chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Chills, Cough, Discomfort, Fatigue
Clinical narrative: One week after the first dose  for one day I had the following symptoms - temperature 100.5, chills, body aches, headaches,  horrible fatigue. Then next day I was fine. In 3 days I woke up from discomfort - body ache, trmperature 99.  After the second dose in 12 hours I developed a fever - 100.4 and fatigue . Symptoms for one day. Today - one week after the second doseQ- temperature 100.7,  horrible chills, fatigue, cough ( just a little bit. I stayed at home for a year. And now I was waiting to be fully vaccinated before socializing
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: One week after the first dose  for one day I had the following symptoms - temperature 100.5, chills, body aches, headaches,  horrible fatigue. Then next day I was fine. In 3 days I woke up from discomfort - body ache, trmperature 99.  After the second dose in 12 hours I developed a fever - 100.4 and fatigue . Symptoms for one day. Today - one week after the second doseQ- temperature 100.7,  horrible chills, fatigue, cough ( just a little bit. I stayed at home for a year. And now I was waiting to be fully vaccinated before socializing
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling, Rash erythematous, Swelling
Clinical narrative: I swell up; got my tongue swell up; face turned like red and swelled up; face turned like red and swelled up; like I had a third degree burn on my face and burning really very bad; my arms swelled up; my arms swelled up and they did a completely red rash like red, got in rashes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Mar2021 (two three weeks prior the report, as reported) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had BNT162b2 vaccine like two or three weeks prior the report, in Mar2021, and got home like in 2 hours later after the face turned like red and swelled up like having a third degree burn on face and burning really very bad and then 5 minutes later the arms swelled up and they did a completely red rash like red, got in rashes and they called the ambulance that gave the patient an EPIPEN and patient went to hospital in Mar2021 because of swelling up, got the tongue swell up (reason for hospitalization was not further clarified). Patient asked if it is considered an allergic reaction. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: I swell up; got my tongue swell up; face turned like red and swelled up; face turned like red and swelled up; like I had a third degree burn on my face and burning really very bad; my arms swelled up; my arms swelled up and they did a completely red rash like red, got in rashes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Mar2021 (two three weeks prior the report, as reported) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had BNT162b2 vaccine like two or three weeks prior the report, in Mar2021, and got home like in 2 hours later after the face turned like red and swelled up like having a third degree burn on face and burning really very bad and then 5 minutes later the arms swelled up and they did a completely red rash like red, got in rashes and they called the ambulance that gave the patient an EPIPEN and patient went to hospital in Mar2021 because of swelling up, got the tongue swell up (reason for hospitalization was not further clarified). Patient asked if it is considered an allergic reaction. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Ear swelling, Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: I swell up; got my tongue swell up; face turned like red and swelled up; face turned like red and swelled up; like I had a third degree burn on my face and burning really very bad; my arms swelled up; my arms swelled up and they did a completely red rash like red, got in rashes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Mar2021 (two three weeks prior the report, as reported) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had BNT162b2 vaccine like two or three weeks prior the report, in Mar2021, and got home like in 2 hours later after the face turned like red and swelled up like having a third degree burn on face and burning really very bad and then 5 minutes later the arms swelled up and they did a completely red rash like red, got in rashes and they called the ambulance that gave the patient an EPIPEN and patient went to hospital in Mar2021 because of swelling up, got the tongue swell up (reason for hospitalization was not further clarified). Patient asked if it is considered an allergic reaction. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Swelling face
Clinical narrative: I swell up; got my tongue swell up; face turned like red and swelled up; face turned like red and swelled up; like I had a third degree burn on my face and burning really very bad; my arms swelled up; my arms swelled up and they did a completely red rash like red, got in rashes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Mar2021 (two three weeks prior the report, as reported) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had BNT162b2 vaccine like two or three weeks prior the report, in Mar2021, and got home like in 2 hours later after the face turned like red and swelled up like having a third degree burn on face and burning really very bad and then 5 minutes later the arms swelled up and they did a completely red rash like red, got in rashes and they called the ambulance that gave the patient an EPIPEN and patient went to hospital in Mar2021 because of swelling up, got the tongue swell up (reason for hospitalization was not further clarified). Patient asked if it is considered an allergic reaction. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood disorder, Headache, Joint lock, Limb discomfort
