chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever 100.4; chills; muscle aches; nausea; tired; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old-non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 04May2021 at 11:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and gluten sensitivity. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021, the patient underwent PCR test and the result was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. On 05May2021, the patient underwent temperature check and the result was 100.4 with unspecified units. On 05May2021 at 00:00, the patient experienced fever 100.4, chills, muscle aches, nausea and tiredness. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events of fever, chills, muscle aches, nausea and tiredness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data (result updated for Body temperature as 100.4), Event details (Treatment received selected as No for all events), updated narrative (The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Low grade fever; Aching back; Aching legs; Headache; Fatigue; General feeling of being out of it; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 03May2021 at 08:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Concomitant medications included metoprolol (METOPROLOL 25 ER) and had received it within 2 weeks of vaccination for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 12Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03May2021 at 22:00, (at 48 hours after second shot) the patient was still experiencing low grade fever, aching back and legs, headache, fatigue, and a general feeling of being "out of it". The patient's side effects began about 12 to 14 hours after shot was administered. The clinical outcome of the events low grade fever, aching back and legs, headache, fatigue, and a general feeling of being "out of it" were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Penicillin allergy added as medical history in tab and narrative.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; Aching back; Aching legs; Headache; Fatigue; General feeling of being out of it; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 03May2021 at 08:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Concomitant medications included metoprolol (METOPROLOL 25 ER) and had received it within 2 weeks of vaccination for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 12Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03May2021 at 22:00, (at 48 hours after second shot) the patient was still experiencing low grade fever, aching back and legs, headache, fatigue, and a general feeling of being "out of it". The patient's side effects began about 12 to 14 hours after shot was administered. The clinical outcome of the events low grade fever, aching back and legs, headache, fatigue, and a general feeling of being "out of it" were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Penicillin allergy added as medical history in tab and narrative.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle twitching, Nausea, Tachycardia, Visual impairment
Clinical narrative: Vision was becoming narrow; very nauseous; Heart started beating very fast; Muscles twitching especially tongue into the back of throat; Feeling faint; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8736) via an unspecified route of administration in the left arm on an unknown date in May2021 at 10:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Patient had no medical and past drug history. Patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, within 2 minutes after the vaccination, she started feeling faint and her vision was becoming narrow. The patient also felt very nauseous and her heart started beating very fast. After about 30 minutes of the vaccination, she started to feel her muscles twitching, especially her tongue into the back of her throat. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient was received any treatments. The clinical outcome of the events feeling faint, vision was becoming narrow, very nauseous, heart started beating very fast and muscles twitching and was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient details (updated), Events detail (Treatment Received updated as unknown).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; chills; joint pains; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 04May2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient past drug history included lactose. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 01:00 the patient experienced injection site pain, tiredness, headache, chills and joint pains. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, tiredness, headache, chills and joint pains was recovering at the time of this report.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: an agency (coding updated for known_allergies: Lactose Reaction from Lactose intolerance to Drug allergy), Events detail (Treatment updated as No for events), updated narrative ("The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events" added).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Feverish; Local soreness; Moderate fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 8733) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 59-year-old) as a dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced feverish, local soreness and moderate fatigue. No therapeutic measures were taken as the result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event feverish, local soreness and moderate fatigue was recovered on unknown date in 2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added age at Vaccination and relevant narrative sentence updated, removed Lab data Body temperature normal and relevant narrative sentence
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Contusion, Oropharyngeal pain, Pain, Vaccination site pain
Clinical narrative: Extreme aching in left arm at injection site; Bruising; Sore throat; Chest tightness; Ache in both legs and down left side of body; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 17:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Patient had no drug history. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 08:00, the patient experienced extreme aching in left arm at injection site, extreme ache in down left side of body and both legs, bruising, sore throat and chest tightness. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme aching in left arm at injection site, extreme ache in down left side of body and both legs, bruising, sore throat and chest tightness was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient details (initials). Updated Vaccine start time (17:00), treatment received for events was no. updated narrative (Administration time for 1st and 2nd dose updated from 05:00 to 17:00 (05:00 PM), "No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no allergies to medications, food, or other products" added).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Pain
Clinical narrative: By evening was feeling achy; soreness in the shoulder/back area; soreness in the shoulder/back area; Soreness under arm gland area; This is a spontaneous report from a non-contactable consumer (patient) communicated to a Pfizer sales representative. A 6-decade-old male patient (in his 50s) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date in 2021 (at the age of 6-decade-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously taken first dose of COVID-19 (MANUFACTURER UNKNOWN) on unspecified date for covid-19 immunization. On an unspecified date in 2021, the patient reported that he received vaccine in the morning, by evening was feeling achy and continued to have soreness in the shoulder/back area, also soreness under arm gland area. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Feeling abnormal, Headache, Overdose
