chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Hot, Red, sore and a 4 cm in diameter redness; Hot, Red, sore and a 4 cm in diameter redness; Hot, Red, sore and a 4 cm in diameter redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID prior vaccination Yes. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose 3 (Booster), Single, Lot No: FJ8757, via an intramuscular at arm Left), administration date: 10Dec2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot No: EP6955, via an intramuscular at arm Left), administration date: 24Mar2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Lot No: EL3248, via an intramuscular at arm Left, Time: 14:00), administration date: 03Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Arm soreness at injection site", "Slight headache", "Fatigue". The following information was reported: FEELING HOT (non-serious) with onset 20Oct2022 at 09:00, outcome "not recovered", ERYTHEMA (non-serious), PAIN (non-serious) all with onset 20Oct2022 at 09:00, outcome "not recovered" and all described as "Hot, Red, sore and a 4 cm in diameter redness". The events "hot, red, sore and a 4 cm in diameter redness" required emergency room visit. Therapeutic measures were not taken as a result of feeling hot, erythema, pain.  Additional information: Patient had no known allergies. Patient received no other vaccine in four weeks. COVID prior vaccination. Patient did not get COVID tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in urine/Didnt put it together until mom also had at same time this week and we were both vaxed on same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD URINE PRESENT (non-serious) with onset Oct2022, outcome "unknown", described as "Blood in urine/Didnt put it together until mom also had at same time this week and we were both vaxed on same day". Additional information: Reporter stated that Blood in urine, had happened anywhere from 1 day to 2 plus weeks after injections. Didn't put it together until mom also had at same time this week and we were both vaxed on same day  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-202201246463 Same reporter/vaccine/event, different patient.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Product use issue, Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site, fatigue, fever & chills; Pain at injection site, fatigue, fever & chills; Pain at injection site, fatigue, fever & chills; Pain at injection site, fatigue, fever & chills; Other vaccine same date product: Flu; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 18Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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: PRODUCT USE ISSUE (non-serious) with onset 18Oct2022, outcome "unknown", described as "Other vaccine same date product: Flu"; VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious), PYREXIA (non-serious), CHILLS (non-serious) all with onset 19Oct2022, outcome "unknown" and all described as "Pain at injection site, fatigue, fever & chills". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site pain, fatigue, pyrexia, chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Headache, Product use issue, Pyrexia
Clinical narrative: Fever of 100; chills; headache; Other Vaccine on Same date product: Flu shot (Influenza vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 17:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 19Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (Dose:3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose:1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 19Oct2022, outcome "unknown", described as "Other Vaccine on Same date product: Flu shot (Influenza vaccine)"; PYREXIA (non-serious) with onset 20Oct2022 at 07:00, outcome "recovering", described as "Fever of 100"; CHILLS (non-serious) with onset 20Oct2022 at 07:00, outcome "recovering"; HEADACHE (non-serious) with onset 20Oct2022 at 07:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, headache.  Additional information: The patient had no known allergies. The patient did not receive other vaccine in four weeks. The patient was not tested for COVID 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.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Interchange of vaccine products, Off label use, Product use issue
Clinical narrative: Diarrhea; Off label use; Product use for unapproved combination; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High A1C" (unspecified if ongoing), notes: High A1C; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; PROPRANOLOL; METFORMIN; ESCITALOPRAM. Past drug history included: Darvocet, reaction(s): "Known allergies: Darvocet", notes: Known allergies: Darvocet; Lipitor, reaction(s): "Known allergies: Lipitor", notes: Known allergies: Lipitor. Vaccination history included: moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 12Jul2022, when the patient was 57-year-old, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 027H21b, Location of injection: Arm Right), administration date: 26Nov2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 18Oct2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 18Oct2022, outcome "unknown", described as "Product use for unapproved combination"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18Oct2022, outcome "unknown"; DIARRHOEA (non-serious) with onset 20Oct2022, outcome "recovered" (Oct2022), described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not the diagnosed with COVID-19, Since the vaccination, the patient had