chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Constipation, Decreased appetite, Weight decreased
Clinical narrative: constipation; abdominal pain; lack of appetite; weight loss (8-10 pounds in last several months);; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ), (Batch/Lot number: unknown) at 5 mg 2x/day. The patient's relevant medical history included: "eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete , unknown manufacturer), for COVID-19 Immunization. The following information was reported: CONSTIPATION (non-serious), outcome "not recovered"; ABDOMINAL PAIN (non-serious), outcome "not recovered"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "lack of appetite"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "weight loss (8-10 pounds in last several months);". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports previously reported abdominal pain has improved since switching to Xeljanz 5mg twice daily; however, patient reported 1 episode of abdominal pain while traveling recently. Reports ongoing lack of appetite; weight loss (8-10 pounds in last several months); constipation that has been worse over the last 3-4 months. Patient states Xeljanz has helped the most for his eczema. Patient reports 1-2 missed doses per week and 1 week of missed doses when he received his COVID-19 booster.  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: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID like four weeks ago/inefficacy; diagnosed with COVID like four weeks ago/inefficacy; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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), outcome "unknown" and all described as "diagnosed with COVID like four weeks ago/inefficacy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance
Clinical narrative: 8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 Orange cap dose; 8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 Orange cap dose; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 8-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: "Underlying neurological disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 Orange cap dose". The events "8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 orange cap dose" required emergency room visit.  Additional information: Comirnaty/Pfizer BioNTech Covid-19 vaccine /Orange cap 10 mcg. She was sent to the emergency room immediately (the adverse event occurred within 15 minutes of the vaccination). Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Diverticulitis, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: Acute diverticulitis; Abscess; stiff; fatigue; ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4459772-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162623) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIVERTICULITIS (hospitalization, medically significant), outcome "unknown", described as "Acute diverticulitis"; ABSCESS (hospitalization), outcome "unknown"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiff"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "ache". The patient was hospitalized for diverticulitis (start date: Jun2022); the patient was hospitalized for abscess (start date: Jun2022). The action taken for adalimumab was temporarily withdrawn.  Clinical course: On Unknown Dates, The Patient Experienced Acute Diverticulitis, Abscess, Stiff and covid vaccine issue/fatigue and achy. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. In Jun2022, the patient was hospitalized due to an abscess and acute diverticulitis. She was stiff due to being off of Humira. She also had covid vaccine issues of fatigue and achy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "fatigue" and "ache" related to BNT162b2 while reporter's causality for the event(s) of acute diverticulitis, abscess, stiffness was not provided. Reporter causality for events Acute diverticulitis, Abscess, Stiffness (Musculoskeletal stiffness), Ache and Fatigue with Adalimumab (Humira) was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events acute diverticulitis, abscess, stiffness  and the administration of the vaccine is unlikely. Based on the nature of the events  "fatigue" and "ache", a causal relation between the reported events and the administration of the vaccine BNT162b2 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Fatigue
Clinical narrative: anaphylactic shock; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4645344 (RA).  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Immobile, Spina bifida
Clinical narrative: her neighbor got spina bifida after COVID vaccine; her neighbor got spina bifida after COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SPINA BIFIDA (medically significant), IMMOBILE (medically significant), outcome "unknown" and all described as "her neighbor got spina bifida after COVID vaccine". Clinical course as follows: reporter reported her neighbor got spina bifida after COVID vaccine. he had the vaccine, and he got the second one and it made him immobile. That's pretty rare for people. He's got Spina bifida maybe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on information provided, the events more likely represent intercurrent illnesses which are unrelated to BNT162b2 (BNT162B2). The case will be reassessed once more information become 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: COVID-19, Drug ineffective
Clinical narrative: we already had the COVID; we already had the COVID; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old (reported as 30-34 years) female patient received BNT162b2 (BNT162B2), as dose number unknown, 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), outcome "unknown" and all described as "we already had the COVID". Clinical course: Patient reported inefficacy after COVID vaccine. Probably, because they already had the COVID in May.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200950020 same drug/event, different patient;US-PFIZER INC-202200950021 same drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Dizziness, Drug ineffective, Dysphonia
