chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count normal, Chills, Diarrhoea, Hypersensitivity, Laboratory test normal
Clinical narrative: Allergic reaction; Diarrhea; Chills; Palpitation; Tongue and throat swelling; Tongue and throat swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO141), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. The patient's medical history included asthma and allergy. Concomitant medication included levosalbutamol hydrochloride (XOPENEX) for asthma and cetirizine hydrochloride (ZYRTEC) for allergy. About hour and a half to two hours after the vaccine, on 21Dec2020, the patient experienced had an allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling. The patient took diphenhydramine (BENADRYL) 25 mg as treatment. It helped some. She woke up this morning (22Dec2020) and still had the symptoms. So, she went to the emergency room. They gave her diphenhydramine 25 mg IV, methylprednisolone (SOLUMEDROL), and famotidine (PEPCID). The patient underwent lab tests and procedures which included blood count and chemistry and lab work which showed normal on 22Dec2020. Outcome of the events was unknown. The patient thinks that the product had causality to the events.  Information on the lot/batch number has been requested.; Sender's Comments: The patient's medical history included asthma and allergy. Based on information available, the reported allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling was likely related to the use of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course.  The case will be reassessed should additional information become 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pharyngeal swelling, Swollen tongue
Clinical narrative: Allergic reaction; Diarrhea; Chills; Palpitation; Tongue and throat swelling; Tongue and throat swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO141), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. The patient's medical history included asthma and allergy. Concomitant medication included levosalbutamol hydrochloride (XOPENEX) for asthma and cetirizine hydrochloride (ZYRTEC) for allergy. About hour and a half to two hours after the vaccine, on 21Dec2020, the patient experienced had an allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling. The patient took diphenhydramine (BENADRYL) 25 mg as treatment. It helped some. She woke up this morning (22Dec2020) and still had the symptoms. So, she went to the emergency room. They gave her diphenhydramine 25 mg IV, methylprednisolone (SOLUMEDROL), and famotidine (PEPCID). The patient underwent lab tests and procedures which included blood count and chemistry and lab work which showed normal on 22Dec2020. Outcome of the events was unknown. The patient thinks that the product had causality to the events.  Information on the lot/batch number has been requested.; Sender's Comments: The patient's medical history included asthma and allergy. Based on information available, the reported allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling was likely related to the use of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course.  The case will be reassessed should additional information become 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Rash
Clinical narrative: General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Rash on chest/neck; This is a spontaneous report from a contactable Pharmacist. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscularly on 22Dec2020 13:15 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced rash on chest/neck. General weakness requiring assistance to stand on 22Dec2020 17:00 with outcome of recovered in Dec2020. The date report was first received from source was 23Dec2020. Patient received Fluid bolus, IV benadryl, IV steroid as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The events were reported as non-serious.; Sender's Comments: The reported events rash on chest/neck and general weakness requiring assistance to stand were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course.  The case will be reassessed should additional information become 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Feeling hot, Flushing, Pruritus, Rash macular
Clinical narrative: 15 min after the vaccine I was flushed and felt hot , ears felt hot as well.  I had a  macular rash on chest and arms. My throat felt itchy and they immediately gave me benedryl.  I was tahycardic as well. When I got home from the ER that night I had to take more benedryl and then the next morning  I was still itchy and my voice was hoarse so I took more xyzal and famotidine. The rash subsided and I continued taking xyzal twice a day , benedryl and famotidine for a week.  After my vaccine the itching did not subside for about 48 hours and it was very difficult to control. I had to take max doses of antihistamines to control the hoarseness In my voice and itching
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Throat irritation
Clinical narrative: 15 min after the vaccine I was flushed and felt hot , ears felt hot as well.  I had a  macular rash on chest and arms. My throat felt itchy and they immediately gave me benedryl.  I was tahycardic as well. When I got home from the ER that night I had to take more benedryl and then the next morning  I was still itchy and my voice was hoarse so I took more xyzal and famotidine. The rash subsided and I continued taking xyzal twice a day , benedryl and famotidine for a week.  After my vaccine the itching did not subside for about 48 hours and it was very difficult to control. I had to take max doses of antihistamines to control the hoarseness In my voice and itching
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial paralysis, Laboratory test, Pain in jaw
