chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: experienced random uncomfortableness; swollen lymph nodes under my arms; The swelling continued and only started subsiding until after the Booster; lymph node pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Jan2022 17:00 (Lot number: FL3198) as dose 3 (booster), single, administered in arm left, administration date 25Apr2021 (Lot number: EW0170) as dose 2, single and administered in arm left, administration date 02Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HP" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2015 (ongoing); SIMVASTATIN taken for blood cholesterol, start date: 2020 (ongoing). The following information was reported: DISCOMFORT (non-serious) with onset Apr2021, outcome "recovered", described as "experienced random uncomfortableness"; LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "unknown", described as "swollen lymph nodes under my arms"; SWELLING (non-serious) with onset Apr2021, outcome "recovering", described as "The swelling continued and only started subsiding until after the Booster"; LYMPH NODE PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "lymph node pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient had both of COVID vaccines back in April and have experienced random uncomfortableness from time to time because of swollen lymph nodes under my arms. Patient had ultrasounds that have confirmed the swelling and will be going for an MRI in a few weeks. Patient reluctant to go for my booster. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia was Unknown. Patient experienced lymph node pain after my first vaccine in April, the swelling continued and only started subsiding until after the Booster in Jan2022. At First, after the booster the swelling was worse for the first week, now the Discomfort is minimal, almost gone.  No follow-up attempts are possible. No further information is expected.  Follow-Up (23Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2022 (Lot number: FE3594) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 19Jan2022, outcome "not recovered", described as "hump at injection site"; VACCINATION SITE WARMTH (non-serious) with onset 19Jan2022, outcome "not recovered", described as "injection site very warm to touch"; VACCINATION SITE PRURITUS (non-serious) with onset 19Jan2022, outcome "not recovered", described as "injection site very itchy down to the mid arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "injection site red"; VACCINATION SITE PAIN (non-serious) with onset 19Jan2022, outcome "not recovered", described as "injection site tenderness pain". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site warmth, vaccination site pruritus, vaccination site erythema, vaccination site pain. Additional information: The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Event reported as hump at injection site, site very warm to touch very itchy down to the mid arm red tenderness pain. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient was not tested for COVID-19.No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Fatigue, Headache, Hyperhidrosis
Clinical narrative: after the 1st dose I could barely bare weight, stand up and walk for over a week; chills; sweats; headaches; fever; tingling throughout body; tiredness; muscle weakness; Delayed & inconsistent menstrual cycles; Forgetfulness; migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Feb2021 (Lot number: EL3246) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSSTASIA (non-serious) with onset Feb2021, outcome "not recovered", described as "after the 1st dose I could barely bare weight, stand up and walk for over a week"; CHILLS (non-serious) with onset Feb2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset Feb2021, outcome "not recovered", described as "sweats"; HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset Feb2021, outcome "not recovered", described as "fever"; PARAESTHESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "tingling throughout body"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "tiredness"; MUSCULAR WEAKNESS (non-serious) with onset Feb2021, outcome "not recovered", described as "muscle weakness"; MENSTRUAL DISORDER (non-serious) with onset Feb2021, outcome "not recovered", described as "Delayed & inconsistent menstrual cycles"; MEMORY IMPAIRMENT (non-serious) with onset Feb2021, outcome "not recovered", described as "Forgetfulness"; MIGRAINE (non-serious) with onset Feb2021, outcome "not recovered", described as "migraines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysstasia, chills, hyperhidrosis, headache, pyrexia, paraesthesia, fatigue, muscular weakness, menstrual disorder, memory impairment, migraine. Additional information: If other vaccine in four weeks: No. Adverse event: Numbness and tingling in my legs from the waist done. Daily headaches/migraines. Forgetfulness. Delayed & inconsistent menstrual cycles. with both the 1st & 2nd dose within 10 mins of it being administered I had chills, sweats, headaches, fever, tingling throughout body, tiredness, muscle weakness, - these lasted over a week for both doses. after the 1st dose I could barely bare weight, stand up and walk for over a week. Adverse events start time: 03:15PM. No covid prior vaccination. If covid was tested post vaccination. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200130355 similar report from same reporter
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Menstrual disorder, Migraine, Muscular weakness, Paraesthesia
