chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 26-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Reporter informed about temperature excursions with freezer in the facility, where she works. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter stated that, in her facility where she works at there had been temperature excursions with her freezer. It has been happening for weeks since April 2022. The storage condition at the time of the excursion was frozen. The vial with lot number affected were 065K21A and 045L21A. The maximum or minimum temperatures reached were as follows maximum 30 Fahrenheit Degrees and minimum 18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The reporter does not have the information on date vial(s) moved from freezer to refrigerator. The vials currently stored in frozen state. On visual inspection no changes were observed in any vaccine state. The Proposed desired Use by Date was not reported. No treatment medications were reported. This case was linked to MOD-2022-591989 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna COVID 19 vaccine after temperature excursion; Patients received the Moderna COVID 19 vaccine after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP reported that the facility where she works, there had been temperature excursions with freezer. It had been happening for weeks since April 2022  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vails were stored in frozen state.Visual inspection did not noted any vaccine state change.  No treatment information was provided.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter informed about temperature excursions with freezer in the facility, where she works. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication were provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 degrees Fahrenheit and minimum minus 18.9 degrees Fahrenheit. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vials were stored in frozen state. The visual inspection did not noted any vaccine state change.   No treatment information was reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Poor quality vaccine administered; Patients received the Moderna COVID 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion). On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient had administered the Moderna Covid 19 vaccine after temperature excursion; Patient had administered the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient had administered the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had administered the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022.Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion.and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and No vaccine state change was observed.  No treatment medication were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographism) and URTICARIA (migratory hives) in a 20-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (Dermatographism) and URTICARIA (migratory hives). At the time of the report, MECHANICAL URTICARIA (Dermatographism) and URTICARIA (migratory hives) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant drug was reported. No Treatment medications were reported. It was reported that reporter read an article on the (National Center Information) website, where a young man in his 20s, experienced dermatographism and migratory hives, after receiving the Moderna vaccine. This case was linked to MOD-2022-593007, MOD-2022-593014 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient 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 included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies noted.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral treatment drug Paxlovid, dtarting from 07Jun2022 till 11Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast swelling, Neck pain
Clinical narrative: Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.; Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.; Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 at 18:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: LEVETIRACETAM. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM), administration date: 20May2022, when the patient was 23-year-old, for COVID-19 Immunization. The following information was reported: BREAST SWELLING (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 11Jun2022 at 07:15, outcome "not recovered" and all described as "Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.". Therapeutic measures were not taken as a result of breast swelling, neck pain, back pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not diagnosed with COVID-19 post vaccination. No Known allergies. The patient has not received any vaccines within 4 weeks. Other medications in two weeks was Levetiracetam ER  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Interchange of vaccine products, Joint swelling, Movement disorder
Clinical narrative: I have my right wrist and elbow have been swelled and are sore to touch, with limited movement; I have my right wrist and elbow have been swelled and are sore to touch, with limited movement; My left shoulder is sore and painful all the time; Fatigue is every night; DOSE 1, 2, 3 : Moderna and DOSE 4: BNT162B2; DOSE 1, 2, 3 : Moderna and DOSE 4: BNT162B2; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 at 16:45 as dose 4 (booster), single (Lot number: Fm0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; AMLODIPINE; PRAVASTATIN. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine. Vaccination history included: moderna (DOSE 1; Lot number: 032H02A; Anatomical Location:Arm Left, Time of administration: 04:45 PM), administration date: 06Jan2021, when the patient was 58-year-old, for COVID-19 immunization; moderna (DOSE 2; Lot number: 032H02A; Anatomical Location:Arm Left, Time of administration: 04:45 PM), administration date: 03Feb2021, when the patient was 58-year-old, for COVID-19 immunization; moderna (DOSE 3; Lot number:939906; Anatomical Location:Arm Left, Time of administration: 04:45 PM), administration date: 04Nov2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious) all with onset 09May2022 at 16:45, outcome "unknown" and all described as "DOSE 1, 2, 3 : Moderna and DOSE 4: BNT162B2"; FATIGUE (non-serious) with onset 14May2022, outcome "not recovered", described as "Fatigue is every night"; JOINT SWELLING (non-serious), MOVEMENT DISORDER (non-serious) all with onset 14May2022, outcome "not recovered" and all described as "I have my right wrist and elbow have been swelled and are sore to touch, with limited movement"; ARTHRALGIA (non-serious) with onset 14May2022, outcome "not recovered", described as "My left shoulder is sore and painful all the time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of joint swelling, movement disorder, arthralgia, fatigue.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Device date was provided as 20Jun2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test
