chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: partial dose of FLUZONE HD due to some of the vaccine leaking during administration, caller reported needle was intact in syringe and intact in arm but patient felt liquid running down arm, with no AE; partial dose of FLUZONE HD due to some of the vaccine leaking during administration, caller reported needle was intact in syringe and intact in arm but patient felt liquid running down arm, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via the agency (Reference number- 00331639) and transmitted to Sanofi on 26-Oct-2020.  This case involves a 71-year-old female patient who received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] lot number UJ535AB, expiry date 30-Jun-2021) via an intramuscular route in the right deltoid for prophylactic vaccination on 26-Oct-2020.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of actual medication error due to vaccine underdose and Exposure via skin contact.  Pharmacist reporting patient received partial dose of FLUZONE HD due to some of the vaccine leaking during administration.  Caller reported needle was intact in syringe and intact in arm but patient felt liquid running down arm.  Caller reporting unable to tell where the leaking was coming from- the point of needle insertion or from the barrel of the syringe.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: body aches; nausea; Fatigue; fever 102; chills; Initial information regarding an unsolicited valid non-serious case received from a consumer via The agency (Reference number- 00335748) and transmitted to Sanofi on 28-Oct-2020.  This case involves a 77 years old female patient who experienced body aches (pain), nausea, chills, fever 102 (pyrexia) and fatigue, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included fluzone with no adverse event, fluzone high dose in 2017 with fatigue and chils, regular Fluzone in 2018 with no adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date in 2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2019, the patient developed a non-serious body aches (pain), nausea, chills, fever 102 (pyrexia) and fatigue, within few hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date in 2019: 102 (unit not reported).   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the events (events lasted for 2 days). On the third day, she felt better. This year she received the regular flu vaccine and she felt fine.  There will be no information on the batch number for this case.
Sex: F
Vaccine: DTAP
Symptoms: Patient uncooperative, Underdose
Clinical narrative: The patient reached down and grabbed the needle and the nurse then had to withdraw the needle out of the patient's thigh and some of it spilled; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 years old female patient who reached down and grabbed the needle and the nurse then had to withdraw the needle out of the patient's thigh and some of it spilled (Underdose) while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE  (lot C5732AA;expiration date: 24-Apr-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency) it was reported that patient who was on a delayed catch up schedule for Daptacel came for her second dose. The patient reached down and grabbed the needle and the nurse then had to withdraw the needle out of the patient's thigh and some of it spilled. The patient only got some of the Daptacel dose. They did not know how much. She was due for her next one in Dec.  It was not reported if the patient received a corrective treatment.  Outcome was not applicable.  No further infprmation was reported
Sex: M
Vaccine: FLU4
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: liquid was leaking from the injection site on the patients arm/no AE; quite a bit ran out of the injection site after the needle was withdrawn/no AE; Initial information was received on 19-Nov-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves an unknown demographics male patient for whom it was reported that the patient was extremely tense while vaccination and a liquid was leaking from the injection site on the patients arm (Exposure via skin contact) and quite a bit ran out of the injection site after the needle was withdrawn (Wrong technique in product usage process), while he received Influenza Quadrival A-B vaccine (Fluzone Quadrivalent).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reportd.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine (Other dosing details were unknown, dosing interval twice, lot: UT7006MA expiry date: 30-Jun-2021) for prophylactic vaccination.  It was a case of actual medication error due to exposure via skin contact (latency: same day) and Wrong technique in product usage process.  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 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.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Woke up the next day with Chills and Headache.  Got progressively worse over the day.  Fever 101º F, muscle aches and pains.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Aspartate aminotransferase increased, Chest X-ray abnormal, Erythema multiforme, Full blood count abnormal, Metabolic function test
Clinical narrative: Patient developed low fever and a severe rash all over body with target lesions 10 days after vaccination and taken to ER where he was given steroids.  He was seen at the clinic 5 days later where he was found with the same rash (mom said was a bit better).  No fever.  Diagnosed with erythema multiforme.  Mom stopped steriods and child was prescribed antihistamine/Pepcid combination.  Called today (1 week later) and mom referred rash is fading away and child is well.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash, White blood cell count
Clinical narrative: Patient developed low fever and a severe rash all over body with target lesions 10 days after vaccination and taken to ER where he was given steroids.  He was seen at the clinic 5 days later where he was found with the same rash (mom said was a bit better).  No fever.  Diagnosed with erythema multiforme.  Mom stopped steriods and child was prescribed antihistamine/Pepcid combination.  Called today (1 week later) and mom referred rash is fading away and child is well.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Discomfort, Headache, Hyperhidrosis
