chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Feeling of body temperature change, Headache, Hyperhidrosis, Illness
Clinical narrative: experienced headaches; kidneys don't seem like to working properly ; problem in going to bathroom ; both peeing and pooping; kidneys don't seem like to working properly ; problem in going to bathroom ; both peeing and pooping; I am very sick; I can't remember my from taking this shot; I do not feel good/ I feel crazy; Confusion; I eat particulate and then sometimes I don't eat at all; Body ache; I felt like I was strangled in my throat like it was choking and I couldn't get over it; Sweating/sweat; I get hot that all the time in the night and it wakes me up; Feeling hot and cold; Teeth chattering; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 65-years-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 05Jul2021 (at the age of 65 years) as dose 1, single for COVID-19 immunization. Medical history included drug hypersensitivity (allergic to medicines and the patient take no medicines) from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no prior vaccination within 4 weeks. Patient added "he had Headaches, a whole of bunch of confusion. His kidneys don't seem like to working properly. He has a problem in going to bathroom and in both peeing and pooping and he eat particulate and then sometimes he don't eat at all. He was very sick. He drink a lot of water but side effects confusion, body ache, he felt like he was strangled in his throat like it was choking and he couldn't get over it and finally he get whole bunch of water and then finally it went away to an extent. He can still feel it in still feel it in his throat, acting funny. He do not feel good/ he feel crazy. He can't remember his address from taking this shot. He need to see a doctor, what he need to see, all hot and cold, sweat/ sweating, he get hot that all the time in the night and it wakes him up and his teeth starts chattering, they just starts chattering away/ teeth chattering ". The patient experienced Feeling hot and cold. No treatment was received for the events. Clinical outcome of the event was reported as unknown.  The lot number for vaccine was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Oropharyngeal discomfort, Pain, Renal disorder
Clinical narrative: experienced headaches; kidneys don't seem like to working properly ; problem in going to bathroom ; both peeing and pooping; kidneys don't seem like to working properly ; problem in going to bathroom ; both peeing and pooping; I am very sick; I can't remember my from taking this shot; I do not feel good/ I feel crazy; Confusion; I eat particulate and then sometimes I don't eat at all; Body ache; I felt like I was strangled in my throat like it was choking and I couldn't get over it; Sweating/sweat; I get hot that all the time in the night and it wakes me up; Feeling hot and cold; Teeth chattering; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 65-years-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 05Jul2021 (at the age of 65 years) as dose 1, single for COVID-19 immunization. Medical history included drug hypersensitivity (allergic to medicines and the patient take no medicines) from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no prior vaccination within 4 weeks. Patient added "he had Headaches, a whole of bunch of confusion. His kidneys don't seem like to working properly. He has a problem in going to bathroom and in both peeing and pooping and he eat particulate and then sometimes he don't eat at all. He was very sick. He drink a lot of water but side effects confusion, body ache, he felt like he was strangled in his throat like it was choking and he couldn't get over it and finally he get whole bunch of water and then finally it went away to an extent. He can still feel it in still feel it in his throat, acting funny. He do not feel good/ he feel crazy. He can't remember his address from taking this shot. He need to see a doctor, what he need to see, all hot and cold, sweat/ sweating, he get hot that all the time in the night and it wakes him up and his teeth starts chattering, they just starts chattering away/ teeth chattering ". The patient experienced Feeling hot and cold. No treatment was received for the events. Clinical outcome of the event was reported as unknown.  The lot number for vaccine was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Became immediately woozy and started seeing stars; Felt fatigued; rapid heart rate/heart rate was pretty high, in the 160s-170s; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 at single dose for COVID-19 immunisation. The patient's medical history included COVID-19 on an unspecified date in 2020. She had COVID in the month of December and ended up in the hospital and received the monoclonal antibodies by day 2 or 3. The patient reported she had a cardiac implant to monitor her heart rate (a loop recorder). The patient's concomitant medications were not reported. On an unspecified date in Mar2021 at about 5 in the evening, the patient reported that she had her first dose of the vaccination, the moment vaccine was injected, she became immediately woozy and started seeing stars which subsided within a few seconds. The patient reported that within an hour, she felt fatigued and nothing more than that. The patient reported that at about 8, she started out of nowhere getting a rapid heart rate and so she called her local doctor. The patient reported that she to local emergency room and called a nurse and explained what she was feeling. Her heart rate was pretty high, in the 160s to 170s, electrocardiogram (EKG) was taken and her heart was fine. The patient reported that she never had shortness of breath or rash. They asked her if she had taken a pain reliever and she said no and she had not taken anything before or after and the nurse suggested Ibuprofen. The patient took an Ibuprofen 800mg. The patient reported when she left, they had put on her paperwork she had an adverse reaction to the vaccination, and she needed to contact her primary care doctor and her cardiologist before she proceeded to get the second dose. The patient reported that she was fine when she woke up the next morning. The