chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Autonomic neuropathy
Clinical narrative: Male consumer states that he has had 4 Pfizer Covid 19 vaccines and at the same time developed Idiopathic Peripheral Neuropathy/His brother has also had 4 Pfizer shots and has the same issue.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 immunization; Bnt162b2 (Dose: 2, Single), for COVID-19 immunization; Bnt162b2 (Dose: 3, Single), for COVID-19 immunization.   The following information was reported: AUTONOMIC NEUROPATHY (medically significant), outcome "unknown", described as "Male consumer states that he has had 4 Pfizer Covid 19 vaccines and at the same time developed Idiopathic Peripheral Neuropathy/His brother has also had 4 Pfizer shots and has the same issue.". The events "male consumer states that he has had 4 pfizer covid 19 vaccines and at the same time developed idiopathic peripheral neuropathy/his brother has also had 4 pfizer shots and has the same issue." required physician office visit.  Clinical course: The male consumer stated that he has had 4 Pfizer COVID-19 vaccines and at the same time developed idiopathic peripheral neuropathy. He relayed that he has been to a Neurologist and Pediatrist and has not found any answers. He would like to know if there was information on this being reported with the vaccine or not. He stated that his brother has also had 4 Pfizer shots and has the same issue. He relayed that there was a disconnect because if you google idiopathic peripheral neuropathy and COVID vaccines then a lot of information came up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
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 37-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The covid test has rebounded after finishing the treatment and has remained positive for a week. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pulmonary function test, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The second time she contracted COVID-19 was in 2022, after she had already received vaccination; The second time she contracted COVID-19 was in 2022, after she had already received vaccination; she had fever at work; This is a spontaneous report received from 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), on 04Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 02May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "contracted COVID-19", start date: 2020 (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 16Aug2022, outcome "not recovered" and all described as "The second time she contracted COVID-19 was in 2022, after she had already received vaccination"; PYREXIA (non-serious) with onset 16Aug2022, outcome "unknown", described as "she had fever at work". The patient underwent the following laboratory tests and procedures: Pulmonary function test: (unspecified date) //2022; SARS-CoV-2 test: (19Aug2022) positive, notes: PCR test; (16Aug2022) positive. Additional information:This second time the patient contracted COVID-19 was in 2022. She went to a private doctor to have her lungs checked, she stated that she could breathe, but her voice was hoarser and she had more phlegm. On Tuesday afternoon 16Aug2022 she began to feel unwell, she had fever at work, when she got home around 7:00 she did a rapid-test which came back positive for COVID-19; on Friday 19Aug2022 she made an appointment and there they did the other  test (PCR),  she got the results on Sunday night which also confirmed she was positive (COVID). She requested information about Paxlovid, for emergency use, she wants to know if it is indicated for her and how to take it (she has not started taking Paxlovid yet).    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Malaise, Productive cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: The second time she contracted COVID-19 was in 2022, after she had already received vaccination; The second time she contracted COVID-19 was in 2022, after she had already received vaccination; she had fever at work; This is a spontaneous report received from 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), on 04Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 02May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "contracted COVID-19", start date: 2020 (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 16Aug2022, outcome "not recovered" and all described as "The second time she contracted COVID-19 was in 2022, after she had already received vaccination"; PYREXIA (non-serious) with onset 16Aug2022, outcome "unknown", described as "she had fever at work". The patient underwent the following laboratory tests and procedures: Pulmonary function test: (unspecified date) //2022; SARS-CoV-2 test: (19Aug2022) positive, notes: PCR test; (16Aug2022) positive. Additional information:This second time the patient contracted COVID-19 was in 2022. She went to a private doctor to have her lungs checked, she stated that she could breathe, but her voice was hoarser and she had more phlegm. On Tuesday afternoon 16Aug2022 she began to feel unwell, she had fever at work, when she got home around 7:00 she did a rapid-test which came back positive for COVID-19; on Friday 19Aug2022 she made an appointment and there they did the other  test (PCR),  she got the results on Sunday night which also confirmed she was positive (COVID). She requested information about Paxlovid, for emergency use, she wants to know if it is indicated for her and how to take it (she has not started taking Paxlovid yet).    