chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient felt the flu afterward. It was awful. Lasted for days.; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case is linked to case 2020SA300039 and 2020SA300020 (same source).  This case involved a patient of unknown demographics who felt the flu afterward. It was awful and lasted for days (Influenza), while the patient received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt the flu afterward. It was awful and lasted for days (Influenza) following the administration of influenza vaccine.  No laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: the patient was so so sick; ended up with full blown flu; Initial information regarding this unsolicited valid non-serious social media via case was received from a consumer (patient) and transmitted to Sanofi on 22-Oct-2020.  This case was linked to cases 2020SA300020, 2020SA300035, 2020SA300034, 2020SA300036, 2020SA300037, 2020SA300038, 2020SA300040, 2020SA300041, 2020SA300042, 2020SA300043, 2020SA300044 and 2020SA300045.  This case involved a patient with unknown demographics, who was so so sick (illness) and ended up with full blown flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, 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 so sick (illness) and ended up with full blown flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness and influenza.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: I was dying I felt so bad; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media on 23-Oct-2020.  This case involved a patient of an unknown age and gender who was dying and felt bad (Feeling abnormal), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the patient would never get another dose. The patient was not sick but was coerced by one of co-worker to take and then immediately afterwards thought was dying and felt so bad (Feeling abnormal).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was unknown for the event of feeling abnormal.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: the patient had mild cold type reaction, not always; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 23-Oct-2020.  This case was linked to cases 2020SA300462, 2020SA300492, 2020SA300498, 2020SA300506, 2020SA300510, 2020SA300666, 2020SA300533, 2020SA300563, 2020SA300607, 2020SA300614, 2020SA300636, 2020SA300692 and 2020SA300703.  This case involved a patient of unknown demographics who experienced had mild cold type reaction, not always (nasopharyngitis), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, 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. The patient did finally get all the important shots.  On an unknown date, once in a while the patient developed a non-serious mild cold type reaction, not always (nasopharyngitis), unknown latency following the administration of INFLUENZA VACCINE. It was reported that was a small thing compared to a case of the flu. If one got the shot they would not be spreading it others either, like their family.  Relevant laboratory test was not reported.  Final diagnosis was nasopharyngitis.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Severe chills, minor soreness in arm
Sex: U
Vaccine: FLUX
Symptoms: Headache, Night sweats, Pain
Clinical narrative: headache; body aches; night sweats; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient who experienced headache, body aches (pain) and night sweats, when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, body aches (pain) and night sweats 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 pain, headache and night sweats.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involve a patient (unknown age) who experienced flu (influenza) , when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, 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: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I get very sick; Initial information received regarding this unsolicited valid non-serious case received from a consumer (patient) and transmitted to Sanofi 29-Oct-2020.  This case was linked to cases 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306276, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300, 2020SA306301, 2020SA306302, 2020SA306303, 2020SA306304, 2020SA306305 and 2020SA306306.  This case involved a patient of unknown demographics who got very sick, while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, 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 got very sick (illness), 3 to 5 days (as reported) following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu symptoms; Initial information was received on 07-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who had flu symptoms [influenza], 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 manufacture) [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 symptoms (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 event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: was sick for 3 months; Initial information was received on 12-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a patient (unknown demography) who was sick for 3 months (illness), while the patient received vaccine 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 was sick for 3 months (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: sick; Initial information was received on 14-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a patient (unknown demography) who was sick (illness), while the patient received vaccine 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 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: sick; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient (unknown demography) who was sick (illness), while the patient received vaccine 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 was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that she never had sick after that she received it 10 times.  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: Influenza