Clinical narrative: Home test antigen COVID test performed today July 10, 2022 was positive; Home test antigen COVID test performed today July 10, 2022 was positive; Decrease appetite; Hoarseness; Nausea; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown), in Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 29Jan2022 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: DIZZINESS (non-serious) with onset 10Jul2022, outcome "unknown"; DYSPHONIA (non-serious) with onset 10Jul2022, outcome "unknown", described as "Hoarseness"; NAUSEA (non-serious) with onset 10Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Home test antigen COVID test performed today July 10, 2022 was positive"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Decrease appetite". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: Home test antigen COVID test performed today July 10, 2022 was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The 15 year girl who was vaccinated with pfizer COVID vaccine 2 doses in May and Jun2021 and a booster dose in 29Jan2022 who woke up today Sunday 10Jul with hoarseness and later in the day developed nausea and dizziness. She also developed some decrease appetite. Home test antigen COVID test performed today 10Jul2022 was positive. Optional Information already mentioned in the description of the event. Nothing else to add. Event took place after use of product.  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: Nausea, SARS-CoV-2 test
Clinical narrative: Home test antigen COVID test performed today July 10, 2022 was positive; Home test antigen COVID test performed today July 10, 2022 was positive; Decrease appetite; Hoarseness; Nausea; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown), in Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 29Jan2022 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: DIZZINESS (non-serious) with onset 10Jul2022, outcome "unknown"; DYSPHONIA (non-serious) with onset 10Jul2022, outcome "unknown", described as "Hoarseness"; NAUSEA (non-serious) with onset 10Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Home test antigen COVID test performed today July 10, 2022 was positive"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Decrease appetite". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: Home test antigen COVID test performed today July 10, 2022 was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The 15 year girl who was vaccinated with pfizer COVID vaccine 2 doses in May and Jun2021 and a booster dose in 29Jan2022 who woke up today Sunday 10Jul with hoarseness and later in the day developed nausea and dizziness. She also developed some decrease appetite. Home test antigen COVID test performed today 10Jul2022 was positive. Optional Information already mentioned in the description of the event. Nothing else to add. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: brain fog with it; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog with it". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Pain, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; body aches; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 58-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. 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), outcome "unknown" and all described as "tested positive for COVID"; PAIN (non-serious), outcome "unknown", described as "body aches"; COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID.  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: COVID-19, Cough, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "low fever"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "positive rapid test/infection". The patient underwent the following laboratory tests and procedures: Pyrexia: (Jun2022) 100.6; SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Critical information: Are you reporting any issue (side effects, complaints, etc.) with the product: Yes. Did the reported issue occur after use of the product: Yes. Event information: Patient has a hemorrhoid condition that seems every time she goes to the bathroom is bleeding started on 28Jun2022. Patient was not admitted to hospital due to the event. Treatment was received and its improved. Patient experienced abdominal discomfort on 29Jun2022. Patient was not admitted to hospital due to the event. Patient was not admitted to hospital due to the event. Treatment was received and patient is fine now. Product information: Name of the product: pf-07321332 ritonavir (PAXLOVID), Reason for taking: Positive rapid test, Dosage and how often taken: 150mg BID, Date started: 27Jun2022, 28Jun2022, 29Jun2022 (Am only), Lot/Batch number: GC8236, Still taking: No, 29Jun2022 PM dose. Name of the product: Hemorrhoidal ointment, Reason for taking: Heavy bleeding, Dosage and how often taken: As needed, Date started: 28Jun2022, Still taking: Yes. Name of the product: Ibgard, Reason for taking: Abdominal pain, Dosage and how often taken: 1 capsules TID, before meals, Date started: 29Jun2022, Still taking: No, 02Jul2022. Name of the product: Colace, Reason for taking: Stool softeners, Dosage and how often taken: Daily, Date started: 29Jun2022, Still taking: Yes. On 11Jul2022 additional information reported that I have no existing medicine condition, my symptoms included low fever (100.5), cold, cough, No sore throat, headache etc. After day 1 of paxlovid I developed severe rectal bleeding, abdominal pain, metallic taste in mouth. I had 2 Pfizer vaccinations without any side effects. This medication was worse than the infection. 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: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "contracted COVID-19". Additional information: Patient was a vaccinated and twice boosted mother of 4 children and part time acute care speech language pathologist. Patient's husband and four children (Ages 5,5 (twins), 7, and 9) have each had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. Patient stated they were all vaccinated and boosted with Covid-19 vaccines and have contracted the virus. 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-202200950512 Same reporter/vaccine/event, different patient. PFIZER INC-202200950513 Same reporter/vaccine/event, different patient. PFIZER INC-202200950514 Same reporter/vaccine/event, different patient. PFIZER INC-202200950515 Same reporter/vaccine/event, different patient. PFIZER INC-202200952811 Same reporter/vaccine/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID vaccination and she still got breakthrough COVID; COVID vaccination and she still got breakthrough COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient younger than 10 years old (0-9 years old) received BNT162b2 (BNT162B2), as dose number unknown, 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), outcome "unknown" and all described as "COVID vaccination and she still got breakthrough COVID". DR reported that her girlfriend's daughter experienced inefficacy after Pfizer COVID vaccine. And she did her, him, COVID vaccination and she still got breakthrough COVID and she's like, it was a little more susceptible, like she could have been better protected with a higher dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: because she had a cold; This is a spontaneous report received from non-contactable reporter(s) (Other HCP and Consumer or other non HCP).  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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "because she had a cold".  Additional information: 'Age/Date of Birth: 0-9 years'   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, International normalised ratio
