chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Lymphadenopathy
Clinical narrative: Burning sensation in the breast; She specified she then sees that her breast is still "tender"/ it feels tender; Swollen lymph node; 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 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Sep2021 (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: BREAST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Burning sensation in the breast"; BREAST TENDERNESS (non-serious) with onset 2021, outcome "not recovered", described as "She specified she then sees that her breast is still "tender"/ it feels tender"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Swollen lymph node". Therapeutic measures were taken as a result of breast tenderness.  Additional information: The patient asked if a burning sensation in the breast was reported as a side effect from Comirnaty, and if she had a swollen lymph node. She stated receiving the first dose 19Sep2021 and being scheduled for her second dose today. She explained ever since the first dose, her right breast has been "bothering" her. She described it as a "burning sensation in" the breast. She mentioned she "sometimes felt it and other times don't". She also said she sometimes had to feel her breast for her to know that her symptom is still there. She specified she then sees that her breast is still "tender". The patient expressed she did not feel comfortable taking the second dose before getting enough information and seeing her doctor. She specified having an appointment with her doctor this Monday. Unsuccessful warm-transfer attempted, patient disconnected before being conferenced in with agent. The patient asked why was it not recommended to have a mammogram following the receipt of Comirnaty. Response: Responded per section "Drug or Food Interaction/ Concomitant Administration"  from VR-Consumer Inquiry Management (Off-Label or No Info). No information retrieved from sections "4 CONTRAINDICATIONS" and "5 WARNINGS AND PRECAUTIONS",  PI, LAB-1448-1.0, Revised: Aug2021; and section "10 DRUG INTERACTIONS" from Full EUA PI, LAB-0157-8.0, Revised: 22Sep2021. Patient asked what was the longest time she could wait to get the second dose of Comirnaty without impacting it's efficacy or having to repeat the series. The patient expressed not wanting to receive the second dose as schedule given her reaction to the first dose. The patient hung up the call hence, warm transfer could not be done. Call back was done however, it was unsuccessful. Hence, limited information available over the call.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: When I had the other 2 doses i was ok, just a bit tired; 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) (Batch/Lot number: unknown) as dose 2, single and (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: FATIGUE (non-serious), outcome "unknown", described as "When I had the other 2 doses i was ok, just a bit tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Diarrhea; loss of appetite; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 (Lot number: FF2589) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: CRANBERRY; VIT D3; FISH OIL. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose lot number: FF2589, prev dose vaccine location: Left Arm, prev dose administration time: 11:00 AM), administration date: 18Sep2021, when the patient was 29 years old, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 11Oct2021 06:00, outcome "not recovered", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 11Oct2021 06:00, outcome "not recovered", described as "loss of appetite"; DIZZINESS (non-serious) with onset 11Oct2021 06:00, outcome "not recovered", described as "dizziness". Therapeutic measures were not taken as a result of diarrhoea, decreased appetite, dizziness.  Additional information: There was no other vaccine in four weeks. Other medication in two weeks included Cranberry supplemnt, vitamin d3, fish oil, and pre. The patient was not covid tested post vaccination. The patient had no Known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Vaccination site pain
Clinical narrative: Temperature 99.2; injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Oct2021 09:00 (Lot number: FC3183) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lower and upper back pain" (unspecified if ongoing), notes: Lower and upper back pain; "Lower and upper back pinched nerves" (unspecified if ongoing), notes: Lower and upper back pinched nerves; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA, administration date 30Sep2021; TRAMADOL; TYLENOL; LIDOCAINE; BIOFREEZE PAIN RELIEVING. Past drug history included: Iodine, reaction(s): "known allergies: Intravenous iodine", notes: known allergies: Intravenous iodine; Levitra, reaction(s): "known allergies: Levitra", notes: known allergies: Levitra; Plaquenil, reaction(s): "known allergies: plaquenil", notes: known allergies: plaquenil. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3302, Administration time: 01:00, Vaccine location: Left arm), administration date: 16Jan2021, when the patient was 78 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot number: EM9810, Administration time: 01:00, Vaccine location: Left arm), administration date: 08Feb2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 15Oct2021 08:00, outcome "recovering", described as "Temperature 99.2"; VACCINATION SITE PAIN (non-serious) with onset 15Oct2021 08:00, outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, vaccination site pain.  Additional information: The patient had received other vaccine in four weeks with influenza. The patient had other medications in 2 weeks with tramadol, tylenol, lidocaine patch, boiofreeze. The patient had treatment with tylenol for adverse events temperature 99.2 and injection site pain. Patient had covid prior vaccination and had covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Immunisation, Injection site pain, Off label use, Pyrexia