Clinical narrative: 2:00 PM mild headache, nausea/stomach pain -- Tylenol 8:00PM symptoms feeling worse -- 3:00 AM sweating, shivering, muscle aches, temple pressure and tension headache. 6:00 AM intensified symptoms, no relief.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Tension headache
Clinical narrative: 2:00 PM mild headache, nausea/stomach pain -- Tylenol 8:00PM symptoms feeling worse -- 3:00 AM sweating, shivering, muscle aches, temple pressure and tension headache. 6:00 AM intensified symptoms, no relief.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: After vaccination - redness for approximately 1 day which resolved  Then starting 12/9/20 - Redness, and warm to touch at injection site with borders about 5 inches
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: 3 kids who get sick after the shot; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious social media case through global digital media received from a consumer.  This case involved adult patient for whom 3 kids who get sick after the shot (Illness) was reported, while patients received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(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 3 kids who get sick after the shot (Illness) was reported, unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  Final diagnosis was 3 kids who get sick after the shot.   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 available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Malaise
Clinical narrative: Patient got very ill; Patient had an awful allergic reaction; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious social media case from consumer (patient) via Social media.  This case involved a patient with unknown demographic who got very ill (Illness) and had an awful allergic reaction (Hypersensitivity), while he/she received INFLUENZA VACCINE.  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 very ill (Illness) and had an awful allergic reaction (Hypersensitivity) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient was told to never get another one. Had never got one since per his/her doctor. This was years ago. All his/her doctors since had told him/her not to also.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for both the events, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Ear infection, Influenza, Malaise, Pharyngitis streptococcal, Sinusitis
Clinical narrative: horribly sick w flu; double ear infections; major sinus infection strep throat; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case 2020SA306302, 2020SA306301, 2020SA306304, 2020SA306305, 2020SA306306, 2020SA306276, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300 and 2020SA306303.  This case involves a patient of an unknown age who was horribly sick w flu (illness), double ear infections (ear infection) and major sinus infection strep throat (sinusitis), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient was horribly sick w flu (illness), double ear infections (ear infection) and major sinus infection strep throat (sinusitis).  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: Vaccination complication
Clinical narrative: test for the flu shot and was very alergic to it; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case through digital media received from a consumer (Patient).  This case involved adult patient who test for the flu shot and was very allergic to it (Hypersensitivity), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Allergy to vaccine.   On an unknown date, the patient received a dose  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who test for the flu shot and was very allergic to it (Hypersensitivity), 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, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Malaise
Clinical narrative: got very sick; had an allergic reaction; Initial information received on 31-Oct-2020 regarding an unsolicited valid non-serious social media case through the agency received from a consumer (Patient).  This case involved adult patient of unknown demographics who got very sick (Illness) and had an allergic reaction (Hypersensitivity), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Rubber sensitivity.   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 got very sick (Illness) and had an allergic reaction (Hypersensitivity), 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 for both the events at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Malaise
Clinical narrative: patient got a flu shot yesterday and wasn't feeling very good last night. Had the chills for a little while; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case 2020SA307599, 2020SA307615, 2020SA307606, 2020SA307607, 2020SA307613, 2020SA307609, 2020SA307610, 2020SA307611, 2020SA307612 and 2020SA307608.  This case involves a patient of unknown age who got a flu shot yesterday and wasn't feeling very good last night. had the chills for a little while (chills), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got a flu shot yesterday and wasn't feeling very good last night. had the chills for a little while (chills).  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: Influenza
Clinical narrative: patient had the flu a few times. With 3 of those times being after patient had the shots; Initial information was received on 30-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case 2020SA307387, 2020SA307451, 2020SA307452, 2020SA307939, 2020SA307940, 2020SA308033, 2020SA308034, 2020SA306301 and 2020SA302198.  This case involves an 82-year-old patient who had the flu a few times. With 3 of those times being after patient had the shots (influenza), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient only had 3 shots and had the flu a few times. with 3 of those times being after patient had the shots (influenza). Definitely allergic to something in them.  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: Influenza
