chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Ovarian cyst, Postmenopausal haemorrhage, Ultrasound ovary, Ultrasound scan
Clinical narrative: 2nd dose made her start her period. She didn't had a period in 7 or 8 years; she was having heavy periods that were causing her to have cysts; she was having heavy periods/ heavy period every other week for 6 week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 2, single (Lot number: EWO185) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing), notes: she had endometriosis. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EWO185; Expiration date: unknown), administration date: 06Aug2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "2nd dose made her start her period. She didn't had a period in 7 or 8 years"; OVARIAN CYST (non-serious), outcome "unknown", described as "she was having heavy periods that were causing her to have cysts"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "she was having heavy periods/ heavy period every other week for 6 week". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of postmenopausal haemorrhage, ovarian cyst, heavy menstrual bleeding.  Additional information: It was reported that, the 2nd dose made her start her period. She didn't had a period in 7 or 8 years, it was a full period for 6 weeks. When she took the Pfizer shot she started her period. She got heavy bleeding, she had endometriosis and she bleed out and up inside of her and her doctor didn't want her to do that. She got excessive bleeding. Reporter stated that, she started her period and could have had cysts on her ovaries. She did not know why this happened with a vaccination, it did not cause her to do that with the flu shot. Reporter stated that, she talked to another girl every time she took a shot she did the same thing, she started hers too and she was the same age. She had talked to several other people and they have the same thing. She hasn't bleed until the Pfizer shots. Attempted clarification again and reporter stated that, she was having heavy periods that were causing her to have cysts so she was then put on premarin to stop her menstrual cycle.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201140024 same patient/product/event, different dose;US-PFIZER INC-202201139438 same reporter/product/event, different patient;US-PFIZER INC-202201140024 same patient, different dose and different event.;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8735), in right arm, on 21May2021 as dose 2, single (Lot number: ER8731), in right arm, on 27Nov2021 as dose 3 (booster), single (Lot number: F58757), in right arm and on 10May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Narcolepsy" (unspecified if ongoing), notes: other medical history: Narcolepsy; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.   Clinical Course: COVID 19 Treatment Paxlovid received from 27Aug2022 to 31Aug2022. No other medication received in 2weeks.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Caller states several have had the same thing even a women who hadn't bleed in 15-20 years she; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient in her 60's received BNT162b2 (BNT162B2), 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; Covid-19 vaccine (1ST BOOSTER DOSE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Caller states several have had the same thing even a women who hadn't bleed in 15-20 years she".  Clinical information: Agent stated that the caller was reporting that after the 2nd booster Pfizer shot it caused her to start menstruating. Caller stated several have had the same thing even a women who hadn't bleed in 15-20 years she was in her 60s. Caller declined to complete report.   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-202201140024 same reporter/drug/event, different patient;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose number unknown, single (Lot number: FJ4989) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST; PRAVASTATIN; LEVOTHYROXINE; OLMESARTAN; HYDROCHLOROTHIAZIDE. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin family". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received vaccine but did not received other medications in 2 weeks. Treatment started on 28Aug2022 and stopped on 01Sep2022 for treatment of COVID-19. Lot number and dose number was unknown. The patient had no known allergies.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Insomnia, Myalgia, Pyrexia
