chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Immune system disorder, Inflammatory marker increased, Magnetic resonance imaging
Clinical narrative: Acute inflammation of the left hip joint; excruciating pain; increased synovial fluid in the left hip joint; unable to move, walk of bare weight on the left side; unable to move, walk of bare weight on the left side; elevated markers of inflammation in peripheral blood; highly elevated immune infiltration; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Apr2021 14:15 (Lot Number: EW0150) (received at 34-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included herniated lumbar discs. The patient was not pregnant. Concomitant medication(s) included levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient experienced Acute inflammation of the left hip joint, excruciating pain, unable to move, walk of bare weight on the left side, elevated markers of inflammation in peripheral blood, MRI showed increased synovial fluid in the left hip joint, analysis showed highly elevated immune infiltration present in the synovial fluid, with no presence of concurrent infection or elevated markers of systemic autoimmune disease, or secondary conditions that could lead to joint inflammation, all on 15Apr2021 05:00 AM. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI): increased synovial fluid on 15Apr2021 increased synovial fluid in the left hip joint, analysis showed highly elevated immune infiltration present in the synovial fluid; nasal swab test: negative on 16Apr2021. Therapeutic measures were taken as a result of the adverse events which included aspiration of fluid from joint, anti-inflammatories. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 4 days. Outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, SARS-CoV-2 test, Synovial fluid analysis abnormal
Clinical narrative: Acute inflammation of the left hip joint; excruciating pain; increased synovial fluid in the left hip joint; unable to move, walk of bare weight on the left side; unable to move, walk of bare weight on the left side; elevated markers of inflammation in peripheral blood; highly elevated immune infiltration; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Apr2021 14:15 (Lot Number: EW0150) (received at 34-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included herniated lumbar discs. The patient was not pregnant. Concomitant medication(s) included levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient experienced Acute inflammation of the left hip joint, excruciating pain, unable to move, walk of bare weight on the left side, elevated markers of inflammation in peripheral blood, MRI showed increased synovial fluid in the left hip joint, analysis showed highly elevated immune infiltration present in the synovial fluid, with no presence of concurrent infection or elevated markers of systemic autoimmune disease, or secondary conditions that could lead to joint inflammation, all on 15Apr2021 05:00 AM. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI): increased synovial fluid on 15Apr2021 increased synovial fluid in the left hip joint, analysis showed highly elevated immune infiltration present in the synovial fluid; nasal swab test: negative on 16Apr2021. Therapeutic measures were taken as a result of the adverse events which included aspiration of fluid from joint, anti-inflammatories. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 4 days. Outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Muscle spasms, Nerve injury, Pain in extremity, Thrombosis
Clinical narrative: sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has been damaged or early stage of thrombosis; not sure if there was a nerve that has been damaged or early stage of thrombosis; severe arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Apr2021 at 09:30 (at the age of 56 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication was none. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 18Apr2021 at 18:00, the patient experienced severe arm pain that was described as arm pain was too painful and have been woken up out of her sleep and she has limited range of motion and she was not sure if there was a nerve that has been damaged or early stage of thrombosis. On 20Apr2021, the patient experienced sustain cramps in her right leg. The patient did not receive treatment for the events.  The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 test negative
Clinical narrative: Debilitating migraines; This is a spontaneous report from a contactable other HCP.   A 44-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Feb2021 12:00 (Batch/Lot Number: EN5318) as single dose at the age of 43-year-old for COVID-19 immunisation, administered at a facility.  The patient medical history was none. No known allergies. The concomitant medications were not reported. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant. The female patient received bnt162b2 (BNT162B2), dose 1 on in arm left 17Jan2021 04:00 PM (Batch/Lot # EL8992) at the age of 43-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced debilitating migraines on 28Mar2021. The event was considered serious as per disability or permanent damage. No treatment received for the event. COVID was tested post vaccination: Nasal Swab, PCR, resulted negative on 14Apr2021. The outcome of event was recovered with sequelae/lasting effects.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of migraine. There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Deep vein thrombosis, Heart rate, Pulmonary embolism, Sinus tachycardia