Clinical narrative: patient got the flu once, the year my doctor convinced me to get the flu shot; Initial information was received on 01-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got the flu once, the year patent's doctor convinced to get the flu shot (influenza), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got the flu once, the year patent's doctor convinced to get the flu shot (influenza).  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: Body temperature increased, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Got a flu shot. The next two days patient had chills; tired; headache; sweats; a 100 temperature; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got a flu shot. The next two days patient had chills (chills), tired (fatigue), headache, sweats (hyperhidrosis) and a 100 temperature (body temperature increased), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got a flu shot. The next two days patient had chills (chills), tired (fatigue), headache, sweats (hyperhidrosis) and a 100 temperature (body temperature increased).  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: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: deathly ill; Initial information regarding an unsolicited valid serious case received from a consumer via Social media and transmitted to Sanofi on 06-Dec-2020.  This case is linked to case 2020SA351069 (same reporter).  This case involves female patient of unknown age who was deathly ill (illness) while she 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious deathly ill (illness) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown for illness.  There will be no information regarding batch number for the case.; Sender's Comments: Sanofi company comment dated 07-Dec-2020: This case concerns an adult female patient who presented with Illness after vaccination with INFLUENZA VACCINE. However, patient's medical condition, laboratory tests ruling out alternate etiologies and concomitant medications were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Death, Malaise
Clinical narrative: stayed sick all winter long, couple of times even hospitalised; Initial information was received on 06-Dec-2020 regarding an unsolicited valid serious social media case from a non-healthcare professional (son/daughter of the patient) via social media .  This case is linked to the case 2020SA350795 (mother of reporter, wife of patient).  This case involved a male patient of an unknown age who stayed sick all winter long and couple of times was even hospitalized (Illness), after receiving INFLUENZA VACCINE.  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 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 that the reporter's mother used to get the flu shot every year and would get deathly ill and stepfather of the reporter stayed sick all winter long, a couple of times was even hospitalized (Illness) following administration of INFLUENZA VACCINE (unknown date and latency, serious event).   The patient was already died at the time of reporting, the cause of death was not reported   After the patient's death, reporter's mother stop taking something that made her sick and she never got sick with the cold and flu again and lived another 15 years.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Information on the batch number was requested.; Sender's Comments: This case involved a patient of an unknown age and gender who presented with illness after vaccination with INFLUENZA VACCINE. 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: Influenza, Vaccine positive rechallenge
Clinical narrative: patient got the flu every year after having a mandatory flu shot. Ended up in hospital every year.; Initial information received on 05-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer.  This case involves an unknown age male patient who got the flu every year after having a mandatory flu shot and ended up in hospital every year (influenza), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu every year after having a mandatory flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Relevant laboratory data was not 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.; Sender's Comments: This case involves an unknown age male patient who got the flu every year after having a mandatory flu shot and ended up in hospital every year (influenza). Time to onset is unknown. However, additional information on patients medical condition at the time of vaccination, concomitant medication and 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: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: ended up in the hospital for days, never had it before and ended up with the flu every year after for 3 years; Initial information received on 06-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a 22-year-old patient of unknown gender who ended up in the hospital for days, never had it before and ended up with the flu every year after for 3 years (influenza), while patient received Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after administration of suspect vaccine, the patient ended up in the hospital for days (seriousness criteria), never had it before and ended up with the flu every year after for 3 years (influenza).  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.; Sender's Comments: Sanofi company comment dated 09-Dec-2020: This case concerns a male patient who presented with flu after vaccination with Influenza Vaccine from unknown manufacturer. The time to onset was unknown. However, patient's medical condition, concomitant medication, laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: dang shot made me  so sick/ Deathly ill with The FLU; Initial information regarding an unsolicited valid serious case was received from a non-healthcare professional (patient) via social media on 07-Dec-2020.  This case involved a patient of an unknown age and gender for whom it was reported that dang shot made so sick/ Deathly ill with The FLU (Illness) 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 at an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the dang shot made the patient so sick that the patient was in the hospital for 2 weeks and was deathly ill with the flu (Illness). The patient further reported to stop it as the laboratory did not know how it reacted on people.  No relevant laboratory details were provided.  The event of influenza was reported as serious due to event caused hospitalization by the reporter. The patient was hospitalized for 2 weeks (14 days).  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involved a patient of an unknown age and gender who presented with Illness 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: U
Vaccine: FLUX
Symptoms: Angioedema
