chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Disorientation, Dizziness, Heart rate
Clinical narrative: 10 itchy welts on inside of left arm; one large swollen mass; elevated blood pressure and heart rate; elevated blood pressure and heart rate; dizziness; disorientation; This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old male patient received BNT162B2, via an unspecified route of administration, administered in arm left on 04Oct2021 (Batch/Lot Number: FF8841) at the age of 81 years old, as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), via an unspecified route of administration (right arm) from 04Oct2021 (Batch/Lot number was not reported, NDC: 70461-0121-03) to 04Oct2021, at dose 1, single [65+ 0.5ml] for an unspecified indication. Medical history included pre hypertension, "BPH" (reported as Blood pressure high), bladder cancer 15 years remission, tonsillectomy, appendectomy and gall bladder removal. No known allergies. Concomitant medication(s) included hydrochlorothiazide and terazosin, both taken for unspecified indications, start and stop dates were not reported. Other medications also included vitamins. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EL3302), administered in arm left on 10Feb2021 at 03:15 PM; second dose of BNT162B2 (Batch/Lot Number: EN6203), administered in arm left on 04Mar2021 at 03:15 PM. It was reported that adverse event After second shot included three incidents of itchy hives on inside of left leg, left arm, and back over a period of several months. No history of hives. No COVID prior vaccination and was not COVID tested post vaccination. Four days after 3rd shot (also reported as "Apr2021"), about 10 itchy welts on inside of left arm which formed into one large swollen mass and required injection of antihistamines at emergency room. This was also accompanied by elevated blood pressure and heart rate. Also, dizziness and disorientation. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events were unknown.
Age: 81.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Heart rate increased, Swelling, Urticaria
Clinical narrative: 10 itchy welts on inside of left arm; one large swollen mass; elevated blood pressure and heart rate; elevated blood pressure and heart rate; dizziness; disorientation; This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old male patient received BNT162B2, via an unspecified route of administration, administered in arm left on 04Oct2021 (Batch/Lot Number: FF8841) at the age of 81 years old, as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), via an unspecified route of administration (right arm) from 04Oct2021 (Batch/Lot number was not reported, NDC: 70461-0121-03) to 04Oct2021, at dose 1, single [65+ 0.5ml] for an unspecified indication. Medical history included pre hypertension, "BPH" (reported as Blood pressure high), bladder cancer 15 years remission, tonsillectomy, appendectomy and gall bladder removal. No known allergies. Concomitant medication(s) included hydrochlorothiazide and terazosin, both taken for unspecified indications, start and stop dates were not reported. Other medications also included vitamins. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EL3302), administered in arm left on 10Feb2021 at 03:15 PM; second dose of BNT162B2 (Batch/Lot Number: EN6203), administered in arm left on 04Mar2021 at 03:15 PM. It was reported that adverse event After second shot included three incidents of itchy hives on inside of left leg, left arm, and back over a period of several months. No history of hives. No COVID prior vaccination and was not COVID tested post vaccination. Four days after 3rd shot (also reported as "Apr2021"), about 10 itchy welts on inside of left arm which formed into one large swollen mass and required injection of antihistamines at emergency room. This was also accompanied by elevated blood pressure and heart rate. Also, dizziness and disorientation. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events were unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Trigeminal neuralgia
Clinical narrative: Trigeminal Neuralgia; Most intense pain to the right-side of my face; This is a spontaneous report from a contactable HCP (patient). A non-pregnant 41-year-old female patient received BNT162B2 via an unspecified route of administration on 23Mar2021 14:00 (41-year-old) (Batch/Lot Number: ER 8730) as dose 1, single in arm left for COVID-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), intervertebral disc protrusion (3 bulging discs), migraines (since childhood), environmental allergies. Concomitant medication included ibuprofen; diphenhydramine hydrochloride (BENADRYL); and cetirizine hydrochloride (ZYRTEC). No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Within 2 days of the 1st vaccine (25Mar2021), she started feeling the most intense pain to the right-side of her face. After 2 days of no longer being able to stand the pain, & persistent symptoms she went to the ER and no medication worked. She was told by the ER Dr. that her symptoms seemed to be trigeminal neuralgia, and to follow-up w/a Neurologist. After a slow increase of carbamazepine over the subsequent 3-4 months (and baclofen and ibuprofen as needed for intense pain), she was finally able to get the pain and symptoms controlled. Treatment received (carbamazepine/ baclofen). The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not resolved. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received BNT162B2 on 13Apr2021 14:00 (Batch/Lot Number: EW0151) as dose 2, single; and on 08Oct2021 04:45 PM (Batch/Lot Number: FF8841) as dose 3 single; both in arm left for COVID-19 immunisation.; Sender's Comments: Based on the reported information ,a causal relationship between the events Trigeminal Neuralgia and Facial Pain and suspected drug cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Immunisation, Investigation, Neuropathy peripheral
