chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced nausea on an unspecified date. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This is a spontaneous case report received by Pfizer. A non-contactable elderly male consumer (patient, self-reported).   An elderly male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscularly, on an unspecified date, as a single dose for COVID-19 immunization and risankizumab (SKYRIZI, unknown formulation) via Subcutaneous, on an unspecified date for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient reported that on an unspecified date, he experienced sore arm and fatigue. The patient received unspecified treatment for the events. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Ear infection, Muscle spasms
Clinical narrative: Severe spasms, whole mouth, shoulders, down both arms, everywhere; Chest pains; Ear infection; This is a spontaneous report from a contactable consumer. A 62-year-old-Female consumer (patient), received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ER8732, Expiration Date: 13Jul2021), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 12:45 (Age at vaccination 62 year) as SINGLE DOSE for covid-19 immunisation. Medical history included, cardiac failure. Concomitant medication(s) included hydrocortisone, neomycin sulfate, polymyxin b sulfate (ANTIBIOTIC EAR). Historical vaccine includes bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6207, Expiration Date: 13Jul2021), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 12:45 as DOSE 1, SINGLE for covid-19 immunisation. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines administered on Same Date of the Pfizer Suspect. Concomitant Products Antibiotic she did not know the name or dose but has been taking for 5 days. Caller stated she was on lots of medications, as she is in heart failure. But only provided the Antibiotic she has been taking for the last 5 days for an ear infection. This is the only new medication. She stated it was a big pill, not a capsule, by mouth. Caller did not have any further details to provide on report about the Antibiotic. On 03Apr2021 patient experienced severe spasms, whole mouth, shoulders, down both arms, everywhere, on an unspecified date in 2021 chest pains and ear infection. Therapeutic measures were taken as a result of severe spasms, whole mouth, shoulders, down both arms, everywhere took Tylenol and it has not been working. No Emergency Room visit. The patient not wanted to report her AE and be warm-transferred, thus, e-transmitted. Response received was provided disclaimer that Pfizer is unable to make treatment recommendations for individual patients and responded per EUA fact sheet under "6 OVERALL SAFETY SUMMARY". Spoke from CONS document regarding listed adverse events may not be all possible side effects as serious or unexpected side effects may occur. The outcome for event severe spasms, whole mouth, shoulders, down both arms, everywhere was not recovered, for chest pain and ear infection its unknown.   No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Infection, Pain in extremity
Clinical narrative: Had little infection; diarrhea; little bit of soreness the next day in arm; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had little infection. On 30Mar2021, the patient experienced little diarrhea and little bit of soreness the next day in arm. Patient stated, patient took the vaccine the 24Mar2021 and have been sit in the office. There was no yell, was quite feeling for about 4,5 minutes before patient took the shot that want to say it really. It would have been some mess was happened by visit. There was, patient just wanted to know it was alright to take it had little infection. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Little diarrhea yesterday and little bit of soreness the next day on my arm.; Little diarrhea yesterday and little bit of soreness the next day on my arm.; I took the the vaccine the 24 of this month/I got it 24 and I go back. later on did the second; This is a spontaneous report received from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration in Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. Patient had a little diarrhea in Mar2021 (yesterday as reported) and little bit of soreness the next day on my arm in Mar2021. Also had little infection in Mar2021. It was reported that patient got dose 1 on 24Mar2021 and went back. Later on did the second in Mar2021. There was, just wanted to know if it is alright to take it, had little infection. Patient had a little diarrhea in Mar2021 (yesterday as reported) and little bit of soreness the next day on my arm in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: soreness at injection site; pain under arm; tired; This is a spontaneous report from a non-contactable consumer (patient).   An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. First dose was administed in left arm in Feb2021. The patient medical history was not reported. No known allergies. The patient's concomitant medications were not reported. The patient experienced soreness at injection site, pain under arm, tired, all on an unspecified date. No treatment. No covid prior or post vaccination. The events outcome was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; injection site pain; This is a spontaneous report from a non-contactable consumer (patient).  A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) age at vaccination of 29-years-old, as single dose, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 02Apr2021 and injection site pain on 02Apr2021. No treatments were given. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: felt very sick within a day of the shot; This is a spontaneous report from a contactable consumer or other non hcp.     A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  Relevant medical history and concomitant medications were not reported.  The patient experienced felt very sick within a day of the shot (illness) on an unspecified date with outcome of recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: tested positive 28Dec2020; Post Covid Syndrome Headaches.