chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Condition aggravated, Culture urine
Clinical narrative: flu like symptoms; They kind of progressed.; She took his temperature, because he felt hot.  It was over 100 degrees Fahrenheit.  It may have been 106.7 degrees Fahrenheit or 101 degrees Fahrenheit.  She does not remember exactly.; Sweating and fever; Tired; Chills; Body Aches; Passed out and dropped to the floor; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 15:00(age at vaccination:47-Year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient didn't received other medications. Medical history included covid-19 from Jan2021 to Jan2021 He had COVID around 15Jan2021 or 16Jan2021. The patient's concomitant medications were not reported. The patient experienced she took his temperature, because he felt hot. It was over 100 degrees fahrenheit. it may have been 106.7 degrees fahrenheit or 101 degrees fahrenheit. she does not remember exactly. on 07Apr2021 18:00, passed out and dropped to the floor on 07Apr2021 with outcome of recovering, sweating and fever on 07Apr2021 18:00 with outcome of recovering, tired on 07Apr2021, chills on 07Apr2021, body aches on 07Apr2021, flu like symptoms on an unspecified date, they kind of progressed. on an unspecified date patient had Emergency room visit for the events. The patient underwent lab tests and procedures which included blood test: everything was normal on unspecified date, chest x-ray: everything was normal on unspecified date, culture urine: everything was normal on unspecified date, magnetic resonance imaging: everything was normal on unspecified date. The outcome of the event loss of consciousness, sweating fever, fatigue, chills, pain was recovering, the outcome of the events loss of consciousness, influenza like illness, condition aggravated was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Loss of consciousness, Magnetic resonance imaging, Pain
Clinical narrative: flu like symptoms; They kind of progressed.; She took his temperature, because he felt hot.  It was over 100 degrees Fahrenheit.  It may have been 106.7 degrees Fahrenheit or 101 degrees Fahrenheit.  She does not remember exactly.; Sweating and fever; Tired; Chills; Body Aches; Passed out and dropped to the floor; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 15:00(age at vaccination:47-Year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient didn't received other medications. Medical history included covid-19 from Jan2021 to Jan2021 He had COVID around 15Jan2021 or 16Jan2021. The patient's concomitant medications were not reported. The patient experienced she took his temperature, because he felt hot. It was over 100 degrees fahrenheit. it may have been 106.7 degrees fahrenheit or 101 degrees fahrenheit. she does not remember exactly. on 07Apr2021 18:00, passed out and dropped to the floor on 07Apr2021 with outcome of recovering, sweating and fever on 07Apr2021 18:00 with outcome of recovering, tired on 07Apr2021, chills on 07Apr2021, body aches on 07Apr2021, flu like symptoms on an unspecified date, they kind of progressed. on an unspecified date patient had Emergency room visit for the events. The patient underwent lab tests and procedures which included blood test: everything was normal on unspecified date, chest x-ray: everything was normal on unspecified date, culture urine: everything was normal on unspecified date, magnetic resonance imaging: everything was normal on unspecified date. The outcome of the event loss of consciousness, sweating fever, fatigue, chills, pain was recovering, the outcome of the events loss of consciousness, influenza like illness, condition aggravated was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sweating fever
Clinical narrative: flu like symptoms; They kind of progressed.; She took his temperature, because he felt hot.  It was over 100 degrees Fahrenheit.  It may have been 106.7 degrees Fahrenheit or 101 degrees Fahrenheit.  She does not remember exactly.; Sweating and fever; Tired; Chills; Body Aches; Passed out and dropped to the floor; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 15:00(age at vaccination:47-Year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient didn't received other medications. Medical history included covid-19 from Jan2021 to Jan2021 He had COVID around 15Jan2021 or 16Jan2021. The patient's concomitant medications were not reported. The patient experienced she took his temperature, because he felt hot. It was over 100 degrees fahrenheit. it may have been 106.7 degrees fahrenheit or 101 degrees fahrenheit. she does not remember exactly. on 07Apr2021 18:00, passed out and dropped to the floor on 07Apr2021 with outcome of recovering, sweating and fever on 07Apr2021 18:00 with outcome of recovering, tired on 07Apr2021, chills on 07Apr2021, body aches on 07Apr2021, flu like symptoms on an unspecified date, they kind of progressed. on an unspecified date patient had Emergency room visit for the events. The patient underwent lab tests and procedures which included blood test: everything was normal on unspecified date, chest x-ray: everything was normal on unspecified date, culture urine: everything was normal on unspecified date, magnetic resonance imaging: everything was normal on unspecified date. The outcome of the event loss of consciousness, sweating fever, fatigue, chills, pain was recovering, the outcome of the events loss of consciousness, influenza like illness, condition aggravated was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin disorder, Skin haemorrhage, Urticaria