Clinical narrative: Temperature 99.2; injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Oct2021 09:00 (Lot number: FC3183) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lower and upper back pain" (unspecified if ongoing), notes: Lower and upper back pain; "Lower and upper back pinched nerves" (unspecified if ongoing), notes: Lower and upper back pinched nerves; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA, administration date 30Sep2021; TRAMADOL; TYLENOL; LIDOCAINE; BIOFREEZE PAIN RELIEVING. Past drug history included: Iodine, reaction(s): "known allergies: Intravenous iodine", notes: known allergies: Intravenous iodine; Levitra, reaction(s): "known allergies: Levitra", notes: known allergies: Levitra; Plaquenil, reaction(s): "known allergies: plaquenil", notes: known allergies: plaquenil. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3302, Administration time: 01:00, Vaccine location: Left arm), administration date: 16Jan2021, when the patient was 78 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot number: EM9810, Administration time: 01:00, Vaccine location: Left arm), administration date: 08Feb2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 15Oct2021 08:00, outcome "recovering", described as "Temperature 99.2"; VACCINATION SITE PAIN (non-serious) with onset 15Oct2021 08:00, outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, vaccination site pain.  Additional information: The patient had received other vaccine in four weeks with influenza. The patient had other medications in 2 weeks with tramadol, tylenol, lidocaine patch, boiofreeze. The patient had treatment with tylenol for adverse events temperature 99.2 and injection site pain. Patient had covid prior vaccination and had covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Investigation
Clinical narrative: Heart issues and Problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 21 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart issues and Problems". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My son received your vaccine, the second of his shots coming in Jul2021.Not long after that he has been having heart issues and Problems. He was a perfectly healthy 21-year-old man. He is going under some testing now but he is sure that your vaccine is causing all of this. This letter is to put you on notice of a lawsuit against you should anything happen to him or he has long term effects from your vaccine  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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Epstein-Barr viraemia, Epstein-Barr virus antibody, Malaise
Clinical narrative: EBV was activated; feeling run down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EN6203) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose number: 1, prev dose lot number - L9264), administration date: 06Feb2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: EPSTEIN-BARR VIRAEMIA (non-serious) with onset Oct2021, outcome "unknown", described as "EBV was activated"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "feeling run down". The events "ebv was activated" and "feeling run down" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Doctor related that EBV was activated and this could be related to vaccine. The patient had no covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo lasting more than 3+ hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 17:30 (Lot number: FF2587) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 07:00 AM), administration date: 16Feb2021, when the patient was 27 years old, for Covid-19 Immunisation, reaction(s): "Inappropriate schedule of product administration"; Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Vaccine Administration Time: 07:30 AM), administration date: 01Feb2021, when the patient was 27 years old, for Covid-19 Immunisation. The following information was reported: VERTIGO (non-serious) with onset 16Oct2021 09:00, outcome "not recovered", described as "Vertigo lasting more than 3+ hours". The event "vertigo lasting more than 3+ hours" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Fatigue; Headache; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 15:45 (Lot number: 301358A) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 27Sep2021 23:45, outcome "recovered" (28Sep2021), described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021 23:45, outcome "recovered" (28Sep2021), described as "Sore arm"; FATIGUE (non-serious) with onset 28Sep2021 23:45, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of headache, pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: Cessation of the menstrual cycle; stopped menstruating.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16May2021 (Lot number: EW0179) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dont know, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0175), administration date: 25Apr2021, when the patient was 17 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Cessation of the menstrual cycle"; AMENORRHOEA (non-serious) with onset 27Jul2021, outcome "not recovered", described as "stopped menstruating.". Therapeutic measures were not taken as a result of menstrual disorder, amenorrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Cessation of the menstrual cycle. Teen child with regular menstrual periods has stopped menstruating. Not other possible cause was found. No previous history of irregularities before getting the vaccine. Reporting in case there could be a connection. Doctor visit will occur before October ends if periods do not return. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Oct2021 10:00 (Lot number: FE3590, Expiration Date: 05Nov2021) 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), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose: 2, Consumer also informed that the second dose got him very sick, with flu like symptoms, no more information provided), administration date: 2021, for COVID-19 immunization, reaction(s): "very sick", "flu like symptoms". The following information was reported: BALANCE DISORDER (non-serious) with onset 16Oct2021, outcome "unknown", described as "Equilibrium is off, my balance is, I feel like I am going to fall over". Additional information: I was just calling on, I had my Pfizer booster on Thursday and it has been 6 months before I had have my other two shots. What is going on right now is, I went to work this morning and my equilibrium is off, my balance is, I feel like I am going to fall over. Now, is that a side effect from that booster?". I am going to wait until tomorrow and if I am still feeling this way, I might go to an emergency. You cannot answer that? You haven't had anyone with this reaction. Consumer also informed that the second dose got him very sick, with flu like symptoms, no more information provided. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Don't know if this does matter my first shot that I got, I got the horrible headache like, I was on headache for several days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 (Lot number: FC3181) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Attention deficit disorder" (unspecified if ongoing); "I had asthma when I was child" (unspecified if ongoing), notes: patient don't had like, patient had inhaler when need it but don't use it that often; "Reactive airways disease", start date: 15Nov1984 (unspecified if ongoing), notes: Patient was born with reactive airways disease but yeah as of right now don't have. Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder. The following information was reported: HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Don't know if this does matter my first shot that I got, I got the horrible headache like, I was on headache for several days".  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Pain in extremity
Clinical narrative: Her glucose dropped about almost 50 points/sugar was 100 and 84; Arm was hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 14:30 (Lot number: FF2589) at the age of 77 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Covid 19 virus", start date: Jan2021 (unspecified if ongoing), notes: she had Covid 19 virus; "Diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Lot number: FD0809; Anatomical Location: arm), administration date: 18Sep2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious) with onset 13Oct2021, outcome "recovered" (17Oct2021), described as "Her glucose dropped about almost 50 points/sugar was 100 and 84"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovering", described as "Arm was hurting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Day after the shot her glucose dropped about almost 50 points. Thought something was wrong with the test strips or meter. She called her diabetic coach and was sent a Brand-new meter and strips and now it's 4 days later and it's almost back to normal. Believes it was the shot that was the problem. Usually, her sugar was between 125-135 and the first day afterwards it was 100 and 84 the next day. Tried both the old one and the new one and her numbers were still like 90. 2 days later it is back to normal. It was a 4-day span of low numbers and the only thing different was the second shot. Usually checks her sugar once or twice daily and when it was down to 84 she tested it 5 times. States it just dawned on her of what could possibly cause her drop in sugar and her arm was hurting and thought maybe it was the shot. The events did not result in emergency room or physician office visit. Illness/AE were none. Family medical history relevant to events was none. Relevant tests were none (except glucose test). No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer vaccine. Vaccination Facility Type: Pharmacy/Drug Store. Vaccine was not administered at Facility. No events after first BNT162B2 shot. Livongo glucose meter for glucose test once or twice daily. Unable to provide the NDC, UDI, Lot, or expiry for the old or new Livongo glucose meter. Unable to provide the NDC for the old Livongo test strips but provided the Lot number of 891230 and expiry of 07Sep2022. Reporter seriousness for the events was unspecified.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Vaccination site pain
Clinical narrative: Injection site slight pain; Fatigue; Chills; Stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Oct2021 09:15 (Lot number: EW0217) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 26Sep2021; FLUOXETINE; KURVELO taken for contraception. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 25Jan2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "slight soreness in my right arm"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "fatigue", "I had slight muscle soreness", "very slight chills", "My right arm was also a bit sore.". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Injection site slight pain"; FATIGUE (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Stomach ache". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, abdominal pain upper.  Additional Information: It was reported that, the patient received as fluoxetine (20 mg), Kurvelo for birth control as other medications within 2 weeks of vaccination. The patient was not received treatment for adverse events. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Injection site slight pain; Fatigue; Chills; Stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Oct2021 09:15 (Lot number: EW0217) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 26Sep2021; FLUOXETINE; KURVELO taken for contraception. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 25Jan2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "slight soreness in my right arm"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "fatigue", "I had slight muscle soreness", "very slight chills", "My right arm was also a bit sore.". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Injection site slight pain"; FATIGUE (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Stomach ache". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, abdominal pain upper.  Additional Information: It was reported that, the patient received as fluoxetine (20 mg), Kurvelo for birth control as other medications within 2 weeks of vaccination. The patient was not received treatment for adverse events. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: second dose they did have headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old male patient received bnt162b2 (COMIRNATY) (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: Comirnaty (Dose 1), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "second dose they did have headaches".   Follow-up: 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101381084 Same reporter/vaccine/event, different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Second dose they did have headaches; 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 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 03Feb2021 (Lot number: EL3246) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Caller says this was diagnosed in 1956 or 1957.; "Antacid" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [FAMOTIDINE] taken for hyperchlorhydria. Vaccination history included: Bnt162b2 (Caller says they both got their first doses on 12Jan2021 with LOT: EL3246.), administration date: 12Jan2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "Second dose they did have headaches". Therapeutic measures were not taken as a result of headache.  Additional information: Patient had second dose they did have headaches and hers lasted over a month and then began to go away. Patient started taking Pepcid 6 or 7 or 8 years ago. Vaccine was administered at hospital.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Sep2021 (Lot number: FF8841) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing); "antacid" (unspecified if ongoing). Concomitant medication(s) included: ESOMEPRAZOLE taken for antacid therapy. Vaccination history included: Bnt162b2 (First dose, LOT: EL3246), administration date: 12Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Second dose, LOT: EL3246), administration date: 03Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "second dose they did have headaches". The following information was reported: HEADACHE (non-serious), NAUSEA (non-serious) all with onset 29Sep2021, outcome "not recovered" and all described as "They began to have symptoms of headache, nausea after eating". Therapeutic measures were not taken as a result of headache, nausea.  Additional information: It was reported that patient when he don't eat, he don't feel as bad and don't notice the nausea, and as soon as he eat he feel nauseated. He takes concomitant medications as stomach one, and a blood pressure medication.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: had a response to her nervous system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY) (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: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "had a response to her nervous system".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Malaise, Pain, Pyrexia
Clinical narrative: feeling sick; aching just like a fever; it is not feeling good at all; He is in bed; he is aching just like a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 15Oct2021 02:00 (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: MALAISE (non-serious) with onset 16Oct2021, outcome "unknown", described as "feeling sick"; PAIN (non-serious) with onset 16Oct2021, outcome "unknown", described as "aching just like a fever"; FEELING ABNORMAL (non-serious) with onset 16Oct2021, outcome "unknown", described as "it is not feeling good at all"; BEDRIDDEN (non-serious) with onset 16Oct2021, outcome "unknown", described as "He is in bed"; PYREXIA (non-serious) with onset 16Oct2021, outcome "unknown", described as "he is aching just like a fever".  Additional information: The reporter called to see if  her husband can take like Advil or something. He had the Pfizer shot yesterday and it is not feeling good at all. He is in bed, aching, feeling sick and all that and asked Can he take Tylenol or anything. He had it yesterday, yesterday at 2 o'clock and today he is home. Come home from work not feeling good and he is in bed and he is aching just like a fever and all that. Reporter stated, If he can take something for that like he should take it, He was in bed, sick right now. Reporter was informed to visit ER. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise
Clinical narrative: I had just been lot of breathlessness in the morning; I am feeling some of the symptoms on the paper; 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 (COMIRNATY) (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: DYSPNOEA (non-serious), outcome "unknown", described as "I had just been lot of breathlessness in the morning"; MALAISE (non-serious), outcome "unknown", described as "I am feeling some of the symptoms on the paper".  Additional information: Patient wanted to known he had his first vaccine shot (Covid-19 Vaccine) the other day and I had just been lot of breathlessness in the morning and the papers they email you said to contact for anything like that." Later patient hung up the call abruptly. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Gingival pain, Glossodynia, Oropharyngeal pain
