chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: By 8PM I was feeling extremely tired, went to bed. Woke up at 11:30PM with a fever was cold and shivering, Woke up again at 1:30AM and my mouth was completely dry and my right hand was cramped and could not move. These all my Sjogren's symptoms but more severe than I had ever felt them before. At 4:30AM my fever was 99.3 and I still had all the aforementioned symptoms. I was extremely tired and felt nauseous. By 8AM I had stomach cramping followed by diarrhea. My stomach was too upset to eat at all the entire day of the 14th. I had off and on stomach pains with diarrhea. I was very tired and could not stay awake for very long. My temperature went back down to my normal 97.2 by 10 AM. My right hand is still very hard to move and painful today on the 16TH. My stomach still feels queasy. I have not had a fever again, but still feel horrible. I have not gone to my primary doctor because there is nothing he can do to help.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick; Initial information was received on 22-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (24 hours) following the administration of INFLUENZA VACCINE.  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.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain in deltoid muscle upon pressure at night. Hard to lay on the side of the vaccine due to pain in the arm
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: I received the vaccine @ 3:40 pm 12-15-20 and felt fine until around 9:00 pm 12-15-20 when I noted headache, nausea, no energy, overall not feeling well, and injection site pain. I did not have a fever. Symptoms still present @ 6:00 am 12-16-20.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: get sick; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who got sick (illness), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer 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 sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that he/she will not get the flu vaccine because he/she  get sick from the flu shot, yes and do have problems with the flu vaccine. Every year that patient don't get the flu shot, don't get sick and every year when the patient gets the flu vaccine gets sick.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle, aches, fever, shivering, fatigue, trouble sleeping.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Headache, muscle, aches, fever, shivering, fatigue, trouble sleeping.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves male patient (age not reported) who experienced flu (influenza), while he received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination with reaction of flu.  The patient's 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 and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  The patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: felt sicker; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves female patient (unknown age) who felt sicker (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious felt sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, this is not true for everyone because the reporter also knows people who had gotten the flu shot that haven't got sick sense and have no side effects. There are even people, even on comments on here that say it had severe side effects for people they know, but say you cannot compensated if a vaccination screws up you or your loved ones. Don't know what the factors are why it works for some and not others. Maybe immune system, maybe allergies who knows.  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, Vaccine positive rechallenge
Clinical narrative: patient got very sick every time patient took a flu shot; Initial information was received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who got very sick every time patient took a flu shot (illness), while patient was treated with influenza vaccine.  Vaccination(s) included influenza vaccine with patient had the flu twice before the vaccines came and was sicker with the shots.  Medical history, 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 an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got very sick every time patient took a flu shot (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves male patient (unknown age) who was sick (illness), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious event, was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  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: got sick; Initial information was received on 23-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who got sick (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient took one once and got sicker that year than ever before not saying shot caused it but it sure, as hell didn't help.  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: got sick; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demographics) who got sick (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) right after the administration of INFLUENZA VACCINE.  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: H1N1 influenza, Influenza, Influenza A virus test positive, Medical induction of coma, Pneumonia