Clinical narrative: whole body is very, very itchy from head to toe, itchy skin/very itching where itchy I am making myself bleed it; broke out with hives, very itchy; My whole body is very, very itchy from head to toe and that's yeah, very itchy, itchy skin; Little bumps all over my arm and all over my body, little tiny bumps; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID-19 (skin reaction) in Feb2021 to an unknown date. Concomitant medications were not reported. The patient experienced whole body is very, very itchy from head to toe, itchy skin/very itching where itchy i am making myself bleed it, broke out with hives, very itchy, my whole body is very, very itchy from head to toe and that's yeah, very itchy, itchy skin and little bumps all over my arm and all over my body, little tiny bumps on an unspecified date. On an unspecified date, the reporter stated, "My reaction was I broke out with hives, very itchy. My whole body is very, very itchy from head to toe and that's yeah, very itchy, itchy skin." Further stated, "Yeah, very itching where itchy I am making myself bleed it, stop that. Little bumps all over my arm and all over my body, little tiny bumps. When I had COVID back in February I end up with a skin reaction and then when I got the vaccine it got worse." Then stated, "Okay, yeah, because I mean I can't stand that, I can't. I have never been like this. I have been very, very healthy until I had this vaccine. I mean are you guys going to help me or anything. I mean, I am that desperate. So, with you I am both ready to time tackle and all that." The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Hypoaesthesia, Hypoaesthesia oral, Insomnia, Magnetic resonance imaging
Clinical narrative: difficulty sleeping and needing to take a sleeping medication; she reports symptoms of numbness in her body, that started on her right side and spread to the left side including her fingers and her tongue.; numbness/she reports symptoms of numbness in her body; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left in Apr2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. Medical history included systemic lupus (2011 or 2012). The patient concomitant medications were not reported. Caller stated the first dose of the Pfizer Covid Vaccine was on 12Apr2021 or 13Apr2021, and 18 days later, starting approximately 30Apr2021, she reported symptoms of numbness in her body, that started on her right side and spread to the left side including her fingers and her tongue. Caller received her second dose 02May2021 or 03May2021 and after that she developed the numbness again in her body. Caller stated a few days after the second dose, she reported dizziness and blurred vision. Caller stated she went to the Emergency department, and they did a CT scan, but they did not find anything. Caller stated she was prescribed Meclizine. After she took the medication, the dizziness and blurred vision resolved. Caller stated she still has ongoing numbness in her body, and it has spread to her back. Caller stated on 13Jul2021, she saw a neurologist and she was given Vitamins B2, Magnesium, and Q10. Caller stated on 16Jul2021, she had another MRI test, and the results are unknown at this point. Caller reported the numbness has been ongoing now for 2 months and 20 days and it was giving her a lot of pain and it was getting worse. Caller stated she cannot drive or work and has to take breaks if she goes for a walk. Caller stated she also has difficulty sleeping and she needs to take a sleeping medication since taking the vaccine. Patient was asking for the reason she was having numbness (i.e., was it related to vaccine) and was also asking for treatment advice. The patient underwent lab tests and procedures which included computerised tomogram scan: normal on an unspecified date, magnetic resonance imaging: unknown results on 16Jul2021. Therapeutic measures were taken as a result of adverse events. The outcome of insomnia was recovered on 21Jun2021 and the outcome of other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Grip strength, Grip strength decreased, Hemiplegia
