chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: 2 days of flu-like symptoms post 2nd dose; This is a spontaneous report from a contactable Consumer (husband) reported for himself.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (1st Dose) for COVID-19 immunisation. It was reported that the patient's spouse queried that had have there been Covid-19 Vaccine studies looking specifically on Epstein-Barr Virus and Herpes II virus, and any related reactions, positive, perhaps lessened viral load, or no reaction. Reporter stated his wife, 66, has had post vaccination flare-ups, and wondering if there are studies to find and share info. On an unspecified date, the reporter also stated they both had 2 days of flu-like symptoms post 2nd dose of COVID-19 vaccination that cleared, and we are grateful and thankful for your work. The clinical outcome of the event was resolved.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: had both doses of the covid vaccine, has not had her period since receiving the covid vaccine; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP1533), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 11:30 (at the age of 44-year-old) as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:30 (Batch/Lot Number: EW0101) (at the age of 44-year-old) as dose 2, single for covid-19 immunization. Medical history included ongoing diabetes mellitus from 2017, and liver transplant from 2019, patient took mediations to suppress her immune system. She had a low immune system. Patient had a family history of diabetes, both her parents had diabetes. Patient was on several medications for her liver transplant. Patient did not take any other vaccines within four weeks, prior to covid-19 immunization. On an unknown date in 2021, it was reported that, caller has already had both doses of the covid vaccine, has not had her period since receiving the covid vaccine, and caller wants to know if that was a normal thing. Her last period was 16Mar2021. The events did not result in Emergency Room/Physician Office visit. Relevant Tests reported as none. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Ophthalmic migraine, Vision blurred
Clinical narrative: Ocular migrane; Blurred vision; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 (at the age of 46-years-old) (Batch/Lot Number: EW0191) as single dose for COVID-19 immunisation. Medical history included thyroid cancer, asthma, degenerative joints. Concomitant medication(s) included levothyroxine; meloxicam; etanercept (ENBREL), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient previously took PERCOCET [oxycodone hydrochloride;paracetamol] and experienced allergy. The patient had no covid prior vaccination. On 04Jun2021, the patient experienced ocular migraine, blurred vision followed by dizziness and headache. The patient did not receive any treatment for the events. The patient had no tested covid post vaccination. Outcome of the events was not recovered.  Follow-up activities closed no further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: feeling achy; His joints are a little sore; feeling tired.; This is a spontaneous report from a Pfizer sponsored program. A non-contactable Male consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Jun2021 as dose 2, single dose for covid-19 immunization.The patient medical history and concomitant medications were not reported.  It was reported that he called in because he got the 2nd dose of the vaccine the previous day on 11Jun2021.On an unspecified date, patient said he was feeling achy. His joints were a little sore and he was feeling tired. He wanted to know if it was safe for him to take Tylenol. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: Stung by a bee which is disappeared within the hour and I have been in Poison Ivy and it's not spreading normally; This is a spontaneous report from a contactable consumer (Patient) from a medical team.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), 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. It was reported that patient was already been vaccinated with Pfizer COVID-19 vaccine. The patient had been stung by a bee which got disappeared within an hour. On an unspecified date, the patient had been in Poison Ivy and it was not spreading normally. It got spread throughout the body in a heartbeat. Patient took prednisone to get rid of it. The clinical outcome for the event was reported as unknown.   Information about lot/batch number is requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Claustrophobia, Condition aggravated, Nightmare
Clinical narrative: Claustrophobia got much worse resulting in nightmares and inability to ride in elevators prior to vaccination
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test positive, Anxiety, Blood pressure increased, Cognitive disorder, Communication disorder
Clinical narrative: Increased heartbeat, heart palpitations, significant increase in blood pressure at 150/90, for a healthy young 23 year old who would usually receive a blood pressure test of 120/70 during normal circumstances. Inability to sleep or stay asleep since the vaccination, every time I attempt to fall asleep, heart rate increases, convulsion occurs followed loss of feeling in extremities. Cognitive decline, inability to remember certain events, and communication skills have greatly diminished.  Reduced Appetite. Neurological Symptoms (Numbness throughout body, Entire body is numb). Anxiety Attacks.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Electrocardiogram abnormal, Heart rate increased, Hypoaesthesia, Insomnia
