chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Sep-2022 at 6:46 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Sep-2022 at 6:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant products reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022. Date vial moved from freezer to refrigerator was 07-Sep-2022. The vial underwent temperature excursion.  No adverse reactions reported for the patient.  No treatment products reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Temperature excursion product administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     The patient had no allergies.  The information was unknown whether the patient ever been diagnosed or tested positive for COVID-19.     On 16-Sep-2022 at 1:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient).    The time of fourth dose administration was 03:58 pm. No concomitant medication was provided.  On an unknown dates, the patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. The patient had received on deltoid body site for dose 4.   Date vial was moved from freezer to refrigerator on 7-Sep-2022.  The refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the local department and made aware of the situation.   Reportedly, the nurse called for a clinic where was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 12:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 12:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was unknown if the patient had ever tested positive or been diagnosed with COVID-19. The vial(s) moved from freezer to refrigerator on 7-Sep-2022.  It was reported that the vaccines had undergone several temperature excursions in Aug 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 included: "CVID (Common Variable Immunodeficiency)" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; LEVOTHYROXINE; HIZENTRA. Past drug history included: Fentanyl, reaction(s): "Allergy", notes: Known allergies: Fentanyl. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: positive test after completing the entire Paxlovid course and 4 days of negative tests; Positive, notes: positive test after, completing the entire Paxlovid course and 4 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 at 17:15 as dose 1, single (Lot number: EN6198), in left arm, on 21Mar2021 at 17:15 as dose 2, single (Lot number: GP7534), in left arm, on 24Sep2021 at 17:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 11Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "degenerative disk disease" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing); "asthmatic" (unspecified if ongoing); "had high cholesterol" (unspecified if ongoing). There were no concomitant medications. The patient had "Paxlovid rebound" after 6 days of testing negative for COVID. The patient reported that on 25Oct2022, she tested positive for COVID and immediately took Paxlovid which helped with all the symptoms. After her isolation period, she flew home and was feeling well and strong, ready to come home. She even went swimming in the ocean that morning. She took her time flying home because she did not want to infect anyone on her flight, nor at home, including her animals. She had a comfortable flight and slept well. Upon arrival her home, she still felt well. However, as soon as she stepped out and exited the baggage claim area, she took one breath of the outside air, and felt her throat close and react to the air pollution. She could feel pollution particle stick to her throat. On the drive home, her throat and ears felt like they were having an allergic reaction to poor air quality. At home, she got sick again. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (unspecified date) positive; (25Oct2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Outcome of the events was not recovered.
Age: 56.0
Sex: F
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(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took 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". 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
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 Bivalent Booster; 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 56-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 01Apr2021 as dose 2, single (Lot number: ER8734), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FE2589) and on 26Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 09Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing), notes: Pre diabetic, obstructive sleep apnea, hypertension; "obstructive sleep apnea" (unspecified if ongoing), notes: Pre diabetic, obstructive sleep apnea, hypertension; "hypertension" (unspecified if ongoing), notes: Pre diabetic, obstructive sleep apnea, hypertension. Concomitant medication(s) included: LAMOTRIGINE, start date: 01Sep2022, stop date: 06Nov2022; OLMESARTAN, start date: 01Sep2022, stop date: 06Nov2022; METFORMIN, start date: 01Sep2022, stop date: 06Nov2022; MEDROL A, start date: 12Oct2022, stop date: 17Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "not recovered", described as "Moderna Bivalent Booster"; VACCINATION FAILURE (medically significant), outcome "unknown", 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: I never tested negative and retest positive; Negative, notes: Did not test negative until 16 days after starting treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose 1, 2, and 3: Moderna, dose 4: Pfizer BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 25Mar2021 as dose 1, single (Lot number: 002B21A), in left arm, on 30Apr2021 as dose 2, single (Lot number: 017C21A), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PST" (unspecified if ongoing); "LCIS" (unspecified if ongoing). Concomitant medication(s) included: RALOXIFENE (EXELAN), start date: 01Dec2020, stop date: 06Nov2022. Past drug history included: Macrodantin, reaction(s): "known allergies: Macrodantin", notes: known allergies: Macrodontia. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03May2022, outcome "not recovered", described as "dose 1, 2, and 3: Moderna, dose 4: Pfizer BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Nov2022) Positive, notes: positive with AG home test; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP (High Blood pressure)" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. 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. Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 25Oct2022 to 30Oct2022. Clinical course: The patient had Paxlovid rebound on 04Nov2022, which was recovering with no treatment at the time of the report.  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.
