chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
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) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2 NOS), on 12Sep2022 as dose number unknown, single (Lot number: A57144B) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATOMOXETINE, start date: 01Jun2019; B12 [CYANOCOBALAMIN], start date: 01Jun2019; D3, start date: 01Jun2019. Past drug history included: Amoxicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 28Jan2023 to 01Feb2023.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "medically obese" (unspecified if ongoing), notes: Other medical history: medically obese; "BMI high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: High. 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.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache
Clinical narrative: Right side of chest hurts; Is tired; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Feb2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 08Feb2023, outcome "not recovered", described as "Right side of chest hurts"; HEADACHE (non-serious) with onset 2023, outcome "not recovered"; FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "Is tired".  Additional information: It was reported that the patient took first dose of Pfizer Covid Vaccine last Friday. Unable to confirm the date of last Friday due to caller declining to complete the report. Had to get Pfizer Covid Vaccine for a job at the hospital. The patient had a headache every day since and could not get rid of headache. Then yesterday, 08Feb2023 and today, 09Feb2023, the right side of chest hurts.  The patient wanted to know what needed to do or was something serious. She was tired of being on hold. She also reported she would deal with it and if got serious would go to hospital.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Illness, Influenza, Migraine
Clinical narrative: Flu; right deltoid-arm felt like it weighed 40-50 pounds more than it should; right deltoid (arm)- mostly painful; sick; Bedridden; migraines; is tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right deltoid for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3rd, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Flu"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "right deltoid-arm felt like it weighed 40-50 pounds more than it should"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "right deltoid (arm)- mostly painful"; ILLNESS (non-serious), outcome "unknown", described as "sick"; BEDRIDDEN (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown", described as "migraines"; FATIGUE (non-serious), outcome "unknown", described as "is tired". Additional Information: Patient stated that he was reporting side effects for the Pfizer Covid 19 Bivalent. Is for his fourth shot. Thinks its the usual side effects. Mentioned that his arm felt like it weighed 40-50 pounds more than it should. Clarified his arm as his right deltoid. Mentioned that his arm was not swelling at the time so he did not call the doctor where he got the Pfizer Covid 19 Bivalent from. Later stated that he had 48 hours of minor swelling of his arm that was mostly painful but not actual painful swelling. Later clarified there was swelling but that it was more painful than swollen. Thinks that he got mostly Covid symptoms. Has not had Covid before. Has never met anyone that got the shot that did not have that symptom of the arm. Later clarified that everyone got this same shot, Pfizer Covid 19 Biavalent and the Moderna and got this symptom of the arm felt like it weighs 40-50 pounds. Has no further details to provide. Stated that if he would have known then he would have brought a list of those people. Declined to complete reports. Stated that he has the flu and is so sick that he is bedridden. Has been bedridden going on his third day. Commented that this is why people don't get the shot it makes them sick. Mentioned that he had migraines and is tired.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Flu; right deltoid-arm felt like it weighed 40-50 pounds more than it should; right deltoid (arm)- mostly painful; sick; Bedridden; migraines; is tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right deltoid for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3rd, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Flu"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "right deltoid-arm felt like it weighed 40-50 pounds more than it should"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "right deltoid (arm)- mostly painful"; ILLNESS (non-serious), outcome "unknown", described as "sick"; BEDRIDDEN (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown", described as "migraines"; FATIGUE (non-serious), outcome "unknown", described as "is tired". Additional Information: Patient stated that he was reporting side effects for the Pfizer Covid 19 Bivalent. Is for his fourth shot. Thinks its the usual side effects. Mentioned that his arm felt like it weighed 40-50 pounds more than it should. Clarified his arm as his right deltoid. Mentioned that his arm was not swelling at the time so he did not call the doctor where he got the Pfizer Covid 19 Bivalent from. Later stated that he had 48 hours of minor swelling of his arm that was mostly painful but not actual painful swelling. Later clarified there was swelling but that it was more painful than swollen. Thinks that he got mostly Covid symptoms. Has not had Covid before. Has never met anyone that got the shot that did not have that symptom of the arm. Later clarified that everyone got this same shot, Pfizer Covid 19 Biavalent and the Moderna and got this symptom of the arm felt like it weighs 40-50 pounds. Has no further details to provide. Stated that if he would have known then he would have brought a list of those people. Declined to complete reports. Stated that he has the flu and is so sick that he is bedridden. Has been bedridden going on his third day. Commented that this is why people don't get the shot it makes them sick. Mentioned that he had migraines and is tired.   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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Unknown/ Dose #5: Moderna; 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 67-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EN6201), on 02Mar2021 as dose 2, single (Lot number: EN6200) and on 06Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Sep2022 as dose 5 (booster), single (Lot number: 030622B) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 02Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "gastric reflux" (unspecified if ongoing); "Hx of blood clots" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Unknown/ Dose #5: Moderna"; VACCINATION FAILURE (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: (07Feb2023) Positive; (11Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment of paxlovid from 27Jan2023 to 01Feb2023.
