chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Brain injury, Depression, Feeling abnormal, Gastrointestinal disorder
Clinical narrative: Interchange of vaccine products; Brain damage; Digestive issues; Brain fog; Anxiety; Depression; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 10Oct2022, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from a contactable reporter (consumer) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "COVID", start date: Apr2020 (unspecified if ongoing); "Long haul COVID", start date: Apr2020 (unspecified if ongoing); "Type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: MODERNA COVID-19 VACCINE (as dose 1, single), for COVID-19 immunisation; MODERNA COVID-19 VACCINE (as dose 2, single), for COVID-19 immunisation; BNT162B2 (as dose 3 (booster), single), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; BRAIN INJURY (medically significant), outcome "unknown", described as "Brain damage"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "Digestive issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog"; ANXIETY (non-serious), outcome "unknown"; DEPRESSION (non-serious), outcome "unknown". Clinical course: The patient had COVID in Apr2020 and since then has had long haul COVID.  After having COVID in Apr2020, she had two primary COVID vaccines of Moderna, two Pfizer COVID booster vaccines, and one Pfizer COVID bivalent booster vaccine. She had some side effects after the second Pfizer COVID booster, but it was very mild. Initially, she had mainly digestive issues. She also experienced brain fog, anxiety, depression, and brain damage (as reported).   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-202201218327 same patient and drug, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Brain damage; Digestive issues; Brain fog; Anxiety; Depression; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 10Oct2022, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from a contactable reporter (consumer) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "COVID", start date: Apr2020 (unspecified if ongoing); "Long haul COVID", start date: Apr2020 (unspecified if ongoing); "Type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: MODERNA COVID-19 VACCINE (as dose 1, single), for COVID-19 immunisation; MODERNA COVID-19 VACCINE (as dose 2, single), for COVID-19 immunisation; BNT162B2 (as dose 3 (booster), single), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; BRAIN INJURY (medically significant), outcome "unknown", described as "Brain damage"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "Digestive issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog"; ANXIETY (non-serious), outcome "unknown"; DEPRESSION (non-serious), outcome "unknown". Clinical course: The patient had COVID in Apr2020 and since then has had long haul COVID.  After having COVID in Apr2020, she had two primary COVID vaccines of Moderna, two Pfizer COVID booster vaccines, and one Pfizer COVID bivalent booster vaccine. She had some side effects after the second Pfizer COVID booster, but it was very mild. Initially, she had mainly digestive issues. She also experienced brain fog, anxiety, depression, and brain damage (as reported).   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-202201218327 same patient and drug, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Depression, Dyspepsia, Feeling abnormal
Clinical narrative: After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified.; After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified.; had mainly digestive issues; brain fog; anxiety; depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she had Covid virus", start date: Apr2020 (unspecified if ongoing), notes: Mentioned she had Covid virus in Apr2020; "she is a Type 1 diabetic" (unspecified if ongoing), notes: she is a Type 1 diabetic. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization completed), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster)), for COVID-19 Immunization; Bnt162b2 (Dose 4 (Booster)), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified."; DYSPEPSIA (non-serious), outcome "unknown", described as "had mainly digestive issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; ANXIETY (non-serious), outcome "unknown"; DEPRESSION (non-serious), outcome "unknown".  Additional information: Patient had some of these side effects after the second Pfizer Covid booster, but not to this extent, it was very mild. She thought really long and hard before getting the new bivalent Pfizer vaccine. After having the bivalent booster, the first two days she was aboslutely fine, it was the third day after getting the vaccine that the brain fog, depression and anxiety started. Its been really bad, they are not different symptoms, they are just worse. She's really been stuck in bed.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201218322 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified.; After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified.; had mainly digestive issues; brain fog; anxiety; depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she had Covid virus", start date: Apr2020 (unspecified if ongoing), notes: Mentioned she had Covid virus in Apr2020; "she is a Type 1 diabetic" (unspecified if ongoing), notes: she is a Type 1 diabetic. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization completed), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster)), for COVID-19 Immunization; Bnt162b2 (Dose 4 (Booster)), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified."; DYSPEPSIA (non-serious), outcome "unknown", described as "had mainly digestive issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; ANXIETY (non-serious), outcome "unknown"; DEPRESSION (non-serious), outcome "unknown".  Additional information: Patient had some of these side effects after the second Pfizer Covid booster, but not to this extent, it was very mild. She thought really long and hard before getting the new bivalent Pfizer vaccine. After having the bivalent booster, the first two days she was aboslutely fine, it was the third day after getting the vaccine that the brain fog, depression and anxiety started. Its been really bad, they are not different symptoms, they are just worse. She's really been stuck in bed.