chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac disorder, Feeling abnormal, Pain in extremity, Palpitations
Clinical narrative: heart palpitations; sore arm; blood rushing; it is kind of an electrical feel through her whole body//it is an energy force going through her body; have a heart condition; 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 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EU6208) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: Verbatim: Coronary artery disease. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "not recovered", described as "sore arm"; SENSATION OF BLOOD FLOW (non-serious) with onset Mar2021, outcome "unknown", described as "blood rushing"; PALPITATIONS (non-serious) with onset 15Mar2021, outcome "not recovered", described as "heart palpitations"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "it is kind of an electrical feel through her whole body//it is an energy force going through her body"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "have a heart condition". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient had her Pfizer first dose on Saturday 13Mar2021 and she is getting heart palpitations, states it is kind of an electrical feel through her whole body, states she does have a heart condition, states it is a weird thing, she is reaching out to Cardiologist later today, caller is wondering what it is, or what to do about it, it is an energy force going through her body. Wondering, she did blood work, they said you may have a reaction if you have high antibodies to the zoster virus, just have that tested, and it is super high, states this is prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of blood flow
Clinical narrative: heart palpitations; sore arm; blood rushing; it is kind of an electrical feel through her whole body//it is an energy force going through her body; have a heart condition; 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 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EU6208) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: Verbatim: Coronary artery disease. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "not recovered", described as "sore arm"; SENSATION OF BLOOD FLOW (non-serious) with onset Mar2021, outcome "unknown", described as "blood rushing"; PALPITATIONS (non-serious) with onset 15Mar2021, outcome "not recovered", described as "heart palpitations"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "it is kind of an electrical feel through her whole body//it is an energy force going through her body"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "have a heart condition". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient had her Pfizer first dose on Saturday 13Mar2021 and she is getting heart palpitations, states it is kind of an electrical feel through her whole body, states she does have a heart condition, states it is a weird thing, she is reaching out to Cardiologist later today, caller is wondering what it is, or what to do about it, it is an energy force going through her body. Wondering, she did blood work, they said you may have a reaction if you have high antibodies to the zoster virus, just have that tested, and it is super high, states this is prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 15:00 (Lot number: EN6198) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Potassium, reaction(s): "allergies: potassium", notes: allergies: potassium. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Feb2021 03:00, outcome "recovered" (27Feb2021), described as "injection site pain".  Additional information: No other vaccines received in four weeks of COVID-19 vaccination. Facility at which vaccine was administered reported as Hospital. Reported that 12 hours after the 1st dose, patient experienced the injection site pain, which woke her up, but it was gone within a day. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: pain in the lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 62-year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PULMONARY PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "pain in the lungs". Additional information: The patient experienced a sharp pain in the lungs which lasted about 3mins and then it went away. Her doctor office did not think it was from the vaccine. Caller wanted to know would the cold like symptoms can last more than 1 to 2 days. Caller stated a friend of hers got the Pfizer covid vaccine and experienced cold like symptoms. They lasted one day and was gone the next day. cold symptoms like chills, aches and pain, feeling sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hot flush
Clinical narrative: "hot flashes", his "ear lobes got hot but didn't turn color". He says it's been "on/off"; "hot flashes", his "ear lobes got hot but didn't turn color". He says it's been "on/off"; 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 78 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Mar2021 11:00 (Lot number: EN6208, Expiration Date: Jun2021) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Verbatim: Hypertension/Diagnosed at 48 years old; "Glaucoma" (ongoing), notes: Verbatim: Glaucoma. There were no concomitant medications. The following information was reported: HOT FLUSH (non-serious), EAR DISCOMFORT (non-serious) all with onset 13Mar2021, outcome "recovering" and all described as ""hot flashes", his "ear lobes got hot but didn't turn color". He says it's been "on/off"". Therapeutic measures were not taken as a result of hot flush, ear discomfort.  Additional information: The caller received the Pfizer BioNTech COVID-19 vaccine last Thursday and then started to get what he calls as "hot flashing" where his ears don't turn red but are hot. Also, a little bit of the side of his face, beneath his ears, heated up. The rest of his body was okay. He clarifies it started last Saturday, and it went away one day and would come back on, it would happen on and off. The caller confirms he received the vaccine on 11Mar2021 and by Saturday, 13Mar2021, he had the hot flashing. Caller states like today, he became a little bit heated. His ears and earlobes became heated, but its not as bad as it was a couple days ago. Last night, it was like somebody turned up the heat. Caller explains on a scale of 1-10, the heat/ hot flashing could have been a 9.5 to begin with and now, it seems to be like a 7 plus. It's getting down a little bit.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Brain natriuretic peptide increased, Chest X-ray, Fatigue, Lethargy