Clinical narrative: I feel I am dying; Headache/headache is killing her; I have been throwing up/vomiting; I can't keep down my stomach; some of my blood fall down in my cab. Keep freezing up; My legs keep locking up on me like hell.; pain; I can't keep down my stomach; My legs keep locking up on me like hell.; This is a spontaneous report received a contactable consumer, the patient. A female of unspecified age received a single dose (unspecified dose number) of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route on an unspecified date, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient reported that ever since the shot she has been unable to keep her stomach normal and has a headache. The patient explained that she 'cannot keep down my stomach and some of my blood fall down in my cab, keep freezing up'. She is vomiting and has a headache that is killing her. The patient stated that her legs keep locking up on her like hell. The patient reported the she feels like she is dying. The patient inquired if the representative understood that she was in pain and asked if she should go to the hospital.  The outcome of the events unable to keep her stomach normal, cannot keep down my stomach and some of my blood fall down in my cab, keep freezing up, vomiting, headache, legs keep locking up on her, and she feels like she is dying was unknown.   Follow-up attempts to obtain Batch/Lot/Exp. information are ongoing
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Near death experience, Pain, Vomiting
Clinical narrative: I feel I am dying; Headache/headache is killing her; I have been throwing up/vomiting; I can't keep down my stomach; some of my blood fall down in my cab. Keep freezing up; My legs keep locking up on me like hell.; pain; I can't keep down my stomach; My legs keep locking up on me like hell.; This is a spontaneous report received a contactable consumer, the patient. A female of unspecified age received a single dose (unspecified dose number) of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route on an unspecified date, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient reported that ever since the shot she has been unable to keep her stomach normal and has a headache. The patient explained that she 'cannot keep down my stomach and some of my blood fall down in my cab, keep freezing up'. She is vomiting and has a headache that is killing her. The patient stated that her legs keep locking up on her like hell. The patient reported the she feels like she is dying. The patient inquired if the representative understood that she was in pain and asked if she should go to the hospital.  The outcome of the events unable to keep her stomach normal, cannot keep down my stomach and some of my blood fall down in my cab, keep freezing up, vomiting, headache, legs keep locking up on her, and she feels like she is dying was unknown.   Follow-up attempts to obtain Batch/Lot/Exp. information are ongoing
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Peripheral swelling
Clinical narrative: chills; swollen arm; feeling cold day and night; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in left arm on 20mar2021 at 16:26 as single dose for COVID-19 immunisation. The patient did not had medical history. The patient's concomitant medications were not reported. The patient did not receive any vaccines within 4 weeks prior to COVID-19 vaccine. The patient did not receive any additional vaccines on same date of the Pfizer suspect. On 20Mar2021, the patient had a swollen arm. She knew this was normal. She had no rash, but the swelling lasted quite a few days. That evening, she had night chills. She was feeling cold day and night. No matter how much or what she was wearing she was constantly cold. Eventually her arm swelling went down after 5 days. She iced, massaged and used the arm as advised, but it was the chills that were unbelievable. Therapeutic measures were taken as a result of swollen arm. On 26Mar2021, the outcome of the event swollen arm was recovered and on 09Apr2021, the rest of the events recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Erythema, Peripheral swelling, SARS-CoV-2 test positive