Clinical narrative: after the 1st dose I could barely bare weight, stand up and walk for over a week; chills; sweats; headaches; fever; tingling throughout body; tiredness; muscle weakness; Delayed & inconsistent menstrual cycles; Forgetfulness; migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Feb2021 (Lot number: EL3246) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSSTASIA (non-serious) with onset Feb2021, outcome "not recovered", described as "after the 1st dose I could barely bare weight, stand up and walk for over a week"; CHILLS (non-serious) with onset Feb2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset Feb2021, outcome "not recovered", described as "sweats"; HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset Feb2021, outcome "not recovered", described as "fever"; PARAESTHESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "tingling throughout body"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "tiredness"; MUSCULAR WEAKNESS (non-serious) with onset Feb2021, outcome "not recovered", described as "muscle weakness"; MENSTRUAL DISORDER (non-serious) with onset Feb2021, outcome "not recovered", described as "Delayed & inconsistent menstrual cycles"; MEMORY IMPAIRMENT (non-serious) with onset Feb2021, outcome "not recovered", described as "Forgetfulness"; MIGRAINE (non-serious) with onset Feb2021, outcome "not recovered", described as "migraines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysstasia, chills, hyperhidrosis, headache, pyrexia, paraesthesia, fatigue, muscular weakness, menstrual disorder, memory impairment, migraine. Additional information: If other vaccine in four weeks: No. Adverse event: Numbness and tingling in my legs from the waist done. Daily headaches/migraines. Forgetfulness. Delayed & inconsistent menstrual cycles. with both the 1st & 2nd dose within 10 mins of it being administered I had chills, sweats, headaches, fever, tingling throughout body, tiredness, muscle weakness, - these lasted over a week for both doses. after the 1st dose I could barely bare weight, stand up and walk for over a week. Adverse events start time: 03:15PM. No covid prior vaccination. If covid was tested post vaccination. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200130355 similar report from same reporter
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: after the 1st dose I could barely bare weight, stand up and walk for over a week; chills; sweats; headaches; fever; tingling throughout body; tiredness; muscle weakness; Delayed & inconsistent menstrual cycles; Forgetfulness; migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Feb2021 (Lot number: EL3246) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSSTASIA (non-serious) with onset Feb2021, outcome "not recovered", described as "after the 1st dose I could barely bare weight, stand up and walk for over a week"; CHILLS (non-serious) with onset Feb2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset Feb2021, outcome "not recovered", described as "sweats"; HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset Feb2021, outcome "not recovered", described as "fever"; PARAESTHESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "tingling throughout body"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "tiredness"; MUSCULAR WEAKNESS (non-serious) with onset Feb2021, outcome "not recovered", described as "muscle weakness"; MENSTRUAL DISORDER (non-serious) with onset Feb2021, outcome "not recovered", described as "Delayed & inconsistent menstrual cycles"; MEMORY IMPAIRMENT (non-serious) with onset Feb2021, outcome "not recovered", described as "Forgetfulness"; MIGRAINE (non-serious) with onset Feb2021, outcome "not recovered", described as "migraines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysstasia, chills, hyperhidrosis, headache, pyrexia, paraesthesia, fatigue, muscular weakness, menstrual disorder, memory impairment, migraine. Additional information: If other vaccine in four weeks: No. Adverse event: Numbness and tingling in my legs from the waist done. Daily headaches/migraines. Forgetfulness. Delayed & inconsistent menstrual cycles. with both the 1st & 2nd dose within 10 mins of it being administered I had chills, sweats, headaches, fever, tingling throughout body, tiredness, muscle weakness, - these lasted over a week for both doses. after the 1st dose I could barely bare weight, stand up and walk for over a week. Adverse events start time: 03:15PM. No covid prior vaccination. If covid was tested post vaccination. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200130355 similar report from same reporter
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Fatigue, Headache
