chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Investigation, Lymphadenopathy, Metabolic function test, Neck pain
Clinical narrative: lymph nodes are enlarged on her neck and armpit area.; pain in the neck; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Aug2021 (Lot number: EW0169) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: Verbatim: Tachycardia; "Insomnia" (unspecified if ongoing), notes: Verbatim: Insomnia; "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "Obesity" (unspecified if ongoing), notes: Verbatim: Obesity; "Sleep" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE taken for sleep disorder; PROPRANOLOL taken for tachycardia. Past drug history included: Levaquin, reaction(s): "Allergic to Levaquin", notes: She is Allergic to Levaquin and Doxycycline.; Doxycycline, reaction(s): "Allergy: Doxycycline". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Aug2021, outcome "recovered" (Aug2021), described as "lymph nodes are enlarged on her neck and armpit area."; NECK PAIN (non-serious) with onset 11Aug2021, outcome "recovered" (Aug2021), described as "pain in the neck". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received first vaccination dose on 09Aug2021, after she has been having issues with lymph nodes. On the right side the lymph nodes are enlarged on patient neck and armpit area. Patient got an ultrasound done with labs. Patient's HCP still recommended to get the 2nd Pfizer vaccine. Enlarged Lymph nodes: It started about 2 days after the first dose, it started off with pain in the neck, patient did not have a sore throat but when moving the neck she could feel it pull, patient then physically felt the enlargement by feeling it with touch. It had subsided after a week and a half. Patient clarified that she was already prescribed amitriptyline prior to receiving the vaccines as needed for sleep. Patient was on propranolol twice a day for tachycardia. Reporter stated that patient has had a lot of lab work done starting on 18Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: lymph nodes are enlarged on her neck and armpit area.; pain in the neck; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Aug2021 (Lot number: EW0169) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: Verbatim: Tachycardia; "Insomnia" (unspecified if ongoing), notes: Verbatim: Insomnia; "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "Obesity" (unspecified if ongoing), notes: Verbatim: Obesity; "Sleep" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE taken for sleep disorder; PROPRANOLOL taken for tachycardia. Past drug history included: Levaquin, reaction(s): "Allergic to Levaquin", notes: She is Allergic to Levaquin and Doxycycline.; Doxycycline, reaction(s): "Allergy: Doxycycline". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Aug2021, outcome "recovered" (Aug2021), described as "lymph nodes are enlarged on her neck and armpit area."; NECK PAIN (non-serious) with onset 11Aug2021, outcome "recovered" (Aug2021), described as "pain in the neck". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received first vaccination dose on 09Aug2021, after she has been having issues with lymph nodes. On the right side the lymph nodes are enlarged on patient neck and armpit area. Patient got an ultrasound done with labs. Patient's HCP still recommended to get the 2nd Pfizer vaccine. Enlarged Lymph nodes: It started about 2 days after the first dose, it started off with pain in the neck, patient did not have a sore throat but when moving the neck she could feel it pull, patient then physically felt the enlargement by feeling it with touch. It had subsided after a week and a half. Patient clarified that she was already prescribed amitriptyline prior to receiving the vaccines as needed for sleep. Patient was on propranolol twice a day for tachycardia. Reporter stated that patient has had a lot of lab work done starting on 18Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: experienced a dead arm in the injection arm; Couldn't lift arm because it hurt.Felt like was punched in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 11:00 (Lot number: EW0182) at the age of 20 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Neurofibromatosis" (ongoing), notes: Neurofibromatosis, type 1 (von Recklinghausen's disease). Diagnosed at 14 years old Investigation. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "experienced a dead arm in the injection arm"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Couldn't lift arm because it hurt. Felt like was punched in the arm".  No follow-up attempts are possible. No further information is expected.  Additional Information:  Diagnosed at 14 years old Investigation. NDC number and  Expiry Date of COVID-19 Vaccine was Unknown.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; low fever; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Comirnaty (Dose Number: 2, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Comirnaty (Dose Number: 1, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Fatigue"; PYREXIA (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "low fever"; PAIN (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "body aches". Therapeutic measures were not taken as a result of fatigue, pyrexia, pain.  