chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Pollakiuria, Respiratory disorder
Clinical narrative: Chills; Panting; Numb fingertips and feet; Slightly nauseated; Felt weird; Three urination between 10:30pm to 2am (very abnormal); felt tired and wiped out; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 12Apr2021 10:30 (at the age of 46 years old) as single dose for COVID-19 immunization. Other medical history included was none. Concomitant medication(s) included atorvastatin. Historical vaccine included: The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not re-ported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced just a sore arm. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 26Apr2021 22:15, the patient felt weird, panting, numb fingertips and feet, slightly nauseated. On 26Apr2021 22:30, the patient experienced chills and got very bad, No fever but big chills. On 27Apr2021, 2:30am: the Pulse was 100bpm and felt off chills were gone. On 26Apr2021, the patient experienced three urinations between 10:30pm to 2am (very abnormal), for next-16 hours the patient felt tired and wiped out and next day (27Apr2021) was fine. The patient underwent lab tests and procedures which included heart rate was 95 bpm on 26Apr2021 and heart rate was 100 bpm on 27Apr2021 at 2:30 am, oxygen saturation: 99 % on 26Apr2021. The reporter assessed the events as non-serious. The patient did not receive any therapeutic measures for the events. The outcome of the events felt weird, panting and chills was recovered on 27Apr2021, and the other events was recovered on unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Little nagging cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced little nagging cough since he received the Covid-19 vaccine on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  .
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: feet broke out in a hives allergic reaction, from his knees down to his feet; itches bad; This is a spontaneous report from a contactable consumer(patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration on 07May2021 at 15:30 (age at vaccination 42 years-old) as dose 2, single for COVID-19 immunization . The patient's medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: LEW0151, Expiration date: 31Jul2021) on 14Apr2021 (age at vaccination 42 years-old) between 13:30-14:00 as dose 1, single for COVID-19 immunization. When he woke up Sunday morning on 09May2021 the caller stated his feet broke out in a hives allergic reaction, from his knees down to his feet and it itches bad. No additional vaccines administered on same date of the Pfizer suspect. No emergency room and physician office visit was reported. It was reported as product complaint. The patient took Cortisone 10 cream and Benadryl as a treatment but that didn't help that much. Clarified, after he put it on, for an hour or two it allows him to not itch it but after 4-5 hours it started to itch again. Stated he tried not to itch it or it gets red. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dry skin, Inappropriate schedule of product administration, Off label use, Pruritus
Clinical narrative: The first shot was on 10Mar2021 and my second shot was on 01May2021; The first shot was on 10Mar2021 and my second shot was on 01May2021; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Fever; Chills; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737, Expiration Date: Unknown) via an unspecified route of administration, administered in left arm on 01May2021 (at the age of 42-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. The first shot was on 10Mar2021, and his second shot was on 01May2021 (Off label use, inappropriate schedule of vaccine administered). On an unspecified date in May2021, patient stated, he had little rash on his body after his vaccine next day. It gave him fever, chills, got rash on body like his both sides, (his waist also), above his ribs and also on calves but asked he knew how long it was going to take to be gone. Patient asked what the best advice was, to use some cream or take some medicine. He was not quite sure which one is the best. He was just itching. Patient was using body lotion cream. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: The first shot was on 10Mar2021 and my second shot was on 01May2021; The first shot was on 10Mar2021 and my second shot was on 01May2021; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Fever; Chills; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737, Expiration Date: Unknown) via an unspecified route of administration, administered in left arm on 01May2021 (at the age of 42-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. The first shot was on 10Mar2021, and his second shot was on 01May2021 (Off label use, inappropriate schedule of vaccine administered). On an unspecified date in May2021, patient stated, he had little rash on his body after his vaccine next day. It gave him fever, chills, got rash on body like his both sides, (his waist also), above his ribs and also on calves but asked he knew how long it was going to take to be gone. Patient asked what the best advice was, to use some cream or take some medicine. He was not quite sure which one is the best. He was just itching. Patient was using body lotion cream. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Rash pustular, Tenderness
