chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Experienced palpitations for half a month.; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Experienced palpitations for half a month.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Experienced palpitations for half a month.). At the time of the report, PALPITATIONS (Experienced palpitations for half a month.) had resolved.            No concomitant product use was reported.  The patient took 2 booster doses of Moderna and patient was not happy with it because patient experienced palpitations for half a month. The patient was informed that Moderna caused heart inflammation 4 times more likely. The patient wanted to know if Pfizer BionTech Covid-19 Bivalent Vaccine would cause inflammation of the heart/brain paralysis less likely than with Moderna Covid-19 Vaccine.  No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; inadvertently administered an expired (30 day use by date - 13-Oct-2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)).    No concomitant medications was reported. It was reported that the vaccine was administered on 18-oct-2022 around noon time. No treatment drug details was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022; No Adverse event; Patient administered an expired (30 day use by) bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022) and NO ADVERSE EVENT (No Adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022 at 10:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022 at 10:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022).    No concomitant medication information was provided.  Reported that Vial size was 2.5 ml. The vial was initially stored in the refrigerator on 17-Sep-2022 and 30 day use by date was 17Oct2022. The vial did not undergo any temperature excursions.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2022: Live follow up received contains significant information: Updated patient demographics.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID Test Positive/treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID Test Positive/treatment of COVID-19) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID Test Positive/treatment of COVID-19). At the time of the report, COVID-19 (COVID Test Positive/treatment of COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.   Patient started to get symptoms again and tested positive for COVID again. vaccine LOT number provided 041J21A.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series; Monovalent booster dose administered instead of 2nd primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series), INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series) and INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series), INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series) and INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose).    Concomitant medication was not provided.  The dose administered was monovalent booster as second dose  instead of primary series second dose.  Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives and Urticaria all over the body; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives and Urticaria all over the body) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2022. On 29-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced URTICARIA (Hives and Urticaria all over the body). The patient was treated with CETIRIZINE for Hives, at a dose of 2 daily in the morning; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, at a dose of 20 milligram once a day and MONTELUKAST SODIUM (SINGULAIR) for Hives, at a dose of 10 milligram once a day. At the time of the report, URTICARIA (Hives and Urticaria all over the body) outcome was unknown.      Concomitant drugs were not reported. Patient received first dose of Moderna COVID-19 vaccine on 22-Apr-2021 Lot number 009C21A, second dose on 20-May-2021 Lot number 006C21A and first booster dose on 22-Nov-2021 Lot number 939909. It was reported that the event restarted after the bivalent booster.   This case was linked to MOD-2022-660885 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site left arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 032M20A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site left arm) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient did not experience any adverse reaction after the primary doses of Moderna COVID-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-660904 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Made patient sleepy; Injection site left arm soreness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (Made patient sleepy) and VACCINATION SITE PAIN (Injection site left arm soreness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced SOMNOLENCE (Made patient sleepy) and VACCINATION SITE PAIN (Injection site left arm soreness). At the time of the report, SOMNOLENCE (Made patient sleepy) and VACCINATION SITE PAIN (Injection site left arm soreness) outcome was unknown.     No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-660901 (Patient Link).
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue, Sensory disturbance
Clinical narrative: Pfizer COVID-19 Bivalent Vaccine and a flu shot; Pfizer COVID-19 Bivalent Vaccine and a flu shot; feels her skin is biting her; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tuberculosis vaccines (2 weeks ago), for Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Pfizer COVID-19 Bivalent Vaccine and a flu shot"; SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "feels her skin is biting her".  Additional information: The reporter mentioned she had a patient who received the TB shot 2 weeks ago, then the Pfizer COVID-19 Bivalent Vaccine and a flu shot today. Patient felt her skin was biting her. She wanted to know if there was any information about the administration of this vaccines together. The reporter mentioned this did not happen at her store.  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: Based on the available information, there is reasonable possibility of causal association between the events  and the suspect drug  BNT162b2
Age: 63.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Interchange of vaccine products, Off label use, Product use issue, Vaccination site rash, Vaccination site swelling
Clinical narrative: Prev dose brand=Janssen; Swelling and rash on injection arm; Swelling and rash on injection arm; Other vaccine same date product=Influenza; Other vaccine same date product=Influenza; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 11:15 as dose 3 (booster), single (Lot number: GH9693) at the age of 63 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 15Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". Vaccination history included: BNT162b2 (dose 2 (booster), administered in the right arm at 09:30, Lot number: Fm0173), administration date: 28May2022, when the patient was 62-year-old, for COVID-19 Immunization; janssen (dose 1, administered in the right arm at 14:00, Lot number: 207A21A), administration date: 26May2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 15Oct2022, outcome "unknown" and all described as "Other vaccine same date product=Influenza"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 15Oct2022 at 19:00, outcome "not recovered" and all described as "Swelling and rash on injection arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Prev dose brand=Janssen". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site rash.  Additional information: Other medications in two weeks included "BP medications".