Clinical narrative: Pro BNP was way high; fatigued; feeling lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 92 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN NATRIURETIC PEPTIDE INCREASED (non-serious), outcome "unknown", described as "Pro BNP was way high"; LETHARGY (non-serious) with onset Feb2021, outcome "unknown", described as "feeling lethargic"; FATIGUE (non-serious), outcome "unknown", described as "fatigued". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: A day or two after having the shot, he was feeling lethargic, had no energy and wanted to sleep. He went to his cardiologist and he did some labs and is Pro BNP was way high (952). His doctor had him do a chest x-ray which was normal except for some deterioration in his shoulders and he is scheduled to have an echo tomorrow. His second shot is scheduled 18Mar and he doesn't know what to do. Patient's cardiologist did not think this increase was from covax. Now he is afraid to get the second covax scheduled for this Thursday.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, Chills, Cold sweat, Dry mouth, Hyperhidrosis
Clinical narrative: This morning, she complains of feeling nervous; jittery; chills; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; 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 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 74 years as single dose for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NERVOUSNESS (non-serious), outcome "unknown", described as "This morning, she complains of feeling nervous"; AGITATION (non-serious), outcome "unknown", described as "jittery"; CHILLS (non-serious), outcome "unknown", described as "chills"; COLD SWEAT (non-serious), HYPERHIDROSIS (non-serious), DRY MOUTH (non-serious), outcome "unknown" and all described as "this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.". Therapeutic measures were not taken as a result of nervousness, agitation, chills, cold sweat, hyperhidrosis, dry mouth. The patient said she was hurrying to try to get her phone number, the patient did not know she would need it. The patient was calling to find out, she took the first shot last Thursday and it had gone okay but this morning the patient had this jitteriness, like she feels nervous. The patient did not know if it was a coincidence but she had a little chill late at night but it had been cool there so that could had caused it. The patient tried to find out from the other lady the patient talked to how important was the second shot, because the patient might not take the second shot so she wanted to know how protected she was with one shot. The patient clarifies she was calling about the Pfizer COVID 19 vaccine. The patient sees Pfizer on the card, if the patient can make out the writing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: This morning, she complains of feeling nervous; jittery; chills; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; 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 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 74 years as single dose for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NERVOUSNESS (non-serious), outcome "unknown", described as "This morning, she complains of feeling nervous"; AGITATION (non-serious), outcome "unknown", described as "jittery"; CHILLS (non-serious), outcome "unknown", described as "chills"; COLD SWEAT (non-serious), HYPERHIDROSIS (non-serious), DRY MOUTH (non-serious), outcome "unknown" and all described as "this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.". Therapeutic measures were not taken as a result of nervousness, agitation, chills, cold sweat, hyperhidrosis, dry mouth. The patient said she was hurrying to try to get her phone number, the patient did not know she would need it. The patient was calling to find out, she took the first shot last Thursday and it had gone okay but this morning the patient had this jitteriness, like she feels nervous. The patient did not know if it was a coincidence but she had a little chill late at night but it had been cool there so that could had caused it. The patient tried to find out from the other lady the patient talked to how important was the second shot, because the patient might not take the second shot so she wanted to know how protected she was with one shot. The patient clarifies she was calling about the Pfizer COVID 19 vaccine. The patient sees Pfizer on the card, if the patient can make out the writing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Nasopharyngitis, Nervousness
Clinical narrative: This morning, she complains of feeling nervous; jittery; chills; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; 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 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 74 years as single dose for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NERVOUSNESS (non-serious), outcome "unknown", described as "This morning, she complains of feeling nervous"; AGITATION (non-serious), outcome "unknown", described as "jittery"; CHILLS (non-serious), outcome "unknown", described as "chills"; COLD SWEAT (non-serious), HYPERHIDROSIS (non-serious), DRY MOUTH (non-serious), outcome "unknown" and all described as "this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.". Therapeutic measures were not taken as a result of nervousness, agitation, chills, cold sweat, hyperhidrosis, dry mouth. The patient said she was hurrying to try to get her phone number, the patient did not know she would need it. The patient was calling to find out, she took the first shot last Thursday and it had gone okay but this morning the patient had this jitteriness, like she feels nervous. The patient did not know if it was a coincidence but she had a little chill late at night but it had been cool there so that could had caused it. The patient tried to find out from the other lady the patient talked to how important was the second shot, because the patient might not take the second shot so she wanted to know how protected she was with one shot. The patient clarifies she was calling about the Pfizer COVID 19 vaccine. The patient sees Pfizer on the card, if the patient can make out the writing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, Chills, Cold sweat, Dry mouth, Hyperhidrosis
