chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 48-year-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 07Aug2021 16:00 (at the age of 48-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included hepatitis c (Hep C). There were no known allergies reported. Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication from 04Aug2021 to an unspecified stop date (Aleve 3days before vaccine). 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 and since the vaccination, the patient has not been tested for COVID-19. On 08Aug2021 02:00, the patient experienced post menopausal bleeding. The patient did not receive treatment for the reported event. The clinical outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer. A contactable consumer reported for a 20-year-old female patient (reporter's daughter) received bnt162b2 (BNT162B2), 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. Reporter stated that, her received the vaccine. She was diagnosed with Bells Palsy on an unknown date. The reporter was Wondering what would be the likelihood that it was caused by the vaccine. She was 20 and due to this had numerous MRI and doctors' visits. The patient lab test included numerous MRI results was unknown. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: passed away from the Delta Variant; passed away from the Delta Variant; This is a spontaneous report from a contactable consumer (relative) from a Pfizer-sponsored program . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 and 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient daughter had just received an email from Pfizer stating that the patient should come in for a third dose to cover for the Delta Variant. The patient passed away from the Delta Variant on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away from the Delta Variant; passed away from the Delta Variant
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19 and general malaise and flu-like symptoms with fever; This is a spontaneous report from a contactable consumer(patient).  A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021, at 45-year-old, as single dose (Batch/Lot number was not reported) and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021, at 45-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he was tested positive for COVID-19 on an unspecified date in 2021. Symptoms included general malaise and flu-like symptoms with fever (102.7 F) on 10Aug2021. Patient felt better and was self-isolating at home. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program, reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both 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. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101094997 same reporter/SD/AE, different patient;US-PFIZER INC-202101094998 same reporter/SD/AE, different patient;US-PFIZER INC-202101094540 same reporter/SD/AE, different patient;US-PFIZER INC-202101094996 same reporter/SD/AE, different patient;US-PFIZER INC-202101094994 same reporter/SD/AE, different patient;US-PFIZER INC-202101094993 same reporter/SD/AE, different patient;US-PFIZER INC-202101094995 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the variant; no previous history of covid and was fully vaccinated being very sick due to the variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program, reporting same event under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both 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. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the variant, and was in the hospital. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095250 Same reporter/event/drug, different patient;US-PFIZER INC-202101094644 Same reporter/event/drug, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Penis disorder
Clinical narrative: contracted COVID after getting the shot; contracted COVID after getting the shot; Penis has got smaller, considerably smaller; This is a spontaneous report from a contactable consumer. This was the second case (second patient) out of the two cases.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: 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. On an unspecified date, the patient experienced that penis had got smaller, considerably smaller and reported stated that the patient did not seem to have any sort of protection from COVID, he had contracted it. The patient was suffering with symptoms. It was reported that patient contracted COVID after getting the shot. The outcome of events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Investigation, Pain in extremity
Clinical narrative: My arm feel a little sore on the right but I am alright for today; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: 72359-016-4), dose 1 via an unspecified route of administration, administered in Arm Right on 12Aug2021 at 10:00 (at the age of 53 year) as dose 1, single for COVID-19 immunisation at facility. The patient medical history and concomitant medications were not reported. Patient had no known allergies. 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. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 12Aug2021 at 10:00 AM, patient arm felt a little sore on the right but patient was alright for today. On 12Aug2021 at 12:00 PM, patient talked to the doctor then wait and did vitals and then went and got examine a deep in my soul patient had did that everything was fine and then patient took a shot when your while then patient have to do some more blood work and that would be. The patient underwent lab tests and procedures on 12Aug2021 which included covid-19: negative (Nasal Swab). It was reported that no therapeutic measures were taken for the events experienced. The outcome of event was recovered on an unknown date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoptysis, Organ failure, Renal failure
