chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; myalgia; fever; Pain in my hips affected my ability to walk/gait; Pain was 8/10, constant, achy and throbbing; This is a spontaneous report from a contactable physician.  A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685 expiration date unknown), intramuscularly, on an unspecified date in  Dec2020 at 17:00 (at the age of 32-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Just shy of twenty-four hours after receiving the vaccine,  the patient developed bone/ joint pain in hips and shoulders, myalgias, a fever and pain in her hips which affected her ability to walk/gait. Her pain was 8/10, constant, achy and throbbing. Movement and sitting in the same position exacerbated the symptoms. The patient specified that she did not receive any treatment for the events. She did mention, however, that a hot shower and sleep eased her symptoms.  The clinical outcome of bone pain, joint pain, myalgia, fever, pain and difficulty in walking was reported as self-limited and resolved completely within 12-14 hours. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient received vaccine the 28th of December 2020. Physical exam show erythema, warm to touch, itching, slightly raised area and blanching to palpation. Circle drawn around redness previous night (2inx1.5in approx) and redness has progressed to larger diameter . Denies pain at sight. Patient has long painted nails. Patient given oral antibiotics, cephalexin 500mg taken 4 times a day for 10 days as well as topical steroid cream, triamcin acet 0.025% to be applied to area twice a day for 2 days. Instructed to follow up in two days to evaluation. During follow up, area noted to be improving. Instructed to continue current treatment and return if worsening of symptoms or development of new symptoms, fever/chills.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted Sars-Cov-2 in between her two doses; contracted Sars-Cov-2 in between her two doses; This is a spontaneous report from a Contactable Other HCP. A female patient of an unspecified age started to receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was due for her 2nd dose of Pfizer-Biontech Covid19 vaccine on 06Jan2020. She contracted Sars-Cov-2 in between her two doses, want to know if she should receive her second dose as scheduled. Patient had COVID-19 test with unknown result. Outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (contracted SARS CoV 2) with BNT162b2 cannot be completely excluded.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: very bad dizziness that lasted over an hour
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Chest discomfort, Chest pain, Drooling, Dyspnoea
Clinical narrative: I run twice a week. One 6-8 mile and one 10-12 mile run.  I breathe through my nose mostly and I'm in very good pulmonary and cardiovascular condition.  I went for a run and 1 mile in I started drooling a lot! Spitting out mouthfuls every 15-30 seconds and I never spit.  Then my chest got tight and hurt and got irritated.  The feeling was identical to Bronchitis.  I started walking home and my breathing rate increased with wheezing. I got nauseous and was bent over with saliva poring out of my mouth.  Walking up one flight of stairs was difficult.  I have a finger pulse oximeter and it was at 84!  Breathing was very rapid and difficult. After 5 minutes it went up to 94 and then up to 98-99 after 1 more minute (when my pulse fell back under 100bpm.  Chest tightness continued for about 1 hour before I was back to normal for the most part. by today I feel 100% again.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Nausea, Respiratory rate increased, Respiratory tract irritation, Salivary hypersecretion
Clinical narrative: I run twice a week. One 6-8 mile and one 10-12 mile run.  I breathe through my nose mostly and I'm in very good pulmonary and cardiovascular condition.  I went for a run and 1 mile in I started drooling a lot! Spitting out mouthfuls every 15-30 seconds and I never spit.  Then my chest got tight and hurt and got irritated.  The feeling was identical to Bronchitis.  I started walking home and my breathing rate increased with wheezing. I got nauseous and was bent over with saliva poring out of my mouth.  Walking up one flight of stairs was difficult.  I have a finger pulse oximeter and it was at 84!  Breathing was very rapid and difficult. After 5 minutes it went up to 94 and then up to 98-99 after 1 more minute (when my pulse fell back under 100bpm.  Chest tightness continued for about 1 hour before I was back to normal for the most part. by today I feel 100% again.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: I run twice a week. One 6-8 mile and one 10-12 mile run.  I breathe through my nose mostly and I'm in very good pulmonary and cardiovascular condition.  I went for a run and 1 mile in I started drooling a lot! Spitting out mouthfuls every 15-30 seconds and I never spit.  Then my chest got tight and hurt and got irritated.  The feeling was identical to Bronchitis.  I started walking home and my breathing rate increased with wheezing. I got nauseous and was bent over with saliva poring out of my mouth.  Walking up one flight of stairs was difficult.  I have a finger pulse oximeter and it was at 84!  Breathing was very rapid and difficult. After 5 minutes it went up to 94 and then up to 98-99 after 1 more minute (when my pulse fell back under 100bpm.  Chest tightness continued for about 1 hour before I was back to normal for the most part. by today I feel 100% again.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine with aura, Visual impairment