Clinical narrative: Said to have suffered multiple strokes; While in Germany was hospitalized unable use her left side; Can't grip or grab anything with left hand, limping when walking; Can't grip or grab anything with left hand, limping when walking; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). An unspecified age (pregnant-unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an intramuscular route of administration on an unspecified date Jul2021, as  dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced said to have suffered multiple strokes and was hospitalized unable use her left side, can't grip or grab anything with left hand, and limping when walking. On an unspecified date, the patient underwent lab tests and procedures which included grip or grab, Grip strength: Can't grip or grab anything with left hand, can't grip or grab anything with left hand, limping when walking; and Magnetic resonance imaging: Unknown results. Caller stated, adverse events resulted in hospitalization. The outcome for all the vents was unknown.  Follow-up (22Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to the Non-HCP letter via email follow up that included: I have no further details than what was provided in the initial report.  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.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Said to have suffered multiple strokes; While in Germany was hospitalized unable use her left side; Can't grip or grab anything with left hand, limping when walking; Can't grip or grab anything with left hand, limping when walking; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). An unspecified age (pregnant-unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an intramuscular route of administration on an unspecified date Jul2021, as  dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced said to have suffered multiple strokes and was hospitalized unable use her left side, can't grip or grab anything with left hand, and limping when walking. On an unspecified date, the patient underwent lab tests and procedures which included grip or grab, Grip strength: Can't grip or grab anything with left hand, can't grip or grab anything with left hand, limping when walking; and Magnetic resonance imaging: Unknown results. Caller stated, adverse events resulted in hospitalization. The outcome for all the vents was unknown.  Follow-up (22Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to the Non-HCP letter via email follow up that included: I have no further details than what was provided in the initial report.  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.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: extreme vertigo; the first dose was probably on 03FEB2021 but I have not received the second one yet; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), via unspecified rout of administration on 03Feb2021 as a dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she got the first Pfizer COVID-19 vaccination on the (place name), and they gave her a card but she lost it, the first dose was probably on 03Feb2021 but she had not received the second one yet because she had a reaction to it; the next morning probably on 04Feb2021 it was about 9 or 10 hours later, she got extreme vertigo and she was in the hospital, the diagnosis was extreme intense vertigo that lasted for 6 weeks, she was terrified because she live alone, she just called # the y took me to the hospital, she learned different positions to alleviate vertigo and she did that over the time one morning it was gone. If she moved the head, if she even tilted my head, that would trigger it." "my doctor said yeah go ahead for second dose" "my girlfriend called (Pfizer Safety) for me, they gave her a number #". She asked "anyway they said they give it at (pharmacy name), do I have to have the card to get 2nd dose. my doctor said I can get another COVID vaccine. The outcome of event was recovered for vertigo and Unknown for the first dose was probably on 03Feb2021 but I have not received the second one yet.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: diagnosed with pulmonary embolism on 13Apr2021; date of first covid vaccine was 08Apr2021. PE was diagnosed at hospital so unknown exact length of hospital stay; This is a spontaneous report from a contactable physician. A 65-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 1 intramuscular, administered in Arm Right on 08Apr2021 (65-years-old at the time of vaccination), (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation in hospital. Medical history included gout, chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD), osteoarthritis, type 2 diabetes mellitus (T2DM), hypertension (HTN) from an unknown date and unknown if ongoing. Patient had known allergies to NKDA. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient received prescribed medications as other vaccine in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient stated, he was diagnosed with pulmonary embolism on 13Apr2021; date of first covid vaccine was 08Apr2021. PE was diagnosed at hospital so unknown exact length of hospital stay. Adverse event resulted in Emergency room/department or urgent care, Hospitalization. Number of days of hospitalization was zero. Therapeutic measures were taken for the event as anticoagulation, now on apixaban. The clinical outcome of the event was recovering at the time of the report.; Sender's Comments: Based on the plausible temporal relation, the association between the event of Pulmonary Embolism and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factors for the event are patient's medical history of Hypertension, Diabetes Mellitus (Type II) and Coronary artery disease 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Erythema, Pain, Peripheral swelling
