chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 28Jun2022 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: URTICARIA (non-serious) with onset 13Jul2022, outcome "recovered" (17Jul2022), described as "hives".  Additional information: It was reported that caller was a pharmacist called on behalf of his daughter (2y/o female) who had a reaction to her first dose of the Pfizer Covid19 vaccine. He reports, "she got her first Pfizer dose like 28Jun2022 and then the hives started on 13Jul2022" noting the hives were "over her whole body" and "got worse for a couple of days", and by yesterday they were "completely cleared". He states that "the allergist said it could be from the vaccine". He's looking for information about a delayed reaction to the vaccine. Also, from PI "Adverse Reactions in Post Authorization Experience: Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine." [LAB; Revised: 17Jun2022]. No information for incidence/onset of hives after vaccine administration. Typically, adverse events reported closer to time of administration. No info for delayed allergic reactions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Consumer stated that she tested positive for covid last Saturday; Consumer stated that she tested positive for covid last Saturday; 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 62-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), COVID-19 (medically significant), outcome "unknown" and all described as "Consumer stated that she tested positive for covid last Saturday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient enquired if it will be okay for her to already receive the second booster dose as she was test Covid positive  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Heart arrhythmias; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: FK9895; also reported as FR9895) at the age of 50 years, in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset May2022, outcome "not recovered", described as "Heart arrhythmias". Clinical course: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Therapeutic measures were not taken as a result of arrhythmia.
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 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: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin", notes: Known allergies: Ceftin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2 week of covid vaccination. He received Paxlovid as antiviral drug as treatment of COVID-19 started on 03Jul2022 to 07Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 21Jan2021 as dose 2, single (Lot number: EL3247), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL], start date: 05Jun2017; HYDROCODONE, start date: 03Aug2011; OMEPRAZOLE, start date: 05Apr2013. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course:The patient received treatment for paxlovid. Treatment start date- 09Jul2022 till 13Jul2022. The patient had received other medication in 2 weeks.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available, a possible causal relationship between reported events Vaccination failure and COVID 19 and suspect drug BNT162B2 cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, SARS-CoV-2 test, X-ray
Clinical narrative: Felt like the vaccine gave her flu like symptoms; really sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical Location: Unknown , Lot Number / Expiry Date: Unknown, Date: Unknown, Age at Immunization if date not available: 44 years), when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Felt like the vaccine gave her flu like symptoms"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "really sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness, illness.  Additional information: Patient did not receive any prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations. Antipyretic Use (around the date(s) of Vaccination): Patient got really sick after the second vaccine, so she may have taken Tylenol. Felt like the vaccine gave her flu like symptoms that day. Had to call out of work the whole day.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 69 year old male calling about PAXLOVID. Caller added he had all the Pfizer vaccines.The initial 2 doses and 2 Boosters doses.; 69 year old male calling about PAXLOVID. Caller added he had all the Pfizer vaccines.The initial 2 doses and 2 Boosters doses.; 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 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "69 year old male calling about PAXLOVID. Caller added he had all the Pfizer vaccines.The initial 2 doses and 2 Boosters doses.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Male patient calling about PAXLOVID. He finished 8 days, numbness in tongue, lips and throat, wanted to make sure they are related to PAXLOVID. The reason he is calling today is because he talked to his Primary Care Physician and his Doctor suggested to call Pfizer and ask about his symptoms he is experiencing. His Doctor is not familiar with the PAXLOVID product, it is so new. The caller doesn't want to go back and forth. The caller wants to be sure his experience is escalated to the medical team   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