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201218322 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 03May2022 as dose 4 (booster), single (Lot number: FP4554), in left arm 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 included: "known allergies: egg white sensitivity" (unspecified if ongoing), notes: known allergies: egg white sensitivity; "known allergies: Nickle" (unspecified if ongoing), notes: known allergies: Nickle; "known allergies: Cadmium" (unspecified if ongoing), notes: known allergies: Cadmium; "known allergies: Chromium" (unspecified if ongoing), notes: known allergies: Chromium; "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure controlled with Triamterene-HCTZ. Concomitant medication(s) included: TRIAMTERENE & HCTZ taken for hypertension, start date: 01Jan2018. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Percocett, reaction(s): "known allergies: percocett". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid for the treatment of COVID 19. Treatment start date: 06Oct2022, Treatment stop date: 08Oct2022.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness
Clinical narrative: heart arrhythmia; Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm 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 completed, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 10Oct2022 at 22:00, outcome "not recovered", described as "Dizzy"; ARRHYTHMIA (medically significant) with onset 10Oct2022 at 22:00, outcome "not recovered", described as "heart arrhythmia". Therapeutic measures were not taken as a result of arrhythmia, dizziness.  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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Diagnostic procedure, Dizziness, Dyspnoea, Palpitations
Clinical narrative: Heart related problems - super ventricular tachycardia, possible AFib; Heart related problems - super ventricular tachycardia, possible AFib; shortness of breath; dizziness; pounding chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 2, single (Lot number: EN6201) at the age of 44 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2/Pfizer covid 19 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right), administration date: 28Jan2021, when the patient was 44-year-old, for COVID-19 Immunization. The following information was reported: VENTRICULAR TACHYCARDIA (medically significant), ATRIAL FIBRILLATION (medically significant) all with onset 01Mar2021, outcome "not recovered" and all described as "Heart related problems - super ventricular tachycardia, possible AFib"; DIZZINESS (non-serious) with onset 01Mar2021, outcome "not recovered"; PALPITATIONS (non-serious) with onset 01Mar2021, outcome "not recovered", described as "pounding chest"; DYSPNOEA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "shortness of breath". The events "heart related problems - super ventricular tachycardia, possible afib", "shortness of breath", "dizziness" and "pounding chest" required physician office visit. The patient underwent the following laboratory tests and procedures: covid tested, Nasal swab: Negative, notes: post vaccination; diagnostic testing: unknown results. Therapeutic measures were taken as a result of ventricular tachycardia, atrial fibrillation, dyspnoea, dizziness, palpitations. Additional information: The patient had no other vaccine in four weeks and no known allergies. It was noted that under other medical history that he had nothing heart related until he got the COVID shot. He received treatment for the adverse events (AE) noted as medication / diagnostic testing.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ventricular tachycardia
Clinical narrative: Heart related problems - super ventricular tachycardia, possible AFib; Heart related problems - super ventricular tachycardia, possible AFib; shortness of breath; dizziness; pounding chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 2, single (Lot number: EN6201) at the age of 44 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2/Pfizer covid 19 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right), administration date: 28Jan2021, when the patient was 44-year-old, for COVID-19 Immunization. The following information was reported: VENTRICULAR TACHYCARDIA (medically significant), ATRIAL FIBRILLATION (medically significant) all with onset 01Mar2021, outcome "not recovered" and all described as "Heart related problems - super ventricular tachycardia, possible AFib"; DIZZINESS (non-serious) with onset 01Mar2021, outcome "not recovered"; PALPITATIONS (non-serious) with onset 01Mar2021, outcome "not recovered", described as "pounding chest"; DYSPNOEA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "shortness of breath". The events "heart related problems - super ventricular tachycardia, possible afib", "shortness of breath", "dizziness" and "pounding chest" required physician office visit. The patient underwent the following laboratory tests and procedures: covid tested, Nasal swab: Negative, notes: post vaccination; diagnostic testing: unknown results. Therapeutic measures were taken as a result of ventricular tachycardia, atrial fibrillation, dyspnoea, dizziness, palpitations. Additional information: The patient had no other vaccine in four weeks and no known allergies. It was noted that under other medical history that he had nothing heart related until he got the COVID shot. He received treatment for the adverse events (AE) noted as medication / diagnostic testing.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Malaise, Nausea, Pyrexia