Clinical narrative: Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER, Lot number: EL1284, expiry date not reported), via an unspecified route of administration on 04Jan2021 09:00 at a single dose on Left arm for COVID-19 immunisation. Medical history included Migraine, asthma, seasonal allergies, RLS (Restless legs syndrome). Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), sumatriptan succinate (IMITREX), fluticasone propionate (FLONASE ALLERGY RELIEF). The patient previously took Amoxicillin, codeine and experienced allergies. The patient experienced ocular migraine, onset at 14:00, took 1 dose of Imitrex (25 mg) at 14:15. Vision began to improve at 14:40. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: Joint pain; I started feelings like I am having flu like symptoms like chills; Body fatigue; This is a spontaneous report from a contactable consumer.  A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported ), via an unspecified route of administration on the upper arm on 23Dec2020 at a single dose for COvid-19 immunization. Medical history included triglycerides (abnormal).  Concomitant medication included eicosapentaenoic acid ethyl ester (VASCEPA) for triglycerides. The patient is a dialysis technician in a dialysis Unit. The vaccine was given in a facility. The patient got the Covid Vaccine on 23Dec2020 and its like more than a week now, on an unspecified date, he felt joint pain, body fatigue and two nights ago, he started feelings like he was having flu like symptoms like chills he took his temperature and its normal so he doesnt know if there is a reported reactions like this that he was feeling and he would like to know what does he needs to do, to know anything and an advice. He was scheduled for the blood work done at this month. The patient was taking only paracetamol (TYLENOL) for his joint pain, and chills and that's the only thing that he is experiencing right now. The consumer did not undergo emergency room or physician office. Outcome of the event chills was not recovered, while for the other events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching and swelling at injection site
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19 more than a week after receiving our COVID-19 vaccine; tested positive for COVID-19 more than a week after receiving our COVID-19 vaccine; This is a spontaneous report from a non-contactable consumer. A 45-years-old patient of an unspecified gender started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient tested positive for COVID-19 more than a week after receiving COVID-19 vaccine. Outcome of the event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Diarrhoea, Dizziness, Flushing, Insomnia
Clinical narrative: Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: she has been itching for hours and the sensation keeps coming and going; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration and unspecified date at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. On an unknown date, the patient stated that she has been itching for hours and the sensation keeps coming and going. It worsens in the morning and not so much in the evening. She said that there was no rash, just itching. The patient was asking any information on itching as a side effect of the vaccine. Outcome of the event was not recovered.   Information about Lot/Batch number is requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nightmare, Thirst
Clinical narrative: Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain in extremity
Clinical narrative: extreme fatigue and extreme migraine starting 9 hours after vaccine and lasting 24 hours, slightly sore arm for 24 hours
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Hyperhidrosis, Pain, Somnolence
Clinical narrative: Body aches; Sweating; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had side effects symptoms for 8 days after receiving the COVID-19 vaccine. Side effects reported were body aches, sweating, loss of appetite, weakness and sleepiness, the patient is being treated for his symptoms. The patient wanted to know how long his symptoms will last, stated that 8 days is not normal. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EH9899), intramuscular on the left deltoid on 29Dec2020 at SINGLE DOSE as COVID prevention at the hospital.  