Clinical narrative: Pateint got flu every time; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who got flu every time [influenza], 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 manufacture) [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 flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse administered the expired vaccine to six month old patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00311934) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 6 months old patient (gender unspecified) was administered the expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine (Lot no: UJ060AAA and expiry date: 04-Oct-2020) via unknown route in unknown administration site for prophylactic vaccination on 12-Oct-2020 (expired product administered)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.  It was a case of an actual medication error due to expired product administered (latency same day).  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: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Shivering, mild fever, muscle pain, fatigue; Treated with Acetaminophen, rest, Ibuprofen; outcome not known yet as it's only 22 hours later
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administered HIB vaccine in which the diluent had expired 4 days prior. Expiration date on diluent 11/26/20 and expiration date on the powder 5/2/21. Mom was made aware on 12/9/20 after we realized that the vaccine had expired. Mom did not mention any problems with patient at this time. Mom also made aware that this does not harm patient it just makes dose ineffective and will need to repeat the dose.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Severe muscle pain. Headache. Nausua
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Feeling abnormal, Pain, SARS-CoV-2 test negative
Clinical narrative: 8hours after he received shot, he started temperature, body aches, chills, weakness, brain fog. Thought it was covid, but had neg result. He is still having the same symptoms now. We are awaiting his second covid test results before patient can go to ER.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Eczema, Food allergy, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: 2 wks after shots, patient developed 100.9 temp and was inconsolable. Since it was after  hours, our doctor told us we had to go to the ER. Checked for RSV & cath'd for a UTI. They sent us home with no answers. I had to call back days later for them to tell me it was an unspecified virus. Of course, she had just been injected/given 19 viruses exactly 2 wks prior, but no one asked about recent vaccinations or mentioned checking her for any of those viruses. No treatment given other than Tylenol. Fever lasted for 2 days. Patient would go on to develop eczema and slight reaction to peanut butter many months later. TERRIBLE sleeper, only sleeping for 7 minutes at a time. She started daycare a couple weeks later and they would let us know if she slept for 30 minutes the entire day. Most days, she didn't. Has some sensory issues that remain.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Sensory disturbance, Sleep disorder, Urine analysis
Clinical narrative: 2 wks after shots, patient developed 100.9 temp and was inconsolable. Since it was after  hours, our doctor told us we had to go to the ER. Checked for RSV & cath'd for a UTI. They sent us home with no answers. I had to call back days later for them to tell me it was an unspecified virus. Of course, she had just been injected/given 19 viruses exactly 2 wks prior, but no one asked about recent vaccinations or mentioned checking her for any of those viruses. No treatment given other than Tylenol. Fever lasted for 2 days. Patient would go on to develop eczema and slight reaction to peanut butter many months later. TERRIBLE sleeper, only sleeping for 7 minutes at a time. She started daycare a couple weeks later and they would let us know if she slept for 30 minutes the entire day. Most days, she didn't. Has some sensory issues that remain.
Sex: F
Vaccine: PPV, UNK
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: swelling and multiple wheals on her right upper arm near the injection site; swelling and multiple wheals on her right upper arm near the injection site; This spontaneous report as received from a physician and refers to a 55-year-old female patient. The patient current condition included penicillin allergy. Concomitant therapy included flu shot (unspecified). There was no information about the patient's medical history provided.   On 08-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) lot # t020639, expiration date 13-MAR-2022, 1 dosage form, intramuscularly in the right deltoid muscle for pneumonia prevention. On the same date in the evening, the patient developed swelling and multiple wheals on her right upper arm near the injection site. The reporter said the wheals were 7-8 inches in diameter. One wheal developed on the top of her arm, one wheal on the side of her arm, and one 5-6 inches below the injection site. The patient said the wheal on top of her arm and the one on the side of her arm have disappeared. The only remaining wheal was the one 5-6 inches below the injection site. The patient did not receive any treatment for the wheals.The outcome of peripheral swelling and urticaria was reported as recovering.  The causality assessment between the events and the suspect therapy was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: t020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Expired product administered, Feeling hot
Clinical narrative: titer was performed and needed additional dose of MMRII; the patient received the childhood vaccine and this dose was a booster; expired product administered; "hot feeling"; woosy; vasovagal response; This spontaneous report was received from a nurse and refers to a 22-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.   On 12-NOV-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)( lot # r031681, expiration date: 01-NOV-2020), subcutaneously, in right arm. The reporter stated that the patient received the childhood vaccine and this dose was a booster. (The titer was performed on unspecified date and needed additional dose of the vaccine). The patient reported that when she has had blood work done or any type of injection in the past, she has become dizzy and lightheaded. During adminstration of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) to the patient, on 12-NOV-2020,  the patient developed a "hot feeling" and became "woosy". The patient did not lose consciousness, but the customer had her lay back with a cold towel on her head for a few minutes after the injection. The patient's symptoms resolved on the same day. It was reported that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) did not experience any temperature excursions prior to administration.  