chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Allergy to chemicals
Clinical narrative: developed a polyethylene glycol (PEG) allergy; This is a spontaneous report from a contactable consumer (Patient).   A 88-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, on as unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced developed a polyethylene glycol (peg) allergy. Caller asked about the efficacy of the booster vaccine. If not efficacy will that allergy be affected when she had the booster. Caller stated that this was not satisfactory, she would like to hear more from research staff about it, seems to be there has to be more information coming up and she would like to know how to keep in touch with this. Further Explained that there was no information regarding anyone reporting developing the PEG allergy after receiving the Pfizer Covid-19 vaccine and that our contraindication for not receiving a dose of the vaccine was anyone who had a severe allergic reaction to a previous dose or any ingredient in the vaccine. Referred to HCP, explained there was no further information to provide. Survey offered. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, Induration
Clinical narrative: I got my period and all the pain came back; My periods are lasting 2 months at this point; weird bumps on my body; dose_number=1/administration_date=10Mar2021;dose_number=2/administration_date=25Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm right on 25Apr2021 12:00 PM (Age at Vaccination:47 years) at single dose for COVID-19 immunization at School or Student Health Clinic. The patient medical history included Diverticulitis, endometriosis and known allergies to Penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. The patient Concomitant medications within 2 weeks of vaccination included Elagolix Sodium (ORILISSA) taken for endometriosis from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on 10Mar2021 12:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that On 27Apr2021 12:00 PM, 2 days after I got the 2nd Pfizer vax the patient experienced I got my period and all the pain came back. My periods are lasting 2 months at this point.  ID RATHER HAVE COVID. Also..I'm getting weird bumps on my body. I'm in pain every day thanks to your vaccinations. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and treatment included Depo shot. The outcome of events was resolved.  The Lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: feeling nauseous; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Sep2021 caller had the first dose of the Pfizer COVID-19 vaccine in August and she is due for the second shot on Friday. She said that she had been feeling pretty good but yesterday and today, she is feeling nauseous. She said that that is her only symptom. She wanted to know if she should be concerned having the adverse event weeks after getting the vaccine. She wanted to know if something bad is starting to happen to her. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Dizziness, Drug ineffective
Clinical narrative: tested positive for Covid on Aug 25th; tested positive for Covid on Aug 25th; feeling sick; weakness; fever; slight cough; dizziness; feeling not good; This is a spontaneous report from a contactable consumer or other non hcp. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 07Aug2021 (age at vaccination 54-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid on Aug25th and feeling sick, weakness, fever, slight cough, dizziness, feeling not good on 21Aug2021. The clinical course was reported as she works for the school system. She had her first Covid vaccine dose on 07Aug2021. She started feeling sick on 21Aug2021 with symptoms including weakness, fever, slight cough, dizziness, and feeling not good. She tested positive for Covid on 25Aug2021 and missed her second dose which was supposed to be on 28Aug2021. She has been symptom free since 04Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 25Aug2021. The clinical outcome of the event tested positive for covid was unknown and other events was recovered on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid on Aug 25th; tested positive for Covid on Aug 25th; feeling sick; weakness; fever; slight cough; dizziness; feeling not good; This is a spontaneous report from a contactable consumer or other non hcp. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 07Aug2021 (age at vaccination 54-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid on Aug25th and feeling sick, weakness, fever, slight cough, dizziness, feeling not good on 21Aug2021. The clinical course was reported as she works for the school system. She had her first Covid vaccine dose on 07Aug2021. She started feeling sick on 21Aug2021 with symptoms including weakness, fever, slight cough, dizziness, and feeling not good. She tested positive for Covid on 25Aug2021 and missed her second dose which was supposed to be on 28Aug2021. She has been symptom free since 04Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 25Aug2021. The clinical outcome of the event tested positive for covid was unknown and other events was recovered on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain
Clinical narrative: developed a still neck with pain, barely can turn head left or right, and its really tensed up; developed a still neck with pain, barely can turn head left or right, and its really tensed up; developed a still neck with pain, barely can turn head left or right, and its really tensed up; This is a spontaneous report received from a contactable consumer or other non hcp. A 54-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 02Sep2021,at the age of 54 years old, as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced she developed a still neck with pain, barely can turn head left or right, and its really tensed up on 05Sep2021.Therapeutic measures were taken as a result of developed a still neck with pain, barely can turn head left or right, and its really tensed up.Patient has been taking extra strength tylenol but its barely helped.