chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinusitis, Sneezing
Clinical narrative: Little tightness in his chest; Today it has been worse.; It was a little green this morning; He feels like he has a bad sinus infection; Nose has been running for almost 24 hours; Coughing; Sneezing; pain in the arm; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737, Expiry date: not provided), via an unspecified route, on unspecified date (at the age of: 62-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Past drug event included Claritin which patient takes every day and took it before the shot. On 20May2021, patient nose started running on Thursday morning/nose has been running for almost 24 hours. It stopped during the day. He laid up in his recliner last night because he could not lay with his nose running so much. It fluctuates and will stop for an hour or so then he starts sneezing and it starts running again. It is clear now. It was a little green this morning (21May2021). He thought he had some kind of infection. It is ironic that it happened right after the shot. He takes Claritin every day and he took it before the shot, he does not have this problem during the day. He was taking Claritin and Ibuprofen like they said to take for pain in the arm or something like that yesterday and last night. Today (21May2021) it has been worse. He feels like he has a bad sinus infection (21May2021). He asks if that is possible after the Covid vaccine. His wife had it, but she did not have this kind of side effect. His nose is running, and it says nothing on the sheet about it. He was coughing. He hopes it is not getting into his chest. The coughing started on 20May2021. On 21May2021, his chest started feeling tight this morning/has a little tightness in his chest. He asks if he needs to call the doctor to get something to knock it out. From an unspecified date, he has been sneezing and sneezing as well for over 24 hours now. He will sneeze and it makes his nose run too. That was why he wanted to know if it is related or if there is something to take or if he needs to go to the doctor. He just wanted something he can take over the counter. He asked how long these questions will take. He just needs something to take to feel better. While reporting an AE, patient mentioned that he took Ibuprofen and Claritin for a running nose, cough, sneezing, and tightness in his chest and has not gotten better. The clinical outcome of nose has been running was not recovered, it was a little green was recovered on 21May2021 and for another events outcome was unknown.  No Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 22-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, in right arm, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history included MS (multiple sclerosis), seizures and autism. The patient concomitant medications not reported. Reportedly, patient took oral pill and intravenous medication for MS (he thinks once in a year). The patient historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#and expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On May 10, 2021, patient experienced 4 nose bleeds since he took the 2nd shot. The reporter wondered was that a normal side effect. On an unspecified date in May 2021, the outcome of the event recovered. Follow-up attempts completed. Information about batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Myalgia, Pain, Speech disorder
Clinical narrative: Severe body aches and pressure on my body; Severe body aches and pressure on my body; Muscle pain in the chest and in the upper back in the shoulders; Having a lot of trouble being able to talk; really hurts my chest; This is a spontaneous report from contactable consumer. This consumer (patient) reported that:  A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0153) 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. On an unspecified date, the patient experienced severe body aches and pressure on my body, muscle pain in the chest and in the upper back in the shoulders, having a lot of trouble being able to talk and really hurts my chest. The patient received first dose Pfizer Covid-19 Vaccine on Monday about 4-5 days ago 16:15 in the afternoon. The patient was still experiencing severe body aches and pressure on body, muscle pain in the shoulders and in the chest and especially in the upper back in the shoulders and in the chest and was wondering if that was normal for 5 days away. The patient was having a lot of trouble being able to talk. It really hurts the patient's chest. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.   No Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Throat irritation
Clinical narrative: Tickling in my throat and a cough; every day I am experiencing something; Getting headache in front of my forehead; Tickling in my throat and a cough; every day I am experiencing something; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 17May2021 as dose 1, single for covid-19 immunization. Medical history included diabetes mellitus. The patient concomitant medications were not reported. The patient experienced tickling in my throat and a cough; every day i am experiencing something, getting headache in front of my forehead on an unspecified date. Consumer stated, patient took the Pfizer Vaccine on the 17th which was last Monday and patient still having side effects and it was 7th day or 6th day now and normally the reading says in 2 to 3 days everything will be gone but nothing is gone in fact everyday it's something different. Patient told them, patient was diabetic (Intent: History). patient went to the doctor yesterday but patient didn't go for that. patient went because had to get medicine for patients diabetes but that's not the point, after the shot patient started getting tickling in my throat and a cough and patient still have the tickling and cough and at night it get worst. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient had the first dose and experienced rashes on nose like she had the second dose; This is a spontaneous report from a contactable consumer (patient) reported for self. A male patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported as he had the first dose and experienced rashes on nose like he had the second dose. The outcome of the was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.Sender's Comments: Linked Report(s) : PFIZER INC-2021517224 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a contactable consumer (Patient's parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chest pain on an unspecified date. The outcome of event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: she is experiencing rash and itching all over her body.; she is experiencing rash and itching all over her body.; This is a spontaneous report from a contactable consumer. This report was received via a sales representative.   A 18 years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 25May2021 (age at vaccination: 17 years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25May2021, the patient experienced rash and itching all over her body. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest pain, Dizziness, Myalgia