Clinical narrative: was given 6 times the normal dose; bad headaches; brain fog; trouble breathing; weak; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller, female, calling on behalf of brother-in-law, he was given 6 times the normal dose of vaccine along with 71 other inmates. She's not sure what date he received the vaccine. She states it was all over the news. Both nurses have been suspended. He is still having side effects like bad headaches, brain fog, trouble breathing and is weak on an unspecified date. The prison now wants to administer a second dose to him. She is calling to whether or not if this is appropriate and wants documentation on why he shouldn't get the second dose because he got such a high dose the first time. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow up needed, further information has been requested.  Follow-up (19Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: Sore arm and achy for a day; Initial information was received on 31-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had sore arm and achy for a day (pain in extremity) after receiving vaccines INFLUENZA VACCINE and corona virus disease of 2019 (COVID-19) 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 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 (batch number and expiry not reported) via unknown route in the arm Not Otherwise Specified (NOS) for prophylactic vaccination.  On an unknown date, the patient received a Booster dose of suspect COVID-19 VACCINE not produced by pharmaceutical company (batch number and expiry not reported) via unknown route in the arm NOS for prophylactic vaccination.  On an unknown date the patient developed a non-serious sore arm and achy for a day (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "Flu shot in one arm and covid booster in the other. Sore arm and achy for a day."  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 treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with INFLUENZA VACCINE.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Clinic immunized TWO patients with expired vaccines with no adverse event reported; Initial information received on 01-Nov-2021 regarding an unsolicited valid  non-serious case received from via other health professional under reference number: US-SA-SAC20211108000274.  This case involves Adult and unknown gender patient who was administered an expired dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  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 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.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick for one week; Initial information was received on 03-Nov-2021 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional via social media.  This case involves a male patient (age unspecified) who was sick for one week (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past 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 was not reported) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date, the patient was sick for one week (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " Same here I will never get the flu shot. My neighbor get the shot and he's sick for one week".  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.  On an unknown date, the patient recovered from the event.  The reporter did not report causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: Two days after caught the only cold; Initial information was received on 02-Nov-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-SAC20211109000972).  This case involves adult patient of unknown age and gender who experienced two days after caught the only cold (nasopharyngitis), 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 two days after caught the only cold (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I've had in 20 years. Other guys I know said the same happened to them. I don't do vaccines anymore.  It is unknown if the patient experienced any additional symptoms/events.  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
Clinical narrative: flu; Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had flu (influenza), 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 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 expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious flu (influenza) (2 weeks) following the administration of INFLUENZA VACCINE.  It was reported "This case is received from Social media. The following potential adverse event has been found on a public post for Flu Shot Fridays 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. No Diabolical shot is to be praised. Also have been sharing. I got the flu 2 weeks after I took it. I have not had the flu since. Do not need that Diabolical shot."  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.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information was received on 04-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who experienced sore arm (pain in extremity) after receiving INFLUENZA VACCINE and Coronavirus disease (COVID-19) VACCINE  The patient's medical treatment(s), vaccination(s), concomitant medications 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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a booster dose of suspect COVID-19 VACCINE not produced by pharmaceutical company lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "I got my COVID booster and flu shot together last week and other than a sore arm for one day had no side effects"  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 event (sore arm).  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Initial information received on 03-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had got very sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got flu shot once, got very sick. never again".  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, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Neurological symptom
Clinical narrative: a neurological sensation in her body; Initial information received on 02-Nov-2021 regarding an unsolicited valid  non-serious case from a other health professional.  This case involves an unknown age female patient who experienced a neurological sensation in her body (neurological symptom) while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical treatment, vaccination, 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 dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE 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 a neurological sensation in her body (neurological symptom) (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 event (a neurological sensation in her body).  On an unknown date, the patient recovered from neurological symptom.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bedridden
Clinical narrative: In bed for a month; Initial information was received on 05-Nov-2021 regarding an unsolicited valid serious case received from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who was in bed for a month (bedridden) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past 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 (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious in bed for a month (bedridden) (unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to disability.  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 treatment for the event.  At time of reporting, outcome of the event was unknown.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient (unknown demographics) who experienced bedridden after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's past vaccination(s), vaccination tolerance, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Illness, Nasopharyngitis