Clinical narrative: giant hives; Initial information received on 06-Dec-2020 regarding an unsolicited valid serious social media case from a consumer (Patient) via social media.  This case involves a patient of unknown demographics who experienced giant hives (angioedema), while patient received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergy to vaccine for which patient was use to wear mask every year from October through March.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced giant hives (angioedema) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that the shot does not give you the flu.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns an patient of unknown demographics who presented with giant case hives after vaccination with INFLUENZA VACCINE. The time to onset is unknown. The patient had prior allergy to vaccine. Moreover, concomitant medications, patient's medical condition and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Muscle ache, headache, nausea.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Gait inability, HIV antibody negative, Pain, Swelling
Clinical narrative: Redness pain swelling body covered in hives, and couldn't walk at the time of reaction.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Redness pain swelling body covered in hives, and couldn't walk at the time of reaction.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Left arm redness, swelling , warm at touch, and painful. Cetirizine given. MOC  informed  to apply cold compress.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Morning after vaccine was given- pt developed severe edema to LUE,redness, itching,and warm to touch.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Hypertension, Influenza virus test negative, Injection site erythema
Clinical narrative: uneasy and not feeling well, nausea,  tylenol 12/08/2020 and loose bowel movement,  12/09/2020 nausea, pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection, high fever, high blood pressure at work; seen at employee health and sent home. Went to urgent care after leaving work 12/09/2020, tested for flu and covid-19 -- results negative. Sent home to take tylenol, rest and plenty fluids. 12/10/2020 pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection,
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site urticaria, Malaise, Nausea, Pain
Clinical narrative: uneasy and not feeling well, nausea,  tylenol 12/08/2020 and loose bowel movement,  12/09/2020 nausea, pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection, high fever, high blood pressure at work; seen at employee health and sent home. Went to urgent care after leaving work 12/09/2020, tested for flu and covid-19 -- results negative. Sent home to take tylenol, rest and plenty fluids. 12/10/2020 pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection,
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: uneasy and not feeling well, nausea,  tylenol 12/08/2020 and loose bowel movement,  12/09/2020 nausea, pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection, high fever, high blood pressure at work; seen at employee health and sent home. Went to urgent care after leaving work 12/09/2020, tested for flu and covid-19 -- results negative. Sent home to take tylenol, rest and plenty fluids. 12/10/2020 pain in L arm, soreness in body, very fatigue, L arm swollen and very red at injection site, large wept at site of injection,
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Patient needed a second dose of Tdap
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypersensitivity
Clinical narrative: Delayed, local hypersensitivity reaction at injection site
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness developed below injection site that is warm to the touch and sore. SIte itches as well. Symptoms began the day after administration and patient came to the pharmacy two days after administration to report. Contacting her primary provider to report. Instructed patient on how to manage symptoms and encouraged her to contact her provider as well.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient reports redness and lump under the skin at area of injection
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a patient received improperly stored vaccine; This spontaneous report has been received from the administrator of a doctor's office concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 16-OCT-2020,  the patient was vaccinated with an improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form,  Lot # S027467, expiration date 02-MAR-2021 for prophylaxis (dosage regimen, patient route of administration and anatomical location were not reported).        The temperature was reported to had been at 17.2 °Fahrenheit (F) for 1 hour and 30 minutes.   There was digital data logger involved and a previous temperature excursion was reported to had been at 12.2 °F for 1 hour.  No other information was available.; Sender's Comments:  US-009507513-2011USA013430: US-009507513-2011USA013458:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE; PEDVAXIB was administered post temperature excursion; Temperature 9.2C; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-NOV-2020, the patient was vaccinated with improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T001207, expiration date 09-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. There was no adverse event (AE) reported. Administered dose of the vaccine was stored in the temperature of 9.2 degrees Celsius (9.2C) for 9 minutes. There was no previous temperature excursion. Digital data logger was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA000913: US-009507513-2012USA000976: US-009507513-2012USA000834: US-009507513-2012USA000997: US-009507513-2012USA001384:
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event; 21 year old patient got his 1st dose of MMR II a month ago.; This spontaneous report as received from a pharmacist refers to a 21-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On an unknown date in November 2020 (reported as a month ago), the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis, therefore experienced product administered to patient of inappropriate age. No additional adverse event was reported. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: fourth dose at the age of 16; This spontaneous report was received from a mother concerning her 16-year-old (currently 22 year old) son. There was no information about the patient's medical history, concurrent conditions or concomitant medication.      At the age of 14 year old, approximately in 2012 the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the second dose approximately in 2013 at the age of 15 received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), and the fourth dose of  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) at the age of 16, approximately in 2014  for prophylaxis (doses, routes of administration, lot numbers and expiration dates were not reported).  The mother want to know if the patient need a booster of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The reporter confirmed the consumer received 4 doses all together.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site discomfort