Clinical narrative: Muscle soreness; trouble sleeping the following night; fatigue; low grade fever (1.3 F higher); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 12:15 as dose 4 (booster), single (Lot number: GH9694) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering", described as "Muscle soreness"; FATIGUE (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering", described as "low grade fever (1.3 F higher)"; INSOMNIA (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering", described as "trouble sleeping the following night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, insomnia, fatigue, pyrexia.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101295064 same reporter, same patient, different dose, different AEs.;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 10:00 as dose 1, single (Lot number: EN9581), in right arm, on 19Feb2021 at 10:00 as dose 2, single (Lot number: EL9266), in left arm and on 11Feb2022 at 10:00 as dose 3 (booster), single (Lot number: FL3209) at the age of 33 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Diabetes type 1" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". 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: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid treatment was from 06Sep202 to 07Sep2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201151177 Same reporter/patient, same drug/different dose, different event.;
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Injection site urticaria, Muscle fatigue, Myalgia
Clinical narrative: 2.5 inch welt or hive at injection site; 2.5 inch welt or hive at injection site; a orange sized swelling in armpit of left arm,; muscle fatigue; pain across pectoral muscles; Itchy red skin up and down left arm and neck.; Itchy red skin up and down left arm and neck.; Itchy red skin up and down left arm and neck.; Nausea; Dose 3 (07Sep2022); Dose 4 (07Sep2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 19:00 as dose 4 (booster), single (Lot number: GHG9694), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "allergies" (unspecified if ongoing), notes: other medical history:allergies; "Known allergies: Pomogranate" (unspecified if ongoing); "Known allergies: red 40" (unspecified if ongoing). Concomitant medication(s) included: FLULAVAL QUADRIVALENT, on 01Sep2022. Vaccination history included: BNT162b2 (Product: Pfizer, Batch / lot number: FF2593, Dose number: 3, Vaccine location: Right arm), administration date: 07Sep2022, for Covid-19 immunization, reaction(s): "2.5 inch welt or hive at injection", "2.5 inch welt or hive at injection", "a orange sized swelling in armpit of left arm", "muscle fatigue", "pain across pectoral muscles", "Itchy red skin up and down left arm and neck", "Itchy red skin up and down left arm and neck", "Itchy red skin up and down left arm and neck", "Nausea"; Covid-19 vaccine (Primary immunization series complete, Covid-19 vaccine[unknown manufacturer]), for Covid-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Sep2022, outcome "unknown", described as "Dose 3 (07Sep2022); Dose 4 (07Sep2022)"; VACCINATION SITE REACTION (non-serious), INJECTION SITE URTICARIA (non-serious), outcome "recovering" and all described as "2.5 inch welt or hive at injection site"; SWELLING (non-serious), outcome "recovering", described as "a orange sized swelling in armpit of left arm,"; MUSCLE FATIGUE (non-serious), outcome "recovering"; MYALGIA (non-serious), outcome "recovering", described as "pain across pectoral muscles"; PRURITUS (non-serious), ERYTHEMA (non-serious), ERYTHEMA (non-serious), outcome "recovering" and all described as "Itchy red skin up and down left arm and neck."; NAUSEA (non-serious), outcome "recovering". Therapeutic measures were not taken as a result of vaccination site reaction, injection site urticaria, swelling, muscle fatigue, myalgia, pruritus, erythema, erythema, nausea.  Additional information: Patient did not have COVID prior vaccination and patient did not test COVID post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Swelling, Vaccination site reaction
Clinical narrative: 2.5 inch welt or hive at injection site; 2.5 inch welt or hive at injection site; a orange sized swelling in armpit of left arm,; muscle fatigue; pain across pectoral muscles; Itchy red skin up and down left arm and neck.; Itchy red skin up and down left arm and neck.; Itchy red skin up and down left arm and neck.; Nausea; Dose 3 (07Sep2022); Dose 4 (07Sep2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 19:00 as dose 4 (booster), single (Lot number: GHG9694), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "allergies" (unspecified if ongoing), notes: other medical history:allergies; "Known allergies: Pomogranate" (unspecified if ongoing); "Known allergies: red 40" (unspecified if ongoing). Concomitant medication(s) included: FLULAVAL QUADRIVALENT, on 01Sep2022. Vaccination history included: BNT162b2 (Product: Pfizer, Batch / lot number: FF2593, Dose number: 3, Vaccine location: Right arm), administration date: 07Sep2022, for Covid-19 immunization, reaction(s): "2.5 inch welt or hive at injection", "2.5 inch welt or hive at injection", "a orange sized swelling in armpit of left arm", "muscle fatigue", "pain across pectoral muscles", "Itchy red skin up and down left arm and neck", "Itchy red skin up and down left arm and neck", "Itchy red skin up and down left arm and