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Discomfort, Inappropriate schedule of product administration, Muscle strain, Muscle tightness, Neck pain
Clinical narrative: Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm; Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm; Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm; Lots of Swelling & Discomfort on bottom of Right Armpit; Lots of Swelling & Discomfort on bottom of Right Armpit; Dose Number 1 :28Dec2021,Dose Number 2:31Oct2022; Dose Number 1 :28Dec2021,Dose Number 2:31Oct2022; Location of injection for vaccine received same date: Fluarix Quad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 31Oct2022 at 14:00 as dose 2 (bivalent), single (Lot number: GJ3275), in right arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 31Oct2022 as dose number unknown, single (Lot number: 58160-0890-52), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 330368D, Location of injection: Arm Right, Vaccine Administration Time: 11:45 AM), administration date: 28Dec2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "Dose Number 1 :28Dec2021,Dose Number 2:31Oct2022"; PRODUCT USE ISSUE (non-serious) with onset 31Oct2022, outcome "unknown", described as "Location of injection for vaccine received same date: Fluarix Quad"; SWELLING (non-serious), DISCOMFORT (non-serious) all with onset 01Nov2022, outcome "unknown" and all described as "Lots of Swelling & Discomfort on bottom of Right Armpit"; NECK PAIN (non-serious), MUSCLE STRAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 01Nov2022, outcome "unknown" and all described as "Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm". The events "right side of neck area soreness & pain & pulling & muscle tightness up & down to arm" and "lots of swelling & discomfort on bottom of right armpit" required emergency room visit. It was unknown if therapeutic measures were taken as a result of neck pain, muscle strain, muscle tightness, swelling, discomfort.
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Off label use, Product use issue, Swelling
Clinical narrative: Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm; Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm; Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm; Lots of Swelling & Discomfort on bottom of Right Armpit; Lots of Swelling & Discomfort on bottom of Right Armpit; Dose Number 1 :28Dec2021,Dose Number 2:31Oct2022; Dose Number 1 :28Dec2021,Dose Number 2:31Oct2022; Location of injection for vaccine received same date: Fluarix Quad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 31Oct2022 at 14:00 as dose 2 (bivalent), single (Lot number: GJ3275), in right arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 31Oct2022 as dose number unknown, single (Lot number: 58160-0890-52), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 330368D, Location of injection: Arm Right, Vaccine Administration Time: 11:45 AM), administration date: 28Dec2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "Dose Number 1 :28Dec2021,Dose Number 2:31Oct2022"; PRODUCT USE ISSUE (non-serious) with onset 31Oct2022, outcome "unknown", described as "Location of injection for vaccine received same date: Fluarix Quad"; SWELLING (non-serious), DISCOMFORT (non-serious) all with onset 01Nov2022, outcome "unknown" and all described as "Lots of Swelling & Discomfort on bottom of Right Armpit"; NECK PAIN (non-serious), MUSCLE STRAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 01Nov2022, outcome "unknown" and all described as "Right side of Neck Area soreness & pain & Pulling & Muscle Tightness up & down to Arm". The events "right side of neck area soreness & pain & pulling & muscle tightness up & down to arm" and "lots of swelling & discomfort on bottom of right armpit" required emergency room visit. It was unknown if therapeutic measures were taken as a result of neck pain, muscle strain, muscle tightness, swelling, discomfort.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 75 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 18Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pernicious anemia" (unspecified if ongoing); "history of prostate cancer" (unspecified if ongoing), notes: history of prostate cancer. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hyperaesthesia, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: lymphadenopathy; very sensitive to touch; pain around the armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "b/l breast lumpectomy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunisation series complete but Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Nov2022 at 06:00, outcome "recovered"; AXILLARY PAIN (non-serious) with onset 02Nov2022 at 06:00, outcome "recovered", described as "pain around the armpit"; HYPERAESTHESIA (non-serious) with onset 02Nov2022 at 06:00, outcome "recovered", described as "very sensitive to touch". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, hyperaesthesia, axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medications within 2 weeks prior to the vaccination. No known allergies were reported.  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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 13:30 as dose 4 (booster), single (Lot number: GJ3277) at the age of 59 years, in right 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 covid-19 immunisation. The patient's relevant medical history included: "high BP" (unspecified if ongoing); "allergies with shellfish" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "thyroid" (unspecified if ongoing), notes: All other normal meds was s on patient continued (for thyroid); "allergies wiith sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Breast pain, Mammogram, Mammogram abnormal, Mass