Clinical narrative: stated that her organs have completely failed; stated that she cannot breathe; stated that she is coughing up blood; Stated that her organs and kidneys have completely failed; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that her organs have completely failed, stated that she cannot breathe, and stated that she is coughing up blood, all on unspecified dates. Additional Context: Reporter wanted to know why her family member got the Covid vaccine shot, fully vaccinated and is in the hospital fighting for their life. Stated that her organs and kidneys have completely failed, that she cannot breathe and is coughing up blood. Wanted CEO phone number and email. Wanted to share her grievances with the company for pouring toxins in her family member's body. Stated that they are doing experimental treatment on people and they are not lab rats. Stated that Pfizer is killing people. Stated that her aunt was a Covid nurse and never once caught Covid and got the vaccine and is now fighting for her life. Stated that she is calling the Supreme Court. Stated that this is a crime against humanity. Stated that this is killing people and making them sick. The patient was hospitalized for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 antibody test
Clinical narrative: Woke up out of a dead sleep the next day with severe chest pains; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 33-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on Jul2021 (at the age of 33-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history of the patient included systemic inflammation, nervous system disorder and seizure disorder. The patient had no known allergies. The concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. The patient experienced woke up out of a dead sleep the next day with severe chest pains on an unspecified date in Aug2021. The patient reported unlike any chest pain she had experienced and she no stranger to panic attacks or tightness in chest. The event lead to physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date in Aug2021. Therapeutic measures were taken as a result of event that included took Xanax for 2 days with zero relief of persistent chest pains. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Photophobia
Clinical narrative: sun and light hurts his head; worst headache/migraine right above his eyes and back of head; worst headache/migraine right above his eyes and back of head; This is a spontaneous report from a contactable consumer, the patient. This 44-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0176, Expiry Date: 31Aug2021) via unspecified route in the right arm (right shoulder) on 08Jul2021 at 12:00-12:30PM (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included headaches, allergic to penicillin, and wife contracted COVID (ongoing). His parents have diabetes, but he doesn't. There were no vaccinations received within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient reported that he has been having the worst headache ever since he received his first shot. The headache began the second day after his first shot (10Jul2021). He clarifies they are like migraines, it's been the same headache for weeks. It's right above his eyes and the back of his head. He made an appointment with a neurologist in a few weeks. He has never experienced headaches like this before. He doesn't wear glasses, contacts, anything like that. His job is so tedious and dangerous, he has been put on almost like a 'work idol' basically to lessen his responsibility due to the headaches. It was scaring him. He clarifies he has experienced headaches before, but he has never experienced a headache at this magnitude before. The headache is continuous, it's all day today (12Aug2021). He wakes up with it and goes to sleep with it. It's lasted for weeks. The headaches are so bad he has to stay in the house all day, it's just like the sun and light hurts his head and makes it so much worse, he just stays in a room. He confirms the headaches have worsened. Now, it's more like a thumping headache. The events did not require a visit to the ER or physician's office. The patient stated he has been wanting to go, but the reason he couldn't is because after he took the first vaccine, his wife contracted COVID. She works in the healthcare field and had to take the vaccine, but ended up catching COVID after taking the vaccine. So, he (patient) had to quarantine for 2 weeks after that. The outcome of the events was not recovered.  The patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 12Aug2021 at 14:23 (Lot: EW0182, Expiry: Aug2021) in the left arm as a single dose for COVID-19 immunization.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MEN
Symptoms: Blood test, Deafness unilateral, Magnetic resonance imaging normal
Clinical narrative: deaf in one ear with 80% hearing loss; This is a spontaneous report from Pfizer-sponsored program. A contactable physician (patient's mother) reported that a 16-year-old female patient received meningococcal group b rlp2086 (manufacturer unknown) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced deaf in one ear with 80% hearing loss. The patient had a MRI with no lesions showing, blood work was pending, suspect the cause was idiopathic. The outcome of event was unknown.  Pfizer is a marketing authorization holder of meningococcal group b rlp2086 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, General physical health deterioration, Neoplasm progression