The causal relationship between the adverse events and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a physician's medical office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at the physician's medical office for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: home sick with the flu; home sick with the flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case was linked to 2020SA290963, 2020SA291400, 2020SA291402 and 2020SA291094 (same reporter).  This case involved a patient with unknown demographics who was home sick with the flu (Illness and Influenza), while they received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was home sick with the flu (Illness and Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory test data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of both the events were unknown, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: been sick twice; Initial information received on 14-Oct-2020 regarding an unsolicited non-valid non-serious social media case received from a consumer.  This case involves adult patient who have been sick twice (Illness), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient have been sick twice (Illness), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient was talked into the flu shot once and got sick; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious case from a consumer via social media.  This case is linked to case 2020SA297294 (same reporter).  This case involves a female patient of an unknown age who was talked into the flu shot once and got sick (illness), while she 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 talked into the flu shot once and got sick (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 event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Discomfort
Clinical narrative: never had a bad reaction, some disconfort for a day or two; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 20-Oct-2020.  This case was linked to case 2020SA297164, 2020SA297294, 2020SA297232, 2020SA297338, 2020SA297344, 2020SA297203, 2020SA297183, 2020SA297189, 2020SA297215, 2020SA297197, 2020SA297198, 2020SA297259, 2020SA297264, 2020SA297224, 2020SA297275, 2020SA297193, 2020SA297278, 2020SA297301, 2020SA295993, 2020SA290234, 2020SA273251, 2020SA285105, 2020SA289150 and 2020SA297164.  This case involved a patient of unknown demographics who never had a bad reaction but some discomfort for a day or two (Discomfort), while patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, 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.  It was reported that the patient never had a bad reaction but on an unknown date the patient developed a non-serious discomfort for a day or two (discomfort), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was discomfort.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, Syringe issue
Clinical narrative: pharmacist however cut her finger from the broken syringe/the barrel of the syringe collapsed and broke while the needle was still in the patient's arm; pharmacist however cut her finger from the broken syringe; the pharmacist pushed on the plunger of the syringe to inject the vaccine, the barrel of the syringe collapsed and broke; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA305671.  This case involved adult female patient for whom pharmacist however cut her finger from the broken syringe (Occupational exposure to product ), the pharmacist pushed on the plunger of the syringe to inject the vaccine, the barrel of the syringe collapsed (Needle issue) and broke and pharmacist however cut her finger from the broken syringe/the barrel of the syringe collapsed and broke while the needle was still in the patient's arm (Injury associated with device) was reported for the patient, while administered INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started using FLUZONE HIGH DOSE IM US PRE-FILLED SYRINGE dosage unknown (with an unknown batch number and expiration date) for prophylactic vaccination.  On an unknown date, the pharmacist however cut her finger from the broken syringe (Occupational exposure to product ), the pharmacist pushed on the plunger of the syringe to inject the vaccine, the barrel of the syringe collapsed (Needle issue) and broke and pharmacist however cut her finger from the broken syringe/the barrel of the syringe collapsed and broke while the needle was still in the patient's arm (Injury associated with device) was reported for the patient, unknown latency following the administration of INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE].  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for Injury associated with device and not applicable for rest events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: patient had flu and died from it; Initial information was received on 06-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional via social media.   This case involves a patient (unknown demographics) who experienced flu (influenza), after the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, 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 unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, it was unknown if autopsy was done.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from social media involves patient (unknown demographics) who experienced influenza after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient had flu and died from it
Sex: F
Vaccine: FLUX
Symptoms: Autopsy, Death