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose number unknown (booster), single (Lot number: GH9697), in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". 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 which included Paxlovid from an unspecified date in Feb2023 to an unspecified date in Feb2023.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: ST; fatigue; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 43-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years 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, reaction(s): "ag test 10Feb2023"; Covid-19 vaccine (Dose: 2, manufacturer unknown), for Covid-19 Immunization, reaction(s): "ag test 10Feb2023"; Covid-19 vaccine (Dose: 3, manufacturer unknown), for Covid-19 Immunization, reaction(s): "ag test 10Feb2023". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 09Feb2023, outcome "recovering", described as "ST"; NASAL CONGESTION (non-serious) with onset 09Feb2023, outcome "recovering", described as "congestion"; FATIGUE (non-serious) with onset 09Feb2023, outcome "recovering". It was unknown if therapeutic measures were taken as a result of oropharyngeal pain, fatigue, nasal congestion.  Additional information: Facility type vaccine was workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300063647 same patient, different dose/drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 13:00 as dose 1, single (Lot number: En6207), in left arm, on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Jan2022 at 13:00 as dose 3 (booster), single (Lot number: fj5683), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jan2022, stop date: 29Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (lot number: Gf1783) from 30Jan2023 to 04Feb2023.  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: 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) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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.  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 the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 71.0
Sex: F
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; Vaccine brand other=moderna/ Vaccine dose number=5,4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 13Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: GF6389), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27May2022 as dose 4 (booster), single (Lot number: OSNM21A), in left arm and on 04Nov2022 as dose 5 (booster), single (Lot number: 017H22A Walf), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27May2022, outcome "unknown", described as "Vaccine brand other=moderna/ Vaccine dose number=5,4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID Treatment).
Age: 61.0
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(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 at 14:00 as dose 1, single (Lot number: ER8729), in left arm, on 26Apr2021 at 14:00 as dose 2, single (Lot number: EW0175), in left arm, on 21Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 15Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis"; "prediabetic". The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19 and included treatment with PAXLOVID.