patient reported she did not have that much pain in her arm either and she was struggling on deciding whether she should get the second dose or not. The patient reported her husband is concerned because of the new delta variant and she only had one dose. The patient reported that about an hour after the Ibuprofen intake, her heart rate came down. The patient reported her doctor told it could have reduced the inflammation response to the vaccine but could not explain why the moment she received vaccine, she became lightheaded and woozy. The patient had recovered from the events on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: I had the Pfizer, the first one I just had chills for three days; This is a spontaneous report from a contactable consumer (patient). An 81-year-old patient with unknown gender received 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 22Mar2021 (at the age of 80-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included arthritis (Verbatim: Arthritis). Concomitant medications included influenza vaccine (INFLUENZA VACCINE) taken for an unspecified indication, start and stop date were not reported.  On 22Mar2021, the patient experienced chills for three days. The patient stated with the first shot got chills four shot on the same day, the patient had the chills for about three days, it was for first three days, and then it was okay. The patient had no other symptoms, and the patient had no other symptoms, and the patient had no swelling of the injection area, or redness nothing the patient did not even feel it. The outcome of event was recovered on 25Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Feeding disorder, Gait inability, Headache
Clinical narrative: Experiencing super bad headache and it's a long way like weird symptoms where the room is spinning; She can't even walk, eat or drink anything/can't walk on her own; vomiting; vertigo; dizzy; can't walk by herself; nausea; is still is not well; she has not been eating; being dehydrated; This is a spontaneous report from a contactable consumer (Daughter). This consumer reported for a 50-year-old female patient (Mother).   A 50-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 10Jul2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Reporter stated, I just don't know if you can tell me, my mom and I got the shot on Saturday, but she is experiencing a super bad headache and it's a long way like weird symptoms where the room is spinning, she can't even walk, eat or drink anything and went to the Hospital, and they gave her pills and sent her home and it had been 4 days she had the symptoms. Her mom had her 2nd COVID shot on July 10th and on the Sunday 11Jul2021 she woke up 2 o'clock at the morning. She was vomiting and she has sense then vertigo type symptoms, super dizzy and she has been like that for 4 to 5 days now, can't walk by herself, pounding headache. Daughter took her to the ER yesterday 15Jul2021 at 1:30 and they her gave her fluids because of being dehydrated and they also gave her unknown nausea, anti-nausea pills as treatment. I guess, they gave her, the doctor in the emergency room. She feels a little better with the not being dehydrated. But she is still not well that's why she is calling. She thinks she might get some medical advice. Alright so she disconnected. I guess it took too long. Can you call back? Well yeah, she said I am at a loss at what to do. And so, my interpretation to that she is thinking that we were medical that helps but not really, product not specified. The patient received treatment for the events. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Nausea, Vertigo, Vomiting
Clinical narrative: Experiencing super bad headache and it's a long way like weird symptoms where the room is spinning; She can't even walk, eat or drink anything/can't walk on her own; vomiting; vertigo; dizzy; can't walk by herself; nausea; is still is not well; she has not been eating; being dehydrated; This is a spontaneous report from a contactable consumer (Daughter). This consumer reported for a 50-year-old female patient (Mother).   A 50-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 10Jul2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Reporter stated, I just don't know if you can tell me, my mom and I got the shot on Saturday, but she is experiencing a super bad headache and it's a long way like weird symptoms where the room is spinning, she can't even walk, eat or drink anything and went to the Hospital, and they gave her pills and sent her home and it had been 4 days she had the symptoms. Her mom had her 2nd COVID shot on July 10th and on the Sunday 11Jul2021 she woke up 2 o'clock at the morning. She was vomiting and she has sense then vertigo type symptoms, super dizzy and she has been like that for 4 to 5 days now, can't walk by herself, pounding headache. Daughter took her to the ER yesterday 15Jul2021 at 1:30 and they her gave her fluids because of being dehydrated and they also gave her unknown nausea, anti-nausea pills as treatment. I guess, they gave her, the doctor in the emergency room. She feels a little better with the not being dehydrated. But she is still not well that's why she is calling. She thinks she might get some medical advice. Alright so she disconnected. I guess it took too long. Can you call back? Well yeah, she said I am at a loss at what to do. And so, my interpretation to that she is thinking that we were medical that helps but not really, product not specified. The patient received treatment for the events. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Diarrhoea, Hypoaesthesia, Inflammation