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) (Other HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Based on the information available, a possible causal relationship between reported events Drug Ineffective and COVID 19 and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted virus after vaccination; Contracted virus after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415).  A male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted virus after vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 at 14:30 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), 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); "High cholesterol" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: Other medical history: HTN. The patient's concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Past drug history included: Hydrocodone, reaction(s): "Known allergies: Hydrocodone". The patient had no other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid start and stop in Jul2022.  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 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Heavy menstrual bleeding, Peripheral circulatory failure, SARS-CoV-2 test
Clinical narrative: Increase in circulation issues, fingers turning purple.; having longer period duration/Increase in menstrual flow; Increase is Asthma attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 09:45 as dose 1, single (Lot number: EW0181) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Migraines" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL CIRCULATORY FAILURE (medically significant) with onset 01Mar2021, outcome "recovered with sequelae", described as "Increase in circulation issues, fingers turning purple."; ASTHMA (medically significant) with onset 01Mar2021, outcome "recovered with sequelae", described as "Increase is Asthma attacks"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 01Mar2021, outcome "recovered with sequelae", described as "having longer period duration/Increase in menstrual flow". The events "increase in circulation issues, fingers turning purple.", "having longer period duration/increase in menstrual flow" and "increase is asthma attacks" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of peripheral circulatory failure, heavy menstrual bleeding, asthma.  Clinical course: On 01Aug2021 patient was administered with dose 2 on left arm location. Patient took treatment was received for AE with Inhaler/Nebulizer/Dehumidifier. Increase in circulation issues fingers turning purple. Increase is asthma attacks. Also, she has been experiencing Increase in menstrual flow and having longer period Duration. Example I had a period for 5 straight weeks.  Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: swollen lymph nodes in arm pits; headache/pressure; fever; fatigue; This is a spontaneous report received from a contactable reporter (Consumer).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 15Jul2022 at 17:15 as dose 3 (booster), single (Lot number: FL8094) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose number: 2; lot number=FK5618, administration route: Intramuscular, administration time: 05:00 PM, vaccine location=Left arm), administration date: 03Dec2021, when the patient was 10-year-old, for COVID-19 immunization; BNT162b2 (dose number: 1; lot number: FK5618, administration route: Intramuscular, administration time=05:15 PM, vaccine location: Left arm), administration date: 12Nov2021, when the patient was 10-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering"; PYREXIA (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering", described as "headache/pressure"; LYMPHADENOPATHY (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering", described as "swollen lymph nodes in arm pits". The events "swollen lymph nodes in arm pits", "headache/pressure", "fever" and "fatigue" required physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, headache, pyrexia, fatigue.  Additional information: Patient has not received other vaccine in four weeks and has not received other medications in two weeks. Patient has no Covid prior vaccination, and no Covid test post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2021 as dose 1, single (Lot number: EW0191), in left arm, on 16Jun2021 as dose 2, single (Lot number: EW0196), in left arm and on 28Feb2022 at 09:30 as dose 3 (booster), single (Lot number: 331300A) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; Codeine; Bydurion; Ozempic; Emycin; "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Hiatal Hernia" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Migraines" (unspecified if ongoing), notes: Migraines; "Environmental allergies" (unspecified if ongoing), notes: Environmental allergies. Concomitant medication(s) included: BREO ELLIPTA, start date: 01Feb2021, stop date: Jul2022; JARDIANCE, start date: 01Feb2021, stop date: Jul2022; ESCITALOPRAM, start date: Feb2021, stop date: Jul2022; BUPROPION HCL XL, start date: Feb2021, stop date: Jul2022; DEXILANT, start date: Feb2021, stop date: Jul2022; CETIRIZINE, start date: Feb2021, stop date: Jul2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Sulfa; Codeine; Bydurion; Ozempic; Emycin; Bydureon, reaction(s): "Known allergies: Bydureon", notes: Known allergies: Sulfa; Codeine; Bydureon; Ozempic; Emycin; Ozempic, reaction(s): "Known allergies: Ozempic", notes: Known allergies: Sulfa; Codeine; Bydurion; Ozempic; Emycin; Emycin, reaction(s): "Known allergies: Emycin", notes: Known allergies: Sulfa; Codeine; Bydurion; Ozempic; Emycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that report was about COVID treatment. The patient had received other medication in 2 weeks. Anti viral details: Product: COVID 19 treatment, brand: Paxlovid. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. The device date was reported as 18Jul2022.