chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: only 'fluey' symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "only 'fluey' symptoms". Additional information: Patient reported that she had 3 shots all together - all Pfizer COVID 19 vaccines with her last shot on Aug2021 (primary series and a booster). Reported that she 'had a very strong reaction to last 2 COVID shots'. Stated that the 1st shot (Pfizer COVID vaccine) 'didn't do anything that bad'- reported only 'fluey' symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346626 Same patient and drug; different dose and events.;US-PFIZER INC-202201346627 Same patient and drug; different dose and events.;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling, Ultrasound scan
Clinical narrative: armpit swelling after the covid vaccines; the arm swelling after the first two vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6198) at the age of 73 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "armpit swelling after the covid vaccines"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "the arm swelling after the first two vaccines". The events "armpit swelling after the covid vaccines" and "the arm swelling after the first two vaccines" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, peripheral swelling.   Additional information: The patient got dose 1 in left upper arm left deltoid. Her doctor sent her for an ultrasound and nothing was detected as amiss. Patient had armpit swelling after the covid vaccines. Patient had no treatment for the event but just had ultrasound for arm swelling after the first two vaccines just to make sure that it was not cancerous lumps. The ultrasound as nothing swollen for nodes or lymph nodes at that time and she did not remember when the ultrasound was but it was probably a couple of months after the doses of vaccine. The swelling was ongoing now (at the time of this report) and was squishy and felt different than the other side. Result of assessment for relatedness of drug to reaction/event(s) was reported as Yes. The report was not related to a study or programme. Investigations were conducted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201343399 same reporter/patient with different events/product;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngeal swab, Paralysis, SARS-CoV-2 test
Clinical narrative: I ended up basically paralyzed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Other medical history: Hashimoto; "high blood pressure" (unspecified if ongoing), notes: Other medical history:  high blood pressure. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: PARALYSIS (hospitalization, disability, life threatening) with onset 30Nov2021, outcome "not recovered", described as "I ended up basically paralyzed". The event "i ended up basically paralyzed" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (31Oct2022) Negative; SARS-CoV-2 test: (31Oct2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of paralysis.  Additional information: The patient had no other vaccine in four weeks and had no known allergies.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Poor quality sleep, Pyrexia
Clinical narrative: fever; body aches; nausea; restless sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 12:30 as dose 4 (booster), single (Lot number: GJ3275) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; OSTEO BI-FLEX [ASCORBIC ACID;BOSWELLIA SERRATA RESIN;CHONDROITIN SULFATE;COLLAGEN;GLUCOSAMINE HYDROCHLORIDE;HYALURONIC ACID;MANGANESE SULFATE;METHYLSULFONYLMETHANE;SODIUM;SODIUM BORATE]; CALCIUM; CETIRIZINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER9231; Anatomical location: Left arm), administration date: 06Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9261; Anatomical location: Left arm), administration date: 27Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot Number: 330258D; Anatomical location: Left arm), administration date: 26Dec2021, when the patient was 55-year-old, for COVID-19 Immunization; flucelvax pfs (Anatomical location: Arm Left), administration date: 05Nov2022, when the patient was 55-year-old, for Immunization. The following information was reported: NAUSEA (non-serious) with onset 27Nov2022 at 22:00, outcome "recovered" (Nov2022); POOR QUALITY SLEEP (non-serious) with onset 27Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "restless sleep"; PAIN (non-serious) with onset 28Nov2022 at 08:00, outcome "recovered" (Nov2022), described as "body aches"; PYREXIA (non-serious) with onset 28Nov2022 at 08:00, outcome "recovered" (Nov2022), described as "fever". Therapeutic measures were taken as a result of nausea, poor quality sleep, pyrexia, pain.  Additional information: Began with nausea at 10 pm that night, restless sleep with continued nausea, by 8 am fever and body aches. Slept all day took Advil and Zofran, less nausea by 5p, still with a fever and aching. All symptoms improved and resolved by 8 am the next morning. The patient had no known allergies. The patient received other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346629 Same reporter/drug, different event/patient.;
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes below her chin blew up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "only 'fluey' symptoms". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Lymph nodes below her chin blew up".  Additional information: Lymph nodes went down after a few weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346192 Same patient and drug; different dose and event;US-PFIZER INC-202201346627 Same patient and drug; different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram
Clinical narrative: Lymph nodes on the' left side of her left breast blew up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "only 'fluey' symptoms"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "lymph nodes below her chin blew up". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Lymph nodes on the' left side of her left breast blew up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Lymph nodes went down after a few weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346192 Same patient and drug; different dose and event;US-PFIZER INC-202201346626 Same patient and drug; different dose and event;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling, Ultrasound scan
Clinical narrative: After the 2nd covid vaccine she noticed her left armpit swelling; the arm swelling after the first two vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 2, single (Lot number: EN6208) at the age of 73 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number:EN6198; anatomical location: Deltoid Left), administration date: 20Feb2021, when the patient was 73-year-old, for Covid-19 Immunization, reaction(s): "the arm swelling after the first two vaccines". The following information was reported: SWELLING (non-serious), outcome "not recovered", described as "After the 2nd covid vaccine she noticed her left armpit swelling"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "the arm swelling after the first two vaccines". The events "after the 2nd covid vaccine she noticed her left armpit swelling" and "the arm swelling after the first two vaccines" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, peripheral swelling.  Additional information: It was also reported that there were no other conditions. NDC number was unknown and there was no other product. Patient height was 5 feet 2.5 inches. After the 2nd covid vaccine she noticed her left armpit swelling and read that was happening so that is why all subsequent ones she did on her left arm and it just feels different under her arm now and was swollen; her doctor sent her for an ultrasound and nothing was detected as amiss but the swelling was ongoing now and was squishy and feels different than the other side. The ultrasound shows as nothing swollen for nodes or lymph nodes at that time and she did not remember when the ultrasound was but it was probably a couple of months after the doses of vaccine. For being diagnosed with covid and the armpit swelling after the covid vaccines, states it was medically significant because people want to get treatment if it was discerned to being enlarged lymph nodes or breast cancer and it was important to get these statistics. Had no treatment for the reported event but just had the ultrasound for the arm swelling after the first two vaccines and that was it just to make sure that it was not cancerous lumps.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201343399 same reporter/patient with different AE/product;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound scan
Clinical narrative: After the 2nd covid vaccine she noticed her left armpit swelling and read that was happening so that is why all subsequent ones she does on her left arm; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 74 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose administered on 20Feb2021 with lot EN6198 to left upper arm left deltoid and she was asked but did not state dosage; patient card does not have expiry dates or NDC numbers written on it), administration date: 20Feb2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "the arm swelling after the first two vaccines", "COVID-19", "COVID-19"; BNT162b2 (2nd dose administered on 12Mar2021 with lot EN6208 to left deltoid), administration date: 12Mar2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "After the 2nd covid vaccine she noticed her left armpit swelling", "COVID-19", "COVID-19".  The following information was reported: SWELLING (non-serious), outcome "unknown", described as "After the 2nd covid vaccine she noticed her left armpit swelling and read that was happening so that is why all subsequent ones she does on her left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling.  Additional information: After the 2nd covid vaccine she noticed her left armpit swelling and read that was happening so that is why all subsequent ones she does on her left arm and it just feels different under her arm now and is swollen; her doctor sent her for an ultrasound and nothing was detected as amiss but the swelling is ongoing now and is squishy and feels different than the other side. The ultrasound as nothing swollen for nodes or lymph nodes at that time and she does not remember when the ultrasound was but it was probably a couple of months after the doses of vaccine. Had no treatment for the reported event but just had the ultrasound for the arm swelling after the first two vaccines and that was it just to make sure that it was not cancerous lumps.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 0.3 ml single (Lot number: EN5318, Expiration Date: 31May2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: amoxicillin due to history of a hip replacement. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Additional information: She states she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, "I always get a sore arm where I get the shot.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 0.3 ml single (Lot number: EN5318, Expiration Date: 31May2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: amoxicillin due to history of a hip replacement. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Additional information: She states she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, "I always get a sore arm where I get the shot.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Constipation, Echocardiogram, Electrocardiogram ambulatory