Clinical narrative: I have my right wrist and elbow have been swelled and are sore to touch, with limited movement; I have my right wrist and elbow have been swelled and are sore to touch, with limited movement; My left shoulder is sore and painful all the time; Fatigue is every night; DOSE 1, 2, 3 : Moderna and DOSE 4: BNT162B2; DOSE 1, 2, 3 : Moderna and DOSE 4: BNT162B2; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 at 16:45 as dose 4 (booster), single (Lot number: Fm0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; AMLODIPINE; PRAVASTATIN. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine. Vaccination history included: moderna (DOSE 1; Lot number: 032H02A; Anatomical Location:Arm Left, Time of administration: 04:45 PM), administration date: 06Jan2021, when the patient was 58-year-old, for COVID-19 immunization; moderna (DOSE 2; Lot number: 032H02A; Anatomical Location:Arm Left, Time of administration: 04:45 PM), administration date: 03Feb2021, when the patient was 58-year-old, for COVID-19 immunization; moderna (DOSE 3; Lot number:939906; Anatomical Location:Arm Left, Time of administration: 04:45 PM), administration date: 04Nov2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious) all with onset 09May2022 at 16:45, outcome "unknown" and all described as "DOSE 1, 2, 3 : Moderna and DOSE 4: BNT162B2"; FATIGUE (non-serious) with onset 14May2022, outcome "not recovered", described as "Fatigue is every night"; JOINT SWELLING (non-serious), MOVEMENT DISORDER (non-serious) all with onset 14May2022, outcome "not recovered" and all described as "I have my right wrist and elbow have been swelled and are sore to touch, with limited movement"; ARTHRALGIA (non-serious) with onset 14May2022, outcome "not recovered", described as "My left shoulder is sore and painful all the time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of joint swelling, movement disorder, arthralgia, fatigue.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Device date was provided as 20Jun2022.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate decreased, Myocardial infarction
Clinical narrative: heart attack; heart rate was low; some heavy chest pain symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had a second heart operation and in the past three weeks, four weeks" (unspecified if ongoing), notes: I had a second heart operation and in the past three weeks, four weeks. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN, The first dose was on 13Jan2021), administration date: 13Jan2021, for COVID-19 immunization; coviD-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN, The second dose was 11Feb2021), administration date: 11Feb2021, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "heart rate was low"; CHEST PAIN (non-serious), outcome "unknown", described as "some heavy chest pain symptoms". The patient underwent the following laboratory tests and procedures: Heart rate: low, notes: My heart rate was low.  Clinical course: Consumer stated that, I laid in the bed for couple of day. Well it was the third COVID shot (Pfizer COVID-19 Vaccine) that knocked me out. That COVID shot was so bad that I had a heart attack with it. My heart rate was low and I had a second heart operation and in the past three weeks, four weeks, I was given some heavy chest pain symptoms and I am trying to find out can I get a prescription refill as a preventive measure.  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: 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). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 08Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm 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) all with onset 15Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Other medication were received in 2 weeks. Antiviral details included Product: COVID 19 Treatment. Brand was Paxlovid. Indication was for Treatment of COVID-19. Vaccine was received and vaccine brand was Pfizer / BioNTech. Vaccine lot unknown reason was not available/provided to reporter at the time of report completion. On day 5 of paxlovid 07Jun, patient tested negative for Covid Started having a severe cold on 14Jun with constant sneezing, severe headache and overall tired, patient tested positive for Covid on 15Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: 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 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2021 as dose 1, single (Lot number: 044b21a) and on 20May2021 as dose 2, single (Lot number: 022b21a) for covid-19 immunisation. The patient's relevant medical history included: "Intolerance to corn/soy" (unspecified if ongoing); "Intolerance to corn/soy" (unspecified if ongoing). Date of last menstrual period: 11Apr2022. The patient was 9  pregnant at the event onset. The patient is expected to deliver a baby(s) on 18Jan2023. Concomitant medication(s) included: ZOFRAN MELT; UNISOM 2; VITAMIN B6. 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: COVID rebound. Symptom free and very light antigen line by completion of paxlovid course. Symptoms returned (cough and congestion) and strong line on antigen test on day 9.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid symptoms came back. Congestion, sneezing, fatigue; Covid symptoms came back. Congestion, sneezing, fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Systemic lupus erythematosus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "Covid symptoms came back. Congestion, sneezing, fatigue". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Scab, Vaccination site nodule
