chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersomnia, Pain in extremity
Clinical narrative: Pain in her leg; She has to sleep every hour because of the pain in both legs; Soreness in her shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), via an unspecified route of administration on 19May2021 as unknown, single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced soreness in her shoulder. On 23May2021, the patient had pain in her leg, and she has to sleep every hour because of the pain in both legs. She stated experiencing soreness in her shoulder at first. Three days ago, she started experiencing pain in her leg. She looked it up on the internet and found that a lot of people have been experiencing the same effect. She added that she must sleep every hour because of the pain in both legs. She mentioned that she did some exercise, but nothing special. Did not report swelling. She stated "it's weird. The pain was going up and down. I started to "google" my symptoms" She stated being scared to death and worried. She was fine before getting the Pfizer BioNTech COVID-19 vaccine. Not clear if she already spoke to DSU. She mentioned speaking to someone and then said, "you are the first person". Therefore, I offered a warm-transfer to safety, but caller asked to e-submit. I asked for HCP information, but she did not provide. Caller mentioned she has an appointment with her doctor tomorrow. Caller stated, "your vaccine was not safe" "it's new, no one knows" "everyone tells you it's very safe, here it could ruin the people's lives". The outcome of the event arthralgia was not recovered, pain in extremity was not recovered, hypersomnia was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Inflammation, Musculoskeletal chest pain, Pain
Clinical narrative: have had "moving pains" throughout my body starting 4 days after the first dose and continuing until now (approx. 6 weeks past my first dose and almost 3 weeks past my second dose.); They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; I've also had swelling and inflammation in my pointer finger; I've noticed the swelling is worse at the same time the pains are moving around my body; I've also had swelling and inflammation in my pointer finger; This is a spontaneous report from a contactable consumer (patient himself). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration in left arm on 18Apr2021 at 17:00 as dose 1, single (at the age of 39-years-old) for COVID-19 immunization. The patient did not receive any other vaccine in four weeks and other medications in two weeks of vaccination. The patient's known allergies were none. The patient medical history was not reported. There were no concomitant medications. The patient experienced that he had moving pains throughout his body starting 4 days after the first dose and continued until now (approx. 6 weeks past his first dose and almost 3 weeks past his second dose), they have literally travelled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines, he also had swelling and inflammation in his pointer finger and he had noticed the swelling was worse at the same time the pains were moving around my body on an unspecified date. It was reported that the moving pains literally move all across his body over the course of a few days. Leaving one area of his body and then manifesting somewhere else. He had never experienced anything like that before and it was so strange. The only thing he could attribute it to that is different was obtaining that vaccine. They were not debilitating pains nor did they impede his activity in anyway, but were definitely present and they were travelling throughout his body. It was reported that he was assuming it was a form of inflammation brought on by the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Renal pain
Clinical narrative: have had "moving pains" throughout my body starting 4 days after the first dose and continuing until now (approx. 6 weeks past my first dose and almost 3 weeks past my second dose.); They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; I've also had swelling and inflammation in my pointer finger; I've noticed the swelling is worse at the same time the pains are moving around my body; I've also had swelling and inflammation in my pointer finger; This is a spontaneous report from a contactable consumer (patient himself). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration in left arm on 18Apr2021 at 17:00 as dose 1, single (at the age of 39-years-old) for COVID-19 immunization. The patient did not receive any other vaccine in four weeks and other medications in two weeks of vaccination. The patient's known allergies were none. The patient medical history was not reported. There were no concomitant medications. The patient experienced that he had moving pains throughout his body starting 4 days after the first dose and continued until now (approx. 