Clinical narrative: Flu like symptoms; Explosive diarrhea; she didn't feel good; inflammation; Left shoulder pain; Right shoulder, elbow, arm pain/worsened; Right shoulder, elbow, arm pain/worsened; Right shoulder, elbow, arm pain/worsened; right arm can be numb; weak.; This is a spontaneous report from a contactable consumer or other non hcp.  A 56-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 intramuscular on 05Apr2021 16:30 (Batch/Lot Number: EP7534) as dose 2, single for covid-19 immunisation. Medical history included ongoing irritable bowel, ongoing coeliac disease, ongoing hypertension, von Willebrand's disease, asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, The patient experienced left shoulder pain on Apr2021 with outcome of recovering , right shoulder, elbow, arm pain/worsened on Apr2021 with outcome of not recovered , right shoulder, elbow, arm pain/worsened on Apr2021 with outcome of not recovered , right shoulder, elbow, arm pain/worsened on Apr2021 with outcome of not recovered , right arm can be numb on Apr2021 with outcome of not recovered , weak on Apr2021 with outcome of not recovered , flu like symptoms on an unspecified date with outcome of recovered , explosive diarrhoea on Apr2021 with outcome of recovering , she didn't feel good on Apr2021 with outcome of recovering , inflammation on Apr2021 with outcome of unknown.  Therapeutic measures were taken as a result of left shoulder pain (arthralgia), right shoulder, elbow, arm pain/worsened (arthralgia), right shoulder, elbow, arm pain/worsened (pain in extremity), right shoulder, elbow, arm pain/worsened (condition aggravated) , explosive diarrhea (diarrhoea).  Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: Flu like symptoms; Explosive diarrhea; she didn't feel good; inflammation; Left shoulder pain; Right shoulder, elbow, arm pain/worsened; Right shoulder, elbow, arm pain/worsened; Right shoulder, elbow, arm pain/worsened; right arm can be numb; weak.; This is a spontaneous report from a contactable consumer or other non hcp.  A 56-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 intramuscular on 05Apr2021 16:30 (Batch/Lot Number: EP7534) as dose 2, single for covid-19 immunisation. Medical history included ongoing irritable bowel, ongoing coeliac disease, ongoing hypertension, von Willebrand's disease, asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, The patient experienced left shoulder pain on Apr2021 with outcome of recovering , right shoulder, elbow, arm pain/worsened on Apr2021 with outcome of not recovered , right shoulder, elbow, arm pain/worsened on Apr2021 with outcome of not recovered , right shoulder, elbow, arm pain/worsened on Apr2021 with outcome of not recovered , right arm can be numb on Apr2021 with outcome of not recovered , weak on Apr2021 with outcome of not recovered , flu like symptoms on an unspecified date with outcome of recovered , explosive diarrhoea on Apr2021 with outcome of recovering , she didn't feel good on Apr2021 with outcome of recovering , inflammation on Apr2021 with outcome of unknown.  Therapeutic measures were taken as a result of left shoulder pain (arthralgia), right shoulder, elbow, arm pain/worsened (arthralgia), right shoulder, elbow, arm pain/worsened (pain in extremity), right shoulder, elbow, arm pain/worsened (condition aggravated) , explosive diarrhea (diarrhoea).  Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: Measle type rash at neck area; This is a Spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID19 VACCINE, Lot#:EP7534), via an unspecified route of administration in arm left on 15Mar2021 12:00 at age of 73-year-old as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient's concomitant medication included atorvastatin calcium (LIPITOR) from 2021. Prior to vaccination, the patient was not diagnosed as COVID-19. The patient was not pregnant at time of the vaccination. In 2021 following first dose after vaccine, the patient experienced measle type rash at neck area. The adverse event measle type rash at neck area resulted in visiting doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse enent measle type rash at neck area and included treatment with Steriods. Since the vaccination, the patient had not been tested for COVID-19. The outcome of adverse event measle type rash at neck area was not recovered.    No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: the patient got terribly sick; Initial information was received on 30-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer (under reference number: US-SA-SAC20211006000280).  This case is linked to cluster cases 2021SA330955 and 2021SA330912.  This case involves an adult male patient who experienced non serious event "the patient got terribly sick" (illness) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations 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.  On an unknown date the patient developed a non-serious the patient got terribly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The reporter's husband for 26 years was forced to take a flu shot and every year he got terribly sick. Her mother-in-law took one last year and shortly after had a stroke. This shot was as dangerous as the COVID shot. Her dad got Guillain barre syndrome from a flu shot."  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, 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: FLUR4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin reaction
Clinical narrative: redness and swelling in arm; redness in arm; swelling in arm; itching in arm; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient (unknown age and gender) who had redness and swelling (inflammation) and itching (pruritus) in arm after receiving QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV).  The patient's past vaccination(s) included annual influenza vaccine (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination, without having any adverse reactions.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious redness and swelling (inflammation), redness (erythema), swelling (peripheral swelling) and itching (pruritus) in arm, (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: got the flu from a flu shot; Initial information received on 27-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from via consumer non health care professional (under reference number: US-SA-SAC20210930001330) in United States.  This case involves Adult and unknown gender patient who experienced got the flu from a flu shot (Influenza) while receiving INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [FLUZONE UNSP].  The patient's past medical treatments, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a doseof suspect INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED (lot 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 event got the flu from a flu shot (influenza) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED.  