks, 6 days. APGARS 8/9. Birth weight 3270 grams. Elevated bilirubin while hospitalized; treated with phototherapy. Had 2 week follow-up: screening normal, breastfeeding, small umb hernia noted
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Pain
Clinical narrative: Pt experiencing unresolved pain.  Lump under left arm with pain upon moving.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Induration, Pain
Clinical narrative: Pt experiencing unresolved pain.  Lump under left arm with pain upon moving.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Herpes zoster ophthalmicus; Shingles; Information has been received from a lawyer regarding a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 26-DEC-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route, anatomical location, lot# and expiration date unknown) for its intended purpose: the prevention of shingles. Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), pt suffered severe side effects including shingles rash and was diagnosed with shingles and Herpes Zoster Ophtalmicus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of use of zoster vaccine live (ZOSTAVAX).  Upon internal review, Herpes Zoster Ophtalmicus was considered to be a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Laboratory test, Mobility decreased, Pain, Paralysis
Clinical narrative: pain; paralyzed from the waist down; issues with her mobility and balance; issues with her mobility and balance; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   The patient reported that she was totally paralyzed and she believed it was due to the zoster vaccine live (ZOSTAVAX) she took on an unknown date in February 2017 (reported as 29-FEB-2017) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). She explained she started to have issues with her mobility (Mobility decreased ) and balance (Balance disorder) 5-10 days after the vaccine was given. She went to go visit her cousin in another city and on 27- OCT-2017, she started to have even harder time maintaining her balance. Her cousin took her to the hospital on 29-OCT-2017 and she was completely paralyzed from the waist down (paraplegia), she stated they did some tests (unspecified) and gave her medicine. At the time of reporting, the patient had not recovered from mobility decreased, balance disorder and paraplegia. The patient anted compensation for all the pain she endured.   Upon internal review, the event paraplegia was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a physician's office for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue 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 include 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 events was considered to be not recovered/not resolved. The reporter considered the events of shingles and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: sore arm; This spontaneous report was received from a lawyer and a female patient who approximately in 2000, was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown), for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).       On an unknown date, the patient experienced sore arm (pain in extremity).    The outcome of pain in extremity was unknown.  Causality assessment was not provided.    Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) which caused shingles (captured in MARRS 2004USA001156).; Sender's Comments:  US-009507513-2004USA001156: US-009507513-2012USA004280:
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Engerix Was Administered for the Second Dose; Initial Report Received on 13-Nov-2020  A pharmacist reported that a 32 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for her first dose of hepatitis B immunization, and then Engerix for the second dose.   No medical history was reported.   No concomitant medications were reported.  On 15-Oct-2020, the patient received the first dose of HEPLISAV-B to the right deltoid (Lot # 933622, expiration date 01-Aug-2021 and NDC # not reported).  On 13-Nov-2020, 30 days after the first injection, the patient received Engerix (Lot # 239TF, expiration date 04-Jun-2022) for the second dose to the left deltoid. No adverse reactions were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Received the Second Dose of HEPLISAV-B (A Year After the First Dose); Received a Dose of HEPLISAV-B and then a dose of ENGERIX-B; Initial Report Received on 16-Nov-2020 and 17-Nov-2020  A pharmacist reported that a 40 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for his first dose of hepatitis B immunization, then ENGERIX-B for his second dose. He was then administered the second dose of HEPLISAV-B a year after the first dose.  No medical history was reported.   No concomitant medications were reported.  On 19-Nov-2019, the patient received the first dose of HEPLISAV-B (Lot # 933837, expiration date 05-May-2021 and NDC # not reported) from a pharmacy.  On 11-Jun-2020, 206 days after receiving the first injection of HEPLISAV-B, the patient was given Engerix-B (Lot # KC57F, expiration date 04-Sep-2021) from another pharmacy.  On 16-Nov-2020, the pharmacist contacted medical information to get information on HEPLISAV-B administration after a dose 2 of Engerix-B.  On an unspecified date after receiving the information, a year after receiving the first dose of HEPLISAV-B, the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) was administered.  At the time of the report, the customer had not reported any adverse events with regards to the vaccinations received.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: shot made patient very sick; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involves a patient (unknown age and gender) who had INFLUENZA VACCINE which made him/her very sick (Illness).  The patient's medical history, medical treatment(s), vaccination(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 at unknown administration site for prophylactic vaccination.  On an unknown date, the patient was very sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: always made sick; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious social media case was received from a consumer (patient) via Social media.  This case is linked to case 2020SA297501.  This case involves a patient of an unknown age and gender who got always sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, 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 unknown administration site for prophylactic vaccination.  On an unknown date, the patient got always sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that if it don't make you sick for 24 hours it want work.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown, at the time of reporting.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: felt like crap for 2 days; Initial information received on 12-Dec-2020 and additional information received on 22-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case is linked to case 2020SA300039 and 2020SA300039.  This case involves a patient of unknown demographics who felt like crap for 2 days (feeling abnormal), when received Influenza Vaccine.  The patient's medical history, medical treatments, vaccinations, 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 (batch number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect the patient felt like crap for 2 days (feeling abnormal).  