Clinical narrative: bilateral pulmonary embolism; right DVT; sinus tachycardia; Afib with RVR.; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 68-year-old male patient received BNT162B2 (Pfizer COVID vaccine), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Unknown) as single dose for Covid-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease (GERD), and deep vein thrombosis (DVT) original diagnosis from Jan2018. The patient previously received the first dose of BNT162B2 on 19Mar2021 for Covid-19 immunisation. The physician reported the patient had bilateral pulmonary embolism and a right DVT on 11Apr2021. The patient went to the ER on 11Apr2021. She confirms the pulmonary embolisms and the DVT were diagnosed 11Apr2021 when the patient went to the ER. She has more of the patient's story, caller does not think this would be linked to the vaccine but that is for someone else to decide she is reporting. The day of the event the patient's heart was racing, he passed out and went to the ER, he had sinus tachycardia and Afib with RVR (date/s unspecified). His heart rate was up to 140s and 150s. The patient has history of hypertension, GERD, and previous DVT, the original DVT that patient had was diagnosed in Jan2018 and he was placed on Xarelto at that time and he was on Xarelto until Jun2019. He has not been on anything for this since that time, until this episode. Caller says reporter did not provide any specific treatment information that the patient has received for the event she is reporting. Reporter provided the patient went to the emergency room, he did not say if the patient was admitted or had hospitalization. The outcome of events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Drug causality would seem unlikely for  BNT162B2. The reported events may be regarded as natural progression of patient's pre-existing conditions. 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 Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient has Covid after receiving the vaccine; patient has Covid after receiving the vaccine; This is a spontaneous report from a contactable physician reporting for a patient via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Covid vaccine and now has Covid. They want to give the patient a treatment of antibodies. The patient underwent lab tests and procedures which included sars-cov-2 test: now has COVID on an unspecified date. Reporter has questions on how that would affect the vaccine. Outcome of the event was unknown.  Information about lot/batch has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencies as appropriate.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Fatigue, Memory impairment, Seizure
Clinical narrative: increased seizure activity/mini seizures; increased seizure activity/mini seizures; confusion and memory issues; confusion and memory issues; fatigue/tired; This is a spontaneous report from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:00 (Lot Number: EW1064) as SINGLE DOSE  (at age of 17 years old) for covid-19 immunisation. Medical history included epilepsy (interactable epilepsy) from an unknown date and unknown if ongoing.  There were no concomitant medications.  Historical vaccine information included BNT162B2 dose 1 on 25Mar2021 09:00, lot number as ER8733,  in the left arm for COVID-19 immunisation(at age of 17 years old). On 17Apr2021, the patient experienced increased seizure activity, fatigue/tired, confusion and memory issues. After the 2nd shot, about 4-5 hours, he experienced increased seizure activity and it has progressed to today, today he is a little bit better but it has progressed to point he is having a lot of confusion and memory issues. He has several different types of seizures but he has what are called mini seizures, the blank stare, the confusion. Nothing has stopped completely, he isn't back to his baseline as far as his seizures. He always has seizures, daily so she is calling about the increased activity and when she says his baseline she means he has not returned back to his baseline activity, but he is doing better than yesterday.  Saturday, Sunday, and Monday were horrible. Today he started to get back to his normal self. The events did not require a visit to the Emergency Room or Physician Office. Outcome of the increased seizure activity/mini seizures, confusion and memory issues were recovering. Outcome of fatigue/tired were not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Apnoea, Culture, Dermatitis acneiform, Dysphagia
Clinical narrative: Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative.  The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Ear swelling, Hypersensitivity, Illness, Influenza like illness
Clinical narrative: Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative.  The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Lymphadenopathy, Migraine, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative.  The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, SARS-CoV-2 test, Scratch, Streptococcus test, Urine analysis