not 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: the injection site and its still there it's like a 1 and a half inch almost oval it's red; the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen.; the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen.; I had a low grade temperature; Chills; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Dec2021, when the patient was 76 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 18Oct2022, outcome "recovered", described as "I had a low grade temperature"; PAIN (non-serious) with onset 18Oct2022, outcome "unknown", described as "body ache"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen."; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "the injection site and its still there it's like a 1 and a half inch almost oval it's red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated, "It all started on Tuesday she got the vaccine on Monday the 17 and all the other reaction except the redness that came right away the other reaction all came on Tuesday." "she did, it came the next day she had a low grade temperature, chills, body ache, the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen. But the low grade temperature doesn't last long, it only lasted a few hours." Consumer stated, "she don't see there is an expiration, it says GH9702, no (Consumer was not sure). Well it says (Pharmacy name) but she can't read what the writing is underneath (Pharmacy name) is a Pharmacy where she got it from." No prior vaccination (Within 4 weeks).  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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: the injection site and its still there it's like a 1 and a half inch almost oval it's red; the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen.; the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen.; I had a low grade temperature; Chills; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Dec2021, when the patient was 76 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 18Oct2022, outcome "recovered", described as "I had a low grade temperature"; PAIN (non-serious) with onset 18Oct2022, outcome "unknown", described as "body ache"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen."; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "the injection site and its still there it's like a 1 and a half inch almost oval it's red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated, "It all started on Tuesday she got the vaccine on Monday the 17 and all the other reaction except the redness that came right away the other reaction all came on Tuesday." "she did, it came the next day she had a low grade temperature, chills, body ache, the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen. But the low grade temperature doesn't last long, it only lasted a few hours." Consumer stated, "she don't see there is an expiration, it says GH9702, no (Consumer was not sure). Well it says (Pharmacy name) but she can't read what the writing is underneath (Pharmacy name) is a Pharmacy where she got it from." No prior vaccination (Within 4 weeks).  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: U
Vaccine: PNC20
Symptoms: Gait disturbance, Mobility decreased
Clinical narrative: get my walking properly which I haven't been able to do for 9 months because of this shot; 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 patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Jan2022 at 11:00 as dose number unknown, single (Batch/Lot number: unknown), in arm for 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 immunisation; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (booster dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 15Jan2022 at 09:00, outcome "unknown", described as "get my walking properly which I haven't been able to do for 9 months because of this shot". Therapeutic measures were taken as a result of gait disturbance.  Additional information: when the patient was walking slowly around the back of the car, patient said it was March of this year, when patient  was still on physical therapy to get patient's walking properly which patient hadn't been able to do for 9 months because of this shot.  Patient had shot on arm on 14Jan2022. Less than 24 hours later after patient had shot at 11 O' clock in the morning, patient knew the exact date that when the lousy shot was put in patient's arm. Patient didn't have any problem with them, covid 1, covid 2, booster, not the problem in the world, not a problem with the vaccine that all covid1. covid2 and the booster but since they gave the patient that Prevnar 20 bronchial pneumonial Flu shot, the next morning when patient woke up at 9 O' clock, patient couldn't get out of the bed, get up the dog, patient could not even walk.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 at 12:00 as dose 1, single (Lot number: EM9810), in right arm, on 25Feb2021 at 13:00 as dose 2, single (Lot number: EN6203), in right arm, on 23Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 11Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Apr2014, stop date: 08Oct2022; TAMSULOSIN, start date: 01Oct2018, stop date: 08Oct2022. The following information was reported: VACCINATION FAILURE (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. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he did get Covid about a year ago; he did get Covid about a year ago; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), 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 "he did get Covid about a year ago". The patient has had two primary doses of the Pfizer Covid 19 vaccine and 2 booster doses. The last booster dose was around 6 months ago. He relays that he did get Covid about a year ago. Reports no problems with the vaccines. He would like to know if he should get another booster dose?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Neck pain