Clinical narrative: pain in my fingertips and pain in heels of my feet; my fingertips feel like a burning sensation like it burned my finger  then the heels of both of my feet have equal sensation; every time I walk it's just pain like pins and needles that type of sensation; neuropathy; Fever; Tiredness; Sluggishness; the third shot; the third shot; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 via an unspecified route of administration on 08Oct2021 at about 4 pm (at 53-year-old) (Batch/Lot Number: 30155BA) as dose 3 (booster), single in arm left for COVID-19 immunisation. Medical history included blood pressure high, blood cholesterol abnormal (reported as "Patient history: Cholesterol"). Concomitant medications included propranolol (PROPRANOLOL); losartan potassium; and atorvastatin (one is blood pressure, one is high blood pressure and cholesterol). Unspecified investigation in Jul2021 showed normal. After the previous two shots of BNT162B2 the patient had no symptoms but the third shot had multiple symptoms, the 'effect' next day (09Oct2021) was tiredness and sluggishness, the second day which was Sunday (10Oct2021) was the fever and then the third day (11Oct2021) which was yesterday and 12Oct2021 ("today") he have experienced pain in his fingertips and pain in heels of his feet. So, he guess it's also called neuropathy, never had before in his life but his fingertips felt like a burning sensation like it burned his finger and then the heels of both of his feet have equal sensation and every time he walk it's just pain like pins and needles that type of sensation and that started "yesterday" (11Oct2021) and it got worse today and he was assuming that this is a side effect because he have no underline conditions that would bring this about so suddenly so quickly. Just ibuprofen to take care of the fever, he had fever for few hours and the fever did go away. The outcome of the events neuropathy, pain in fingers/ heel, burning foot, pins and needles was not resolved; of events tiredness and sluggishness was unknown; of event fever was resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Paraesthesia, Pyrexia, Sluggishness
Clinical narrative: pain in my fingertips and pain in heels of my feet; my fingertips feel like a burning sensation like it burned my finger  then the heels of both of my feet have equal sensation; every time I walk it's just pain like pins and needles that type of sensation; neuropathy; Fever; Tiredness; Sluggishness; the third shot; the third shot; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 via an unspecified route of administration on 08Oct2021 at about 4 pm (at 53-year-old) (Batch/Lot Number: 30155BA) as dose 3 (booster), single in arm left for COVID-19 immunisation. Medical history included blood pressure high, blood cholesterol abnormal (reported as "Patient history: Cholesterol"). Concomitant medications included propranolol (PROPRANOLOL); losartan potassium; and atorvastatin (one is blood pressure, one is high blood pressure and cholesterol). Unspecified investigation in Jul2021 showed normal. After the previous two shots of BNT162B2 the patient had no symptoms but the third shot had multiple symptoms, the 'effect' next day (09Oct2021) was tiredness and sluggishness, the second day which was Sunday (10Oct2021) was the fever and then the third day (11Oct2021) which was yesterday and 12Oct2021 ("today") he have experienced pain in his fingertips and pain in heels of his feet. So, he guess it's also called neuropathy, never had before in his life but his fingertips felt like a burning sensation like it burned his finger and then the heels of both of his feet have equal sensation and every time he walk it's just pain like pins and needles that type of sensation and that started "yesterday" (11Oct2021) and it got worse today and he was assuming that this is a side effect because he have no underline conditions that would bring this about so suddenly so quickly. Just ibuprofen to take care of the fever, he had fever for few hours and the fever did go away. The outcome of the events neuropathy, pain in fingers/ heel, burning foot, pins and needles was not resolved; of events tiredness and sluggishness was unknown; of event fever was resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: 4 doses of vaccines were administered after they were under diluted, it was believed that with only 0.8 ml of diluent; 4 doses of vaccines were administered after they were under diluted, it was believed that with only 0.8 ml of diluent; This is a spontaneous report from a Pfizer sponsored program received from a contactable nurse. This nurse reported similar events for 4 patients. This is one of the four reports. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: PAA166078; Expiration Date: 17Oct2021), via an unspecified route of administration on 12Oct2021 (at the age of 74-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: not reported; Expiration Date: not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation and also received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: not reported; Expiration Date: not reported), via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunisation. It was reported that on 12Oct2021, 4 doses of PFIZER-BIONTECH COVID-19 VACCINES were administered after they were under diluted, it was believed that with only 0.8 ml of diluent as only 4 doses were drawn once mixed. The caller was wanting to know the Pfizer recommendation. The events were assessed as serious as per the reporter.; Sender's Comments: Based on plausible temporal relationship the causal role of the BNT162B2 Vaccination cannot be excluded for reported at risk events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101368323 Same reporter/drug/AE, different patient;US-PFIZER INC-202101368631 Same reporter/drug/AE, different patient;US-PFIZER INC-202101368632 Same reporter/drug/AE, different patient
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Femur fracture, Influenza like illness
Clinical narrative: Fell and broke femur; Fell and broke femur; flu like symptoms; Felt lousy; This is a spontaneous report from a contactable consumer (patient). A 77 year old female patient received bnt162b2 (BNT162B2, Lot Number: EL9262), Dose 2 via an unspecified route of administration, administered in the left arm on 12Feb2021 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162b2 on 22Jan2021 (Lot Number: Unknown) via an unspecified route of administration in the left arm for COVID-19 immunisation. On 12Feb2021, after the second dose of bnt162b2, the patient experienced felt lousy and flu like symptoms. On 27Sep2021, the patient fell and broke her femur; medically significant events.  The patient recovered from the events, after 6 hours. The patient was recovering from the fall and broken femur. The patient previously received the first dose of BNT162b2 on 12Oct2021 (Lot Number: FF2590) via an unspecified route of administration in the left arm for COVID-19 immunisation.   Follow-Up (19Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Elevated sedimentation rate; arthropathy, unspecified, involving shoulder region (sick on shoulder); This is a spontaneous report based on the information received by Pfizer. This report received from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2, intramuscularly on 17Mar2021 (Batch/Lot Number: FN6208FX; Expiration Date: Jun2021) as single dose, second dose intramuscularly on 20Apr2021 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot number was not reported) to May2021, at 40 mg (1 in 2 weeks), subcutaneous from May2021 (Batch/Lot number was not reported) and ongoing, at 40 mg, weekly (1 in 1 week) for rheumatoid arthritis. Medical history included tobacco Use from an unknown date to 1990 (stopped 1990), alcohol Use from an unknown date to 2000 (stopped 2000), sulfa drugs allergy manifestation by affects liver, methotrexate allergy manifestation by affects liver, anaemia, anxiety, pain, fibromyalgia, heart, restless legs, diabetes. Concomitant medications included metformin taken for diabetes, glipizide (GLIPIZIDE) taken for diabetes, dulaglutide (TRULICITY) taken for diabetes, ropinirole (ROPINIROLE) taken for restless legs, losartan taken for heart, carvedilol taken for heart, cyclobenzaprine taken for fibromyalgia, tramadol taken for pain, duloxetine taken for anxiety, colecalciferol (VITAMIN D), iron taken for anaemia. The patient experienced rheumatoid arthritis flare up on Apr2021, lack of drug effect/humira not working on May2021, elevated sedimentation rate on Apr2021, arthropathy, unspecified, involving shoulder region (sick on shoulder) on Apr2021. Adalimumab (HUMIRA) not working with Humira 40 mg/0.4 ml (Adalimumab). The patient was treated with prednisone. The action taken for adalimumab was dose increased. The outcome of events was not recovered.  Causality for Humira 40mg/0.4ml (Adalimumab): The reporter's causality for the event of elevated sedimentation rate was not provided. The reporter's causality for the events of rheumatoid arthritis flare up and sick on shoulder with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility. The reporter's causality for the event of Humira not working with Humira 40mg/0.4ml (Adalimumab) was a reasonable possibility.  Causality with bnt162b2: The reporter's causality for events elevated sedimentation rate and lack of drug effect was not reported, for events Rheumatoid arthritis flare up and Arthropathy, unspecified, involving shoulder region (sick on shoulder) was Possible related.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Poor feeding infant, Product use issue