Medical history included ongoing hypothyroidism for about 3 or 4 years, sinus headache, and ear pressure. It was reported that the patient had palpitations in the past but has not had any recently. Concomitant medications included ongoing liothyronine sodium (CYTOMEL) for hypothyroidism and phenylephrine (PHENYLEPHRINE) from unknown date until 31Dec2020 for ear pressure and sinus headache. The patient had her first dose of the COVID vaccine on 29Dec2020 and she had no problems at first, but she stated that she was seeing an increase in the amount of chest palpitations that she was having since 31Dec2020. She knew it was cold and fly season (uncommon for her to have ear pressure and headaches with weather changes) and she had to take some sinus medicines, so she just blew the palpitations off as having come from those sinus medicines but she was no longer taking those medicines and the palpitations were still persisting. The patient also mentioned that she was watching her caffeine intake, and she even was not having any more caffeine than she normally does. She really noticed the palpitations over the holiday weekend, and it felt like it was getting worse, and then she started feeling like she needed to reset herself. Outcome of the event was not recovered. As per causality, the patient also mentioned that it was unknown if the palpitations were caused by the vaccine, but she feared that they were. She also mentioned that she had no other vaccines on the same day as the COVID Vaccine so she was not sure.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no a/e, pt is under the age limit
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Paralysis, Pyrexia, SARS-CoV-2 test
Clinical narrative: I was pretty sick, I felt palsy; I was pretty sick, I felt palsy; I developed the fever for all about 30 hours after the vaccination; Headache; This is a spontaneous report from a contactable physician. This physician reported for himself that a 67-years-old male patient received BNT162B2 (BioNTech Covid 19 vaccine; Batch/lot number: EL1284), via an unspecified route of administration on 30Dec2020 at SINGLE DOSE for "Because I am a physician, a healthcare provider" (covid-19 immunization).  Medical history included had Covid back on the 4th of December.  There were no concomitant medications. Physician stated he was wondering he just took your Pfizer Covid vaccination, the first one. He took it couple of days ago. He took it on the 30th of this month, two days ago. Physician further stated he developed the fever for all about 30 hours after the vaccination. Just because he developed the fever with the first one, it was like a 101.7 that was about 36 hours. So the question was just because he developed the fever with the first one, he was pretty sick, he meant he felt palsy, you know headache and all that it was like probably developed the same with the second one? Patient weight was maybe 125 pounds. When probed if vaccine was prescribed by any Physician, Physician stated he went himself. Causality by physician stated as "he think so". Lab work reported as He did not have the results yet. He just look a Covid screening test because he had Covid back on the 04Dec. So, he just took a Covid screening test. Treatment received included aspirin. The outcome of all events was unknown.; Sender's Comments: The causal relationship between BNT162B2 and the event palsy cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: SARS-CoV-2 test positive
Clinical narrative: had the COVID-19 vaccine on 28Dec2020 and was tested positive today (04Jan2021) for COVID-19; had the COVID-19 vaccine on 28Dec2020 and was tested positive today (04Jan2021) for COVID-19; This is a spontaneous report from a contactable other hcp via the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID-19 vaccine on 28Dec2020 and was tested positive today (04Jan2021) for COVID-19. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported positive with Covid 19 test after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient developed an exanthem involving the trunk, arms, neck, legs within 12 hour of his last dose of 875mg Amoxacillin for tooth abscess on day ten post the first immunization for COVID-19 (Moderna). The rash was maculopapular and mildly itchy treated within a couple of hours post discovery (member awakened with rash this AM) with benadryl via urgent care, no major change after benadryl.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable other hcp, the patient. This female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tinnitus 3 days after getting the vaccine. She stated it was getting worse over time. The clinical outcome of tinnitus was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Pt states palpitations.  PT monitored, VS at released from observation area were normal for this patient.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature abnormal, Chest pain, Fatigue, Malaise
Clinical narrative: Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Pruritus
Clinical narrative: itchy face; warm face; facial flushing; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (04Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable other hcp and a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, expiry date: Mar2021, via an unspecified route of administration on 04Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. An intern called to see if there was any cholesterol in the Covid vaccine or the amount of cholesterol in the vaccine. The patient had itchy face and warm face after receiving the vaccine. It was clarified that there was cholesterol in the vaccine, she would just like to know the source, she also clarified that the patient had facial flushing. The 1st Dose was on 04Jan2021, she reported facial flushing a few minutes later went away, the patient has already left. The patient states that she is vegan and wanted to know the source of cholesterol and if that could cause the facial flushing. The outcome of the event facial flushing was recovered while other events were unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Oropharyngeal pain