Additional information: No other vaccine in fourweeks. No covid prior vaccination and no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 17:00 (Lot number: 301458A) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Right, Vaccine Administration Time: 10:00), administration date: 29Sep2021, when the patient was 30 years old, for Covid-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 19Oct2021 06:00, outcome "unknown", described as "Brain fog". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: malaise; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "malaise"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (01Nov2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Feb2021 16:30 (Lot number: EN6200, Expiration Date: 20Jun2021) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colonscopy", start date: 10Nov2020 (unspecified if ongoing), notes: No issues; "psoriasis", start date: 1974 (ongoing), notes: Have been using biologic stelava for 8yrs.; "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for depression (ongoing); ZOCOR taken for blood pressure measurement (ongoing); PRILOSEC [OMEPRAZOLE] taken for gastrooesophageal reflux disease (ongoing); ZESTRIL taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Dose =1, Route of administration=Intramuscular, Anatomical site of location=Right Shoulder, Drug Lot Number and Expiration Date: Lot # EL9262, 20May2021, At: 10:30), administration date: 21Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Anatomical Site of injection for dose 2 was right shoulder. Vaccination Facility Type was Hospital. Prior Vaccinations within 4 weeks was none. As a result of the Pfizer vaccine. Patient now have continuous ringing in her ears. While it is extremely bothersome, it was something patient can deal with at its current level. Patient was eligible for a booster shots but was concerned that tinnitus will get worse and will become unbearable.   Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: A little swelling but it didn't last very long; 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 female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Feb2021 (Lot number: EN6203) at the age of 78 years as dose 2, single and administered in arm left, administration date 05Feb2021 (Lot number: EN9581) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "sinuses" (unspecified if ongoing), notes: she does take Flonase or Nasonex for her sinuses; "allergies" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE] taken for sinusitis; NASONEX taken for sinusitis. Past drug history included: Antibiotic, reaction(s): "allergic to a lot of antibiotics". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Feb2021, outcome "recovered", described as "A little swelling but it didn't last very long".  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: a metallic taste in the mouth; 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 received bnt162b2 (BNT162B2), administration date 07Aug2021 (Lot number: EW0185, Expiration Date: Aug2021) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome", start date: 1991 (ongoing), notes: she has an autoimmune disorder; "Epstein-barr virus", start date: 1991 (ongoing), notes: she has an autoimmune disorder; "Cholesterol" (unspecified if ongoing); "all  four wisdom teeth pulled" (unspecified if ongoing), notes: prior to vaccines four wisdom teeth pulled and was on doxycycline, tylenol and ibuprofen. Family history included: "Cardiac issues/ Heart problems" (unspecified if ongoing); "Cholesterol issues/ High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for hypercholesterolaemia (ongoing); COQ 10. Past drug history included: Doxycycline for all  four wisdom teeth pulled, notes: prior to vaccines four wisdom teeth pulled and was on doxycycline, tylenol and ibuprofen.; Tylenol for all  four wisdom teeth pulled, notes: prior to vaccines four wisdom teeth pulled and was on doxycycline, tylenol and ibuprofen.; Ibuprofen for all  four wisdom teeth pulled, notes: prior to vaccines four wisdom teeth pulled and was on doxycycline, tylenol and ibuprofen. The following information was reported: DYSGEUSIA (non-serious) with onset 07Aug2021, outcome "recovered" (07Aug2021), described as "a metallic taste in the mouth".  Additional Information: Caller states she takes Pravastatin prophylactically due to intense family history of high cholesterol and heart problems. She states it was an immediate metallic taste after the first shot and only lasted a few seconds. States this did not happen with the second dose of the vaccine. Vaccine was not Administered at (privacy) Facility. No Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Palpitations