Clinical narrative: Tested Positive for Covid19 after receiving the Covid vaccine.; little bump and a little redness on the left arm; little bump and a little redness on the left arm; Tested Positive for Covid19 after receiving the Covid vaccine.; This is a spontaneous report received from a contactable consumer.   A 64-years-old female patient (consumer) received first dose of BNT162B2 (Solution for injection), (Batch/Lot Number: LOT:ER8727), on 23MAR2021 at 10:40 (24 hour clock) and second dose (Batch/Lot Number: LOT: EP7533.) on 13Apr2021 at 09:00 via an unspecified route of administration as a single dose for covid-19 immunisation. The medical history of patient included Hypothyroid (ongoing), Cholesterol (ongoing). The Concomitant medications included Hypothyroid Pill (ongoing). The patient reported little bump and a little redness on the left arm from 13 Apr2021 (ongoing). The seriousness for little bump and a little redness on the left arm was unspecified. Patient further explained she had 4 negative tests for Covid19 after that, this past Tuesday, 13APR2021, she had her second shot. At same time, she had a test done for Covid19 on that day. Patient received the results and they said she was positive for Covid19 (13APR2021). Patient was wondering if because she had the virus in her system [from the vaccine] if that is what caused her to test positive? patient stated she had no fe-ver, no headache, or any symptoms. She just had a little bump and a little redness on the arm and got the vaccine, no pains or nothing. patient was wondering if because she already had the first vaccine, if when they did the test at same time as she got the second shot, did that cause her to test positive? Patient wants to know what she should do?  Patient reported usually sleeps on that arm and maybe she was pressing to hard on it. Patient did not received any treatment. Also patient did not require any visit to emergency Room and Physician Office. Patient further reported description of productcom-plaint: Patient stated she tested positive for Covid19 on 13APR2021, the same day she received her second dose of the vaccine. The outcome of the event was unknown.  Follow up attempts are required. Further information was expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid19 after receiving the Covid vaccine.; little bump and a little redness on the left arm; little bump and a little redness on the left arm; Tested Positive for Covid19 after receiving the Covid vaccine.; This is a spontaneous report received from a contactable consumer.   A 64-years-old female patient (consumer) received first dose of BNT162B2 (Solution for injection), (Batch/Lot Number: LOT:ER8727), on 23MAR2021 at 10:40 (24 hour clock) and second dose (Batch/Lot Number: LOT: EP7533.) on 13Apr2021 at 09:00 via an unspecified route of administration as a single dose for covid-19 immunisation. The medical history of patient included Hypothyroid (ongoing), Cholesterol (ongoing). The Concomitant medications included Hypothyroid Pill (ongoing). The patient reported little bump and a little redness on the left arm from 13 Apr2021 (ongoing). The seriousness for little bump and a little redness on the left arm was unspecified. Patient further explained she had 4 negative tests for Covid19 after that, this past Tuesday, 13APR2021, she had her second shot. At same time, she had a test done for Covid19 on that day. Patient received the results and they said she was positive for Covid19 (13APR2021). Patient was wondering if because she had the virus in her system [from the vaccine] if that is what caused her to test positive? patient stated she had no fe-ver, no headache, or any symptoms. She just had a little bump and a little redness on the arm and got the vaccine, no pains or nothing. patient was wondering if because she already had the first vaccine, if when they did the test at same time as she got the second shot, did that cause her to test positive? Patient wants to know what she should do?  Patient reported usually sleeps on that arm and maybe she was pressing to hard on it. Patient did not received any treatment. Also patient did not require any visit to emergency Room and Physician Office. Patient further reported description of productcom-plaint: Patient stated she tested positive for Covid19 on 13APR2021, the same day she received her second dose of the vaccine. The outcome of the event was unknown.  Follow up attempts are required. Further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of unspecified age had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 25Mar2021at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced for Sore throat, Stuffy nose, pain, cough and Soreness at injection site. Dates for At risk for not getting the second dose of vaccine. Dates for Vaccine scheduled 22 days after the first dose. Caller unwilling to complete the report. Laboratory Investigations were not reported. Additional Context: Caller states that tomorrow she is supposed to get the second dose of the shot. Caller states that on 12Apr2021, she was in the emergency room having a sore throat, pain, and stuffy nose. Caller states that she got a strep throat test, because her grandchild had strep throat, and she reports the test was negative. Caller wants to know if it is safe to get the second dose of the vaccine tomorrow.   PSCC Communication: Caller declined to complete report. Full details not obtained and notified several times that Medical Information and/or Pfizer is unable to provide medical advice but may have resources to help answer some questions. caller abruptly disconnected before other information could be obtained.  