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Indication: Treatment of COVID-19; Indication: 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 16:30 as dose 1, single (Lot number: EN6202), in left arm, on 22Mar2021 at 15:30 as dose 2, single (Lot number: ER2613), in left arm, on 29Sep2021 at 14:30 as dose 3 (booster), single (Lot number: 30135ba), in right arm and on 18May2022 at 13:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (Jul2022) positive, notes: I have tested positive for COVID after taking PAXLOVID treat as prescribed; (Jul2022) negative, notes: I tested negative after 6th day with a home test; (18Jul2022) positive, notes: I'm positive with home test this morning; (Jul2022) positive, notes: tested positive with PCR on the 7th day after starting treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The Patient had no known allergies. Patient had tested positive for COVID after taking PAXLOVID treat as prescribed. She tested negative after 6th day with a home test and tested positive with PCR on the 7th day after starting treatment. Today is 18Jul, she was positive with home test this morning and was experiencing mild symptoms, congestion and runny nose. No Fever. Adverse event start time: 10:00 AM. The patient did not receive other medications in two weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Giant cell arteritis, Headache, Pain, Pain in jaw, Polymyalgia rheumatica
Clinical narrative: Diagnosed with PMR with GCA; Diagnosed with PMR with GCA; Temporal pain; jaw pain; body pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 14:00 as dose 1, single (Lot number: 33030) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), GIANT CELL ARTERITIS (non-serious) all with onset 27Dec2021 at 14:00, outcome "unknown" and all described as "Diagnosed with PMR with GCA"; HEADACHE (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "Temporal pain"; PAIN (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "body pain"; PAIN IN JAW (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "jaw pain". The events "diagnosed with pmr with gca", "temporal pain", "jaw pain" and "body pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative, notes: Other. Therapeutic measures were taken as a result of polymyalgia rheumatica, giant cell arteritis, headache, pain in jaw, pain.  Clinical Course: Age group reported as (18-64 Years). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: Na. Adverse event: Temporal pain, develop to jaw pain then body pain. Diagnosed with PMR with GCA. No covid prior vaccination. Covid was tested post vaccination. Prednisone was given as treatment for AE. No Other medical history. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid test post vaccination, type: Other, test name Home kit.; Sender's Comments: Based on the available information in the case, the causal association between the event polymyalgia rheumatica and the suspect drug cannot be excluded. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Diagnosed with PMR with GCA; Diagnosed with PMR with GCA; Temporal pain; jaw pain; body pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 14:00 as dose 1, single (Lot number: 33030) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), GIANT CELL ARTERITIS (non-serious) all with onset 27Dec2021 at 14:00, outcome "unknown" and all described as "Diagnosed with PMR with GCA"; HEADACHE (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "Temporal pain"; PAIN (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "body pain"; PAIN IN JAW (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "jaw pain". The events "diagnosed with pmr with gca", "temporal pain", "jaw pain" and "body pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative, notes: Other. Therapeutic measures were taken as a result of polymyalgia rheumatica, giant cell arteritis, headache, pain in jaw, pain.  Clinical Course: Age group reported as (18-64 Years). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: Na. Adverse event: Temporal pain, develop to jaw pain then body pain. Diagnosed with PMR with GCA. No covid prior vaccination. Covid was tested post vaccination. Prednisone was given as treatment for AE. No Other medical history. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid test post vaccination, type: Other, test name Home kit.; Sender's Comments: Based on the available information in the case, the causal association between the event polymyalgia rheumatica and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0161), in left arm, as dose 2, single (Lot number: EW0171), in left arm and as dose 3 (booster), single (Lot number: 33030BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "obesity" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "iron deficiency" (unspecified if ongoing); "acute asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". The patient received paxlovid on 06Jul202 for treatment of COVID.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2022 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), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that other medical history and known allergies were noted as unknown. Other medication in 2 weeks reported as unknown. Antiviral details noted as patient received Paxlovid (administrator route noted as oral) for treatment of Covid-19. Treatment start date was reported as 05Jul2022 and stop date was reported as 09Jul2022.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known the information available the Causal relation between the events and suspect drug cannot be excluded completely.