Clinical narrative: Increased heartbeat, heart palpitations, significant increase in blood pressure at 150/90, for a healthy young 23 year old who would usually receive a blood pressure test of 120/70 during normal circumstances. Inability to sleep or stay asleep since the vaccination, every time I attempt to fall asleep, heart rate increases, convulsion occurs followed loss of feeling in extremities. Cognitive decline, inability to remember certain events, and communication skills have greatly diminished.  Reduced Appetite. Neurological Symptoms (Numbness throughout body, Entire body is numb). Anxiety Attacks.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Myocarditis, Neurological symptom, Palpitations, Seizure
Clinical narrative: Increased heartbeat, heart palpitations, significant increase in blood pressure at 150/90, for a healthy young 23 year old who would usually receive a blood pressure test of 120/70 during normal circumstances. Inability to sleep or stay asleep since the vaccination, every time I attempt to fall asleep, heart rate increases, convulsion occurs followed loss of feeling in extremities. Cognitive decline, inability to remember certain events, and communication skills have greatly diminished.  Reduced Appetite. Neurological Symptoms (Numbness throughout body, Entire body is numb). Anxiety Attacks.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: Increased heartbeat, heart palpitations, significant increase in blood pressure at 150/90, for a healthy young 23 year old who would usually receive a blood pressure test of 120/70 during normal circumstances. Inability to sleep or stay asleep since the vaccination, every time I attempt to fall asleep, heart rate increases, convulsion occurs followed loss of feeling in extremities. Cognitive decline, inability to remember certain events, and communication skills have greatly diminished.  Reduced Appetite. Neurological Symptoms (Numbness throughout body, Entire body is numb). Anxiety Attacks.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Product dose omission issue
Clinical narrative: missed the second dose; dizziness; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) (age at the time of vaccination: 65-years-old), via unspecified route of administration on 26May2021 as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the first dose on 26May2021 and the second dose was due today at 11:30 but he experienced dizziness and missed it on an unspecified date. He wanted recommendations on what to do about it. He clarified the medication as Pfizer Covid 19. Patient stated that he experienced condition of dizziness. He wanted to know where to get to the dose that he missed today.   Information regarding the batch/lot number has been requested.  Follow-up (01Jul2021): This follow-up is being submitted to notify that 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: I was late getting my second shot; I was late getting my second shot; I got second shot yesterday and my left side of my face feels a little bit numb; This is a spontaneous report from a contactable consumer (patient, self-reported). A 40-Years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: SA6780 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date (age at vaccination: 40 years), as a single dose for COVID-19 immunization. The patient's medical history included eczema. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, on 05Mar2021 (age at vaccination: 40 years), as a single dose for COVID-19 immunization and had throat got swollen, tightness, my lips became tingly, nausea, tired, and not feeling well/feeling ill. The patient reported that she got second shot yesterday and on 22Jun2021, her left side of her face feels a little bit numb almost like the Novocaine at the dentist was wearing off. It feels a little bit part of left part of her cheek. She stated it is little bit, it's very mild. She was late getting her second shot and that was okay right? Because they said even if you were late you could get the 2nd shot. Lab test included tested for Covid antibody antigen, she doesn't have the reports back. That was last week. Treatment received for event with motrin 600 mg, benadryl 50 mg on 22Jun2021 at 12:45 pm, motrin 200mg on 22Jun2021 at 10pm, benadryl 25mg on 22Jun2021 at 11pm. Outcome of the event I got second shot yesterday and my left side of my face feels a little bit numb was not recovered and for all other event, it was unknown.  Follow-up attempts are needed. Further Information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Breast swelling, Epistaxis, Feeling abnormal, Mouth ulceration