Clinical narrative: A really bad one muscle ache and pains and dizziness; A really bad one muscle ache and pains and dizziness; I really got pain in my shoulders and my upper chest; I have been out of energy; A really bad one muscle ache and pains and dizziness/ I am busy I have muscle pain all over the body like I have the flu and I don't have the flu; I really got pain in my shoulders and my upper chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN8732, NDC number, UPC number, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The report was not related to a study or programme. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient received first vaccination shot about 3-4 weeks ago. Then, received second shot and got reaction to it, really bad muscle ache, pains and dizziness. The patient tried to figure out how long this going to take until it goes away. The patient was taking pain pills because of pain in shoulders and upper chest. The patient was out of energy and had muscle pain all over the body like flu and didn't had flu. The patient went to orange coast hospital, and they provided with the injection and the patient wanted them to clear up the problem. Consumer was informed about Pfizer medical information department. The outcome of events pain, dizziness, myalgia was not resolved and for all other events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A really bad one muscle ache and pains and dizziness; A really bad one muscle ache and pains and dizziness; I really got pain in my shoulders and my upper chest; I have been out of energy; A really bad one muscle ache and pains and dizziness/ I am busy I have muscle pain all over the body like I have the flu and I don't have the flu; I really got pain in my shoulders and my upper chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN8732, NDC number, UPC number, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The report was not related to a study or programme. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient received first vaccination shot about 3-4 weeks ago. Then, received second shot and got reaction to it, really bad muscle ache, pains and dizziness. The patient tried to figure out how long this going to take until it goes away. The patient was taking pain pills because of pain in shoulders and upper chest. The patient was out of energy and had muscle pain all over the body like flu and didn't had flu. The patient went to orange coast hospital, and they provided with the injection and the patient wanted them to clear up the problem. Consumer was informed about Pfizer medical information department. The outcome of events pain, dizziness, myalgia was not resolved and for all other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Mobility decreased
Clinical narrative: Extreme muscle pain/soreness; swelling in entire left arm and upper left back/shoulder; Tingling in entire left arm from shoulder to fingertips; Decreased mobility; headaches; stomach pain; diarrhea; tiredness/fatigue; This is a spontaneous report from a contactable consumer (Patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0167), dose 2 via an unspecified route of administration, administered in Left arm on 05May2021 11:30 as dose2, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (Other medical history: Ibs-C, chronic constipation, slow transit , constipation) and Known allergies: Sulfa meds, SSRIs, Iodine. There were no concomitant medications. The patient previously took iodine and experienced allergy. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Left arm on 06Apr2021 03:00 as dose1, single for COVID-19 immunization. On 05May2021, the patient experienced extreme muscle pain/soreness, swelling in entire left arm and upper left back/shoulder, tingling in entire left arm from shoulder to fingertips, decreased mobility, headaches, stomach pain, diarrhea and tiredness/fatigue. The patient had an emergency room visit due to this event. Patient was treated with unspecified pain medications, muscle relaxants, steroids and physical therapy as a therapeutic measure of all the events. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Peripheral swelling
Clinical narrative: Extreme muscle pain/soreness; swelling in entire left arm and upper left back/shoulder; Tingling in entire left arm from shoulder to fingertips; Decreased mobility; headaches; stomach pain; diarrhea; tiredness/fatigue; This is a spontaneous report from a contactable consumer (Patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0167), dose 2 via an unspecified route of administration, administered in Left arm on 05May2021 11:30 as dose2, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (Other medical history: Ibs-C, chronic constipation, slow transit , constipation) and Known allergies: Sulfa meds, SSRIs, Iodine. There were no concomitant medications. The patient previously took iodine and experienced allergy. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Left arm on 06Apr2021 03:00 as dose1, single for COVID-19 immunization. On 05May2021, the patient experienced extreme muscle pain/soreness, swelling in entire left arm and upper left back/shoulder, tingling in entire left arm from shoulder to fingertips, decreased mobility, headaches, stomach pain, diarrhea and tiredness/fatigue. The patient had an emergency room visit due to this event. Patient was treated with unspecified pain medications, muscle relaxants, steroids and physical therapy as a therapeutic measure of all the events. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Very heavy period within 24 hours of getting the vaccine; This is a spontaneous report from a contactable consumer(patient). A 14-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the arm left on 14Jul2021 16:45 (at the age of 14-years-old) at single dose for covid-19 immunisation. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient medical history was reported as none and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient concomitant medication was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced very heavy period within 24 hours of getting the vaccine on 15Jul2021 12:00 PM. The event did not result in Emergency Room Visit nor Physician Office Visit. No treatment was received for the event. The patient had not tested positive for COVID-19 since the vaccination. The outcome of the event was recovering.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Arm swollen and very red; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult and unknown gender patient who experienced arm swollen and very red (inflammation) after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE first one in 1964 and every year since.  Past medical treatment(s) concomitant medication 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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious arm swollen and very red (inflammation) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Wonder what was in the that one".   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  Patient was recovered from event on an unknown date its about 3 days.  There will be no information available on the batch number for this case.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wrong product administered