Clinical narrative: tumor grow to the size of a soft ball/ grow a tumor that size that fast (history of ongoing multiple myloma); She steadily declined every day after getting the shot and died May 3rd./ she could not get out of bed without help; This is a spontaneous report from a contactable consumer (patient's son). A non-pregnant 83-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose in her left arm, on 03Mar2021 10:00, at the age of 83-year-old of vaccination, for Covid-19 immunization. The patient had a history of ongoing multiple myloma. Concomitant medications included lenalidomide (REVLIMID), gabapentin, and acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had multiple myeloma and was informed in late February that her blood work numbers indicated her cancer had come out of remission. She received the Covid shot on 03Mar2021. Within 3 weeks she had a tumor grow to the size of a soft ball. She steadily declined every day after getting the shot and died 03May2021. Before the shot she was walking 2 mi per day by the end of March she could not get out of bed without help. The reporter considered that the events started on 04Mar2021. Unspecified chemotherapy was received for her condition. Her condition resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was the reporter's belief that no one grew a tumor that size that fast without help. The reporter believed that the combination of the timing of the cancer coming out of remission and getting the Covid shot was the cause of her fast decline.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: tumor grow to the size of a soft ball/ grow a tumor that size that fast; She steadily declined every day after getting the shot and died May 3rd./ she could not get out of bed without help
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Angiogram, Diplopia, Hallucination, Scan brain
Clinical narrative: Hallucinations; Double vision; This is spontaneous report from a contactable consumer (patient). An 85-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Feb2021 (at the age of 85 years) (Batch/Lot Number: EL9267) as a single dose for COVID-19 immunization. Medical history included high blood pressure, thyroid disorder, allergic to penicillin, and ongoing glasses wearer. Concomitant medications included losartan for hypertension; metoprolol for hypertension; and levothyroxine for thyroid disorder. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 (Batch/Lot Number: EL9263) for COVID-19 immunization. The patient also previously took epinephrine and experienced allergy. Since Mar2021, the patient had double vision which was already for 5 months at the time of report. When the patient first had it, had hallucinations and it was very weird that patient never tied it to the shot until started hearing that other people had double vision too. Patient saw how bad it was on 06Mar2021 as patient have not driven since 06Mar2021, everything was looking double, the cars were coming at patient instead of going straight. It took a while for patient to get an appointment with the ophthalmologist. Patient finally went and have been going every single month to see him and there was no change. Patient still had double vision. The patient thought that the adverse event has gotten worse. Patient told the doctor and he is going to send the patient to another doctor. Patient also went to a neurologist. They took a brain scan and had an angiogram, everything in patient's brain was ok. The doctor is going to send patient to another one that might prescribed prisms in glasses because patient did not want surgery. It is surgery or prism. Patient have not had any treatment. Outcome of the event hallucinations was recovered on an unspecified date in 2021 and of the event double vision was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Being Covid vaccinated, break to Covid and he is positive; Being Covid vaccinated, break to Covid and he is positive; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an intramuscular route of administration on 26May2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported by primary source- Being COVID vaccinated, break to COVID and he is positive on an unspecified date. Lab test included Sars-cov-2 test positive on an unspecified date. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Heart injury, Inappropriate schedule of product administration
Clinical narrative: Heart does not feel right, Heart feels 'strained'; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA7485), via an unspecified route of administration in left arm on 12Aug2021 13:15 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8729), via an unspecified route of administration in left arm on 09Apr2021 16:00 (at the age of 51-years-old) as dose 1, single for COVID-19 immunization. The patient was not having any known allergies. Prior to vaccination, the patient did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced heart does not feel right, heart feels 'strained' on 13Aug2021 01:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose1, single and second dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had both doses of the PFIZER-BIONTECH COVID-19 VACCINE and tested positive for Covid on 11Aug2021. Patient would like to know more about her antibodies given that she tested positive Covid and has been vaccinated. She would like to know if the booster dose becomes available. Also mentioned that at this time, a booster dose (an extra or third dose after receiving the two-dose series) is not recommended or authorized yet. Events considered as non-serious. Lab tests included that patient tested positive for Covid on 11Aug2021. Outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Pain, Pyrexia
Clinical narrative: He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; This is a spontaneous report from a -sponsored program Support. A contactable consumer reported similar events for himself and wife. This report is for reporter self. A contactable consumer reported a 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 10Apr2021 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 19Mar2021 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that patient and his wife received both doses of the Pfizer COVID 19 vaccine-1st dose 19Mar2021 and 2nd dose was 10Apr2021, not exactly sure of the schedule as he does not have his card with him. He is experiencing general body pain specifically on shoulder, feeling like he has a fever-headache, he has no energy at all, asking for recommendations on what to do with the symptoms and if they need to consult their doctor, his wife also experienced similar symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101047312 same reporter, events, diff pt
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral, Pain