6 weeks past his first dose and almost 3 weeks past his second dose), they have literally travelled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines, he also had swelling and inflammation in his pointer finger and he had noticed the swelling was worse at the same time the pains were moving around my body on an unspecified date. It was reported that the moving pains literally move all across his body over the course of a few days. Leaving one area of his body and then manifesting somewhere else. He had never experienced anything like that before and it was so strange. The only thing he could attribute it to that is different was obtaining that vaccine. They were not debilitating pains nor did they impede his activity in anyway, but were definitely present and they were travelling throughout his body. It was reported that he was assuming it was a form of inflammation brought on by the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report from a contactable other hcp. A 62-years-old female patient (Non Pregnant; Consumer) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EP 6995), intramuscular, administered in Arm Left on 20Mar2021 13:30 (the Age of 62-Years-Old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included Pre-diabetes/glucose intolerance, peripheral neuropathy, PACs, PVCs, osteopenia from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) ,sitagliptin phosphate (JANUVIA), atorvastatin (ATORVASTATIN), valaciclovir (VALACICLOVIR), famotidine (FAMOTIDINE), calcium citrate (CALCIUM CITRATE)and vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The Patient did not take any other vaccine in four weeks On 21Mar2021, at 12:00 pm the patient experienced diarrhea within 24 hours of first dose. Intermittent occurrence until dose 2. Non-responsive to antibiotic therapy, diet modification. No improvement. Awaiting endoscopic exam. The patient took Antibiotic therapy, symptomatic treatment, FODMAP diet for treatment of the events. The outcome for Diarrhoea was not recovered. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021654173 same patient/reporter/product, different event,
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Memory impairment
Clinical narrative: arm hurt; diarrhea; knees hurt; cold; had a temperature; Lightheaded; tired; Memory was worsened; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route of administration on 13Mar2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Following second dose vaccination on an unspecified date, the reporter states that the patient was fairly normal but had experienced arm hurt, diarrhea, knees hurt. The patient felt cold, had a temperature which was just the fay after and was gone. However, the patient had felt lightheaded, very tired for a day or two and then alright for a while, memory was worsened mare than before. The reporter wanted to know if other people were having some of these same things. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-2021688836 Same reporter/drug/events, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: arm hurt; diarrhea; knees hurt; cold; had a temperature; Lightheaded; tired; Memory was worsened; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route of administration on 13Mar2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Following second dose vaccination on an unspecified date, the reporter states that the patient was fairly normal but had experienced arm hurt, diarrhea, knees hurt. The patient felt cold, had a temperature which was just the fay after and was gone. However, the patient had felt lightheaded, very tired for a day or two and then alright for a while, memory was worsened mare than before. The reporter wanted to know if other people were having some of these same things. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-2021688836 Same reporter/drug/events, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Urinary tract infection, Vaccination site reaction, Vaccination site warmth
Clinical narrative: injection site reaction appeared.; Round, raised, red and warm to touch; Round, raised, red and warm to touch; Patient diagnosed with uti on 6/6 and prescribed Bactrim.; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown), via an unspecified route of administration on 03Jun2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient diagnosed with uti (Urinary tract infection) on 06Jun2021 and prescribed Bactrim. On 10Jun2021 patient experienced injection site reaction appeared. Round, raised, red and warm to touch. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves adult male patient 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 vaccination(s) included flu in Feb-2019, had flu A and Mar-2019, had flu B.  The patient's 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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in Jan-2021, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Since this is a public post on an influencer post for the Sanofi flu shot campaign, Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. We have got our flu shots in October every year for the past 5 years. In Feb 2019 my teenage son & husband both had flu A. Then in March 2019 same teenage son had Flu B. In Jan 2021 again same teenage son had Flu A. Going to pass on Flu shots this year & see how we do!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information on lot number for this case.; Sender's Comments:  SanofiPVPortal20211027000309:Portal ID for reporter husband 2021SA355175:Case ID for Reporter 2021SA361607:Case ID for reporter husband
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arms; Initial information received on 25-Oct-2021 regarding an unsolicited valid social media  non-serious case from a consumer/non-healthcare professional.  This case involves a patient (unknown age and gender) who had sore arms (pain in extremity) after receiving INFLUENZA VACCINE and Coronavirus disease of 2019 (COVID-19 VACCINE).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and COVID-19 VACCINE not produced by Sanofi Pasteur (lot numbers and expiry dates not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arms (pain in extremity) (unknown latency) following the administration of vaccines.  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 for the event was unknown.  There will be no information on the batch available for this case.