Clinical narrative: patient received dose 1 as Moderna and dose 3 as BNT162B2; She had serious neck pain.; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "head injury ", "She had these neurologic side effects as well happen with the first ones she received."; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "not recovered", described as "patient received dose 1 as Moderna and dose 3 as BNT162B2"; NECK PAIN (non-serious), outcome "not recovered" and all described as "She had serious neck pain.".  Additional information: She mentioned the previous vaccines she had was the Moderna Covid Vaccine. She had these neurologic side effects as well happen with the first ones she received. The first vaccines she received was the Moderna.  She wonders if now and believes she is having side effects from mixing both the Moderna and Pfizer vaccines. She has had two subsequent vaccines and booster. She clarify neurologic side effects after getting the Pfizer Covid-19 Bivalent 12 year plus vaccine. She had serious neck pain. The serious neck pain was so painful she has to use two pillows to sleep on to  elevate her head. The pain is all around her entire neck; the is pain so bad.  This started within the week of getting the vaccine.  Reporter mentioned she is expecting a call from her provider to discuss the side effects  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Balance disorder, Fall, Feeling abnormal, Headache
Clinical narrative: fever; headache; so sick I missed two days of work; brain fog; loosing my balance; fell twice; body aches/sever pain in my left side; bloating with nausea; bloating with nausea; high blood pressure; swollen Liver; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Aug2021 at 15:30 as dose 2, single (Lot number: FL3181) at the age of 59 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Strawberries" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose number=1, lot number=EY058U,, dose administration time=03:30 PM, vaccine location=Left arm), administration date: 23Jul2021, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: ABDOMINAL DISTENSION (disability), NAUSEA (disability) all with onset 29Oct2021, outcome "not recovered" and all described as "bloating with nausea"; FEELING ABNORMAL (disability) with onset 29Oct2021, outcome "not recovered", described as "brain fog"; FALL (disability) with onset 29Oct2021, outcome "not recovered", described as "fell twice"; HYPERTENSION (disability) with onset 29Oct2021, outcome "not recovered", described as "high blood pressure"; BALANCE DISORDER (disability) with onset 29Oct2021, outcome "not recovered", described as "loosing my balance"; PAIN (disability) with onset 29Oct2021, outcome "not recovered", described as "body aches/sever pain in my left side"; HEPATOMEGALY (disability) with onset 29Oct2021, outcome "not recovered", described as "swollen Liver"; PYREXIA (disability), outcome "not recovered", described as "fever"; HEADACHE (disability), outcome "not recovered"; ILLNESS (disability), outcome "not recovered", described as "so sick I missed two days of work". The events required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2021) Negative. Therapeutic measures were taken as a result of hypertension, Dr prescribed blood pressure medicine.; Sender's Comments: Based on the available information in the case, an association between the reported events and bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatomegaly, Hypertension, Illness, Nausea, Pain
Clinical narrative: fever; headache; so sick I missed two days of work; brain fog; loosing my balance; fell twice; body aches/sever pain in my left side; bloating with nausea; bloating with nausea; high blood pressure; swollen Liver; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Aug2021 at 15:30 as dose 2, single (Lot number: FL3181) at the age of 59 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Strawberries" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose number=1, lot number=EY058U,, dose administration time=03:30 PM, vaccine location=Left arm), administration date: 23Jul2021, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: ABDOMINAL DISTENSION (disability), NAUSEA (disability) all with onset 29Oct2021, outcome "not recovered" and all described as "bloating with nausea"; FEELING ABNORMAL (disability) with onset 29Oct2021, outcome "not recovered", described as "brain fog"; FALL (disability) with onset 29Oct2021, outcome "not recovered", described as "fell twice"; HYPERTENSION (disability) with onset 29Oct2021, outcome "not recovered", described as "high blood pressure"; BALANCE DISORDER (disability) with onset 29Oct2021, outcome "not recovered", described as "loosing my balance"; PAIN (disability) with onset 29Oct2021, outcome "not recovered", described as "body aches/sever pain in my left side"; HEPATOMEGALY (disability) with onset 29Oct2021, outcome "not recovered", described as "swollen Liver"; PYREXIA (disability), outcome "not recovered", described as "fever"; HEADACHE (disability), outcome "not recovered"; ILLNESS (disability), outcome "not recovered", described as "so sick I missed two days of work". The