Clinical narrative: Pneumonia; patient was put in an induced coma; alpha strain of flu; H1N1 flu; Initial information received on 08-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer (patient) via social media.  This case is linked to case 2020SA355629.  This case involves a patient of an unknown demography who experienced pneumonia, had alpha strain of flu (influenza) and H1N1 flu (H1N1 influenza), and underwent induced coma (medical induction of coma) after receiving INFLUENZA VACCINE.  The patient's 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 experienced a serious pneumonia 4 months following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient was put in an induced coma (medical induction of coma), had alpha strain of flu (influenza) and H1N1 flu (H1N1 influenza) 4 months following the administration of INFLUENZA VACCINE.  It was reported that some peoples bodies will overreact to the vaccine by working too hard to create antibodies to the dead flu injected, thus weakening the immune system, and leaving the body without protection to other strains of flu. The patient never had a problem in life catching the flu. Not until he/she got a vaccine. Have not had it since, either. Needless to say, the reporter would not get any more flu vaccines. It may work for others and it is not healthy for everyone.  Relevant laboratory test results included: Influenza A virus test on an unknown date was positive.  It was not reported if the patient received a corrective treatment.  The events outcome was unknown, at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case involves a patient who experienced pneumonia, alpha strain of flu (influenza) and H1N1 influenza, had medical induction of coma while he/she received INFLUENZA VACCINE.Time to onset is compatible. 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: Feeling abnormal, Malaise, Vaccine positive rechallenge
Clinical narrative: patient tought patient was going to die the last time patient took it; Took flu shot twice. Sick as a dog and will never take again; Initial information was received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who thought patient was going to die the last time patient took it (feeling abnormal) and took flu shot twice. Sick as a dog and will never take again (illness), 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, thought patient was going to die the last time patient took it (feeling abnormal) and took flu shot twice. Sick as a dog and will never take again (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; Initial information was received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who tested positive for covid (sars-cov-2 test positive), 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, patient tested positive for covid (sars-cov-2 test positive).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (age and gender unspecified) who experienced flu, while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Flublok was administered to a pregnant patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care profession via The Agency (Reference number- 00324247) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 34 years old female patient received on (08-Oct-2020) 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot no: UJ446AA and expiry date: 18-Mar-2021 Strength = standard) once via intramuscular route in left arm for prophylactic vaccination and while she was pregnant (vaccine exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The estimation due date was 04-Apr-2021.  The patient was 14 weeks pregnant.   The date of last menstrual period was not reported.  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was also a case of vaccine exposure during pregnancy.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received a Fluzone Quadrivalent instead of the Fluzone High-Dose Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00362060) and transmitted to Sanofi on 17-Nov-2020.  This case involves a 65 years old female received 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot no and expiry date were not reported) via intramuscular route in unknown administration site for prophylactic vaccination instead of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on an unknown date (wrong product administered)  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was a case of an actual medication error due to wrong vaccine administered (latency same day).  The physician now wants to give her a booster to increase her immune response because they feel she should have received the High-Dose. Health care professional does not know when the immunization was given or other information about the events as it occurred at a different facility.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood test normal, Fear, Feeling abnormal, Injection site pain
Clinical narrative: she is unable to raise the right hand due to the pain; it is hard to get up due to the pain; she has been experiencing  pain in her back near kidneys and lungs, from shoulder all the way down her back; her right hand her was hot; pain from the injection site of the right arm; Initial information regarding this unsolicited valid non-serious case received from a consumer (patient) and transmitted to Sanofi on 11-Dec-2020.  This case involved a 67 year old female patient who was unable to raise the right hand due to the pain; it was hard to get up due to the pain (movement disorder), she had been experiencing pain in her back near kidneys and lungs, from shoulder all the way down her back and pain from the injection site of the right arm (back pain and vaccination site pain) and her right hand her was hot (skin warm), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Relevant medical history included cardiac failure congestive.  Past medical treatment, vaccination details, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing diabetes, high Cholesterol, high blood pressure. It was reported that her blood pressure stayed high now. The patient was a pacemaker user.   On 02-Dec-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in the right arm for prophylactic vaccination. No other vaccines were administered.  On 03-DEC-2020, the patient developed non-serious pain from the injection site (vaccination site pain) of the right arm, to the right shoulder, and to the lungs and kidneys (back pain). She was unable to raise the right hand due to the pain; she felt terrible due to the pain; that it was hard to get up due to the pain (movement disorder) her right hand her was hot (skin warm). The caller reported that the reactions begun 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She did go to the emergency room; that in the emergency room they ran many tests described as having x-rays, being taken through a tunnel shaped machine, and having the blood drawn but none of the test showed anything.  