chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Mydriasis, SARS-CoV-2 test, Vision blurred
Clinical narrative: my left pupil dilated fully for no reason; My left eye vision was blurry; I felt light headed and dizzy; I felt light headed and dizzy; I do frequently get blurry vision and dizzy spells now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 10:00 (Lot number: Ew0178) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Ew0167, Administration time: 10:00 AM, Vaccine location: Left arm), administration date: 29Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: MYDRIASIS (non-serious) with onset 22May2021 08:00, outcome "recovered with sequelae", described as "my left pupil dilated fully for no reason"; VISION BLURRED (non-serious) with onset 22May2021 08:00, outcome "recovered with sequelae", described as "My left eye vision was blurry"; DIZZINESS (non-serious), DIZZINESS (non-serious) all with onset 22May2021 08:00, outcome "recovered with sequelae" and all described as "I felt light headed and dizzy"; DIZZINESS (non-serious) with onset 22May2021 08:00, outcome "recovered with sequelae", described as "I do frequently get blurry vision and dizzy spells now". The events "my left pupil dilated fully for no reason", "my left eye vision was blurry", "i felt light headed and dizzy", "i felt light headed and dizzy" and "i do frequently get blurry vision and dizzy spells now" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of mydriasis, vision blurred, dizziness, dizziness, dizziness.  Additional information: The patient had not other vaccine in 4 weeks and had not other medications in 2 weeks. 2 days after second dose patient left pupil dilated fully for no reason. Patient right remained normal size. Patient left eye vision was blurry and felt light headed and dizzy. It stayed dilated for 4 days, slowly going back down to normal size. Once it went back to normal it has remained that way but she do frequently get blurry vision and dizzy spells now. The adverse event resulted in doctor (other healthcare professional) office (clinic visit). The patient was recovered with lasting effects. Patient had not covid prior vaccination and had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: felt her heart was beating a little faster for a while; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Aug2021 (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: HEART RATE INCREASED (non-serious), outcome "unknown", described as "felt her heart was beating a little faster for a while". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Date Received: 07Oct2021; 17:18:06 UTC. Question: Call was warm transferred, NTID #, Reportum # . Per, call was transferred to her by USMI agent with INT-#. Documenting possible duplicate AE, e-transmitting report for review (50 years old, Female - age was obtained from original INT-#, was not able to capture it during my call). New AE information obtained from the caller. Caller did not provide any other personal information. Caller wanted more information on how the Pfizer-BioNtech Vaccine works. Caller wants to know what does the previous MI means when she said "primes" the immune system. She also wants to know how long the antibodies stay and how long we can produce antibodies. Question: Call was warm transferred, NTID #, Reportum # . Call was transferred to her by agent with INT-#. Documenting possible duplicate AE, e-transmitting report for review (50 years old, Female - age was obtained from original INT-#, was not able to capture it during my call). New AE information obtained from the caller. During the call, she mentioned that after getting the 1st dose, after a day or two she felt her heart was beating a little faster for a while, that's why she decided not to get the vaccine. She's not sure if that's the vaccines effect or maybe she's nervous or something, she's not really sure.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: No menstral period since 27May2021; No menstral period since 27May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER8729) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: AMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "No menstral period since 27May2021". Therapeutic measures were not taken as a result of amenorrhoea, menstrual disorder.  Additional information: Patient received Covid-19 vaccine from School or Student Health Clinic facility. Patient does not received any other vaccine within 4 weeks of Covid-19 vaccination. Patient received Multivitamin & Calcium w/ Vit D within 2 weeks of Covid-19 vaccination. Patient does not have any prior vaccination. Patient was not tested for Covid-19 since vaccination. Patient does not have any known allergy.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: lymphadenophaty right axilla; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 22Dec2020 15:00 (Lot number: EK9231) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (ongoing), notes: Childhood. There were no concomitant medications.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Dec2020, outcome "recovered" (29Dec2020), described as "lymphadenophaty right axilla"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Dec2020, outcome "recovered" (29Dec2020), described as "flu like symptoms". Therapeutic measures were not taken as a result of lymphadenopathy, influenza like illness.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Started menstrual bleeding/Started a week before my regular period which usually last four days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Sep2021 16:45 (Lot number: EC3184) at the age of 50 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: MENSTRUATION IRREGULAR (non-serious) with onset 17Sep2021 04:00, outcome "recovered" (04Oct2021), described as "Started menstrual bleeding/Started a week before my regular period which usually last four days". The event "started menstrual bleeding/started a week before my regular period which usually last four days" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Patient stated that menstrual bleeding started three days after receiving the vaccine which was one week early. Her menstrual cycle has been every 28 days and last about four days. After the first vaccine she started her monthly menstrual period, it lasted 18 days, stopped on the day she got her second covid vaccine. Till 13Dec patient did not had a menstrual period. She did not receive any other vaccine in four weeks and no medications received within two weeks. She was not tested positive for Covid prior to vaccination and was not tested positive since the vaccination. She also stated that the Pfizer product had a causal relationship to the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: hand feeling like it was numb; Tingling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Mar2021 11:00 (Lot number: ER2613) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (ongoing); "Rosacea" (ongoing); "cholesterol" (ongoing); "may-thurner" (ongoing); "gall bladder removed" (ongoing), notes: gall bladder removed. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing); ASPIRIN (E.C.) (ongoing); DOXYCYCLINE taken for rosacea (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); VITAMIN D3 (ongoing); CALCIUM (ongoing). Vaccination history included: Bnt162b2 (1st dose, Time: Noon, Anotomical site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EN6202), administration date: 24Feb2021, when the patient was 72 years old, for Covid-19 immunization.  The following information was reported: HYPOAESTHESIA (non-serious), outcome "recovered", described as "hand feeling like it was numb"; PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Limb discomfort
Clinical narrative: Diarrhea; covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 10:00 (Lot number: FC3181) at the age of 48  as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anti-inflammatory" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for anti-inflammatory therapy, start date: 23Aug2021, stop date: 04Sep2021. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; LIMB DISCOMFORT (non-serious) with onset 17Aug2021, outcome "unknown", described as "covid arm".  Additional information: No Prior vaccine in four weeks. Patient had diarrhea for one week and COVID arm. With 2nd dose patient woke up in the morning clammy nauseous , vomited and slept the whole day and night .The next 2 day had loss of appetite and headache also had swollen lymph node in left Arm pit where vaccine was given. Patient had been getting migraines one X week since 2nd vaccine for 3 weeks . Now patient also had COVID Arm the next day both time.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Costochondritis, SARS-CoV-2 test
Clinical narrative: Costochondrites; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 13:00 (Lot number: Fe3592) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Central sensitization" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fg3182, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 10Sep2021, when the patient was 16 years old, for COVID-19 Immunization. The following information was reported: COSTOCHONDRITIS (non-serious) with onset 01Oct2021 20:00, outcome "not recovered", described as "Costochondrites". The event "costochondrites" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of costochondritis.  Additional information: COVID vaccine received at facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: Cymbalta Motrin received as a treatment for adverse event. No COVID prior vaccination. Tested COVID post vaccination. On 04Oct2021 patient had COVID test nasal swab (PCR) type post vaccination and the result of the test was negative. No known allergies.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: experienced the same palpitation and dizziness; experienced the same palpitation and dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 27 year-old male 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: PALPITATIONS (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "experienced the same palpitation and dizziness".  Additional information:Caller wanted to know if Pfizer BioNtech Covid-19 Vaccine's reported AEs included dizziness and palpitations and if it would be possible that it would stay permanent.Caller wanted to know the efficacy of the Pfizer BioNTech Covid-19 Vaccine after one dose.Caller wanted to know where to access updated information on the efficacy of the Pfizer BioNTech Covid-19 Vaccine.Caller stated that she thinks the side effects for skinny people like her is caused by more dosage compared to other body types. Caller also mentioned that she researched that there are 3 million side effect cases for pfizer, moderna and johnson and johnson covid-19 vaccines and hoped for more access to information.Batch/lot number: Not Provided.Is report related to a study or programme: No.Expiry Date of COVID vaccine: Not Provided.Other Products: Not Provided.Patient History: Not Provided. Investigation Assessment: Not Provided.She has heard from her neighbor that the neighbor knows a guy who has a doctor and that 27-year-old doctor also experienced the same dizziness and palpitations that the caller has experienced.Reporter seriousness for also experienced the same dizziness and palpitations that the caller has experienced: Unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Cardiac stress test abnormal
Clinical narrative: a cardiac stress test and the results"came back not normal, but not terrible; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years 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 (2 nd dose), for COVID-19 immunization.  The following information was reported: CARDIAC STRESS TEST ABNORMAL (non-serious), outcome "unknown", described as "a cardiac stress test and the results"came back not normal, but not terrible". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports they missed 4 weeks of Xeljanz for their initial COVID19 vaccine doses, then 2 weeks for their 3rd dose of COVID19 vaccine. Patient reports they recently had a cardiac stress test and the results "came back not normal, but not terrible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: chills; myalgia; fatigue; nausea; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization, reaction(s): "Chills", "Fatigue", "Myalgia".  The following information was reported: CHILLS (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "chills"; MYALGIA (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "myalgia"; FATIGUE (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "fatigue"; NAUSEA (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "nausea"; DIARRHOEA (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "diarrhea". Therapeutic measures were not taken as a result of chills, myalgia, fatigue, nausea, diarrhoea.  