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: bilateral lower facial numbness after their first dose that lasted for 4 days; This is a spontaneous report from a contactable pharmacist reported for a patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: was not reported), via an unspecified route of administration, administered anatomical location not reported on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first dose, on unspecified date, the patient has experienced for 4 days, bilateral lower facial numbness. Patient sought emergency medical attention at the time but is unsure of the treatment received. Reporter instructed the patient to report. Reporter wanted to check with Pfizer Medical Information to see if this adverse event was likely to be caused by the vaccine and if the patient could safely receive the second dose of COMIRNATY vaccine. Advised reporter that no information is available to suggest a causal relationship between the PFIZER-BIONTECH COVID-19 vaccine and facial numbness. Advised reporter that Pfizer cannot make the determination on whether or not the patient receives the second dose of the vaccine. Deferred to clinical judgment and patient decision. The outcome of the event was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhagic disorder, Oral mucosal blistering
Clinical narrative: developed blood blisters in his mouth; hemorrhagic reaction; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), dose 1 via an unspecified route of administration on Dec2020 (at the age of 64-years-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that, patient stated that he is hoping he is talking to the right person; that he had already talked to somebody else. He states that he got his first dose of the Pfizer BioNTech Covid-19 vaccine in DEC2021, and had a hemorrhagic reaction, that it is not bad enough to be in the hospital. States that he has heard there have been instances where that has happened, even one person that died in his city (withheld), and that it was in the newspaper. Reports that 2 or 3 days after his dose, he developed blood blisters in his mouth.  It didn't go beyond that, and they resolved. About 2 weeks later, the same thing happened. The same thing happened about 3 more times, sporadically, but hasn't happened again in the last 5 months. States he has never had that happen before the vaccine. He did not get the second dose. He reports that he is being pressured at work to be fully vaccinated and is extremely uncomfortable with that; he is afraid of a worse hemorrhagic situation that could hospitalize or kill him. He is asking, what is somebody like him supposed to do about that. The reporter assessed the seriousness as non-serious. The outcome of the event developed blood blisters in his mouth was recovered on an unspecified date of 2021 and outcome was unknown for other event.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182128 similar report from same reporter
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: big red bruise behind legs; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 49 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big red bruise behind legs causing contusion on Sep2021 with outcome of unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dysgeusia, Fatigue
Clinical narrative: chest pain; metallic taste in his mouth "that comes and goes."; felt fatigue/exhaustion; weakness; This is a spontaneous report from a contactable consumer from Pfizer sponsored program (patient himself). A 36-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 03Sep2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller's mother was on the phone and she transferred the phone to her son (36 y/o male). He received his first Comirnaty vaccine on 03Sep2021. He immediately experienced a metallic taste in his mouth that comes and goes. He experienced chest pain on 07Sep2021 and had felt fatigue, weakness, and exhaustion since receiving the vaccine and that was still continuing. Caller seeking information on these side effects. The outcome of events metallic taste in his mouth that comes and goes, chest pain was unknown, and rest of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Echocardiogram, Electrocardiogram
Clinical narrative: She's had some issues come up with her heart and she has heard that heart issues are being noted with the vaccine.; 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), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was having some side effects and she was under a doctors care and she knew she needs to report her side effects. She was asking what kind of information she needed to provide for reporting her side effects. She did not see her doctor again until this Friday, 10Sep2021 and she did not know if her doctor should be the one reporting. On an unspecified date, she had some issues came up with her heart and she has heard that heart issues are being noted with the vaccine. She thought this was serious enough to mention. It was reported that she will see her doctor again on Friday (on reporting date) and she'll have more information to provide like the results of her EKG and echocardiogram. Before filing a safety report, she would like to speak to her doctor and get more information regarding her test results and medical information. The patient underwent lab tests and procedures which included echocardiogram and electrocardiogram with unknown results performed on an unspecified date. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Nervousness
Clinical narrative: I have been so sick; nervous; sweating; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced illness, nervousness and sweating causing hyperhidrosis on an unspecified date with outcome of unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Skin warm
Clinical narrative: I had the skin was hot, like it had a fever in that area and was sore.; I had the skin was hot, like it had a fever in that area and was sore.; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported I had the skin was hot, like it had a fever in that area and was sore. on an unspecified date. The outcome of the events was reported as unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus test, Investigation, Lyme disease, Pain in extremity