It was also reported that the providers thought it might be an allergic reaction and she was given something for the pain that helped some but she still continued to have pain. The patient had gotten the flu vaccine for years and this had not happen. The pharmacy reported to her that she did not get the high dose. She was scared and upset with the pain and the only thing different this year is that she was on more medications.  Final diagnosis was vaccination site pain, back pain, movement disorder and skin warm.   An unknown corrective treatment was received.  At the time of reporting, the patient had not recovered from the reported events.  There would be no information available on batch number for this case.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Skin warm, X-ray normal
Clinical narrative: she is unable to raise the right hand due to the pain; it is hard to get up due to the pain; she has been experiencing  pain in her back near kidneys and lungs, from shoulder all the way down her back; her right hand her was hot; pain from the injection site of the right arm; Initial information regarding this unsolicited valid non-serious case received from a consumer (patient) and transmitted to Sanofi on 11-Dec-2020.  This case involved a 67 year old female patient who was unable to raise the right hand due to the pain; it was hard to get up due to the pain (movement disorder), she had been experiencing pain in her back near kidneys and lungs, from shoulder all the way down her back and pain from the injection site of the right arm (back pain and vaccination site pain) and her right hand her was hot (skin warm), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Relevant medical history included cardiac failure congestive.  Past medical treatment, vaccination details, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing diabetes, high Cholesterol, high blood pressure. It was reported that her blood pressure stayed high now. The patient was a pacemaker user.   On 02-Dec-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in the right arm for prophylactic vaccination. No other vaccines were administered.  On 03-DEC-2020, the patient developed non-serious pain from the injection site (vaccination site pain) of the right arm, to the right shoulder, and to the lungs and kidneys (back pain). She was unable to raise the right hand due to the pain; she felt terrible due to the pain; that it was hard to get up due to the pain (movement disorder) her right hand her was hot (skin warm). The caller reported that the reactions begun 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She did go to the emergency room; that in the emergency room they ran many tests described as having x-rays, being taken through a tunnel shaped machine, and having the blood drawn but none of the test showed anything.  It was also reported that the providers thought it might be an allergic reaction and she was given something for the pain that helped some but she still continued to have pain. The patient had gotten the flu vaccine for years and this had not happen. The pharmacy reported to her that she did not get the high dose. She was scared and upset with the pain and the only thing different this year is that she was on more medications.  Final diagnosis was vaccination site pain, back pain, movement disorder and skin warm.   An unknown corrective treatment was received.  At the time of reporting, the patient had not recovered from the reported events.  There would be no information available on batch number for this case.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Right sided facial/lip swelling.  Started about 0200 on 12/16/20.  Patient sometimes gets angioedema, so unsure if this is related but wanted to report
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Once I stopped taking ibuprofen/acetaminophen, at noon on Friday, I developed an intermittent low-grade fever (around 100.5), intense body aches, fatigue and nausea, and the injection site was swollen, red and hot to the touch. These symptoms continued through four days after the day of injection. Most symptoms are gone now, but my arm is still swollen, tender, warm to the touch and bruised. It sometimes aches enough that I need to take ibuprofen.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Tenderness
Clinical narrative: Once I stopped taking ibuprofen/acetaminophen, at noon on Friday, I developed an intermittent low-grade fever (around 100.5), intense body aches, fatigue and nausea, and the injection site was swollen, red and hot to the touch. These symptoms continued through four days after the day of injection. Most symptoms are gone now, but my arm is still swollen, tender, warm to the touch and bruised. It sometimes aches enough that I need to take ibuprofen.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: severe rash and blisters on his back and his and legs; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.  On or about 23-AUG-2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) in a pharmacy (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: severe rash and blisters on the pt's back and his legs.  The outcome of the event was unknown. The relatedness between severe rash and blisters on the pt's back and his legs and zoster vaccine live (ZOSTAVAX) was reported related.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Incorrect route of product administration, Injection site pain, Insomnia, Neuralgia