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: her friend tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program, CEP 159558. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. On 31Mar2021, the patient tested positive for Covid. The patient 2nd dose is scheduled for 19Apr2021.The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he (son) came positive; he (son) came positive; This is a spontaneous report from a contactable consumer (patient's father). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient (son) started feeling symptoms on Monday (05Apr2021). So, the father (reporter), patient's mother, and the patient got tested 2 days ago, Thursday, 08Apr2021. The patient (son) came positive and the father and mother's result came back negative. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: he is in isolation at this time and have not tested for covid yet.; This is a spontaneous case is received from a contactable consumer or other non hcp. A 35-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 31Mar2021 (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 he is in isolation at this time and have not tested for COVID yet. (exposure to sars-cov-2). The outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody nose last night; This is a spontaneous report from a contactable consumer (parent).   A 18-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 15Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer reported that his son received his first dose of the Pfizer-Biontech Covid19 vaccine, yesterday on 15Apr2021. He had a bloody nose last night, that has since resolved. On an unspecified date, the patient had bloody nose. Consumer wanted to know if that was a commonly reported AE, and if they needed to be concerned. The outcome of the event was resolved on an unspecified date.  The response provided to reporter as: Reviewed fact sheet for "blood", "bleeding", and "nose" with no results [LAB-1457-7.0; Revised: 06April2021].  Answered as per guidance in "VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0)".  Referred back to HCP, caller indicated they had already contacted HCP.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: I have been diagnosed with Type 1 Diabetes.  I have never had trouble with blood sugars until now.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female (pregnant: No) patient received 2nd dose of BNT162B2, Lot Number: EL3249 on 12Jan2021 01:15PM on Left arm at single dose for Covid-19 immunisation. Medical history was Hypothyroidism, High cholesterol. Concomitant drugs included Atorvastatin, sertraline hydrochloride (ZOLOFT), ergocalciferol (Vit D), Levothyroxine. Known allergies to Erythromycin previously. Historical Vaccine was 1st dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 01:15PM on Left arm for Covid-19 immunisation. She had been diagnosed with Type 1 Diabetes from 01Apr2021 01:15PM. She had never had trouble with blood sugars until now. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. AE treatment: Many lab tests, Bicarbonate drip, Insulin. Patient recovered with lasting effects. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is not a reasonable possibility that event type 1 diabetes mellitus is related to BNT162B2.  This is an intercurrent medical condition. 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.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Pyrexia, Visual impairment
Clinical narrative: outer left corner of her eye had been painful to the touch and the pain radiates inside of her head; headache/internal inflammation; fever; visual changes, objects appearing smaller; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported ), via an unspecified route of administration, administered in left arm on 10Apr2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient had her first dose of Bnt162b2 on an unspecified date. On 11Apr2021, sunday patient had "normal side effects" including fever. On Wednesday, 14Apr2021, she reports that the outer left corner of her eye had been painful to the touch, and the pain radiates inside of her head, and that her eye is not visibly swollen. The headache/internal inflammation has resulted in visual changes, specifically objects appearing smaller than previously. She states that the visual changes are present even if she closes her left eye, and just looks out of her right. She also stated that she closes her left eye the vision changes remain. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Epilepsy, Laboratory test, Seizure