Clinical narrative: the rash is getting bumps and they get a little sore, there is a little pus coming out of some of the bumps; experiencing a rash going up her arm and it itches a lot; experiencing a rash going up her arm and it itches a lot; the rash is getting bumps and they get a little sore, there is a little pus coming out of some of the bumps; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 21Apr2021 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 64 years). Medical history none. There were no concomitant medications. Previously patient received first dose of covid-19 vaccination on 31Mar2021 in her right arm and has lot number ER8734 for covid-19 immunisation. The patient experienced a rash going up her arm and it itches a lot, the rash is getting bumps and they get a little sore and there is a little pus coming out of some of the bumps on an unspecified date. Consumer stated she took both doses of the Pfizer vaccine and took the 1st shot in her left arm and the 2nd shot in her right arm and after the 2nd shot she started experiencing a rash going up her arm and it itches a lot and she does not know but it looks terrible. Consumer later clarifies in the call the 1st dose of the Pfizer Vaccine was administered on 31Mar2021 in her right arm and has lot ER8734 and the 2nd dose was administered on 21Apr2021 with lot EW0161 in her left arm. Consumer stated that rash started about 4-5 days after the 2nd dose of the Pfizer Vaccine and started off small and she did not think anything about it and then it started spreading up her arm. Consumer stated she has not required treatment for the reported event and believes she needs to go in for it because the rash was getting bumps and they get a little sore and there was a little pus coming out of some of the bumps. Consumer states she was calling to find out what she needs to do because the rash is spreading up her arm; states the rash was on the same arm where she was administered the 2nd dose of the Pfizer vaccine which is her left arm. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Eyelid function disorder
Clinical narrative: feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt she could hardly open her eyes and felt that pain would kill her; feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt she could hardly open her eyes and felt that pain would kill her; feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt she could hardly open her eyes and felt that pain would kill her; This is a spontaneous report from a contactable consumer (report for her mother). A 52-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0169, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration, administered in left arm on 14May2021 as dose 2, single (at the age of 52-years-old) for COVID-19 immunisation. The patient medical history was not reported. Patient had not received concomitant medications. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported and Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on an unspecified date as dose 1, single (at the age of 52-years-old) for COVID-19 immunisation. On 15May2021 (morning), patient was feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt, she could hardly open her eyes and felt that pain would kill her. Patient received no treatment for all the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Product administration error
Clinical narrative: Shoulder Pain; Neck pain; Thinks it was administered incorrectly; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Mar2021 (at the age of 74-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of Pfizer COVID vaccine and believes it was administered incorrectly because she was still having shoulder and neck pain that started the day after. It was reported that She wants to know if the quality was still efficient if it was given incorrectly. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nasal congestion, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Low grade fever; Nausea; Diarrhoea; Runny nose; Congestion; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (parent). A male patient of an unspecified age received bnt162b2 (COVID 19 VACCINE, solution for injection, Lot number and Expiry date were not reported), dose 1 via an unspecified route of administration on 27May2021 as dose 1, single for COVID-19 immunisation. Investigation assessment was not provided. The patient medical history was not reported. The patient concomitant medication was not reported. Other products were not provided. On 31May2021, the patient experienced low grade fever, nausea, diarrhoea, runny nose, congestion. Reporter stated that, wants to know if patient has a COVID test, would it show as positive result? the caller was fully aware these are symptoms of having the COVID 19 virus, and since he already had the first dose, there was more reason they should know if the COVID test will show as positive. Reporter to reach out to a primary care doctor for information concerning the low-grade fever and whether her grandson's symptoms are COVID related. The clinical outcome of the events was reported as unknown.  Lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm; Fever; Aches and Pains; This is a spontaneous report from a Pfizer sponsored program  COVID-19 Vaccine Testing-2021, a non-contactable physician reported for patient.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, fever, aches, and pains. It was stated that, the event was caused by suspect product. The outcome of the events was recovered on an unspecified date.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had 9 allergic reactions which are severe; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via on an unspecified route of administration on 17Apr2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced 9 allergic reactions which were severe, and she had been back and forth to the emergency. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Her hands, fingers and muscle joints are aching; Her hands, fingers and muscle joints are aching; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's aunt) reported for a 32-year-old female patient (reporters niece).   A 32-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her hands, fingers and muscle joints are aching. It was reported that patient received 1st Pfizer Covid vaccine 1 1/2 to 2 months ago. where the patient experienced pain in hand, fingers and muscle joints which she mentioned the events were coming and going. She also mentioned that it took 2-3 weeks for her to feel better. The reporter wanted to know will these go away and is it safe to take the second Pfizer vaccine dose. Outcome of all the events was recovering.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Dizziness, Pyrexia