Clinical narrative: My breast milk dried up; My breast milk dried up; My breast milk dried up; This is a spontaneous report from a contactable other HCP (patient).   A 25-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 06Oct2021 (at the age of 25-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history was none. No known allergies.  The patient's concomitant medications were not reported. Patient was not pregnant. No other vaccine in four weeks. Other medications in two weeks: Prenatals. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced her breast milk dried up (disability) on 07Oct2021 with outcome of not recovered. No treatment received for the event. Event resulted in disability or permanent damage. The clinical course of events was as follows: My breast milk dried up. She was producing 25+ ounces a day with him feeding as well, now she was barely producing 5 ounces a day without him eating. Everyday her supple ts worse and worse. Sha has tried power pumping, everything to get it back and nothing. She was given no education on the vaccine while breastfeeding even though she clicked that box that asked if she was breastfeeding or pregnant. Covid was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 19 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via intramuscular, in Left Arm, on 19Mar2021 (at the age of 18-year-old) as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via intramuscular, in Left Arm, on 09Apr2021 (at the age of 18-year-old) as DOSE 2, SINGLE  both for covid-19 immunization. Medical history included allergy to Some adhesives. There were no concomitant medications. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The patient tested positive for covid-19 on 13Oct2021 at 10:30. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Oct2021, sars-cov-2 test: negative on 08Oct2021, sars-cov-2 test: positive   on 13Oct2021.No treatment was received for the events. The outcome of the events was recovering at time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Feeling abnormal, Juvenile idiopathic arthritis, Post-traumatic pain
Clinical narrative: Passenger in motor vehicle accident; post-traumatic pain; Juvenile idiopathic arthritis flare; Discomfort; Tiredness; Feels bad; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4114036-00) from a contactable consumer (patient).  A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular in 2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for Moderate to severe hidradenitis suppurativa. The patient medical history was not reported. The patient's concomitant medications were not reported. In 2021, the patient experienced Pfizer vaccine caused minor discomfort/tiredness/generally felt bad. In Sep2021, the patient experienced juvenile idiopathic arthritis flare in hands. In Oct2021, the patient experienced was a passenger in a car accident/that had left in quite a bit of pain all over. On 01Oct2021, the patient experienced was a passenger in a car accident/that had left in quite a bit of pain all over. he action taken in response to the events for adalimumab was unknown. In 2021, the juvenile idiopathic arthritis flare in hands and pfizer vaccine caused minor discomfort/tiredness/generally felt bad resolved, the outcome of event Post-traumatic pain was not recovered, the outcome of rest events was unknown.  The reporter's assessment of the causal relationship of the events Feeling abnormal, Discomfort, Fatigue with the suspect product bnt162b2 was provided as Possible and for events Juvenile Idiopathic Arthritis flare, Road traffic accident and Post traumatic pain as Not reported..   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Juvenile Idiopathic arthritis flare, Feeling abnormal, discomfort and Fatigue and suspect drug BNT162B2 cannot be completely 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 Based on information available, events Road traffic accident and Post traumatic pain are  considered unrelated to BNT162B2 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident
Clinical narrative: Passenger in motor vehicle accident; post-traumatic pain; Juvenile idiopathic arthritis flare; Discomfort; Tiredness; Feels bad; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4114036-00) from a contactable consumer (patient).  A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular in 2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for Moderate to severe hidradenitis suppurativa. The patient medical history was not reported. The patient's concomitant medications were not reported. In 2021, the patient experienced Pfizer vaccine caused minor discomfort/tiredness/generally felt bad. In Sep2021, the patient experienced juvenile idiopathic arthritis flare in hands. In Oct2021, the patient experienced was a passenger in a car accident/that had left in quite a bit of pain all over. On 01Oct2021, the patient experienced was a passenger in a car accident/that had left in quite a bit of pain all over. he action taken in response to the events for adalimumab was unknown. In 2021, the juvenile idiopathic arthritis flare in hands and pfizer vaccine caused minor discomfort/tiredness/generally felt bad resolved, the outcome of event Post-traumatic pain was not recovered, the outcome of rest events was unknown.  The reporter's assessment of the causal relationship of the events Feeling abnormal, Discomfort, Fatigue with the suspect product bnt162b2 was provided as Possible and for events Juvenile Idiopathic Arthritis flare, Road traffic accident and Post traumatic pain as Not reported..   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Juvenile Idiopathic arthritis flare, Feeling abnormal, discomfort and Fatigue and suspect drug BNT162B2 cannot be completely 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 Based on information available, events Road traffic accident and Post traumatic pain are  considered unrelated to BNT162B2 vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery occlusion, SARS-CoV-2 test