Clinical narrative: 5-6 episodes of vomiting; headache; fever up to 102f; lower lip swelling; joint pains; weakness; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 15:30 (Lot number: FL0007) at the age of 7 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 03:30 AM), administration date: 29Dec2021, when the patient was 7 years old, for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "5-6 episodes of vomiting"; HEADACHE (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "fever up to 102f"; LIP SWELLING (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "lower lip swelling"; ARTHRALGIA (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "joint pains"; ASTHENIA (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "weakness"; FATIGUE (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "tiredness". The events "5-6 episodes of vomiting", "headache", "fever up to 102f", "lower lip swelling", "joint pains", "weakness" and "tiredness" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, headache, pyrexia, lip swelling, arthralgia, asthenia, fatigue.  Additional information: Adverse event: 2 days after the vaccine, he developed headache, fever up to 102f, lower lip swelling, joint pains, weakness, tiredness and 5-6 episodes of vomiting. Ae resulted in: Doctor or other healthcare professional office/clinic visit. Patient was recovering, there was no treatment, no prior Covid vaccination, not tested for Covid post vaccination, no known allergies and there was no other medical history.   No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia, Vomiting
Clinical narrative: 5-6 episodes of vomiting; headache; fever up to 102f; lower lip swelling; joint pains; weakness; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 15:30 (Lot number: FL0007) at the age of 7 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 03:30 AM), administration date: 29Dec2021, when the patient was 7 years old, for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "5-6 episodes of vomiting"; HEADACHE (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "fever up to 102f"; LIP SWELLING (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "lower lip swelling"; ARTHRALGIA (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "joint pains"; ASTHENIA (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "weakness"; FATIGUE (non-serious) with onset 22Jan2022 18:00, outcome "recovering", described as "tiredness". The events "5-6 episodes of vomiting", "headache", "fever up to 102f", "lower lip swelling", "joint pains", "weakness" and "tiredness" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, headache, pyrexia, lip swelling, arthralgia, asthenia, fatigue.  Additional information: Adverse event: 2 days after the vaccine, he developed headache, fever up to 102f, lower lip swelling, joint pains, weakness, tiredness and 5-6 episodes of vomiting. Ae resulted in: Doctor or other healthcare professional office/clinic visit. Patient was recovering, there was no treatment, no prior Covid vaccination, not tested for Covid post vaccination, no known allergies and there was no other medical history.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Headache
Clinical narrative: fever; chills; body aches; headache; loss of appetite; unable to sleep all night; major joint hurt; overall unwellness; diarrhea; Sweating; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 44-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 01Feb2021 14:00 (Lot number: EL9810) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single; Batch/Lot number: EL3249; via intramuscular route; Anatomical site: Right deltoid; Time: 14:00), administration date: 01Jan2021, when the patient was 44 years old, for Covid-19 immunization, reaction(s): "Soreness at injection site". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; DECREASED APPETITE (non-serious) with onset 2021, outcome "recovered" (2021), described as "loss of appetite"; INSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "unable to sleep all night"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "major joint hurt"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "overall unwellness"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "diarrhea"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sweating". Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Family Medical History Relevant to AE reported as none. Relevant tests reported as none. Specific relevant test for thromboembolic events with thrombocytopenia reported as none. The 1st vaccine only side effects was soreness at injection site for a day or two. The 2nd vaccine side effects were similar to booster but not near as bad and only lasted approximately 36 hours. She felt so bad and she thinks that getting it again would not be healthy and felt as though this was a reaction that got worse each time and a 4th dose would send her to hospital. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Malaise, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; headache; loss of appetite; unable to sleep all night; major joint hurt; overall unwellness; diarrhea; Sweating; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 44-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 01Feb2021 14:00 (Lot number: EL9810) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single; Batch/Lot number: EL3249; via intramuscular route; Anatomical site: Right deltoid; Time: 14:00), administration date: 01Jan2021, when the patient was 44 years old, for Covid-19 immunization, reaction(s): "Soreness at injection site". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; DECREASED APPETITE (non-serious) with onset 2021, outcome "recovered" (2021), described as "loss of appetite"; INSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "unable to sleep all night"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "major joint hurt"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "overall unwellness"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "diarrhea"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sweating". Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Family Medical History Relevant to AE reported as none. Relevant tests reported as none. Specific relevant test for thromboembolic events with thrombocytopenia reported as none. The 1st vaccine only side effects was soreness at injection site for a day or two. The 2nd vaccine side effects were similar to booster but not near as bad and only lasted approximately 36 hours. She felt so bad and she thinks that getting it again would not be healthy and felt as though this was a reaction that got worse each time and a 4th dose would send her to hospital. No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: really tired; excessive heat production; blocked/clogged ears; trouble hearing; face was red; sweating; Headache; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jan2022 19:45 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Covid vaccine: 03Jan2022, Lot Number / Expiry Date: FK5618/unknown, Route, Anatomical Location: right arm), administration date: 03Jan2022, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 25Jan2022, outcome "not recovered", described as "really tired"; FEELING HOT (non-serious) with onset 24Jan2022, outcome "not recovered", described as "excessive heat production"; EAR DISCOMFORT (non-serious) with onset 24Jan2022, outcome "recovered" (24Jan2022), described as "blocked/clogged ears"; HYPOACUSIS (non-serious) with onset 24Jan2022, outcome "unknown", described as "trouble hearing"; ERYTHEMA (non-serious) with onset 24Jan2022, outcome "recovered" (24Jan2022), described as "face was red"; HYPERHIDROSIS (non-serious) with onset 24Jan2022, outcome "not recovered", described as "sweating"; HEADACHE (non-serious) with onset 24Jan2022, outcome "not recovered", described as "Headache".  Additional Information: Additional vaccines administered on the same day and prior vaccination within 4 weeks was reported as none. The reporter stated that about 20 minutes later while driving home, the patient complained of excessive heat production and blocked/clogged ears which caused trouble hearing, ''hard for me to hear, mommy I'm too hot''. At home, the patient's face was red, was sweating only a little bit but not profusely. The reporter went to wake her child up, he was still tired, and he had no fever.   No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis
Clinical narrative: really tired; excessive heat production; blocked/clogged ears; trouble hearing; face was red; sweating; Headache; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jan2022 19:45 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Covid vaccine: 03Jan2022, Lot Number / Expiry Date: FK5618/unknown, Route, Anatomical Location: right arm), administration date: 03Jan2022, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 25Jan2022, outcome "not recovered", described as "really tired"; FEELING HOT (non-serious) with onset 24Jan2022, outcome "not recovered", described as "excessive heat production"; EAR DISCOMFORT (non-serious) with onset 24Jan2022, outcome "recovered" (24Jan2022), described as "blocked/clogged ears"; HYPOACUSIS (non-serious) with onset 24Jan2022, outcome "unknown", described as "trouble hearing"; ERYTHEMA (non-serious) with onset 24Jan2022, outcome "recovered" (24Jan2022), described as "face was red"; HYPERHIDROSIS (non-serious) with onset 24Jan2022, outcome "not recovered", described as "sweating"; HEADACHE (non-serious) with onset 24Jan2022, outcome "not recovered", described as "Headache".  Additional Information: Additional vaccines administered on the same day and prior vaccination within 4 weeks was reported as none. The reporter stated that about 20 minutes later while driving home, the patient complained of excessive heat production and blocked/clogged ears which caused trouble hearing, ''hard for me to hear, mommy I'm too hot''. At home, the patient's face was red, was sweating only a little bit but not profusely. The reporter went to wake her child up, he was still tired, and he had no fever.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: I got hives shaped rash on calves and forearms; I got hives shaped rash on calves and forearms; itching; two pea-sized blisters appeared above the heel and on the shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 (Lot number: EN6204) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal (spring) hay fever" (unspecified if ongoing), notes: Other medical history: I have a history of seasonal (spring) hay fever that was cured by hypersensitization.; "Known allergies: grass pollen" (unspecified if ongoing), notes: Known allergies: grass pollen. Concomitant medication(s) included: SYNTHROID; SIMVASTATIN; FISH OIL; CALCIUM; TURMERIC [CURCUMA LONGA]. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EN6205, prev dose lot unknown: False, prev dose administration date: 28Feb2021, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No side effects". The following information was reported: URTICARIA (non-serious), RASH (non-serious) all with onset Apr2021, outcome "recovered" (2021) and all described as "I got hives shaped rash on calves and forearms"; PRURITUS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "itching"; BLISTER (non-serious) with onset 2021, outcome "unknown", described as "two pea-sized blisters appeared above the heel and on the shoulder". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Nausea, Pain in extremity, Somnolence