events required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2021) Negative. Therapeutic measures were taken as a result of hypertension, Dr prescribed blood pressure medicine.; Sender's Comments: Based on the available information in the case, an association between the reported events and bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; headache; so sick I missed two days of work; brain fog; loosing my balance; fell twice; body aches/sever pain in my left side; bloating with nausea; bloating with nausea; high blood pressure; swollen Liver; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Aug2021 at 15:30 as dose 2, single (Lot number: FL3181) at the age of 59 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Strawberries" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose number=1, lot number=EY058U,, dose administration time=03:30 PM, vaccine location=Left arm), administration date: 23Jul2021, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: ABDOMINAL DISTENSION (disability), NAUSEA (disability) all with onset 29Oct2021, outcome "not recovered" and all described as "bloating with nausea"; FEELING ABNORMAL (disability) with onset 29Oct2021, outcome "not recovered", described as "brain fog"; FALL (disability) with onset 29Oct2021, outcome "not recovered", described as "fell twice"; HYPERTENSION (disability) with onset 29Oct2021, outcome "not recovered", described as "high blood pressure"; BALANCE DISORDER (disability) with onset 29Oct2021, outcome "not recovered", described as "loosing my balance"; PAIN (disability) with onset 29Oct2021, outcome "not recovered", described as "body aches/sever pain in my left side"; HEPATOMEGALY (disability) with onset 29Oct2021, outcome "not recovered", described as "swollen Liver"; PYREXIA (disability), outcome "not recovered", described as "fever"; HEADACHE (disability), outcome "not recovered"; ILLNESS (disability), outcome "not recovered", described as "so sick I missed two days of work". The events required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2021) Negative. Therapeutic measures were taken as a result of hypertension, Dr prescribed blood pressure medicine.; Sender's Comments: Based on the available information in the case, an association between the reported events and bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Has aches; 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 omi ba.4-5 (COMIRNATY), on 20Oct2022 as dose number unknown (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 (Primary immunization series completed, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Has aches". Additional Information: The patient reported that she had aches, is walking around fine, is just achy. The patient wanted to know if Tylenol could be taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: Headache; Fatigue; all over joint and body pain; all over joint and body pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Cystic fibrosis" (unspecified if ongoing), notes: Cystic fibrosis Caller says this is genetic so report it as at birth. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "not recovered"; FATIGUE (non-serious), outcome "not recovered"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "all over joint and body pain". Therapeutic measures were taken as a result of headache, fatigue, arthralgia, pain. Additional information: Patient got the Pfizer COVID-19 vaccine bivalent booster on the 06Oct and reported adverse reactions as she was now off work for being sick intermittently, but not intermittently, since vaccine. Now she was on steroids to suppress her immune system. She started on the same day as her doctor appointment on 18Oct2022. She was taking Prednisone 20mg once a day by mouth, and the reason for that was headaches, fatigue, all over joint and body pain since the vaccine was administered, with no other signs of being sick. She was not congested, no cough, it was like the reaction after her initial doses but it has not gone away. Her symptoms started on 06Oct2022, and her headaches stayed about the same since they started. She has treated those with Ibuprofen over the counter, she was taking 600mg PRN. Her fatigue treatment was taking time off work and sleeping, and it got worse over time. Her aches got worse over time as well. She says that she was going to have a recheck on Monday with her doctor about how long she was going to take the Prednisone. Pfizer COVID-19 vaccine bivalent booster: Caller does not see LOT/EXP on the receipt she got from # (facility name withheld), she does not have injection records, those would be on # (facility name withheld) site which she has not figured out how to access yet. She doesn't have a vaccine card to provide NDC/LOT/EXP from previous doses of Pfizer COVID-19 vaccine either, those are in her employee file.  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-202201249184 same product, patient and different dose.;