Clinical narrative: weakness; Fever; Dehydrated; Dizzy; This is a spontaneous report from a non-contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 04May2021 (age at vaccination: 68-years-old) as dose number unknown, single for covid-19 immunization. Medical history included Hypothyroidism, Degenerative Disc Disease, High blood pressure and Overactive bladder. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]); tizanidine hydrochloride (ZANAFLEX); baclofen (BACLOFEN); gabapentin (GABAPENTIN); lisinopril (LISINOPRIL); oxybutynin hydrochloride (DITROPAN); nortriptyline (NORTRIPTYLINE); tramadol (TRAMADOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, patient experienced weakness, fever, dehydrated, dizzy. The outcome of the events was reported as recovered on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sneezing
Clinical narrative: sneezing; mild cold; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported), dose 1, via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. After receiving first dose of vaccine, the patient experienced sneezing, mild cold on an unspecified date. Therapeutic measures were taken as a result of sneezing, mild cold with tylenol. The outcome of events was unknown at the time of this report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Pruritus, Rash, Skin exfoliation
Clinical narrative: loss of his short term memory; rash, his skin is hard and breaky; itchy; it comes off like pieces of plastic; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he received both Pfizer shots. On an unspecified date, the patient reported he was having loss of his short term memory. He had a rash, his skin was hard and breaky, it was itchy and it comes off like pieces of plastic (unspecified dates). He also had a fever for a while after the second shot, and he was not able to remember anything. He could remember all his past, from when he was 3 years old, but he could not remember if he was doing something. He stated he did not have a memory problem before. The outcome of the events were unknown.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Pruritus, Pyrexia, Rash, Skin exfoliation
Clinical narrative: Loss of his short term memory; Rash, his skin is hard and breaky; Itchy; It comes off like pieces of plastic; Fever; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced loss of his short-term memory, rash, itchy and it comes off like pieces of plastic. On an unspecified date, the patient experienced loss of his short-term memory, rash, his skin is hard and breaky, itchy, it comes off like pieces of plastic and fever for a while after the second shot. He was not able to remember anything. He can remember all his past, from when he was 3 years old, but he can't remember if he was doing something. He stated he didn't have a memory problem before. Outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: severe burning and was even "jumping" with the injection; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from nurse and consumer/ non health care professional via Regulatory Authority (under reference 00827108).  This case is linked to cases 2021SA345810 and 2021SA361277 (same reporter).  This case involves a 30 years old female patient who had severe burning and was even "jumping" with the injection (vaccination site pain), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2127 and expiration date: 30-Jun-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe burning and was even "jumping" with the injection (vaccination site pain) (unknown latency) following the administration of 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."  No laboratory data were reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Got sick and end up in bed for several days; Initial information was received on 28-Oct-2021 regarding an unsolicited valid serious case from a consumer (patient) via Social media.  This case involves an adult patient of unknown gender who got sick and end up in bed for several days (illness), after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination and got sick (illness). The patient's medical history, concomitant therapy, medical treatment(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 expirydate not reported) via an unknown route at an unknown administration site for prophylactic vaccination  On an unknown date, the patient got sick and end up in bed for several days (illness; serious) (unknown latency) following the administration of INFLUENZA VACCINE. This event was lead to disability.  Patient took flu shot every year and end up in bed for several days and when he/she did not get the flu shot was not sick at all.  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 for the event.  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 gender who experienced illness after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding concurrent 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.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: made me soooooo sick; Initial information received on 28-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer via social media via Digital Media.    This case involves Adult female patient (age unknown) who experienced made me soooooo sick (illness)while receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer batch number, expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.   an unknown date the patient experienced a non-serious made me soooooo sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"The flu shot made me soooooo sick. Won't be doing it again".  