Clinical narrative: Pemphigus; Nose bleeds; Globus sensation; Swelling left breast; Blood blisters in my mouth; Mouth ulcers; Skin ulcers; This is a spontaneous report from a contactable physician (Patient himself). A 56-year-old male patient received bnt162b2 (Manufacturer: Pfizer, Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 08Jan2021 09:00 (Batch/Lot Number: Ek9231) as dose 2, single for covid-19 immunisation in the hospital. Medical history included reflux from an unknown date and known allergies were none. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Manufacturer: Pfizer Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 20Dec2020 10:45 (Batch/Lot Number: Ek5730) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not since vaccination. The patient reported that he started with some nose bleeds which he assumed was dry winter then developed shotgun 2to 3 weeks globus sensation. Then developed swelling left breast then started with blood blisters in his mouth. Then mouth ulcers. Then started with skin ulcers. All this was due to pemphigus on 15Jan2021. The patient underwent lab test which included biopsy proven with IF on 04Jun2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the event pemphigus and the suspect vaccine BNT162B2 cannot be excluded. 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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Oral blood blister, Pemphigus, Skin ulcer
Clinical narrative: Pemphigus; Nose bleeds; Globus sensation; Swelling left breast; Blood blisters in my mouth; Mouth ulcers; Skin ulcers; This is a spontaneous report from a contactable physician (Patient himself). A 56-year-old male patient received bnt162b2 (Manufacturer: Pfizer, Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 08Jan2021 09:00 (Batch/Lot Number: Ek9231) as dose 2, single for covid-19 immunisation in the hospital. Medical history included reflux from an unknown date and known allergies were none. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Manufacturer: Pfizer Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 20Dec2020 10:45 (Batch/Lot Number: Ek5730) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not since vaccination. The patient reported that he started with some nose bleeds which he assumed was dry winter then developed shotgun 2to 3 weeks globus sensation. Then developed swelling left breast then started with blood blisters in his mouth. Then mouth ulcers. Then started with skin ulcers. All this was due to pemphigus on 15Jan2021. The patient underwent lab test which included biopsy proven with IF on 04Jun2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the event pemphigus and the suspect vaccine BNT162B2 cannot be excluded. 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.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Myocarditis, Pain
Clinical narrative: I just worried about if I have like that the a Myocarditis; I have like the pain on the left side of my chest pain and all the way penetrates to the back; I got the sore pain after like the 2 days gone; I have like the pain on the left side of my chest pain and all the way penetrates to the back; I have like the pain on the left side of my chest pain and all the way penetrates to the back; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiry date: unknown) dose 1 via an unspecified route of administration on 08Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, "I just had the first shot of Pfizer on 08Jun2021 and 3 or 4 days after and I had chest pain on the left side and all the way penetrates to the back. So it's like a pressure pain and but up to now I still had the pain but not as much like 2 or 3 days before. I just worried about Myocarditis. I just want to make sure, that my heart is ok on an unspecified date in Jun2021." The outcome of events i have like the pain on the left side of my chest pain and all the way penetrates to the back is not recovered and for the other events it was unknown.  Information about lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes ophthalmic, Herpes zoster
Clinical narrative: she contracted eye herpes; shingles; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 14-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administered in left arm on an unspecified date (Batch/Lot number was not reported) on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and Raynaud's phenomenon. The family history included autoimmune disorder (autoimmune runs in our family). The concomitant medication included methylphenidate (DAYTRANA) patch, paroxetine and methylphenidate hydrochloride (RITALIN); all were received started on unspecified date and indication. On an unspecified date, she contracted eye herpes, treated it like it was pink eye and then it got worse and shingles. The reporter stated, "they thought it was a bacterial pink eye and we went to instant care and it didn't get any better and so we went to ophthalmologist who diagnosed her with herpes eye and that is like shingles, it is like chickenpox shingles within same family". So, they said, it was herpes eye and I read on the internet that there are mostly women who get this but there were couple of cases of women who have autoimmune that get shingles or herpes or some adverse effect like my daughter got that and ran in to the eye. Reporter further stated, "because I am concerned because that is what happened to my daughter. I don't know if I should get the shingle shots, I mean she is 14, you wouldn't take the shingles shot but now it is too late, she already has it, so that is why I am little bit concerned. But I just wanted to report this because children may not be formally diagnosed with autoimmune. I know she had some symptoms, I don't know if it is related, I don't, I have no idea but it is just weird that she got the herpes eye. Therapeutic measures were taken as a result of the event with vala like clover 500 mg for herpes for 2 months. The outcome of the events was reported as not recovered.