chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after receiving the vaccine; tested positive for COVID after receiving the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for covid after receiving the vaccine on an unspecified date. Caller reported adverse event and mentioned friend who tested positive for Covid after received Covid 19 Vaccine. The reporter was out with friends last Sunday on 11Jul2021, and on Tuesday, 13Jul2021, one of them texted her to let her know that he tested positive for Covid. She did not have all the information. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After being infected by my son in law who is also vaccinated with the Pfizer vaccine; After being infected by my son in law who is also vaccinated with the Pfizer vaccine; This is a spontaneous report received from a contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-COVID19 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 got infected with covid-19 after being infected by his son in law who was also vaccinated with the pfizer vaccine on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Wednesday July14.The patient reported that he was fully vaccinated in February.The outcome of the event was unknown.  Information on lot /batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Incomplete course of vaccination, SARS-CoV-1 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP via clinic. A 81-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: ER8727, Expiration date: unknown), via an unspecified route of administration on 19Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received his first vaccine dose on March 19th (Lot ER8727, no expiration date). asking when he was able to get his second vaccine dose or if he needs to repeat the entire series because he had covid. Caller reports that first vaccine dose her husband was diagnosed with Covid through a rapid Covid test at rite aid, stating, suspect he may have already had Covid because he contracted Covid a few days after he got the vaccine. Caller reports that a few days after her husband received the vaccine started feeling sick he wasn't able to notice if or when he had any symptoms. Caller reports that her husband got Monoclonal antibodies and Remdesivir while in the hospital. She reports that the Monoclonal antibody people said wait 90 days to get the vaccine, then our Family doctor wanted him to wait 120 days. Now he (my husband) is nervous and jerky because of the delta strain. Caller states, there was so much conflicting information just want to clarify when he should get the second dose or if he needs to repeat the series. The patient underwent lab tests and procedures which included rapid Covid test unknown result on an unspecified date. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: sudden death of a 13-year-old (place)child who had a second dose of Pfizer vaccine; This is a spontaneous report from a non-contactable consumer (columnist). A 13-year-old male patient received second dose of BNT162b2 (FIZER-BIONTECH COVID-19 mRNA 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's medical history and concomitant medications were not reported. It was reported that remained strangely silent over the sudden death of a 13-year-old child who had a second dose of Pfizer vaccine. 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.; Reported Cause(s) of Death: Sudden death
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac flutter, Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; Feelings of having a fast-beating, fluttering, or pounding heart; his breath sometimes is short, like short in breathe, but not too much; Chest pain; Feelings of having a fast-beating, fluttering, or pounding heart; Feelings of having a fast-beating, fluttering, or pounding heart; This is a spontaneous report from a contactable consumer or other non hcp (Patient). This consumer reported that a 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Age at vaccination 31 years) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : ER8733), via an unknown route of administration on 24Mar2021 (Age at vaccination 31 years) as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; his breath sometimes is short, like short in breathe, but not too much and chest pain. It was reported that caller states that he got his vaccine 3 months ago, clarified later in the call to the COVID vaccine, he had the 1st dose and then the 2nd dose 2 months ago. After that he had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better, and his breath sometimes is short, like short in breath, but not too much. The pain in his heart bothers him. Pain in his heart: He thinks it started like 2 and a half months ago after his 2nd dose. Sometimes it is better and sometimes it is worse, it is back and forth. Short in breath: The short of breath happens not too much, just a few times but right now he doesn't have it. Caller stated that he has experienced the symptoms (Chest pain, Shortness of breath, Feelings of having a fast-beating, fluttering, or pounding heart) and would like to know where he should go to be evaluated and treated. Caller stated after that about two and half months ago he had pain in his heart and occasional shortness of breath. Caller stated that he is still having pain in the heart but no shortness of breath now as it only happened a few times. The clinical outcome of all the events were not resolved while the outcome of the event chest pain was unknown.  Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; Feelings of having a fast-beating, fluttering, or pounding heart; his breath sometimes is short, like short in breathe, but not too much; Chest pain; Feelings of having a fast-beating, fluttering, or pounding heart; Feelings of having a fast-beating, fluttering, or pounding heart; This is a spontaneous report from a contactable consumer or other non hcp (Patient). This consumer reported that a 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Age at vaccination 31 years) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : ER8733), via an unknown route of administration on 24Mar2021 (Age at vaccination 31 years) as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; his breath sometimes is short, like short in breathe, but not too much and chest pain. It was reported that caller states that he got his vaccine 3 months ago, clarified later in the call to the COVID vaccine, he had the 1st dose and then the 2nd dose 2 months ago. After that he had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better, and his breath sometimes is short, like short in breath, but not too much. The pain in his heart bothers him. Pain in his heart: He thinks it started like 2 and a half months ago after his 2nd dose. Sometimes it is better and sometimes it is worse, it is back and forth. Short in breath: The short of breath happens not too much, just a few times but right now he doesn't have it. Caller stated that he has experienced the symptoms (Chest pain, Shortness of breath, Feelings of having a fast-beating, fluttering, or pounding heart) and would like to know where he should go to be evaluated and treated. Caller stated after that about two and half months ago he had pain in his heart and occasional shortness of breath. Caller stated that he is still having pain in the heart but no shortness of breath now as it only happened a few times. The clinical outcome of all the events were not resolved while the outcome of the event chest pain was unknown.  Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: with arm soreness and a bit more tired; with arm soreness and a bit more tired; This is a spontaneous report from a contactable Other-HCP. A 64-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization and received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021(at the age of 64-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Covid vaccine twice on Apr2021 with arm soreness and a bit more tired afterwards but doing ok now. The outcome of the events was resolved on unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Internal haemorrhage
Clinical narrative: She had to take to the Hospital because she is losing the blood, they told this is internal bleeding, so they gave her the blood transfusion but still losing the blood; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Mother-in-law) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Reporter stated, "Why I am calling is that I have few questions about the side effects for the Pfizer Covid-19 vaccine vaccination. It was for my mother-in-law (consumer) after the second dosage vaccination, after one month. On an unspecified date, she had to take to the hospital, and she was losing the blood. I was just asking you was it normal after one month of the second dosage. She was losing the blood, they told this is internal bleeding but she didn't have any internal bleeding, so they gave her the blood transfusion but she was still losing the blood." The patient was hospitalized on an unspecified date. Reporter stated, "I will ask for my mother-in-law if she get more information, I would call because I want to get more information like was it from the vaccination if she gets advice from the Doctor, if they know the procedure to help her." Outcome of the event was not recovered.  Information about Lot/ Batch number have been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Spontaneous miscarriage with no previous history of miscarriages.; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 25-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: ewo198) via an unspecified route of administration, administered in arm left on 06Jul2021 at 16:30 pm as dose 1, single dose for covid-19 immunization (at the age of 25-years-old). Medical history included pregnancy from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. It was reported that on 06Jul2021 the pregnant female patient received first dose of vaccine and on 18Jul2021 at 14:00 pm she had spontaneous miscarriage with no previous history of miscarriages. The mother was 4 weeks pregnant at the onset of the event. The mother was due to deliver on 28Mar2022. Patient had not received any treatment for the event. The outcome of the event was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; tinnitus; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as  Dose 2, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at Dose 1,Single for COVID-19 immunization. Patient really felt tinnitus was related to COVID vaccine. It started on an unspecified date about 3 weeks after the second dose. Patient went to ear specialist. She noted patient had mild hearing loss which patient have never had before. She said the tinnitus was related to the loss of hearing. She could not confirm or deny any vaccine cause. She did say she sees hearing loss and tinnitus with the Covid infection. Patient would just like you to add it to our studies. It was not going away. Adverse events resulted into physician's office visit. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low-grade fever observed on 18JUL2021.; This is a spontaneous report from a contactable Pfizer colleague reported for a 15-year-old male patient that, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in Arm Left on 17Jul2021 (at the age of 15-year-old) as single dose for covid-19 immunization. There were no concomitant medications. Known allergies and other medical history was reported as no. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Arm Left on 26Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 15-year-old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low-grade fever observed on 18Jul2021. Seriousness was reported as non-serious. Patient did not receive treatment for adverse event. The outcome of the event was resolved on unknown date in Jul2021.  Information about lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Inflammation, White blood cell count, White blood cell count increased