Clinical narrative: Ultrasound revealed venous blood clot (DVT).; she developed pain, redness and swelling in lower left leg.; she developed pain, redness and swelling in lower left leg.; she developed pain, redness and swelling in lower left leg.; This is a spontaneous report from a contactable physician. A 71-year-old non-pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EN5318), intramuscular, administered in the left arm on 02Feb2021 at 13:00 as single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL1283), intramuscular, administered in the left arm on 19Jan2021 at 13:00 as single dose (age at the time of vaccination 71-year-old) for covid-19 immunisation. The patient's medical history included hypothyroidism and penicillin allergy. The patient's concomitant medications included thyroid hormone. Patient did not receive any in vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID tested post vaccination. On 02Feb2021, she developed pain, redness and swelling in lower left leg. Ultrasound revealed venous blood clot (DVT). No other cause was found-not on hormones, negative hyper coagulable work up, no trauma or prolonged sedentary status. Therapeutic measures were taken as a result of the events and she was treated with blood thinner (Eliquis). The outcome of the event ultrasound revealed venous blood clot (DVT) was unknown, and other events was recovered with sequel.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of "Deep vein thrombosis" due to temporal relationship and current known drug safety profile. 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: Loss of consciousness, Nausea, Vomiting
Clinical narrative: black outs, even passed out; nausea; vomiting; This is a spontaneous report from a contactable consumers received from a Pfizer sponsored program. This is 1 of 2 reports. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EV0178; Expiration date was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced black outs, even passed out, nausea, vomiting on Jul2021. Therapeutic measures were taken as a result of the events. It was reported that patient just recently turned 18 and she had her Covid vaccine on 13Jul2021 (not clarified) and had side-effects. Date was scheduled for 2nd shot of vaccine and consumer stated that it could be 03Aug2021. For treatment in response to vent, consumer stated that the day she had vaccine, she went to the hospital and just gave me pain medicines (further clarification unknown) and some like fluids and then felt better. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Asthenia, Bone pain, Brain injury, Confusional state
Clinical narrative: My brain function feels sluggish all the time now.; I started to feel a loss of energy; body aches/mild ache from my head to my toes, in my muscles and bones; confusion; complete change in appetite.; dizziness; feels like I'm overheating.; mild ache from my head to my toes, in my muscles and bones; mild ache from my head to my toes, in my muscles and bones; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical Vaccine BNT162B2 product: COVID 19, brand: Pfizer, lot number: EM9810, lot unknown: False administration date09Feb2021 administration time:11:15 PM dose number:1 vaccine location: Left arm for COVID-19 immunisation. Patient has no known allergies. Patient was not tested covid prior vaccination ,Not tested covid prior vaccination. On 07Mar2021 07:00 adverse event:  After receiving the 2nd dose/shot, within 4-5 days, Patient started to feel loss of energy, body aches, confusion, complete change in Her brain function feels sluggish all the time now. Patient have a mild ache from her head to my toes, in muscles and bones that never goes away, constant dizziness, and a feeling of being just under the weather. It's been 5 months since patient received the 2nd shot, and she haven't felt the same since. Patient struggle to make it through each day, her demeanor has changed alot from who she was prior to receiving the vaccine. Patient never feel well enough to do the things she used to do on a weekly/daily basis, like mountain climbing, swimming, and hikes. Her body always feels like I'm overheating. Patients want to be me again so badly, she hates being, and feeling like this every day. She feels like I just got off a bad carnival ride, and can't get that normal feeling back. After 5 months, someone needs to know what I've been going through because, it's not going away. The Outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Myalgia, Pain
Clinical narrative: My brain function feels sluggish all the time now.; I started to feel a loss of energy; body aches/mild ache from my head to my toes, in my muscles and bones; confusion; complete change in appetite.; dizziness; feels like I'm overheating.; mild ache from my head to my toes, in my muscles and bones; mild ache from my head to my toes, in my muscles and bones; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical Vaccine BNT162B2 product: COVID 19, brand: Pfizer, lot number: EM9810, lot unknown: False administration date09Feb2021 administration time:11:15 PM dose number:1 vaccine location: Left arm for COVID-19 immunisation. Patient has no known allergies. Patient was not tested covid prior vaccination ,Not tested covid prior vaccination. On 07Mar2021 07:00 adverse event:  After receiving the 