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: worst case of the flu ever; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious social media case was received from a consumer (patient) via Social media.  This case involves a patient of an unknown demographic experienced worst case of the flu ever (influenza), when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date in 1976, 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 unknown administration site for prophylactic vaccination.  On an unknown date in 1976, the patient developed a non-serious worst case of the flu ever (influenza) two days following the administration of INFLUENZA VACCINE.  Adverse event lasted a week and took 3 trips to the Doctor.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: little cold, but not too bad; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 27-Oct-2020.  This case is linked to cases 2020SA305230 and 2020SA305527.  This case involves a patient of an unknown age who had a little cold, but not too bad (Nasopharyngitis) when the patient received INFLUENZA VACCINE>  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination   On an unknown date (latency unknown) after administration of INFLUENZA VACCINE, patient experienced little cold, but not too bad (Nasopharyngitis). The patient got the cold before INFLUENZA VACCINE settled in the two weeks duration and was feeling much better at the time of this report.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as recovering, at the time of reporting.  There will be no information regarding the batch number for the case.
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: Got flu shot, had a little cold, but not too bad; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case is linked to cases 2020SA305170, 2020SA305230 and 2020SA305527.  This case involves a male patient of unknown age who had a little cold, but not too bad (nasopharyngitis), after he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received an unknown dose of 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 (unknown latency), the patient had a little cold, but not too bad (nasopharyngitis), 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 patient was recovering from the event.  There will be no information available on lot number.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: sicker than any other time; flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Social Media and transmitted to Sanofi on 29-Oct-2020.  This case is linked to cases 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300, 2020SA306301, 2020SA306302, 2020SA306303, 2020SA306304, 2020SA306305 and 2020SA306306.  This case involves unknown age and gender patient who was sicker than any other time (Illness) and got flu (influenza), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, 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 was sicker than any other time (Illness) and got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE and it was reported that would not take more shots.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Events outcome was unknown, at the time of reporting.  There will be no information regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got the flu shot in 1994 and was really sick that year; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 31-Oct-2020.  This case involves an unknown age and gender patient who got really sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE.   On an unknown date in 1994, the patient got the INFLUENZA VACCINE (produced by unknown manufacturer) (batch number unknown) via an unknown route in an unknown administration site for prophylactic vaccination and was really sick that year (illness) (unknown latency).   It was not reported if the patient received a corrective treatment.  Event outcome was unknown, a the time of reporting.  There will be no information regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu after it; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 31-Oct-2020.  This case was linked to cases 2020SA307606, 2020SA307607, 2020SA307608, 2020SA307609, 2020SA307610, 2020SA307611, 2020SA307612, 2020SA307613, 2020SA307614 and 2020SA307599 (same reporter).  This case involved a patient with unknown demographics who got the flu (influenza) after the patient received INFLUENZA VACCINE.  The patient's past vaccination(s) included flu vaccine. Always got the flu after it. Been without 40 something years. Relevant medical history, past medical treatment, 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves a patient with an unspecified demography who got flu (influenza), when received 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) [batch 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 flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu every time she took shot.  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 event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got sick as hell; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).   This case involves patient (unknown demographics) who got sick as hell (illness), while patient received INFLUENZA VACCINE [Flu shot].  Medical treatment, concomitant medication and family history were not provided.   Medical history includes a similar reaction (illness) to the INFLUENZA VACCINE in the past.  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 sick as hell (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got shot twice and sick as hell.   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 event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick as hell; Initial information was received on 11-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via social media.  This case involves a patient (unknown demography) who got sick as hell (illness), after the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date in 1972, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1972, the patient was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient never had one and flu since.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got a sick as a dog; Initial information was received on 11-Nov-2020 regarding an unsolicited valid non-serious case from a social media (Facebook) via consumer or non-health care professional (patient).  This case involves patient (with unknown demographics) who was sick (got sick as a dog) (illness), while patient received 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) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (got a sick as a dog) (illness) (non-serious) 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 event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: They make the patient sick; Initial information was received on 12-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who got sick (illness), after the patient received influenza vaccine.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of Influenza vaccine [batch number and expiration date not reported] unknown dose via an unknown route and administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the sick (illness) the patient tried it and was super careful.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: the patient had almost killed; Initial information regarding this unsolicited valid serious social media from a consumer (patient) and transmitted to Sanofi on 04-Dec-2020.  