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; WARFARIN. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "I had my lawyer, had two, uh, Pfizer, two, uh, boosters. She's in the hospital now". The patient underwent the following laboratory tests and procedures: International normalized ratio: 1.8; 5. Reporter stated his lawyer experienced COVID vaccine inefficacy; Pt (patient) reports INR spike while taking Lipitor. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I received the pfizer vaccine for covid in 2021 and since that time I have been having joint pain in both hands and in elbow area; 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 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "I received the pfizer vaccine for covid in 2021 and since that time I have been having joint pain in both hands and in elbow area". Additional information: Patient would like to discuss this with someone. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have been vaccinated with the Pfizer vaccines, 1 Pfizer booster; positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose number unknown, (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I have been vaccinated with the Pfizer vaccines, 1 Pfizer booster"; COVID-19 (medically significant), outcome "unknown", described as "positive Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took your drug Paxlovid last week for 5 days after a positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional info: Patient reported, I took your drug Paxlovid last week for 5 days after a positive Covid test. I am a 71 year old female with no underlying conditions except my age. I had been vaccinated with the Pfizer vaccines, 1 Pfizer booster, and 1 Moderna booster. I was pretty sick with typical Covid symptoms and your drug seemed to help since I recovered within a week. However, I had an extreme nasty taste in my mouth the entire time I took Paxlovid. It was at times unbearable but I did not stop usage. Try to fix this issue. CEP Number:  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: Haematochezia, Pulmonary thrombosis
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4459126-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for Crohn's disease (Moderate to severe adult Crohn's disease). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Pulmonary Thrombosis (medically significant), outcome "recovered", described as "Blood clot in lung"; Haematochezia (medically significant), outcome "recovered", described as "Blood in stool". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of "blood clot in lung" and "blood in stool" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Additional information: Events of blood clot in lung and non-serious blood in stool with Humira (Adalimumab). On unknown dates, the patient experienced blood clot in lung and non-serious blood in stool. On unknown dates, blood clot in lung and non-serious blood in stool resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient had blood in stool and sometimes could not go to the bathroom. She had blood clot in lung. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of C blood clot in lung and non-serious blood in stool with Humira (Adalimumab) was no reasonable possibility. AbbVie's opinion is that the event of blood clot in lung is not assessable. AbbVie's opinion is that there is no reasonable possibility that the event of blood in stool is related to Humira (Adalimumab). Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of C blood clot in lung and non-serious blood in stool with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  blood clot in lung and  blood in stool  cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 39-year-old female patient received BNT162b2 (BNT162B2), on 11Sep2021 as dose 1, single (Lot number: 301308a) at the age of 38 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Is the patient a smoker/former smoker: No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Dec2021, outcome "unknown" and all described as "The vaccine doesn't work/I still ended up with COVID/AE onset date was 10Dec2021". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Remdesivir. Additional information: The patient have a positive test for SARS-CoV2 and unknown if the patient have SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized and was not admitted to an Intensive Care Unit. The patient has not displayed any clinical signs at rest indicative of severe systemic illness, did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The event required the initiation of new medication or other treatment or procedure which includes Paxlovid and did not take ibuprofen flonase 600 mg. It was unknown if any pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications nor received any other vaccines around the time of COVID-19 vaccination. Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Incorrect dose administered, Overdose
Clinical narrative: irregular heart beat; administered possibly a double dose on the 2nd vaccine; administered possibly a double dose on the 2nd vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 64-year-old male 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown" and all described as "administered possibly a double dose on the 2nd vaccine"; HEART RATE IRREGULAR (medically significant), outcome "unknown", described as "irregular heart beat". Therapeutic measures were taken as a result of heart rate irregular.  Additional information: Reported her brother was administered possibly a double dose on the 2nd vaccine and now is being treated for an irregular heartbeat. He is 64 years old and in good health. He had to have a procedure by a cardiologist for a heart ablation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia
Clinical narrative: Patient experienced numbness in the vaccinated arm after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HYPOAESTHESIA (non-serious), outcome "unknown", described as "Patient experienced numbness in the vaccinated arm after receiving the vaccine".  Additional information: It was also reported that event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Headache