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pulmonary function test, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from 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), on 02May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 1, second time she contracted COVID-19 was in 2022, after she had already received vaccination; on 04Apr2021 she got the first dose of Pfizer-BioNTech COVID-19 vaccine), administration date: 04Apr2021, when the patient was 61-year-old, for covid-19 immunization, reaction(s): "second time she contracted COVID-19 was in 2022, after she had already received vaccination", "second time she contracted COVID-19 was in 2022, after she had already received vaccination". The following information was reported: MALAISE (non-serious) with onset 16Aug2022, outcome "unknown", described as "feel unwell"; PYREXIA (non-serious) with onset 16Aug2022, outcome "unknown", described as "fever"; DYSPHONIA (non-serious), outcome "unknown", described as "her voice is hoarser"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "she has more phlegm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller mentioned that the first time she contracted COVID-19 was in 2020, before vaccines were out there. Booster dose she got on 2022 was Moderna COVID-19 vaccine. This second time she contracted COVID-19 she went to a private doctor to have her lungs checked, she stated that she can breathe, but her voice is hoarser and she had more phlegm. On Tuesday afternoon 16Aug2022 she began to feel unwell, she had fever at work, when she got home around 7:00 she did a rapid-test which came back positive for COVID-19; on Friday 19Aug2022 she made an appointment in (store name withheld) and there they did the other test (PCR), she got the results on Sunday night which also confirmed she was positive (COVID). She requested information about Paxlovid, for emergency use, she wants to know if it is indicated for her and how to take it (she has not started taking Paxlovid yet). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Malaise, Productive cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from 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), on 02May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 1, second time she contracted COVID-19 was in 2022, after she had already received vaccination; on 04Apr2021 she got the first dose of Pfizer-BioNTech COVID-19 vaccine), administration date: 04Apr2021, when the patient was 61-year-old, for covid-19 immunization, reaction(s): "second time she contracted COVID-19 was in 2022, after she had already received vaccination", "second time she contracted COVID-19 was in 2022, after she had already received vaccination". The following information was reported: MALAISE (non-serious) with onset 16Aug2022, outcome "unknown", described as "feel unwell"; PYREXIA (non-serious) with onset 16Aug2022, outcome "unknown", described as "fever"; DYSPHONIA (non-serious), outcome "unknown", described as "her voice is hoarser"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "she has more phlegm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller mentioned that the first time she contracted COVID-19 was in 2020, before vaccines were out there. Booster dose she got on 2022 was Moderna COVID-19 vaccine. This second time she contracted COVID-19 she went to a private doctor to have her lungs checked, she stated that she can breathe, but her voice is hoarser and she had more phlegm. On Tuesday afternoon 16Aug2022 she began to feel unwell, she had fever at work, when she got home around 7:00 she did a rapid-test which came back positive for COVID-19; on Friday 19Aug2022 she made an appointment in (store name withheld) and there they did the other test (PCR), she got the results on Sunday night which also confirmed she was positive (COVID). She requested information about Paxlovid, for emergency use, she wants to know if it is indicated for her and how to take it (she has not started taking Paxlovid yet). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 55-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Dose Number: 3, Batch/Lot No: EW0178, Location of injection: Arm Left), administration date: 11Nov2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06May2022, outcome "not recovered", described as "Swelling in lymph nodes in neck". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: No other vaccine in four weeks. Prior to the vaccine patient did not have covid and post vaccination covid tested was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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 "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Caller recently acquired Paxlovid and wants to know if she should receive the medication if she had two doses of the primary series of the Pfizer COVID-19 vaccine and a booster dose. Almost a year later since she received the shots (6 to 7 months) she tested positive for COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 01Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: RA1570), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:  Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Covid-19 treatment Paxlovid was given form 13Aug2022 to 18Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive rapid test 22Aug2022; symptoms started 21Aug2022 but rapid test was negative; Positive rapid test 22Aug2022; symptoms started 21Aug2022 but rapid test was negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day 