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0217; Expiration Date: Sep2021), dose 1 via an unspecified route of administration on 21Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced had an allergic reaction on 21Jun2021. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: my period began 16 days early/4 days after the Covid 19 vaccination my period began 16 days early; bled for 21 days total. (My regular periods are 5 days long); This is a spontaneous report form a contactable consumer (patient). A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in arm left on 11Apr2021 18:45 (at the age of 44-years-old) (Batch/Lot number: ER7533, Expiration Date: was not reported) as DOSE 1 single for covid-19 immunisation. The patient's medical history was reported as none. concomitant medication included the contraceptive pill. Patient reported 4 days after the Covid 19 vaccination her period began 16 days early on 15Apr2021 07:30 at. As she on the pill her menstruation is regulated. She was 5 days into a new pill pack when the bleeding began (which means she last period had only finished 5 days previously) and she bled for 21 days total. (Her regular periods are 5 days long) on an unspecified date in 2021. This is highly unusual, she has been on the pill for most of my adult life and have never had a breakthrough bleed during the month. She has never experienced an extended bleed. Patient had not received any treatment. Patient had no allergies. Vaccination facility type was reported as School or Student Health Clinic. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received contraceptive pill within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, he was not tested for COVID-19. The seriousness of the events was reported as non-serious. The outcome of the event my period began 16 days early/4 days after the Covid 19 vaccination my period began 16 days early was resolved on an unspecified date in Apr2021 and other event was reported as unknown.   No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Had a fever for one day with the vaccine/ the both. My brother was sick with the fever for a day that all I know. Mild low fever for a day; My brother was sick with the fever for a day that all I know; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother) of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter who reported for brother (patient), stated, "I believe my brother, he also did a Pfizer and he had a fever for one day with the vaccine, on the second vaccine, the both. My brother was sick with the fever for a day that all I know. Mild low fever for a day but I don't know. They didn't tell me so, I don't know." The patient underwent lab tests and procedures which included body temperature which showed mild low on an unspecified date. The outcome of the events was recovered on an unspecified date in 2021.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 18Jun2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 19Jun2021, 1 day after the administration of second dose of vaccine, the patient experienced chills. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lipids increased
Clinical narrative: This is a spontaneous report from a non-contactable Other Health Care Professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; 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. It was reported that reporter wanted to know about Pfizer COVID-19 vaccine and Infertility. Reporter said they have an article and report number (#). Reporter stated the lipid concentration in the ovaries are 12.3 after 48 hours of administering the Pfizer covid vaccine in patient, reporter wanted to know why its high. Reporter said his colleagues were fired from the job for asking this questions. Reporter wants to remain anonymous for safety reasons and does not want to provide any details or contact number also. Reporter stated he does not feel safe administering this vaccine. Reporter stated there is no patient involved ( when asked for clarification). The patient underwent lab tests and procedures which included lipids increased: 12.3 on a unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event of lipids increased and the suspect vaccine BNT162B2 cannot be excluded. 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Fatigue, Feeling abnormal