Clinical narrative: Arm was barely sore; This is a spontaneous report from a contactable consumer (patient) and other Healthcare professional.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3246) 1 via an unspecified route of administration on 27Jan2021 (73-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Vaccine was not administered at (privacy) facility. The patient's Medical history included redundant colon, IBSC (Irritable bowel syndrome), a little elevated cholesterol, arthritis, right hip replacement, vitamin B12 deficiency while she was in college, low estrogen and progesterone. There were no concomitant medications. The reporter stated that she has had this weakness three other times in her life but every time they found the cause of it. One time she had the Epstein bar virus in 1990s. The she had Vitamin B12 deficiency in college. Then in the early 2000s she had low estrogen and progesterone. Recently they checked her for all of this, and it came back normal. The patient's B12 was fine, and it showed that she had Epstein Bar, but they did a titer (result unknown) and checked to see if she had a current infection, and it came back negative. The patient had not received any other vaccine within 4 weeks of covid-19 vaccination.  The patient was not other adverse events following prior vaccination. On an unknown date in 2021, the patient had experienced arm was barely sore. On an unknown date in 2021, the patient underwent lab test and procedure which included lyme disease: unknown results, nothing has come back that. No investigation assessment was reported. The patient had not visited to emergency room/physician office for resulted events. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast disorder
Clinical narrative: experienced breast sensation/a let down response; This is a spontaneous report from a contactable consumer (patient's friend). A non-pregnant female 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 an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medication or past drug history of the patient were not reported. On an unspecified date, four days after receiving first dose of vaccination patient experienced breast sensation and a let down response, it was not related to her monthly cycle and never experienced this before. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: die from this; This is a spontaneous report from a contactable consumer (friend). This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died from this on an unspecified date in 2021. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-202101178224 same reporter/drug/event, different patient.; Reported Cause(s) of Death: die from this
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Lymphatic disorder
Clinical narrative: lumps formed in her breast; lymphatic reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 for covid-19 immunization and experienced breast sensation / Let down response. On an unspecified date the patient experienced a lymphatic reaction and lumps formed in her breast. She was currently undergoing close monitoring to determine the severity. The clinical outcome of the event was unknown at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She said she felt tired after receiving it; This is a spontaneous report from a contactable consumer. This consumer reported for an unknown female patient that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Sep2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. Reporter stated this morning my neighbour told me she received the 2nd dose of the Pfizer Covid Vaccine yesterday. She said she felt tired on an unspecified date in Sep2021, after receiving it and did not mention any other symptoms. The outcome of the event was reported as unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium decreased, Blood pressure increased, Blood pressure measurement, Heart rate
Clinical narrative: potassium was low; blood pressure and heart rate went up; blood pressure and heart rate went up; she got sick, she clarified that after the first dose; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EL9264) via an unspecified route of administration, administered in arm left on 11Feb2021 (age at vaccination- 68 years) as dose 1, single for COVID-19 immunization. Medical history included Blood pressure and early glaucoma and was taking medicine for her eyes and had to stop taking it since the doctor where she went to get her eyes tested said it was causing a reaction or interaction with her blood pressure medication at the time. Clarifies that after she got sick, the doctor told her that the blood pressure medicine she was taking was causing a toxic reaction. The blood pressure medication she was taking called dorzolimide, she does not have manufacturer or lot number to provide. States she was on the blood pressure medication prior to vaccine without any problems, the doctor told her that it was causing a toxic reaction after taking the covid vaccine. This was documented as reported. Concomitant medication(s) included dorzolamide taken for blood pressure. On 11Feb2021 the after the first dose, it was just that night, she went to ER and was told her potassium was low. The reason why her blood pressure and heart rate went up was because her potassium was low. Treatment: Her blood pressure medication was changed. They could not find a blood pressure medicine and she kept trying different ones. She had blood pressure problems before the vaccine, but it only started going up like that after the vaccine and it would not go down. The outcome of the event sickness was unknown and rest events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Illness
Clinical narrative: potassium was low; blood pressure and heart rate went up; blood pressure and heart rate went up; she got sick, she clarified that after the first dose; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EL9264) via an unspecified route of administration, administered in arm left on 11Feb2021 (age at vaccination- 68 years) as dose 1, single for COVID-19 immunization. Medical history included Blood pressure and early glaucoma and was taking medicine for her eyes and had to stop taking it since the doctor where she went to get her eyes tested said it was causing a reaction or interaction with her blood pressure medication at the time. Clarifies that after she got sick, the doctor told her that the blood pressure medicine she was taking was causing a toxic reaction. The blood pressure medication she was taking called dorzolimide, she does not have manufacturer or lot number to provide. States she was on the blood pressure medication prior to vaccine without any problems, the doctor told her that it was causing a toxic reaction after taking the covid vaccine. This was documented as reported. Concomitant medication(s) included dorzolamide taken for blood pressure. On 11Feb2021 the after the first dose, it was just that night, she went to ER and was told her potassium was low. The reason why her blood pressure and heart rate went up was because her potassium was low. Treatment: Her blood pressure medication was changed. They could not find a blood pressure medicine and she kept trying different ones. She had blood pressure problems before the vaccine, but it only started going up like that after the vaccine and it would not go down. The outcome of the event sickness was unknown and rest events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory disease, Feeling abnormal, Sinusitis
