chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Arthritis, Joint swelling, Off label use, Product use issue
Clinical narrative: armpit swelling; left hand knuckle swelling; left hand knuckle pain; arthritis pain; Start Date/Time: [Pfizer] 30-SEP-2022/Location of injection for vaccine received same date: Influenza Pfizer - left arm; Start Date/Time: [Pfizer] 30-SEP-2022/Location of injection for vaccine received same date: Influenza Pfizer - left arm; This is a spontaneous report received from contactable reporter(s) (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 30Sep2022 at 15:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; PHENTERMINE; MELOX. 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 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "Start Date/Time: [Pfizer] 30-SEP-2022/Location of injection for vaccine received same date: Influenza Pfizer - left arm"; SWELLING (non-serious) with onset 01Oct2022, outcome "not recovered", described as "armpit swelling"; ARTHRITIS (non-serious) with onset 01Oct2022, outcome "unknown", described as "arthritis pain"; ARTHRALGIA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "left hand knuckle pain"; JOINT SWELLING (non-serious) with onset 01Oct2022, outcome "not recovered", described as "left hand knuckle swelling". Therapeutic measures were taken as a result of swelling, joint swelling, arthralgia, arthritis.  Additional information: the patient had COVID prior to her vaccination. She was not tested for COVID post vaccination. She had no known allergies.
Age: 47.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Swelling
Clinical narrative: armpit swelling; left hand knuckle swelling; left hand knuckle pain; arthritis pain; Start Date/Time: [Pfizer] 30-SEP-2022/Location of injection for vaccine received same date: Influenza Pfizer - left arm; Start Date/Time: [Pfizer] 30-SEP-2022/Location of injection for vaccine received same date: Influenza Pfizer - left arm; This is a spontaneous report received from contactable reporter(s) (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 30Sep2022 at 15:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; PHENTERMINE; MELOX. 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 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "Start Date/Time: [Pfizer] 30-SEP-2022/Location of injection for vaccine received same date: Influenza Pfizer - left arm"; SWELLING (non-serious) with onset 01Oct2022, outcome "not recovered", described as "armpit swelling"; ARTHRITIS (non-serious) with onset 01Oct2022, outcome "unknown", described as "arthritis pain"; ARTHRALGIA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "left hand knuckle pain"; JOINT SWELLING (non-serious) with onset 01Oct2022, outcome "not recovered", described as "left hand knuckle swelling". Therapeutic measures were taken as a result of swelling, joint swelling, arthralgia, arthritis.  Additional information: the patient had COVID prior to her vaccination. She was not tested for COVID post vaccination. She had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: My wife has got the side effects and she is running a fever almost to 103; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 14Oct2022 as dose number unknown, 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: PYREXIA (non-serious) with onset Oct2022, outcome "unknown", described as "My wife has got the side effects and she is running a fever almost to 103". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC, UPC number and Expiry Date of COVID-19 Vaccine were unknown. Patient had a shot in the afternoon.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Infectious mononucleosis
Clinical narrative: diagnosed with mononucleosis 3 weeks ago; feeling fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 21-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious) with onset Sep2022, outcome "unknown", described as "diagnosed with mononucleosis 3 weeks ago"; FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "feeling fatigued". Additional information: patient was diagnosed with mononucleosis 3 weeks from this report and they said it could take months before he is not feeling fatigued and all of those things.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 14:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: GEODON [ZIPRASIDONE HYDROCHLORIDE]; KLONOPIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received Geodon and Klonopin in two weeks. The patient received COVID 19 Treatment from 04Oct2022 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: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 70-year-old female 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 "COVID-19".  Clinical course: Reporter called in and said her wife has covid-19 and now asking how long can she able to get the Pfizer COVID-19 vaccine, Bivalent withheld: Husband of a 70 year-old female patient called about his wife who has COVID-19 and wanted to know how long she needs to wait to get the Pfizer COVID-19 Vaccine Bivalent and stated that his wife has received the 1st three doses with the Pfizer COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria, Vaccination site swelling
