chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Headache, Musculoskeletal pain
Clinical narrative: typical headache; center of my chest discomfort; a little tightening; back pain; chest pain; pain between my shoulder blades; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Sep2021 (at the age of 48-years-old ) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 07Sep2021, within few hours after vaccination the patient experienced typical headache, center of my chest discomfort, a little tightening, it would be intermittent on and off and she had that for few days and then started with a  back pain, pain  between shoulder blades and about 6th day her chest pain was really bad almost went to the ER, and then on the 6-7th day back pain was constant, now back pain not often, comes and goes. Patient stated that she was very concerned with getting a second dose because she would not want to go through the same or possibly something worse. Caller stated that she is trying to get the antibody test, stated that she may have had COVID before the vaccine but she is not 100% sure because testing was not available through her doctors office so she could not do that. As noted in the fact sheet for recipients, patient should not get the Pfizer-BioNTech COVID-19 vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They refer patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Patient healthcare provider knows her health situation and has access to information that can better help inform this decision. Seriousness of the events reported as non-serious. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Urticaria
Clinical narrative: developed a few hives and a hour later those faded and then two more locations of hives appeared around 3 pm and they are fading again; She got a booster dose today; she got a booster dose today; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 62-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: not reported, Expiry date: Unknown) via an unspecified route of administration on 22Sep2021 as dose 3, single (at the age of 62-year-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of Pfizer COVID vaccine on 16Mar2021 and the second dose on 06Apr2021 for COVID-19 immunisation. On 22Sep2021, the patient had booster dose today and she got a booster dose today and 35-40 minutes afterwards she developed a few hives and a hour later those faded and then two more locations of hives appeared around 3 pm and they are fading again, on an unspecified date in Sep2021, experienced she would be dead already. Caller stated she feels as though this was related to the vaccine and wants to know if she should not get any booster doses in the future. Caller states that she was assuming that the reaction was not severe because if it was, she would be dead already, so she wants to know if hives has been reported as a reaction. The outcome of the event hives was recovered on Sep2021, she would be dead and patient had booster dose today was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: One of my family members had no medical history she took the vaccine now she's dead.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified as dose number unknown, single for COVID-19 immunisation. The patient medical history was reported as none. The concomitant medications were not reported. The reporter stated that so many side effects had not been listed on the Pfizer website. Many people experience death, stroke and other problems. Reporter stated that one of the reporter's family members had no medical history she took the vaccine now she's dead on an unspecified date. Reporter stated to have seen so many people dying after receiving the vaccine. People who had no medical history get sick after the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253587 same reporter/product, different patient / event.; Reported Cause(s) of Death: One of my family members had no medical history she took the vaccine now she's dead.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Heart rate, Heart rate increased, Insomnia
Clinical narrative: it is hard for me to breath.; I can feel the palpitations/bad palpitations and I can hear the palpitations /my heart is racing.; my heart rate went up to 120 beats per minute; it's very uncomfortable; it's hard for me to sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: FA6780, Expiry date: unknown) via an unspecified route of administration on 23Jul2021 (age at vaccination is 67-years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: FA6780, Expiry date: unknown) via an unspecified route of administration on 02Jul2021 as dose 1, single for COVID-19 immunization (age at vaccination is 67-years). On 23Jul2021 the patient experienced my heart rate went up to 120 beats per minute (medically significant). On 25Jul2021 the patient experienced my heart is racing, I can feel the palpitations/bad palpitations and I can hear the palpitations, it is hard for me to breath. All these events are recorded in physician office visit. On unspecific date in Jul2021 the patient experienced it's very uncomfortable and it's hard for me to sleep. She already been to the cardiologist and had to wear a Halter monitor for 5 days. Informed she will go back to the cardiologist in next week, Monday 27Sep2021. She had one of those (pulse) oximeter they put on fingers, and on one time occasion her heart rate went up to 120 beats per minute. The patient underwent lab tests and procedures which included heart rate: went up to 120 beats per minute on an unknown date in 2021. The outcome of the events was reported as not recovered.  Follow-up activities closed: No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: it is hard for me to breath.; I can feel the palpitations/bad palpitations and I can hear the palpitations /my heart is racing.; my heart rate went up to 120 beats per minute; it's very uncomfortable; it's hard for me to sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: FA6780, Expiry date: unknown) via an unspecified route of administration on 23Jul2021 (age at vaccination is 67-years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: FA6780, Expiry date: unknown) via an unspecified route of administration on 02Jul2021 as dose 1, single for COVID-19 immunization (age at vaccination is 67-years). On 23Jul2021 the patient experienced my heart rate went up to 120 beats per minute (medically significant). On 25Jul2021 the patient experienced my heart is racing, I can feel the palpitations/bad palpitations and I can hear the palpitations, it is hard for me to breath. All these events are recorded in physician office visit. On unspecific date in Jul2021 the patient experienced it's very uncomfortable and it's hard for me to sleep. She already been to the cardiologist and had to wear a Halter monitor for 5 days. Informed she will go back to the cardiologist in next week, Monday 27Sep2021. She had one of those (pulse) oximeter they put on fingers, and on one time occasion her heart rate went up to 120 beats per minute. The patient underwent lab tests and procedures which included heart rate: went up to 120 beats per minute on an unknown date in 2021. The outcome of the events was reported as not recovered.  