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 21Aug2022, outcome "not recovered" and all described as "Positive rapid test 22Aug2022; symptoms started 21Aug2022 but rapid test was negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Negative, notes: COVID test type post vaccination: Nasal Swab; (22Aug2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria not Results in death/ Life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect. Facility type vaccine was unknown. Patient received no other vaccine in four weeks. Other medications in two weeks were unknown. Positive rapid test 22Aug2022; symptoms started 21Aug2022, but rapid test was negative. Patient had no covid prior vaccination. Patient tested covid post vaccination. Awareness date: 22Aug2022; Device timestamp: 23Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid positive; covid positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic rhinitis" (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 Aug2022, outcome "not recovered" and all described as "covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Negative; (19Aug2022) Positive; (Aug2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 11Aug2022 to 15Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
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. Other Case identifier(s): 22K-163-4510312-00.  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular 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 02Aug2022, outcome "recovered" (Aug2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter's causality for the event(s) of COVID and GI upset with Humira (Adalimumab) was a reasonable possibility.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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) (Physician).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK5730), in left arm, on 26Jan2021 as dose 2, single (Lot number: EL0142), in left arm and on 20Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 45 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive; (01Aug2022) Negative; (23Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Anti-viral details for COVID 19 treatment included Paxlovid, treatment start date: 28Jun2022, treatment stop date: 02Jul2022. COVID-19 infection on 27Jun2022. Tested positive 28Jun2022, started Paxlovid for 5 days and stopped 03Jul2022, then tested negative on 01Aug2022 and now again positive when tested on 23Aug2022 event start date was 23Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient received BNT162b2 (BNT162B2), on 19Aug2022 at 13:15 as dose 3 (booster), single (Lot number: FM9992) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot number: ER8727), administration date: 27Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot Number: ER8729), administration date: 17Apr2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Aug2022, outcome "unknown"; HEADACHE (non-serious) with onset Aug2022, outcome "unknown", described as "Headaches"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset Aug2022, outcome "unknown" and all described as "I had burning and tingling running across the knuckles of my right hand; base of the toes on both feet"; FATIGUE (non-serious) with onset Aug2022, outcome "unknown", described as "I had fatigue, spent two full days in bed"; VACCINATION SITE LYMPHADENOPATHY (non-serious) with onset Aug2022, outcome "unknown", described as "I had swelling of the lymph nodes in the right arm pit where the injection site was"; DIARRHOEA (non-serious) with onset Aug2022, outcome "recovered" (Aug2022), described as "I had two days of diarrhea"; PARAESTHESIA (non-serious) with onset 19Aug2022 at 13:30, outcome "unknown", described as "I had pins and needles shooting up my shoulder, up to the right side of my neck"; MUSCULOSKELETAL PAIN (non-serious), PAIN (non-serious) all with onset 20Aug2022, outcome "unknown" and all described as "I had burning pain under my left scapula". The events "i had swelling of the lymph nodes in the right arm pit where the injection site was", "i had pins and needles shooting up my shoulder, up to the right side of my neck", "i had burning pain under my left scapula", "chills", "i had fatigue, spent two full days in bed", "headaches" and "i had burning and tingling running across the knuckles of my right hand; base of the toes on both feet" required physician office visit. Therapeutic measures were taken as a result of vaccination site lymphadenopathy, paranesthesia, musculoskeletal pain, pain, chills, fatigue, headache, diarrhea, burning sensation, paranesthesia. Additional information: Within the 15 minutes after the injection patient had pins and needles shooting up shoulder, up to the right side of the neck. Treatment received was 200 milligram Ibuprofen, Icepack. Patient reported this to doctor and is fully informed on the list of adverse events that was experienced from the booster. That was really bad. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain, Paraesthesia, Vaccination site lymphadenopathy