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dry mouth, Lethargy, Middle insomnia
Clinical narrative: woke up in middle of night; Cold sweats; Chills; Soreness in arm of injection site; Lethargy; Dry mouth; Dose number: 1 (Pfizer Bivalent); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 09:15 as dose 1, single (Lot number: GH9702) at the age of 46 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "Stents" (unspecified if ongoing), notes: stents of hypertension; "Hypertension" (unspecified if ongoing), notes: stents of hypertension. Concomitant medication(s) included: LISINOPRIL. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Oct2022 at 09:15, outcome "unknown", described as "Dose number: 1 (Pfizer Bivalent)"; CHILLS (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022); COLD SWEAT (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022), described as "Cold sweats"; DRY MOUTH (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022); LETHARGY (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022); VACCINATION SITE PAIN (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022), described as "Soreness in arm of injection site"; MIDDLE INSOMNIA (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022), described as "woke up in middle of night". Therapeutic measures were not taken as a result of middle insomnia, cold sweat, chills, vaccination site pain, lethargy, dry mouth.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient woke up in middle of night with cold sweats chills and soreness in arm of injection site, lethargy, dry mouth. Patient did not receive other vaccine in four weeks. Other medications in two weeks included Lisinopril 10mg per day.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong product administered
Clinical narrative: woke up in middle of night; Cold sweats; Chills; Soreness in arm of injection site; Lethargy; Dry mouth; Dose number: 1 (Pfizer Bivalent); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 09:15 as dose 1, single (Lot number: GH9702) at the age of 46 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "Stents" (unspecified if ongoing), notes: stents of hypertension; "Hypertension" (unspecified if ongoing), notes: stents of hypertension. Concomitant medication(s) included: LISINOPRIL. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Oct2022 at 09:15, outcome "unknown", described as "Dose number: 1 (Pfizer Bivalent)"; CHILLS (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022); COLD SWEAT (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022), described as "Cold sweats"; DRY MOUTH (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022); LETHARGY (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022); VACCINATION SITE PAIN (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022), described as "Soreness in arm of injection site"; MIDDLE INSOMNIA (non-serious) with onset 13Oct2022 at 02:00, outcome "recovered" (Oct2022), described as "woke up in middle of night". Therapeutic measures were not taken as a result of middle insomnia, cold sweat, chills, vaccination site pain, lethargy, dry mouth.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient woke up in middle of night with cold sweats chills and soreness in arm of injection site, lethargy, dry mouth. Patient did not receive other vaccine in four weeks. Other medications in two weeks included Lisinopril 10mg per day.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood glucose, Glycosylated haemoglobin, Haemoglobin, Tinnitus
Clinical narrative: Tinnitus has increased in volume times 2 over the past year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HB controlled well" (unspecified if ongoing); "border dibeties" (unspecified if ongoing), notes: border dibeties (140 gl,6.1 a1c),; "high cholesterol controlled" (unspecified if ongoing); "Tinnitus", start date: 01Jan1960 (ongoing), notes: Tinnitus, I've had this all my life; start time: 12 :00 AM. Concomitant medication(s) included: VALSARTAN; METOPROLOL SUCCINATE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Batch/lot number: EL9269; Anatomical location: Right arm), administration date: 02Feb2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE: Batch/lot number: EN6202; Anatomical location: Right arm), administration date: 28Feb2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus has increased in volume times 2 over the past year". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient was planning new booster (injection 4) in Oct2022. Patient would update if tinnitus volume increases to higher level after booster. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and not tested post vaccination. Had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia
Clinical narrative: Metallic taste in mouth; tingling nose; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 at 12:30 as dose 4 (booster), single (Lot number: GJ5342) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 16Oct2022 at 12:30, outcome "recovering", described as "Metallic taste in mouth"; PARAESTHESIA (non-serious) with onset 16Oct2022 at 12:30, outcome "recovering", described as "tingling nose". Therapeutic measures were not taken as a result of dysgeusia, paraesthesia.  Additional information: Patient had no other vaccine in four weeks. Patient also had no COVID prior vaccination and was not COVID tested post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Incorrect dose administered, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Moderna-Dose 1, Dose 2, Dose 4/Pfizer/BioNTech-Dose 3, Dose 5; Moderna-Dose 1, Dose 2, Dose 4/Pfizer/BioNTech-Dose 3, Dose 5; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Jul2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Mar2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly low IGg's" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Jul2021 at 13:00, outcome "unknown", INCORRECT DOSE ADMINISTERED (non-serious) with onset Oct2022, outcome "unknown" and all described as "Moderna-Dose 1, Dose 2, Dose 4/Pfizer/BioNTech-Dose 3, Dose 5"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19, which included Paxlovid from 06Oct2022 to 11Oct2022. Clinical course: The patient never had nasal symptoms or fever before and during her treatment with Paxlovid. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment (Paxlovid), which included Mobic, Bystolic, Gabapentin, Baby aspirin, an unspecified medication from Bayer, multiple unspecified vitamins, Zinc, and D3.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness
Clinical narrative: Chills; Flulike symptoms; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, on 13Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine, for covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 14Oct2022 at 14:30, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Oct2022 at 14:30, outcome "unknown", described as "Flulike symptoms"; FATIGUE (non-serious) with onset 14Oct2022 at 14:30, outcome "unknown", described as "Tired".   Additional information: Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pain assessment
Clinical narrative: The worst pain I have ever had; My underarm lymph node swelled up to the size of a grapefruit; I felt like I was about to vomit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: Covid-19 vaccine (DOSE 1,SINGLE Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "The worst pain I have ever had"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "My underarm lymph node swelled up to the size of a grapefruit"; NAUSEA (non-serious), outcome "recovered", described as "I felt like I was about to vomit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, lymphadenopathy, nausea.  Additional clinical information: With this shot and with the last booster I had on 09Nov2021 my underarm lymph node swelled up to the size of a grapefruit and was the worst pain I have ever had. I happen to have a high tolerance for pain but this came in constant waves for 48 hours and every time it hit a 10 in pain I felt like I was about to vomit. I am hesitant to ever vaccinate again it was so horrible and I am pro vaccine. If COVID prior vaccination and If COVID tested post vaccination: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 17:00 as DOSE 4 (BOOSTER), SINGLE (lot number: GH9694) at the age of 28 years, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 28Mar2021 at 12:30 as DOSE 1, SINGLE (lot number: EP6955), administered in the left arm, on 18Apr2021 at 12:30 as DOSE 2, SINGLE (lot number: ER8731), administered in the left arm, and on 02Nov2021 at 17:30 as DOSE 3 (BOOSTER), SINGLE (lot number: FH8020), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction: "Allergic to ciproflaxcin." The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Oct2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Vaccination failure, COVID-19 which included administration of Paxlovid from 07Oct2022 to 11Oct2022.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 1, single (Lot number: EW0158), in left arm and on 01May2022 as dose 2, single (Lot number: EW0175) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: other medical history: Crohn's disease; "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin; "rheumatoid arthritis" (unspecified if ongoing), notes: other medical history: rheumatoid arthritis; "chronic pain" (unspecified if ongoing), notes: other medical history: chronic pain. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0158 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0158, fill lot EP8693, and the bulk formulated drug product lot EW8072. The final scope included the reported finished goods lot EW0175, fill lot EP8726, and the bulk formulated drug product EP8607. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. ID of Previously Completed Inv: Link (Previously Investigated CR): ID of Previously Completed Inv:   Clinical course: It was reported that, the patient received Paxlovid for the treatment of Covid-19 from 02Oct2022 to 07Oct2022. The patient received other medications in 2 weeks.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetanus shot, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral treatment Paxlovid for covid-19 from 30Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Inappropriate schedule of product administration, Muscular weakness, Nausea