It is unknown if the patient experienced any additional symptoms/ event.   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 was Unknown for the event got the flu from a flu shot.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: I developed frozen shoulder; Initial information was received on 27-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced "I developed frozen shoulder" (periarthritis), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious event I developed frozen shoulder (periarthritis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received any corrective treatment for the event.  It was reported "Last time I got a flu shot, I developed frozen shoulder. It's lasted 2 years".  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Periarthritis, Product administered at inappropriate site
Clinical narrative: flu aped frozen shoulder; more than likely the person who gave you the shot gave it way too high; Initial information was received on 28-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves an adult patient (gender not reported) had flu aped frozen shoulder (periarthritis) after receiving vaccine INFLUENZA VACCINE and more than likely the person who gave the shot gave it way too high (product administered at inappropriate site).  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to vaccine administered at inappropriate site (latency: same day).  It was reported "so more than likely the person who gave you the shot gave it way too high. That was one of the first things that were taught when administering vaccines. This happened to a friend of mine"  On an unknown date, the patient developed a non-serious flu aped frozen shoulder (periarthritis) (unknown latency) following the administration of INFLUENZA VACCINE. This lasted two years.  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 any corrective treatment.  At the time of report, the outcome of the event was unknown.  There would be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain barré syndrome; Initial information was received on 28-Sep-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves (unknown age) female patient who experienced guillain barré syndrome (guillain-barre syndrome) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (suspension for injection, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious guillain barré syndrome (guillain-barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and hospitalized for this event.  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.  The event outcome was unknown for guillain barré syndrome.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a (unknown age) female patient who experienced guillain-barre syndrome (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Areflexia, Autoimmune disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: diagnosed with an autoimmune condition called CIDP . It's the chronic of Guillaine-Barre; face was numb ,hands were numb, then my feet; tongue was tingly; no reflexes in my legs; little reflex in my arms; Initial information was received on 29-Sep-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced diagnosed with an autoimmune condition called CIDP. it's the chronic of Guillaine-Barre (chronic inflammatory demyelinating polyradiculoneuropathy), face was numb, hands were numb, then my feet (hypoaesthesia), tongue was tingly (paraesthesia), no reflexes in my legs (areflexia) and little reflex in my arms (hyporeflexia), after receiving INFLUENZA VACCINE (MONOVALENT).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.  On an unknown date, the patient developed serious event diagnosed with an autoimmune condition called CIDP. it's the chronic of Guillaine-Barre (chronic inflammatory demyelinating polyradiculoneuropathy) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT). This event was assessed as medically significant.  On an unknown date, the patient developed non-serious event face was numb, hands were numb, then my feet (hypoaesthesia), tongue was tingly (paraesthesia), no reflexes in my legs (areflexia) and little reflex in my arms (hyporeflexia) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT).  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns unknown demographic patient (unknown age and unknown gender) who had chronic inflammatory demyelinating polyradiculoneuropathy, hypoaesthesia, paraesthesia, areflexia and hyporeflexia after receiving INFLUENZA VACCINE (MONOVALENT) (unknown manufacturer). The time to onset is compatible with the role of the vaccine. Further information regarding medical history, condition at the time of vaccination, past medical treatment, 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 vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Hyporeflexia, Paraesthesia oral
Clinical narrative: diagnosed with an autoimmune condition called CIDP . It's the chronic of Guillaine-Barre; face was numb ,hands were numb, then my feet; tongue was tingly; no reflexes in my legs; little reflex in my arms; Initial information was received on 29-Sep-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced diagnosed with an autoimmune condition called CIDP. it's the chronic of Guillaine-Barre (chronic inflammatory demyelinating polyradiculoneuropathy), face was numb, hands were numb, then my feet (hypoaesthesia), tongue was tingly (paraesthesia), no reflexes in my legs (areflexia) and little reflex in my arms (hyporeflexia), after receiving INFLUENZA VACCINE (MONOVALENT).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.  On an unknown date, the patient developed serious event diagnosed with an autoimmune condition called CIDP. it's the chronic of Guillaine-Barre (chronic inflammatory demyelinating polyradiculoneuropathy) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT). This event was assessed as medically significant.  On an unknown date, the patient developed non-serious event face was numb, hands were numb, then my feet (hypoaesthesia), tongue was tingly (paraesthesia), no reflexes in my legs (areflexia) and little reflex in my arms (hyporeflexia) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT).  