chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Ventricular extrasystoles
Clinical narrative: heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); more and more palpitations; it was getting progressively worse after every vaccine; My blood pressure is all over the place; Fluctuating heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe immune deficiency" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: patient already had heart issues before vaccinations; "palpitations" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations aggravated", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations aggravated", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations; it was getting progressively worse after every vaccine"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: "Before I had any of the vaccine I already had heart issues. After I had the vaccine and the boosters I have had more and more palpitations. I have been having a lot of PVC's. My blood pressure is all over the place. I have Fluctuating heart rate. All of that is because of all the vaccines. I noticed it was getting progressively worse after every vaccine. It has gotten better the longer I haven't taken a vaccine. My last vaccine was in September 2022 and it has improved while not having any more vaccines".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Heart rate, Heart rate irregular, Palpitations
Clinical narrative: heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); more and more palpitations; it was getting progressively worse after every vaccine; My blood pressure is all over the place; Fluctuating heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe immune deficiency" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: patient already had heart issues before vaccinations; "Palpitations" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations; it was getting progressively worse after every vaccine"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "Before I had any of the vaccine I already had heart issues. After I had the vaccine and the boosters I have had more and more palpitations. I have been having a lot of PVC's. My blood pressure is all over the place. I have Fluctuating heart rate. All of that is because of all the vaccines. I noticed it was getting progressively worse after every vaccine. It has gotten better the longer I haven't taken a vaccine. My last vaccine was in September 2022 and it has improved while not having any more vaccines". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose (dose 4);
Sex: U
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Ventricular extrasystoles
Clinical narrative: heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); more and more palpitations; it was getting progressively worse after every vaccine; My blood pressure is all over the place; Fluctuating heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe immune deficiency" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: patient already had heart issues before vaccinations; "Palpitations" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations; it was getting progressively worse after every vaccine"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "Before I had any of the vaccine I already had heart issues. After I had the vaccine and the boosters I have had more and more palpitations. I have been having a lot of PVC's. My blood pressure is all over the place. I have Fluctuating heart rate. All of that is because of all the vaccines. I noticed it was getting progressively worse after every vaccine. It has gotten better the longer I haven't taken a vaccine. My last vaccine was in September 2022 and it has improved while not having any more vaccines". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose (dose 4);
Sex: F
Vaccine: COVID19
Symptoms: Peroneal nerve palsy
Clinical narrative: Got dropped foot within 10 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERONEAL NERVE PALSY (non-serious), outcome "unknown", described as "Got dropped foot within 10 days".  Additional information: When the reporter was asked if there is any other people who got the vaccine (Pfizer COVID-19 Vaccine) and experienced the same issues, reporter stated, "Yes, because I know 2 girls they got dropped foot within 10 days". The reporter also stated, "That is not my place to report about their medical information but I will give them this number for them to call because I don't know the total exact."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400555 same drug/event, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Extremity due to vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Extremity due to vaccine".
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity
Clinical narrative: muscle jerked and twitched; sore on left arm/it is been hurting since; 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 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "muscle jerked and twitched"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore on left arm/it is been hurting since".  Additional information: the patient reported that when the vaccination provider put the shot in his arm, his muscle jerked and twitched, then the patient stated that his arm has been hurting since and it's been a month. The patient put hot packs on his arm, however they have not worked. Patient stated that he is going to try ice on it now.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 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: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Nov2023, outcome "unknown", described as "flu like symptoms".  Additional information: the patient received yesterday Pfizer's Comirnaty vaccine and he is now experiencing flu like symptoms, he wanted to know if he can he take tylenol.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Heart alternation, Heart rate abnormal
Clinical narrative: Extreme low energy; Feels like my heart is over working; Extremely tired; Muscle ache; Hard to breathe sometimes; Lack of sleep; Cold hands & feet; almost like my heart beat is off; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ASTHENIA (non-serious), outcome "unknown", described as "Extreme low energy"; HEART ALTERNATION (non-serious), outcome "unknown", described as "Feels like my heart is over working"; FATIGUE (non-serious), outcome "unknown", described as "Extremely tired"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; DYSPNOEA (non-serious), outcome "unknown", described as "Hard to breathe sometimes"; INSOMNIA (non-serious), outcome "unknown", described as "Lack of sleep"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "Cold hands & feet"; HEART RATE ABNORMAL (non-serious), outcome "unknown", described as "almost like my heart beat is off".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Peripheral coldness