Clinical narrative: according to the autopsy report it contributed to killing my mother; Initial information was received on 04-Dec-2020 regarding an unsolicited valid serious social media case from a consumer via social media.  This case involves female patient (unknown age) whom it was reported that according to the autopsy report INFLUENZA VACCINE contributed to killing her (death).  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 were not reported) not reported via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient died due to INFLUENZA VACCINE (death) (unknown latency). Additionally, this event was assessed as medically significant.  It was not reported if the patient received any corrective treatment before death.  An autopsy was done, however details were not reported.  Information on the batch number was requested.; Sender's Comments: This is a poorly documented social media case received from social media involves a female patient (unknown age) who died after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. It was reported that according to the autopsy report it contributed to killing her. However there is no additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: according to the autopsy report it contributed to killing my mother
Sex: M
Vaccine: FLUX
Symptoms: Death, Wheelchair user
Clinical narrative: patient is dead/Death NOS; after flu vaccination patient was on put on wheelchair; Initial information regarding an unsolicited valid serious case received from a consumer via social media on 04-Dec-2020.  This case involves a male patient who recieved INFLUENZA VACCINE was put on wheelchair (Wheelchair user), then died (Death).  The patient's medical history, medical treatment(s), concomitant medication, 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 in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) after flu vaccination patient was put on wheelchair (Wheelchair user), later he died (Death).  Seriousness: event wheelchair user (disability).  Laboratory details were not reported prior to death was not reported.  It was not reported if the patient received a corrective treatment.  It was unknown if an autopsy was performed and cause of death was not reported.  There will be no information available on batch number for this case.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a male patient who was a wheelchair user and later died after vaccination with company suspect Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication ruling out alternate etiologies, laboratory tests were not reported. One vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: patient is dead/Death NOS
Sex: U
Vaccine: FLUX
Symptoms: Death, Neoplasm malignant
Clinical narrative: flu shots ended up with cancer and gone from cancer; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer.  This case involves two patients with unknown demographics who experienced cancer (neoplasm malignant), while he/she received 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, patients 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, patients ended up with cancer (neoplasm malignant) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment prior to death.  It is unknown if an autopsy was done. The cause of death was reported as Neoplasm malignant.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from social media involves two patients with unknown demographics who had cancer (neoplasm malignant) and died after vaccination with an INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cancer
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323899, 2020SA323872, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 37 year old female patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered) on 13-Nov-2020 (batch number: UJ552AA and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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: 49.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 49 year old female patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered) on 13-Nov-2020 (batch number: 11/25/1970 and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: 4 days).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323795, 2020SA323899, 2020SA323872, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 54 year old male patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered, latency: same day) on 09-Nov-2020 (batch number: UJ567AB and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event extra dose administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, achiness, very sore at shot injection site.  Low energy
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Significant arm pain; strong chills the night of the vaccine administration.  Arm pain resolved over few days.  The effects were not alarming or significant enough to warrant medical follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Blood glucose normal, Febrile convulsion, Metabolic function test normal
Clinical narrative: Simple febrile seizure- Seen in ER for febrile seizure (simple), that occurred 24 hours after the vaccines were administered. The seizure was not witnessed in the ER but mother reported 1.5 minutes of seizure activity before calling EMS. No other significant signs of infection on ER workup. Was discharged from ER after evaluation.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal discomfort, Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Second Dose of Shingrx: all over body pain, pain at injection site, chills, shakiness, fever and upset stomach
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Second Dose of Shingrx: all over body pain, pain at injection site, chills, shakiness, fever and upset stomach
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Injection site pain, Nausea
Clinical narrative: I had no reaction to first shingrix shot 2 months ago. This second shot,  experiencing muscle soreness around shot site, fatigue, fever 99.8, chills within 12 hours of vaccination. Restless sleep that night. In morning,  nausea and dry heaves until pain relieved by several BMs, Slept all day, no appetite. Fatigue next day but no fever.  I have no reason to think this is COVID; however, Iwill be tested today (to protect family I live with)
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia, Retching
Clinical narrative: I had no reaction to first shingrix shot 2 months ago. This second shot,  experiencing muscle soreness around shot site, fatigue, fever 99.8, chills within 12 hours of vaccination. Restless sleep that night. In morning,  nausea and dry heaves until pain relieved by several BMs, Slept all day, no appetite. Fatigue next day but no fever.  I have no reason to think this is COVID; however, Iwill be tested today (to protect family I live with)