Clinical narrative: Extreme pain in lower back; inflammation in lower back; elevated white blood count; This is a spontaneous report from a contactable consumer (patient). A 46-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 left on 05Jun2021 02:45 PM (Age at Vaccination: 46 years) as dose 2, single for COVID-19 immunisation. Facility type vaccine was reported as Pharmacy or Drug Store. The patient medical history included Chronic hives and had none known allergies. Covid prior vaccination was reported as none. Other vaccine same date product was reported as None. Other vaccine in four weeks was reported as no. The patient Concomitant medications in two weeks included Fexofinidine . The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left on 18May2021 03:00 PM (at the age of 46 years) as dose 1, single for COVID-19 immunization. On 11Jun2021 03:00 PM, the patient experienced Extreme pain in lower back, inflammation in lower back, elevated white blood count. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid tested post vaccination was reported as no. The lab tests included test: White blood cell count, result: Increased on 11Jun2021. Therapeutic measures were taken as a result of events and treatment included Steroids and antibiotics. The outcome of the events was not recovered.  Information about lot/batch has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypertension, Menstruation delayed, Pyrexia
Clinical narrative: I have bled for 20 days and it is still ongoing; menstrual cycle was delayed a week; high blood pressure; I had a fever; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 11:00 (Batch/Lot Number: EW0153) as DOSE 2, SINGLE for Covid-19 immunisation. Medical history included Temperature intolerance, Vertigo, Heat stroke, Food allergy and Shellfish allergy from an unknown date and unknown if ongoing and included Historical Vaccine BNT162B2 for COVID-19 immunisation as Dose 1 on arm left at 2:30 Pm with Lot number ER2613. The patient's concomitant medications were not reported. The patient experienced I have bled for 20 days and it is still ongoing, Menstrual cycle was delayed a week, High blood pressure and I had a fever on 05Jul2021 12:00. No other vaccine was given in four weeks. There was no treatment received for any of the events. Patient did not have Covid prior vaccination and patient was not tested for Covid 19. The outcome for all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection after full vaccination. Vaccination in April, infection in July; COVID infection after full vaccination. Vaccination in April, infection in July; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single, both doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced COVID infection after full vaccination. Vaccination in April, infection in July on an unspecified date in Jul2021. Event took place after use of product. The patient underwent lab tests and procedures which included COVID infection was positive on an unspecified date in Jul2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Feeling abnormal, Hypoaesthesia oral, Paraesthesia oral, Stomatitis
Clinical narrative: tingling and numbness sensation; I couldn't  feel or move my tongue/ I couldn't move it for about a week; couldn't  feel or move my tongue. It seemed swollen and numb; couldn't  feel or move my tongue. It seemed swollen and numb; small hole underneath  my tongue; had canker sores appear all inside my mouth and the veins underneath  my tongue  began turning white; had canker sores appear all inside my mouth and the veins underneath  my tongue  began turning white; My tongue began feel scorched, the sores would appear  on my jaw and inside my lip; My tongue began feel scorched, the sores would appear  on my jaw and inside my lip; This is a spontaneous report from a contactable consumer, the patient.  A 38-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 16Mar2021 at 16:30 (at the age of 38-years-old) as dose 1, single and dose 2 via an unspecified route of administration, in left arm on an unspecified date in 2021 (at 38-years-old)(Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history was none. Known allergies were none. The patients concomitant medications were none. Patient had not received any other vaccine in four weeks. The patient stated on 31Mar2021 at 13:15, she couldn't feel or move her tongue. It seemed swollen and numb. she couldn't move it for about a week. Then she had the small hole underneath her tongue squirt spit and then she could move it. Then after that patient had canker sores appear all inside her mouth and the veins underneath her tongue began turning . Patient tongue began to feel scorched, the sores would appear on her jaw and inside her lip. After using Ceapocal mouth wash it subsided. After taking the second shot the doctor prescribed her medication just in case it happened again. To this day her tongue still feels scorched tingling and numbness sensation. The events did not result in emergency room/ physician office visit. The patient received treatment for the events (magic mouthwash/ diphenhydramine 25 mg capsule/me). Patient doent had covid prior vaccination and was not tested to covid post vaccination. The outcome of the events was recovered with lasting effects.  Information on lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue discomfort, Tongue injury, Vein disorder