Clinical narrative: Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative.  The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (the patient). This 51-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm, upper arm, on 06Apr2021 14:00 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient denied being sick at the time of vaccination. The patient's medical history was not reported. No relevant family medical history was reported. There were no concomitant medications. On the night of 08Apr2021, the patient was having intense pain down her neck and behind her left ear, and it has been waking her up at night. On 09Apr2021, she went to Urgent Care and they misdiagnosed her with a possible oncoming ear infection. On Saturday morning (10Apr2021), she woke up and could not move the left side of her face so she went to the ER (emergency room) and they diagnosed her with Bell's Palsy. On 10Apr2021 at the ER, blood test for Lyme disease was negative. The ER gave the patient a steroid and antiviral pill and told her to follow up with her primary doctor in 8 days. The patient went to her physician's office on 19Apr2021 to follow-up with her Bell's Palsy. The patient stated that intense pain (down her neck and behind her left ear) was apparently a symptom of the Bell's Palsy. The only improvement with the Bell's Palsy was that she can sip out of straw a little easier but lips are still to the side. The clinical outcome of the event Bell's Palsy was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dizziness, Eye disorder, Fatigue
Clinical narrative: fatigue; Eyesight; Dizzy; bell's palsy; This is a spontaneous report from a contactable consumer (patient's son). A 97-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6207) intramuscularly in the right arm on 11Mar2021 at 14:00 as a single dose for COVID-19 immunization. Patient's medical history included glaucoma for more than 25 years - 'implants caser' (as reported), thyroid disorder for more than 25 years, eye disorder, and gastrointestinal disorder. The patient had no other prior vaccinations to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6201) intramuscularly in the right arm on 18Feb2021 at 15:00 as a single dose for COVID-19 immunization and experienced cannot focus with her eyes and full body aches and pains. Ongoing concomitant medications included timolol ("Timnol") drops for the eyes since more than 5 years, levothyroxine sodium (LEVOTHYROXIN) pill for thyroid since more than 20 years, and omeprazaole pill for stomach for 5 years. One week after the second injection (Mar2021), the patient experienced Bell's Palsy at 20:30, reported as serious for important medical event. On 12Mar2021 at 22:00, patient was dizzy and 'eyesight', both events reported as non-serious. It was further described as, "She saw patient over everything so she slept. Day after 2nd she had to had most of day as too Dizzy/fatigued to be mobile. Dangling/twisting side of face last 7 days ongoing." The patient did not receive treatment for Bell's palsy, dizzy or eyesight. The clinical outcome of Bell's palsy was not recovered, of dizzy was recovering, of eyesight was recovered on unspecified date, of fatigued was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185916 Same patient, reporter, event, different vaccine dosing
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Mar2021, as single dose, for COVID-19 immunisation. Medical history included being exposed to COVID virus on an unspecified date. The patient's concomitant medications were not reported. The patient received her first dose at the end of Mar2021 and she was exposed and tested positive for COVID virus on an unspecified date. She was scheduled for her second dose on 20Apr2021 and asked if it was safe for her to receive the vaccine. The outcome of the event was unknown  Information of the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Swelling
Clinical narrative: swelling; malar edema; This is a spontaneous report based on the information received by Pfizer. (Reference Number: GL-041221-9190). A contactable physician reported for a 60-year-old female patient that:  Reported Adverse Events: Patient injected with Sculptra Aesthetic and Restylane Silk 18 months ago. Recently returned to physician after 2nd COVID vaccine (unspecified) with swelling and malar edema; treating with steroids and antihistamines; ongoing; Sender's Comments: Based on chronological connection to the vaccine and known the potential for allergic reactions post Covid-19 vaccination, causality between events swelling and malar edema and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right deltoid on 18Feb2021 (Batch/Lot Number: ENb298) as a single dose for COVID-19 immunization. Medical history included diabetes-onset date: years, stroke on 12Feb2002, breast cancer in Dec2015 and cholesterol, headaches, restless legs. Concomitant medications included rosuvastatin calcium (ROSUVASTATIN CALCIUM GENERIC) taken for cholesterol from an unspecified start date and ongoing; tocopherol, ubidecarenone (COQ-10 ST) taken for cholesterol from an unspecified start date and ongoing; gabapentin enacarbil (HORIZANT) taken for headaches, restless legs from an unspecified start date and ongoing; anastrozole (ANASTROZOLE) taken for an unspecified indication from an unspecified start date and ongoing; empagliflozin (EMPAGLIFLOZIN) taken for an unspecified indication from an unspecified start date and ongoing; eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication from an unspecified start date and ongoing; denosumab (PROLIA) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose, lot number: EL1298) on 28Jan2021 for COVID-19 immunization and experienced blood pressure systolic high and dizziness. The patient felt extremely tired on an unspecified date and was hospitalized for about a week (7 days), had a sore arm on an unspecified date and was hospitalized for 2 days and experienced muscle pain on an unspecified date. No treatment was administered for the event extremely tired, for the muscular pain Tylenol was taken starting 24 hours after shot - stayed in shot area. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Tingling in throat, after first vaccine.; This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient experienced tingling in throat, after first vaccine on an unspecified date. The outcome of the event was not reported.  Information on the Lot/Batch number has been requested