Clinical narrative: feeling ill / just not feeling well; Chills; Fever; Nausea; overall lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose number unknown (booster), single (Lot number: GJ5342) at the age of 59 years 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 completed; unknown manufacturer), for COVID-19 immunization, reaction(s): "Adverse events unspecified"; Flu (took a flu shot in March (unspecified year)), for Immunization, reaction(s): "Adverse events unspecified". The following information was reported: CHILLS (non-serious) with onset 11Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 11Oct2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 11Oct2022, outcome "unknown"; MALAISE (non-serious) with onset 11Oct2022, outcome "unknown", described as "feeling ill / just not feeling well"; LETHARGY (non-serious) with onset 11Oct2022, outcome "unknown", described as "overall lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, chills, pyrexia, nausea, lethargy. Additional information: Consumer reported that he and his wife both took the Bivalent Pfizer COVID-19 vaccine booster on 03Oct at approximate 6 PM and today starting this morning, both of them started feeling ill. By the afternoon, they both have chills, fever, nausea, just overall lethargy and just not feeling well. The patient (wife) took a test and it was negative but they just found it odd that the side effects took a one whole week to take effect. Normally, side effects have come in on the past with their vaccinations, side effects they have been very mild or they started within 24 to 48 hours. But this is an entire week, an entire week has gone by. Treatment for side effects included Ibuprofen.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221622 Same product and event, different patient;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: feeling ill / just not feeling well; Chills; Fever; Nausea; overall lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose number unknown (booster), single (Lot number: GJ5342) at the age of 59 years 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 completed; unknown manufacturer), for COVID-19 immunization, reaction(s): "Adverse events unspecified"; Flu (took a flu shot in March (unspecified year)), for Immunization, reaction(s): "Adverse events unspecified". The following information was reported: CHILLS (non-serious) with onset 11Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 11Oct2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 11Oct2022, outcome "unknown"; MALAISE (non-serious) with onset 11Oct2022, outcome "unknown", described as "feeling ill / just not feeling well"; LETHARGY (non-serious) with onset 11Oct2022, outcome "unknown", described as "overall lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, chills, pyrexia, nausea, lethargy. Additional information: Consumer reported that he and his wife both took the Bivalent Pfizer COVID-19 vaccine booster on 03Oct at approximate 6 PM and today starting this morning, both of them started feeling ill. By the afternoon, they both have chills, fever, nausea, just overall lethargy and just not feeling well. The patient (wife) took a test and it was negative but they just found it odd that the side effects took a one whole week to take effect. Normally, side effects have come in on the past with their vaccinations, side effects they have been very mild or they started within 24 to 48 hours. But this is an entire week, an entire week has gone by. Treatment for side effects included Ibuprofen.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221622 Same product and event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), 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 Number: 1, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Had a sore hand". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional Information: It was unknown if other vaccine in four weeks was administered. It was unknown if patient had covid prior to vaccination and if covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Malaise, Nausea, Pyrexia
Clinical narrative: feeling ill; just not feeling well; Chills; Fever; Nausea; overall lethargy; 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 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose number unknown (booster), single (Lot number: GJ5342) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Mild Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for Covid-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 11Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 11Oct2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 11Oct2022, outcome "unknown"; MALAISE (non-serious) with onset 11Oct2022, outcome "unknown", described as "feeling ill; just not feeling well"; LETHARGY (non-serious) with onset 11Oct2022, outcome "unknown", described as "overall lethargy". Therapeutic measures were taken as a result of malaise, chills, pyrexia, nausea, lethargy.  Additional information: The patient and his wife both took the Bivalent Pfizer COVID-19 Vaccine Booster on October 3rd at approximate 6 PM and starting this morning (at the time of reporting) both of them started feeling ill. By the afternoon they both had chills, fever, nausea, just overall lethargy and just not feeling well. The patient's wife took a test and it was negative but they were just finding it odd that the side effect took a one whole week to took effect. So patient asked if it was normal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221570 Same product and event, different patient;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Epicondylitis, SARS-CoV-2 test