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient received BNT162b2 (BNT162B2), on 19Aug2022 at 13:15 as dose 3 (booster), single (Lot number: FM9992) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot number: ER8727), administration date: 27Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot Number: ER8729), administration date: 17Apr2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Aug2022, outcome "unknown"; HEADACHE (non-serious) with onset Aug2022, outcome "unknown", described as "Headaches"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset Aug2022, outcome "unknown" and all described as "I had burning and tingling running across the knuckles of my right hand; base of the toes on both feet"; FATIGUE (non-serious) with onset Aug2022, outcome "unknown", described as "I had fatigue, spent two full days in bed"; VACCINATION SITE LYMPHADENOPATHY (non-serious) with onset Aug2022, outcome "unknown", described as "I had swelling of the lymph nodes in the right arm pit where the injection site was"; DIARRHOEA (non-serious) with onset Aug2022, outcome "recovered" (Aug2022), described as "I had two days of diarrhea"; PARAESTHESIA (non-serious) with onset 19Aug2022 at 13:30, outcome "unknown", described as "I had pins and needles shooting up my shoulder, up to the right side of my neck"; MUSCULOSKELETAL PAIN (non-serious), PAIN (non-serious) all with onset 20Aug2022, outcome "unknown" and all described as "I had burning pain under my left scapula". The events "i had swelling of the lymph nodes in the right arm pit where the injection site was", "i had pins and needles shooting up my shoulder, up to the right side of my neck", "i had burning pain under my left scapula", "chills", "i had fatigue, spent two full days in bed", "headaches" and "i had burning and tingling running across the knuckles of my right hand; base of the toes on both feet" required physician office visit. Therapeutic measures were taken as a result of vaccination site lymphadenopathy, paranesthesia, musculoskeletal pain, pain, chills, fatigue, headache, diarrhea, burning sensation, paranesthesia. Additional information: Within the 15 minutes after the injection patient had pins and needles shooting up shoulder, up to the right side of the neck. Treatment received was 200 milligram Ibuprofen, Icepack. Patient reported this to doctor and is fully informed on the list of adverse events that was experienced from the booster. That was really bad. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid about a year later; tested positive for Covid about a year later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid about a year later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was tested positive for COVID about a year later.  Clinical course: Patient stated, she/he had three shots for COVID. Two vaccinations (Later suspect clarified as Pfizer COVID-19 Vaccine) and a booster and then she/he was tested positive for COVID about a year later and was wondering would the medication Paxlovid, will that be a good drug for patient to take?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 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: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: NAPROXEN, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication was Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications the patient received within 2 weeks of vaccination was Naproxen on 01Feb2022. Patient had no known allergies. Patient received treatment for Covid-19 from 15Aug2022 to 20Aug2022. The patient received treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Illness, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: EW0158) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. Concomitant medication(s) included: ENALAPRIL taken for hypertension. Vaccination history included: BNT162b2 (Dose 1, Lot No: ERZ613), administration date: 23Mar2021, when the patient was 63-year-old, for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "I have been having muscle pain"; ILLNESS (non-serious), outcome "unknown", described as "they made me sick". The events "i have been having muscle pain" and "they made me sick" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia. Additional information: She went to the Emergency room and then they kept her and they sent her to another hospital of what they saying. Yeah, they gave her something for muscle spasm but they made her sick and she ended back in Emergency room. Yes, but they made her sick and She was supposed to take them.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Illness, Muscle spasms, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: EE2590) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. Concomitant medication(s) included: ENALAPRIL taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1, Single, Lot: ERZ613), administration date: 23Mar2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, Single, Lot: EW0158), administration date: 16Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "myalgia", "illness". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "they made me sick"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "muscle spasm"; MYALGIA (non-serious), outcome "not recovered", described as "I have been having muscle pain". The events "they made me sick", "muscle spasm" and "i have been having muscle pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, muscle spasms, myalgia. Additional information: Consumer stated, she had been having muscle pain and took the two vaccination Pfizer vaccination (Confirmed as Pfizer Covid19 vaccine) and was reading where they say it cause muscle pain so she called in. So, she wanted to report it that she was having muscle pain because on the paper that she got it says one of the side effects is muscle pain. She started experiencing muscle pain around her birthday. She went to the Emergency room and then they kept her and they sent her to another hospital of what they saying. Yeah, they gave her something for muscle spasm but they made her sick and ended back in Emergency room. She stated name of treatment medication was unknown as her doctor throw it away. Prior vaccinations was reported as no. Patient received another dose of covid-19 vaccine on 12Jul2022 (batch/lot number: FJ6963).