Clinical narrative: Heart blockage in 3 arteries.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 01Oct2021 (at the age of 61-years-old) at dose 2, single for COVID-19 immunisation. Medical history included COVID prior vaccination and diabetes. Concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unspecified date for COVID-19 immunisation. No other vaccine received in four weeks; no other medications in two weeks. The patient experienced heart blockage in 3 arteries on 02Oct2021. The event resulted in hospitalization in Oct2021 and was treated with open heart surgery. The patient underwent lab tests and procedures, which included COVID tested post vaccination on 09Oct2021 via nasal swab: negative. The patient was recovering from the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Erectile dysfunction
Clinical narrative: erectile dysfunction; burning when urinating; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on 30Jul2021 at 11:00 (at the age of 60-years-old) at dose 1, single for COVID-19 immunization. Medical history included COVID prior vaccination. COVID was not tested post vaccination. Known allergies reported as none; other medical history was reported as none. Concomitant medications were not reported. The patient did not receive other vaccine in four weeks and other medications in two weeks were reported as none. One week after, on 06Aug2021, patient began to experience burning when urinating and approximately 3 three afterward, on 27Aug2021 (as reported), he began experience erectile dysfunction. No treatment was administered for the events. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Plantar fasciitis, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Extreme joint pain consistent with rheumatoid arthritis from shoulders down to my feet; extreme joint pain consistent with rheumatoid arthritis from shoulders down to my feet; Plantar fasciitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on 02Apr2021 11:00 AM (at the age of 50-years-old) at dose 1, single for COVID-19 immunisation. The patient was not pregnant. Medical history included COVID prior vaccination, asthma and allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) taken at 10mg, budesonide, formoterol fumarate (SYMBICORT); both reported as other medications in two weeks. No other vaccine received in four weeks. The patient experienced extreme joint pain consistent with rheumatoid arthritis from shoulders down to her feet on 07Apr2021. This lasted for 6-8 weeks. She was taking ibuprofen 3 times per day to make sitting and standing comfortable. The symptoms eventually went away but she still had plantar fasciitis from 07Apr2021. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included COVID tested post vaccination on 22Sep2021 via nasal swab: negative. No treatment was received for plantar fasciitis. The patient recovered with sequel from extreme joint pain consistent with rheumatoid arthritis from shoulders down to her feet in 2021, had not recovered from plantar fasciitis.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Gait disturbance, Menstrual disorder, Muscle tightness
Clinical narrative: legs were in pain/sharp pains on the right side of my thigh; had trouble swallowing; my thighs were tight and very hard, I could barely walk; my thighs were tight and very hard, I could barely walk; pain in her thighs which feels muscular; chest pains here and there; have not gotten my period; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 21Sep2021 at 17:00 (Batch/Lot Number: Fc3181) (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. Medical history included anemia and mitral valve prolapse. Concomitant medications included vitamin d nos and unspecified multivitamins; both taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot: FF8839), administered in the left arm in Aug2021 at 16:30 (at the age of 39-years-old) for COVID-19 immunisation and experienced heart palpitate, tongue went numb and have not gotten her period. The patient also has known allergies to acetylsalicylic acid (ASPIRIN). On 22Sep2021, after the second dose, patient reported that her legs were in pain. Patient felt sharp pains on the right side of my thigh and had trouble swallowing. The pharmacist suggested that patient should go to the ER. Patient was given pain meds and told it was an effect from the vaccine. Patient was told to take Tylenol and follow up with her doctor. Patient also reported that her thighs were tight and very hard that she could barely walk. Patient had to take rest constantly because of the pain. Patient followed up with the doctor, had an ultrasound, waiting on results. It is now mid-October and patient still have pain in her thighs which feels muscular, but she is not sure and cannot walk for a long period of time. Patient now have to see a rheumatologist. The patient get chest pains here and there but the doctor said her heart is ok. Patient also have not gotten her period since the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient was given IV pain medications and Tylenol Extra Strength as treatment for the events. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101371429 same patient/drug, different dose/events