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 21Dec2020 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Dec2020 patient was given the first dose of Pfizer covid vaccine, unfortunately unknown to everyone patient was already positive, became symptomatic on 22Dec2020 and tested positive on 28Dec2020. Since that time patient has been experiencing post Covid Syndrome Headaches from an unknown date in Dec2020. Patient would like to know whether should take the second vaccine and when. Outcome of events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: SVT; This is a spontaneous report from a contactable physician. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), (At the age of 60-years) dose 1 via an unspecified route of administration, administered in Arm Right on 15Mar2021 15:00 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included supraventricular tachycardia and History of svt. S/p ablation Onset date: 20-year Hx of sporadic episodes Pertinent details: Hx of 2 ablations- last one Nov2020. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient did not diagnose with COVID Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. No Allergies ware reported. The patient concomitant medications were not reported. The patient experienced supraventricular tachycardia on 25Mar2021. Patient was visited Emergency room for event. Treatment received for the adverse event: Adenosine. It was reported that patient received Treatment: B blocker for 2nd dose. Seriousness Criteria: Important medical event. The outcome of event was recovered on 2021.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of supraventricular tachycardia. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site bruising, Vaccination site pain
Clinical narrative: Low grade fever; chills; soreness & bruising at injection site; soreness & bruising at injection site; This is a spontaneous report from a contactable consumer(patient). A 51-years-old non-Pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration on 01Apr2021 at 09:30 into right arm as SINGLE DOSE for COVID-19 immunization at clinic. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 09Mar2021 at 11:30 am into right arm as SINGLE DOSE for COVID-19 immunization at clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 at 22:00, the patient experienced Low grade fever, chills, soreness & bruising at injection site. No treatment was given for the events. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus infection, Drug ineffective
Clinical narrative: Caller got first dose and then got covid; Caller got first dose and then got covid; This is a spontaneous report from a contactable consumer or other non hcp. This report from a Pfizer sponsored program. This contactable consumer reported for herself that a female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, caller got first dose and then got COVID. It was reported that caller got first dose and then got COVID and missed her second dose. The clinical outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: from 8 to 10 days after receiving the first dose of the vaccine they both took a COVID-19 test (on Monday) and tested positive with symptoms; This is a spontaneous report from a contactable consumer or other non health care professional (patient's wife) via a medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 24Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After 5 days of vaccination, the patient started to develop a reaction in which he lost the smelling sensation, was short of breath and had fatigue and from 8 to 10 days after receiving the first dose of the vaccine, took a COVID-19 test (on Monday) and tested positive. The patient did not have any social contact after the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Apr2021. The outcome of events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: now he's tested positive for Covid as well; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported has been exposed to someone who has covid on 29Mar2021 and now he's tested positive for Covid as well. Since is living in the same house with husband, she was quarantined because of that and she can not make the 2nd dose on time. She wanted to Know that they're in this kind of situation are they still going to have the 2nd dose. Their 2nd doses were on 07Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test was tested positive on an unspecified date. The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; sore; Fatigue; tested positive to have covid virus; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solu-tion for Injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 20Mar2021 as single dose for covid-19 immunization. Medical history included lymphoma from an unknown date and unknown if ongoing (a lymphoma survivor). The patients concomitant medications were not reported. On 01Apr2021 the patient tested positive to have covid virus. His wife got positive but not taken any of the doses yet. He also mentioned that he experienced fever, sore and fatigue on an unspecified date. The patient will get the 2nd dose on 12Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Apr2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: blood pressure is sky high/ BP was over 200; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient sister).A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number was not reported and Expiry date was reported), dose 1 via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.The patient experienced blood pressure is sky high and bp was over 200, headache on an unspecified date. She wonders if that is related to the vaccine; caller states she does not have the lot number to provide for the sister's Pfizer Vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: over 200. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia, Suspected COVID-19