Clinical narrative: there was a tender area on my left breast that became more painful and I could feel a mass; there was a tender area on my left breast that became more painful and I could feel a mass; the mammo turned diagnostic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Lot number: EW0191) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Degenerative Disc Disease" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies:Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Skelaxin, reaction(s): "Known allergies: Skelaxin". The following information was reported: MAMMOGRAM ABNORMAL (disability) with onset 18Jul2021, outcome "not recovered", described as "the mammo turned diagnostic"; MASS (disability), BREAST PAIN (disability) all with onset 18Jul2021, outcome "not recovered" and all described as "there was a tender area on my left breast that became more painful and I could feel a mass". The events "there was a tender area on my left breast that became more painful and i could feel a mass" and "the mammo turned diagnostic" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: (18Feb2022) Negative, notes: Blood test; Mammogram: (Jul2021) stable, notes: This is concerning as I just had a stable mammogram 1 week prior to the first vaccine; (03Aug2021) Unknown results, notes: Unfortunately, the mammo turned diagnostic; SARS-CoV-2 test: (28Feb2022) Negative, notes: Nasal Swab; (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of mass, breast pain, mammogram abnormal. The vaccine was administered in hospital. The patient did not receive any other vaccine in past 4 weeks.  Clinical course: Three days post first vaccine, there was a tender area on patient's left breast that became more painful and patient could feel a mass. This was concerning to patient as she just had a stable mammogram 1 week prior to the first vaccine. Patient contacted her GP and he ordered another mammogram, which was performed 03Aug2021 (2 days before the 2nd vaccine was due). Unfortunately, the mammo turned diagnostic. Since that time, the situation escalated and patient since had 2 general anesthetic procedures, multiple in-office local anesthetic procedures and now another procedure in the next month to remove a significant portion of my breast including the nipple.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: there was a tender area on my left breast that became more painful and I could feel a mass; there was a tender area on my left breast that became more painful and I could feel a mass; the mammo turned diagnostic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Lot number: EW0191) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Degenerative Disc Disease" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies:Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Skelaxin, reaction(s): "Known allergies: Skelaxin". The following information was reported: MAMMOGRAM ABNORMAL (disability) with onset 18Jul2021, outcome "not recovered", described as "the mammo turned diagnostic"; MASS (disability), BREAST PAIN (disability) all with onset 18Jul2021, outcome "not recovered" and all described as "there was a tender area on my left breast that became more painful and I could feel a mass". The events "there was a tender area on my left breast that became more painful and i could feel a mass" and "the mammo turned diagnostic" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: (18Feb2022) Negative, notes: Blood test; Mammogram: (Jul2021) stable, notes: This is concerning as I just had a stable mammogram 1 week prior to the first vaccine; (03Aug2021) Unknown results, notes: Unfortunately, the mammo turned diagnostic; SARS-CoV-2 test: (28Feb2022) Negative, notes: Nasal Swab; (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of mass, breast pain, mammogram abnormal. The vaccine was administered in hospital. The patient did not receive any other vaccine in past 4 weeks.  Clinical course: Three days post first vaccine, there was a tender area on patient's left breast that became more painful and patient could feel a mass. This was concerning to patient as she just had a stable mammogram 1 week prior to the first vaccine. Patient contacted her GP and he ordered another mammogram, which was performed 03Aug2021 (2 days before the 2nd vaccine was due). Unfortunately, the mammo turned diagnostic. Since that time, the situation escalated and patient since had 2 general anesthetic procedures, multiple in-office local anesthetic procedures and now another procedure in the next month to remove a significant portion of my breast including the nipple.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Severe 10/10 crushing and aching pain to maxilla and mandible areas. Distressing pain.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 at 20:15 as dose 4 (booster), single (Lot number: GH9697) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MIRALAX; COLACE; CLONOPIN; MAGNESSIUM CARBONATE; BEANO. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); manufacturer unknown), for Covid-19 Immunization. The following information was reported: PAIN IN JAW (non-serious) with onset 30Oct2022 at 23:45, outcome "recovered", described as "Severe 10/10 crushing and aching pain to maxilla and mandible areas. Distressing pain.". Therapeutic measures were taken as a result of pain in jaw.