Clinical narrative: Induced seizures in each of them; they are epileptic; now they are epileptic; There is some correlation between the diagnosis of epilepsy, their medications (Unspecified Medications), the vaccine (Pfizer Covid-19 Vaccine);  had seizures as a result; This is a spontaneous report from a contactable consumer (parent). This consumer reported same events for two patients. This is the first of 2 reports. An adult female patient (reporter's daughter) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EW0162) on unspecified date as a single dose for COVID-19 immunization. The patient's medical history included prematurity, brain damage, many disabilities, respiratory compromise, cognitive impairment, and legally blind. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, LOT#: EN6205) on 09Apr2021 as a single dose for COVID-19 immunization. Concomitant medications were not reported. After the second dose the patient with special needs which is having a medical condition and had seizures as a result. The patient experienced seizures, once within about 4 hours and then the next within 12 to 18 hours (unspecified dates). The reporter stated the patient has some different medical ailments, disability medications and it seems though there may be reactions within 24 hours, induced seizures and now epileptic. The patient has not had a breakthrough seizure in years and so reporter thought maybe there is some correlation between the diagnosis of epilepsy, her medications (unspecified products) and the vaccine she got. Lab test was not specified, but reporter stated there was because she was taken by ambulance to emergency room the night of her vaccine. The outcome of the events (seizures, epileptic, correlation between the diagnosis of epilepsy, her medications and the vaccine) was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422246 Same reporter/diff patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: A bruise appeared immediately; This is an initial spontaneous report from a contactable consumer. A 80-years-old female patient received frist dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in left arm on 13Apr2021 18:40 at a single dose for COVID-19 immunization. No medical history and concomitant medications were reported.The patient had a bruise appeared immediately, they put a Band-Aid over it, it spread about 2 inches in diameter on on left arm at injection site. She had the vaccine first one Tuesday, it never hurt, I didn't even have to take Tylenol. She don't know if it was a reaction to that or the Xarelto, it is local, never got reddened or anything. Her second dose of vaccine scheduled on 04May2021.The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash around the area of the injection site; rash around the area of the injection site. She stated it itches all the time; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 03Apr2021 single dose for covid-19 immunisation. Medical history included rash before the vaccine due to bed bugs. The patient concomitant medications were not reported. Patient reported that did not receive a reaction on the site where she took it. She gets bit during the night. she waited one hour at the facility because she read that severe allergic reactions happen for one minute to one hour after the vaccine. She had clusters of red bumps and itchy bumps but it could possibly be from bed bugs. She stated this happened a week or so after the vaccine. The difference after the vaccine is that some were redder. She now has rash around the area of the injection site. She stated it itches all the time. She rubs it with soap. The events assessed as non-serious. She stated some feel like they do not itch. She is seeing HCP Monday. She has not had any swelling. Some rashes have gone away. She asked if rash is a reported side effect specifically rash all over the body and does it go away. She asked should she get the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: UNK
Symptoms: Epilepsy, Seizure
Clinical narrative: Induced seizures in each of them; they are epileptic; now they are epileptic; There is some correlation between the diagnosis of epilepsy, their medications (Unspecified Medications), the vaccine (Pfizer Covid-19 Vaccine); had seizuresas a result; This is a spontaneous report from a contactable consumer (patient's mother)   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation  . The patient recevied the first dose of the same vaccine on 10Apr2021 (Lot#EN6205). Medical history included brain injury from an unknown date and unknown if ongoing Verbatim: Brain damage  , Respiratory compromise from an unknown date and unknown if ongoing Verbatim: Respiratory compromise , Prematurity  from an unknown date and unknown if ongoing Verbatim: Prematurity , Cognitive impairment from an unknown date and unknown if ongoing Verbatim: Cognitive impairment , Legally blind  from an unknown date and unknown if ongoing and Many disabilities   from an unknown date and unknown if ongoing .The patient's concomitant medications were not reported.  Reporter stated, "I am actually just trying to report some side effects that I have heard and wanted to make sure you all have the information not actually for myself particularly, my reactions were fine. But I do have with me two adult daughters. And they have some different medical ailments, disability medications and it seems though there may be reactions in both of them within 24 hours induced seizures in each of them and now they are epileptic. But they have not had a breakthrough seizures in years and so, I thought maybe there is some correlation between the diagnosis of epilepsy, their medications (Unspecified Medications) and the vaccine (Pfizer Covid-19 Vaccine) they got. After second dose two of my daughters with special needs which are having a medical condition and had seizures as a result. I am calling to make sure that Pfizer has the information documented directly because I have not heard that in any shape