Clinical narrative: We were sick we possibly have Covid; ache; I had a fever for two days off and on; have been sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported similar events for 2 patients. This is 1 of 2 reports. A female patient of an unspecified age received first dose of bnt162b2 (Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced we were sick we possibly have covid, ache, i had a fever for two days off and on, have been sick. Patient stated my husband and I both got the Pfizer shot on Monday night the first dose, now we have been sick. The patient had a fever for two days off and on and ache. My husband had a fever for 3 to 4 days and could we possibly have gotten Covid from it because he is gonna take the Covid test now because we were fine before the shot but now we find we were sick we possibly have Covid. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416222 Same reporter/diff patient
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 antibody test
Clinical narrative: joint pain; This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, Expiration Date: unknown), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing nodal marginal zone b-cell lymphoma, neoplasm malignant and arthritis. Concomitant medication(s) included ibrutinib (IMBRUVICA) taken for neoplasm malignant; valaciclovir hydrochloride (VALTREX) taken for neoplasm malignant. Historical vaccine included BNT162B2 on 20Jan2021 for covid-19 immunization. The physician reported, he has no antibodies against Sars-CoV-2, he waited a little over a month and saw his oncologist who ran a blood test to see what antibodies he had. He has CLL (chronic lymphocytic leukemia, he is on medication for cancer (Imbruvica and Valtrex). Since he tested negative for antibodies to protect from the virus caller would like to know if possibly the vaccine gives you or helps your immunity with elevated T cells. Also, he added that he experienced joint pain causing pain at the back and knees, but did not have any adverse events such as fever, tiredness etc. after taking the vaccine and he can't identify if it is joint pain due to his arthritis or the side effects of the Covid-19 vaccine. Outcome of events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421720 Same product and event, different patient
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Diarrhoea, Fatigue, Haematochezia, Hot flush
Clinical narrative: bloody/reddish stool; low platelet count; fatigue; nausea; hot flash; legs feel heavy/leg muscles tired; irritability; anxiety; diarrhea; This is a solicited report from a Pfizer-sponsored program contactable other healthcare professional and contactable 66-year-old female patient reported that she received palbociclib (IBRANCE), via oral from 01Apr2021 (Batch/Lot number was not reported) and ongoing, at 125 mg, daily, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 300 mg, twice day for breast cancer; bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included venlafaxine taken for an unspecified indication, start and stop date were not reported. Current dose: ibrance 125 mg (milligram) daily for 21 days and off for 7 days. patient reported she had fatigue, nausea for 2 minutes followed by a hot flash for 3 min and then goes away but occurs sometimes every two hours but has gotten better. legs feel heavy/leg muscles tired like she's been riding a bicycle for a long time. patient also reports when she started ibrance she had her 2nd covid vaccination and is not sure if that has also contributed to her side effects after starting ibrance. md (medical doctor) aware. no further information given. patient reports previously mentioned fatigue continues and remains the same, nausea continues but is better with anti-nausea medication, hot flashes continue and md prescribed venlafaxine (started today) to help out along with helping new report of irritability and anxiety, and previously mentioned legs feeling physically tired continues and remains the same. patient also has a new report of occasional diarrhea after starting ibrance. md aware. no further information given. The patient underwent lab tests and procedures which included platelet count: low. The action taken in response to the events for palbociclib was dose not changed , for bnt162b2 was not applicable. The outcome of events bloody/reddish stool, low platelet count was unknown, for events fatigue, hot flash, irritability, anxiety, diarrhea, outcome was recovering, for event legs feel heavy/leg muscles tired outcome of not recovered and for event nausea it was recovered.   No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on the available information and considering the reported events can be associated with ibrance, its role was considered possible.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Irritability, Limb discomfort, Nausea, Platelet count, Platelet count decreased
Clinical narrative: bloody/reddish stool; low platelet count; fatigue; nausea; hot flash; legs feel heavy/leg muscles tired; irritability; anxiety; diarrhea; This is a solicited report from a Pfizer-sponsored program contactable other healthcare professional and contactable 66-year-old female patient reported that she received palbociclib (IBRANCE), via oral from 01Apr2021 (Batch/Lot number was not reported) and ongoing, at 125 mg, daily, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 300 mg, twice day for breast cancer; bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included venlafaxine taken for an unspecified indication, start and stop date were not reported. Current dose: ibrance 125 mg (milligram) daily for 21 days and off for 7 days. patient reported she had fatigue, nausea for 2 minutes followed by a hot flash for 3 min and then goes away but occurs sometimes every two hours but has gotten better. legs feel heavy/leg muscles tired like she's been riding a bicycle for a long time. patient also reports when she started ibrance she had her 2nd covid vaccination and is not sure if that has also contributed to her side effects after starting ibrance. md (medical doctor) aware. no further information given. patient reports previously mentioned