Clinical narrative: The Patient present Sore throat , cough ,hoarseness . the doctor gave him Benadryl 50 mg IM now
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; This is a spontaneous report from a contactable Nurse. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter called about Covid vaccine and has a question connected to the AE he has reported. Wants to know if neuropathy is a side effect of the vaccine. Event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this case, pending further details such as medical history, clinical course, specified event description, at this moment, the mentioned neuropathy is considered related to BNT162B2 for reporting purpose.   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 RA, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Microembolism, Skin discolouration, Tenderness
Clinical narrative: Development of microemboli on distal, fourth right phalange on the ventral surface. Just past the DIP. Small blue hue below skin surface with mild tenderness on deep palpation.; This is a spontaneous report from a non-contactable Physician (patient). This adult female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 23Dec2020 09:30 at single dose on right arm for COVID-19 immunisation. Medical history included migraine with aura. Concomitant medication included propranolol, loratadine (CLARITINE) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefprozil (CEFZIL) and experienced allergies. The patient experienced development of microemboli on distal, fourth right phalange on the ventral surface. Just past the DIP. Small blue hue below skin surface with mild tenderness on deep palpation on 24Dec2020 12:00. The event was considered as non-serious. Treatment for the events was unknown. The outcome of the event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event microemboli on distal phalange with BNT162b2 can not be fully 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Neck pain, Photophobia
Clinical narrative: headache, nausea, light sensitivity, neck pain, general not feeling well, not sleeping well
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Chest discomfort, Chest pain, Electrocardiogram normal, Influenza like illness
Clinical narrative: States the intermittent muscle pain, and pain in chest and arms is worse now; tightness come into his chest; started having pains in his muscles in  his chest and arms and they would reach up into throat; pains in muscles, chest and arms; pains in muscles, chest and arms/it hit him in the chest; pains in muscles, chest and arms; AFib; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot/batch number and Expiration date were not provided), intramuscular at left arm on an unspecified date at single dose for immunization. Medical history included seasonal allergies (serious reaction to Mountain Cedar because he lives in the mountains). Concomitant medication included finasteride, testosterone; both from 2013 and ongoing. Patient stated when he first took the vaccine he had flu like symptoms (19Feb2015) for 2 weeks and AFib (19Feb2015) and other problems, states these issues resolved after 3 weeks, stated later he developed a situation, states when he started to use any energy or adrenaline he started having pains in his muscles in  his chest and arms and they would reach up into throat (all from Nov2018), states this was intermittent, sometimes would have it and sometimes wouldn't have it, states this really came into play in Nov2018, states he was working out one day and it hit him in the chest and had to stop working out, did not understand what happening, states at that time, he has a serious reaction to Mountain Cedar because he lives in the mountains, and he had just started taking Claritin to cover the mountain cedar problem. Over time in the spring, he gets off of antihistamine and it still continues, recently in the last month it has really come into play and he can just walk across a room quickly an the can feel the tightness come into his chest, the physician that did administer the vaccine put him on an EKG two years after vaccine to check if he has a heart problem, states he has a near perfect EKG. Stated the intermittent muscle pain, and pain in chest and arms is worse now than it was when it first started. States that he will work through it and it will dissipate after about 15 minutes. The patient wanted to know if there is an antidote to the vaccine. The outcome of the events AFib and Flu like symptoms were recovered in 2015; events Muscle pain, Chest pain, Pain in arm and Condition worsened were not recovered; other events were unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: States the intermittent muscle pain, and pain in chest and arms is worse now; tightness come into his chest; started having pains in his muscles in  his chest and arms and they would reach up into throat; pains in muscles, chest