Clinical narrative: Extreme low energy; Feels like my heart is over working; Extremely tired; Muscle ache; Hard to breathe sometimes; Lack of sleep; Cold hands & feet; almost like my heart beat is off; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ASTHENIA (non-serious), outcome "unknown", described as "Extreme low energy"; HEART ALTERNATION (non-serious), outcome "unknown", described as "Feels like my heart is over working"; FATIGUE (non-serious), outcome "unknown", described as "Extremely tired"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; DYSPNOEA (non-serious), outcome "unknown", described as "Hard to breathe sometimes"; INSOMNIA (non-serious), outcome "unknown", described as "Lack of sleep"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "Cold hands & feet"; HEART RATE ABNORMAL (non-serious), outcome "unknown", described as "almost like my heart beat is off".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EN6206) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), on 14Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Second dose, Lot. EN6206), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Second dose, Lot. EN6206), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Third dose, Lot. FH8027), administration date: 14Nov2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Full blood count, Headache
Clinical narrative: severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; chronic pain over entire head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 21-year-old male patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Chronic depression", start date: Jan2018 (ongoing); "Anxiety", start date: Jan2018 (ongoing); "OCD", start date: Jan2018 (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; FLUOXETINE; NORTRIPTYLINE. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "chronic pain over entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". The events "severe muscle ache and joint pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300180183 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-PV202300192087 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myalgia, Nausea, X-ray
Clinical narrative: severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; chronic pain over entire head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 21-year-old male patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Chronic depression", start date: Jan2018 (ongoing); "Anxiety", start date: Jan2018 (ongoing); "OCD", start date: Jan2018 (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; FLUOXETINE; NORTRIPTYLINE. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "chronic pain over entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". The events "severe muscle ache and joint pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300180183 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-PV202300192087 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Headache, Myalgia
Clinical narrative: severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; chronic pain over entire head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 21-year-old male patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Chronic depression", start date: Jan2018 (ongoing); "Anxiety", start date: Jan2018 (ongoing); "OCD", start date: Jan2018 (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; FLUOXETINE; NORTRIPTYLINE. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "chronic pain over entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". The events "severe muscle ache and joint pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300180183 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-PV202300192087 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; chronic pain over entire head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 21-year-old male patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Chronic depression", start date: Jan2018 (ongoing); "Anxiety", start date: Jan2018 (ongoing); "OCD", start date: Jan2018 (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; FLUOXETINE; NORTRIPTYLINE. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "chronic pain over entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". The events "severe muscle ache and joint pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300180183 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-PV202300192087 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Full blood count, Headache
Clinical narrative: chronic pain all entire head; severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received bnt162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FLUOXETINE; NORTRIPTILINA. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "chronic pain all entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". The events "chronic pain all entire head", "severe muscle ache and joint pain", "extreme fatigue", "chest pain" and "nausea" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400483 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300397042 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myalgia, Nausea, X-ray
Clinical narrative: chronic pain all entire head; severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received bnt162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FLUOXETINE; NORTRIPTILINA. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "chronic pain all entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". The events "chronic pain all entire head", "severe muscle ache and joint pain", "extreme fatigue", "chest pain" and "nausea" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400483 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300397042 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Headache, Myalgia
Clinical narrative: chronic pain all entire head; severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received bnt162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FLUOXETINE; NORTRIPTILINA. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "chronic pain all entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". The events "chronic pain all entire head", "severe muscle ache and joint pain", "extreme fatigue", "chest pain" and "nausea" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400483 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300397042 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: chronic pain all entire head; severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received bnt162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FLUOXETINE; NORTRIPTILINA. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "chronic pain all entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". The events "chronic pain all entire head", "severe muscle ache and joint pain", "extreme fatigue", "chest pain" and "nausea" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400483 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300397042 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Sex: F
Vaccine: COVID19
Symptoms: Peroneal nerve palsy
Clinical narrative: Got dropped foot within 10 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), 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: PERONEAL NERVE PALSY (non-serious), outcome "unknown", described as "Got dropped foot within 10 days".  Additional information: When the reporter was asked if there is any other people who got the vaccine (Pfizer COVID-19 Vaccine) and experienced the same issues, reporter stated, "Yes, because I know 2 girls they got dropped foot within 10 days". The reporter also stated, "That is not my place to report about their medical information but I will give them this number for them to call because I don't know the total exact."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300396841 same drug/event, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: low energy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "low energy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Arm itching for 9 days post vaccination; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset Nov2023, outcome "unknown", described as "Arm itching for 9 days post vaccination".