Clinical narrative: twinges (of pain) in his left thigh; soreness at the injection site (left shoulder).; nerve pain perhaps shingles-type nerve pain; asked if the shot was given intramuscularly  / is not sure because but the person administering the shot did pinch his skin up; he couldn't get comfortable while sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, injection site pain, nerve pain and intramuscular formulation administered by other route. In December 2020, the patient experienced discomfort. On an unknown date, the outcome of the pain in extremity, injection site pain and discomfort were not recovered/not resolved and the outcome of the nerve pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in extremity, nerve pain, discomfort and intramuscular formulation administered by other route to be related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix around 2:00 or 2:30 pm in the left deltoid. The customer care asked, if the shot was given intramuscularly and the patient said he thinks so but was not sure because but the person administering the shot did pinch his skin up and he states that he did not recall his skin being pinched up for Shingrix dose 1. He indicated that he did not know if pinching the skin up would have affected the ability of the needle to reach the muscle. When asked the patient if the injection was done on the back of the arm and he said no.   The patient was experiencing soreness at the injection site (left shoulder). This had not resolved. He reported that yesterday by evening he experienced twinges (of pain) in his left thigh. He was not sure if it was nerve pain perhaps shingles-type nerve pain. The pain was on the inside of the left thigh, high up, sharp and local. He said the pain kept him up for a couple hours last night (in the middle of the night) because he couldn't get comfortable while sleeping. He said the pain comes and goes and he did not injure himself or do anything out of the ordinary. He said the pain comes in waves. The pain was a little better this morning  but he did have a sharp leg/thigh pain right before calling. The patient was calling because he wanted to see if he should call his doctor. He was concerned that maybe the pain could be something serious like a blood clot. He stated he was almost sure this the thigh pain wa related to the Shingrix shot because it started a few hours after getting the shot. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: twinges (of pain) in his left thigh; soreness at the injection site (left shoulder).; nerve pain perhaps shingles-type nerve pain; asked if the shot was given intramuscularly  / is not sure because but the person administering the shot did pinch his skin up; he couldn't get comfortable while sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, injection site pain, nerve pain and intramuscular formulation administered by other route. In December 2020, the patient experienced discomfort. On an unknown date, the outcome of the pain in extremity, injection site pain and discomfort were not recovered/not resolved and the outcome of the nerve pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in extremity, nerve pain, discomfort and intramuscular formulation administered by other route to be related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix around 2:00 or 2:30 pm in the left deltoid. The customer care asked, if the shot was given intramuscularly and the patient said he thinks so but was not sure because but the person administering the shot did pinch his skin up and he states that he did not recall his skin being pinched up for Shingrix dose 1. He indicated that he did not know if pinching the skin up would have affected the ability of the needle to reach the muscle. When asked the patient if the injection was done on the back of the arm and he said no.   The patient was experiencing soreness at the injection site (left shoulder). This had not resolved. He reported that yesterday by evening he experienced twinges (of pain) in his left thigh. He was not sure if it was nerve pain perhaps shingles-type nerve pain. The pain was on the inside of the left thigh, high up, sharp and local. He said the pain kept him up for a couple hours last night (in the middle of the night) because he couldn't get comfortable while sleeping. He said the pain comes and goes and he did not injure himself or do anything out of the ordinary. He said the pain comes in waves. The pain was a little better this morning  but he did have a sharp leg/thigh pain right before calling. The patient was calling because he wanted to see if he should call his doctor. He was concerned that maybe the pain could be something serious like a blood clot. He stated he was almost sure this the thigh pain wa related to the Shingrix shot because it started a few hours after getting the shot. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got one vaccine earlier this year and still got the flu; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 17-Nov-2020.  This case involved patient with an unknown age who got one dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number unknown via an unknown route in an unknown administration site for prophylactic vaccination) earlier this year and still got the flu (influenza)  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   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 the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: get sick; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a patient who got sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious get sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Myalgia & unable to lift arm
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: get flu like symyons; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who get flu like symyons (influenza like illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was  get flu like symyons (influenza like illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Just got mine this sm/ boy is my arm sore; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involved adult patient for whom just got mine this sm/ boy is my arm sore (Arthralgia) was reported, while patient 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 patient just got mine this sm/ boy is my arm sore (Arthralgia) was reported, 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: Illness