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Illness, Muscle spasms, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 12Jul2022 as dose 4 (booster), single (Lot number: FJ6963) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: Verbatim: Hypertension. Concomitant medication(s) included: ENALAPRIL taken for hypertension. Vaccination history included: covid-19 vaccine (Dose 1, Lot no. ERZ613), administration date: 23Mar2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot no. EW0158), administration date: 16Apr2021, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "patient have been having muscle pain; patient was having muscle pain", "they made her sick"; BNT162b2 (Dose 3, Lot no. EE2590), administration date: 22Oct2021, when the patient was 64-year-old, for Covid-19 immunization, reaction(s): "patient have been having muscle pain; patient was having muscle pain", "they made her sick". The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "patient have been having muscle pain"; ILLNESS (non-serious), outcome "unknown", described as "They made her sick"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasm". The events "patient have been having muscle pain", "they made her sick" and "muscle spasm" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, muscle spasms. Additional information: Patient had not any prior vaccinations. It was reported that, consumer stated patient have been having muscle pain and she took the two vaccination Pfizer vaccination (Confirmed as Pfizer Covid19 vaccine) and she was reading where they said it cause muscle pain so she was calling in. Reporter stated, "23Mar2021, patient took the first one and the fourth month 16 2021(Confirmed as 16Apr2021) and then 22Oct2021 and then 12Jul2022 and patient was having muscle pain since Jun2021." Patient started experiencing her muscle pain around her birthday. She wanted to report it that she was having muscle pain because on the paper that she got it said one of the side effects was muscle pain." Treatment: Consumer stated she went to the Emergency room and then they kept her and they sent her to another hospital of what they saying. They gave her something for muscle spasm but they made her sick (Event captured conservatively) and she ended back in Emergency room. They made her sick and she was supposed to take them."
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 which include paxlovid from 10Aug2022 to 14Aug2022.  Clinical course: 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: 65.0
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 65 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), notes: other medical history: asthma; "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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 57.0
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) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: 048L21A CU511081) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, 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: Treatment for covid-19 Test; (Aug2022) Negative, notes: On day 8 after testing positive; (Aug2022) Positive, notes: On day 7 after testing positive; (Aug2022) Positive, notes: A rapid antigen test was only faintly negative; (Aug2022) Positive, notes: a rapid antigen test was strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  Clinical Course: It was reported that on day 7 after testing positive, her COVID symptoms were very minor and a rapid antigen test was only faintly negative. On day 8 after testing positive, her COVID symptoms resumed and a rapid antigen test was strongly positive. It is now day 9 and her symptoms and test results are still strong. The patient received treatment with Paxlovid from 14Aug2022 to 18Aug2022. The patient received other medication within 2 weeks of vaccination. The patient had no known allergies and no other medical history.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 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 had no relevant medical history. Patient had no known allergies. Concomitant medication(s) included: TYLENOL (other medication in 2weeks), start date: 12Aug2022, stop date: 17Aug2022. 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: (24Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 12Aug2022 to 16Aug2022.  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: started taking Paxlovid last Sunday and is on her 4th day of the treatment; started taking Paxlovid last Sunday and is on her 4th day of the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient 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 "started taking Paxlovid last Sunday and is on her 4th day of the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FL3184), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, 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 had no other medication in 2 weeks. The patient was treated for COVID-19 with Paxlovid from 12Aug2022 to 16Aug2022. The patient previously received a COVID-19 Vaccine. Symptoms were significantly diminished from original infection which began 11Aug2022. Original infection symptoms were headache, sore throat, muscle aches and nasal discharge. No known allergies.