or form there was a seizure associated with response after the vaccine.".When paraphrased the concern, Reporter stated, "Yeah both of them, experience the seizure once within about 4 hours and then the next within I say 12 to 18 hours". .; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422134 Same reporter/diff patient;US-PFIZER INC-2021422193 Same reporter/diff patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he got his 1st dose of the vaccine on 01Apr2021 and tested positive with the Covid-19 after he got the 1st dose.; he got his 1st dose of the vaccine on 01Apr2021 and tested positive with the Covid-19 after he got the 1st dose.; This is a spontaneous report from a contactable consumer (patient) reporting himself. A male patient of an unspecified age received BNT162B2 (Solution for injection; PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: Unknown) dose 1 via an unspecified route of administration on 01Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, he got his 1st dose of the vaccine on 01apr2021 and tested positive with the covid-19 after he got the 1st dose. (drug ineffective) (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Apr2021. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Investigation
Clinical narrative: Stroke; Mild headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at right arm on 23Mar2021 (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient had no COVID prior vaccination and no known allergies. There were other concomitant medications (unspecified) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 02Mar2021 at 16:15 (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. On an unspecified date in 2021, the patient experienced mild headache day after second vaccine. On 27Mar2021 at 09:45, patient had a stroke. The adverse events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days. Therapeutic measures were taken as a result of the events and included "testing regarding stroke" (as reported). The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a contactable consumer. This consumer reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, (Lot number and expiry date not reported) via unspecified route of administration on unspecified date as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. After second dose of Covid vaccine, Patient was diagnosed with pneumonia 2 days later. Patient felt fine before vaccination and until day 2 second dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Suffered fatigue after second dose of COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient suffered fatigue after second dose of COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Insomnia, Nocturia
Clinical narrative: horrible dry mouth conditions for 6-7 weeks; He has only been able to sleep on average 3 to 4 hours a night; awoken every 20 minutes all night long and many times had to urinate; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 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. It was reported that caller is a 65 year old male who states that "almost exactly" 3 weeks after receiving his second dose of the Pfizer BioNTech COVID-19 vaccine, he started experiencing "horrible" dry mouth conditions for 6-7 weeks. He states that due to this persistent dry mouth, he has only been able to sleep on average 3 to 4 hours a night for the past 6 to 7 weeks. Caller reports that he had just come back from an ENT specialist regarding this and was told by this doctor that he has seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination and/or COVID-19 itself. Caller states that his doctor also referenced an article in a British journal that came out a few days ago that stated COVID-19 is shown to infect the salivary glands. He states that his doctor is unable to give any further recommendations other than give him things to keep him comfortable such as Salagen. Caller also mentions that after receiving the vaccine, he was being awoken every 20 minutes all night long and many times had to urinate but reports that this side effects has subsided. He states he read on Twitter about a woman who also had COVID-19 who reported having "bad" dry mouth and "was urinating more often than she had in her whole life." Caller would like to know if there have been any reports similar to his side effects that he experienced after the vaccine. Caller is concerned about whether they could be related to the vaccine or to having COVID-19 (which he does not state that he has). Outcome of the events was recovered.  No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: rash; fever; pain in his arm; This is a spontaneous report received from a contactable consumer. A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date, 47 days ago at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. Historical vaccine included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On an unspecified date, the patient experienced a rash, fever, and pain in his arm around the affected area. He specified the pain extended to his shoulder but is now localized at the affected area. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Computerised tomogram, Dizziness, Loss of consciousness