Sex: F
Vaccine: FLUX
Symptoms: Paraparesis
Clinical narrative: partial paralyzed weak legs; 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 a female patient of unknown date who had partial paralyzed weak legs (Paraparesis) after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had partial paralyzed weak legs (Paraparesis; serious) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and patient visited the emergency room  for these events.  It was unknown if the patient experienced any additional symptoms/events.  Reporter stated she was very much adamant not to get flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the events.  On an unknown date, patient had recovered from the events.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient of unknown age who experienced partial paralyzed weak legs (Paraparesis)after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Never got the flu before the flu shot; Initial information received on 25-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age male patient who never got the flu before the flu shot (influenza) 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 event "never got the flu before the flu shot" (influenza) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Every year since the birth of my son my wife has forced me to get a flu shot. I am looking forward to getting the flu once again for the fourth year in a row. Never got the flu before the flu shot. Sure glad I am protected now."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Muscle twitching
Clinical narrative: facial twitching; I spent that winter sicker than I had ever been; Initial information received on 25-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via Digital Media.  This case involves adult patient (unknown gender) who experienced facial twitching (muscle twitching) and patient spent that winter sicker than had ever been (illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious facial twitching (muscle twitching), spent that winter sicker than had ever been (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported  "I only got flu shot 3 times in my life. The last one caused facial twitching which lasted for many months and I spent that winter sicker than I had ever been. My own doctor attributed it to the shot. Said was rarest thing the patient ever seen. So dear didn't play doctor and encourage someone what to do. You didn't know their story."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I still got the flu, but it was mild; Initial information was received on 25-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 patient (unknown gender and unknown age) who experienced "I still got the flu, but it was mild" (influenza), 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 I still got the flu, but it was mild (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "I still got the flu, but it was mild and only lasted about three days. So much better than the year it took me three months to recover."  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: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: It makes me sick/ Full blown sick; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional via social media.  This case involves patient (unknown age and gender) who had sick/ full blown sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "it makes me sick/ full blown sick" (illness) (unknown latency) following the administration of vaccine.  It was reported "Not me! It makes me sick. Patient Full blown sick. Why would I do that?"  No laboratory data were 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 available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 26-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via.  This case involved a patient (unknown demographic) who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Aged care residents had been experimented on with flu shots since before 1980. I worked at one (1980-82); on the 1st night after the flu shots, 2 things happen: they all get the flu & some did not live through it. Why did young people need a booster, for more blood clots?"  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 reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling cold
Clinical narrative: FREEZING; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211101001189).   This case involves a patient of (unknown demographics) who experienced freezing (feeling cold), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious freezing (feeling cold) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Pain, Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatica; Symptoms for polymyalgia rheumatica were intensely painful; Initial information received on 28-Oct-2021 regarding an unsolicited valid serious case received from a non-healthcare professional (under the reference number: US-SA-SAC20211102000455).  