chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2022 as dose 1, single (Batch/Lot number: unknown), in Feb2022 as dose 2, single (Batch/Lot number: unknown) and in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chron's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing), notes: Other medical history: Thyroid issues. The patient took concomitant medications. Past drug history included: Cephalexin, reaction(s): "known allergy: Cephalexin", notes: known allergy: Cephalexin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2022 at 16:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Nov2022) Positive, notes: Covid Rapid test shows positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: 5 days after completing Paxlovid, Covid symptoms (runny nose, stuffy head, phlemy throat, head and neck ache, fatigue) began again. Covid Rapid test shows positive.   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: 34.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: 8020) at the age of 34 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. Concomitant medication(s) included: PAROXETINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Versed, reaction(s): "Known allergies: Versed", notes: Known allergies: Versed. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: day 1 of Covid-19; Positive, notes: day 2 of Covid-19; Positive, notes: day 3 of Covid-19; Positive, notes: day 4 of Covid-19; Positive, notes: day 5 of Covid-19; Positive, notes: day 6 of Covid-19; Positive, notes: day 7 of Covid-19; Negative, notes: negative for 2 days; Negative, notes: negative for 2 days; Postive, notes: on day 15th. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid started on 04Nov2022 till 09Nov2022.  Clinical Course: I tested positive for Covid for 7 days then negative for 2 days and then positive again. I am still testing positive on my 15th day after my initial positive test.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: eyes are all swollen; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2), for Covid-19 immunization; Covid-19 vaccine (DOSE: 3), for Covid-19 immunization. The following information was reported: EYE SWELLING (non-serious) with onset Jun2022, outcome "not recovered", described as "eyes are all swollen"; RASH (non-serious) with onset Jun2022, outcome "not recovered".  Additional Information: The reporter stated that her husband (55 years) has had an awful reaction to the 4th vaccine of the Pfizer COVID vaccine back in the beginning of Jun. He has a lot of symptoms of COVID and an awful rash. His eyes are all swollen, it was a horrible mess. They have been told that the 4th booster shot was changed and apparently that was the one that gave him the awful reaction. [After confirming when the bivalent booster dose was authorized] He did not get this recent booster; he got the booster vaccine that came out in about Mar or Apr. He was still dealing with the situation now in Nov. The reporter enquired what was it in the mRNA that was changed for the new booster dose. She enquired if the first 3 doses did not contain this change of the DNA strand of the virus is that. The reporter asked if the mRNA breaks down when the vaccine breaks down or does the mRNA stay in the body forever and how long would the immune system continue to produce antibodies also would the antibodies show up in the blood test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Loss of consciousness, Syncope
Clinical narrative: 17 hours after the vaccination I fainted/passed out.; 17 hours after the vaccination I fainted/passed out.; Interchange of vaccine product; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 13:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN. Vaccination history included: janssen (Dose 2,, lot number=213D21A,, location=Left arm), administration date: 03Jan2022, when the patient was 69-year-old, for COVID-19 immunization; janssen (Dose 1,, lot number=201A21A,, location=Left arm), administration date: 10Apr2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Nov2022 at 13:30, outcome "unknown", described as "Interchange of vaccine product"; SYNCOPE (medically significant), LOSS OF CONSCIOUSNESS (medically significant) all with onset 15Nov2022 at 10:00, outcome "recovered" (2022) and all described as "17 hours after the vaccination I fainted/passed out.". The event "17 hours after the vaccination i fainted/passed out." required physician office visit. Therapeutic measures were not taken as a result of syncope, loss of consciousness.  Clinical Course: The patient had no medical history. No known allergies. Not covid tested post vaccination.   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: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: tiredness; Dizziness/ lightheaded; fever; headache; chills; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 16:45 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "Dizziness/ lightheaded"; CHILLS (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered"; PYREXIA (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered"; PAIN (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "soreness"; FATIGUE (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "tiredness". Therapeutic measures were not taken as a result of fatigue, dizziness, pyrexia, headache, chills, pain.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tiredness; Dizziness/ lightheaded; fever; headache; chills; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 16:45 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "Dizziness/ lightheaded"; CHILLS (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered"; PYREXIA (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered"; PAIN (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "soreness"; FATIGUE (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "tiredness". Therapeutic measures were not taken as a result of fatigue, dizziness, pyrexia, headache, chills, pain.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for 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: 65.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cough, Nasopharyngitis, Off label use, Product use issue