Clinical narrative: he was admitted to the ER for neuropathy and pain radiating down his arms, legs and genitalia; he was admitted to the ER for neuropathy and pain radiating down his arms, legs and genitalia; his symptoms are getting worse; This is a spontaneous report from a contactable physician (parent) via medical information team. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 09Aug2021 as dose 2, single for Covid-19 immunization. The patients 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; Expiration date: unknown) via an unspecified route of administration at single dose for Covid-19 immunization. On 09Aug2021, patient was admitted to the emergency room for neuropathy and pain radiating down his arms, legs and genitalia. As per agent, his symptoms were getting worse. Adverse events resulted into emergency room visit. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Neuropathy and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthma, Near death experience
Clinical narrative: My friend's son is in the hospital with anaphylaxis; If for example my friend's son who is in the hospital now with  anaphylaxis, he may die; He got very, very high asthma and anaphylactic asthma; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: unknown), 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. It was reported that my friend's son is in the hospital with anaphylaxis; if for example my friend's son who is in the hospital now with anaphylaxis, he may die; he got very, very high asthma and anaphylactic asthma on an unspecified date. The patient was hospitalized on an unspecified date for the event anaphylaxis. Reporter stated, Okay, I am calling I mean, I myself, I am fine. I have taken the vaccine from Pfizer but my friend's son, he got very, very high asthma and anaphylactic asthma and he has severe issues . My child is over the age of 12-13 but she has severe anaphylaxis and severe asthma and is allergic to like so many things, certain things that are in vaccine (further not clarified). So, the problem is if we give it to her she can have a bad reaction and she can die from anaphylactic shock (further not clarified). So, I need to know from you, are you still thinking it's okay because from the data it's showing anaphylactic issues and my friend's son is in the hospital with anaphylaxis. I also want to tell you I spoke to you guys about five months ago on the same issue and you guys advised, not to take it. So, I need to ask again here, because that will be her. Reporter stated, I wanted to ask you a question. If for example my friend's son who is in the hospital now with anaphylaxis, he may die (further not clarified). Product details (LOT, NDC, UPC and Expiry date) cannot be probed. Reporter reported about friend's son who is in hospital going through asthma and anaphylaxis, was referring to vaccine. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Swelling
Clinical narrative: She developed a swollen with presence of nod on her right shoulder blade; She developed a swollen with presence of nod on her right shoulder blade; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age 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 04Aug2021 as single for COVID-19 immunization. No medical history and concomitant medications were reported. Two days after being vaccinated on 06Aug2021, the patient developed a swollen with presence of nod on her right shoulder blade. On 09Aug2021, patient went to her doctor and he prescribed her with Doxycycline 100 mg x 10 days. The patient who was scheduled to take her 2nd dose on 25Aug2021 wanted to know if it was okay that she was taking Doxycycline 100 mg and wanted to know if it was okay for her to take the blood thinners concomitantly with the Pfizer-BioNTech Covid-19 Vaccine. The reporter considered the events as non-serious. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Muscle twitching, Seizure
Clinical narrative: Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; This is a spontaneous report from a contactable Nurse (patient).   A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number FC3181), via an unspecified route of administration in Arm Right on 08Aug2021 at 16:00 (at 41 years) as single dose for covid-19 immunisation. Medical history included Epilepsy, Hashimoto,lupus, Inflammatory bowel disease (IBD) , autoimmune liver hepatitis and seizure (seizure norm was one or two a month). No Covid prior vaccination, nor Covid tested post vaccination. The patient had known allergies to Penicillin (Pcn), duloxetine hydrochloride (CYMBALTA), pseudoephedrine and azithromycin (ZITHROMAX Z-PACK).Concomitant medications included levetiracetam (KEPPRA), hydroxychloroquine (HYDROXYCHLOROQUIN), levothyroxine, vitamin D all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Patient felt fine on day 1 (08Aug2021); on the 2nd day (09Aug2021) she started having seizures off and on for 1 week and for 2 days after initial dose, constant twitch of lower right lip. Patient still having off and on numbness in right arm since 09Aug2021. Seizures seem to be slowing. Her seizure norm was one or two a month. After vaccine it was multiple seizure in one day. Headache started on 09Aug2021 barely relieved by TYLENOL.No treatment given for the other events. Events resulted all in Doctor or other healthcare professional office/clinic visit. The final outcome of all the events was reported as  recovering.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Seizures  . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site discomfort, Vaccination site erythema