Clinical narrative: itching on his arm and back of his scapula.; swollen in the arm like a welt in the injection site; allergic reaction; a welt on his arm; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 63 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose #4: , Date: 13May2022 , Lot: FP4554, NDC: unknown , Expiry: unknown), administration date: 13May2022, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose #3: , Date: 09OCt2021 , Lot: FF2590 , NDC: unknown , Expiry: unknown), administration date: 09Oct2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose #2: outside source, Date: 06Feb2021, Lot: EM9810, NDC: unknown , Expiry: unknown), administration date: 06Feb2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose #1: from an outside source, Date: 19Jan2021, Lot: EL3247 , NDC: unknown, Expiry: unknown), administration date: 19Jan2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching on his arm and back of his scapula."; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen in the arm like a welt in the injection site"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction"; URTICARIA (non-serious), outcome "unknown", described as "a welt on his arm".  Additional information: Caller was asking for the components of the vaccine. Agent also stated there was a complaint, caller said they usually get a list of components when they receive the boxes and for this vaccine nothing was in the boxes.  Follow-up attempts are completed. No further information is expected. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she's going to take the 2nd booster shot and back in march she had covi; she's going to take the 2nd booster shot and back in march she had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Private. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "she's going to take the 2nd booster shot and back in march she had covi"; COVID-19 (medically significant), outcome "unknown", described as "she's going to take the 2nd booster shot and back in march she had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: back in march she had covid.  Clinical course: Patient stated that, she's going to take the 2nd booster shot and back in March she had Covid-19. She stated as well that she took the flu shot 2 weeks ago and she wanted to know if she can get the booster shot now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: our last booster was about 6 months ago, but we both had covid; our last booster was about 6 months ago, but we both had 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 female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "our last booster was about 6 months ago, but we both had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Unknown result, notes: our last booster was about 6 months ago, but we both had covid in September.  Clinical course: Patient explained our last booster was about 6 months ago, but we both had covid in September.  When can we get our next booster, we're both high-risk..  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-202201233438 Same reporter/drug/event, different Patient;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 71 years 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 had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 14Oct2022, outcome "unknown", described as "Tested positive for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that a patient got her Pfizer COVID-19 bivalent booster in 11Oct2022, Tuesday, tested positive for COVID today and was prescribed with Paxlovid. Caller wanted to know any interaction or contraindication for taking Paxlovid for a patient who recently had a Pfizer booster dose. Administration of an antiviral drug at any interval before or after COVID-19 vaccination is unlikely to impair development of a protective antibody response. Initiate Paxlovid treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. It is authorized for the treatment of mild-to-moderate coronavirus in 12 years of age and older with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Patient got Pfizer Covid19 Vaccine booster Tuesday of this week and tested positive for Covid today. Caller would like to know if it is ok for the patient to take Paxlovid and that there would be no interaction or contraindication when taking Paxlovid. Reporter Type was she is a pharmacy intern calling on behalf of the patient who is picking up the Paxlovid. Attempted to clarify and caller states she is not calling on behalf of the pharmacy or pharmacist. Caller doesn't think the patient is a healthcare professional. Patient was not admitted to hospital and primary care prescribed the Paxlovid but got it filled there at hospital. Prior Vaccinations (within 4 weeks) was unknown and AE following prior vaccinations was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Mycobacterium tuberculosis complex test, Sensory disturbance
Clinical narrative: it feels like something is biting her skin; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "it feels like something is biting her skin". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The caller is a pharmacist who stated she has a 45-year-old female patient that got the bivalent booster, and also had a TB test done a couple of weeks ago, who was complaining that it felt like something is biting her skin.  She did not get the vaccine at (withheld), and was not currently at the store, so no lot number available.  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: Feeling abnormal, Systemic lupus erythematosus
Clinical narrative: Systemic Lupus; Weird; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Systemic Lupus"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Weird". The events "systemic lupus" and "weird" required physician office visit.  Clinical course: The reporter stated that very soon after having Comirnaty, the patient started having very weird, generalized symptoms. The reporter referred the patient to a Rheumatologist and the patient was diagnosed with Systemic Lupus. The caller was asking about other patients that may have been reported possibly having an autoimmune type of flare when the caller connected the reporter to medical. Caller is unaware of any other medications, medical conditions, labs, testing, or treatments for the patient relevant to these events. At that time, the caller did not think about it being an adverse event because the reporter wasn't even sure that it was an adverse event related to Comirnaty.