Clinical narrative: I've been having heart palpitation; headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "I've been having heart palpitation"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information- It was reported that patient  been having heart palpitation & headaches since vaccinated (I got the Pfizer shots) thinking of doing a EKG. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: My entire left side of my face was numb for 4 to 5 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FE3590) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovarian syndrome" (unspecified if ongoing). Concomitant medication(s) included: VIT D; ZINC; MAGNESIUM. The following information was reported: HYPOAESTHESIA (non-serious) with onset 12Oct2021, outcome "recovered" (Oct2021), described as "My entire left side of my face was numb for 4 to 5 hours". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated, she got her first shot last Tuesday and about an hour or one and half after she got her shot, her entire left side of face was numb for 4 to 5 hours. It went away. She called her primary healthcare provider and she said that it was entirely up to the patient to get the second shot. So she have 'waiver' for her job that says she could not get the second shot. Her primary care providers (PCP) refused to sign a 'waiver' that says that it is not ideal for her to get the second shot. He said contact the company where you got the shot. So she called the companies that actually was administering the Pfizer shots. The pharmacist said for legal purposes, a doctor, primary care should be signing up 'waiver'. So, neither one of them will find. Patient contacted a telehealth doctor and they said that because telehealth doctor did not see what had happened, then they could not give her a 'waiver' either. So they suggested her that I contact insurance company and here I am. They also said it was not a right idea for patient to take the second shot either. On confirming that She had taken the first shot of Pfizer COVID-19 Vaccine, she stated "The very first one, yes." On paraphrasing if the patient wants to know whether she should take the second shot or not, she stated "Yes." Patient was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Patient stated It didn't give me an expiration date on her card. It says Pfizer and then the LOT number. When again probed for anatomical site, Patient stated Left shoulder. Scheduled date for second shot was 02Nov2021. No Investigation Assessment.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose abnormal
Clinical narrative: "I have the booster this morning I am having terrible blood sugar reading all of a sudden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: BLOOD GLUCOSE ABNORMAL (non-serious) with onset 19Oct2021, outcome "unknown", described as ""I have the booster this morning I am having terrible blood sugar reading all of a sudden". Relevant laboratory tests and procedures are available in the appropriate section. Consumer stated, the patient had the booster this morning and had terrible blood sugar reading all of a sudden, the patient tried to reach the pharmacy they give it to the patient, withheld, they do not know nothing, the patient did not had much help from Pfizer either. Consumer stated, the patient know just now called, the patient had been transferring 3 times, and he said they had to hit the option 3, did hit the option 3. No, the patient keep getting the patient could had died by now mam (further clarification unknown), this should not be happening. First of all the patient at disadvantage the patient no computer, the patient had to speak to someone, the patient first inclination when the patient came home this morning being 170 something blood glucose deciliter before the patient took it 343 (further clarification unknown hence event captured as per verbatim) and should not happened and the patient am trying to call the pharmacist the withheld she was gone, the girl that still there, they did not think that there is any change in the composition.  QR comment: further clarification unknown about country of incidence and reporter country hence captured as united states by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Insomnia, Lymphadenopathy, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Oct2021 15:00 (Lot number: FE3590) at the age of 50 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTROGEN; TOPAMAX. Vaccination history included: Bnt162b2 (Dose= 1st, Date/time= 30Jul2021, Anatomical site of injection: Left arm, Route of Administration= Intramuscular, Batch/ lot number= FA7Y85), administration date: 30Jul2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 17Oct2021 23:30, outcome "not recovered", described as "Can't sleep"; HEADACHE (non-serious) with onset 17Oct2021 23:30, outcome "not recovered", described as "Constant headache"; LYMPHADENOPATHY (non-serious) with onset 18Oct2021 23:45, outcome "not recovered", described as "Swollen lymph nodes under arm"; PAIN IN EXTREMITY (non-serious) with onset 17Oct2021 23:45, outcome "not recovered", described as "Sore arm"; DIARRHEA (non-serious) with onset 18Oct2021, outcome "recovering", described as "Loose stools". Therapeutic measures were not taken as a result of insomnia, headache, lymphadenopathy, pain in extremity, diarrhea. Additional information: Facility type vaccine was pharmacy or drug store. Patient not administered other vaccine in four weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Relevant tests were none. Prior vaccination (within 4 weeks) was none. Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness
Clinical narrative: Fatigue; flu-like symptoms the day after; 4 days after (which is today) considerable dizziness experienced; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 10:45 (Lot number: Pf25813) at the age of 78 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose lot number: EP6955, prev dose vaccine location: Left Arm , prev dose administration time: 09:30 AM), administration date: 24May2021, when the patient was 77 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, prev dose lot number: EN6204, prev dose vaccine location: Left Arm , prev dose administration time: 11:00 AM), administration date: 03May2021, when the patient was 77 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 20Oct2021 07:00, outcome "not recovered", described as "Fatigue"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Oct2021 07:00, outcome "not recovered", described as "flu-like symptoms the day after"; DIZZINESS (non-serious) with onset 20Oct2021 07:00, outcome "not recovered", described as "4 days after (which is today) considerable dizziness experienced". Therapeutic measures were not taken as a result of fatigue, influenza like illness, dizziness.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: My blood glucose is gone through the roof; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I also had your first and your second one they are back in February and March, My blood glucose is gone through the roof.), administration date: Feb2021, for Covid-19 immunization, reaction(s): "blood glucose is gone through the roof"; Bnt162b2 (I also had your first and your second one they are back in February and March, My blood glucose is gone through the roof.), administration date: Mar2021, for Covid-19 immunization, reaction(s): "blood glucose is gone through the roof". The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "not recovered", described as "My blood glucose is gone through the roof". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (02Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Retching
Clinical narrative: arm pain; Nausea; Dry heaves; Fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 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: 01, Single), for COVID-19 Immunization, reaction(s): "arm pain".The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm pain"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; RETCHING (non-serious), outcome "recovered", described as "Dry heaves"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue".  Additional information: The patient had arm pain following second injections for 24-48 hours. Patient also experienced nausea, dry heaves and fatigue for 24 hours after second dose. Optional Information: No significant underlying medical conditions.  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-202101408013 Same reporter, patient and drug / different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain following first and second injections for 24 - 48 hours; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "Patient experienced arm pain following first and second injections for 24 - 48 hours".  Clinical course: Patient experienced arm pain following first and second injections for 24 - 48 hours. Patient also experienced nausea, dry heaves and fatigue for 24 hours after second dose.  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-202101408012 Same reporter, patient and drug / different dose and events
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; 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 (COMIRNATY), administration date 14Oct2021 (Batch/Lot number: unknown) 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: 1, No events reported), for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious) with onset Oct2021, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset Oct2021, outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "diarrhea".  Additional information: He took the second Pfizer Covid shot on Thursday and he's had some side effects and even has them still today. had nausea, vomiting, diarrhea (running to the bathroom more than normal). He does not need to go to the hospital or anything. He is at work right now and trying to find out the best option will be best or if there was anything recommended. Asks are any of these kind of side effects normal or heard of, or is it abnormal.   Follow-up attempts completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oxygen saturation, Pain
Clinical narrative: Flu like symptoms; Achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Oct2021 10:30 (Lot number: FF8841) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "on oxygen all the time at home" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 20Oct2021, outcome "recovering", described as "Flu like symptoms"; PAIN (non-serious) with onset 20Oct2021, outcome "recovering", described as "Achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: It was reported that patient took COVID vaccine yesterday. Today she has some achiness and flu like symptoms since she woke up this AM but noted that they are starting to subside. The caller would like to know if her symptoms are okay and normal.  After guidance provided the caller states that the one side effect listed that she likes the most is the decreased appetite. She said she was given so many papers to read about the vaccination and after today's guidance she does think everything is fine. She notes that she has taken Tylenol but sometimes when the pain is more than what Tylenol will take care of, she takes a BC powder which is quicker and faster. Provider is next door to where the patient lives. She understands that the vaccination is new and testy. Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, and decreased appetite.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and pain at the injection site; swelling and pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent(patients mother).  A 15 year-old female patient received bnt162b2 (BNT162B2) (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: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "swelling and pain at the injection site".  Additional information: NDC number, Expiry Date  and reason for no lot number of Pfizer Covid 19 Vaccine was not provided, caller unwilling to complete the report of Pfizer Covid 19 Vaccine: Not Provided. Investigation Assessment was not provided. The reporter stated that she doesn't know if what she experienced is a side effect of the vaccine but she was told to call and report any possible side effects. Also stated that both of her girls are 15 years old, and when they got their Pfizer Covid 19 vaccines they both got swelling and pain at the injection site, but one of them has started to feel a stabbing pain. Verified that both girls are 15. Stated, she thought the vaccine was FDA approved for kids? Declined to provide mailing address or email address. Caller stated she thought that Comirnaty is already FDA approved for children. Caller asked if the vaccine is FDA approved for adults. Caller also asked what EUA means. She also enquired "what was Pfizer's statement about vaccine mandates?" Caller stated she doesn't understand why at school at news they require children to be vaccinated in order to be attending in person. She also stated it's confusing why it's mandated even if the vaccine is not yet FDA approved for children. Caller said there's still lot of things not known which makes it upsetting.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 46-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 46, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (moderate arm pain), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: arm pain/ soreness in his arm; feeling it and wanted to know if the booster would have aggravated it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Oct2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single and administration date 25Mar2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose 1, single; Lot number: EN6199), administration date: 04Mar2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "arm pain/ soreness in his arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "feeling it and wanted to know if the booster would have aggravated it". Therapeutic measures were taken as a result of pain in extremity. Additional information: He took his first Pfizer Covid vaccine was on 04Mar2021 with lot EN6199, the second dose was 25Mar2021 with ER8730 and states he does not know the exact date of his booster dose and does not know the lot number but states it was on 15Oct2021 and they gave him two receipts and on his wife's receipt it has lot FE3590; he was unable to provide lot number for his own booster dose despite further attempts at clarification. Patient had the Pfizer Booster dose administered about 2 weeks ago in his left arm and he can feel it in his right arm and the soreness began but he may be wrong on when it happened and he may have felt it before and was trying to find out if he felt it before he got the booster and now knows he was feeling it and wanted to know if the booster would have aggravated it. He can't really say if he felt it before the booster dose and has been taking Tylenol 3 and the soreness was still there and that was why he was inquiring about this and stated that he has no lot, expiry date or NDC or dosage to provide for the Tylenol as it was not with him at this time but states it was over the counter Tylenol 3. Reporter questioned that "If his arm was sore before you got the booster dose can it aggravate the other arm and stated that he was taking Tylenol 3 previously and he didn't know if that was related or not but because the form they give us with the listed side effects, it said arm pain, does that mean where he got the shot or anywhere. He got clarified with the representative that he was asking if he gets the injection in one arm can he have the side effect of arm pain in the other. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Heart rate, Heart rate increased