Clinical narrative: woke up with partial right sided facial paralysis/went to the ER to r/o a stroke and was confirmed to be Bell's Palsy/complete right sided facial paralysis; woke up with right sided jaw pain that lasted all day; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ek5730, via an unspecified route of administration on 18Dec2020 12:15 at Hospital at the Right arm at single dose for COVID-19 immunisation. Medical history included Allergies to Chemical Sunscreen from an unknown date. Concomitant medication included Daily Multivitamin which was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient woke up with right sided jaw pain on 22Dec2020 07:00 AM that lasted all day. 23Dec2020 she woke up with partial right sided facial paralysis. The patient went to the ER (Emergency Room) to r/o (rule out) a stroke and was confirmed to be Bell's Palsy. 24Dec2020 she woke up with complete right sided facial paralysis. The events resulted in Emergency room.  The patient underwent lab tests and procedures which included CT (computerised tomogram) scan: unknown results in Dec2020. Therapeutic measures were taken as a result of the events and included RX (prescription) medication, OTC (Over-the-counter) pain meds. The outcome of the events was not recovered.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event facial paralysis 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Joint dislocation, Surgery, Upper limb fracture
Clinical narrative: Fractured and dislocated rt shoulder while doing exercise; Fractured and dislocated right shoulder while doing exercise; This is a spontaneous report from a contactable Physician (patient). A 54-years-old female patient received first dose bnt162b2 (BNT162B2, Lot number: EK5730), via an unspecified route of administration on 19Dec2020 14:30 at single dose on Left arm  for COVID-19 immunisation. Medical history was none. Concomitant medication included ergocalciferol (VIT D), fish oil (OMEGA 3 FISH OILS), ubidecarenone (CO Q10), apple cider vinegar (APPLE CIDER VINEGAR). The patient experienced Fractured and dislocated right shoulder while doing exercise on 20Dec2020 09:30 AM. Therapeutic measures included getting surgery. The event outcome was not recovered. The event was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products.; Sender's Comments: The events of fractured and dislocated right shoulder were most likely due to an intercurrent accident during exercise and unrelated to vaccination with BNT162B2. The impacts of this report on the benefit/risk profile of the 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor
Clinical narrative: patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; This is a spontaneous report from a non-contactable other hcp reporting for a patient.  A 58-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EH9899), intramuscular on 21Dec2020 16:00 at single dose on left arm for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was reported that during her 15 minute waiting period after the injection (21Dec2020 16:15), the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse. Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals. Patient discharge: stable to go home and follow up with PCP. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the compatible time association, the dizziness and shakiness are possibly related to suspect BNT162B2 administration. 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: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Physical examination, Vertigo
Clinical narrative: As I stated on previous page, had no ill effects from the first shingle shot on 10/21/20 given by Staff at Pharmacy.  Had 2nd shot on 12/20/21 by, PA at Pharmacy.  Woke up around 2:00 a.m. and the room and bed felt like it was spinning and tilting, never had that feeling before.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Enlarged uvula, Headache, Immediate post-injection reaction, Lip swelling
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot number EK5730) in the left arm at single dose on 17Dec2020 16:00 (04:00PM) for COVID-19 immunization. Medical history included angioedema, migraines, asthma. Known allergies: Sulfa, Clonazepam, Estrogen, IMITREX. Concomitant medications included XYZAL, BREO ELLIPTA, Nortriptyline, Propranolol, and CIMETIDIN. Patient was not pregnant at the time of vaccination. Facility type vaccine was hospital. There was no other vaccine in four weeks. Immediately after receiving vaccine tongue felt fuzzy/little swollen (17Dec2020 16:00). Also lightheaded, dizzy, eyes not focusing very well (17Dec2020 16:00). After 10-15 minutes, eyes focusing better but still lightheaded. 1 hour later noted swelling of uvula, posterior palatal arches, neck, face, lips, intermittent wheezing (17Dec2020). Next day headache and rash started (18Dec2020). Now day 8 with continued intermittent severe swelling, wheezing, rash, headache and some level of oral and facial swelling every day as noted above. Muscle aches started last night (23Dec2020). Events "tongue felt fuzzy/little swollen, lightheaded, dizzy, eyes not focusing very well, swelling of uvula, posterior palatal arches, neck, face, lips, intermittent wheezing" lead to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment of above mentioned events included antihistamines, steroids, inhaler, H2 blocker. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Since the vaccination, has the patient been tested for COVID-19 was no. The outcome of event eyes not focusing very well was recovering. The outcome of other events was not recovered. Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palatal swelling, Paraesthesia oral, Rash, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot number EK5730) in the left arm at single dose on 17Dec2020 16:00 (04:00PM) for COVID-19 immunization. Medical history included angioedema, migraines, asthma. Known allergies: Sulfa, Clonazepam, Estrogen, IMITREX. Concomitant medications included XYZAL, BREO ELLIPTA, Nortriptyline, Propranolol, and CIMETIDIN. Patient was not pregnant at the time of vaccination. Facility type vaccine was hospital. There was no other vaccine in four weeks. Immediately after receiving vaccine tongue felt fuzzy/little swollen (17Dec2020 16:00). Also lightheaded, dizzy, eyes not focusing very well (17Dec2020 16:00). After 10-15 minutes, eyes focusing better but still lightheaded. 