Age: 56.0
Sex: M
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 57-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 08:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right 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 covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of 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 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose number unknown, single (Lot number: EL9264) at the age of 78 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: Sep2010, stop date: 23Oct2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Tested positive again one week later. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR: Positive (31May2022);PCR: Positive (31May2022); 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), on 15Jul2021 as dose 1, single (Lot number: EW0191), in left arm and on 05Aug2021 as dose 2, single (Lot number: EW0191) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Degenerative Disc Disease" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Skelaxin, reaction(s): "Known allergies: Skelaxin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "unknown" and all described as "PCR: Positive (31May2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Feb2022) Negative, notes: Blood test, Covid test name post vaccination=anti-spike IgG; (28Feb2022) Negative, notes: Nasal Swab, Covid test name post vaccination=High Sens. PCR; (31May2022) Positive, notes: Nasal Swab, Covid test name post vaccination=PCR.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201281012 same reporter/patient/product, different dose/event.;
Age: 65.0
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). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), on 25Mar2021 as dose 2, single (Lot number: ER2613), on 01Dec2021 as dose 3 (booster), single (Lot number: FH8027) and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9729), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "OSA" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "sulfonamide" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 23Oct2022 to 28Oct2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Blister, Hypoaesthesia
Clinical narrative: Has numbness; back problems; gotten a blister on buttocks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9269), administration date: 09Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "1st blister", "numbness", "back problems"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6198), administration date: 02Mar2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF8839), administration date: 27Sep2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FM7553), administration date: 17May2022, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: BLISTER (non-serious) with onset 27Oct2022, outcome "unknown", described as "gotten a blister on buttocks"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Has numbness"; BACK DISORDER (non-serious), outcome "unknown", described as "back problems". Therapeutic measures were taken as a result of blister.  Additional Information: This is not 1st time but this is the 2nd time that caller has gotten a blister on buttocks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282459 same patient and event, different dose/drug;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Blister, Hypoaesthesia
Clinical narrative: Has numbness; back problems; 1st blister; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLISTER (non-serious) with onset 09Feb2021, outcome "not recovered", described as "1st blister"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Has numbness"; BACK DISORDER (non-serious), outcome "unknown", described as "back problems". Therapeutic measures were taken as a result of blister.  Additional information: The patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Lot number: EN6198), received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF8839) and also received BNT162b2 (BNT162B2), on 17May2022 as dose 4(booster), single (Lot number: FM7553) for covid-19 immunisation. The patient also received BNT162B2, BNT162B2 OMI BA.4-5, on 27Oct2022 as dose 5 (booster), single (Lot number: GH9697) for covid-19 immunisation. It was reported that first time got blister and thought might had bumped up against oven door open and thought hit the rail but was a blister so didn't have any concern, thought odd. Had numbness and back problems so really didn't really felt like burn. Stop date of adverse event was reported as not ongoing, but just a dark circle, the blister popped. The blister was being treating with antibiotic ointment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282427 same patient and event, different dose/drug;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: She has chills; Body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she has allergies to some medications" (unspecified if ongoing); "Some things and had strong allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She has chills"; PAIN (non-serious), outcome "unknown", described as "Body pain".  Additional information: The patient had allergies to some medications and some things and had strong allergies and spoke with someone that Pfizer vaccines didn't ask anything that she couldn't have it. She had chills and body pains and wanted to know if the 4 dose had the same things as the first 3 vaccines.  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-202201282774 Same patient/product/events, different dose;US-PFIZER INC-202201282775 Same patient/product/events, different dose;