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: she had cancer treatment last August all the vaccines have been wiped off her body, she is now asking if she has to start with the primary series again?; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (21Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (primary immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "she had cancer treatment last August all the vaccines have been wiped off her body, she is now asking if she has to start with the primary series again?". Clinical course: Caller mentioned that his wife had the primary series as well as the two booster doses of the Pfizer Covid-19 vaccine however she had cancer treatment last August and the Covid-19 vaccine's immunity are all gone and they're having a hard time scheduling for the primary series again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated with 5 of Pfizer's vaccines, including the latest one/third day with covid; fully vaccinated with 5 of Pfizer's vaccines, including the latest one/third day with covid; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM taken for hypertension; TEMAZEPAM taken for hypertension; CLONIDINE taken for hypertension; LISINOPRIL taken for hypertension. Patient is fully vaccinated with the Pfizer vaccine. Clarified as fully vaccinate with the Covid-19 Vaccine. Reporter stated he has taken five of our vaccines. He added he just received the new one, the most recent one to fight, the booster, the new Covid-19 Booster. He received the new one on 07Oct2022. Patient has taken five of our vaccines. This is the third day with covid.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated with 5 of Pfizer's vaccines, including the latest one/third day with covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 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 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Diabetes mellitus" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (non-serious), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Additional information: Patient received treatment Paxlovid from 05Oct2022 to 09Oct2022. 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: administered to a patient this morning after it had been sitting at room temperature since yesterday; administered to a patient this morning after it had been sitting at room temperature since yesterday; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose number unknown (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 (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "administered to a patient this morning after it had been sitting at room temperature since yesterday". 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.  Additional information: The report was assessed as non-serious. RN, who is working remotely today, is calling about the bivalent gray cap formulation of the vaccine that was administered to a patient this morning after it had been sitting at room temperature since yesterday around 8am and then was punctured this morning.  It was left at room temperature beyond the 12 hour window. RN does not know age and gender of patient, just that they were getting the bivalent Pfizer booster.  It was administered by the medical assistant and she was notified around 10AM.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 09:00 as dose 1, single (Lot number: EL1283), in left arm, on 06Feb2021 at 10:00 as dose 2, single (Lot number: EL9264), in left arm, on 04Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 19Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 at 20:00 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Known allergies: NSAIDs" (unspecified if ongoing), notes: Known allergies: NSAIDs; "Known allergies: dye" (unspecified if ongoing), notes: Known allergies: dye. Concomitant medication(s) included: SERTRALINE, start date: 03Dec2018, stop date: 21Oct2022; AMLODIPINE, start date: 01Jan2019, stop date: 21Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, an association between the reported events and bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: who finished taking Paxlovid; who finished taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 06May2022 as dose number unknown (booster), single, as dose 2, single and as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "who finished taking Paxlovid". Clinical course: The patient finished taking Paxlovid and wants to know how long he has to wait to get the bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine as a booster. He received his last Covid booster (did not clarify manufacturer) on 06May2022. How long after stopping Paxlovid can he get the bivalent Covid Booster? The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Result Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: caller already had two boosters and he was diagnosed with COVID-19 early this month; caller already had two boosters and he was diagnosed with COVID-19 early this month; 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.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown, FL9265 or maybe EL9265), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown, EL9267 or might be EI9267), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown, FE2588 or FI2588) and on 06May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 80 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Oct2022, outcome "recovered" and all described as "caller already had two boosters and he was diagnosed with COVID-19 early this month". Patient already had two boosters and he was diagnosed with COVID-19 early this month 07Oct2022. Patient also stated that he took a complete course of Paxlovid, though he was symptom free from the second day on. Patient had an appointment for the gray cap bivalent Pfizer BioNTech COVID 19 vaccine and asked if he should get it. 07Oct2022, was diagnosed with Covid-19. Symptoms were very mild and only lasted for 1 day. Doctor put him on Paxlovid, the 5 day regimen, that it helped immensely. By the second day, the symptoms were gone. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.