This case involves a female patient who experienced polymyalgia rheumatica, symptoms for polymyalgia rheumatica were intensely painful (pain) when received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  On 02-OCT-2018, patient had past vaccination FLUZONE HIGH DOSE with (first dose: lot number: UJ030AA, expiry date: 05-MAY-2019, route: intramuscular, site: left deltoid) for prophylactic vaccination.  On 05-SEP-2019, patient had past vaccination FLUZONE HIGH DOSE with (second dose: lot number: UJ232AB, expiry date: 10-APR-2020, route: intramuscular, site: left deltoid) for prophylactic vaccination.  On 03-MAR-2021, patient had past vaccination with COVID-19 VACCINE MODERNA for prophylactic vaccination.  Patient had additional anxiety over COVID-19 VACCINE MODERNA.  The patient's medical history, past concomitant medication and family history were not provided.  On 01-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (suspension for injection, lot number: UJ715AA and expiry date: 30-JUN-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a serious polymyalgia rheumatica (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On 28-SEP-2021 the patient developed a serious symptoms for polymyalgia rheumatica which were intensely painful (pain) (twenty seven days) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  The patient was treated with PREDNISONE for polymyalgia rheumatica and pain.  Patient's General Practitioner (GP) had put her on 20 mg of Prednisone per day and had referred her to a Rheumatologist. This was definitely a miracle drug as using it correctly and daily she was without pain. Prednisone is an immunosuppressant.  At the time of reporting, the outcome was unknown for the events (polymyalgia rheumatica, pain).; Sender's Comments: This case concerns a female patient who experienced polymyalgia rheumatica (unknown latency), pain (twenty-seven days) after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown for polymyalgia rheumatica and compatible for pain. Past vaccination included FLUZONE HIGH DOSE and COVID-19 VACCINE MODERNA. The patient was treated with PREDNISONE. 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 individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hemiplegia, Paralysis
Clinical narrative: Guille Barre Syndrome; paralyzed; Initial information received on 29-Oct-2021 regarding an unsolicited valid Social Media serious case from a consumer/non-health care professional.  This case involves an unknown age female patient who had paralyzed (paralysis) and guille barre syndrome (Guillain Barre syndrome) 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 serious paralyzed (paralysis) and guille barre syndrome (Guillain Barre syndrome) (unknown latency) following the administration of vaccine. Two years later patient still paralyzed on one side.  This events were assessed as medically significant.  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 not resolved for the event paralysis and was Unknown for the event Guillain Barre syndrome.  There would be no information on the batch number for this case.; Sender's Comments: This case concerns an unknown age female patient who had paralysis and Guillain Barre syndrome after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible. However, patient's medical condition at the time of vaccination and laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Abdominal pain, Muscle spasms, Pain in extremity, Vomiting
Clinical narrative: abdominal pain; Cramps; Vomiting; sore arm; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist via a non-healthcare professional via call center via Global Medical Information (GMI) (Reference number- 00822956) in the United States.  This case is linked to cases 2021SA355291, 2021SA357413 and 2021SA359230 (same reporter).  This case involves a patient of (unknown demographics) who had abdominal pain, cramps (muscle spasms), vomiting and sore arm (pain in extremity) when received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, total, once, lot number: UJ732AB and expiry date: 30-JUN-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious abdominal pain, cramps (muscle spasms), vomiting and sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "The caller wants to know if their office had received a bad batch of the vaccine. She said that she gave all the vaccinations and about 10 percent of about 70 patients had injection site reactions to varying degrees, a lot more than they usually have. There were times when she could see the reactions happening right after the injection. She does not know the exact number of patients. They all received the same lot. Then she said, 2 patient had severe reactions. One had abdominal pain, cramps, vomiting and a sore arm. The other patient had those symptoms and also fever, chills and headache."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for the events (abdominal pain, muscle spasms, vomiting and pain in extremity).  The reporter assessed the causal relationship for events (abdominal pain, muscle spasms, vomiting and pain in extremity) with the FLUZONE HIGH-DOSE QUADRIVALENT as not reported.