Clinical narrative: tingling and numbness sensation; I couldn't  feel or move my tongue/ I couldn't move it for about a week; couldn't  feel or move my tongue. It seemed swollen and numb; couldn't  feel or move my tongue. It seemed swollen and numb; small hole underneath  my tongue; had canker sores appear all inside my mouth and the veins underneath  my tongue  began turning white; had canker sores appear all inside my mouth and the veins underneath  my tongue  began turning white; My tongue began feel scorched, the sores would appear  on my jaw and inside my lip; My tongue began feel scorched, the sores would appear  on my jaw and inside my lip; This is a spontaneous report from a contactable consumer, the patient.  A 38-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 16Mar2021 at 16:30 (at the age of 38-years-old) as dose 1, single and dose 2 via an unspecified route of administration, in left arm on an unspecified date in 2021 (at 38-years-old)(Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history was none. Known allergies were none. The patients concomitant medications were none. Patient had not received any other vaccine in four weeks. The patient stated on 31Mar2021 at 13:15, she couldn't feel or move her tongue. It seemed swollen and numb. she couldn't move it for about a week. Then she had the small hole underneath her tongue squirt spit and then she could move it. Then after that patient had canker sores appear all inside her mouth and the veins underneath her tongue began turning . Patient tongue began to feel scorched, the sores would appear on her jaw and inside her lip. After using Ceapocal mouth wash it subsided. After taking the second shot the doctor prescribed her medication just in case it happened again. To this day her tongue still feels scorched tingling and numbness sensation. The events did not result in emergency room/ physician office visit. The patient received treatment for the events (magic mouthwash/ diphenhydramine 25 mg capsule/me). Patient doent had covid prior vaccination and was not tested to covid post vaccination. The outcome of the events was recovered with lasting effects.  Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migraine; Headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ew0150) via intramuscularly in left arm on 04Apr2021 at 12:15 as dose 1 single (at the age of 44-year-old) for COVID-19 immunization.  Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There were no prior vaccination within 4 weeks. The patient stated that, twelve hours after the first dose, on 05Apr2021 at 00:15, patient developed a migraine, headache, which lasted (on and off) for a day. Patient also received second dose of BNT162b2 (ew0172) via intramuscularly in left arm on 25Apr2021. There were no relevant tests done. Therapeutic measures were taken as a result of the events (unspecified). The outcome of the events was recovered on 06Apr2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood disorder, Cardiac disorder, Computerised tomogram, Liver disorder
Clinical narrative: Acute Massive Pulmonary Embolism detected via CT scan; Syncope; Severe anemia; Leg pain; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Long term effects require continuous use of blood thinners; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 34-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 09:00 (at the age of 34-years-old) as Dose 1, Single for COVID-19 immunization. Medical history included none. Concomitant medications included desogestrel, ethinylestradiol (APRI) taken for an unspecified indication, start and stop date were not reported. Patient received vaccine Facility in: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Event occurred on 11Mar2021, exactly two weeks following 1st dose of COVID vaccine. Acute Massive Pulmonary Embolism detected via CT scan following sudden leg pain and syncope. Negatively impacted cardiac, liver, and kidney function. Long term effects require continuous use of blood thinners. Presently experiencing severe anaemia treated through infusion treatments. Continued follow up required with Gastroenterology, Cardiology, Pulmonology, Hematology, and Gynecology. Patient visited Emergency room/department or urgent care. The events assessed as serious (Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage). Treatment was received for the events as infusion. Patient admitted in hospital for 4 days. The patient underwent lab tests and procedures which included computerised tomogram: acute massive pulmonary embolism and acute massive pulmonary embolism detected via CT scan following sudden leg pain and syncope, sars-cov-2 test: negative on 11Mar2021 Nasal Swab. The outcome of the events was reported as recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary embolism, Renal disorder, SARS-CoV-2 test, Syncope