Age: 39.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 21:00 as dose 4 (booster), single at the age of 39 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 had no relevant medical history. The patient's concomitant medications were not reported. 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: tested positive 6 days after finished paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, SARS-CoV-2 test
Clinical narrative: bronchial spasms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Dairy Allergy" (unspecified if ongoing), notes: Dairy Allergy; "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BRONCHOSPASM (non-serious), outcome "unknown", described as "bronchial spasms". The event "bronchial spasms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Age at Vaccination 38 year. My doctor called them bronchial spasms. She had them for up to a year after. The worst was 24 hours after 1st dose. It was horrifying. She will never get any version of this type of shot again. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient had diagnosed with COVID-19 and since the vaccination, the patient had tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300063074 same patient, different dose and event;
Age: 67.0
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.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: morphine", notes: known allergies: morphine. 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: (unspecified date) Positive; (06Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 27Jan2023 to 01Feb2023).  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: 76.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 76 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's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "heart desease" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing); "Aortic valve stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Xeralto, reaction(s): "Known allergies: Xeralto". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19: treated with Paxlovid from 29Jan2023 to 02Feb2023.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chest pain, Inappropriate schedule of product administration, Palpitations
Clinical narrative: fainting; Chest pain; heart palpitations; extreme blood pressure drop at some times out of no where; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose brand unknown=True,, Is bivalent=False,, Vaccine location=Left arm), administration date: 14May2021, when the patient was 31-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CHEST PAIN (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering"; BLOOD PRESSURE DECREASED (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering", described as "extreme blood pressure drop at some times out of no where"; SYNCOPE (hospitalization, medically significant, life threatening) with onset 30Jun2022, outcome "recovering", described as "fainting"; PALPITATIONS (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering", described as "heart palpitations". The patient was hospitalized for syncope, chest pain, palpitations, blood pressure decreased (hospitalization duration: 14 day(s)). The events "fainting", "chest pain", "heart palpitations" and "extreme blood pressure drop at some times out of no where" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (30Jun2022) drop at some times, notes: extreme blood pressure drop at some times out of no where. It was unknown if therapeutic measures were taken as a result of syncope, chest pain, palpitations, blood pressure decreased, inappropriate schedule of product administration. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainting; Chest pain; heart palpitations; extreme blood pressure drop at some times out of no where; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose brand unknown=True,, Is bivalent=False,, Vaccine location=Left arm), administration date: 14May2021, when the patient was 31-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CHEST PAIN (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering"; BLOOD PRESSURE DECREASED (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering", described as "extreme blood pressure drop at some times out of no where"; SYNCOPE (hospitalization, medically significant, life threatening) with onset 30Jun2022, outcome "recovering", described as "fainting"; PALPITATIONS (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering", described as "heart palpitations". The patient was hospitalized for syncope, chest pain, palpitations, blood pressure decreased (hospitalization duration: 14 day(s)). The events "fainting", "chest pain", "heart palpitations" and "extreme blood pressure drop at some times out of no where" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (30Jun2022) drop at some times, notes: extreme blood pressure drop at some times out of no where. It was unknown if therapeutic measures were taken as a result of syncope, chest pain, palpitations, blood pressure decreased, inappropriate schedule of product administration. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose number unknown (booster), single (Lot number: GH9703) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 1" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 05May2021, stop date: 28Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Jan2023 to 02Feb2023.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  drug ineffective , COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blister, Burning sensation, Pruritus, Rash
Clinical narrative: Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning; itchy; Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning; Some raised bumps developed into fluid-filled blisters.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Single, unknown manufacturer), for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), RASH (non-serious) all with onset Oct2022, outcome "not recovered" and all described as "Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning"; BLISTER (non-serious) with onset Oct2022, outcome "not recovered", described as "Some raised bumps developed into fluid-filled blisters."; PRURITUS (non-serious) with onset Oct2022, outcome "not recovered", described as "itchy". The events "raised skin rash, extremely itchy, occurring over most of body. extremely itchy and burning. back, upper legs and upper arms the worse. some raised bumps developed into fluid-filled blisters. burning", "itchy" and "some raised bumps developed into fluid-filled blisters." required physician office visit. Therapeutic measures were taken as a result of burning sensation, pruritus, rash, blister. Additional information: Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning/itching fluctuates but has never cleared. AE treatment: Antihistamines, topical cortisone, prednisone. Patient did not received any other vaccine in four weeks. Patient received other medication in two weeks: Anti rejection thyroid. Patient did not had COVID prior vaccination. Patient was not tested for COVID post vaccination. Known allergies: No.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Pain, Respiratory symptom