2nd dose/shot, within 4-5 days, Patient started to feel loss of energy, body aches, confusion, complete change in Her brain function feels sluggish all the time now. Patient have a mild ache from her head to my toes, in muscles and bones that never goes away, constant dizziness, and a feeling of being just under the weather. It's been 5 months since patient received the 2nd shot, and she haven't felt the same since. Patient struggle to make it through each day, her demeanor has changed alot from who she was prior to receiving the vaccine. Patient never feel well enough to do the things she used to do on a weekly/daily basis, like mountain climbing, swimming, and hikes. Her body always feels like I'm overheating. Patients want to be me again so badly, she hates being, and feeling like this every day. She feels like I just got off a bad carnival ride, and can't get that normal feeling back. After 5 months, someone needs to know what I've been going through because, it's not going away. The Outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Head discomfort, Hyperhidrosis, Influenza like illness
Clinical narrative: Date of first (+)ve test: Monday, 19Jul; Date of first (+)ve test: Monday, 19Jul; Light case so far, similar to mild flu-like symptoms; some head congestion; runny nose; loss of smell but not taste; sweating; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6199; Expiration Date: 30Jun2021), via an unspecified route of administration on 25Mar2021 (at the age of 59-year-old) as dose 2, single, dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation.  The patient had no medical history. There were no concomitant medications. On 18Jul2021, patient experienced body ache and sweating but no temperature or cough. On 19jul2021, patient experienced vaccination failure, covid-19, similar to mild flu-like symptoms, no fever, no body ache, some head congestion and runny nose, loss of smell but not taste. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Jul2021, sars-cov-2 test: postive on 19Jul2021. The outcome of the event covid-19 was not recovered and the outcome of events body ache, sweating, flu-like symptoms, some head congestion, runny nose, loss of smell but not taste were unknown. The product Quality Complaint group provided additional investigational results which indicated the following: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Date of first (+)ve test: Monday, 19Jul; Date of first (+)ve test: Monday, 19Jul; Light case so far, similar to mild flu-like symptoms; some head congestion; runny nose; loss of smell but not taste; sweating; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6199; Expiration Date: 30Jun2021), via an unspecified route of administration on 25Mar2021 (at the age of 59-year-old) as dose 2, single, dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation.  The patient had no medical history. There were no concomitant medications. On 18Jul2021, patient experienced body ache and sweating but no temperature or cough. On 19jul2021, patient experienced vaccination failure, covid-19, similar to mild flu-like symptoms, no fever, no body ache, some head congestion and runny nose, loss of smell but not taste. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Jul2021, sars-cov-2 test: postive on 19Jul2021. The outcome of the event covid-19 was not recovered and the outcome of events body ache, sweating, flu-like symptoms, some head congestion, runny nose, loss of smell but not taste were unknown. The product Quality Complaint group provided additional investigational results which indicated the following: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19
Symptoms: Infection, Shock
Clinical narrative: went into shock; infection; This is a spontaneous report from a Pfizer-Sponsored Program. A contactable male consumer (Patient) reported for himself. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller had first vaccine and then was admitted into the hospital and went into shock and had infection on an unspecified date. He was not able to get second vaccine. He wanted to know if he should get second vaccine or start over. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Had a stroke 4 hours after vaccine; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in right arm on 25Mar2021 at 10:30 (at the age of 49-year-old) as a single for COVID-19 immunisation at public health clinic facility. Medical history included multiple allergies from an unknown date and unknown if ongoing known allergies were reported as yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did receive other unspecified vaccines within 2 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 25Mar2021 at 13:30, the patient experienced had a stroke 4 hours after vaccine. The patient was hospitalized for had a stroke 4 hours after vaccine (cerebrovascular accident) for 2 days. Adverse event had not resulted in for death, life-threatening, prolonged hospitalisation or Congenital anomaly/birth defect but resulted in hospitalization, disability, or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Mar2021. The outcome of the event was reported as resolving.