Clinical narrative: patient Receive a dose of Flulaval instead of Fluzone/ no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 72-year- old female patient who received dose of INFLUENZA VACCINE INACT SPLIT 3V [ FLULAVAL] instead of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (wrong product administered).   The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE INACT SPLIT 3V [FLULAVAL] not produced by Sanofi Pasteur (batch number and expiry date not reported) instead of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED[FLUZONE] suspension for injection (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.   It was a case of actual medication error due to wrong vaccine administered (latency same day).   It was reported "We recently had a 72 year old female patient receive a dose of Flulaval instead of Fluzone. I contacted the Centers for Disease (CDC), who directed me to my State Department of Health to determine whether we should re-dose the patient, and if so- when. The State Department of Health representative confirmed that we should re-dose the individual, but asked that I contact you for guidance on when to re-dose. I would appreciate any information you can provide regarding how soon after administration of a sub-therapeutic dose of influenza vaccine, we should administer a therapeutic dose to this patient".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I used to get them every year and every year I got the flu; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had "i used to get them every year and every year i got the flu" (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious" i used to get them every year and every year i got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "This case is a social media case.The following potential adverse event has been found on a public post for Flu Shot on social media. Since this is a public post on the Sanofi campaign we are assuming the consumer is referring to the Sanofi flu vaccine. I used to get them every year and every year I got the flu, stopped getting shots have not had the flu in 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 for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm gets a little sore; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who experienced arm gets a little sore (pain in extremity) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm gets a little sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have gotten my Flu shot over 20 years . Just my arm gets a little sore. Get mine next week at the Doctors office."  It was unknown if the patients experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patients received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Very sore arm, red and swollen; Very sore arm; Red arm; Swollen arm; Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional.  This case involves a patient (unknown demographics) who had very sore arm, red and swollen (inflammation) with symptoms sore arm (pain in extremity), red arm (erythema) and swollen arm (peripheral swelling) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's medical treatment(s), 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 non-serious very sore arm, red and swollen (inflammation) with symptoms sore arm (pain in extremity), red arm (erythema) and swollen arm (peripheral swelling) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have to take the enhanced because of age and that insurance won't cover anything else. Sigh. Very sore arm, red, swollen, Et cetera (etc). But improved a bit today."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the event was resolving.  The reporter did not report the causality of events with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Eye swelling, Palatal swelling, Pyrexia, Swollen tongue
Clinical narrative: had severely swollen tongue; had severely swollen eyes; had severely swollen palate; ran a fever for a week; Initial information received on 20-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) who had severely swollen tongue (swollen tongue), swelling of eyes (eye swelling),swelling of palate (palatal swelling) and ran a fever for a week (pyrexia) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) 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 expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious swollen tongue (swollen tongue), swelling of eyes (eye swelling), swelling of palate (palatal swelling) and ran a fever for a week (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events  No laboratory data reported.  It was reported "Flu Shot Fridays Last year after the flu shot I had severely swollen eyes, tongue, and palate and ran a fever for a week. A week of my life I can not get back. Never again for a shot that is 17-50% effective."  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 on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Condition aggravated, Influenza
Clinical narrative: flu; Initial information was received on 21-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-SAC20211027000376).  This case is linked to case 2021SA355960 (CLUSTER).  This case involves adult patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history included COVID-19 with mild flu this year.  The patient's 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 "Got a few shot couple years, as well as my partner, we both got the flu anyway, was way worse than the mild Covid we had this year".  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: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: flu; Initial information was received on 23-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-SAC20211027000391).  This case involves a patient of unknown demographics who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE.  The patient's medical history, past medical treatment, 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 "Got the flu shot 3 years ago then got the flu. The only time in over ten years I got your shot I got sick."  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: FLUX
Symptoms: Influenza