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: I went back to the hospital and couple days later they told me that actually I have Deep vein thrombosis now in my legs; my Crohn's had caused really bad flare up/I have been in the hospital for 5 days now with the clot and Crohn's Flare; I also have superficial clot in that left leg that was the pain began on the edges/blood clot; the arm is much better now. You know that's not really sore; I just was too tired/extreme fatigue; really bad like pain; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  Medical history included multiple sclerosis from an unknown date and unknown if ongoing, ileostomy from an unknown date and unknown if ongoing, back surgery from an unknown date and unknown if ongoing, Crohn's disease from an unknown date and unknown if ongoing , blood clot in arm back from 2014 to an unknown date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 08Mar2021 and experienced terrible diarrhea and neuralgia. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported;  (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; oxycodone (OXYCODONE) taken for an unspecified indication, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported.  After second dose on 29th  (29Mar2021) immediately he was really bad like pain and had shortness of breath. The patient stated that she had a back surgery and so she always felt bad, so she didn't think anything of it. But then she ended up into ER after the second dose and discovered that her Crohn's had caused really bad flare up. She mentioned her foot was looking strange but she was just too tired and left the ER. She then went back to the hospital and couple days later they told her that she actually had deep vein thrombosis now in her legs. She also had superficial clot in that left leg where the pain began on the edges. The patient reported that the vaccine was basically started the Crohn's flare up. The patient also stated that  "the arm was much better now and not really sore".  The patient was hospitalized for DVT from unknown date and for Crohn's flare up for 5 days.  The patient underwent lab tests and procedures which included endoscopy, sigmoidoscopy, ultrasound scan: all on  unknown date with unknown result. The patient was treated with Entyvio and on blood thinners now for a blood clot. The outcome of pain in extremity was recovering while others was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Drug ineffective, Dyspepsia
Clinical narrative: was unsure if the patient had COVID-19 virus; was unsure if the patient had COVID-19 virus; Inability to eat; Severe sweating; Stomach cramping/pain; Headaches that wouldn't go away; Diarrhea; A fever of of 100 degrees or more; Felt like his eyes were going to pop out; Stomach burning; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A male patient of unspecified age (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included headache. The patient's concomitant medications were not reported. The reporter stated her husband got his first dose on 09Apr2021, and she (the reporter) received her second dose on 12Apr2021. The reporter is concerned about the patient because he began having severe sweating, stomach cramping/pain, headaches that wouldn't go away, diarrhea, inability to eat, a fever of 100 degrees or more and felt like his eyes were going to pop out along with stomach burning after receiving the first dose of COVID-19 vaccine (in Apr2021). The reporter stated the patient had a headache before his first dose and was unsure if the patient had COVID-19 virus or if it is side effects after his first dose of COVID-19 vaccine. The reporter clarified side effects several times. The reporter also stated she had no side effects with the COVID-19 vaccine. The patient had not yet recovered from headache, while unknown outcome for the remaining events.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Hyperhidrosis, Ocular discomfort, Pyrexia
Clinical narrative: was unsure if the patient had COVID-19 virus; was unsure if the patient had COVID-19 virus; Inability to eat; Severe sweating; Stomach cramping/pain; Headaches that wouldn't go away; Diarrhea; A fever of of 100 degrees or more; Felt like his eyes were going to pop out; Stomach burning; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A male patient of unspecified age (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included headache. The patient's concomitant medications were not reported. The reporter stated her husband got his first dose on 09Apr2021, and she (the reporter) received her second dose on 12Apr2021. The reporter is concerned about the patient because he began having severe sweating, stomach cramping/pain, headaches that wouldn't go away, diarrhea, inability to eat, a fever of 100 degrees or more and felt like his eyes were going to pop out along with stomach burning after receiving the first dose of COVID-19 vaccine (in Apr2021). The reporter stated the patient had a headache before his first dose and was unsure if the patient had COVID-19 virus or if it is side effects after his first dose of COVID-19 vaccine. The reporter clarified side effects several times. The reporter also stated she had no side effects with the COVID-19 vaccine. The patient had not yet recovered from headache, while unknown outcome for the remaining events.