Clinical narrative: she experienced the following reaction chills,colds, and was kind of nervous; she experienced the following reaction chills,colds, and was kind of nervous; she experienced the following reaction chills,colds, and was kind of nervous; 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 female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), NASOPHARYNGITIS (non-serious), NERVOUSNESS (non-serious), outcome "unknown" and all described as "she experienced the following reaction chills,colds, and was kind of nervous". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: she experienced the following reaction chills,colds, and was kind of nervous; she experienced the following reaction chills,colds, and was kind of nervous; she experienced the following reaction chills,colds, and was kind of nervous; 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 female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), NASOPHARYNGITIS (non-serious), NERVOUSNESS (non-serious), outcome "unknown" and all described as "she experienced the following reaction chills,colds, and was kind of nervous". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Nasopharyngitis, Nervousness
Clinical narrative: she experienced the following reaction chills,colds, and was kind of nervous; she experienced the following reaction chills,colds, and was kind of nervous; she experienced the following reaction chills,colds, and was kind of nervous; 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 female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), NASOPHARYNGITIS (non-serious), NERVOUSNESS (non-serious), outcome "unknown" and all described as "she experienced the following reaction chills,colds, and was kind of nervous". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nipple disorder, Nipple swelling
Clinical narrative: swollen and lumpy area under his nipples; swollen and lumpy area under his nipples; 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 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NIPPLE SWELLING (non-serious), NIPPLE DISORDER (non-serious), outcome "unknown" and all described as "swollen and lumpy area under his nipples".  Additional Information: Caller, male, aged 72, received first dose of vaccine on 24Feb2021. A few days later developed swollen and lumpy area under his nipples. This has been ongoing issue for 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: experienced tiredness/tiredness feeling; more fatigued; 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 89 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: EN6200) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Supplementation therapy" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM SILVER +50 taken for supplementation therapy; MIRALAX taken for diverticulum. Vaccination history included: Bnt162b2 (EL1283 first dose), administration date: 28Jan2021, when the patient was 89 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "experienced tiredness/tiredness feeling"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "more fatigued".  Additional information: Centrum Silver, Dosage text: 1 tablet a day by mouth, MiraLax Dosage text: 1/2 dose as needed by mouth 2-3 times a week.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Pain in extremity
Clinical narrative: temperature spiked to 101F; cills and tremors; headache; sore arm; tremors; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "temperature spiked to 101F"; CHILLS (non-serious), outcome "unknown", described as "cills and tremors"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm"; TREMOR (non-serious), outcome "unknown", described as "tremors". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, chills, headache, pain in extremity, tremor.  Additional information: Patient got the Pfizer COVID-19 vaccine yesterday (15Mar2021) and felt fine after vaccination. Seven hours later, her temperature spiked to 101F and had chills and tremors. she also developed headache and sore arm. She took Tylenol for her symptoms Today (16Mar2021), she feels fine but still has a sore arm. She wanted to know if those are normal with the vaccine and if the adverse event worsen after the second dose of the vaccine. She mentioned that she might not get the second dose of the vaccine because of her experience with the first.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: temperature spiked to 101F; cills and tremors; headache; sore arm; tremors; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "temperature spiked to 101F"; CHILLS (non-serious), outcome "unknown", described as "cills and tremors"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm"; TREMOR (non-serious), outcome "unknown", described as "tremors". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, chills, headache, pain in extremity, tremor.  Additional information: Patient got the Pfizer COVID-19 vaccine yesterday (15Mar2021) and felt fine after vaccination. Seven hours later, her temperature spiked to 101F and had chills and tremors. she also developed headache and sore arm. She took Tylenol for her symptoms Today (16Mar2021), she feels fine but still has a sore arm. She wanted to know if those are normal with the vaccine and if the adverse event worsen after the second dose of the vaccine. She mentioned that she might not get the second dose of the vaccine because of her experience with the first.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feeling pain on the left side of [their] arm where [they] got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "feeling pain on the left side of [their] arm where [they] got the shot".  