This case involved a patient of unknown demographics who was almost killed (near death experience), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history included cannabis use.  Past medical treatment, vaccination details, 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 (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was almost got killed (near death experience), unknown latency following the administration of INFLUENZA VACCINE.  This event was assessed as medically significant as per important medical event (IME) list.  Relevant laboratory test was not reported.  Final diagnosis was near death experience.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown demographics who reportedle had a near death experience after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Patient's medical condition included use of cannabis. Concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: patient spent months in the hospital fighting for his life after taking flu shot and had an extreme reaction to it; Initial information regarding an unsolicited valid serious case received from a consumer via Social media on 07-Dec-2020.   This case involves an unknown age male patient who spent months in the hospital fighting for his life after taking the Influenza Vaccine and had an extreme reaction to it (Adverse reaction).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date patient received Influenza vaccine produced by unknown manufacturer (lot number and expiry date unknown) via an unknown route at an unknown site for prophylactic vaccination.  On an unknown date, (unknown latency) following vaccination, patient who spent months in the hospital fighting for his life and had an extreme reaction to it (Adverse reaction) (Seriousness criteria- Hospitalization)  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown for the event.  There will be no information regarding batch number for the case.; Sender's Comments: Sanofi company comment dated 09-Dec-2020: This poorly document case concerns patient who was presented adverse reaction with INFLUENZA VACCINE. The time to onset is unknown. However, patient's medical condition, concomitant medications and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: can still get the flu even though you get the shot, both type A and B few years ago; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (patient) via social media on 06-Dec-2020.  This case involved a patient of an unknown age and gender who reported that can still get the flu even though you get the shot and developed both type a and b few years ago (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(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 an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that someone could get the flu even though that person got a flu shot and the patient had both type A and B of flu few years ago (Influenza).  No relevant laboratory details were reported.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster, Vaccine positive rechallenge
Clinical narrative: break out in shingles; Initial information regarding an unsolicited valid non-serious case from a consumer (patient) via social media on 07-Dec-2020.  This case involves an unknown demography patient who got INFLUENZA VACCINE and broke out in shingles (Herpes zoster).  Medical history, medical treatments, vaccinations, 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 (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) following vaccination patient broke out in shingles (Herpes zoster).  Case details- every time patient get the flu shot the patient broke out in Shingles, would rather had flu.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was Unknown for Herpes zoster.  There will be no information available regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Pneumonia
Clinical narrative: pneumonia; sick; Initial information regarding an unsolicited valid serious social media case was received from a non-healthcare professional (patient) via social media on 07-Dec-2020.  This case involves a patient of an unknown age and gender who experienced pneumonia and was sick (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (batch number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the patient was so sick (Illness) and had pneumonia and was placed on antibiotics (Z-pack) cough syrups. Doctor of the patient almost put the patient in the hospital, but the patient preserved and after a week, was way better. The patient was now afraid to take a coronavirus infectious disease (COVID-19) immunization because of fear that the patient could die. So the patient would take the chances and would take lots of vitamins, eat healthy and wear a mask and hope for the best.  No relevant laboratory details were provided.  The event of pneumonia was assessed as medically significant as per the important medical events list and the event of illness was assessed as non-serious.  Outcome of both the events was resolving at the time of report.  Information on the batch number was requested for this case.; Sender's Comments: This case involves a patient of an unknown age and gender who presented with pneumonia after receiving  INFLUENZA VACCINE from unknown manufacturer. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: patient passed away, death NOS; Initial information received on 08-Dec-2020 regarding an unsolicited valid serious case received from a consumer via social media.  This case is linked to case 2020SA353949.  This case involves male patient of an unknown age who passed away (death), while he 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 passed away (death), one week following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting no autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case involves a male patient of an unknown age who died, one week after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible with the role of the vaccine. 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 passed away, death NOS
Sex: U
Vaccine: FLUX
Symptoms: H2N2 influenza
Clinical narrative: got asian influenza, it almost killed me; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (patient) via social media on 07-Dec-2020.  This case involved a patient of an unknown demographics who got Asian influenza and it almost killed the patient (H2N2 influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine (swine flu vaccine (1976), monovalent) for prophylactic vaccination.  On an unknown date in 1980, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  It was reported by the patient that if someone had a cold and got flu shot, that person would catch the flu or strain of the flu virus that was not covered by the vaccine.   On an unknown date in 1980 (unknown latency), the patient got the swine flu vaccine and a normal flu shot and the patient was caught by Asian influenza and it almost killed the patient (H2N2 influenza). The patient did not have a flu shot since 1980 and had not been caught by flu since 1980.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of H2N2 influenza was resolved at the time of reporting.  There will be no information available on the batch number for this case.