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Systemic lupus erythematosus and the suspect drug BNT162b2 (COMIRNATY) cannot be excluded. The case will be reassessed once new information is available. 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: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholera" (unspecified if ongoing), notes: High cholera. Concomitant medication(s) included: ROSUVASTATIN, start date: Jun2022, stop date: 01Oct2022; EZETIMIBE, start date: Jan2015. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had no known allergies. The patient received paxlovid for the treatment of COVID-19 from 01Oct2022 to 05Oct2022. The patient had no adverse event with paxlovid.  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: 51.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient started Paxlovid one day after he started showing symptoms and testing positive. Symptoms went away and tested negative. Then 4 days later he started showing symptoms again and tested positive. His symptoms were worse than the first time.  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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Known allergies: Augmentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Covid 19 treatment, brand: pfizer, treatment start date: 03Oct2022, treatment stop date: 07Oct2022, indication for treatment of Covid-19. Other medication in 2 weeks product is entyvio, start date: 10Oct2022,and stop date: 10Oct2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Vaccine brand other=Moderna dose 3,2,1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 15:45 as dose 4 (booster), single (Lot number: GJ5342) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 at 12:00 as dose 1, single (Lot number: 001A21A), in left arm, on 09Apr2021 at 11:00 as dose 2, single (Lot number: 032B21A), in left arm and on 10Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PMR" (unspecified if ongoing), notes: PMR; "Osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Sep2022 at 15:45, outcome "unknown", described as "Vaccine brand other=Moderna dose 3,2,1"; COVID-19 (non-serious) with onset 30Sep2022, outcome "unknown", described as "Treatment of COVID-19". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19 included Paxlovid medicine 30Sep to 05Oct2022.  Additional Information: No other medication in 2 weeks was reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose 1 and 2: Pfizer / BioNTech; dose 3 and 4: Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: IBS. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1 and 2: Pfizer / BioNTech; dose 3 and 4: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Negative; (11Oct2022) Negative; (12Oct2022) Negative; (16Oct2022) 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Immune system disorder, Malaise, Myalgia, Pyrexia
Clinical narrative: get really, really sick; muscle aches; fever; my immune system is down; couldn't get out of bed I was too weak; 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 elderly female patient received BNT162b2 (COMIRNATY), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Factor V" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Feb2021, for COVID-19 immunization, reaction(s): "Couldn't get out of bed I was too weak", "Immune system down", "Get really sick", "Muscle aches", "Fever". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "recovered", described as "couldn't get out of bed I was too weak"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "fever"; MALAISE (non-serious) with onset 2021, outcome "recovered", described as "get really, really sick"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "muscle aches"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "recovered", described as "my immune system is down". Additional information: the patient stated that her symptoms only last 24 hours, she guessed it was not that bad, the fever and muscle aches start at nighttime after getting the injection. The patient's concomitant medications included blood thinners as her told her that she should get it. 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-202201232892 same patient/drug/AE, different dose;US-PFIZER INC-202201233151 same patient/drug/AE, different dose;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9262), on 03Mar2022 as dose 2, single (Lot number: EN 6201) and on 01Dec2021 as dose 3 (booster), single (Lot number: 330268D) for covid-19 immunisation. The patient's relevant medical history included: "Several arterial aneurysms" (unspecified if ongoing), notes: Several arterial aneurysms; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "depression" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing); "Sulfa Drugs allergy" (unspecified if ongoing), notes: Sulfa Drugs allergy. Concomitant medication(s) included: AMLODIPINE BESYLATE, stop date: 05Oct2022; LAMOTRIGINE, stop date: 05Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2022) negative, notes: one day after completing course of Paxlovid; (13Oct2022) positive, notes: tested positive again two days later. Therapeutic measures were taken as a result of vaccination failure, covid-19 Paxlovid treatment was started.  Follow up information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery calcification" (unspecified if ongoing); "Known allergies: Carba Mix and Thioram Mix (2 rubber chemicals)" (unspecified if ongoing), notes: Known allergies: Carba Mix and Thioram Mix (2 rubber chemicals); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "OSA" (unspecified if ongoing), notes: OSA. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: It was reported that rebound. Patient began Paxlovid on the second day of COVID symptom onset. COVID symptoms improved rapidly. But COVID symptoms returned 2 days after completing the five-day course of Paxlovid treatment. Patient had fatigue and still have cough, nasal congestion, copious mucus, burning of nasal mucosa.