Additional information: The patient was asked if they could take Ibuprofen or Tylenol for the pain after vaccination. The patient was concerned that if he takes those medications, they could create some problem with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289826 same reporter/product/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar leveled near 150 with no insulin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Mar2021 12:45 (Batch/Lot number: EN6200) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Triggered Hypoglycemic episode", start date: 12Feb2021, stop date: 12Feb2021, notes: Pertinent Details: Blood sugar went to 24. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer/BioNTech Covid-19 Vaccine, Date/Time of administration: 12Feb2021 12:45 PM, Anatomical site of injection: Upper right arm, Intramuscular, Batch/lot number: EN5318), administration date: 12Feb2021, for covid-19 immunisation, reaction(s): "Hypoglycemic episode", "Blood glucose decreased", "Sleepy", "Face red", "Tiredness", "Unresponsive". The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 05Mar2021, outcome "unknown", described as "blood sugar leveled near 150 with no insulin". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Vaccine facility type was other. No other vaccines within 4 weeks prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness and slight fatigue; Arm soreness and slight fatigue; 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), administered in arm left, administration date 15Mar2021 14:00 (Lot number: EL3247) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=EL3247, administration time=10:00 AM, vaccine location=Left arm, dose number=1), administration date: 22Feb2021, when the patient was 58 years old, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 15Mar2021 16:00, outcome "recovered" (2021) and all described as "Arm soreness and slight fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: It was stated that the patient experienced adverse events several hours after receiving the second dose of the covid-19 vaccine. The patient did not receive any other vaccine in the four weeks. The patient did not receive other medications in two weeks. The patient never had Covid prior vaccination and was not tested for Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain in extremity, Rhinorrhoea
Clinical narrative: Her nose was running like a waterfall; Chills; knees and legs ached; Headache; Sinus pain; didn't feel very good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6205, Expiration Date: 01Jun2021) at the age of 70 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia;diagnosed twenty to twenty five years ago; "Diabetes mellitus" (ongoing), notes: Verbatim: Diabetes; diagnosis for at least 8 to 10 years; "blood pressure high" (ongoing), notes: Verbatim: high blood pressure; "Arthritis" (ongoing), notes: Verbatim: Arthritis;they call it inflammatory arthritis; "Irritable bowel syndrome" (ongoing), notes: Verbatim: Irritable bowel syndrome; "water pill" (unspecified if ongoing); "blood sugar" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for blood glucose abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); HYDROCHLOROTHIAZIDE taken for polyuria (ongoing). Vaccination history included: Bnt162b2, administration date: 04Mar2021, when the patient was 70 years old, for covid-19 immunisation; Shingles vaccine, reaction(s): "pustules". The following information was reported: RHINORRHOEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Her nose was running like a waterfall"; CHILLS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "unknown", described as "knees and legs ached"; HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Headache"; SINUS PAIN (non-serious) with onset 13Mar2021, outcome "unknown", described as "Sinus pain"; MALAISE (non-serious) with onset 13Mar2021, outcome "unknown", described as "didn't feel very good".  Additional information: Patient was on a diet. Her weight is approximately 240 pounds. She gained the COVID fifty pounds. They say from quarantine you gain 15 pounds, but that is not true it is 50 pounds. On Saturday evening, 13Mar2021. It is not nearly as bad now and she was able to exercise. She does not feel bad. Patient did get these pox marks on her face after she got the vaccine that is something related to chicken pox. Caller clarified that she got pustules after getting the Shingles vaccine. That was seven years ago, and she does not have the lot number.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Her nose was running like a waterfall; Chills; knees and legs ached; Headache; Sinus pain; didn't feel very good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6205, Expiration Date: 01Jun2021) at the age of 70 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia;diagnosed twenty to twenty five years ago; "Diabetes mellitus" (ongoing), notes: Verbatim: Diabetes; diagnosis for at least 8 to 10 years; "blood pressure high" (ongoing), notes: Verbatim: high blood pressure; "Arthritis" (ongoing), notes: Verbatim: Arthritis;they call it inflammatory arthritis; "Irritable bowel syndrome" (ongoing), notes: Verbatim: Irritable bowel syndrome; "water pill" (unspecified if ongoing); "blood sugar" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for blood glucose abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); HYDROCHLOROTHIAZIDE taken for polyuria (ongoing). Vaccination history included: Bnt162b2, administration date: 04Mar2021, when the patient was 70 years old, for covid-19 immunisation; Shingles vaccine, reaction(s): "pustules". The following information was reported: RHINORRHOEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Her nose was running like a waterfall"; CHILLS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "unknown", described as "knees and legs ached"; HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Headache"; SINUS PAIN (non-serious) with onset 13Mar2021, outcome "unknown", described as "Sinus pain"; MALAISE (non-serious) with onset 13Mar2021, outcome "unknown", described as "didn't feel very good".  Additional information: Patient was on a diet. Her weight is approximately 240 pounds. She gained the COVID fifty pounds. They say from quarantine you gain 15 pounds, but that is not true it is 50 pounds. On Saturday evening, 13Mar2021. It is not nearly as bad now and she was able to exercise. She does not feel bad. Patient did get these pox marks on her face after she got the vaccine that is something related to chicken pox. Caller clarified that she got pustules after getting the Shingles vaccine. That was seven years ago, and she does not have the lot number.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Computerised tomogram abdomen, Computerised tomogram pelvis, Musculoskeletal chest pain