Sex: U
Vaccine: COVID19
Symptoms: Blindness unilateral, Investigation, Ocular vascular disorder
Clinical narrative: Like the fact that your COVID vaccine made me go blind in one eye!; Eye Stroke/Ocular vascular disorder; The initial case was missing the following minimum criteria: [ICH- unidentifiable reporter]. Upon receipt of follow-up information on [20Nov2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "Like the fact that your COVID vaccine made me go blind in one eye!"; OCULAR VASCULAR DISORDER (non-serious), outcome "unknown", described as "Eye Stroke/Ocular vascular disorder". The events "like the fact that your covid vaccine made me go blind in one eye!" and "eye stroke/ocular vascular disorder" required physician office visit. The patient underwent the following laboratory tests and procedures: Full series of tests: Unknown results, notes: Had full series of tests to determine why with nothing noted. Clinical course: After receiving the Covid-19 vaccinations, patient had an Eye Stoke. Had full series of tests to determine why with nothing noted. The only explanation was the Pfizer Covid 19 vaccines. Patient was now blind in right eye and not able to do half of what patient was able to do before. Patient one doctor who said Eye Stokes have been associated with vaccine, but that mainstream medical didn't agree.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Nov2023): This is a spontaneous follow-up report received from a contactable Consumer. Updated information included: Case was updated from invalid to valid. Reporter information (mailing address, phone number and email address), patient information added, lab data added, Historical vaccine added, suspect information (dose number and dose description) and new event (Eye Stroke) added.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Red blood cell sedimentation rate, Thyroid function test, Thyroiditis subacute
Clinical narrative: Subacute Thyroiditis Following COVID-19 Vaccination; This is a literature report.  A 42-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (UNKNOWN MANUFACTURER)), for COVID-19 immunisation. Case: A patient with no past medical history, presented to the Endocrinology clinic with anterior neck pain around his thyroid area that started 3 days after his 2nd Pfizer COVID-19 vaccine. He described the pain as severe enough to wake him up from sleep. No weight loss, palpitation, heat intolerance or tremors. No prior exposure to stable iodine or radiation treatment. He takes no medications. He denies tobacco or alcohol use. Initial thyroid labs showed a T3 2.8 (2.5 - 4.4 pg/mL), T4 1.4 (0.61 - 1.44 ng/dL), TSH 1.4 (0.45 - 5.33 uIU/mL), TPO antibodies positive, thyroglobulin Ab undetectable, sedimentation rate of 42 (<30 mm/Hr). Ultrasound of the neck showed 1.7-centimeter TIRADS 4 nodules in the left lobe, and 0.9 cm on the right. The patient was noticing a discomfort in the right side of the neck. He was also having swallowing difficulties, low-grade fever, body ache, night sweats and unintentional weight loss. Though he initially presented with thyroid labs that were within the normal reference range, by the time he repeated them one month later, he was hyperthyroid. He was started on prednisone 20 mg and NSAID. At 2 weeks follow-up, his pain and swallowing difficulty have significantly improved. Over time, the patient's thyroid labs normalized and the pain in the neck subsided, repeat neck US 5 months later showed decreased nodule size. Steroids was stopped.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Subacute Thyroiditis cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine, Tri-iodothyronine, Ultrasound neck, Weight
Clinical narrative: Subacute Thyroiditis Following COVID-19 Vaccination; This is a literature report.  A 42-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (UNKNOWN MANUFACTURER)), for COVID-19 immunisation. Case: A patient with no past medical history, presented to the Endocrinology clinic with anterior neck pain around his thyroid area that started 3 days after his 2nd Pfizer COVID-19 vaccine. He described the pain as severe enough to wake him up from sleep. No weight loss, palpitation, heat intolerance or tremors. No prior exposure to stable iodine or radiation treatment. He takes no medications. He denies tobacco or alcohol use. Initial thyroid labs showed a T3 2.8 (2.5 - 4.4 pg/mL), T4 1.4 (0.61 - 1.44 ng/dL), TSH 1.4 (0.45 - 5.33 uIU/mL), TPO antibodies