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: I had lost hearing; I couldn't hear the television and then I couldn't hear people speaking, it was real low; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Deltoid Left on 12Mar2021 (at the age of 78-years-old) as a dose 1, single for covid-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), dose 2 via an unspecified route of administration, administered in Deltoid Left on 02Apr2021 (at the age of 78-years-old) as a dose 2, single for covid-19 immunization. The patient medical history included drug hypersensitivity- Penicillin and Sulphur and allergic to those. Concomitant medication(s) included TELMISARTAN 40 mg; ticagrelor (BRILINTA) 60 mg; FUROSEMIDE 80 mg; AMIODARONE 200 mg; LATANOPROST Dosage text: 0.005. On an unspecified date in 2021, about 2 months after the patient had the shot noticed "I could not hear the television as well and went to the ENT doctor and he said I had lost hearing but at that point he did not know what matter caused it then I could not hear people speaking, it was real low so I went to the ENT. Just a couple months after I had my last shot after that point I was hearing really well and I got hearing aid because I just had the loss in one ear. I had it in my left ear". Therapeutic measures were taken as a result of event- deafness. Outcome of the event was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Coma, Dyspnoea, Illness, SARS-CoV-2 test
Clinical narrative: so sick that he could not breathe; so sick that he could not breathe; Coma; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (Patient 's son) reported for a patient (Father). This is a report received from a Pfizer-sponsored program. A 72-years-old male patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0169 and Expiry date: Unknown), via an unspecified route of administration on 29Jun2021 at 17:00 (at the age of 72-yers-old) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history included hypertension (Blood pressure high) (Caller says his father has high blood pressure, unknown when diagnosed, and he doesn't remember what medication he took). The patient concomitant medications were not reported (Caller says his father got no other vaccinations the same day as they got the COVID-19 vaccine or recently beforehand, and started no new medications. He says his father has high blood pressure). The patient had experienced so sick that he could not breathe on 04Jul2021 (the reporter says his father on the 3rd and on the 4th was so sick that he could not breathe, so they called the ambulance on 4th and he received treatment in the ICU, which he doesn't know what they did since he cannot see him), coma on Jul2021, tested positive for covid-19 on 02Jul2021. The patient received the first dose of the Pfizer COVID-19 vaccine on June 29th and then two days later he tested positive for COVID-19 and he wants to know if he still gets the second dose of vaccine as well. The patient was hospitalized for so sick that he could not breathe and coma for 18 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Jun2021, sars-cov-2 test: positive on 02Jul2021 (the reporter says that before they did the shot they did test two things, and on June 27th they were all negative for COVID-19, which was what make us like doesn't know what is going on, since on the 29th they were all positive after vaccine). Therapeutic measures were taken as a result of so sick that he could not breathe. Outcome of the events so sick that he could not breathe, Coma and tested positive for COVID-19 was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Menstrual disorder, Ultrasound scan
Clinical narrative: I have had my period non stop since getting vaccinated; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Ew0170), via an unspecified route in the left arm on 26Apr2021 (age at vaccination: 45-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Er8733), via an unspecified route in the left arm on 01Apr2021, as a single dose for covid-19 immunization. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 01May2021, patient had her period nonstop since getting vaccinated. Adverse event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures taken as a result of the events included unknown medication. The patient underwent lab tests and procedures which included ultrasound and biopsy, surgery next. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have continually suffered from severe aching legs above knees on both legs; This is a spontaneous report from a contactable Other HCP(Patient). A 55-years-old non pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9269), via an unspecified route of administration on 11Feb2021 at 10:30(at the age of 55-years-old) into left arm as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283), via an unspecified route of administration on 12Jan2021 at 10:30 am (at the age of 55-years-old) into left arm as a single dose for COVID-19 immunization. Medical history included arthritis reactive from an unknown date and unknown if ongoing. Concomitant medication(s) included Estradiol. The patient previously took iodine and experienced iodine allergy. On 12Feb2021 at 03:00 AM, Day after second dose the patient continually suffered from severe aching legs above knees on both legs. Hoped it would abate after a time, but it has not. Prior the vaccination, the patient was not diagnosis with COVID. Post vaccination, the patient was not tested for COVID. The patient did not receive any vaccine in four weeks. No treatment was received for the event. The patient was visited to Doctor or other healthcare professional office/clinic visit for the event. The outcome of the event was not recovered.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Periorbital swelling, Rash