Follow-up activities closed: No follow-up attempts are possible.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that he had personally gone to 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine, but states he doesn't know whether they are moderna or Pfizer or Johnson and Johnson and he doesn't know one person who has died from the actual virus. He just wanted information. The patient died on an unspecified date. Autopsy performed was unknown and cause of death was not reported. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer or other non-healthcare professional. This case split for third patient.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had gone to 4 funerals of people who have died 3 to four days after getting the covid-19 vaccine. The reporter wanted to know now that the Pfizer COVID-19 vaccine was fully approved and enquired if he took the vaccine and had adverse side effects from it who was going to pay for his bills. The reporter stated that he had been doing some research on the amount of people who have died from taking the COVID-19 vaccine and what adverse events they have had after receiving the vaccine. He stated that he had personally gone to 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine, but stated he doesn't know whether they are moderna or Pfizer or Johnson and Johnson and he doesn't know one person who has died from the actual virus. He just wanted information. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: After receiving my 1st shot, my shoulder pain did not go away. I waited, hoping it would get better but it did  not. I went to an orthopedic doctor and I was told it was SIRVA, injury from the shot administered in the wrong location. When I reach using my right arm, I experience great pain.   I am currently in physical therapy. I have been doing physical therapy for 4 weeks. I still am unable to reach with my right arm without pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb abnormal
Clinical narrative: After receiving my 1st shot, my shoulder pain did not go away. I waited, hoping it would get better but it did  not. I went to an orthopedic doctor and I was told it was SIRVA, injury from the shot administered in the wrong location. When I reach using my right arm, I experience great pain.   I am currently in physical therapy. I have been doing physical therapy for 4 weeks. I still am unable to reach with my right arm without pain.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Very sore injection site on left arm approximately 12 hours after injection.  Fever, chills, nausea, vomiting, headache ending approximately  24 hours after injection
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very sore injection site on left arm approximately 12 hours after injection.  Fever, chills, nausea, vomiting, headache ending approximately  24 hours after injection
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated that he was been doing some research on the amount of people who have died from taking the COVID-19 vaccine and what adverse events they have had after receiving the vaccine. He stated that he had personally gone to 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine, but stated he did not knew whether they were moderna or Pfizer or Johnson and Johnson and he did not knew one person who had died from the actual virus. He just wanted information. Caller wanted to know that the Pfizer COVID-19 vaccine was fully approved if he took the vaccine and had adverse side effects from it who was going to pay for his bills. The patient died on an unspecified date. It was not reported if an autopsy was performed and cause of death was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Interchange of vaccine products, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Additional Details: started 10 days after getting shot, has very significant body and joint pain
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Systemic: Headache-Severe, Additional Details: Patient experienced extreme migraines from first COVID pfizer shot at her work at her senoir living facility. Could not get the lot number before she left but I believe she has it on her card
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: the patient died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101275697 same reporter, same vaccine, same adverse event, different patient;US-PFIZER INC-202101276043 same reporter, same vaccine, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: there other leg, there same shot and same day they got shot on numb for about week; 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 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that their other leg, there same shot and same day they got shot on numb for about week on an unspecified date. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain
Clinical narrative: Pain; Lump; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Aug2021 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. Patient had both doses of the vaccine, 1st dose was on Aug2021 and 2nd dose on 10Sep2021, and after 1st dose she only experienced pain and lump (did not mention the specific body part) in 2021. And after 2nd dose, she experienced leg pain within 24 hours, Legs were hurting, feet were burning and really had bad pain. patient had massage to ease the pain, it was hard to sleep and never had this before. She did not take any pain medication or any other drugs in the past. Asked if has anybody reported like leg pain after getting the shot of the Pfizer COVID 19 vaccine. 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), 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 medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain University tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Drug ineffective
