chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, Product administered to patient of inappropriate age
Clinical narrative: two patients under the age of 65 received a dose with no AE; two patients under the age of 65 received a dose with no AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a physician and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00812706).  This case is linked to case 2021SA343609(CLUSTER).  This case involves a 36-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an intramuscular route at the deltoid nos for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  It was reported "Administrative agent reported that two patients under the age of 65 received a dose of Fluzone Quadrivalent High-Dose. She requested information on the use of the vaccine for this population."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 16-Oct-2021,there was no any adverse event in the case process as non-case.  Follow-up information received on 16-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involved adult female patient who experienced flu (influenza) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient past medical treatment, vaccination, family history and concomitant medication 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 intramuscular route in hand for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My ex-wife got the flu shot twice in her life. Both times she got the flu. My co worker got the flu shot twice. Both times she got the flu. My daughter got the flu shot, and she got the flu. I hadn't had a vaccine in over 50 years, not going to start taking one now. Haven't had the flu in over 20 years until a vaccinated family member gave it to me"  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event flu.  At time of reporting, the outcome was unknown for the event flu.  There would be no information available on the batch number for this case.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: infant was given a Covid shot instead of flu vaccine with no reported adverse event; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory authority (under reference number - US-SA-SAC20211006000502).  This case involves infant patient (unknown gender) who was vaccinated with Covid shot  instead of the INFLUENZA VACCINE with no adverse event (Wrong product administered).  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 Covid shot produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination instead of INFLUENZA VACCINE.  It was reported Since this is a public post on the Sanofi campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Reporter some have received the wrong shot even a infant was given a Covid shot. I wouldn't trust anybody with a needle.  There were no laboratory data/results available.  It was case of an actual medication error due to Wrong vaccine administered (latency was on 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 the 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 batch number for this case.
Sex: U
Vaccine: FLU3, FLUR4
Symptoms: Extra dose administered
Clinical narrative: Patient was given flublok on 9/10 and given fluzone high dose on 10/5 with no A/E; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received via an other health professional (under reference number: US-SA-SAC20211008000035).  This case involves an adult patient with an unknown age and gender who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on 9/10 INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 10/5 with no adverse event (extra dose administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On 10-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On 05-Oct-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (after 25 days) lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Clinic manager called me to find out next steps."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on lot number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Malaise
Clinical narrative: patient did not feel well for about 3 days; Initial information received on 06-Oct-2021 regarding an unsolicited valid social media non-serious case from a consumer via Social Media.  This case involves an unknown age and gender patient who did not feel well for about three days (malaise), after receiving INFLUENZA VACCINE and Coronavirus disease (COVID-19) VACCINE.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  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 and a booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur batch number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccinations.  On an unknown date, the patient did not feel well for about three days (malaise/ non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE and of COVID-19 VACCINE.  It was reported "I got my flu shot and. Covid booster at the same time. Didn't feel well for about 3 days. Don't do what I did."  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were lab data/ results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the reported event was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-heath care professional.   This case involves an unknown age and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient medical treatment(s), vaccination(s), 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 in 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.  It was reported "I got my flu shot in Dec 1999, spent the entire month of Jan 2000 with the flu. I never got a flu shot since and I haven't gotten the flu either".   It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/event.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event flu.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Chills, Cough, Headache
Clinical narrative: Left shoulder was sore for a day; fever,chills; aches; coughing; headache; Congestion; 6 following weeks of weakness; hurting lungs; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient of (unknown demographics) who was experienced left shoulder was sore for a day (arthralgia), fever chills (pyrexia), aches (pain), coughing (cough), headache, congestion (respiratory tract congestion), 6 following weeks of weakness (asthenia), hurting lungs (pulmonary pain), after receiving 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious left shoulder was sore for a day (arthralgia), fever chills (pyrexia), aches (pain), coughing (cough), headache, congestion (respiratory tract congestion), 6 following weeks of weakness (asthenia), hurting lungs (pulmonary pain), (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, outcome of the events was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain, Pulmonary pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Left shoulder was sore for a day; fever,chills; aches; coughing; headache; Congestion; 6 following weeks of weakness; hurting lungs; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient of (unknown demographics) who was experienced left shoulder was sore for a day (arthralgia), fever chills (pyrexia), aches (pain), coughing (cough), headache, congestion (respiratory tract congestion), 6 following weeks of weakness (asthenia), hurting lungs (pulmonary pain), after receiving 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious left shoulder was sore for a day (arthralgia), fever chills (pyrexia), aches (pain), coughing (cough), headache, congestion (respiratory tract congestion), 6 following weeks of weakness (asthenia), hurting lungs (pulmonary pain), (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, outcome of the events was unknown.