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: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu A: Initial information was received on 25-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via Regulatory Authority (under reference number: US-SA-SAC20211101000706).  This case is linked to cluster cases 2021SA355175 and 2021SA361705.  This case involves an adult male patient who had flu A (influenza) after receiving INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE every year in October for the past five years.  The patient's medical history, past medical treatments 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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  In Feb-2019, the patient developed a non-serious flu A (influenza) (unknown latency) following the administration of INFLUENZA 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   At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: feel bad; Initial information received on 31-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer via social media via Digital Media.   This case involves an (unknown age and gender) patient who experienced feel bad(feeling abnormal) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer batch number, expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient experienced non-serious feel bad (feeling abnormal) (latency unknown) following the administration of INFLUENZA VACCINE.  It was reported" I took mine and started to feel bad. I shouldn't have taken it".   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: Malaise
Clinical narrative: not feeling well; Initial information received on 30-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via Regulatory Authority.  This case involves a patient (unknown demographic) who had not feeling well (malaise) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious not feeling well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  it was reported "Got mine and was not feeling well."  There were no 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 reported event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Bedridden, Pain, Pyrexia, Tremor
Clinical narrative: he is bedridden with fever, tremors and pain; he is bedridden with fever, tremors and pain; he is bedridden with fever, tremors and pain; Initial information received on 29-Oct-2021 regarding an unsolicited valid social media serious case received from a consumer or non-healthcare professional via social media via Digital Media.  This case involves a 74 years old male patient who is bedridden with fever, tremors and pain (Pyrexia, tremor,pain) after  receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient was bedridden with fever, tremors and pain (Pyrexia, tremor,pain) (unknown latency) following the administration of INFLUENZA VACCINE.   All events were leading to disability (bedridden).  Additional information was reported as healthy 74 year old uncle took that flu shot against his wife's advice and now he is bedridden with fever, tremors and pain. This is an atrocity. And by the way, its the shedding from the flu shit that causes flu season as it gets on everything and makes everyone in contact susceptible. Stop this quackery and virtue signaling now.  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, the outcome was unknown for the reported event.; Sender's Comments: This case involves a 74 years old male patient who was Bedridden with Pyrexia, tremor, pain after the vaccination with INFLUENZA VACCINE . 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 individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu: Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number: US-SA-SAC20211103000877).  This case involves a patient of (unknown demographics) who experienced flu (influenza) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have not had one since I was a child. The same year I got the flu. I haven't had the flu many times in my life so I will just boost my immune system up with clean foods, water and supplements to heal my gut."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (influenza).  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Flu: Initial information received on 30-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from Regulatory Authority a via consumer non health care professional under reference number: US-SA-SAC20211103001270.  This case involves Adult and unknown gender patient who was experienced flu (influenza) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   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 disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event flu (influenza) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was 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 event was reported as unknown.  There was be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient (unknown demographics) who had worse flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 worse flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I got my corona virus disease (Covid) shots, but I'm not doing the flu shots. I was talked into to having the flu shot once and came down with the worse flu I ever had that year." 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 suspect. There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: Felt feverish; horrible stomach cramps; Initial information received on 29-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves adult male patient of an unknown age who experienced felt feverish (pyrexia) and horrible stomach cramps (abdominal pain upper), after receiving INFLUENZA VACCINE.  The patient's vaccination included INFLUENZA VACCINE (Had three in 20 years) after patient experienced each time felt feverish afterwards, then horrible stomach cramps like was beaten with a 2x4.  The patient's medical history, medical treatment, 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 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 felt feverish (pyrexia) and horrible stomach cramps (abdominal pain upper), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "had three in 20 years. Each time felt feverish afterwards, then horrible stomach cramps like i was beaten with a 2x4".  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 events.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Inflammation, Peripheral swelling