Clinical narrative: Sore arm/Leg pain; Legs felt heavy in a painful way; little nausea will be better; Massive headache; Sleepy in a restless way; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: EN6208) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Lot number: EN6201, Reaction: felt very tired), administration date: 25Feb2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "felt very tired", "couldn't keep eyes open from when I got home mid afternoon yesterday till midmorning today", "Injection arm is sore at injection spot", "pain in my left shoulder blade", "mouth, throat, eyes and chest felt slightly dryer than usual", "light headache", "a little nausea", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "mouth, throat, eyes and chest felt slightly dryer than usual/the skin on my hands and feet felt like they had the moisture sucked out of them", "mouth, throat, eyes and chest felt slightly dryer than usual", "mouth, throat, eyes and chest felt slightly dryer than usual"; Bnt162b2 (Reaction: Had trouble walking, Dose:01, Lot number: EN6201), for COVID-19 Immunization, reaction(s): "Had trouble walking"; Bnt162b2 (Reaction: feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling, Dose:01, Lot number: EN6201), for Covid-19 Immunization, reaction(s): "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore arm/Leg pain"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Legs felt heavy in a painful way"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "little nausea will be better"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Massive headache"; SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "Sleepy in a restless way".  Additional information: Dose 2 thoughts: first day really sore arm, legs felt heavy in a painful way, yesterday (day 2) a little nausea, massive headache, day 3 fine so far...first two days, sleepy in a restless way   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test, Skin burning sensation, Urticaria
Clinical narrative: Hives; swollen lymph nodes; burning skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 11:30 (Lot number: EN6202) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal Asthma or Allergy" (unspecified if ongoing); "Seasonal Asthma or Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 24Feb2021 13:00, outcome "not recovered", described as "Hives"; LYMPHADENOPATHY (non-serious) with onset 24Feb2021 13:00, outcome "not recovered", described as "swollen lymph nodes"; SKIN BURNING SENSATION (non-serious) with onset 24Feb2021 13:00, outcome "not recovered", described as "burning skin". The events "hives", "swollen lymph nodes" and "burning skin" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, lymphadenopathy, skin burning sensation.  Additional information: Patient received dose 2 of Pfizer- BioNTech on 17Mar2021 at 12:30 PM in left arm with lot number  ER2613.Facility type vaccine: Hospital. Patient did not had other vaccines in 4 weeks. Patient did not received other medications in 2 weeks.AE treatment: Steroidal cream.Patient did not had Covid prior vaccination. Patient did not had allergies.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: developed itchy skin rash on upper left chest (near injection site).; developed itchy skin rash on upper left chest (near injection site).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Lot number: ep7533) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 62 years old, for COVID-19 Immunization, reaction(s): "itchy skin rash". The following information was reported: PRURITUS (non-serious), RASH (non-serious) all with onset 2021, outcome "not recovered" and all described as "developed itchy skin rash on upper left chest (near injection site).". The event "developed itchy skin rash on upper left chest (near injection site)." and "developed itchy skin rash on upper left chest (near injection site)." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: The patient had no known allergies, Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had been tested for COVID-19, he did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not take other medications within 2 weeks of vaccination. It was reported that About 3 weeks after the second injection, the patient developed itchy skin rash on upper left chest (near injection site). The doctor thought it might be a contact allergy and administered steroid injection (treatment). Rash cleared up for 2 weeks but then returned and has continued for 10 months now. The fact that it remained in just one spot on his body was proof that this is not a contact allergy. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Renal function test, Swelling
Clinical narrative: marble sized swelling in his armpit; swollen lymph nodes under the armpit/swollen lymph nodes under the armpit/swollen lymph nodes under the arm pit was worsened; marble sized swelling in his armpit that was painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 14:00 (Lot number: 33130BA) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1 , Lot: EW0186, Expiration: unknown), administration date: 23Jun2021, when the patient was 34 years old, for Covid-19 Immunization, reaction(s): "he had stage one kidney disease."; Bnt162b2 (Dose 2, Lot: EW0186 (confirms both doses are the same lot number. , Expiration: unknown), administration date: 14Jul2021, when the patient was 34 years old, for Covid-19 Immunization, reaction(s): "he had stage two kidney disease".  