Age: 0.5
Sex: M
Vaccine: IPV, UNK
Symptoms: Extra dose administered
Clinical narrative: both IPOL and PENTACEL were administered on same day to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse and consumer/non-health care professional via Medical Information (MI) (Reference number- 00827332) and transmitted to Sanofi on 25-Oct-2021.  This case is linked to case 2021SA357176  This case involves 6-month-old male patient administered both IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on same day (extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE and HEPATITIS B VACCINE for prophylactic vaccination.  On 25-Oct-2021, the patient received a third 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ494AAA and expiry date: 09-Jul-2022) (Frequency: once) (strength: standard) via intramuscular route in the left thigh, a third dose of suspect IPV (VERO) (lot number: T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the right thigh for prophylactic vaccination respectively (extra dose administered).  It was reported "Caller would like information possible adverse effects of extra dose of IPOL so that she can inform patient's mother. Caller has (product information) PIs for IPOL and PENTACEL; caller was referred to product PIs for more information on potential adverse effects of IPOL administration and PENTACEL administration".   This case was an actual medication error due to extra dose administered (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, Underdose
Clinical narrative: 10 percent of the vaccine was lost when attempting to remove air bubbles from the "single use" product/no AE; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Medical Information- 00829519..  This case involves a patient of unknown demographics to whom  while vaccination INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 10 percent of the vaccine was lost when attempting to remove air bubbles (Underdose).  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "The caller declined to provide any demographics. The caller wanted to know if Fluzone Quadrivalent "single use" will "be enough of a dose" if 10 percent of the vaccine is lost when attempting to remove air bubbles from the "single use" product. The caller stated, "it goes from 700 to 600" when you remove air bubbles from the container. Caller would not confirm if he is a healthcare provider or consumer. Caller states that he is the person that administered the Fluzone Quadrivalent. Caller states that he was getting the air out of the container at the request of the person. When he held it up and tried to get air out he thinks he lost about 10% . It went from 700 to 600. "Do I need to administer anther dose?" Caller states the patient is concerned with Guillain-Barre".  It was a case of an actual medication error due to vaccine under dose (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: 91 year old female patient received expired dose of FLUZONE HD vaccine with no reported adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via other healthcare professional via Medical Information (Reference number- 00829577).  This case involves a 91 year old female patient who received expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA and expiry date: 30-Jun-2021) (Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is. There were no adverse reactions, treatment or ER (emergency room) visits reported post administration".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of FLUZONE HD vaccine was administered with no reported adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and consumer or other nonprofessional via Media information (under the reference 00829581).  This case involves a 92-year-old female patient receiving expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Frequency: once, strength: fluzone high dose, lot UJ515AA, expiry date: 30-Jun-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine use (latency same day)  The reporter reported "Nurse Practitioner reported that the FLUZONE High Dose vaccine from last year, which expired on 30-Jun-2021, was given to 8 patients."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: itching at injection site measuring 70 milimeter X 50 milimeter; edema and erythema at injection site measuring 70 milimeter X 50 milimeter; Injection site reaction to the left arm having an area of edema, erythema, and itching measuring 70 mm X 50 mm.; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00829592) and transmitted to Sanofi on 26-Oct-2021.  This case involves a 43 year old female patient who experienced itching, edema and erythema at injection site measuring 70 milimeter x 50 milimeter (pruritus, inflammation and vaccination site reaction) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past vaccination(s) included influenza for prophylactic vaccination every year.  The patient's past medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergy.  Concomitant medication included unspecified medication for allergy   On 24-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left arm for prophylactic vaccination.  On 24-Oct-2021 the patient developed a non-serious itching, edema and erythema at injection site measuring 70 milimeter x 50 milimeter (pruritus, inflammation and vaccination site reaction) on same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "Caller stated she had a reaction to FLUBLOK at the injection site and wanted to know the ingredients so she won't have the reaction anymore. The consumer reported that the reaction is still continuing; that she has been taking allergy medication and using Benadryl cream for the reaction; that she gets a flu vaccine every year; that it is unknown to the caller if she had the FLUBLOK in the past; that she has known allergy issues; and that her entire family received the FLUBLOK on the same day and no other member had a reaction"  No laboratory data was provided  At time of reporting, the events were not recovered.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: they administered expired TYPHIM VI to a patient with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional via MI (Medical Information - 00831260).  This case involves a 16-years old female patient who was vaccinated with expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunization; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunization.  On 27-Oct-2021, the patient received a 0.5ml {total; once} dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Solution for injection, lot number R24741M and expiry date 05-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "Nurse manager asks what they should do after administering expired product; is it safe to administer expired TYPHIM VI; and what are the most common adverse events of TYPHIM VI?"  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.