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns unknown demographic patient (unknown age and unknown gender) who had chronic inflammatory demyelinating polyradiculoneuropathy, hypoaesthesia, paraesthesia, areflexia and hyporeflexia after receiving INFLUENZA VACCINE (MONOVALENT) (unknown manufacturer). The time to onset is compatible with the role of the vaccine. Further information regarding medical history, condition at the time of vaccination, past medical treatment, 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 vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 29-Sep-2021 regarding an unsolicited valid social media non-serious case received from a consumer (patient) via social media post.  This case involves an adult patient with an unknown age and gender who was sick (illness), after receiving INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.   The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (non-serious event), unknown latency following the administration of INFLUENZA VACCINE.  It was reported "The flu was renamed as Coronavirus disease (Covid-19), numbers were no different than previous years. Flu shots can make you sick not protect you from experience."  It is 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 of the event was reported as unknown.   There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves Adult male patient who experienced flu (Influenza) after receiving vaccine INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE Quit getting the flu shot and have been fine since. Took it for 5 years and had the flu 4 out of five years that I had the shot.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  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 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: Illness
Clinical narrative: sick; Initial information was received on 28-Sep-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient of unknown age and gender who got sick (illness), after receiving INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine (lot number and expiration date and other dosing details were not reported) after which patient got sick for 8 to 10 days.   It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) 8 to 10 days after the administration of INFLUENZA VACCINE.  It was reported "Yup. Gets me sick every year, 8 to 10 days after receiving that vax. None for me, thank you."  It was unknown if the patient experienced any additional symptoms/events.   There were no laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: ill; Initial information was received on 30-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from a Consumer.  This case involves a male patient (unknown age) who was ill (illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I won't be getting my flu shot. I never have and have had no reason to have it. My dad had it and was I'll and he never took it again either".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Age: 31.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: Vaccines was taken on 29-Sep-2021, estimate date of delivery: 22-Nov-2021, with no reported adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non- healthcare professional.  This case involves a 31-year-old female patient who was exposed to vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of vaccines was taken on 29-sep-2021, estimate date of delivery: 22-nov-2021 (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  The gestation period at onset 32 weeks.  The date of last menstrual period was reported as 15-Feb-2021. The estimated due date is 22-Nov-2021.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had unknown previous pregnancy.   On 29-Sep-2021, the patient received a first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 29-Sep-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route at an unknown administration site prophylactic vaccination.  It was a case of exposure during pregnancy (latency same day).  It was actual medication error case due to inappropriate schedule of vaccine administered (latency same day).  At time of reporting, no adverse event reported.  Additionally, at time of reporting, the pregnancy is still ongoing.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu anyway; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced "got the flu anyway" (influenza) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations 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 event "got the flu anyway" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported "I stopped taking them after I took it and got the flu anyway. That was 17 years ago. Haven't gotten the flu since."  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 was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: I got sick are the years that I got the flu shot; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced "i got sick are the years that i got the flu shot" (illness) when received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "i got sick are the years that i got the flu shot" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "No flu shot for me. Because the only years that I got sick are the years that I got the flu shot and every year that I didn't get the flu shot I didn't get sick at all."  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 was Unknown for the event.  There will be no information available on the batch number for this case.
Age: 90.0
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sicker; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from, consumer/non-healthcare professional via social media (under reference number US-SA-SAC20211004001058)  This case involves 90 years elderly patient (unknown gender) who experienced sicker (Illness), after receiving vaccine INFLUENZA VACCINE..  The patient's past vaccination(s) included INFLUENZA VACCINE at 76 years.  The patient's past medical history, medical treatment(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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event (sicker).  At time of reporting, outcome of the events was unknown.  There will be no information available on batch number for this case.