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu shot kept him from getting worseand ending up in the hospital; Initial information was received on 05-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional via social media.  This case involves a male patient (unknown age) who experienced flu shot kept him from getting worse and ending up in the hospital (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), 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 serious flu shot kept him from getting worse and ending up in the hospital (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.; Sender's Comments: This case concerns a male patient (unknown age) who had influenza after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Furthermore, information on patient's medical condition at the time of vaccination, relevant medical history, past medical treatment(s), vaccination(s), concomitant medication, laboratory data excluding other alternate etiologies are missing. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: flu; sick; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via the social media.  This case involves adult patient (unknown age and gender) who experienced flu (influenza) or sick (illness) while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's 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) or sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  it was reported "Got my flu shot,then got the flu or I just got sick".  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Flu shot made patient sick; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care via Social Media.  This case involves a patient of unknown age and gender whose flu shot (INFLUENZA VACCINE) made patient sick (Illness).  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "flu shot made patient sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Flu Shot Fridays never had the flu or flu shot made me sick 20 plus years ago company nurse explained dose was too strong".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm sore; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from a social media via consumer/non-health care professional.  This case involves a patient (unknown demographics) who had arm sore (pain in extremity) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DUPILUMAB (DUPIXENT).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious arm sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red swollen spot on the arm where dose was injected; red swollen spot on the arm where dose was injected; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves Adult (unknown gender) patient who experienced red swollen spot on the arm where dose was injected (vaccination site swelling and vaccination site erythema) when received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry dose not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious red swollen spot on the arm where dose was injected (vaccination site swelling and vaccination site erythema) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  The event outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: get sicker than ever before; Initial information received on 10-Oct-2021 regarding an unsolicited valid social media non-serious case received from a non-healthcare professional under (reference: US-SA-SAC20211015000546).  This case involves a patient of (unknown demographics) who got sicker than ever before (illness) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number 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 event got sicker than ever before (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  The event outcome was unknown for the event (illness).  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus; Initial information was received on 12-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional via Social Media.  This case involves a patient of unknown age and gender who experienced lupus (systemic lupus erythematosus), after receiving 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 in 2009, the patient received only one 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 serious lupus (systemic lupus erythematosus) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown age and gender who experienced systemic lupus erythematosus after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pruritus
Clinical narrative: Severe itching both sides of both hands, plus both Elbows; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional under reference number - US-SA-SAC20211015000955  This case involves a 74-years old female patient who experienced severe itching both sides of both hands, plus both elbows (pruritus), after receiving vaccines BOOSTRIX and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  Concomitant medications included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  On 27-Sep-2021 at 11:45 AM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] (lot number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On 27-Sep-2021 at 11:45 AM, the patient received a dose of suspect BOOSTRIX not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe itching both sides of both hands, plus both elbows (pruritus) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] and BOOSTRIX VACCINE.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, event outcome was unknown.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu more than once; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211016000192).  This case involves a patient of (unknown demographics) who experienced flu more than once (influenza), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 expiry date not reported) via subcutaneous route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu more than once (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Made it to 55 working in area public transportation. I don't think it's a bad thing, but my wife gets the flu shot every year and had the flu more than once. I work with and around the general public and I never had it once. Now in my third decade of this industry."  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: Initial information was received on 13-Oct-2021 regarding an unsolicited valid, social media, non-serious case received from a Consumer.  This case involves a patient (unknown age and unknown gender) who covid (covid-19) and flu (influenza) while receiving 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 not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious covid (covid-19) and flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Did it 4 ten yrs. Got flu Quit 5 yrs. Ago & no flu Got Covid & got good Antibodies".  It is unknown if the patient experienced any additional symptoms/events  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.    At the time of report, the outcome of events was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick for a week after the shot; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211016000311).   This case involves adult patient of unknown age and gender who experienced sick for a week (malaise), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 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 sick for a week (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Flu Shot Fridays my arm was sore for two days; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (patient) via social media.  This case involves adult patient (unknown gender) who experienced "flu shot fridays my arm was sore for two days" (pain in extremity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (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 flu shot fridays my arm was sore for two days (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "flu Shot Fridays my arm was sore for two days".  At time of reporting, 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: Illness