Age: 61.0
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 01Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FK9896) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "high cholesterol" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "history of respiratory infections" (unspecified if ongoing), notes: history of respiratory infections; "Known allergies: allergic to dust" (unspecified if ongoing), notes: Known allergies: allergic to dust; "ACE inhibitors" (unspecified if ongoing), notes: Known allergies: ACE inhibitors. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Negative, notes: 14Jul & 15Jul Neg Antigen Test; (15Jul2022) Negative, notes: 14Jul & 15Jul Neg Antigen Test; (Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: other medication in 2weeks product Metformin ER 500, Losartan 100 MG, Amlodipine 5 MG, Atorvastatin 40 MG. Anti viral details product COVID 19 Treatment, Paxlovid, treatment start date 08Jul2022 and stop date 13Jul2022, lot number GA8853, Indication for Treatment of COVID-19. COVID19 relapse after Paxlovid treatment. 08Jul-13Jul Paxlovid treatment 14Jul & 15Jul Neg Antigen Test; 16Jul slight sore throat 17Jul (evening) sore throat, runny nose 18Jul fatigue, sore throat, runny nose, cough, Test Positive.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 23May2022 as dose 3 (booster), single (Lot number: FP4554) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 2, single (Lot number: 039F21A), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 07Apr2021 as dose 1, single (Lot number: 042A21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Nickel, reaction(s): "Known allergies: Nickel", notes: Known allergies: Nickel. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: COVID-19 Treatment Include Brand: Paxlovid, Treatment start date was 07Jul2022 and stop date was 12Jul2022. Adverse event reported as Congestion, sneezing, fever (100.3), runny nose.Adverse event start date was reported as 16Jul2022. Patient was Recovering. Patient taking any other medications/products within 2 weeks of starting COVID-19 treatment reported as no. Patient previously receive a COVID-19 Vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: pain around injection site; mild fatigue; mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2022 at 17:00 as dose 4 (booster), single (Lot number: FP7134) at the age of 54 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "mild fatigue"; HEADACHE (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "mild headache"; VACCINATION SITE PAIN (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "pain around injection site". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8734), on 19Apr2021 as dose 2, single (Lot number: EW0169), on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 31Mar2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing), notes: Other medical history: Fatty liver; "GERD" (unspecified if ongoing), notes: Other medical history: GERD. Concomitant medication(s) included: CALCIUM +D [CALCIUM CARBONATE;COLECALCIFEROL]; OMEPRAZOLE; RALOXIFENE; VOLTAREN [DICLOFENAC SODIUM]; CLARITIN [CLARITHROMYCIN]; SERTRALINE; MAGNESIUM; RESTASIS; PREMARIN. Past drug history included: Indocin, reaction(s): "Allergy", notes: Known allergies: Indocin.; Osphena, reaction(s): "Allergy", notes: Known allergies: Osphena; Niacin, reaction(s): "Allergy", notes: Known allergies: Niacin; Atorvastatin, reaction(s): "Allergy", notes: Known allergies: Atorvastatin. 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: (unspecified date) Negative, notes: Home test negative 02Jul after course of mild symptoms resolved; (unspecified date) Positive, notes: Home test positive on 04Jul with more symptoms than previously. NP thought 04Jul positive test was a relapse, not Paxlovid rebound,; (unspecified date) Negative, notes: Home tested negative 12Jul; (Jun2021) Unknown results, notes: Home tested plus Jun2021; (Jun2022) Unknown results, notes: PCR plus Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Patient received COVID 19 Treatment with Paxlovid, Treatment start date was 23Jun2022 and Treatment stop date was 27Jun2022, Home tested plus 21Jun. PCR plus 22Jun. Home test negative 02Jul after course of mild symptoms resolved. Home test positive on 04Jul with more symptoms than previously. home tested negative 12Jul. To date (18Jul) intermittent headaches and frontal sinus pressure. NP thought 04Jul positive test was a relapse, not Paxlovid rebound, but I wanted to report to contribute to data collection.
Age: 22.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 22 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: "COVID-19" (unspecified if ongoing); "Obesity" (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 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid (Anti-viral) on an unspecified date in Jul2022 for COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
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 a contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 at 17:00 as dose 3 (booster), single (Lot number: Ew0185) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=28Jun2022, treatment stop date=03Jul2022, lot number=00069-1085-30, indication=Treatment of COVID-19. This cased assessed as non-serious by the reporter.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: viral rebound; viral rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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), COVID-19 (medically significant), outcome "unknown" and all described as "viral rebound".  Clinical course: Description of Event: The office reported at least 3 cases of viral rebound. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-PV202200025379 Same reporter/ drug/ AE, different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: viral rebound; viral rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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), COVID-19 (medically significant), outcome "unknown" and all described as "viral rebound". Clinical course: The office reported at least 3 cases of viral rebound. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-PV202200025379 same drug /event, different patient.;
Age: 65.0
Sex: F
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 2 (initial pfizer dose), single (Lot number: 33030BD), in left arm, on 29Dec2021 as dose 3 (booster), single (Lot number: PE3594), in left arm and on 26Jan2022 as dose 4 (booster), single (Lot number: FJ1614) at the age of 65 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 1808609), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing);. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: thru Day 18 mildly positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was no Seriousness criteria reported. The patient was received OTC products with other medication details were with in 2 weeks used Synthroid, Sulfasalazine, Celebrex, Gabapentin, Lisinopril, Wellbutrin, Diclofenac Sodium Gel and Omeprazole. She was treatment OTC received for the adverse events . The AE had resulted in None of the above. The patient with AE was recovered and Recovering. The patient was received treatment for AE .The patient knew allergies did not reported.  No follow-up attempts are possible. No further information is expected.