neck", "Nausea"; Covid-19 vaccine (Primary immunization series complete, Covid-19 vaccine[unknown manufacturer]), for Covid-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Sep2022, outcome "unknown", described as "Dose 3 (07Sep2022); Dose 4 (07Sep2022)"; VACCINATION SITE REACTION (non-serious), INJECTION SITE URTICARIA (non-serious), outcome "recovering" and all described as "2.5 inch welt or hive at injection site"; SWELLING (non-serious), outcome "recovering", described as "a orange sized swelling in armpit of left arm,"; MUSCLE FATIGUE (non-serious), outcome "recovering"; MYALGIA (non-serious), outcome "recovering", described as "pain across pectoral muscles"; PRURITUS (non-serious), ERYTHEMA (non-serious), ERYTHEMA (non-serious), outcome "recovering" and all described as "Itchy red skin up and down left arm and neck."; NAUSEA (non-serious), outcome "recovering". Therapeutic measures were not taken as a result of vaccination site reaction, injection site urticaria, swelling, muscle fatigue, myalgia, pruritus, erythema, erythema, nausea.  Additional information: Patient did not have COVID prior vaccination and patient did not test COVID post vaccination.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: FG3524) at the age of 38 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: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment start date=30Aug2022, stop date=04Sep2022. No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Investigation, Muscle fatigue, Myalgia, Nausea
Clinical narrative: 2.5 inch welt or hive at injection site; 2.5 inch welt or hive at injection site; a orange sized swelling in armpit of left arm,; muscle fatigue; pain across pectoral muscles; Itchy red skin up and down left arm and neck.; Itchy red skin up and down left arm and neck.; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Known allergies: Pomegranate" (unspecified if ongoing); "Known allergies: red 40" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 01Sep2022 as dose number unknown, single. 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. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE URTICARIA (non-serious), outcome "recovering" and all described as "2.5 inch welt or hive at injection site"; SWELLING (non-serious), outcome "recovering", described as "a orange sized swelling in armpit of left arm,"; MUSCLE FATIGUE (non-serious), outcome "recovering"; MYALGIA (non-serious), outcome "recovering", described as "pain across pectoral muscles"; PRURITUS (non-serious), ERYTHEMA (non-serious), outcome "recovering" and all described as "Itchy red skin up and down left arm and neck."; NAUSEA (non-serious), outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site urticaria, swelling, muscle fatigue, myalgia, pruritus, erythema, nausea.  Additional information: The other vaccine within 4 weeks included Flulaval Quadrivalent. There was no covid prior vaccination and not tested post vaccination. It was reported that the patient experienced 2.5 inch welt or hive at injection site, a orange sized swelling in armpit of left arm, muscle fatigue and pain across pectoral muscles. Itchy red skin up and down left arm and neck Nausea.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site pain, Vaccination site urticaria
Clinical narrative: 2.5 inch welt or hive at injection site; 2.5 inch welt or hive at injection site; a orange sized swelling in armpit of left arm,; muscle fatigue; pain across pectoral muscles; Itchy red skin up and down left arm and neck.; Itchy red skin up and down left arm and neck.; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Known allergies: Pomegranate" (unspecified if ongoing); "Known allergies: red 40" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 01Sep2022 as dose number unknown, single. 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. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE URTICARIA (non-serious), outcome "recovering" and all described as "2.5 inch welt or hive at injection site"; SWELLING (non-serious), outcome "recovering", described as "a orange sized swelling in armpit of left arm,"; MUSCLE FATIGUE (non-serious), outcome "recovering"; MYALGIA (non-serious), outcome "recovering", described as "pain across pectoral muscles"; PRURITUS (non-serious), ERYTHEMA (non-serious), outcome "recovering" and all described as "Itchy red skin up and down left arm and neck."; NAUSEA (non-serious), outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site urticaria, swelling, muscle fatigue, myalgia, pruritus, erythema, nausea.  Additional information: The other vaccine within 4 weeks included Flulaval Quadrivalent. There was no covid prior vaccination and not tested post vaccination. It was reported that the patient experienced 2.5 inch welt or hive at injection site, a orange sized swelling in armpit of left arm, muscle fatigue and pain across pectoral muscles. Itchy red skin up and down left arm and neck Nausea.