Clinical narrative: What feels like tennis elbow in my left elbow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; LAMICTAL; DROSPIRENONE AND ETHINYL ESTRADIOL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6207), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0151), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FJ8762), for COVID-19 immunization. The following information was reported: EPICONDYLITIS (non-serious) with onset 23Sep2022, outcome "not recovered", described as "What feels like tennis elbow in my left elbow". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of epicondylitis.  Additional information: the patient had no other vaccine in four weeks. She felt like she had tennis elbow on her left elbow, which was her non-dominant hand and was not overused or prone to tennis elbow. It was also reported the event occurred progressively 2 weeks after the vaccine, and was still a problem at the time of the report. She did not have COVID prior to vaccination, and was tested for COVID after vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 10:00 as dose 1, single (Lot number: el9261), in left arm, on 17Feb2021 at 15:45 as dose 2, single (Lot number: en6201), in left arm and on 26Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 30135BA) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2022 at 13:15 as dose 4 (booster), single (Lot number: 04bl21a), in left arm and on 09Sep2022 at 11:30 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 27Sep2022 to 02Oct2022.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; REQUIP. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included product: COVID 19 Treatment, Brand: Paxlovid, from 28Sep2022 to 03Oct2022 as treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autoimmune disorder, Blood test, Urticaria
Clinical narrative: all over body hives; developed autoimmune issues; 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 52-year-old female patient received BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "the hormone issues" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; PROGESTERONE taken for endocrine disorder; ESTRADIOL taken for endocrine disorder. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA (medically significant) with onset 2022, outcome "unknown", described as "all over body hives"; AUTOIMMUNE DISORDER (medically significant) with onset 2022, outcome "unknown", described as "developed autoimmune issues". The patient underwent the following laboratory tests and procedures: Antibody test: (26Sep2022) Unknown results, notes: I just had some blood work done to test for some antibodies, I had that tests done 26Sep (Further not clarified); Blood test: (26Sep2022) Unknown results, notes: I just had some blood work done to test for some antibodies, I had that tests done 26Sep (Further not clarified). Therapeutic measures were taken as a result of urticaria.  Additional information: Caller received 4 doses of the Pfizer Covid 19 vaccine. The first three doses were fine.  After the 4th dose she developed all over body hives one or two days later.  She took two benadryl and it went away and was fine.  She had also developed autoimmune issues since then and she thought she should report it. After her fourth dose, she said she got all over body hives. 1 or 2 days later she took 2 Benadryl (Treatment) and it went away and she was fine. She did not elaborate on what on autoimmune issues that she was referring to. Age at the time of adverse event: Consumer stated, Well she guessed she was 52 because now she was 53 but she had a birthday this summer. Consumer stated she just wanted to know if she should avoid getting the next vaccine because otherwise she would have gotten it and she did not want to get COVID either. So she just asked for the reaction and then since the autoimmune stuff came on so quickly, it pretty much started in a couple of weeks after that, she thought it was better to hold off but as she said she did not want to get COVID either. Consumer stated, she did google it and looked like it happened to some other people. So she was sure it was rare. She thought the vaccine was awesome but she just wanted to make sure people should know because it was important.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: initial positive test; Negative, notes: being negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received Paxlovid as COVID 19 Treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Interchange of vaccine products, Tachycardia
Clinical narrative: Tachycardia; She received her Moderna series in Apr2020; In Dec2021, she received the Pfizer COVID booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 43-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 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: Moderna vaccine (Dose 1, Caller stated she received an initial series (two doses) of Moderna in Apr2021 and 5 months after that she developed pericarditis.), administration date: Apr2021, for COVID-19 immunization, reaction(s): "pericarditis"; Moderna vaccine (Dose 2, Caller stated she received an initial series (two doses) of Moderna in Apr2021 and 5 months after that she developed pericarditis.), administration date: Apr2021, for COVID-19 immunization, reaction(s): "pericarditis". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "She received her Moderna series in Apr2020; In Dec2021, she received the Pfizer COVID booster"; TACHYCARDIA (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tachycardia.  Additional information: Caller, a pharmacist, asked was there any reason why a 43 year old female patient should not get the Pfizer covid 19 bivalanet booster. Caller stated she received an initial series (two doses) of Moderna in Apr2021 and 5 months after that she developed pericarditis. Caller stated she received a Pfizer covid booster in Dec2021 and had no issues. Caller stated she did get covid in Jun/Jul2022 and then she had tachycardia. Caller stated she was treated with Paxlovid. Caller stated two echoes were done and the tachycardia was benign. Caller asked should she not get the bivalent since she had these cardiac episodes. Caller wanted to clarify that the CDC recommendation was for pericarditis that occurred more than 3 weeks after the most recent dose. Caller wanted to know if Pfizer had additional information other than the CDC information.  