Clinical narrative: Cold like symptoms deep cough; Cold like symptoms deep cough; Other vaccine same date product=Flu; Other vaccine same date product=Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 65 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 13Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Nov2022, outcome "unknown" and all described as "Other vaccine same date product=Flu"; NASOPHARYNGITIS (non-serious), COUGH (non-serious) all with onset 14Nov2022, outcome "recovering" and all described as "Cold like symptoms deep cough". Therapeutic measures were not taken as a result of nasopharyngitis, cough.  Additional information: The patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19.  Patient had no known allergies.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site inflammation
Clinical narrative: greatly fatigued, sore entire leftside of body; greatly fatigued, sore entire leftside of body; 4 inch round circle of inflammation around injection; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 10:00 as dose 4 (booster), single (Lot number: GJ3274) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Elevated BP" (unspecified if ongoing); "Some dehydration issues" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex, hay fever, tramadol - that's IT. Concomitant medication(s) included: FLU VACCINE VII, in Oct2022 as dose number unknown, single; LEVOTHYROXINE; AMLODIPINE BESYLATE. Vaccination history included: Covid-19 vaccine (Primary immunization series completed unknown manufacturer), for COVID-19 immunization; Bnt162b2 (Dose Number: 3, Batch/Lot No: FJ4989, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: Jun2022, for COVID-19 immunization.  The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 16Nov2022, outcome "recovered" (18Nov2022), described as "4 inch round circle of inflammation around injection"; FATIGUE (non-serious), PAIN (non-serious) all with onset 16Nov2022, outcome "recovered" (18Nov2022) and all described as "greatly fatigued, sore entire leftside of body". Therapeutic measures were not taken as a result of fatigue, pain, vaccination site inflammation.  Additional information: It was reported, the patient took other medications in two weeks include Levothyroxine/Amlodipine Besylate/several supplmts. The patient did well on initial Covid shot and follow up booster. Did fine on 3rd booster in June of 2022. This last one in Nov of 2022 - greatly fatigued, sore entire left side of body - 4 inch round circle of inflammation around injection. Duration of "reaction" a full 48 hours on 16Nov2022 12:00 AM. The patient was recovered. No treatment was given. Covid was not tested prior to or post vaccination.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vomiting
Clinical narrative: fever; chills; fatigue; (Name) had sever and persistent vomiting 8 hours after injection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2022 at 13:45 as dose 1, single (Lot number: FT1551) at the age of 5 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 26Oct2022 as dose number unknown, single. The following information was reported: VOMITING (non-serious) with onset 18Nov2022 at 22:45, outcome "recovering", described as "(Name) had sever and persistent vomiting 8 hours after injection."; CHILLS (non-serious) with onset 19Nov2022, outcome "recovering"; FATIGUE (non-serious) with onset 19Nov2022, outcome "recovering"; PYREXIA (non-serious) with onset 19Nov2022, outcome "recovering", described as "fever". The events "(name) had sever and persistent vomiting 8 hours after injection.", "fever", "chills" and "fatigue" required physician office visit. Therapeutic measures were not taken as a result of vomiting, pyrexia, chills, fatigue.  Additional information: The patient had severe and persistent vomiting 8 hours after injection. She vomited 6 times in 2 hours. And then again a few hours later. The next morning she had a fever, chills, sever fatigue. If covid prior vaccination: Yes. If covid tested post vaccination: No. Known allergies: No. Other medical history: No.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nasopharyngeal swab, Vaccination failure
Clinical narrative: covid test date=14Oct2022, covid test result= Positive; covid test date=14Oct2022, covid test result= Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 06Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2022, outcome "unknown" and all described as "covid test date=14Oct2022, covid test result= Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (14Oct2022) Positive, notes: Nasal Swab.  Additional information: if other vaccine in four weeks: No. Within 24 hours of receiving her first vaccine (15Nov2022) she felt as if her bladder was hit by a truck plus burning. She seen her doctor and long story short she attributed this incident to the vaccine, being that there was no infection present. It was 2022 now and she randomly urinate on herself, the floor. Shortly after that experience she could not walk for three days and was diagnosed with Osteoarthritis of the hip. Now, she was possibly being treated for pinched nerves in my neck due to her left arm and hand going numb and severe muscle pain. What did you do to me???. Patient did not experience covid prior vaccination and was tested post vaccination. Patient did not receive any other vaccines in four 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 known drug safety profile, there is reasonable possibility of causal association between the events (VACCINATION FAILURE, COVID-19) and BNT162B2.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Hypoaesthesia, Myalgia, Nerve compression, Osteoarthritis