Clinical narrative: tested positive for a COVID 19 infection; tested positive for a COVID 19 infection; Loss of smell; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (Lot Number: EP6955) as dose 2, single, via an unspecified route of administration, administered in left arm on 01Mar2021 (Lot Number: EL3248) as dose 1, single for COVID-19 immunisation. Patient 's age at vaccination was 40-year-old. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No concomitant medication was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took cefaclor (CECLOR) and experienced allergy to CECLOR. The patient experienced loss of smell on 23Sep2021. On the evening of 23Sep2021, he tested positive for a COVID 19 infection. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction): negative (Nasal Swab) on 18Sep2021, polymerase chain reaction: positive (nasal swab) on 23Sep2021. The outcome of the event loss of smell was not recovered, outcome of event tested positive for a COVID 19 infection was recovered with lasting effects on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: She did not present her period; 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 (Batch/Lot number was not reported) as dose 1, single, 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. The patient experienced she did not present her period. The outcome for event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19
Symptoms: Myelitis
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable physician, the patient.   A 66-years-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 12Jan2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced transverse myelitis on 22Aug2021. The patient 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 on 23Dec2020 as single for covid-19 immunization. The patient was asking if there had been reports of this diagnosis this far out from the Pfizer COvid-19 doses. He knew it can usually occur in the first few weeks to months after vaccination, from his understanding. The outcome of the event was unknown.  The patient was advised by his neurologist as well as PCP and other physicians not to receive the booster dose of the Pfizer Covid-19 vaccine, but is wanting Pfizer's recommendation on this decision.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of transverse myelitis cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she gave Covid to her 58 year old husband, who got the Pfizer vaccine; she gave Covid to her 58 year old husband, who got the Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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 reporter asked if we can e-mail her a list of the ingredients for the Pfizer BioNTech COVID-19 vaccine Comirnaty and asked if the vaccine works to prevent getting Covid. She stated that she was not vaccinated, but she gave COVID to her 58 year old husband, who got the Pfizer vaccine. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: she presented palpitations in the heart/her heart was thumping so hard; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Aug2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient stated she had the first dose and her heart was thumping so hard (reported as " palpitations in the heart") and she was in the hospital in 2021.The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Memory impairment, Thinking abnormal
Clinical narrative: Weakness; Thoughts are cloudy; Dizzy; Forgetfulness, she will do one thing and then forget what she did; This is a spontaneous report from a contactable other HCP (patient).   A 44-year-old female other HCP (Patient) reported herself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: FF2588), via injection in left deltoid on 20Sep2021 at 20:30 (at the age of 44-year-old) as dose 1, single for covid-19 immunization at pharmacy facility. Vaccine administered at military facility was reported as no. Medical history included hypertension, asthma, chronic migraine, fibromyalgia and glaucoma (from unspecified date to ongoing). Family medical history relevant to events was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other vaccine on the same day of BNT162B2 vaccine. The events reported prior to the vaccination was none. After 3 days of first vaccination, on 23Sep2021, patient developed weakness, dizzy, and her thoughts are cloudy as forgetfulness. Stated that she will do one thing and then forget what she did. Provided seriousness of being dizzy as not serious because she was not falling down. Patient was not hospitalized nor visited to emergency room or physician office, due to the events. Stated she was trying to figure out if she should go to urgent care or try to get an appointment at her doctor's office tomorrow, she was trying to figure out if that was normal. Therapeutic measure was reported as no. The outcome of the events was reported as not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: reporter herself was not vaccinated but she gave COVID to her uncle, the patient who was vaccinated but unknown if Pfizer; reporter herself was not vaccinated but she gave COVID to her uncle, the patient who was vaccinated but unknown if Pfizer; This is a spontaneous report from a contactable consumer. A male patient (reporter's uncle) of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if she can be emailed a list of the ingredients for the Pfizer BioNTech Covid 19 vaccine and Comirnaty and wanted to know if the vaccine works to prevent getting Covid. The reporter herself was not vaccinated but she gave COVID to her uncle, the patient, who was vaccinated but unknown if Pfizer on an unknown date. The 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: Accident, Depression, Feeling abnormal
Clinical narrative: Depression/Depression lessened before the second shot.; Brain fog presented; The patient brain fog contributed to a car accident.; This is a spontaneous report from a non-contactable consumer. This 38-year-old consumer (patient) of unknown gender communicated to a Pfizer sales representative that he/she received the 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 dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date after the first shot the patient presented depression and brain fog. The patient's brain fog contributed to a car accident. It was mentioned that depression lessened before the second shot. The outcome of depression was recovering, the outcome of brain fog and car accident was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Depression, Feeling abnormal, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 38-year-old patient, of an unspecified gender, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. After the first shot, patient experienced depression and brain fog (contributed to a car accident). On unspecified date, patient had lessened depression, then after he received second shot, depression and brain fog returned significantly worse. Anxiety also heightened. Patient still has large swelling at the injection site 3 days post-shot. Outcome of the events: not recovered. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), 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 medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain University tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), 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 medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain location tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse reported for a 13-year-old female patient (granddaughter) that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on 10Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Caller Retired RN stated in behalf of her 13 year old granddaughter who received the 1st dose of the Pfizer COVID 19 vaccine- She had the 1st dose on 10Sep2021 and tested positive for COVID on 14Sep2021 - He wants to know if they need to have 90 day period wait before taking the 2nd dose - The patient will have her 2nd dose on 01Oct2021 - Caller also had COVID 19 before and he was advised to wait for 90 days before getting the 2nd dose. On 14Sep2021 the patient underwent for SARS-CoV-2 test and it was reported as positive .The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: regarding a patient who had Shingles after receiving the Pfizer Covid-19; This is a spontaneous report received from a contactable consumer or other non hcp.A patient of unspecified age and gender received bnt162b2(Pfizer Covid 19-Vaccine,Batch/Lot number was not reported)via an unspecified route of administration on an unspecified date, as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced regarding a patient who had shingles after receiving the pfizer covid-19 on an unspecified date.Patient's information and gender was not written on the questionnaire/form. Unable to ask if the caller is HCP. Unable to transfer, the caller hung up while talking to the representative.The patient received no treatment for the event.The outcome of the events 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: the patient died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253281 same reporter/SD/AE, different patient; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: the patient died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253281 same reporter,same vaccine, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: the patient died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253281 same reporter,same vaccine, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 6 kids in her neighborhood have died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253281 same reporter,same vaccine, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 6 kids in her neighborhood have died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253281 same reporter/SD/AE, different patient;US-PFIZER INC-202101253281 same reporter,same vaccine, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: pulled the needle out, it was dripping on her hand, her shoulder was wet and after 30 minutes, her Band Aid was full of blood; pulled the needle out, it was dripping on her hand, her shoulder was wet and after 30 minutes, her Band Aid was full of blood; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 22Jan2021 (age at vaccination was 68 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included diabetes mellitus from 2000 and ongoing. Concomitant medications included insulin lispro (HUMALOG) taken for diabetes mellitus from 2020 to an unspecified stop date and insulin glargine (LANTUS) taken for diabetes mellitus, start and stop date were not reported. On 22Jan2021, the patient informed that she noticed when operator pulled the needle out, it was dripping on her hand, her shoulder was wet, and after 30 minutes, she had to wait to be sure she had no reaction, and her Band Aid was full of blood, so she was wondering whether or not she received the shot, or did it come out of her arm when she pulled the needle out. She gives herself shots twice a day, she knows how a shot was supposed to be, how liquid was supposed to stay in the arm, not get all over her arm and hand, if you have a Band Aid from a shot, and have blood in the Band Aid, it was most likely the fluid in your arm that came out with the blood (as reported). At the time of reporting, the outcome of the event vaccination site haemorrhage was unknown.  Information on the lot/batch number has been requested.  Amendment: This follow-up is being submitted to add vaccination site bleeding as event.  Follow-up (22Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Vaccination site pain
Clinical narrative: body aches; Chills/rigors; pain around injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 21-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6201, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 19Feb2021 17:00 (at the age of 21-years-old) as dose 2, single for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease, covid-19 from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), citalopram (CITALOPRAM), hydroxyzine hydrochloride (HYDROXIZINE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: El9262, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 22Jan2021 12:00 as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. The patient received lo loestrin, nexium, citalopram, hydroxizine other medication in two weeks. On 20Feb2021 04:00, the patient experienced chills, rigors, pain around injection site, headache, body aches. The patient did not receive treatment for the adverse event. Prior vaccination, patient had not been diagnosed with COVID and had not been tested since the vaccination. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Nausea
Clinical narrative: dizziness; nausea; rapid heart rate; This is a spontaneous report from a contactable consumer (patient himself). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: EN5318, expiry date: unknown) via unspecified route of administration in left arm on 20-Feb2021 09:00 as dose 1, single (age at vaccination: 46-years) for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included Advair, Combivent, Zyrtec, daily multi vitamins, taken for unspecified indication, start and stop date not reported, taken in two weeks. Patient had no known allergies. No other vaccines in four weeks were administered. On 20Feb2021 09:30, after 25 minutes after receiving the shot, patient began to have dizziness, nausea, rapid heart rate. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment was given as a result of the adverse events. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.