The following information was reported: SWELLING (non-serious) with onset 24Jan2022 19:00, outcome "not recovered", described as "marble sized swelling in his armpit"; LYMPHADENOPATHY (non-serious) with onset 24Jan2022 19:00, outcome "not recovered", described as "swollen lymph nodes under the armpit/swollen lymph nodes under the armpit/swollen lymph nodes under the arm pit was worsened"; AXILLARY PAIN (non-serious) with onset 24Jan2022 19:00, outcome "unknown", described as "marble sized swelling in his armpit that was painful". The events "marble sized swelling in his armpit", "swollen lymph nodes under the armpit/swollen lymph nodes under the armpit/swollen lymph nodes under the arm pit was worsened" and "marble sized swelling in his armpit that was painful" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, lymphadenopathy.  Additional information: As of 27Jan2022, it was "3/4 the size of a baseball" and the patient had to keep his arm raised/can't lower his arm all the way because of it. She wants to know if have information on swollen lymph nodes after the vaccine. The patient not received any other product. It was stated that Her partner also had swollen lymph nodes under the arm pit. She just does not know if it supposed to get that large under his armpit. The swelling underneath his arm pit was larger than her fist. No any additional vaccines administered on same date of the Pfizer suspect. The events did not cause Emergency Room visit. No any prior vaccination within 4 weeks. No any family medical history relevant to events. The patient was Advised to consult with HCP.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Swelling, Vaccination site pain
Clinical narrative: Soreness at injection site; mild headache; mild backache; mild chills; swelling in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jan2022 15:30 (Lot number: T-K9729) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2005 (ongoing); "Premature Heart contraction (PACs/PUCs)", start date: 2016 (ongoing); "Transient ischeme attack (Diagnosis)", start date: 23Nov2017, stop date: 24Nov2017. Concomitant medication(s) included: ENALAPRIL MALEATE taken for hypertension, start date: 2005 (ongoing). Vaccination history included: Covid-19 vaccine (Dose: 1st, Date: 04Mar2021, Time (24hrs): Afternoon (1310), Site and route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 04Mar2021, when the patient was 57 years old, for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd , Date: 24Mar2021, Time (24hrs): Afternoon (1310), Site and route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 24Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "Soreness at injection site"; HEADACHE (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "mild headache"; BACK PAIN (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "mild backache"; CHILLS (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "mild chills"; SWELLING (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "swelling in left armpit". Therapeutic measures were not taken as a result of vaccination site pain, headache, back pain, chills, swelling. Additional information: Facility type vaccine was Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Blood test, Investigation, Swelling, Ultrasound scan
Clinical narrative: swelling under his left armpit; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER2613) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "keep hair from falling out" (unspecified if ongoing), notes: keep hair from falling out; "heart health" (unspecified if ongoing), notes: heart health. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol increased, start date: Dec2010; ASPIRIN 81 taken for heart alternation, start date: 2000; FINASTERIDE taken for alopecia. Vaccination history included: Bnt162b2 (Dose 1, Injected in left arm, Lot: EN6202), administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "recovered", described as "swelling under his left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling.  Additional information: Caller says he has been on the same medications for a long time. He says he takes a statin for cholesterol taking this over 10 years ago, an 81mg Aspirin daily, he probably started taking this 20 years ago, and Finasteride to keep his hair from falling out. Caller says that Aspirin was probably for heart health, he didn't have a heart condition and they said to take low dosage Aspirin every day for healthy heart. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: swelling under his left armpit; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER2613) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "keep hair from falling out" (unspecified if ongoing), notes: keep hair from falling out; "heart health" (unspecified if ongoing), notes: heart health. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol increased, start date: Dec2010; ASPIRIN 81 taken for heart alternation, start date: 2000; FINASTERIDE taken for alopecia. Vaccination history included: Bnt162b2 (Dose 1, Injected in left arm, Lot: EN6202), administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "recovered", described as "swelling under his left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling.  Additional information: Caller says he has been on the same medications for a long time. He says he takes a statin for cholesterol taking this over 10 years ago, an 81mg Aspirin daily, he probably started taking this 20 years ago, and Finasteride to keep his hair from falling out. Caller says that Aspirin was probably for heart health, he didn't have a heart condition and they said to take low dosage Aspirin every day for healthy heart. No follow-up attempts are possible. No further information is expected.