Clinical narrative: covid test date=14Oct2022, covid test result= Positive; covid test date=14Oct2022, covid test result= Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 06Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2022, outcome "unknown" and all described as "covid test date=14Oct2022, covid test result= Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (14Oct2022) Positive, notes: Nasal Swab.  Additional information: if other vaccine in four weeks: No. Within 24 hours of receiving her first vaccine (15Nov2022) she felt as if her bladder was hit by a truck plus burning. She seen her doctor and long story short she attributed this incident to the vaccine, being that there was no infection present. It was 2022 now and she randomly urinate on herself, the floor. Shortly after that experience she could not walk for three days and was diagnosed with Osteoarthritis of the hip. Now, she was possibly being treated for pinched nerves in my neck due to her left arm and hand going numb and severe muscle pain. What did you do to me???. Patient did not experience covid prior vaccination and was tested post vaccination. Patient did not receive any other vaccines in four 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 known drug safety profile, there is reasonable possibility of causal association between the events (VACCINATION FAILURE, COVID-19) and BNT162B2.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary incontinence
Clinical narrative: covid test date=14Oct2022, covid test result= Positive; covid test date=14Oct2022, covid test result= Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 06Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2022, outcome "unknown" and all described as "covid test date=14Oct2022, covid test result= Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (14Oct2022) Positive, notes: Nasal Swab.  Additional information: if other vaccine in four weeks: No. Within 24 hours of receiving her first vaccine (15Nov2022) she felt as if her bladder was hit by a truck plus burning. She seen her doctor and long story short she attributed this incident to the vaccine, being that there was no infection present. It was 2022 now and she randomly urinate on herself, the floor. Shortly after that experience she could not walk for three days and was diagnosed with Osteoarthritis of the hip. Now, she was possibly being treated for pinched nerves in my neck due to her left arm and hand going numb and severe muscle pain. What did you do to me???. Patient did not experience covid prior vaccination and was tested post vaccination. Patient did not receive any other vaccines in four 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 known drug safety profile, there is reasonable possibility of causal association between the events (VACCINATION FAILURE, COVID-19) and BNT162B2.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Dyspnoea
Clinical narrative: difficulty breathing; burning near the area of my heart; pain in my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2021 at 13:15 as dose 2, single (Batch/Lot number: unknown) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "born with my stomach malrotated and received two surgerys" (unspecified if ongoing); "born with my stomach malrotated and received two surgerys" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Administration Time: 01:30 PM), administration date: 30Apr2021, when the patient was 17-year-old, for Covid-19 immunization.  The following information was reported: DYSPEPSIA (hospitalization) with onset 15Jun2021 at 14:30, outcome "not recovered", described as "burning near the area of my heart"; DYSPNOEA (hospitalization) with onset 15Jun2021 at 14:30, outcome "not recovered", described as "difficulty breathing"; CHEST PAIN (hospitalization) with onset 15Jun2021 at 14:30, outcome "not recovered", described as "pain in my chest". The events "difficulty breathing", "burning near the area of my heart" and "pain in my chest" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of dyspnoea, dyspepsia, chest pain.  Clinical course: Around the time that patient received second covid shot, began experiencing pain in chest. That was soon followed by difficulty breathing and burning near the area of heart. She originally thought it was something that would be gone in no time and the pain did fluctuate corroborating her belief, but here she was over a year later and it was affecting her day-to-day life at the time of this report. She was recently referred to a cardiologist who she hoped will be able to give the answers and treatment she deserved. If Covid prior vaccination: Unknown. Covid was not tested post vaccination. No known allergies. Lot unknown reason: Not available/provided to reporter at the time of report completion. Facility type Vaccine was other. Unknown if received other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Menstruation irregular