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: was unsure if the patient had COVID-19 virus; was unsure if the patient had COVID-19 virus; Inability to eat; Severe sweating; Stomach cramping/pain; Headaches that wouldn't go away; Diarrhea; A fever of of 100 degrees or more; Felt like his eyes were going to pop out; Stomach burning; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A male patient of unspecified age (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included headache. The patient's concomitant medications were not reported. The reporter stated her husband got his first dose on 09Apr2021, and she (the reporter) received her second dose on 12Apr2021. The reporter is concerned about the patient because he began having severe sweating, stomach cramping/pain, headaches that wouldn't go away, diarrhea, inability to eat, a fever of 100 degrees or more and felt like his eyes were going to pop out along with stomach burning after receiving the first dose of COVID-19 vaccine (in Apr2021). The reporter stated the patient had a headache before his first dose and was unsure if the patient had COVID-19 virus or if it is side effects after his first dose of COVID-19 vaccine. The reporter clarified side effects several times. The reporter also stated she had no side effects with the COVID-19 vaccine. The patient had not yet recovered from headache, while unknown outcome for the remaining events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: My grandma got a PFIZER COVID VACCINE and has now experienced a blood clot that caused a stroke.; My grandma got a PFIZER COVID VACCINE and has now experienced a blood clot that caused a stroke.; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date  as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported.  The reporter stated that  "my grandma got a pfizer covid vaccine and has now experienced a blood clot that caused a stroke."  The patient experienced a cerebrovascular accident on an unspecified date with outcome of unknown and thrombosis  on an unspecified date with outcome of unknown. No further information was provided. Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Skin cancer
Clinical narrative: Diagnosed with cancer on the nose and cheeks; This is spontaneous from a Pfizer sponsored program A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient went to a dermatologist and was diagnosed with cancer on the nose and cheeks after first dose. Outcome was unknown.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis of the leg; This is a spontaneous report from a contactable physician. A 38-year-old male patient received first dose of BNT162B2 (Lot/batch number and expiry date was not reported), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. Medical history included ongoing eczema (Topical steroids), deep vein thrombosis (DVT) since 10 years ago and stopped 6months after treatment, Fasciotomy for compartmental syndrome s/p gunshot wound (Stop date: After surgery) and ongoing Allergies (PRN medication), all on an unknown dates. Patient has history of gunshot wound subsequent compartment syndrome of DVTs status post treatment 10 years ago of the left lower extremity. Family medical history of gunshot wound of compartment syndrome DVT on this side following. Patient had cellulitis of the leg 1 month prior to "11Feb". The patient experienced cellulitis of the leg on 11Feb2021. The outcome of the event was recovered on an unknown date. The physician reported that the patient provided information regarding the reported adverse event with the use of the product. The physician considered that the Pfizer vaccine had no causal effect to the adverse event.  The following information on the lot/batch number has been requested.; Sender's Comments: Based on information provided, the event cellulitis is an inter-current condition, thus unrelated to the suspect drug.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Formication, Inflammation, Neuropathy peripheral, Paraesthesia
Clinical narrative: feels like crawling on the caller's skin, similar to neuropathy; pins and needles on her skin; feels like crawling on the caller's skin, similar to neuropathy; very slight elevation of inflammation; This is a spontaneous report from a contactable consumer (patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number & Expiry date not reported), via unspecified route of administration on 05Apr2021 as Single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported.   The patient doesn't know if it is considered an adverse event but she has experienced what feels like pins and needles on her skin on an unspecoified date. It feels like crawling on the patient's skin, similar to neuropathy. The patient went to her doctor and he did blood work and she had a very slight elevation of inflammation and the doctor didn't seem too concerned, the doctor thought it was an effect of the vaccine. Patient inquired if Pfizer heard of any of this. The Patient doesn't want to get the second dose until these symptoms go away. The outcome of the reported events were unknown.  Communication: The Patient declines to file a safety report as she is heading into a doctor's appointment at this time, no further information or details were captured at this time. The Patient  would like for Pfizer to email her the contact information as she would like to talk to an agent about her questions but does not have the time to do so today. In response to it mention no information found on "pins and needles" possible AE, and refer to HCP for guidance.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.