Clinical narrative: influenza vaccine made the patient sick for a week; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 17-Nov-2020.  This case involves a patient of an unknown age who reported influenza vaccine made the patient sick for a week (illness), while he/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 unknown) via an unknown route in an unknown administration site for prophylactic vaccination which made the patient sick for a week (illness).   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for illness.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: patient had never had the flu from a shot but patient have had reactions that left me feeling bad; Initial information was received on 05-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient's wife) via social media.  This case involves a male patient of unknown age who never had the flu from a shot but patient have had reactions that left me feeling bad (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, 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 an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient never had the flu from a shot but patient have had reactions that left me feeling bad (feeling abnormal).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: It didn't give patient the flu or even flu like symptoms, but patient I felt crappy for about 4 days after; Initial information was received on 05-Dec-2020 regarding an unsolicited non-valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age for whom it was reported that it didn't gave patient the flu or even flu like symptoms, but patient felt crappy for about 4 days after (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, 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 an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient reported it was reported that it didn't gave patient the flu or even flu like symptoms, but patient felt crappy for about 4 days after (feeling abnormal).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Rash
Clinical narrative: SkinRash, Rash & RASH; BURNING SNSATION; INJECTION SITE PAIN
Age: 81.0
Sex: M
Vaccine: BCG
Symptoms: Chills
Clinical narrative: & CHILLS
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema
Clinical narrative: Patient is a 35 yo male with a PMH significant for depression, HTN, HLD, and tremor who received his pneumococcal 23 vaccine in left deltoid on 05/16/19. He developed some redness moving toward the axilla. There was no fluctuance and no swelling. He denied fever or chills. No medical intervention was needed. ErythemaMultiform
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Narrative: Patient states although she is a little better than she was on Monday, she is still feeling a great deal of soreness and pain in her right arm s/p the shingles shot. She states it is difficult to even move her arm. She states she uses her left arm to help move her right arm and it takes her a great deal of time to do simple tasks, including showering and getting dressed. She denies any edema, redness, SOB, CP, or warmth to the site of the injection, stating "you can't even tell a different in my arms just be looking at it. It is all internal". - PER NURSING NOTE Symptoms: Myalgia Treatment:
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Pain in extremity, Pyrexia
Clinical narrative: Shingrix Vaccine - experienced Chills, Fever and Stomach Pain in addition to arm soreness.  Symptoms lasted approx. 8 hours from 12am to 8am.
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Head to toe rash
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult flu shot given to 17 year old. No reaction noted when physical called
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches massive head ache
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: extreme hair loss (alopecia) over the span of 2-3 months
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Nausea
Clinical narrative: Patient received shot around 1pm later that night he started to experience chills, hot/cold, nausea, headache, extreme fatigue, low grade temp (99.1) Associate vomited several times the early the next morning. By the next day, day patient was vomiting less and was able to keep food down. Patient is feeling better the second day, experiencing some nausea.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient received shot around 1pm later that night he started to experience chills, hot/cold, nausea, headache, extreme fatigue, low grade temp (99.1) Associate vomited several times the early the next morning. By the next day, day patient was vomiting less and was able to keep food down. Patient is feeling better the second day, experiencing some nausea.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen upper arm, soreness at sight of injection, redness, heat generating from area. These symptoms have persisted for over 24 hours, almost 48 hours after administering injection.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Full blood count normal, Hyperhidrosis, Lethargy, Tonic posturing
Clinical narrative: Patient within one minute after administration of Flu vaccine developed tonic motions (arched back, cllnched fist bilaterally, eyes rolled back) for approximately 10-15 seconds.  Then became diaphoretic, lethargic for next 15-20 minutes.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Urine analysis normal
Clinical narrative: Patient within one minute after administration of Flu vaccine developed tonic motions (arched back, cllnched fist bilaterally, eyes rolled back) for approximately 10-15 seconds.  Then became diaphoretic, lethargic for next 15-20 minutes.