Clinical narrative: swollen arm and injection site is red and feels like a knife under the skin; swollen arm and injection site is red and feels like a knife under the skin; swollen arm and injection site is red and feels like a knife under the skin; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (BNT162B2, 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 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced swollen arm and injection site is red and feels like a knife under the skin after receiving 1st dose of Pfizer covid 19 vaccine yesterday. The outcome for the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints; severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints; severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints; This is a spontaneous report from a contactable consumer. This 81-year-old male consumer reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunization. The medical history of the patient included ongoing mild arthritis. Concomitant medications included acetaminophen, ibuprofen and celecoxib (Celebrex) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunization and had no side effects. On an unknown date in 2021, a month after vaccination the patient experienced extremely severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints- Worst pain was on his back that he cacouldn hardly move. It was being relieved by putting ice packs 20-25 minutes application- He received acetaminophen 2x a day 2 tabs - Ibuprofen 200mg 2x a day (little relief but not a lot). He was referred to an orthopedic doctor-Prescribed him with Celebrex 200mg but it does relieve the pain. He was also advised to have knee replacement. He asked if the COVID 19 vaccine has caused these symptoms. He had seen that 3rd dose was now available and he did not want to get it. The event outcome was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EY0584; Expiration Date: 31Oct2021) via an unspecified route of administration on 23Jul2021 (at the age of 52-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No prior vaccination to Covid Vaccination before 4 weeks. On an unspecified date, the patient experienced covid positive after getting first dose covid vaccine. Pharmacist reported that patient was asking how to go for the second dose, and how to guide the patient about receiving the second dose of Pfizer BioNTech Covid-19 Vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test resulted with positive. Patient received treatment for events with antibody infusion on 03Aug2021. The outcome of events was unknown. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 (at the age of 39-year-old) as Dose 2,Single for COVID-19 immunization. The patient's 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 number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. 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 been tested for COVID-19. The patient experienced covid 4 months later on 13Aug2021. No therapeutic measure was taken. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 13Aug2021. The outcome of events was not recovered. Information on the Lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: fever; cough; stuffy nose; fatigue; loss of taste; loss of smell; 6Aug2021, he tested positive for COVID-19; This is a spontaneous report from an other-HCP via Pfizer-sponsored program.  A 14-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 28Jul2021 at dose 1 single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 6Aug2021, the patient tested positive for COVID-19.  His taste and smell were returning to normal.  He experienced a fever, cough, stuffy nose, fatigue, and loss of taste and smell on an unknown date.  By Tuesday, after he was diagnosed, he was 100%.  He experienced a very mild case. The patient's other was asking that he can receive his second dose on 18Aug2021. The patient lab test and procedure included COVID-19 with positive results on 06Aug2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: fever; cough; stuffy nose; fatigue; loss of taste; loss of smell; 6Aug2021, he tested positive for COVID-19; This is a spontaneous report from an other-HCP via Pfizer-sponsored program.  A 14-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 28Jul2021 at dose 1 single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 6Aug2021, the patient tested positive for COVID-19.  His taste and smell were returning to normal.  He experienced a fever, cough, stuffy nose, fatigue, and loss of taste and smell on an unknown date.  By Tuesday, after he was diagnosed, he was 100%.  He experienced a very mild case. The patient's other was asking that he can receive his second dose on 18Aug2021. The patient lab test and procedure included COVID-19 with positive results on 06Aug2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: temperature is 98.8 F today and usually it is always 97.3 F; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received first dose and second dose of BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was Unknown) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient reported that his temperature was 98.8 F today and usually it is always 97.3 F. The patient wanted to know if what he was experiencing was a breakthrough infection or unusual side effects after getting two doses of the Pfizer-BioNTech covid-19 vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report from a contactable physician (pediatrician).  A 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported ) via an unspecified route of administration on 18May2021 (at 14 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The pediatrician reported that the patient had a mild case of myocarditis on an unspecified date in 2021, was not hospitalized for it; event lasted 2 days and patient recovered fine from it on an unknown date in 2021.  Patient mother was concerned about him getting second dose, but wanted him to for school.  Physician wanted to know if there were additional recommendations for getting the second dose.  In addition to myocarditis, patient was also greater than 42 days past the date of the first dose. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and myocarditis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: U
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: This is a spontaneous report from a contactable other health professional via medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given a 0.3ml of pfizer vaccine without it being diluted on an unspecified date. The reporter wanted to know how this effects patient's vaccination status and if a second dose needs to be given.  Information on lot/batch number had been requested.