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 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: "History of pe" (unspecified if ongoing), notes: History of pe; "Allergy" (unspecified if ongoing), notes: Relevant past drug history: name of drug was not reported, reaction: allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: (Sep2022) Positive, notes: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: history of pe. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna, dose 5/ Pfizer, dose 4; Pfizer, dose 4; Vaccine brand other: Moderna, Vaccine dose number: 5; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 77 years, in left arm for COVID-19 immunization; elasomeran (COVID-19 VACCINE MODERNA), on 14Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "rheumatoid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Diovan, reaction: "known allergies: Diovan"; Lisinopril, reaction: "known allergies: Lisinopril"; Oxycontin, reaction: "known allergies: Oxycontin". The following information was reported: IMMUNISATION (medically significant) with onset 14Sep2022, outcome "unknown", described as "Pfizer, dose 4"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna, Vaccine dose number: 5"; OFF LABEL USE (medically significant) with onset 14Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna, dose 5/ Pfizer, dose 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive; (10Oct2022) Positive; (12Oct2022) Positive; (14Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Seriousness reported as not serious. Patient will test again on 16Oct2022. AE resulted in: None of the above.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna, dose 5/ Pfizer, dose 4; Pfizer, dose 4; Vaccine brand other: Moderna, Vaccine dose number: 5; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 77 years, in left arm for COVID-19 immunization; elasomeran (COVID-19 VACCINE MODERNA), on 14Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "rheumatoid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Diovan, reaction: "known allergies: Diovan"; Lisinopril, reaction: "known allergies: Lisinopril"; Oxycontin, reaction: "known allergies: Oxycontin". The following information was reported: IMMUNISATION (medically significant) with onset 14Sep2022, outcome "unknown", described as "Pfizer, dose 4"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna, Vaccine dose number: 5"; OFF LABEL USE (medically significant) with onset 14Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna, dose 5/ Pfizer, dose 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive; (10Oct2022) Positive; (12Oct2022) Positive; (14Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Seriousness reported as not serious. Patient will test again on 16Oct2022. AE resulted in: None of the above.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 as dose 4 (booster), single (Lot number: PF1315FJ4991), 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: "Severe coronary artery disease" (unspecified if ongoing), notes: Severe coronary artery disease; "Smoking" (unspecified if ongoing), notes: Smoking; "lung nodules" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Adhesives" (unspecified if ongoing), notes: Known allergies: Adhesives; "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient took concomitant medications. Other medication in 2weeks reported as Yes. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Seriousness reported as No. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti-viral treatment with Paxlovid taken from 08Oct2022 and stopped on 15Oct2022.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: I am having redness and itchiness on the injection site; I am having redness and itchiness on the injection site; 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 patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: 0H9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, I had all my injections (clarified as Pfizer Covid-19 vaccine), all the booster and everything), for Covid-19 immunization; Bnt162b2 (Dose 2, I had all my injections (clarified as Pfizer Covid-19 vaccine), all the booster and everything), for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "I am having redness and itchiness on the injection site". The events "i am having redness and itchiness on the injection site" required physician office visit.  Additional information: Consumer stated, "I had all my injections (clarified as Pfizer Covid-19 vaccine), all the booster and everything and on Wednesday I got the latest the omicron Covid Pfizer (Clarified as Covid 19 vaccine Bivalent). What I wanted to know because I never had this reaction before I am having redness and itchiness on the injection site. Consumer stated, "I do not think this is anything abnormal. I just decided to check because I am 77 years old."  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red swelling on left arm at injection site; Red swelling on left arm at injection site; Some itching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 12:30 as dose 5 (booster), single (Lot number: 6H9703) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "cold agglutinin disease" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE], on 05Oct2022; OLANZAPINE; SYNTHROID; ACTONEL, start date: Sep2022. 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; Covid-19 vaccine (Dose: 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 10Oct2022, outcome "recovered" (13Oct2022) and all described as "Red swelling on left arm at injection site"; PRURITUS (non-serious) with onset 10Oct2022, outcome "recovered" (Oct2022), described as "Some itching". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, pruritus.  Additional information: The patient had received other vaccine in four weeks. The patient had no Covid-19 prior to vaccination and patient had not tested COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.