Clinical narrative: Acute Massive Pulmonary Embolism detected via CT scan; Syncope; Severe anemia; Leg pain; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Long term effects require continuous use of blood thinners; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 34-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 09:00 (at the age of 34-years-old) as Dose 1, Single for COVID-19 immunization. Medical history included none. Concomitant medications included desogestrel, ethinylestradiol (APRI) taken for an unspecified indication, start and stop date were not reported. Patient received vaccine Facility in: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Event occurred on 11Mar2021, exactly two weeks following 1st dose of COVID vaccine. Acute Massive Pulmonary Embolism detected via CT scan following sudden leg pain and syncope. Negatively impacted cardiac, liver, and kidney function. Long term effects require continuous use of blood thinners. Presently experiencing severe anaemia treated through infusion treatments. Continued follow up required with Gastroenterology, Cardiology, Pulmonology, Hematology, and Gynecology. Patient visited Emergency room/department or urgent care. The events assessed as serious (Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage). Treatment was received for the events as infusion. Patient admitted in hospital for 4 days. The patient underwent lab tests and procedures which included computerised tomogram: acute massive pulmonary embolism and acute massive pulmonary embolism detected via CT scan following sudden leg pain and syncope, sars-cov-2 test: negative on 11Mar2021 Nasal Swab. The outcome of the events was reported as recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Fatigue, Hypoaesthesia oral, Nasopharyngitis
Clinical narrative: tongue numb on the end/her tongue is still numb, on the tip not even halfway up; tired; little chill; cold; couldn't swallow/she has always had a swallow problem but last night she could tell it was intense; achy, and neck feels achy; achy, and neck feels achy; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 via an unspecified route of administration on 19Jul2021 (Lot Number: EW0127) as a single for COVID-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing Caller stated that she is a heart patient, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine dose 1, (Lot number EW0186 expiry date was not reported) via unspecified route of administration at left arm on 28Jun2021 for COVID-19 immunisation. The patient did not received vaccination within 4 weeks. The patient took second dose of vaccine and at four in the morning she woke up. She was tired, a little chill and on the second shot she could not swallow, and her tongue was numb on the end. She took omeprazole for swallowing and she had always had a swallow problem but last night she could tell it was intense. She was suggested to take a Benadryl (diphenhydramine) 25 mg and it helped to get the swallowing down and her tongue was still numb, on the tip not even halfway up. It scared her. She called her doctor, and she was going in for an Epi (epinephrine) pen today just in case her tongue gest swollen. It was reported that for achy and neck pain the patient did not receive any treatment. Outcome of the events was Hypoesthesia oral, Chills, Dysphagia, Nasopharyngitis Unknown Fatigue, Neck pain and Pain was Not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: tongue numb on the end/her tongue is still numb, on the tip not even halfway up; tired; little chill; cold; couldn't swallow/she has always had a swallow problem but last night she could tell it was intense; achy, and neck feels achy; achy, and neck feels achy; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 via an unspecified route of administration on 19Jul2021 (Lot Number: EW0127) as a single for COVID-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing Caller stated that she is a heart patient, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine dose 1, (Lot number EW0186 expiry date was not reported) via unspecified route of administration at left arm on 28Jun2021 for COVID-19 immunisation. The patient did not received vaccination within 4 weeks. The patient took second dose of vaccine and at four in the morning she woke up. She was tired, a little chill and on the second shot she could not swallow, and her tongue was numb on the end. She took omeprazole for swallowing and she had always had a swallow problem but last night she could tell it was intense. She was suggested to take a Benadryl (diphenhydramine) 25 mg and it helped to get the swallowing down and her tongue was still numb, on the tip not even halfway up. It scared her. She called her doctor, and she was going in for an Epi (epinephrine) pen today just in case her tongue gest swollen. It was reported that for achy and neck pain the patient did not receive any treatment. Outcome of the events was Hypoesthesia oral, Chills, Dysphagia, Nasopharyngitis Unknown Fatigue, Neck pain and Pain was Not recovered.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Disability, Expired product administered, Poor quality product administered, Product temperature excursion issue
Clinical narrative: stated the patient was in a wheelchair on 08Jul2021; Patients vaccinated with expired use; the 4 patients that received the COVID-19 Vaccine involved in the temperature excursion.; the 4 patients that received the COVID-19 Vaccine involved in the temperature excursion.; This is a spontaneous report from a contactable other hcp. This other HCP reported similar events for 4 patients. This report is for 4th of 4 report.  