Clinical narrative: Within 12 hours of the vaccine my son started expereincing pain in his left testicle and a little bit in his right testicle.; Pain worsened over a couple of weeks to the rib cage and his back.; The pain worsened over a couple of weeks to the rib cage and his back.; He then started getting shooting pain that he experienced in both legs, but primary his left leg, his thighs, biceps, and abdomen.; He then started getting shooting pain that he experienced in both legs, but primary his left leg, his thighs, biceps, and abdomen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 22 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TESTICULAR PAIN (non-serious), outcome "unknown", described as "Within 12 hours of the vaccine my son started expereincing pain in his left testicle and a little bit in his right testicle."; BACK PAIN (non-serious), outcome "unknown", described as "Pain worsened over a couple of weeks to the rib cage and his back."; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "The pain worsened over a couple of weeks to the rib cage and his back."; PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "He then started getting shooting pain that he experienced in both legs, but primary his left leg, his thighs, biceps, and abdomen.". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Testicular pain
Clinical narrative: Within 12 hours of the vaccine my son started expereincing pain in his left testicle and a little bit in his right testicle.; Pain worsened over a couple of weeks to the rib cage and his back.; The pain worsened over a couple of weeks to the rib cage and his back.; He then started getting shooting pain that he experienced in both legs, but primary his left leg, his thighs, biceps, and abdomen.; He then started getting shooting pain that he experienced in both legs, but primary his left leg, his thighs, biceps, and abdomen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 22 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TESTICULAR PAIN (non-serious), outcome "unknown", described as "Within 12 hours of the vaccine my son started expereincing pain in his left testicle and a little bit in his right testicle."; BACK PAIN (non-serious), outcome "unknown", described as "Pain worsened over a couple of weeks to the rib cage and his back."; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "The pain worsened over a couple of weeks to the rib cage and his back."; PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "He then started getting shooting pain that he experienced in both legs, but primary his left leg, his thighs, biceps, and abdomen.". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood test, Echocardiogram, Vomiting
Clinical narrative: She threw up; Stomach was turning funny; Weakness feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 13:15 (Lot number: EN6206) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Leukemia without the cancer" (unspecified if ongoing), notes: Verbatim: Leukemia without the cancer; "Blood disorder" (unspecified if ongoing), notes: Verbatim: Blood disorder. Concomitant medication(s) included: . The following information was reported: VOMITING (non-serious) with onset 16Mar2021, outcome "unknown", described as "She threw up"; ABDOMINAL DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "Stomach was turning funny"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "Weakness feeling". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, abdominal discomfort, asthenia.  Additional information: The patient had a Pfizer injection. Today the patient threw up and reporter noticed that after the injection may be a couple of hours or so. Reporter stated, "the patient took her medication this morning."  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Severe headaches; dizziness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:00 (Lot number: EL3247) at the age of 53 years as dose 2, single and administered in arm right, administration date 23Feb2021 (Lot number: EL3247) for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Batch/Lot no: EL3247 , Anatomical Location: Arm Right), administration date: 23Feb2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 16Mar2021, outcome "recovering", described as "Severe headaches"; DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 16Mar2021, outcome "recovering", described as "fatigue".  Follow up(22Mar2021): This is a follow up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included:  The Pfizer unit recently received the attached report submitted by you via Pfizer. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: one of my friend told me that he had a similar thing happen to him where he felt that some of the vaccine was running down his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE EXTRAVASATION (non-serious), outcome "unknown", described as "one of my friend told me that he had a similar thing happen to him where he felt that some of the vaccine was running down his arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: On my injection site I have a swollen lymph node by my collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EN6204) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Mar2021, outcome "unknown", described as "On my injection site I have a swollen lymph node by my collar bone".  Additional information: Consumer stated, "On my injection site I have a swollen lymph node by my collar bone (Clarification unknown) and I looked it up and it says it is common. My question is should I get the second shot when it comes up? Should I take the second shot if it is still swollen?"  No follow-up attempts are possible. No further information is expected.