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Ultrasound scan
Clinical narrative: legs were in pain/sharp pains on the right side of my thigh; had trouble swallowing; my thighs were tight and very hard, I could barely walk; my thighs were tight and very hard, I could barely walk; pain in her thighs which feels muscular; chest pains here and there; have not gotten my period; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 21Sep2021 at 17:00 (Batch/Lot Number: Fc3181) (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. Medical history included anemia and mitral valve prolapse. Concomitant medications included vitamin d nos and unspecified multivitamins; both taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot: FF8839), administered in the left arm in Aug2021 at 16:30 (at the age of 39-years-old) for COVID-19 immunisation and experienced heart palpitate, tongue went numb and have not gotten her period. The patient also has known allergies to acetylsalicylic acid (ASPIRIN). On 22Sep2021, after the second dose, patient reported that her legs were in pain. Patient felt sharp pains on the right side of my thigh and had trouble swallowing. The pharmacist suggested that patient should go to the ER. Patient was given pain meds and told it was an effect from the vaccine. Patient was told to take Tylenol and follow up with her doctor. Patient also reported that her thighs were tight and very hard that she could barely walk. Patient had to take rest constantly because of the pain. Patient followed up with the doctor, had an ultrasound, waiting on results. It is now mid-October and patient still have pain in her thighs which feels muscular, but she is not sure and cannot walk for a long period of time. Patient now have to see a rheumatologist. The patient get chest pains here and there but the doctor said her heart is ok. Patient also have not gotten her period since the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient was given IV pain medications and Tylenol Extra Strength as treatment for the events. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101371429 same patient/drug, different dose/events
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: Sharp pain left eye; pain to left eye/swelling; This is a spontaneous report from a contactable consumer(patient). A 65-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Not reported) via an intramuscular route of administration, administered in Arm Right on 18Feb2021 at 16:00 as (age at vaccination 65-year-old) dose 2, single for covid-19 immunization. The patients medical history was not reported. The patients concomitant medications were none. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date (age at vaccination 65-year-old) as dose 1, single for covid-19 immunization and experienced very weak and fatigued. No vaccine was administered within 4 weeks Prior to vaccination. The patients medical history and concomitant medications was not reported. On 20Feb2021 at 19:00 the patient experienced sharp pain left eye, pain to left eye/swelling. The patient visited physician office for the events.  Antibiotics was given as a medication for the events. The outcome of the events was reported as recovered on 30Mar2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Immunisation, Off label use
Clinical narrative: Feels something in chest; Caller states it was a Pfizer shot, the third dose; Caller states it was a Pfizer shot, the third dose; This is a spontaneous report from a contactable consumer (patient).   A 91-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single (booster) dose for COVID-19 immunisation.  Medical history included pacemaker from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient reported that "he feels something in chest" in 2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unspecified date.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out and the next day the ambulance came and took him and he always passes out; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. Medical history included needle phobia. The patient's concomitant medications/other products was unknown. On an unspecified date, the patient passed out and on the next day, the ambulance came and took him to the hospital as he always passes out. It was unknown if the investigation's assessment was reported. The outcome of the event was unknown at the time of report.   The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness and BNT162B2.  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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Carpal tunnel syndrome, Computerised tomogram, Feeling abnormal, Hemiparesis