and arms; pains in muscles, chest and arms/it hit him in the chest; pains in muscles, chest and arms; AFib; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot/batch number and Expiration date were not provided), intramuscular at left arm on an unspecified date at single dose for immunization. Medical history included seasonal allergies (serious reaction to Mountain Cedar because he lives in the mountains). Concomitant medication included finasteride, testosterone; both from 2013 and ongoing. Patient stated when he first took the vaccine he had flu like symptoms (19Feb2015) for 2 weeks and AFib (19Feb2015) and other problems, states these issues resolved after 3 weeks, stated later he developed a situation, states when he started to use any energy or adrenaline he started having pains in his muscles in  his chest and arms and they would reach up into throat (all from Nov2018), states this was intermittent, sometimes would have it and sometimes wouldn't have it, states this really came into play in Nov2018, states he was working out one day and it hit him in the chest and had to stop working out, did not understand what happening, states at that time, he has a serious reaction to Mountain Cedar because he lives in the mountains, and he had just started taking Claritin to cover the mountain cedar problem. Over time in the spring, he gets off of antihistamine and it still continues, recently in the last month it has really come into play and he can just walk across a room quickly an the can feel the tightness come into his chest, the physician that did administer the vaccine put him on an EKG two years after vaccine to check if he has a heart problem, states he has a near perfect EKG. Stated the intermittent muscle pain, and pain in chest and arms is worse now than it was when it first started. States that he will work through it and it will dissipate after about 15 minutes. The patient wanted to know if there is an antidote to the vaccine. The outcome of the events AFib and Flu like symptoms were recovered in 2015; events Muscle pain, Chest pain, Pain in arm and Condition worsened were not recovered; other events were unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Paraesthesia
Clinical narrative: Pt described tingling of face and body just at time of vaccination
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Facial paralysis, Magnetic resonance imaging abnormal
Clinical narrative: Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 31Dec2020 11:00 AM via unknown route of administration at single dose for COVID-19 immunization. Medical history included high blood pressure, but went up and down and had to readjust. His BP was high and not sure how long it was that way. Concomitant medications included unspecified blood pressure medications. There were no known allergies. Patient went to ER left side of face sagging. They did MRI it showed he had stroke. It Happened before 4pm that same day as vaccine on 31Dec2020 02:00 PM. And it Happened between 2-4 pm. Patient received treatment. Patient had ER test blood, cat scan, MRI. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. This case was assessed non-serious by reporter. And the events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and fever
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Headache, Heart rate increased
Clinical narrative: Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Tremor
Clinical narrative: Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, Swelling
Clinical narrative: Swollen area under the skin on left hand that is causing  numbness in the palm, thumb and first finger. Some swelling to the hand as well
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Fatigue, myalgia, arthralgia, bone pain, sore throat and pharyngitis.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngitis, SARS-CoV-2 test negative
Clinical narrative: Fatigue, myalgia, arthralgia, bone pain, sore throat and pharyngitis.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fibromyalgia, Headache, Neuropathy peripheral, Pain
Clinical narrative: fibromyalgia and neuropathy on the lower cervical/pain has exacerbated; fibromyalgia and neuropathy on the lower cervical/pain has exacerbated; headache; channeled body pain; fever at 100.7F; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date (reported as 31Jan2020) as a single dose for COVID-19 immunization. Medical history included fibromyalgia and neuropathy on the lower cervical. The patient's concomitant medications were not reported. The patient experienced fibromyalgia and neuropathy on the lower cervical/pain has exacerbated, headache, channeled body pain, and fever at 100.7 F on an unspecified date. It was reported that headache, channeled body pain, and fever at 100.7 F occurred 1 hour after vaccination. The patient underwent lab tests and procedure, which included: body temperature: 100.7 Fahrenheit  on an unspecified date. The patient has been taking unspecified medications for the condition, in addition to acetaminophen (TYLENOL FOR ARTHRITIS). Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of fibromyalgia and neuropathy on the lower cervical/pain has exacerbated, headache, channeled body pain, and fever at 100.7 F was unknown.