Clinical narrative: sinus infection; not feeling well; chronic respiratory issues; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Aug2021, the patient experienced sinus infection. On an unspecified date in 2021, the patient experienced not feeling well and chronic respiratory issues. The clinical details of the events as follows: Caller also is not feeling well and thought she may have a sinus infection. The caller reported having chronic respiratory issues. The caller was scheduled to receive her 2nd dose of the COVID vaccine on 09Aug2021, however she was not feeling well. She said she has a bad sinus infection and was seen by her PCP 07Aug2021. Caller was not tested for COVID, however her husband has recently had COVID. The caller would like to possibly delay the 2nd dose due to her not feeling well and wants to know if she can do this. Caller does suffer from respiratory issues. Caller would like to know when she cleared to get the vaccine by her provider or is feeling better. The patient outcome of the events was unknown at the time of this report.  The lot number for BNT162B2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smelling like somebody smoking cigarettes around me all the time and nobody is smoking around me; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 03Sep2021 as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Sep2021 the patient experienced smelling like somebody smoking cigarettes around reporter all the time and nobody was smoking around reporter. When asked permission for further probing, consumer stated, No, you are fine now. just call them in the morning you are fine. When probed for any further assistance, consumer stated, No, you are fine. LOT# and Expiration Date: Consumer stated, reporter have like card here. Reporter don't have the expiration on the doses that reporter got. No, patient don't have anything on here that patient understand. As consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable consumer (patient's brother). A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient started experiencing flu like symptoms on Aug2021, which only got worse for the next few days. He passed away Monday, 30Aug2021. His death was extremely unexpected since he was feeling great before the Pfizer vaccine. The patient died on 30Aug2021. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: flu like symptoms
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Tinnitus
Clinical narrative: It is severally affecting my quality of life; Acute tinnitus; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 20Jul2021 as dose number unknown, single for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On 20Jul2021, the patient experienced acute tinnitus. On an unspecified date, the patient experienced it is severally affecting my quality of life. The patient reported that she received a Pfizer covid vaccine on 20Jul2021. Within four hours of receiving the vaccine she started having acute tinnitus and it had not stopped since. Before the vaccine she had never had tinnitus before. She had read of others with a similar experience. She enquired was there anything that can be done to help with the ringing. It was severally affecting her quality of life. It was reported that she have tried steroids, acupuncture, a psychotherapist, ENT for sound masking but still had this side effect and was affecting her life. Therapeutic measures were taken as a result of acute tinnitus (tinnitus). The patient also stated that there was another lady that goes to the pharmacy that also had this side effect. The outcome of the event It is severally affecting my quality of life was unknown. The outcome of the event Acute tinnitus was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: It is severally affecting my quality of life; Acute tinnitus; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 20Jul2021 as dose number unknown, single for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On 20Jul2021, the patient experienced acute tinnitus. On an unspecified date, the patient experienced it is severally affecting my quality of life. The patient reported that she received a Pfizer covid vaccine on 20Jul2021. Within four hours of receiving the vaccine she started having acute tinnitus and it had not stopped since. Before the vaccine she had never had tinnitus before. She had read of others with a similar experience. She enquired was there anything that can be done to help with the ringing. It was severally affecting her quality of life. It was reported that she have tried steroids, acupuncture, a psychotherapist, ENT for sound masking but still had this side effect and was affecting her life. Therapeutic measures were taken as a result of acute tinnitus (tinnitus). The patient also stated that there was another lady that goes to the pharmacy that also had this side effect. The outcome of the event It is severally affecting my quality of life was unknown. The outcome of the event Acute tinnitus was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 21Jun2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 31May2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 28Jun2021 at 06:00, the patient's left arm was hurting from top to fingers. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of left arm hurts from top to fingers which included treatment with unspecified nerve medicine and the treatment was ongoing (reported as still trying). The clinical outcome of the event left arm hurts from top to fingers was not resolved at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102F; This is a spontaneous report from a contactable consumer (parent). A 17-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 08Sep2021 (at the age of 17-years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date of Sep2021, the patient experienced 102F fever. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Laboratory test, Pain, Pain in extremity