fatigue continues and remains the same, nausea continues but is better with anti-nausea medication, hot flashes continue and md prescribed venlafaxine (started today) to help out along with helping new report of irritability and anxiety, and previously mentioned legs feeling physically tired continues and remains the same. patient also has a new report of occasional diarrhea after starting ibrance. md aware. no further information given. The patient underwent lab tests and procedures which included platelet count: low. The action taken in response to the events for palbociclib was dose not changed , for bnt162b2 was not applicable. The outcome of events bloody/reddish stool, low platelet count was unknown, for events fatigue, hot flash, irritability, anxiety, diarrhea, outcome was recovering, for event legs feel heavy/leg muscles tired outcome of not recovered and for event nausea it was recovered.   No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on the available information and considering the reported events can be associated with ibrance, its role was considered possible.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: experienced fever after first dose; This is a spontaneous report from Pfizer-sponsored program  CEP 159558. A male contactable consumer reported for himself who received that BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 13APR2021 dose 1 single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication was not reported. Unknowingly patient had possible exposure to Covid 10Apr2021. On an unknown date after vaccination patient experienced fever. Outcome of the events was unknown.  Information regarding lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Dyskinesia, Heart rate increased, Paraesthesia
Clinical narrative: Felt sensation of tightness in chest or fast heartbeat; Felt sensation of tightness in chest or fast heartbeat; Shaking hands; Tingling forearms; Jerking movement in hands; Looked like a parkinson's patient; Brief tingling in lips; Sharp pain in mid back; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in arm right on 19Apr2021 at 12:45 (at an age of 49-years-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history included asthma, sulphonamide allergy and morphine allergy. The patient's concomitant medications were not reported. Patient not diagnosed with covid-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. On 19Apr2021, about 2 minutes after shot the patient experienced shaking hands, tingling forearms, jerking movement in hands looked like a Parkinson's patient. Brief tingling in lips, felt sensation of tightness in chest or fast heartbeat like having had lots of coffee. Sharp pain in mid back this was all very dramatic and fast but disappeared fully within an hour No problems at all overnight or the next day. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on unspecified date in 2021.  Follow-up attempts are needed. Further information is requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Parkinsonism, Tremor
Clinical narrative: Felt sensation of tightness in chest or fast heartbeat; Felt sensation of tightness in chest or fast heartbeat; Shaking hands; Tingling forearms; Jerking movement in hands; Looked like a parkinson's patient; Brief tingling in lips; Sharp pain in mid back; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in arm right on 19Apr2021 at 12:45 (at an age of 49-years-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history included asthma, sulphonamide allergy and morphine allergy. The patient's concomitant medications were not reported. Patient not diagnosed with covid-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. On 19Apr2021, about 2 minutes after shot the patient experienced shaking hands, tingling forearms, jerking movement in hands looked like a Parkinson's patient. Brief tingling in lips, felt sensation of tightness in chest or fast heartbeat like having had lots of coffee. Sharp pain in mid back this was all very dramatic and fast but disappeared fully within an hour No problems at all overnight or the next day. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on unspecified date in 2021.  Follow-up attempts are needed. Further information is requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Migraine
Clinical narrative: Shortness of breath lasting over 1 week; Migraine/Severe Headache; Migraine/Severe Headache; This is a spontaneous report from a contactable consumer (patient).   A 30-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left Arm on 09Apr2021 18:00, at the age of 30-years-old, (Lot Number: EP7534) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included endometriosis, seasonal allergy, and migraine. Concomitant medication included norethindrone; gabapentin; loratadine (CLARITINE); ibuprofen, all were taken for unspecified indication, start and stop date were not reported. Historical vaccine includes dose 1 of BNT162B2 administered on 19Mar2021, 05:45 PM on left arm (No reaction on previous exposure to vaccine).   The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 13Apr2021, the patient experienced migraine/severe headache, shortness of breath lasting over 1 week. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Aphonia, Burning sensation, Cough, Diarrhoea
Clinical narrative: No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezing chills; Cough; Extreme fatigue; Sore throat; Headache; Abdominal pain; Nausea; Diarrhea; Laryngitis; Lungs burn; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in arm left on 14Apr2021 at 13:00 as second dose (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included hypertension and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. Previously patient took first dose of bnt162b2 (Lot number unknown) via an unspecified route of administration in left arm on24Mar2021 at 13:00 PM for covid-19 immunisation and had no reaction. On 15Apr2021 at 13:00 (PM), the patient experienced no voice, very sick, body aches, teeth and gums hurt, face burns, freezing chills, cough, lungs burn, extreme fatigue, sore throat, headache, abdominal pain, nausea, diarrhea and laryngitis. Patient received the treatment of tylenol, dayquil, in bed for two days. The outcome of events was resolving.  Information on lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue, headache, nausea, diarrhea, chill and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events aphonia, sickness, general body pain, teething pain, gum pain, burning sensation in face, cough, painful respiration, sore throat, abdominal pain, laryngitis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Gingival pain, Headache, Illness