Additional information: The patient, who is a pediatrician, received a booster dose of the Pfizer COVID vaccine and experienced chills, myalgia, fatigue, nausea and diarrhea. The symptoms lasted for two days. The patient stated that she had experienced similar symptoms after the second dose of the vaccine except for nausea and diarrhea. The patient did not have covid prior vaccination, not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: chills; myalgia; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 39 years 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 ( product: COVID 19,  dose number: 1,  dose brand: Pfizer, dose lot unknown: True,  dose lot unknown reason: Not available/provided to reporter at the time of report completion.), when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 04Oct2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 04Oct2021, outcome "recovering", described as "myalgia"; FATIGUE (non-serious) with onset 04Oct2021, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of chills, myalgia, fatigue.  Additional Information: Lot unknown reason provided as not available/provided to reporter at the time of report completion. No other vaccine in four weeks reported. No other medications in two weeks. Adverse event reported as the patient, who is a pediatrician, received a booster dose of the Pfizer COVID vaccine and experienced chills, myalgia, fatigue, nausea and diarrhea. The symptoms lasted for two days. The patient stated that she had experienced similar symptoms after the second dose of the vaccine except for nausea and diarrhea. No covid prior and post vaccination. No known allergies and other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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), administration date 17Feb2021 (Lot number: EL0140) at the age of 77 years as dose 2, single and administration date 27Jan2021 (Lot number: EL0140) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient took Ibuprofen and Tylenol. The patient reported that she hardly had any problem, she just had a sore arm. The patient had a Booster dose and experienced sore arm that was really painful.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: with the first dose of the Covid Vaccine the patient had soreness in the legs; Really Tired; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 09Jan2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Patient Medical continuing: yes , Patient Medical comments: verbatim: Blood pressure high; "Hypothyroidism" (ongoing), notes: Structured information(Patient episode name): Hypothyroidism, Patient Medical continuing: yes. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "with the first dose of the Covid Vaccine the patient had soreness in the legs"; FATIGUE (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "Really Tired".  Additional information: Caller stated she did not know the year for the patient's date of birth. She first states it is (year) but then states (year). This was captured as stated by the caller, (year). Family Medical History Relevant to AE(s): None. Prior Vaccinations (within 4 weeks): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse event did not result in Emergency room visit and result in physician office visit. Relevant Tests: None. Patient received second dose on 29Jan2021. Seriousness for the events was reported as not serious. Other products and investigation assessment was reported as no. Relatedness of drug to reaction(s)/event(s).Reaction assessed: First Dose: Soreness in the legs. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed: First Dose: Really Tired. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (150559). A 76-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 76, Mar 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient's international normalised ratio increased (elevated INR), onset 2021, with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: Patient reported having the COVID-19 vaccine back in Mar 2021. After first vaccination patient reported elevated INR. Follow-up (Nov 19, 2021): This follow-up submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Upset, nauseas stomach after the first vaccine; Upset, nauseas stomach after the first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: ABDOMINAL DISCOMFORT (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "Upset, nauseas stomach after the first vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: experienced chills, myalgia, fatigue,headache after receiving a booster shot Pfizer COVID vaccine.; experienced chills, myalgia, fatigue and headache after receiving a booster shot Pfizer COVID vaccine; experienced chills, myalgia, fatigue,headache after receiving a booster shot Pfizer COVID vaccine.; experienced chills, myalgia, fatigue,headache after receiving a booster shot Pfizer COVID vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose number: 1), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "unknown" and all described as "experienced chills, myalgia, fatigue and headache after receiving a booster shot of the Pfizer COVID vaccine. The patient stated that he had similar symptoms after the second dose of the Pfizer COVID vaccine."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My lymph node are very swollen; 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 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "My lymph node are very swollen". Additional Information:Consumer stated, "The LOT#, okay it's like 301538 may be, it's hard to read their hand-writing, I think so yeah because it's hard to read the hand-writing." Consumer stated "I am calling because I had my third shot for the COVID 19 Vaccine booster two days ago on Tuesday and my lymph node are very swollen and I just wanted to call and see if that's okay or this is the common problem that people are experiencing?