Clinical narrative: flu like symtoms; discomfort from injection site; headache; This case was reported by a lawyer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for shingles.   On an unknown date, the patient received Shingrix (injection). On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms, injection site discomfort and headache. The action taken with Shingrix was unknown. On an unknown date, the outcome of the influenza-like symptoms, injection site discomfort and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site discomfort and headache to be related to Shingrix.  Additional details: The patient ingested shingrix on 19 November 2019. This medication was administered by two separate injections. the patient received the first injection without complications. However, within a few hours of receiving the second. injection she experienced flu like symptoms and discomfort at the injection site. She soon developed a bad headache which typical over-the-counter medications did not alleviate.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Illness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: had a sore throat; bad cough; symptoms of a bad cold; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Social media and transmitted to Sanofi on 01-Nov-2020.  This case is linked to cases 2020SA308140, 2020SA308110 and 2020SA308037.  This case involves an unknown age patient who had a sore throat (Oropharyngeal pain), bad cough (Cough) and symptoms of a bad cold (Nasopharyngitis), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccinations included INFLUENZA VACCINE and never had any problem.  Medical history, medical treatments, concomitant medications and family history were not provided.   On an unknown date, patient reported that he/she was never had a problem with the regular INFLUENZA VACCINE but the two times he/she got the high dose shot of INFLUENZA VACCINE for seniors, within two days patient was sick with a bad cough, had a sore throat and symptoms of a bad cold (respiratory symptoms) that lasted over three weeks.   After that patient never received influenza vaccine after that for the last two years and had no problem. Patient reported that he/she leaves alone and go out to the grocery store about once a week. There are no children and no people that visit he/she.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as resolved on an unknown date for all the events.  There will be no information regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 30-Oct-2020.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA307452, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308034, 2020SA306301 and 2020SA302198.  This case involves an unknown age patient who experienced flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, patient reported that every time he/she got INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination and experienced flu (Influenza).   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Influenza.  There will be no information regarding batch number for the case.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient was given influenza vaccine on 11/30/2020 but vaccine was given in inappropriate site. Vaccine was given in inner thigh rather than outer thigh area. Injection site clearly visible on inner thigh. Patient was brought into clinic on 12/2/20 with swelling, redness and pain in left thigh.  On 12/3/20 the symptoms had worsened.  Patient parent contacted provider for further instruction.  Patient was given antibiotic and steroids for possible reaction to vaccine.  As of 12/5/20, patient's symptoms had improved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Patient states arm is still a little sore at the injection site. Patient also reporting occasional numbness in arm that is temporary but reoccurring.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Bruxism, Dysphemia, Fatigue, Posture abnormal
Clinical narrative: AS PER MOM STARTED TO DEVELOP STATTERING AT THE END OF WORDS WITH ABNORMAL FACE GESTURES AS BLINKING,CLENCHING ON  HER TEETH, MOVE HEAD TO SIDE DURING TALKING, TALKING A LOT AND LOOK FATIGUED WHEN SPEAK
Age: 0.5
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Crying, Mobility decreased
Clinical narrative: Mother stated patient could not move left leg, non-stop crying which resolved later in the evening after applying warm compress.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Laboratory test abnormal, Musculoskeletal stiffness, Myalgia
Clinical narrative: Side effects when began including muscle and body aches especially to lower back, both legs, hips, right arm and shoulder, hands and wrists achy and stiff/is being treated currently with prednisone/was diagnosed with PMR on 10-26-2020.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Polymyalgia rheumatica, X-ray abnormal
Clinical narrative: Side effects when began including muscle and body aches especially to lower back, both legs, hips, right arm and shoulder, hands and wrists achy and stiff/is being treated currently with prednisone/was diagnosed with PMR on 10-26-2020.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on arm that vaccine was given to, not at vaccine site but near
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: mmrv vaccine was advertantly given 3 months after 1st dose
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Moderate pain at site, then swelling and redness several inches across affected upper arm x 1 week to date, now moderate itching
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Pain, Peripheral swelling, Retching
Clinical narrative: Patient had no AE to the 1st Shingrix.  Patient AE started 2 hours after injection.  Dry heaves, diarrhea, hands wouldn't stop shaking, body aches all over, excessive sneezing, could hardly walk. Patient referred to Dr. Advised to take Tylenol. Patient slept. Patient feels a little better each day except joints hurt.