Clinical narrative: Irregular period; Worsening symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 40's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Irregular period". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Irregular period"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Worsening symptoms".  Additional information: The patient was in early-mid 40s otherwise healthy female. She experienced irregular period after second COVID vaccine and worsening symptoms after boosters. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Cancer" (unspecified if ongoing); "autoimmune disorder of chronic urticara" (unspecified if ongoing), notes: autoimmune disorder of chronic urticaria; "histamine intolerance" (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 Nov2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid. Treatment, start date: 07Nov2022, Treatment stop date: 11Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: a lot of symptoms of COVID; a lot of symptoms of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "a lot of symptoms of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: It was reported that the patient had an awful reaction to the 4th vaccine of the Pfizer COVID vaccine back in the beginning of June. He had a lot of symptoms of COVID and an awful rash. His eyes were all swollen, it was a horrible mess. It was told that the 4th booster shot was changed and apparently that was the one that gave him the awful reaction. [After confirming when the bivalent booster dose was authorized] He did not get this recent booster; he got the booster vaccine that came out in about Mar or Apr. He was still dealing with the situation in Nov." Caller inquired if it in the mRNA that was changed for the new booster dose as, also inquired if first 3 doses did not contain this change of the DNA strand of the virus. The date of bivalent Pfizer COVID vaccine was inquired. It was inquired if the mRNA breaks down when the vaccine breaks down or does the mRNA stay in the body forever and how long did the immune system take to produce antibodies or if it would show up in the body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25May2022, outcome "unknown", described as "Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and was treated with Paxlovid start date 09Nov2022 to stop date=14Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the nature of the events vaccination failure, covid-19, a causal relation between the reported events and the administration of the vaccine BNT162b2 cannot be excluded.
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) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gallbladder surgery" (unspecified if ongoing), notes: gallbladder surgery. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. 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, BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic cancer undergoing chemo therapy" (unspecified if ongoing); "Pancreatic cancer undergoing chemo therapy" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive, notes: Positive Antigen test at home 5 days after completing complete course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 as dose 3 (booster), single (Lot number: GN2524) at the age of 62 years, in right 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's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: Colitis ulcerative. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, 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 drug ineffective, covid-19.  Clinical course: Patient had receive COVID-19 Vaccine previously. Patient took Paxlovid from 08Nov2022 to 12Nov2022 for the treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid virus; covid virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL unknown; HUMIRA subcutaneous taken for rheumatoid arthritis, start date: 2021. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid virus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Covid rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2 weeks. The patient received anti-viral as COVID 19 Treatment. Covid rebound case after completing medication series.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
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 36-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: PF3594) at the age of 35 years 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's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 18Nov2022, stop date: 20Nov2022. 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: Severe hypertension: systolic consistently over 200 mmHg and diastolic, notes: Severe hypertension with systolic consistently over 200 mmHg and diastolic over 100 mmHg. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Reporter stated that, Report about Covid treatment. Patient was taking other medication in 2weeks. Patient received COVID 19 Treatment was Paxlovid. Treatment start date was 18Nov2022, Treatment stop date was 20Nov2022, Lot number was GE1498. Patient had no known allergies. Patient had Other medical history was obesity.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 11:00 as dose 6 (booster), single (Lot number: GJ6665) at the age of 83 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing), notes: Other medical history: glaucoma; "UTI" (unspecified if ongoing), notes: Other medical history: UTI; "low thyroid" (unspecified if ongoing), notes: Other medical history: low thyroid; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "Known allergies: contrast dye iodine" (unspecified if ongoing), notes: Known allergies: contrast dye iodine. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Other medical history: Breast Cancer. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication was taken in 2 weeks. No any vaccine was received previously. No known allergies. Paxloid treatment : Treatment start date: 11Nov2022, Treatment stop date: 15Nov022,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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: test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient age more than 65 years. patient received other medication in 2weeks. Anti-viral COVID 19 Treatment included Paxlovid, treatment start date: 11Nov2022, treatment stop date: 15Nov2022. Symptoms completely resolved. Then rebound symptoms developed 7d after initiation of Paxlovid (2d after completing course). Mild rebound symptoms w/ test positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events 'drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.