Clinical narrative: At each injection site, the week of 06Jun22, I developed nodules that scabbed.; At each injection site, the week of 06Jun22, I developed nodules that scabbed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: FF2589, Location of injection: Arm Left), administration date: 28Sep2021, when the patient was 30-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FC3182, Location of injection: Arm Right), administration date: 07Sep2021, when the patient was 30-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: VACCINATION SITE NODULE (non-serious) with onset 08Jun2022, outcome "recovered" (Jun2022), SCAB (non-serious) with onset Jun2022, outcome "unknown" and all described as "At each injection site, the week of 06Jun22, I developed nodules that scabbed.". Therapeutic measures were not taken as a result of vaccination site nodule.  Additional information: Patient did not receive any other vaccine in four weeks. COVID was not tested prior vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I am positive again for Covid.; I am positive again for Covid.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 28Jan2021 as dose 2, single (Lot number: EL3249), in right arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in right arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing). Concomitant medication(s) included: RELPAX taken for migraine, start date: 01Jun2022, stop date: 01Jun2022; FAMOTIDINE, start date: 19May2022; CALCIUM, start date: 19May2022. Past drug history included: Clindamycin, reaction(s): "known allergies: Clindamycin", notes: known allergies: Clindamycin. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 20Jun2022, outcome "recovering" and all described as "I am positive again for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I was negative until today; (20Jun2022) Positive, notes: Monday Jun20. Now I am positive again for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: FN6207), in left arm, on 04Apr2021 as dose 2, single (Lot number: EW0151), in right arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "multiple sclerosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "RAD" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s)/Other medication in 2 weeks included: GILENYA; HYDROCHLOROTHIAZIDE; ANASTRAZOLE DENK; MONTELUKAST; ASPIRINE; LOSARTAN; AMLODIPINE; CALCIUM. Past drug history included: Marcaine, reaction(s): "Allergy"; Cipro, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for covid again six days after finishing paxlovid and continuing to isolate; Negative, notes: Tested negative. 2days after finishing paxlovid; Positive, notes: Tested negative. 2days after finishing paxlovid only to have symptoms return on day six after completion and tested positive for Covid again. Tested positive for covid again six days after finishing paxlovid and continuing to isolate. Tested negative 2days after finishing paxlovid only to have symptoms return on day six after completion and tested positive for Covid again. It was unknown if therapeutic measures were taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) I again tested positive the next day (11Jun2022); After testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) I again tested positive the next day (11Jun2022); This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 09Aug2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 as dose 4 (booster), single (Lot number: 013F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: DESCOVY, start date: Apr2016, stop date: 03Jun2022; BUPROPION HYDROCHLORIDE [BUPROPION HYDROBROMIDE], start date: Jan2012; FLUOXETINE, start date: Feb2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022, outcome "recovering" and all described as "After testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) I again tested positive the next day (11Jun2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (01Jun2022) Positive; (12Jun2022) Positive; (19Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical cource: It was reported that after testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) patient again tested positive the next day (12Jun2022) and proceeded to test very positive for the following week, until 19Jun2022. Symptoms such as congestion, coughing, headache and fatigue returned for about 5 days. He was still awaiting a second rapid home test to confirm my negativity.
Age: 29.0
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) (Physician). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive; (19Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: There were no other medications in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 72.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 17:30 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 06Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 04Jun2022.  The following information was reported: VACCINATION FAILURE (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: Unknown Results, notes: Covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Treatment of covid-19 was with paxlovid with start date 04Jun2022 & stop date 08Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke after receiving the second dose of the Pfizer Covid vaccine for adults; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "had a stroke after receiving the second dose of the Pfizer Covid vaccine for adults".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on 20Jun22; Tested positive for COVID-19 on 20Jun22; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose1, single (Lot number: EL3257), in right arm, on 15Mar2021 at 09:00 as dose 2, single (Lot number: EN6203), in right arm and on 30Nov2021 at 09:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: ENPRESSE taken for contraception. Past drug history included: Augmentin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 19Jun2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 20Jun22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: No other vaccine was taken in four weeks. Facility type vaccine was Walkup site  No follow-up attempts are possible. No further information is expected.