Clinical narrative: I broke out into a rash; Rash on my neck, my left arm like where you would bend the elbow and then all my face, it is starting on my face; I broke out into a rash; Rash on my neck, my left arm like where you would bend the elbow and then all my face, it is starting on my face; I broke out into a rash; Rash on my neck, my left arm like where you would bend the elbow and then all my face, it is starting on my face; My eyes were puffy; This is a spontaneous report from a contactable consumer (patient). A 53-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FA6780, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 (at the age of 53-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient relevant medical history was none. The patient's concomitant medications were not reported. The patient reported that, I broke out into a rash; rash on my neck, my left arm like where you would bend the elbow and then all my face, it is starting on my face and my eyes were puffy all on 20Jul2021. Consumer stated that, "I was talking to my doctor and after receiving a first vaccine dose of Pfizer, they suggested that I call because I broke out into a rash. So, I woke up the next morning and my eyes were puffy and since then, I developed a rash on my neck, my left arm like where you would bend the elbow and then all my face, it is starting on my face now." Consumer stated, "Not on the elbow but like on the part where you would bend your arm, "I was taking Benadryl, and was asking was that okay for me to take". Consumer further stated, "Okay, I took a little Benadryl that was it." Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Discomfort, Oedema peripheral, Pain, X-ray
Clinical narrative: Left foot swelling; Felt a little bit of discomfort; Severe pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180), as dose 2, single via an unspecified route of administration in left arm on 08Jun2021 at 11.00 for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0185), as dose 1, single via an unspecified route, administered in left arm on 18May2021 for covid-19 immunization, past drugs include second dose of shingles vaccine in Mar2021 and ongoing vitamins, started about 7 years ago. On an unknown date, the patient experienced left foot swelling around the ankle area. The patient stated that, left foot swelling is ongoing and right now has not worsened and was not worse and he saw his doctor yesterday and is waiting for test results which is x-rays and blood work. The patient was in perfect health and this is throwing him all off and his foot started swelling. He had a physical last year in Sep2020 and it came out clear and he takes no medications. The patient was not treated for the events, as he thought it would go away the first two weeks and he does a lot of walking for his job and did not have severe pain until this Monday and felt a little bit of discomfort and did go to his doctor yesterday. The patient underwent lab tests and procedures which included blood work and x-rays, result unknown. The outcome of the event of left foot swelling was not recovered. The outcome of the event of discomfort and severe pain was unknown.  Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Serology test
Clinical narrative: Had a serology and had a level of 3.9 but her other family members tested above 20.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and Lot Number: not provided), dose 1 via an unspecified route of administration on an unspecified date as single dose and dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. Patient and her other family members did not have a history of COVID. The patient's concomitant medications were not reported. She got the double vaccine as well as the rest of her entire family. Her daughter went to camp and they required serology testing. All her family tested serology above 29 and her number came back at 3.9. She would like to know if she is not as covered as the rests of her family. When she got her vaccine, the rest of her family got pain in their arm and she had no reactions whatsoever. Her husband just told her that her arm hurt a little after getting it. It was like a tetanus shot but nothing bad. Separate report completed for husband. On an unspecified date, the patient had a serology and had a level of 3.9 but her other family members tested above 20. (laboratory test abnormal). she knew that there are also people who are fully vaccinated and tested zero on their antibodies test. The patient underwent lab tests and procedures which included serology test: 3.9 (Serology test came back at 3.9). Outcome of event was unknown.  Information on lot /batch number has been requested.