Clinical narrative: sick; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via regulatory authority (under reference number - US-SA-SAC20211016000431).  This case involves adult patient of unknown age and gender who experienced sick (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 expiry date not reported) via subcutaneous route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had sore arm (pain in extremity), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medications(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 were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "this is a social media case. The following potential adverse event has been found on a public post for Flu Shots. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Got mine at Pharmacy no side effects just sore arm."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise
Clinical narrative: isn't feeling very well; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory authority (under reference number - US-SA-SAC20211016000527).  This case involves an unknown age female patient who experienced isn't feeling very well (malaise), after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Syndrome lupus.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for prophylactic vaccination.  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 isn't feeling very well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine breakthrough infection
Clinical narrative: Both my grown children got the flu after getting the flu shots ten or fifteen years ago; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional.  This case involves 2 children of unknown gender who had "both my grown children got the flu after getting the flu shots ten or fifteen years ago" (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients developed non-serious "both my grown children got the flu after getting the flu shots ten or fifteen years ago" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Hello, The following potential adverse event has been found on a public post for Flu Shot page. Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. I do not care. Stop with the propaganda. Both my grown children got the flu after getting the flu shots ten or fifteen years ago.So nobody in this family gets the flu shot or this vaccine."  It was unknown if the patients experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patients received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Crying, Erythema, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: both legs were red and very swollen.; both legs were red and very swollen.; was extremely irritable crying.; Initial information received on 13-Oct-2021 regarding an unsolicited valid serious case received from a physician under reference number: US-SA-SAC20211018000115.  This case involves a two months old and unknown gender patient who was experienced both legs were red and very swollen (peripheral swelling), (erythema) and was extremely irritable crying (crying). while receiving DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL], ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site, a dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number and expiry date not reported via oral route in unknown administration site and a dose of suspect PNEUMOCOCCAL VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  On an unknown date the patient developed a serious events both legs were red and very swollen. (peripheral swelling), (erythema) and extremely irritable crying. (crying) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE.   These events were leading to congenital anomaly.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment from the events.  At the time of reporting, the outcome was unknown for the events.  There was be no information on the batch number for this case.; Sender's Comments: This case involves a two months old and unknown gender patient who experienced peripheral swelling, erythema, crying (unknown latency) after vaccination with PENTACEL, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Peripheral swelling
Clinical narrative: both legs were red and very swollen.; both legs were red and very swollen.; was extremely irritable crying.; Initial information received on 13-Oct-2021 regarding an unsolicited valid serious case received from a physician under reference number: US-SA-SAC20211018000115.  This case involves a two months old and unknown gender patient who was experienced both legs were red and very swollen (peripheral swelling), (erythema) and was extremely irritable crying (crying). while receiving DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL], ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site, a dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number and expiry date not reported via oral route in unknown administration site and a dose of suspect PNEUMOCOCCAL VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  On an unknown date the patient developed a serious events both legs were red and very swollen. (peripheral swelling), (erythema) and extremely irritable crying. (crying) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE.   These events were leading to congenital anomaly.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment from the events.  At the time of reporting, the outcome was unknown for the events.  There was be no information on the batch number for this case.; Sender's Comments: This case involves a two months old and unknown gender patient who experienced peripheral swelling, erythema, crying (unknown latency) after vaccination with PENTACEL, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: Patient was almost died from  the hospital; Initial information received on 13-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.  This case involves adult patient who experienced had almost died from the hospital (unevaluable event) had always go, because had doctor begged her after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient past medical treatment, vaccination, family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE. [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 serious almost died from the hospital (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  Near death experience event was assessed as medically significant.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves adult patient who experienced unevaluable event after the vaccination with INFLUENZA VACCINE (unknown manufacturer).Time of onset is unknown. Further information regarding medical condition during vaccination, previous vaccination and tolerance, other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 14-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-healthcare professional via Digital Media.  This case involves two patients (unknown demographics) who had the flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patients had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patients had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I don't care. Stop with the propaganda. Both my grown children got the flu after getting the flu shots ten or fifteen years ago. so nobody in this family gets the flu shot or this vaccine."  It was unknown if the patients experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patients received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.