Clinical narrative: The patient also indicated she has been experiencing bad joint pain in hip, knee, and lower back; Headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). Other Case identifier(s): EC-2018-043854.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 29Mar2022 (ongoing) (Lot number: 11111111) at 20 mg, oral for thyroid cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Jun2022, outcome "recovered" (24Jun2022); ARTHRALGIA (non-serious), outcome "unknown", described as "The patient also indicated she has been experiencing bad joint pain in hip, knee, and lower back". The action taken for lenvatinib mesilate was temporarily withdrawn. Therapeutic measures were taken as a result of headache.  Additional information: Patient indicated they have been experiencing new chronic migraines that last for days after adjusting her dosing schedule of lenvima. The patient indicated that about 6-8 weeks ago the patient's specialist took patient off lenvmia for 3 weeks after she was recovering from hand&foot syndrome. After restarting the medication the specialist instructed the patient to take medication for 3 weeks on 1 week off. The patient advised that when starting back on the medication she had headache that lasted the entire week monday through friday with concentrated pain above right eye. The patient indicated no relief with Tylenol and Excedrin but the headache got better and went away by the end of the week. The patient also indicated she has been experiencing bad joint pain in hip, knee, and lower back while taking lenvima and patient indicated these symptoms only began shortly after patient received pfizer covid 19 vaccinations and shingles vaccination. The patients prescriber is aware of all the patient's side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Rheumatoid arthritis, X-ray
Clinical narrative: Rheumatoid arthritis flare up; Inflammation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4460443-00 (Company).  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), in Feb2022 as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious) with onset 2022, outcome "recovering"; RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "Rheumatoid arthritis flare up". The patient underwent the following laboratory tests and procedures: X-ray: (2022) Inflammation, notes: Inflammation. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (adalimumab): The reporter's causality for the event(s) of inflammation and occasional rheumatoid arthritis flare ups was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter considered "rheumatoid arthritis flare up" and "inflammation" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events rheumatoid arthritis flare up and inflammation 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: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: fever; soreness/aches; fatigue; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sensitive to vaccines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "soreness/aches"; FATIGUE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". Additional information: Respondent received the Comiranty booster and within 15 minutes began to feel sick including: fever, soreness, fatigue, aches. Respondent became ill after getting the Comiranty booster including fever, fatigue, soreness, nausea. Reporter consider event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Magnetic resonance imaging, Neoplasm malignant
Clinical narrative: MRI showed a large, fast-growing cancer in her abdomen; intense lower back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "MRI showed a large, fast-growing cancer in her abdomen"; BACK PAIN (non-serious), outcome "unknown", described as "intense lower back pain". The events "mri showed a large, fast-growing cancer in her abdomen" and "intense lower back pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: fast-growing cancer in her abdomen. The patient date of death was unknown. Reported cause of death: "MRI showed a large, fast-growing cancer in her abdomen". It was not reported if an autopsy was performed.  Clinical course: Patient was in good health. No family history of cancer. Her husband had been diagnosed with Alzheimer. VAERS report indicates the baby my vaccinated daughter is carrying is a hundred fold more likely to have birth defects.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: MRI showed a large, fast-growing cancer in her abdomen
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Rash
Clinical narrative: Possibly was contact dermatitis; A rash on arms and legs; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 5-year-old 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: Covid-19 vaccine (Dose 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization.  The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "Possibly was contact dermatitis"; RASH (non-serious), outcome "unknown", described as "A rash on arms and legs".  Additional information: Patient received 2nd dose of orange cap for 5-11. Two days later, patient was fine in the am, but woke up from nap at daycare with a rash on arms and legs. It was individualized, and not grouped together, and without welts. The injection site was clean with no rash. The patient was seen by a provider who believes it was not related to the vaccine, and possibly was contact dermatitis. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Developed fever of 103 overnight; sore arm; headache; myalgia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 11Jul2022 at 12:40 as dose number unknown (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 (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "unknown", described as "Developed fever of 103 overnight"; HEADACHE (non-serious) with onset Jul2022, outcome "unknown"; MYALGIA (non-serious) with onset Jul2022, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Event took place after use of product.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Off label use, Pain, Product use issue
Clinical narrative: received the Comiranty vaccine while breastfeeding; received the Comiranty vaccine while breastfeeding; felt tired; achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). 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: Covid-19 vaccine (Dose: 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "received the Comiranty vaccine while breastfeeding"; FATIGUE (non-serious), outcome "unknown", described as "felt tired"; PAIN (non-serious), outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200955167 same drug, different patient and different event.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A male patient in his 50's received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. 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), outcome "recovering" and all described as "Consumer tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Reporter also reported as he has been vaccinated and received Pfizer booster and tested positive for COVID 19, symptoms mild. He receiving treatment with Paxlovid and is responding well. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.