1 hour later noted swelling of uvula, posterior palatal arches, neck, face, lips, intermittent wheezing (17Dec2020). Next day headache and rash started (18Dec2020). Now day 8 with continued intermittent severe swelling, wheezing, rash, headache and some level of oral and facial swelling every day as noted above. Muscle aches started last night (23Dec2020). Events "tongue felt fuzzy/little swollen, lightheaded, dizzy, eyes not focusing very well, swelling of uvula, posterior palatal arches, neck, face, lips, intermittent wheezing" lead to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment of above mentioned events included antihistamines, steroids, inhaler, H2 blocker. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Since the vaccination, has the patient been tested for COVID-19 was no. The outcome of event eyes not focusing very well was recovering. The outcome of other events was not recovered. Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Vision blurred, Wheezing
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot number EK5730) in the left arm at single dose on 17Dec2020 16:00 (04:00PM) for COVID-19 immunization. Medical history included angioedema, migraines, asthma. Known allergies: Sulfa, Clonazepam, Estrogen, IMITREX. Concomitant medications included XYZAL, BREO ELLIPTA, Nortriptyline, Propranolol, and CIMETIDIN. Patient was not pregnant at the time of vaccination. Facility type vaccine was hospital. There was no other vaccine in four weeks. Immediately after receiving vaccine tongue felt fuzzy/little swollen (17Dec2020 16:00). Also lightheaded, dizzy, eyes not focusing very well (17Dec2020 16:00). After 10-15 minutes, eyes focusing better but still lightheaded. 1 hour later noted swelling of uvula, posterior palatal arches, neck, face, lips, intermittent wheezing (17Dec2020). Next day headache and rash started (18Dec2020). Now day 8 with continued intermittent severe swelling, wheezing, rash, headache and some level of oral and facial swelling every day as noted above. Muscle aches started last night (23Dec2020). Events "tongue felt fuzzy/little swollen, lightheaded, dizzy, eyes not focusing very well, swelling of uvula, posterior palatal arches, neck, face, lips, intermittent wheezing" lead to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment of above mentioned events included antihistamines, steroids, inhaler, H2 blocker. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Since the vaccination, has the patient been tested for COVID-19 was no. The outcome of event eyes not focusing very well was recovering. The outcome of other events was not recovered. Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: First day, shooting pain up the back of the arm. Next day noticed a firm lump 2" from injection site, tricep area with redness and swelling, tenderness and pain all at inj. site. Marked for size and by 12/26 the lump, redness, swelling had increased in size.  Tylenol with no relief, applied heat to lump made it worse. Took Benadryl x 3 doses and symptoms are much improved.  Headache on 12/25-12/26, Fatigue x 3 days, muscle pain in shoulders/neck.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pain, Pain in extremity
Clinical narrative: First day, shooting pain up the back of the arm. Next day noticed a firm lump 2" from injection site, tricep area with redness and swelling, tenderness and pain all at inj. site. Marked for size and by 12/26 the lump, redness, swelling had increased in size.  Tylenol with no relief, applied heat to lump made it worse. Took Benadryl x 3 doses and symptoms are much improved.  Headache on 12/25-12/26, Fatigue x 3 days, muscle pain in shoulders/neck.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe rash; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730 (pending clarification)), intramuscularly at the left arm on 21Dec2020 at 16:00 (04:00 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient's medical history included Diabetic, type 1, allergies to penicillin, and the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient received other unspecified medications within 2 weeks of vaccination. The patient experienced severe rash on 23Dec2020 at 21:30 (09:30 PM). The adverse event resulted in emergency room/department or urgent care: the patient was treated at local ER with prednisone and benadryl. The event was reported as non-serious. The patient recovered from the severe rash on an unspecified date in Dec2020.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of severe rash. 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: fatigue; headache; vague malaise; A wound culture was not sent, but the assumption was that S. aureus was the pathogen; Approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange.  There was a 3 mm pustule on a 1 cm erythematous base.; Approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange.  There was a 3 mm pustule on a 1 cm erythematous base.; Approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange.  There was a 3 mm pustule on a 1 cm erythematous base.; This is a spontaneous report from a contactable physician.  A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 22Dec2020 10:00 at singe dose for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications.  The patient stated, "approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange. There was a 3 mm pustule on a 1 cm erythematous base. At the time I also had mild routine constitutional symptoms from the vaccine: fatigue, headache, vague malaise. I had no fever. The pustule progressed over the following 15-20 hours. I was prescribed doxycycline 100 mg po (orally) bid (two times a day) and the pustule was incised and drained. A wound culture was not sent, but the assumption was that S. aureus was the pathogen. Over the next four days, the lesion resolved without complication". The outcome of fatigue, headache and vague malaise was unknown and other events was recovered on Dec2020.; Sender's Comments: The pustule on the toe with suspected staphylococcus aureus infection was most likely an intercurrent condition and unlikely related to vaccination with 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pustule