Clinical narrative: Cough; Upper respiratory symptoms; Sneezing; Aches; Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH694) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Sicca Syndrome" (unspecified if ongoing); "iGg subclass degiciencies" (unspecified if ongoing), notes: iGg subclass degiciencies; "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 3, booster single, Batch/Lot No: FK9894, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Apr2022, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 2, single, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 07Nov2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; j and j (Dose Number: 1, Batch/Lot No: 1805022, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 06Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: PAIN (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered", described as "Aches"; COUGH (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; FATIGUE (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; HEADACHE (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; SNEEZING (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; RESPIRATORY SYMPTOM (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered", described as "Upper respiratory symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of respiratory symptom.  Additional information: Reported Event: Cough. Sneezing. Upper respiratory symptoms headache. Fatigue. Aches. Positive COVID tests Started 2,3 days after Paxlovid completely done and negative test. Worse symptoms than initial infection. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Treatment received for the adverse event upper respiratory symptom was antibiotics foe sinus and inhaler
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: Cough; Upper respiratory symptoms; Sneezing; Aches; Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH694) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Sicca Syndrome" (unspecified if ongoing); "iGg subclass degiciencies" (unspecified if ongoing), notes: iGg subclass degiciencies; "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 3, booster single, Batch/Lot No: FK9894, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Apr2022, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 2, single, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 07Nov2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; j and j (Dose Number: 1, Batch/Lot No: 1805022, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 06Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: PAIN (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered", described as "Aches"; COUGH (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; FATIGUE (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; HEADACHE (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; SNEEZING (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; RESPIRATORY SYMPTOM (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered", described as "Upper respiratory symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of respiratory symptom.  Additional information: Reported Event: Cough. Sneezing. Upper respiratory symptoms headache. Fatigue. Aches. Positive COVID tests Started 2,3 days after Paxlovid completely done and negative test. Worse symptoms than initial infection. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Treatment received for the adverse event upper respiratory symptom was antibiotics foe sinus and inhaler
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Cough; Upper respiratory symptoms; Sneezing; Aches; Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH694) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Sicca Syndrome" (unspecified if ongoing); "iGg subclass degiciencies" (unspecified if ongoing), notes: iGg subclass degiciencies; "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 3, booster single, Batch/Lot No: FK9894, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Apr2022, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 2, single, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 07Nov2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; j and j (Dose Number: 1, Batch/Lot No: 1805022, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 06Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: PAIN (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered", described as "Aches"; COUGH (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; FATIGUE (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; HEADACHE (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; SNEEZING (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered"; RESPIRATORY SYMPTOM (non-serious) with onset 07Feb2023 at 16:00, outcome "not recovered", described as "Upper respiratory symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of respiratory symptom.  Additional information: Reported Event: Cough. Sneezing. Upper respiratory symptoms headache. Fatigue. Aches. Positive COVID tests Started 2,3 days after Paxlovid completely done and negative test. Worse symptoms than initial infection. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Treatment received for the adverse event upper respiratory symptom was antibiotics foe sinus and inhaler
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Pain, Respiratory symptom
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 1 J and J, Dose Number 2, 3, 4: Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH694) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Nov2021 at 15:00 as dose 2, single (Lot number: FH8020), in left arm and on 23Apr2022 at 13:00 as dose 3 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 06Mar2021 at 13:00 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Sicca Syndrome" (unspecified if ongoing); "iGg subclass degiciencies" (unspecified if ongoing), notes: iGg subclass degiciencies; "known allergies: Penicillin Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Nov2021, outcome "unknown", described as "Dose Number: 1 J and J, Dose Number 2, 3, 4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, 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.Paxlovid was given from 30Jan2023 to 03Feb2023.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 1 J and J, Dose Number 2, 3, 4: Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH694) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Nov2021 at 15:00 as dose 2, single (Lot number: FH8020), in left arm and on 23Apr2022 at 13:00 as dose 3 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 06Mar2021 at 13:00 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Sicca Syndrome" (unspecified if ongoing); "iGg subclass degiciencies" (unspecified if ongoing), notes: iGg subclass degiciencies; "known allergies: Penicillin Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Nov2021, outcome "unknown", described as "Dose Number: 1 J and J, Dose Number 2, 3, 4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, 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.Paxlovid was given from 30Jan2023 to 03Feb2023.