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Oct2021): 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: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Fast heart rate/rapid heartbeat; 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 52 year-old female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: PF2589) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 07Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension. Concomitant medication(s) included: PREMARIN. Vaccination history included: Bnt162b2 (dose: 01), for COVID-19 Immunization; Bnt162b2 (dose: 02), for COVID-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 07Oct2021, outcome "not recovered", described as "Fast heart rate/rapid heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased.  Additional information: Patient, female, aged 52, received her booster dose of the Pfizer BioNTech Covid 19 vaccine yesterday between 1pm and 1:45pm along with her flu vaccine. Later in the day while watching the football game she had a fast heart rate and she took something to try to calm down that she takes for her anxiety. She didn't really think anything of it and then went to sleep after the football game. This morning she woke up and while on her pillow it was still kind of rapid but not as rapid as last night. And it wasn't so bad last that that she panicked, she just kept watching the game. She states it was a mild side effect, no tight chest or anything like that. Consumer Stated, "she noticed last night that she had the rapid heartbeat when (incomplete sentence), because she got the Pfizer vaccine yesterday around 1 o'clock she just really noticed that it was the night time and so, she had took one of her 'Calmotin' (Further clarification unknown) which relax you, a little bit. patient took one of her medication that was 'Calmotin' (Further clarification Unknown) that makes her relax and just because she wanted to check that, if for anxiety so it's that to check that she know to see if that help it or not, heart rate 'fell'  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle was affected. Last month period started on the 18th. This month it started yesterday on the 7th. That's not even two weeks between her cycles. She had always regular with cycle. Always; A 37 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 08:45 (Lot number: Fc3183) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose: 1), administration date: 15Sep2021, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 07Oct2021, outcome "recovering", described as "Menstrual cycle was affected. Last month my period started on the 18th. This month it started yesterday on the 7th. That's not even two weeks between my cycles. I am always regular with my cycle. Always". Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: No other vaccines in four weeks. No other medications in four weeks. No covid prior to vaccination and no covid tested post vaccination. There were no known allergies and no other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Hot flush, Night sweats
Clinical narrative: flush feeling; when I clean my house, it's not hot it's cold and I just get really hot; night sweats; lightheaded, dizzy; feels weird in her head; if feels like an off balance feeling; like under her arm feels sore; 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 48 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 27Sep2021 16:00 (Lot number: 30155BA) at the age of 48 years 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 (First dose Covid-19 vaccine, Lot No. FC3183, Anatomical location: Right deltoid), administration date: 04Sep2021, when the patient was 48 years old, for Covid-19 Immunization, reaction(s): "feels like she sweats all the time", "got really hot and is hot all the time". The following information was reported: HOT FLUSH (non-serious) with onset Sep2021, outcome "not recovered", described as "flush feeling; when I clean my house, it's not hot it's cold and I just get really hot"; NIGHT SWEATS (non-serious) with onset Sep2021, outcome "not recovered", described as "night sweats"; DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "lightheaded, dizzy"; FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "not recovered", described as "feels weird in her head"; BALANCE DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "if feels like an off balance feeling"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "like under her arm feels sore".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341415 same reporter/drug, similar events, different patient
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: flush feeling; when I clean my house, it's not hot it's cold and I just get really hot; night sweats; lightheaded, dizzy; feels weird in her head; if feels like an off balance feeling; like under her arm feels sore; 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 48 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 27Sep2021 16:00 (Lot number: 30155BA) at the age of 48 years 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 (First dose Covid-19 vaccine, Lot No. FC3183, Anatomical location: Right deltoid), administration date: 04Sep2021, when the patient was 48 years old, for Covid-19 Immunization, reaction(s): "feels like she sweats all the time", "got really hot and is hot all the time". The following information was reported: HOT FLUSH (non-serious) with onset Sep2021, outcome "not recovered", described as "flush feeling; when I clean my house, it's not hot it's cold and I just get really hot"; NIGHT SWEATS (non-serious) with onset Sep2021, outcome "not recovered", described as "night sweats"; DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "lightheaded, dizzy"; FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "not recovered", described as "feels weird in her head"; BALANCE DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "if feels like an off balance feeling"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "like under her arm feels sore".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341415 same reporter/drug, similar events, different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vision blurred, Vomiting