Clinical narrative: left eye twitching; increased heart rate; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 17:30 (Lot number: FF2587) at the age of 46 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLEPHAROSPASM (non-serious) with onset 19Oct2021, outcome "not recovered", described as "left eye twitching"; HEART RATE INCREASED (non-serious) with onset 19Oct2021, outcome "not recovered", described as "increased heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blepharospasm, heart rate increased.  Additional information: It was reported that the patient did not taken any other vaccine in four weeks. The patient did not have COVID-19 prior vaccination. The patient did not had COVID-19 tested post vaccination. The patient did not had any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st + 2nd shots - got sore arm - after 1 week ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 11:00 (Lot number: EL2347) as dose 1, single and intramuscular, administered in arm left, administration date 08Feb2021 13:00 (Lot number: EL9265) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bronchithisis (COPD)" (ongoing), notes: Onset date: 4 years ago , Pertinent details: in care of a pulmonary Dr.; "Asthma" (ongoing), notes: Onset date: decades ago; "High cholesterol" (ongoing), notes: Onset date: long ago; "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM taken for hypersensitivity, asthma (ongoing); ERGOCALCIFEROL (ongoing); ALENDRONATE SODIUM taken for osteoporosis (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st + 2nd shots - got sore arm - after 1 week ok".  Clinical course: I phoned the clinic where the shot was given. They said to take Tylenol and Benadryl. I did not take Tylenol knowing this does not help the itching. Treatment drug : Benadryl and Canadryl.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Death, Pain in extremity
Clinical narrative: 1st + 2nd shots - got sore arm - after 1 week ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 11:00 (Lot number: EL2347) as dose 1, single and intramuscular, administered in arm left, administration date 08Feb2021 13:00 (Lot number: EL9265) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bronchithisis (COPD)" (ongoing), notes: Onset date: 4 years ago , Pertinent details: in care of a pulmonary Dr.; "Asthma" (ongoing), notes: Onset date: decades ago; "High cholesterol" (ongoing), notes: Onset date: long ago; "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM taken for hypersensitivity, asthma (ongoing); ERGOCALCIFEROL (ongoing); ALENDRONATE SODIUM taken for osteoporosis (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st + 2nd shots - got sore arm - after 1 week ok".  Clinical course: I phoned the clinic where the shot was given. They said to take Tylenol and Benadryl. I did not take Tylenol knowing this does not help the itching. Treatment drug : Benadryl and Canadryl.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fear, Headache, Poor quality product administered, Product temperature excursion issue
Clinical narrative: her second dose was a bad batch, that the battery pack went down and it was no good; her second dose was a bad batch, that the battery pack went down and it was no good; had a headache; freaking out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team from a Pfizer sponsored program Support.  A 40-year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) 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 1), administration date: Sep2021, for Covid-19 immunization, reaction(s): "little sick". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "had a headache"; FEAR (non-serious) with onset 2021, outcome "unknown", described as "freaking out"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset Sep2021, outcome "unknown" and all described as "her second dose was a bad batch, that the battery pack went down and it was no good".  Additional information: Reporter was calling on behalf of her granddaughter who received two doses of the vaccine. Reporter stated that her granddaughter, saying her second dose was a bad batch, that the battery pack went down, and it was no good. Reporter stated patient was not sure of the dates but in early September she got the second shot and was fine had a headache, some symptoms which was good it worked. Patient got the vaccines in Sep2021, three weeks apart. Reporter stated today patient got a phone call saying the second shot was not good because the battery went out in the refrigerator and to come in for another shot. Reporter asked if she should wait and get an antibody test or wait and get a booster? Reporter stated patient had it in September and they just figured it out today? She stated it should not have happened and they should've monitored it, what happens if she gets another dose? (As reported). Received phone call stating the second dose experienced a temperature excursion. Reporter was asking if patient needs to retake the dose. Stated the patient was freaking out. With the first dose, patient did get a little sick and that was fine. Patient did not want to come in for another shot. Reporter advised patient to get an antibody test. Patient has to get the booster and in eight weeks. Reporter stated this would be four COVID-19 Vaccine shots. Patient was worried. Patient asked the caller should she get the other shot to make up for the bad second dose, or should she wait to see if it worked and then just get the booster? Reporter advised the patient to get a blood antigen test. Reporter seriousness for Second dose batch was bad reported as unspecified.  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 pruritus
Clinical narrative: Mild itch at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Mild itch at injection site".  Additional information: caller stated that his wife got a mild itch on her arm at the injection site after receiving the booster, but it went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.