Clinical narrative: Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date (at 49-years of age) for Covid-19 immunization. Patients medical history and concomitant medications were not reported. She had an allergic reaction to CAT scan contrast dye in the past. It was reported that after the first dose of the vaccine, within several minutes, she felt dizzy and it passed quickly. 4-5 hours later patient got severe dizziness and her family had to walk her to her bed. She was very weak and very dizzy so she laid down. She was dizzy in the morning and then was only mildly dizzy for a number of days. She also had chills and her arm hurt. She stated she saw dizziness at the bottom of the sheet as a more serious reaction and wanted to know if she should get the next dose of the vaccine? Patient also stated she heard that one dose of the vaccine is over 80% effective. No PQC was present. It was reported that patient did a report. Patient was guided to read form PI section 4. Read from Fact sheet under "WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?" regarding the description of serious allergic reactions. Referred to HCP for further discussion. PI: LAB-1457-7.0/ Revised: 06Apr2021 Fact sheet: LAB-1451-4.0/ Revised: 06Apr2021. The patient has a question if she is still considered vaccinated with just one dose? Is it 80% effective? Patient was asked to read from attached document. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date (at 49-years of age) for Covid-19 immunization. Patients medical history and concomitant medications were not reported. She had an allergic reaction to CAT scan contrast dye in the past. It was reported that after the first dose of the vaccine, within several minutes, she felt dizzy and it passed quickly. 4-5 hours later patient got severe dizziness and her family had to walk her to her bed. She was very weak and very dizzy so she laid down. She was dizzy in the morning and then was only mildly dizzy for a number of days. She also had chills and her arm hurt. She stated she saw dizziness at the bottom of the sheet as a more serious reaction and wanted to know if she should get the next dose of the vaccine? Patient also stated she heard that one dose of the vaccine is over 80% effective. No PQC was present. It was reported that patient did a report. Patient was guided to read form PI section 4. Read from Fact sheet under "WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?" regarding the description of serious allergic reactions. Referred to HCP for further discussion. PI: LAB-1457-7.0/ Revised: 06Apr2021 Fact sheet: LAB-1451-4.0/ Revised: 06Apr2021. The patient has a question if she is still considered vaccinated with just one dose? Is it 80% effective? Patient was asked to read from attached document. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dyspepsia, Headache, Nausea
Clinical narrative: vomiting; headache; stomach ache; generalized pain across the body; nausea; heartburn-like sensation; diarrhea; This is a spontaneous case is received from a contactable consumer (patient and patient's daughter). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Lot number: unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experienced heartburn-like sensation and diarrhea. On an unspecified date, the patient experienced vomiting, headache, stomach ache, generalized pain across the body and nausea. She would like to know if the heartburn-like sensation is normal and that is what worries her most. She was scheduled to get the second dose in 2 weeks. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021428556 same reporter/SD/AE, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: vomiting; headache; stomach ache; generalized pain across the body; nausea; heartburn-like sensation; diarrhea; This is a spontaneous case is received from a contactable consumer (patient and patient's daughter). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Lot number: unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experienced heartburn-like sensation and diarrhea. On an unspecified date, the patient experienced vomiting, headache, stomach ache, generalized pain across the body and nausea. She would like to know if the heartburn-like sensation is normal and that is what worries her most. She was scheduled to get the second dose in 2 weeks. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021428556 same reporter/SD/AE, different patients.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200) via intramuscular, administered in Arm Right on 19Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient is not pregnant. No other vaccine received in four weeks. Patient experienced pneumonia after first injection on an unspecified date in 2021. Event resulted in Doctor office visit, Emergency room or urgent care, Hospitalization, Life threatening illness. Patient admitted to hospital for 5 days and received treatment. Unknown if patient had COVID prior vaccination. Unknown if COVID tested post vaccination. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event pneumonia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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. Linked Report(s) : US-PFIZER INC-2021423487 same patient/product, different dose and event