Clinical narrative: Lacy rash; Mild sunburn appearance; Numbness/At 5+ weeks I still experience a kind of numbness; Tingling/tingling in my arms, legs, lips and face; Unable to sleep for 3 days straight; Fatigued; Brain fog; Joint pain; Pain at injection site; Positive ANA after history of negative; This is a spontaneous report from a contactable consumer or other non-health care professional. A 57-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0173), dose 1 intramuscular, administered in Arm Left on 14May2021 09:00 as 1st dose, single for covid-19 immunisation. Medical history included known allergies to Penicillin, casein, nickel, thimerosal and PABA, Immune thrombocytopenia (ITP) and antinuclear antibody negative. Concomitant medications included ergocalciferol (VIT D), Glutathione and MVM. It was reported that patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks. On 17May2021 at 08:00, the patient experienced lacy rash which started 3 days after vaccine, numbness all over body positive ANA which is rising pain at injection site and joint pain. It was reported that patient underwent lab tests and procedures which included antinuclear antibody Positive ANA after history of negative ANA. 2 weeks post vaccination ANA was 1:640 and 5 weeks post vaccination ANA was 1:1280. Both showed the dense fine speckled pattern. ANA was tested because she developed a pronounced lacy rash all over 3 days post vaccination which disappeared after a day or two. That was followed by having a mild sunburn appearance all over with significant numbness and tingling, she was unable to sleep for 3 days straight, was fatigued, and had brain fog. At 5+ weeks she still experienced a kind of numbness and tingling in her arms, legs, lips and face, have fatigue and some brain fog. Also, patient tested positive for sars-cov-2 test on 17Jun2021. On an unknown date, patient was recovered from lacy rash and was not recovered from all other events.  Follow attempts are needed. Additional information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Rash, SARS-CoV-2 test, Sleep disorder
Clinical narrative: Lacy rash; Mild sunburn appearance; Numbness/At 5+ weeks I still experience a kind of numbness; Tingling/tingling in my arms, legs, lips and face; Unable to sleep for 3 days straight; Fatigued; Brain fog; Joint pain; Pain at injection site; Positive ANA after history of negative; This is a spontaneous report from a contactable consumer or other non-health care professional. A 57-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0173), dose 1 intramuscular, administered in Arm Left on 14May2021 09:00 as 1st dose, single for covid-19 immunisation. Medical history included known allergies to Penicillin, casein, nickel, thimerosal and PABA, Immune thrombocytopenia (ITP) and antinuclear antibody negative. Concomitant medications included ergocalciferol (VIT D), Glutathione and MVM. It was reported that patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks. On 17May2021 at 08:00, the patient experienced lacy rash which started 3 days after vaccine, numbness all over body positive ANA which is rising pain at injection site and joint pain. It was reported that patient underwent lab tests and procedures which included antinuclear antibody Positive ANA after history of negative ANA. 2 weeks post vaccination ANA was 1:640 and 5 weeks post vaccination ANA was 1:1280. Both showed the dense fine speckled pattern. ANA was tested because she developed a pronounced lacy rash all over 3 days post vaccination which disappeared after a day or two. That was followed by having a mild sunburn appearance all over with significant numbness and tingling, she was unable to sleep for 3 days straight, was fatigued, and had brain fog. At 5+ weeks she still experienced a kind of numbness and tingling in her arms, legs, lips and face, have fatigue and some brain fog. Also, patient tested positive for sars-cov-2 test on 17Jun2021. On an unknown date, patient was recovered from lacy rash and was not recovered from all other events.  Follow attempts are needed. Additional information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sunburn, Vaccination site pain
Clinical narrative: Lacy rash; Mild sunburn appearance; Numbness/At 5+ weeks I still experience a kind of numbness; Tingling/tingling in my arms, legs, lips and face; Unable to sleep for 3 days straight; Fatigued; Brain fog; Joint pain; Pain at injection site; Positive ANA after history of negative; This is a spontaneous report from a contactable consumer or other non-health care professional. A 57-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0173), dose 1 intramuscular, administered in Arm Left on 14May2021 09:00 as 1st dose, single for covid-19 immunisation. Medical history included known allergies to Penicillin, casein, nickel, thimerosal and PABA, Immune thrombocytopenia (ITP) and antinuclear antibody negative. Concomitant medications included ergocalciferol (VIT D), Glutathione and MVM. It was reported that patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks. On 17May2021 at 08:00, the patient experienced lacy rash which started 3 days after vaccine, numbness all over body positive ANA which is rising pain at injection site and joint pain. It was reported that patient underwent lab tests and procedures which included antinuclear antibody Positive ANA after history of negative ANA. 2 weeks post vaccination ANA was 1:640 and 5 weeks post vaccination ANA was 1:1280. Both showed the dense fine speckled pattern. ANA was tested because she developed a pronounced lacy rash all over 3 days post vaccination which disappeared after a day or two. That was followed by having a mild sunburn appearance all over with significant numbness and tingling, she was unable to sleep for 3 days straight, was fatigued, and had brain fog. At 5+ weeks she still experienced a kind of numbness and tingling in her arms, legs, lips and face, have fatigue and some brain fog. Also, patient tested positive for sars-cov-2 test on 17Jun2021. On an unknown date, patient was recovered from lacy rash and was not recovered from all other events.  Follow attempts are needed. Additional information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Blood blister, Drainage, Fatigue