Clinical narrative: Got a flu shot couple years , got the flu anyway; Initial information received on 20-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown age and gender) who got a flu shot couple years, got the flu anyway (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history included mild corona virus disease (COVID-19).  The patient's medical treatment(s), vaccination(s) 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 expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "got flu shot couple years, got the flu anyway" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got a few shot couple years, got the flu anyway, was way worse than the mild (corona virus disease) Covid I had this year."  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Last time I took a flu shot was the last time I got the flu! Twenty years ago! "  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, outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case is linked to case 2021SA356566 (same reporter).  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  It was unknown if the patient had any concomitant disease or risk factor.  The patient's medical history included mild corona virus disease of 2019 (COVID-19).  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number and expiry not reported, formulation: suspension for injection) 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 QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was reported "Got a few shot couple years, as well as my partner, we both got the flu anyway, was way worse than the mild Covid we had this year."  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, 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: U
Vaccine: FLUX
Symptoms: Asthenia, Chills, Fear, Headache, Impaired work ability
Clinical narrative: weak as new born kitten; fever chills; headache; can not lift arm; Initial information received on 20-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via Social Media.  This case involves Adult patient (unknown gender) who reportedly was weak as new born kitten (asthenia), had fever chills (pyrexia), headache and can not lift arm (mobility decreased) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) 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 booster dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event weak as new born kitten (asthenia), fever chills (pyrexia), headache and can not lift arm (mobility decreased) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Got my booster yesterday with reaction to go along with it very sick had to call in sick my two part time jobs. weak as new born kitten fever chills head ache can not lift arm. I am afraid to get another shot. I need a Prolia shot in December. to much poison for my body."  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 on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Mobility decreased, Pyrexia
Clinical narrative: weak as new born kitten; fever chills; headache; can not lift arm; Initial information received on 20-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via Social Media.  This case involves Adult patient (unknown gender) who reportedly was weak as new born kitten (asthenia), had fever chills (pyrexia), headache and can not lift arm (mobility decreased) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) 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 booster dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event weak as new born kitten (asthenia), fever chills (pyrexia), headache and can not lift arm (mobility decreased) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Got my booster yesterday with reaction to go along with it very sick had to call in sick my two part time jobs. weak as new born kitten fever chills head ache can not lift arm. I am afraid to get another shot. I need a Prolia shot in December. to much poison for my body."  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 on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Influenza, SARS-CoV-2 test negative
Clinical narrative: cough; flu; Initial information received on 24-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves unknown gender patient who experienced cough and flu (influenza) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious cough and flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got my flu shot a month ago, but end up with the flu and later a cough, but thank god it's just about over, feeling much better, cough is leaving, u can hardly talk about the flu with all the doctor's talking about Covid, it's more money in Covid than the flu, I guess ,but I have had covid test several times ,no Covid".  It was unknown if there were laboratory data/results available.  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.
Sex: M
Vaccine: FLUX
Symptoms: Anal incontinence, Impaired work ability
Clinical narrative: his anal seepage is running rampant; Initial information received on 22-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non health care professional via social media under reference number: US-SA-SAC20211027001637.  This case involves an unknown age male patient was experienced his anal seepage is running rampant (anal incontinence) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   It was unknown if the patient had any 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event his anal seepage is running rampant (anal incontinence) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Author/Reporter Comment: A guy at work got his shot and now his anal seepage is running rampant, can't come to work now."  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.
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Gait inability, Guillain-Barre syndrome
Clinical narrative: all of a sudden had GBS; Could not walk for months; Initial information was received on 25-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional via social media.  This case involves adult male patient who experienced all of a sudden had GBS (Guillain-Barre syndrome) and could not walk for months (gait disturbance) while 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 and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious all of a sudden had GBS (Guillain-Barre syndrome) with their symptom could not walk for months (gait disturbance) (unknown latency) following the administration of INFLUENZA VACCINE. These both events were assessed as medically significant.  Additionally, it was reported that horrible side effect that truly does happen. Anyone can look it up and see it for themselves. We have all had the true flu in her house. She prefers to take chances with the flu herself. But she does respect everyone's choice.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for both events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult male patient who experienced Guillain-Barre syndrome and gait disturbance after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Exposure to SARS-CoV-2, Illness, Vaccine positive rechallenge
Clinical narrative: deathly ill; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who was deathly ill (illness) after receiving INFLUENZA VACCINE.  The patient's past medical treatment, vaccination and family history, concomitant medication were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious deathly ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported ''Last 2 flu shots I got made me deathly ill, have not had one in over 8 years and have not been sick once. I have also been exposed to Covid by a lot of people who had it when I was exposed to them and nothing. My immune system is working just fine.''  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 (deathly ill).  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.