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-202201222283 same patient, different suspect drug and event;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: In Jun 2022 -Jul 2022 she got COVID/ She had rebound covid; In Jun 2022 -Jul 2022 she got COVID/ She had rebound covid; She received her Moderna series in Apr2020; In Dec 2021, she received the Pfizer COVID booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID:   A 42-year-old female patient received BNT162b2 (BNT162B2), on 26Dec2021 as dose 3 (booster), single (Lot number: FE3594, Expiration Date: Feb2022) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2020 as dose 1, single (Batch/Lot number: unknown) and in Apr2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pericarditis", start date: Sep2020 (unspecified if ongoing), notes: The pericarditis was in Sep2020, 5 months after moderna series. The doctor couldn't say if it was a direct result from the vaccine she received. There were no concomitant medications. Past drug history included: Sudafed, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Dec2021, outcome "unknown", described as "She received her Moderna series in Apr2020; In Dec 2021, she received the Pfizer COVID booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "In Jun 2022 -Jul 2022 she got COVID/ She had rebound covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: She was treated with Paxlovid. She had rebound covid from that; (2022) Positive, notes: In Jun2022 -Jul2022 she got COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course as follows: The patient got the initial series of Moderna. She got the COVID 19 booster by Pfizer. She received her Moderna series in Apr2020. In Dec2021, she received the Pfizer COVID booster (on 26Dec2021). She didn't have issues with that. Then, in Jun2022 - Jul2022 she got COVID. The doctor said that could be seen in a patient with COVID. She was treated with Paxlovid.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.,Linked Report(s) : PFIZER INC-202201222258 same patient, different suspect drug and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Investigation, Pain in extremity, X-ray
Clinical narrative: sore arm; 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 49-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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller reports she received pfizer vaccine last Sep. After the 1st shot she was fine, just a sore arm. But then 4 days after her 2nd dose she developed reactive arthritis.  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-202201222794 similar report from same reporter;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: sore arm; 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 49-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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller reports she received pfizer vaccine last Sep. After the 1st shot she was fine, just a sore arm. But then 4 days after her 2nd dose she developed reactive arthritis.  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-202201222794 similar report from same reporter;
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna; vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 17:15 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 03Feb2021 as dose 1, single (Lot number: 031L20A), in left arm, on 03Mar2021 as dose 2, single (Lot number: 002a21a), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: 014f21a), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: 065k21a), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE BENAZEPRIL, start date: 01Jun2018, stop date: 29Sep2022; LEVOTHYROXIN, start date: 01May2017, stop date: 29Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022 at 17:15, outcome "unknown", described as "vaccine brand other: Moderna; vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Migraine, Pain
Clinical narrative: Legs being numb; Back and top of her head is killing her; 5 days of pain and misery; 5 days of pain and misery; Migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Mild headache" (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: MIGRAINE (non-serious) with onset 05Oct2022, outcome "not recovered"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Legs being numb"; HEADACHE (non-serious), outcome "unknown", described as "Back and top of her head is killing her"; PAIN (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "5 days of pain and misery". The events "migraine", "legs being numb", "back and top of her head is killing her" and "5 days of pain and misery" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: Patient asked how long the migraine will last, as she is planning a trip with her grandkids. Her HCP told her to take 2 Aleve 220mg every 12 hours, been taking two Aleve and only lasts for 3 hours or not even. Aleve did not help at all. She also called her pharmacist and was advised to drink a lot of water. She stated that she has never had more than a mild headache in her life, and that she is otherwise in very, very good health.  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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Legs being numb; Back and top of her head is killing her; 5 days of pain and misery; 5 days of pain and misery; Migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Mild headache" (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: MIGRAINE (non-serious) with onset 05Oct2022, outcome "not recovered"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Legs being numb"; HEADACHE (non-serious), outcome "unknown", described as "Back and top of her head is killing her"; PAIN (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "5 days of pain and misery". The events "migraine", "legs being numb", "back and top of her head is killing her" and "5 days of pain and misery" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: Patient asked how long the migraine will last, as she is planning a trip with her grandkids. Her HCP told her to take 2 Aleve 220mg every 12 hours, been taking two Aleve and only lasts for 3 hours or not even. Aleve did not help at all. She also called her pharmacist and was advised to drink a lot of water. She stated that she has never had more than a mild headache in her life, and that she is otherwise in very, very good health.  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.