Clinical narrative: feels very stressed; feeling bloated; Abdominal pain / cramping x 3 days; constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Lot number: EN6200) at the age of 65 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cardioversion Procedure", start date: 01Jul2020 (unspecified if ongoing), notes: Transesophageal Echocardiogram and Cardioversion Procedure; "Interventional radiology procedure", start date: 31Dec2020 (unspecified if ongoing), notes: Interventional radiology procedure note; "ascites", start date: 31Dec2020 (unspecified if ongoing); "5.0 liters of yellow fluid obtained from the right abdomen", start date: 07Feb2021 (unspecified if ongoing), notes: Another 5 liters of yellow fluid removed. The patient's concomitant medications were not reported. The following information was reported: CONSTIPATION (non-serious) with onset 26Feb2021, outcome "unknown"; ABDOMINAL PAIN (non-serious) with onset 07Mar2021, outcome "unknown", described as "Abdominal pain / cramping x 3 days"; ABDOMINAL DISTENSION (non-serious) with onset 07Mar2021, outcome "unknown", described as "feeling bloated"; STRESS (non-serious), outcome "unknown", described as "feels very stressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient thinks his abdomen cramping and constipation is due to stress. He is in the process of buying a house in and feels very stressed. He denies any fever, vomiting or urinary symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200103560 same patient, different dose/AE;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Paracentesis, Stress
Clinical narrative: feels very stressed; feeling bloated; Abdominal pain / cramping x 3 days; constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Lot number: EN6200) at the age of 65 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cardioversion Procedure", start date: 01Jul2020 (unspecified if ongoing), notes: Transesophageal Echocardiogram and Cardioversion Procedure; "Interventional radiology procedure", start date: 31Dec2020 (unspecified if ongoing), notes: Interventional radiology procedure note; "ascites", start date: 31Dec2020 (unspecified if ongoing); "5.0 liters of yellow fluid obtained from the right abdomen", start date: 07Feb2021 (unspecified if ongoing), notes: Another 5 liters of yellow fluid removed. The patient's concomitant medications were not reported. The following information was reported: CONSTIPATION (non-serious) with onset 26Feb2021, outcome "unknown"; ABDOMINAL PAIN (non-serious) with onset 07Mar2021, outcome "unknown", described as "Abdominal pain / cramping x 3 days"; ABDOMINAL DISTENSION (non-serious) with onset 07Mar2021, outcome "unknown", described as "feeling bloated"; STRESS (non-serious), outcome "unknown", described as "feels very stressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient thinks his abdomen cramping and constipation is due to stress. He is in the process of buying a house in and feels very stressed. He denies any fever, vomiting or urinary symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200103560 same patient, different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested very positive; Tested very positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Nov2022, outcome "recovered" (Nov2022) and all described as "Tested very positive". Due to his age 70 (no unit provided) and a medication, he could not stop he got IV mono-antibody. He had it bad (his O2 plunged to 88 on 07Nov2022 PM), the reporter had to give him albuterol treatment every 4 hours the night of the 7th. The patient was okay and negative now. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2022) Positive; (Nov2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201297436 same reporter/drug, different patient/event;
Sex: U
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: After my 2nd shot, I started to have neurological problems, including terrible muscle weakness. As it turns out, I have been diagnosed with Myasthenia Gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: MYASTHENIA GRAVIS (disability, medically significant), outcome "unknown", described as "After my 2nd shot, I started to have neurological problems, including terrible muscle weakness. As it turns out, I have been diagnosed with Myasthenia Gravis".  Clinical course: The patient stated that upon reading an article about how our profits drastically increased, the patient has written on how the profitable Covid vaccine affected the patient's life. After the 2nd shot, the patient started to have neurological problems, including terrible muscle weakness. As it turned out, the patient has been diagnosed with Myasthenia Gravis, an incurable autoimmune disease. The patient's doctors could not prove it was the vaccine. The patient stated that he/she never had any problems like this before it. The patient was terminated from his/her 22 year job and was trying to get disability.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: PMR (polymyalgia rheumatica); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004236.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 12Feb2021, for COVID-19 immunization.  The patient had an adverse reaction, an autoimmune condition was triggered, and the patient had to go on steroids for 10 months. She reportedly had high inflammation, a huge inflammatory response, lots of muscle and joint pain, and was diagnosed with PMR (polymyalgia rheumatica). The event was assessed as serious (medically significant). The outcome of the event was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event polymyalgia rheumatica and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatologic reaction and now has inflammatory arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004240 (Novavax).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose-2, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "rheumatologic reaction and now has inflammatory arthritis".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker test, Rheumatoid arthritis