Clinical narrative: hardness; redness and swelling of the arm; egg allergic patient received FLUZONE vaccine; Initial information received on 25-Oct-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional in the .  This case involves an egg allergic seven years old male patient who experienced redness and swelling of the arm (inflammation) and hardness (induration) while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (contraindication to vaccination).  The patient's past vaccination included INFLUENZA VACCINE.  The patient's medical history, past medical treatment and family history were not provided.  At the time of the event, the patient had ongoing food (egg) allergy.   In 2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ087AA and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (as pediatrician thought kids with egg allergies don't usually react, so FLUZONE was used).  On an unknown date the patient developed a non-serious mild redness and swelling of the arm (inflammation) and hardness (induration) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was case of contraindication to vaccination as egg allergic patient received FLUZONE QUADRIVALENT vaccine (latency: same day).  It was reported ''Caller states that for the past 3 years, her son has had a reaction to his flu vaccine. Each year the vaccine was from a different manufacturer. Mother states that one year, the child received one of the flu vaccines that doesn't contain eggs (not Flublok), but he still reacted. His allergist wants to test the child for sensitivity to each ingredient in all 3 vaccines to determine what he is reacting to. She states that the 2018 FLUZONE administration was the first time he reacted, but it gets worse every time, so that was the mildest symptomatically.''  It was not reported if the patient received a corrective treatment for the events (redness and swelling of the arm, hardness).   Laboratory details were not reported.  On an unknown date, the patient had recovered from inflammation and induration.
Sex: M
Vaccine: FLUR4
Symptoms: Diarrhoea, Pain, Pain in extremity
Clinical narrative: when he went to bed and woke up with diarrhea; sore arm; aches and body pain, body ached all over; Initial information regarding an unsolicited valid non-serious case was received from consumer (patient) via Medical Information (Reference number- 00827229) and transmitted to Sanofi on 25-Oct-2021.  This case involves an 88-year-old male patient who experienced sore arm (pain in extremity), aches and body pain, body ached all over (pain) and when he went to bed and woke up with diarrhea (diarrhoea) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing lung cancer and neoplasm malignant (had 4 cancers and underwent chemotherapy treatment and is doing well).  On an unknown date, the patient received a 0.5 mL (total) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore arm (pain in extremity), aches and body pain, body ached all over (pain) and when he went to bed and woke up with diarrhea (diarrhoea) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported about patient's spouse that "Consumer has questions about the flu vaccine and states she received her FLUZONE HIGH DOSE vaccine, and her spouse received the FLUBLOK. Consumer would like to know the difference between the two because she thought that they were getting the same vaccine. Caller reports that following her spouse receiving Flublok."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  On an unknown date, the patient recovered from pain (it was short lived).  At time of reporting, the outcome was unknown for the events pain in extremity and diarrhoea.  There will be no information available on batch number for this case.
Age: 4.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 4 year old patient was administered FLUBLOCK with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via  Medical Information  (Reference number- 00831464) and transmitted to Sanofi on 27-Oct-2021 in a specific country.  This case involves a four-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once, lot UT7316JA, expiry date: 20-JUN-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to product administered to patient of inappropriate age (latency: same day).  It was reported "The caller states that a 4 year old patient was administered FLUBLOCK."  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: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12-month patient was inadvertently given a dose of Flublok with no reported adverse event; Initial information regarding an unsolicited non-valid non serious case was received from other health professional via Regulatory Authority (RA) Reference number: 00832897) and transmitted to Sanofi on 28-Oct-2021 in.  This case involves a 12-year-old female patient who was inadvertently given a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Frequency-1X, Strength: standard, lot QFAA2138, expiry date: 30-Jun-2022] via intramuscular route in the deltoid for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration (latency same day).  It was reporter "Licensed practical nurse (LPN) reported that a 12-year-old patient was inadvertently given a dose of Flublok, yesterday. She requested guidance on how to proceed."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.