Clinical narrative: body/joint pain.; Roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch.; a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch; Blisters continued to get bigger, filled with blood,; Blisters continued to get bigger, filled with blood, and began to itch.; Some sites began to drain.; experienced fever; experienced fever, fatigue, and body/joint pain.; experienced fever, fatigue, and body/joint pain.; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0181), second dose via an unspecified route of administration on left arm on 18Jun2021, 16:00 at single dose for covid-19 immunisation. Patient medical history included allergies to Penicillin, Reglan, Iodine, Sulfa, Gastroparesis, PCOS, Insulin resistance. Concomitant medications included medroxyprogesterone acetate (DEPO-PROVERA) on 03Jun2021 on Left arm, levothyroxine sodium (TIROSINT) 150mcg, topiramate (TOPAMAX) 100mg, Metformin 500mg. She received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0173) via an unspecified route of administration on left arm on 26May2021, 16:00 at single dose for covid-19 immunisation. She was not pregnant at time of vaccination. Prior to vaccination patient was diagnosed with Covid 19. Since the vaccination patient was not tested for Covid 19. Patient reported roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch. Some sites began to drain. Also experienced fever, fatigue, and body/joint pain on 19Jun2021. Treatment received for the adverse event was prescribed Pepcid, Allegra & hydrocortisone cream. Averse events resulted in Emergency room/department or urgent care. The outcome of Events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Vaccination site bruising
Clinical narrative: body/joint pain.; Roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch.; a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch; Blisters continued to get bigger, filled with blood,; Blisters continued to get bigger, filled with blood, and began to itch.; Some sites began to drain.; experienced fever; experienced fever, fatigue, and body/joint pain.; experienced fever, fatigue, and body/joint pain.; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0181), second dose via an unspecified route of administration on left arm on 18Jun2021, 16:00 at single dose for covid-19 immunisation. Patient medical history included allergies to Penicillin, Reglan, Iodine, Sulfa, Gastroparesis, PCOS, Insulin resistance. Concomitant medications included medroxyprogesterone acetate (DEPO-PROVERA) on 03Jun2021 on Left arm, levothyroxine sodium (TIROSINT) 150mcg, topiramate (TOPAMAX) 100mg, Metformin 500mg. She received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0173) via an unspecified route of administration on left arm on 26May2021, 16:00 at single dose for covid-19 immunisation. She was not pregnant at time of vaccination. Prior to vaccination patient was diagnosed with Covid 19. Since the vaccination patient was not tested for Covid 19. Patient reported roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch. Some sites began to drain. Also experienced fever, fatigue, and body/joint pain on 19Jun2021. Treatment received for the adverse event was prescribed Pepcid, Allegra & hydrocortisone cream. Averse events resulted in Emergency room/department or urgent care. The outcome of Events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Heavy menstrual bleeding
Clinical narrative: A week later, I also experienced some minor bleeding for about 6 hours; On the same day as my second dose of the Pfizer Covid-19 vaccine (12Jun2021), I experienced very, very heavy menstrual bleeding. The amount was similar to what is typical a few days after giving birth; This is a spontaneous report from a contactable consumer (reporting on herself). A 32-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 12Jun2021 09:45 (age at 32 years) as dose 1, single for COVID-19 immunization. The patients medical history include 7 weeks postpartum with second child at time of vaccine. No known allergies. No covid prior vaccination and the patient not tested for COVID-19. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 22May2021 10:30 as dose 1, single for COVID-19 immunization. There was no other vaccine in four weeks, no other medications in two weeks. It was reported that on 12Jun2021, on the same day as my second dose of the Pfizer Covid-19 vaccine, patient experience very, very heavy menstrual bleeding. The amount was similar to what is typical a few days after giving birth. The bleeding lasted for a day and a half. A week later, I also experienced some minor bleeding for about 6 hours. On 12Jun2021, I was about 7 weeks postpartum. The outcome of event some minor bleeding for about 6 hours was recovered and the outcome of events very heavy menstrual bleeding and vaginal haemorrhage was unknown.  Information on the batch/lot number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Colonoscopy, Henoch-Schonlein purpura, Rash macular