Clinical narrative: very nasty cold; cough for more than 3 weeks; So sick; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves an unknown demographics patient who experienced very nasty cold (nasopharyngitis), cough for more than 3 weeks (cough) and so sick (illness) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) (Injection) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious very nasty cold (nasopharyngitis), cough for more than 3 weeks (cough) and so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported "I get my flu shot about a month ago, two days later I was so sick with a very nasty cold and cough for more than 3 weeks."  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: gotten the flu maybe only once or twice; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves an unknown demographics patient who experienced flu (influenza) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported "I used to not bother with flu shots (not anti-vax). I'd get the flu every other year, probably more often than that. But I've been getting the flu shot every year for nearly a decade now, in which time I've gotten the flu maybe only once or twice."  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUR4
Symptoms: Burning sensation, Vaccination site pain
Clinical narrative: severe burning and was even "jumping" with the injection; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00827114) and transmitted to Sanofi on 25-Oct-2021.  This case is linked to cases 2021SA361271, 2021SA345810 and 2021SA361282 (same reporter).  This case involves a 64-year-old male patient who experienced severe burning and was even "jumping" with the injection (vaccination site pain) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2127, expiry date 30-Jun-2022) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severe burning and was even "jumping" with the injection (vaccination site pain) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "Nurse reports they received 50 doses of Flublok. They administered 6 so far and stopped using the product. She reports for 4 of the 6 administered to staff they have complained of severe burning and were even "jumping" with the injection. Two of the employees have had rashes and welts on arms at injection site the size of a baseball. The welts were hot to touch and raised."  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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered the expired product with no received expired dose of FLUZONE QUADRIVALENT with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from other health professional via Medical Information (Reference number- 00842588) and transmitted to Sanofi on 04-Nov-2021.  This case is linked to cases 2021SA371630(CLUSTER), 2021SA369789(CLUSTER), 2021SA370183(CLUSTER), 2021SA370209(CLUSTER), 2021SA371632(CLUSTER) and 2021SA369806(CLUSTER).  This case involves a patient (unknown demographic) receiving expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once), (suspension for injection, lot UJ507AC, expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "A Nurse reporting a medication error described as 20-staff members and 7-Residents received expired doses of FLUZONE QUADRIVALENT MDV from 2020-2021 year after receiving these 6-vials of the FLUZONE QUADRIVALENT MDV in the current years flu vaccine shipment. The Nurse reported that the 20-staff members received the dose since the end of Oct-2021; that the information on the staff members are not known, at the time of this report; that the staff has had no reports of adverse issues since dosing; that the 6-Residents received their dose on 03-Nov-2021; that the information for the residents is known to the reporter; that the residents have had no reports of adverse issues since dosing."  At time of reporting, no adverse event 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.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case is linked to cases 2021SA371630 and 2021SA369738 (same reporter). This case involves an 87-year-old female patient who received expired dose INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (Expired vaccine used). The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. On 03-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ507AC and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. It was reported "A Nurse reporting a medication error described as 20-staff members and 7-Residents received expired doses of FLUZONE QUADRIVALENT MDV from 2020-2021 year after receiving these 6-vials of the FLUZONE QUADRIVALENT MDV in the current years flu vaccine shipment". It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported.  Outcome of event was unknown. 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 Regulatory Authority. 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.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Post-acute COVID-19 syndrome
Clinical narrative: long covid; reaction to the vaccine; Initial information received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional via Media Information (under the reference 00844978).  This case involves a female patient (unknown age) who had long covid (coronavirus Disease) [post-acute covid-19 syndrome] and reaction to the vaccine (adverse reaction) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 FLUZONE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious long covid (post-acute covid-19 syndrome) and reaction to the vaccine (adverse reaction) (unknown latency) following the administration of vaccine.  It was reported "Caller is a patient and a nurse. Caller says that she is currently dealing with Long Covid. She wants to find out the ingredients in FLUZONE HD and if it contains any Hexabromocyclododecane (HBCD) or Polysorbate 80. She also mentioned that she had a reaction to the J&J vaccine. Caller also wanted ingredient information for regular FLUZONE."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a expired product on 9/2 and it was administered with no AE; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via the Regulatory Authority (Regulatory Authority Number-00845512).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "yesterday stating that they received a shipment of expired Fluzone High Dose on 9/2 and he reported that a dose was administered. I do not have further details.Is dose not used or not available. Whether product is available for return o If the customer says no then advise them that if this happens again to retain the product for return to better assist in the investigation. o If the customer states picture(s) are available, ask to send us the picture(s). No broken vials or syringes with needles can be returned. Information to be gathered on the type of needle that was used by the end-user (example gauge size) Is the reporter the one who found it? Was he/she the one who opened & checked the shipment? Do they insist it actually arrived in the shipment with the new product? If found by someone in the fridge verses  shipment, state that also. Do they have the original packaging that is carton and is the info on the carton the same as the label?"  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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 batch number for this case.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old female patient received Flublock, with no reported adverse event; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from a Physician via other health care professional via non-healthcare professional via Medical Information (Reference number- 00844192).  This case involves a 17-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], (product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 06-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ725AA and expiry date: 30-Jun-2022) (Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on same day).  It was reported "nurse requests counseling regarding FLUBLOK; on 06NOV2021, a female 17 year old patient received FLUBLOK; caller would like to know adverse events to look out for and counseling regarding dosage meant for adults".  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.