Clinical narrative: Eye blurriness; vomiting; arm soreness; neck soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 11:45 (Lot number: EWO171) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Other medical history: Breast Cancer. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO185, Location of injection: Arm Right, Vaccine Administration Time: 12:00), administration date: 20Sep2021, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: VISION BLURRED (non-serious), outcome "recovered", described as "Eye blurriness"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm soreness"; NECK PAIN (non-serious), outcome "recovered", described as "neck soreness". Therapeutic measures were not taken as a result of vision blurred, vomiting, pain in extremity, neck pain.  Additional information: No other vaccine in four weeks and other medications in two weeks. No COVID prior vaccination and patient did not tested COVID post vaccination. Start date and time for all events were 20Sep2021 at 13:00  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Blister rupture, Burning sensation, Erythema, Pruritus
Clinical narrative: A little red marks that turned into water blisters; as itchy little red marks scattered over arm and legs; The blisters will leak out and will turn into a black scar.; as itchy little red marks scattered over arm and legs; The blisters will leak out and will turn into a black scar.; blister is burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: BLISTER (non-serious), outcome "unknown", described as "A little red marks that turned into water blisters"; PRURITUS (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "as itchy little red marks scattered over arm and legs"; SCAR (non-serious), BLISTER RUPTURE (non-serious), outcome "unknown" and all described as "The blisters will leak out and will turn into a black scar."; BURNING SENSATION (non-serious), outcome "unknown", described as "blister is burning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: A little red marks that turned into water blisters; as itchy little red marks scattered over arm and legs; The blisters will leak out and will turn into a black scar.; as itchy little red marks scattered over arm and legs; The blisters will leak out and will turn into a black scar.; blister is burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: BLISTER (non-serious), outcome "unknown", described as "A little red marks that turned into water blisters"; PRURITUS (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "as itchy little red marks scattered over arm and legs"; SCAR (non-serious), BLISTER RUPTURE (non-serious), outcome "unknown" and all described as "The blisters will leak out and will turn into a black scar."; BURNING SENSATION (non-serious), outcome "unknown", described as "blister is burning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain, Pain in extremity
Clinical narrative: other random pains; Headache; Chills; Tinnitus; Injection site pain vaccination; Unable to sleep on left side with both vaccines for one night.; Left arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 11:30 (Lot number: FF8841) at the age of 60 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Known allergies: sulfa, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1283), administration date: 21Jan2021, when the patient was 60 years old, for COVID-19 IMMUNIZATION, reaction(s): "Chills", "Tinnitus", "ble to sleep on left side", "Left arm pain", "other random pains with injections"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9889), administration date: 31Dec2020, when the patient was 60 years old, for COVID-19 IMMUNIZATION, reaction(s): "Injection site pain". The following information was reported: PAIN (non-serious), outcome "unknown", described as "other random pains"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "recovered", described as "Chills"; TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain vaccination"; INSOMNIA (non-serious), outcome "unknown", described as "Unable to sleep on left side with both vaccines for one night."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm pain". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that patient headache was approx. 5 out of 10 scale at worst, started within 5 mins of injection. For headache patient was given Tylenol 650 mg as a treatment. Chills sporadically during HS, Resolved without intervention. No Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101343017 same reporter/patient/product, different dose/event.;US-PFIZER INC-202101343018 same reporter/patient/product, different dose/event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: other random pains; Headache; Chills; Tinnitus; Injection site pain vaccination; Unable to sleep on left side with both vaccines for one night.; Left arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 11:30 (Lot number: FF8841) at the age of 60 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Known allergies: sulfa, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1283), administration date: 21Jan2021, when the patient was 60 years old, for COVID-19 IMMUNIZATION, reaction(s): "Chills", "Tinnitus", "ble to sleep on left side", "Left arm pain", "other random pains with injections"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9889), administration date: 31Dec2020, when the patient was 60 years old, for COVID-19 IMMUNIZATION, reaction(s): "Injection site pain". The following information was reported: PAIN (non-serious), outcome "unknown", described as "other random pains"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "recovered", described as "Chills"; TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain vaccination"; INSOMNIA (non-serious), outcome "unknown", described as "Unable to sleep on left side with both vaccines for one night."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm pain". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that patient headache was approx. 5 out of 10 scale at worst, started within 5 mins of injection. For headache patient was given Tylenol 650 mg as a treatment. Chills sporadically during HS, Resolved without intervention. No Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101343017 same reporter/patient/product, different dose/event.;US-PFIZER INC-202101343018 same reporter/patient/product, different dose/event.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: after her first dose, she just had a sore arm; 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 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 08:30 (Lot number: EN6202) at the age of 69 years 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) with onset 2021, outcome "recovered" (2021), described as "after her first dose, she just had a sore arm".  No follow-up attempts are possible. No further information is expected.