A 18-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196; Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration, administered in Deltoid Left on 08Jul2021(at the age of 18 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stated the patient was in a wheelchair on 08Jul2021 on an unspecified date, patients vaccinated with expired use on 08Jul2021, the 4 patients that received the covid-19 vaccine involved in the temperature excursion. on 08Jul2021.Patient stated, 4 patients vaccinated with the Pfizer Covid vaccine which was stored in the freezer since 08Jun2021. Reporter is looking for guidance on how to proceed. office manager reported their practice had kept the COVID-19 Vaccine in the freezer since 08Jun2021, past the allowed extended freezer time, and then the COVID-19 Vaccine was then given to 4 patients. said the COVID-19 Vaccine can only be kept in the freezer for 3 weeks. a temperature excursion had occurred on the practice's COVID-19 Vaccine, and the practice's office manager was being transferred to report on the 4 patients that received the COVID-19 Vaccine involved in the temperature excursion. Reported the patient was unaware the COVID-19 Vaccine was involved in a temperature excursion, and the patient had not reported any adverse events to their office since the COVID-19 Vaccine was administered. Patient not received treatment for reported events. The outcome of events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event disability cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100922637 same reporter/product/event, different patient
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Anaemia, Blood iron, Blood iron decreased, Fatigue
Clinical narrative: Sjogren's; aches; fatigue; dryer than usual eyes; anemia; low iron; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Age at Vaccination was 56 years. Medical history included suspected history of Sjogren's. The patient's concomitant medications were not reported. Previously patient bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and no events reported. The patient experienced general aches, pains, fatigue, dryer than usual eyes 24hrs after the 2nd COVID shot. Blood tests report anemia and low iron. He has a suspected history of Sjogren's. Tests were inconclusive for the diagnosis but doctor's assume from the symptoms it is Sjogren's. Optional Information was reported as previously mention, he was suspected of having Sjogren's. Several doctors were in agreement based on tests and physical presentation. It was asked could Sjogren's exacerbate the side effects and cause the anemia and low iron. The outcome of the events was unknown.  Information about Lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Sjogren's syndrome
Clinical narrative: Sjogren's; aches; fatigue; dryer than usual eyes; anemia; low iron; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Age at Vaccination was 56 years. Medical history included suspected history of Sjogren's. The patient's concomitant medications were not reported. Previously patient bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and no events reported. The patient experienced general aches, pains, fatigue, dryer than usual eyes 24hrs after the 2nd COVID shot. Blood tests report anemia and low iron. He has a suspected history of Sjogren's. Tests were inconclusive for the diagnosis but doctor's assume from the symptoms it is Sjogren's. Optional Information was reported as previously mention, he was suspected of having Sjogren's. Several doctors were in agreement based on tests and physical presentation. It was asked could Sjogren's exacerbate the side effects and cause the anemia and low iron. The outcome of the events was unknown.  Information about Lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired since 15Jul2021/3 doses were administered; This is a spontaneous report from a contactable other hcp. This HCP reported similar events for three patients. This report is for 2nd of 3 patients. A 62-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW0186; Expiration Date: 15Jul2021), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jul2021 as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot EW0186 and Expiration date 30Aug2021), via an unspecified route of administration Administered in the Left arm on 28Jun2021 as single dose for COVID-19 immunization. The patient experienced expired since 15jul2021/3 doses were administered (medically significant) on 20Jul2021. Reporter stated that they received Covid-19 vials from a different office and realized that they were already expired since 15Jul2021, and 3 doses were administered today to patients. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924541 Same reporter/SD/AE, different patient;US-PFIZER INC-202100924476 Same reporter/SD/AE, different patient
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: 3 doses were administered; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other-HCP reported similar event for 3 patient. This is 1st of 3 reports. This Other-HCP reported for a 48-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0186 and expiry date: 30Aug2021) via an unspecified route of administration on 20Jul2021 as dose 1, 0.3 ml single on left arm for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. It was mentioned that no other products were received, patient had no history and no investigation assessment was done. The transferring agent stated that she has a HCP on the line that reported that they received Covid-19 vials from a different office and realized that they were already expired since 15Jul2021. On 20Jul2021 the patient was administered 3 doses (overdose). The event outcome was unknown.  The caller verified the information provided by the transferring agent.; Sender's Comments: As there is limited information in the case provided, the causal association between the event overdose and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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,Linked Report(s) : US-PFIZER INC-202100924476 Same reporter/SD/AE, different patient;US-PFIZER INC-202100924472 Same reporter/SD/AE, different patient