Clinical narrative: No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezing chills; Cough; Extreme fatigue; Sore throat; Headache; Abdominal pain; Nausea; Diarrhea; Laryngitis; Lungs burn; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in arm left on 14Apr2021 at 13:00 as second dose (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included hypertension and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. Previously patient took first dose of bnt162b2 (Lot number unknown) via an unspecified route of administration in left arm on24Mar2021 at 13:00 PM for covid-19 immunisation and had no reaction. On 15Apr2021 at 13:00 (PM), the patient experienced no voice, very sick, body aches, teeth and gums hurt, face burns, freezing chills, cough, lungs burn, extreme fatigue, sore throat, headache, abdominal pain, nausea, diarrhea and laryngitis. Patient received the treatment of tylenol, dayquil, in bed for two days. The outcome of events was resolving.  Information on lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue, headache, nausea, diarrhea, chill and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events aphonia, sickness, general body pain, teething pain, gum pain, burning sensation in face, cough, painful respiration, sore throat, abdominal pain, laryngitis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Nausea, Oropharyngeal pain, Pain, Painful respiration
Clinical narrative: No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezing chills; Cough; Extreme fatigue; Sore throat; Headache; Abdominal pain; Nausea; Diarrhea; Laryngitis; Lungs burn; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in arm left on 14Apr2021 at 13:00 as second dose (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included hypertension and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. Previously patient took first dose of bnt162b2 (Lot number unknown) via an unspecified route of administration in left arm on24Mar2021 at 13:00 PM for covid-19 immunisation and had no reaction. On 15Apr2021 at 13:00 (PM), the patient experienced no voice, very sick, body aches, teeth and gums hurt, face burns, freezing chills, cough, lungs burn, extreme fatigue, sore throat, headache, abdominal pain, nausea, diarrhea and laryngitis. Patient received the treatment of tylenol, dayquil, in bed for two days. The outcome of events was resolving.  Information on lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue, headache, nausea, diarrhea, chill and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events aphonia, sickness, general body pain, teething pain, gum pain, burning sensation in face, cough, painful respiration, sore throat, abdominal pain, laryngitis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Teething
Clinical narrative: No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezing chills; Cough; Extreme fatigue; Sore throat; Headache; Abdominal pain; Nausea; Diarrhea; Laryngitis; Lungs burn; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in arm left on 14Apr2021 at 13:00 as second dose (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included hypertension and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. Previously patient took first dose of bnt162b2 (Lot number unknown) via an unspecified route of administration in left arm on24Mar2021 at 13:00 PM for covid-19 immunisation and had no reaction. On 15Apr2021 at 13:00 (PM), the patient experienced no voice, very sick, body aches, teeth and gums hurt, face burns, freezing chills, cough, lungs burn, extreme fatigue, sore throat, headache, abdominal pain, nausea, diarrhea and laryngitis. Patient received the treatment of tylenol, dayquil, in bed for two days. The outcome of events was resolving.  Information on lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue, headache, nausea, diarrhea, chill and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events aphonia, sickness, general body pain, teething pain, gum pain, burning sensation in face, cough, painful respiration, sore throat, abdominal pain, laryngitis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: within a few hours of 1st shot, started feeling "pins & needles" throughout my entire body.  Symptoms still continue even after the 2nd shot; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 20Mar2021 at 10:15 (at the age of 58-years-old) as dose 1, single dose, and again received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number:  EWO158), via an unspecified route of administration, administered in left arm on 10Apr2021 as dose 2, single for COVID-19 immunisation in Health Clinic. Medical history included high blood pressure, cholestrol, pvc's. The patient has no known allergies. The patient has not been diagnosed with covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), metoprolol, amlodipine, atorvastatin. On 20Mar2021 at 12:00 (within a few hours of 1st shot), patient started feeling pins and needles throughout her entire body. Symptoms still continue even after the 2nd shot. The events resulted in Doctor or other healthcare professional office/clinic visit. The reporter considered the event as Serious. Location of injection information is available for all vaccines received on the same date. No treatment was received for the adverse events. The patient has not been tested for Covid since the vaccination. The outcome of the event was not recovered.  Follow up needed, further information has been requested.