Clinical narrative: weakness on his left side; felt like fell off a roof; neck problems with popping; soreness in neck; tightness in the upper part of his back; tingling from his shoulder to his fingertips in both of his arms; numbness on his fingertips; weakness in his left arm; neck issue is arthritis; his shoulder to elbow is an ulnar nerve problem; a carpal tunnel pain in the bottom of his left foot.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EN6207) as DOSE 2, SINGLE for covid-19 immunisation at age of 82 years old. There were no medical history or concomitant medications. The patient previously received the first dose of bnt162b2 on 25Feb2021 (lot number EL9266) in left arm for Covid-19 immunization at age of 82 years old. After 2 weeks, the patient was in bed one night and when he woke up, he felt like fell off a roof. He had neck problems with popping and soreness in neck, tightness in the upper part of his back, tingling from his shoulder to his fingertips in both of his arms but that went away already, numbness on his fingertips, as well as weakness in his left arm. He went to the emergency room for cat scan, MRI, and other electronic test and was told that his neck issue was arthritis and his shoulder to elbow was an ulnar nerve problem and a carpal tunnel pain in the bottom of his left foot. He had weakness on his left side. His left was the worst. The patient stated that it was worse on his left side and with the exception of the tingling, have stayed the same since March and have been 6 months already. He can stand now. After the MRIs and tests, the doctors told him not to take the booster shot. They thought since all of these symptoms came on suddenly within 7 hours that it could have been a reaction to the vaccine. They told him not to take the booster. He was torn because he didn't want his immunity to go down by not getting the booster. He had symptoms on both sides, but it was worst on the left. This happened like 2 weeks later. He thought it was 12Apr2021. The only thing that went away was the tingling. The neck problem has gotten a lot better. He has to wear wrist bands on both wrists at night. He has been doing that for 6 weeks now with no change what so ever. The events all occurred on 12Apr2021. The events required emergency room visit and physician office visit. The outcome of events neck problems with popping, soreness in neck was resolving, events tightness in the upper part of his back, numbness on his fingertips was not resolved, event tingling from his shoulder to his fingertips in both of his arms was resolved, outcome of other events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Magnetic resonance imaging, Muscle tightness, Muscular weakness
Clinical narrative: weakness on his left side; felt like fell off a roof; neck problems with popping; soreness in neck; tightness in the upper part of his back; tingling from his shoulder to his fingertips in both of his arms; numbness on his fingertips; weakness in his left arm; neck issue is arthritis; his shoulder to elbow is an ulnar nerve problem; a carpal tunnel pain in the bottom of his left foot.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EN6207) as DOSE 2, SINGLE for covid-19 immunisation at age of 82 years old. There were no medical history or concomitant medications. The patient previously received the first dose of bnt162b2 on 25Feb2021 (lot number EL9266) in left arm for Covid-19 immunization at age of 82 years old. After 2 weeks, the patient was in bed one night and when he woke up, he felt like fell off a roof. He had neck problems with popping and soreness in neck, tightness in the upper part of his back, tingling from his shoulder to his fingertips in both of his arms but that went away already, numbness on his fingertips, as well as weakness in his left arm. He went to the emergency room for cat scan, MRI, and other electronic test and was told that his neck issue was arthritis and his shoulder to elbow was an ulnar nerve problem and a carpal tunnel pain in the bottom of his left foot. He had weakness on his left side. His left was the worst. The patient stated that it was worse on his left side and with the exception of the tingling, have stayed the same since March and have been 6 months already. He can stand now. After the MRIs and tests, the doctors told him not to take the booster shot. They thought since all of these symptoms came on suddenly within 7 hours that it could have been a reaction to the vaccine. They told him not to take the booster. He was torn because he didn't want his immunity to go down by not getting the booster. He had symptoms on both sides, but it was worst on the left. This happened like 2 weeks later. He thought it was 12Apr2021. The only thing that went away was the tingling. The neck problem has gotten a lot better. He has to wear wrist bands on both wrists at night. He has been doing that for 6 weeks now with no change what so ever. The events all occurred on 12Apr2021. The events required emergency room visit and physician office visit. The outcome of events neck problems with popping, soreness in neck was resolving, events tightness in the upper part of his back, numbness on his fingertips was not resolved, event tingling from his shoulder to his fingertips in both of his arms was resolved, outcome of other events was unknown.   Follow-up attempts are completed. No further information is expected.