Sex: U
Vaccine: COVID19
Symptoms: Decreased immune responsiveness, Neoplasm malignant
Clinical narrative: cancer; decreased immune system; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A patient (no qualifiers provided) 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. Past drug history included: Bnt162b2 for Covid-19 Vaccination, notes: primary series of Pfizer Covid-19 vaccine gray cap, Dose 1 and 2. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; DECREASED IMMUNE RESPONSIVENESS (non-serious), outcome "unknown", described as "decreased immune system".  Clinical course: Warm transfer from [Name withheld] with Support, with a Pharmacist on the line who has a question regarding restarting a series due to cancer for the Pfizer Covid-19 Vaccine, gray cap. The patient received the primary series of Pfizer Covid-19 vaccine gray cap and booster dose. The doctor wants the patient to restart the series.Caller verified information provided. As far as she knows, there was no issue with the patient receiving the vaccines. Pfizer Covid-19 Vaccine: Additional Lots/NDCs/Expiries: Not provided, caller unwilling to complete the report, Booster dose Lot/NDC/Expiry: Not provided, caller unwilling to complete the report. Looks like the doctor's office has a patient with cancer with decreased immune system and wanted to restart the series. Didn't see anything in the CDC guidance  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available "NEOPLASM MALIGNANT " considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to suspect drug . The impact of this report on the benefit/risk profile of the Pfizer drug 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 in extremity
Clinical narrative: It was sore with the other ones although not particularly really really sore; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It was sore with the other ones although not particularly really really sore".  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-202201142435 same patient/product/event, different dose;US-PFIZER INC-202201142436 same patient/product/event, different dose;US-PFIZER INC-202201142437 same patient/product/event, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FO9943), 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: "Hypertension" (unspecified if ongoing); "Known- allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Sep2022) positive, notes: Re-bound infection, tested positive 8Sep2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Covid-19 treatment with Paxlovid from 29Aug2022 to 03Sep2022.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: It was sore with the other ones although not particularly really really sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, (Lot # not provided)), for Covid-19 immunization, reaction(s): "It was sore with the other ones although not particularly really really sore". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It was sore with the other ones although not particularly really really sore".  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-202201142333 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: It was sore with the other ones although not particularly really really sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old 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 (DOSE 1, Lot number: unknown), for COVID-19 immunization, reaction(s): "It was sore with the other ones although not particularly really really sore"; Bnt162b2 (DOSE 2, Lot number: unknown), for Covid-19 immunization, reaction(s): "It was sore with the other ones although not particularly really really sore". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It was sore with the other ones although not particularly really really sore".  Additional information: Caller mentioned that with the prior four doses of the Pfizer Covid-19 vaccines, she had arm soreness but with the fifth dose of bivalent vaccine she had no reaction.  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-202201142333 similar report from same reporter;
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore, although not particularly really really sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years 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, reaction(s): "she had arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "she had arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "she had arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore, although not particularly really really sore".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Severe shoulder pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Aug2022 at 13:30 as dose number unknown, 0.5ml single (Lot number: FJ2598, Expiration Date: Jun2023) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (medically significant) with onset 31Aug2022, outcome "not recovered", described as "Severe shoulder pain". The patient couldn't lift arm. Asking how long that may last. Shoulder pain got a little better, but then returned to the same pain level.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of ARTHRALGIA cannot be fully excluded, considering the temporal relationship.  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: 65.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe shoulder pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Aug2022 at 13:30 as dose number unknown, 0.5ml single (Lot number: FJ2598, Expiration Date: Jun2023) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (medically significant) with onset 31Aug2022, outcome "not recovered", described as "Severe shoulder pain". The patient couldn't lift arm. Asking how long that may last. Shoulder pain got a little better, but then returned to the same pain level.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of ARTHRALGIA cannot be fully excluded, considering the temporal relationship.  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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "migraine" (unspecified if ongoing), notes: Other medical history: migraine; "EDS" (unspecified if ongoing), notes: Other medical history: EDS. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication=Treatment of COVID-19; (07Sep2022) Positive, notes: Return of symptoms on eve of 07Sep2022, positive home covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was unknown if other medication received in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: 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 (other healthcare professional). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as DOSE 1, SINGLE (lot number: EL33486), in the right arm; on 05Feb2021 as DOSE 2, SINGLE (lot number: EN5318), in the right arm; and on 02Oct2021 as DOSE 3 (BOOSTER), SINGLE (lot number: 301558A), in the left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 20Apr2022 as DOSE 4 (BOOSTER), SINGLE (lot number: 057M21A), in the right arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Aug2022) Positive, notes: "COVID-19 treatment." Therapeutic measures were taken as a result of Vaccination failure, Covid-19.; Sender's Comments: Based on the available information, the reported events Vaccination Failure and Covid-19 cannot be excluded for the suspect drug BNT162b2.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "ADHD" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: now testing positive; (05Sep2022) Negative, notes: tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient reported that she tested negative for Covid on 05Sep2022 and was feeling better. She experienced new symptoms on 07Sep2022 and am now testing positive. The patient did not receive other medication in two weeks.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pain in extremity, Pain of skin
Clinical narrative: left armpit was swollen. She doesn't hurt, there was an area about 3 inches across that is swollen and soft.; feeling very fatigued; slightly achy all over; Left arm was slightly sore to the touch; Left arm was slightly sore to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing); "aspirin exacerbated respiratory disease" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies:aspirin"; Quinolones, reaction(s): "Known allergies : quinolones". Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunization; Bnt162b2 (dose 2, single), for Covid-19 immunization; Bnt162b2 (dose 3, single), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN OF SKIN (non-serious) all with onset 08Sep2022 at 07:00, outcome "recovered" and all described as "Left arm was slightly sore to the touch"; FATIGUE (non-serious) with onset 08Sep2022 at 07:00, outcome "recovered", described as "feeling very fatigued"; PAIN (non-serious) with onset 08Sep2022 at 07:00, outcome "recovered", described as "slightly achy all over"; LYMPHADENOPATHY (non-serious) with onset 08Sep2022 at 16:00, outcome "not recovered", described as "left armpit was swollen. She doesn't hurt, there was an area about 3 inches across that is swollen and soft.". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, pain, pain in extremity, pain of skin.  Additional Information: Patient did not received other vaccine within four weeks of COVID vaccine. Patient received other medications within two weeks. Patient has known allergies to antileukotrienes. Patient did not have COVID prior to vaccination. Patient did not tested for COVID post vaccination. Adverse event reported as, woke up feeling very fatigued and slightly achy all over. Left arm was slightly sore to the touch. Patient previously reported other symptoms she had this morning. This afternoon, she noticed that her left armpit was swollen. She doesn't hurt, there was an area about 3 inches across that is swollen and soft.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021090765 same reporter/patient/product, different dose/AE;US-PFIZER INC-2021211563 same reporter/patient/product, different dose/AE;US-PFIZER INC-202101276219 same reporter/patient/product, different dose/AE;
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Diabetes Mellitus Type 2" (unspecified if ongoing); "Diabetic retinopathy" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin for allergies: Erythromycin; Fluorescein for Known allergies: fluorescein. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was received as COVID 19 treatment from 04Sep2022 to an unknown date in Sep2022.  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 reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Tachycardia/heart rate was above 100 upon waking up on 08sep, mostly 115-120 until about 1:00, then around 100 for remainder of the day (currently ongoing).; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH99694) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Other Medical History: Hypothyroidism" (unspecified if ongoing); "Other Medical History: Past hx of severe Covid 19 (Feb2021)", start date: Feb2021 (unspecified if ongoing), notes: Other Medical History: Past hx of severe Covid19 (Feb2021), if covid prior vaccination: Yes. Concomitant medications included: LEVOTHYROXINE; ZOLPIDEM. 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: TACHYCARDIA (non-serious) with onset 08Sep2022 at 07:00, outcome "not recovered", described as "Tachycardia/heart rate was above 100 upon waking up on 08sep, mostly 115-120 until about 1:00, then around 100 for remainder of the day (currently ongoing).". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.  Additional information: the patient had no other vaccine within four weeks. She had COVID prior to vaccination, and was not tested for COVID post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: a little fever; feel a little sore in the arm; This is a spontaneous report received from a non-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), as dose number unknown, 15 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he has coeliac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "a little fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "feel a little sore in the arm".  Additional information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), less or equal 12 years - 15/15 mcg per dos. Reporter reports that he has coeliac disease so he cannot consume gluten, he asks if the new Pfizer Covid19 Bivalent vaccine contains gluten. He mentions that he may feel a little sore in the arm and may be a little fever but that the vaccine won't probably have any effect on his gastrointestinal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.