Clinical narrative: inflammation markers were elevated/the patient reportedly developed rheumatoid arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004229.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 28Mar2021, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Jan2022, outcome "unknown", described as "inflammation markers were elevated/the patient reportedly developed rheumatoid arthritis". The patient underwent the following laboratory tests and procedures: Inflammatory marker test: (Jan2022) elevated, notes: patient's inflammation markers were elevated.  Clinical course: In Jan2022, it was reported that the patient's inflammation markers were elevated, patient developed rheumatoid arthritis  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization), outcome "unknown", described as "stroke". Patient had a stroke within 24 hrs after receiving the Covid-19 vaccine. Hospitalized then went to a hospital and was lost to follow-up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-CEREBROVASCULAR ACCIDENT  Case will be reassessed when new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Inflammation, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: inflammatory response; joint pain; urticaria; her ESR and sed rate were elevated; brain fogginess for about 8 months; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammatory response"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fogginess for about 8 months"; URTICARIA (non-serious), outcome "unknown"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious), outcome "unknown", described as "her ESR and sed rate were elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, arthralgia, feeling abnormal, urticaria, red blood cell sedimentation rate increased.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: inflammatory response; joint pain; urticaria; her ESR and sed rate were elevated; brain fogginess for about 8 months; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammatory response"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fogginess for about 8 months"; URTICARIA (non-serious), outcome "unknown"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious), outcome "unknown", described as "her ESR and sed rate were elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, arthralgia, feeling abnormal, urticaria, red blood cell sedimentation rate increased.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Tachycardia
Clinical narrative: abdominal pain; lightheaded; tachycardia; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ablation for the tachycardia" (unspecified if ongoing), notes: in the past; "ablation for the tachycardia" (unspecified if ongoing), notes: in the past; "Afib" (unspecified if ongoing), notes: She had had Afib treated in the past. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious), outcome "recovered"; DIZZINESS (non-serious), outcome "recovered", described as "lightheaded"; TACHYCARDIA (non-serious), outcome "recovered". The events "abdominal pain", "lightheaded" and "tachycardia" required emergency room visit.  Additional information: The reactions were on the same day of vaccinations. Event took place after use of product. The patient recovered and got her 2nd dose administered on 29Jan2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202201347159 same patient, different dose and different event.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Paraesthesia
Clinical narrative: burning sensation on my upper back; prickly feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jul2021, for COVID-19 Immunization, reaction(s): "burning sensation on my upper back", "prickly feeling". The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "burning sensation on my upper back"; PARAESTHESIA (non-serious), outcome "not recovered", described as "prickly feeling".  Additional information: Since the patient received the COVID-19 vaccine (two doses back in Jul2021), they felt a burning sensation of their upper back, all the way across from shoulder to shoulder, with a prickly feeling. The skin did not feel hot to the touch. This happens numerous times each day. It lasts around 20 seconds.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-PV202200116510 same reporter/patient/drug/events, different dose;
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Emotional poverty, Hypersomnia, Hypophagia, Irritability, Medication error
Clinical narrative: medication error occurred due to vaccine being administered to the wrong patient; increased sleep; decreased crying; irritability; Decreased PO intake; Initial information received on 01-Dec-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient who reported medication error occurred due to vaccine being administered to the wrong patient, increased sleep, decreased crying, irritability and decreased po intake after receiving  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination; and PARACETAMOL (TYLENOL).  On an unknown date, the patient received unknown  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE ( with unknown strength, form, route, batch number and expiry date ) at  unknown administration site for Immunization.  On 29-NOV-2022 the patient had  non-serious events of medication error occurred due to vaccine being administered to the wrong patient (wrong patient received product) , increased sleep (hypersomnia),  decreased crying (emotional poverty) ,  irritability  and  decreased po intake (hypophagia) .  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (medication error occurred due to vaccine being administered to the wrong patient, increased sleep, decreased crying, irritability, Decreased PO intake).  Outcome : Unknown for all events.   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: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Wrong patient