positive, thyroglobulin Ab undetectable, sedimentation rate of 42 (<30 mm/Hr). Ultrasound of the neck showed 1.7-centimeter TIRADS 4 nodules in the left lobe, and 0.9 cm on the right. The patient was noticing a discomfort in the right side of the neck. He was also having swallowing difficulties, low-grade fever, body ache, night sweats and unintentional weight loss. Though he initially presented with thyroid labs that were within the normal reference range, by the time he repeated them one month later, he was hyperthyroid. He was started on prednisone 20 mg and NSAID. At 2 weeks follow-up, his pain and swallowing difficulty have significantly improved. Over time, the patient's thyroid labs normalized and the pain in the neck subsided, repeat neck US 5 months later showed decreased nodule size. Steroids was stopped.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Subacute Thyroiditis cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Imaging procedure, Red blood cell sedimentation rate, SARS-CoV-2 test, Thyroiditis subacute
Clinical narrative: Subacute Thyroiditis Following mRNA Vaccine for COVID-19; This is a literature report.  A 40-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation. Clinical Case: A patient with no significant medical history presented with signs and symptoms of thyrotoxicosis after receiving the Pfizer COVID-19 vaccine. Symptoms began 3 days after receiving the second vaccine dose and included 9 kg unintentional weight loss, arthralgia in both knees, palpitations, fatigue, bilateral thigh weakness, and diffuse neck swelling, pain, and tenderness. Initial treatment with antibiotics for presumed upper respiratory infection did not improve symptoms, and PCR testing for COVID-19 infection was negative. Thyroid ultrasound obtained 15 days after symptoms onset revealed a 4 cm nodule in the left lobe of the thyroid gland. Testing 30 days after onset of symptoms demonstrated TSH<0.005 uIU/mL (ref: 0.45-4.50 uIU/mL), elevated free T4 of 2.53 ng/dL (ref: 0.82-1.77 ng/dL), and elevated erythrocyte sedimentation rate of 42 mm/hr (ref: 0-15 mm/hr). Repeat labs and imaging 9 days later demonstrated improvement with a TSH of 0.071 uIU/mL and free T4 of 1.04 ng/dL as well as decreased nodule size (2.5 cm). At this time, the patient reported resolution of all symptoms and return to baseline weight. Thyroid ultrasound obtained 3 months after symptoms onset demonstrated normal thyroid without detectable nodules or enlargement, and complete normalization of TSH and free T4 levels to 4.250 uIU/mL and 1.22 ng/dL, respectively.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Subacute Thyroiditis cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine free, Ultrasound thyroid, Weight
Clinical narrative: Subacute Thyroiditis Following mRNA Vaccine for COVID-19; This is a literature report.  A 40-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation. Clinical Case: A patient with no significant medical history presented with signs and symptoms of thyrotoxicosis after receiving the Pfizer COVID-19 vaccine. Symptoms began 3 days after receiving the second vaccine dose and included 9 kg unintentional weight loss, arthralgia in both knees, palpitations, fatigue, bilateral thigh weakness, and diffuse neck swelling, pain, and tenderness. Initial treatment with antibiotics for presumed upper respiratory infection did not improve symptoms, and PCR testing for COVID-19 infection was negative. Thyroid ultrasound obtained 15 days after symptoms onset revealed a 4 cm nodule in the left lobe of the thyroid gland. Testing 30 days after onset of symptoms demonstrated TSH<0.005 uIU/mL (ref: 0.45-4.50 uIU/mL), elevated free T4 of 2.53 ng/dL (ref: 0.82-1.77 ng/dL), and elevated erythrocyte sedimentation rate of 42 mm/hr (ref: 0-15 mm/hr). Repeat labs and imaging 9 days later demonstrated improvement with a TSH of 0.071 uIU/mL and free T4 of 1.04 ng/dL as well as decreased nodule size (2.5 cm). At this time, the patient reported resolution of all symptoms and return to baseline weight. Thyroid ultrasound obtained 3 months after symptoms onset demonstrated normal thyroid without detectable nodules or enlargement, and complete normalization of TSH and free T4 levels to 4.250 uIU/mL and 1.22 ng/dL, respectively.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Subacute Thyroiditis cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  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