Clinical narrative: Vomiting; Runny stools; Headache; Weak muscles; Nausea; First dose:21May2021/ Second dose:16Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4140883.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 16Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose:1), administration date: 21May2021, for Covid-19 immunization, reaction(s): "Vomiting", "Runny stools", "Weak muscles", "Nausea"; BNT162b2 (dose:1), administration date: 21May2021, for COVID-19 Immunization, reaction(s): "Headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Jun2022, outcome "unknown", described as "First dose:21May2021/ Second dose:16Jun2022"; VOMITING (non-serious), outcome "not recovered"; DIARRHOEA (non-serious), outcome "not recovered", described as "Runny stools"; HEADACHE (non-serious), outcome "not recovered"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Weak muscles"; NAUSEA (non-serious), outcome "not recovered". The action taken for risankizumab was unknown. 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-PV202200083948 same reporter/drug/patient, different doses/AE;US-PFIZER INC-202201234111 same reporter/drug/patient, different doses/AE;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Runny stools; Headache; Weak muscles; Nausea; First dose:21May2021/ Second dose:16Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4140883.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 16Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose:1), administration date: 21May2021, for Covid-19 immunization, reaction(s): "Vomiting", "Runny stools", "Weak muscles", "Nausea"; BNT162b2 (dose:1), administration date: 21May2021, for COVID-19 Immunization, reaction(s): "Headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Jun2022, outcome "unknown", described as "First dose:21May2021/ Second dose:16Jun2022"; VOMITING (non-serious), outcome "not recovered"; DIARRHOEA (non-serious), outcome "not recovered", described as "Runny stools"; HEADACHE (non-serious), outcome "not recovered"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Weak muscles"; NAUSEA (non-serious), outcome "not recovered". The action taken for risankizumab was unknown. 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-PV202200083948 same reporter/drug/patient, different doses/AE;US-PFIZER INC-202201234111 same reporter/drug/patient, different doses/AE;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Muscular weakness, Nausea, Vomiting
Clinical narrative: Vomiting; Runny stools; Headache; Weak muscles; Nausea; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: US-ABBVIE-4140883 (Company).  A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 21May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years intramuscular for COVID-19 immunisation; risankizumab (SKYRIZI), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "not recovered"; DIARRHOEA (non-serious), outcome "not recovered", described as "Runny stools"; HEADACHE (non-serious), outcome "not recovered"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Weak muscles"; NAUSEA (non-serious), outcome "not recovered". The action taken for risankizumab was unknown. Additional information: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Causality: The reporter's and Company's opinion on causality for the events of Headache, Nausea, Runny stools, Vomiting and Weak muscles with Risankizumab Solution for Injection was Not Provided. The reporter's and Company's opinion on causality for the events of Headache, Nausea, Runny stools, Vomiting and Weak muscles with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Assessment Results: Skyrizi: Headache, Loose stools, Nausea, Weakness, Vomiting; Market Authorization Holder (MAH), Non-Health Care Professional, Global Introspection, Not Reported Pfizer/BioNTech Covid-19 vaccine: Headache, Loose stools, Nausea, Weakness, Vomiting; Market Authorization Holder (MAH), Non-Health Care Professional, Global Introspection, Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise
Clinical narrative: got very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very ill".  Clinical course: It was reported that the patient took the covid and flu shot together and got very ill.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GJ2524 ) at the age of 48 years, in left arm 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 1 day 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as Unknown. Therapeutic measures of drug ineffective, covid-19 included Paxlovid started on 06Oct2022 and stopped on 10Oct2022.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 17 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was not known patient received other medication in 2weeks. She received the treatment Paxlovid from 16Oct2022.  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 in the case, an association between the reported events drug ineffective and covid 19 and suspect product bnt162b2 cannot be ruled out.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: BNT162B2 Dose 1: 13Mar2021 and Dose 2: 31Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 2, single (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 61 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6208, Expiration date: 30Jun2021, Anatomical location: Arm), administration date: 13Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown", described as "BNT162B2 Dose 1: 13Mar2021 and Dose 2: 31Jul2021".  Additional information: Concomitant drug was reported as Eliquis.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201235979 same patient, different drug, different event;