Clinical narrative: I am having soreness in my throat and my upper gum and the tongue; I am having soreness in my throat and my upper gum and the tongue; I am having soreness in my throat and my upper gum and the tongue; It is actually rather uncomfortable; 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 (COMIRNATY), administration date 2021 (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: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), GINGIVAL PAIN (non-serious), GLOSSODYNIA (non-serious) all with onset 2021, outcome "unknown" and all described as "I am having soreness in my throat and my upper gum and the tongue"; DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "It is actually rather uncomfortable".  Additional information: Consumer stated So I am calling because I think, I might be having a side effect from the shot that I got 'recently', my second COVID shot and I wanted to ask if it is one of the side effects of, I am having soreness in my throat and my upper gum and the tongue. It is actually rather uncomfortable but I just I do not know.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; 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 female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 08Oct2021 (Lot number: FF8839) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing). Concomitant medication(s) included: ALOGLIPTIN; ESOMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL; GLIMEPIRIDE; SODIUM CHLORIDE; ATORVASTATIN; KEPPRA [LEVETIRACETAM] taken for seizure; FLORANE. Vaccination history included: Bnt162b2 (The first LOT# she got on 3rd of February this year (confirmed as 03Feb) and the lot number: EL9265), administration date: 03Feb2021, when the patient was 70 years old, for Covid-19 immunization; Bnt162b2 (second shot she got was on 24th of February of this year (confirmed as 24Feb) and the lot number: EN6201), administration date: 24Feb2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 08Oct2021, outcome "not recovered" and all described as "my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, vaccination site swelling, vaccination site erythema, vaccination site pruritus, vaccination site pain.  Additional information: Patient wanted to report bad reaction, shot that she got it a week ago and she went in to see her doctor today or yesterday and they wanted her to report the finding that she had, her arm was swelled up to about a goose egg size and this in the site and it's been red and itchy and sore for a whole week. There were no lab tests.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; 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 female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 08Oct2021 (Lot number: FF8839) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing). Concomitant medication(s) included: ALOGLIPTIN; ESOMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL; GLIMEPIRIDE; SODIUM CHLORIDE; ATORVASTATIN; KEPPRA [LEVETIRACETAM] taken for seizure; FLORANE. Vaccination history included: Bnt162b2 (The first LOT# she got on 3rd of February this year (confirmed as 03Feb) and the lot number: EL9265), administration date: 03Feb2021, when the patient was 70 years old, for Covid-19 immunization; Bnt162b2 (second shot she got was on 24th of February of this year (confirmed as 24Feb) and the lot number: EN6201), administration date: 24Feb2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 08Oct2021, outcome "not recovered" and all described as "my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, vaccination site swelling, vaccination site erythema, vaccination site pruritus, vaccination site pain.  Additional information: Patient wanted to report bad reaction, shot that she got it a week ago and she went in to see her doctor today or yesterday and they wanted her to report the finding that she had, her arm was swelled up to about a goose egg size and this in the site and it's been red and itchy and sore for a whole week. There were no lab tests.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Erythema, Lymphadenopathy, Skin warm
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient experienced erythema (left arm; warm red patch), warm skin, lymphadenopathy (lymph nodes swollen underneath my left arm), and breast swelling (breast is really swollen), with outcome of unknown. Additional information: Patient had side effects from her second shot. Her right arm was fine when she got her first shot (not clarified further). On her left arm, she had a red patch where it was warm. Her lymph nodes were swollen underneath her left arm. Her breast was really swollen. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Very uncomfortable right now; Tight chest; Shortness of breath; Accelerated heart rate; I''m not feeling so well; 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 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, Lot: EM9809), for Covid-19 Immunization, reaction(s): "Tight chest"; Bnt162b2 (Dose:1, Lot: EM9809), for COVID-19 immunization, reaction(s): "Shortness of breath", "Accelerated heart rate"; Bnt162b2 (Dose:2, Lot: EN6198), for COVID-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "Very uncomfortable right now"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Tight chest"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Accelerated heart rate"; MALAISE (non-serious), outcome "unknown", described as "I''m not feeling so well". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (15Nov2021): 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: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Very uncomfortable right now; Tight chest; Shortness of breath; Accelerated heart rate; I''m not feeling so well; 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 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, Lot: EM9809), for Covid-19 Immunization, reaction(s): "Tight chest"; Bnt162b2 (Dose:1, Lot: EM9809), for COVID-19 immunization, reaction(s): "Shortness of breath", "Accelerated heart rate"; Bnt162b2 (Dose:2, Lot: EN6198), for COVID-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "Very uncomfortable right now"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Tight chest"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Accelerated heart rate"; MALAISE (non-serious), outcome "unknown", described as "I''m not feeling so well". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (15Nov2021): 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.