Clinical narrative: medication error occurred due to vaccine being administered to the wrong patient; increased sleep; decreased crying; irritability; Decreased PO intake; Initial information received on 01-Dec-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient who reported medication error occurred due to vaccine being administered to the wrong patient, increased sleep, decreased crying, irritability and decreased po intake after receiving  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination; and PARACETAMOL (TYLENOL).  On an unknown date, the patient received unknown  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE ( with unknown strength, form, route, batch number and expiry date ) at  unknown administration site for Immunization.  On 29-NOV-2022 the patient had  non-serious events of medication error occurred due to vaccine being administered to the wrong patient (wrong patient received product) , increased sleep (hypersomnia),  decreased crying (emotional poverty) ,  irritability  and  decreased po intake (hypophagia) .  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (medication error occurred due to vaccine being administered to the wrong patient, increased sleep, decreased crying, irritability, Decreased PO intake).  Outcome : Unknown for all events.   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: FLUX
Symptoms: Influenza
Clinical narrative: still caught the Flu; Initial information received on 29-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who still caught the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient still caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (still caught the Flu).  At time of reporting, the outcome was Unknown for the event still caught the flu.; Sender's Comments: Sanofi company comment dated on 05-Dec-2022:This case involves patient of unknown demographics who still caught the flu while receiving vaccine INFLUENZA VACCINE.. Furthermore information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 29-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non-healthcare professional ) .  This case involves an unknown age and unknown gender patient who had flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown  dose of suspect INFLUENZA VACCINE produced by unknown ( with unknown strength, form, route, batch number and expiration date ) at  unknown administration site for flu vaccine ( influenza immunization )   On an unknown date the patient had a non-serious event of  flu (influenza) (unknown latency)   No lab data included  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome : Unknown
Sex: U
Vaccine: FLUX
Symptoms: Gastroenteritis viral, Influenza
Clinical narrative: intestinal flu; Initial information received on 29-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who was having intestinal flu while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed intestinal flu (gastroenteritis viral) (unknown latency) following the administration of influenza vaccine.  The patient reported"Got all my flu shots & boosters,still got intestinal flu,so miserable."  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (intestinal flu).  At time of reporting, the outcome was Unknown for the event intestinal flu.
Sex: U
Vaccine: FLUX
Symptoms: Viral infection
Clinical narrative: ended up W/some terrible virus anyway; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who stated ended up w/some terrible virus anyway while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration to be used for Influenza immunization.  On an unknown date the patient had a non-serious ended up w/some terrible virus anyway (viral infection) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  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.
Age: 0.17
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave product outside of indication (indicated at 6 months, but gave to 2 month old child) (with no reported adverse event); Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 2 months old patient of unknown gender who was administered Influenza quadrival A-B vaccine [Fluzone QIV] outside of indication (indicated at 6 months, but gave to 2 month old child) (with no reported adverse event).  The patient's past medical history, 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 Suspension for injection (strength, dose, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event gave product outside of indication (indicated at 6 months, but gave to 2-month-old child) (with no reported adverse event) (product administered to patient of inappropriate age) (unknown latency) following the administration of influenza quadrival A-B vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Gave product outside of indication (indicated at 6 months, but gave to 2 month old child) (with no reported adverse event)).  Outcome: 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 guidelines. 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.