Clinical narrative: Joint pain in hands, knees and feet; Joint pain in hands, knees and feet; Whole Body Soreness/over all body soreness; Very Tired; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FD8448) dose 1 via an unspecified route of administration in left arm on 19Aug2021 09:30 as dose 1, single dose for COVID-19 immunisation. Medical history included none. Concomitant medications not reported. The patient experienced joint pain in hands, knees and feet, whole body soreness/overall body soreness, very tired and on an unspecified date fatigue. On 09Sep2021, the patient underwent lab tests and procedures which included laboratory test: labs drawn at the doctor's office today. Treatment was not taken. Patient was taking a medical assistant class and due for clinicals in the Dr's office. Should patient wait until 2 vaccine doses to do clinicals or is one dose ok. The outcome of fatigue was recovering and outcome of other events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: he did not sleep all night; This is a spontaneous report from a contactable consumer (Caregiver). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 08Sep2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, he (patient) did not sleep all night on an unspecified date. The patient received the 1st dose of the Pfizer Covid vaccine on 08Sep2021, and reported that he did not sleep all night, and would like to know if this a side effect of the vaccine. Added that "He stays up late, but it does not like him not to be able to sleep." Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, SARS-CoV-2 test
Clinical narrative: Didn't menstruate for 5 months; This is a spontaneous report from a contactable healthcare professional. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 04Jan2021 at 18:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medications from an unknown date and unknown if ongoing. On 10Feb2021, after the vaccination, patient did not menstruate for 5 months. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 30Jun2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event did not menstruate for 5 months was recovering at the time of this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: shoulder, feels like someone is constantly sticking you with needles/pain in left arm and shoulder; The Left arm pain started on the same day as receiving the second dose; pain; It feels like someone is injecting him with a needle all over again whenever he  tries to sleep on left side or raise the arm over his head; it's very difficult to sleep on the left side or move arm up and down; pain in left arm and shoulder was reported as worsened.; soreness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: ED7534, Expiry date: 30Jun2021, age at vaccination 63-year-old), via an unspecified route of administration, administered in left arm on 24Mar2021 as dose 2, single for covid-19 immunisation. Medical history included high blood pressure, allergy, allergy to dust, pollen, and environment allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number: EN6205, Expiry date: 30Jun2021, at the age of 63-year-old), via an unspecified route of administration, administered in left arm on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient concomitant medications were not reported. The patient reported, he received the second dose on 24Mar2021 and wanted to know if he should be feeling pain constantly. He is feeling pain in left arm and shoulder every day, it's pain and soreness. It feels like someone constantly sticking him with needles and it's very difficult to sleep on the left side or move arm up and down. It feels like someone is injecting him with a needle all over again whenever he tries to sleep on left side or raise the arm over his head. The only thing he has been doing is exercises and it feels like it helps a little, but its still there. He has not had to go to the emergency room, and he had not seen a physician in regards to this. It seems like it getting worse and that's what prompted him to call. It feels like when he raise his shoulder, his shoulder bone, it feels like he can actually feel the bone in his neck on the left side like an indent, compared to the right side. The outcome of event shoulder feels like someone is constantly sticking you with needles/pain in left arm and shoulder, the left arm pain started on the same day as receiving the second dose was not recovered; for rest of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: hot flashes for a month and a half; This is a spontaneous report from a contactable consumer (patient reported for self). A 79-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient has been experiencing hot flashes for a month and a half from an unspecified date. The patient went through her change of life in her 30's and she was way past that. The patent was turning 80-years-old at the end of the month. The patient saw her health care professional and he did not know what to do but told her that this could happen to a woman later in life. He basically gave her no advice or recommendations of what to do. After the patient received shots, she did not experience any reaction to it. The patient was querying whether hot flashes have been reported after receiving the Pfizer COVID-19 vaccine and how long the hot flashes last. The clinical outcome for the event was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: all over her body pain; lost mobility in her legs; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 21Mar2021 as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On 05Apr2021 the patient experienced all over her body pain , lost mobility in her legs. The outcome of event all over her body pain was not recovered while the outcome of event lost mobility in her legs was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101195270 same reporter/drug/event, different patient;US-PFIZER INC-202101196152 same reporter/drug/event, different patient;US-PFIZER INC-202101196151 same reporter/drug/event, different patient