Clinical narrative: First dose: Henoch-Schonlein Purpura; First dose: red blotches under his skin/blotches on his legs; on legs it looked like vasculitis/vasculitis on his bowel; First dose: severe stomach pain; This is a spontaneous report from a contactable consumer (father of the patient). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0176) via an unspecified route of administration, administered in left arm on 30Apr2021 as dose 1, single (age at vaccination: 16 years) for COVID-19 immunization. Medical history included ongoing crohn's disease. As far as family medical history, it was reported as none and father stated that his son is the only one in the family with Crohn's disease. Concomitant medication included ongoing infliximab (REMICADE) taken for crohn's disease and somatropin (NUTROPIN) taken as growth hormone, both started on unknown dates. The father stated that, after receiving the first dose of COVID vaccine, his son started developing symptoms Henoch-Schonlein Purpura (HSP) which consists of the inflammation of small blood vessels. The symptoms began on or around 07May2021. On his son's legs it looked like a vasculitis. His son had these red blotches under his skin. It did not hurt and he also got vasculitis on his bowel. The symptoms first showed up as blotches on his legs and severe stomach pain. The pain is what alerted him. He was seen at the doctor on 04Jun2021, with a colonoscopy on 09Jun2021. He had a colonoscopy to diagnose the vasculitis on his bowel. It was stated that, the patient also had blood work that showed no abnormalities and a urine sample that did show blood which also indicates HSP. His son was being treated with steroids (treated right now with Prednisone 20mg daily). HSP is a chronic condition and his son has been dealing with it for the last month. The symptoms subsided and the doctor gave the ok to receive the second Covid 19 vaccine. Father reported that his son never had a positive Covid 19 virus test, the PCR test or the Rapid test. Also the patient did not receive any other vaccinations within four weeks prior to the first administration date. About one week after the second Covid 19 vaccine the symptoms flared up again. Now he still had symptoms. He did have photographs of his son's legs he could share. He really did believe the HSP came from the Covid 19 vaccine, but that could be one in a million. The outcome of the events: First dose: Henoch-Schonlein Purpura and red blotches under his skin/blotches on his legs was not recovered and the outcome was unknown for rest of the events.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis, Vasculitis
Clinical narrative: First dose: Henoch-Schonlein Purpura; First dose: red blotches under his skin/blotches on his legs; on legs it looked like vasculitis/vasculitis on his bowel; First dose: severe stomach pain; This is a spontaneous report from a contactable consumer (father of the patient). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0176) via an unspecified route of administration, administered in left arm on 30Apr2021 as dose 1, single (age at vaccination: 16 years) for COVID-19 immunization. Medical history included ongoing crohn's disease. As far as family medical history, it was reported as none and father stated that his son is the only one in the family with Crohn's disease. Concomitant medication included ongoing infliximab (REMICADE) taken for crohn's disease and somatropin (NUTROPIN) taken as growth hormone, both started on unknown dates. The father stated that, after receiving the first dose of COVID vaccine, his son started developing symptoms Henoch-Schonlein Purpura (HSP) which consists of the inflammation of small blood vessels. The symptoms began on or around 07May2021. On his son's legs it looked like a vasculitis. His son had these red blotches under his skin. It did not hurt and he also got vasculitis on his bowel. The symptoms first showed up as blotches on his legs and severe stomach pain. The pain is what alerted him. He was seen at the doctor on 04Jun2021, with a colonoscopy on 09Jun2021. He had a colonoscopy to diagnose the vasculitis on his bowel. It was stated that, the patient also had blood work that showed no abnormalities and a urine sample that did show blood which also indicates HSP. His son was being treated with steroids (treated right now with Prednisone 20mg daily). HSP is a chronic condition and his son has been dealing with it for the last month. The symptoms subsided and the doctor gave the ok to receive the second Covid 19 vaccine. Father reported that his son never had a positive Covid 19 virus test, the PCR test or the Rapid test. Also the patient did not receive any other vaccinations within four weeks prior to the first administration date. About one week after the second Covid 19 vaccine the symptoms flared up again. Now he still had symptoms. He did have photographs of his son's legs he could share. He really did believe the HSP came from the Covid 19 vaccine, but that could be one in a million. The outcome of the events: First dose: Henoch-Schonlein Purpura and red blotches under his skin/blotches on his legs was not recovered and the outcome was unknown for rest of the events.  Follow-up attempts are completed. No further information is expected.