Clinical narrative: fatigue; headache; vague malaise; A wound culture was not sent, but the assumption was that S. aureus was the pathogen; Approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange.  There was a 3 mm pustule on a 1 cm erythematous base.; Approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange.  There was a 3 mm pustule on a 1 cm erythematous base.; Approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange.  There was a 3 mm pustule on a 1 cm erythematous base.; This is a spontaneous report from a contactable physician.  A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 22Dec2020 10:00 at singe dose for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications.  The patient stated, "approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange. There was a 3 mm pustule on a 1 cm erythematous base. At the time I also had mild routine constitutional symptoms from the vaccine: fatigue, headache, vague malaise. I had no fever. The pustule progressed over the following 15-20 hours. I was prescribed doxycycline 100 mg po (orally) bid (two times a day) and the pustule was incised and drained. A wound culture was not sent, but the assumption was that S. aureus was the pathogen. Over the next four days, the lesion resolved without complication". The outcome of fatigue, headache and vague malaise was unknown and other events was recovered on Dec2020.; Sender's Comments: The pustule on the toe with suspected staphylococcus aureus infection was most likely an intercurrent condition and unlikely related to vaccination with 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Culture negative, Dyspnoea, Nausea, Pharyngeal swelling, Vomiting
Clinical narrative: Nausea and vomiting followed by mild SOB and throat swelling.; Nausea and vomiting followed by mild SOB and throat swelling.; Nausea and vomiting followed by mild SOB and throat swelling.; Nausea and vomiting followed by mild SOB and throat swelling.; This is a spontaneous report from a contactable nurse. A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL0140) intramuscularly on the left arm on 24Dec2020 09:00 at single dose for covid-19 immunisation. Medical history included acid reflux, hiatal hernia and ongoing depression. Concomitant medication included amphetamine, dextroamphetamine (DEXTROAMPHETAMINE [DEXAMFETAMINE]) and zolpidem (ZOLPIDEM). On 24Dec2020 13:00, the patient experienced nausea and vomiting followed by mild shortness of breath (SOB) and throat swelling. The events were reported as serious since the patient was brought to the emergency room and was hospitalized. The patient was treated with steroids (unspecified) and breathing support. The patient underwent lab tests and procedures which included nasal swab test: negative on 24Dec2020. Outcome of the events recovered on an unspecified date.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on the reported events cannot be excluded. Consider also contributory effect of patient risk factors.  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Flushing, Hypersensitivity, Oropharyngeal discomfort, Palatal oedema
Clinical narrative: The patient is a 37-year-old female presenting to the emergency department with an allergic reaction after receiving a Covid vaccine.  Began having palpitations and flushing 5 minutes after the injection.  Reported a heaviness in her throat.  This has not improved but not worsening.  Reports some difficulty swallowing.  Denies any difficulty breathing.  Denies rash.  Has never had similar symptoms previously.  Denies fever chills nausea vomiting lightheadedness or dizziness.  Symptoms have been constant since onset.  Has not taken anything to alleviate her symptoms.   Review of Systems  Constitutional: Negative for activity change, chills and fever.  HENT: Negative for congestion and rhinorrhea.        Throat swelling trouble swallowing  Eyes: Negative for pain and visual disturbance.  Respiratory: Negative for chest tightness and shortness of breath.   Cardiovascular: Positive for palpitations. Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Endocrine: Negative for polydipsia and polyuria.  Genitourinary: Negative for dysuria and flank pain.  Musculoskeletal: Negative for back pain and myalgias.  Skin: Negative for rash and wound.  Neurological: Negative for weakness and headaches.  Psychiatric/Behavioral: Negative for confusion and suicidal ideas.  All other systems reviewed and are negative.  BP 114/69  | Pulse (!) 106  | Temp 36.9 °C (98.5 °F) (Oral)  | Resp 21  | Ht 162.6 cm (5' 4")  | Wt 84 kg (185 lb 3 oz)  | SpO2 98%  | BMI 31.79 kg/m²   Physical Exam Vitals signs and nursing note reviewed.  Constitutional:      General: She is not in acute distress.    Appearance: She is well-developed.  HENT:        Mouth/Throat:     Comments: Uvula slightly edematous, tongue does not appear swollen, lips are not swollen, no stridor, breathing comfortably and speaking in full sentences Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No stridor.  Abdominal:     Palpations: Abdomen is soft.     Tenderness: There is no abdominal tenderness. There is no guarding or rebound.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.     Findings: No rash.     Comments: No obvious rash  Neurological:     Mental Status: She is alert and oriented to person, place, and time.     Cranial Nerves: No cranial nerve deficit.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pharyngeal swelling
Clinical narrative: The patient is a 37-year-old female presenting to the emergency department with an allergic reaction after receiving a Covid vaccine.  Began having palpitations and flushing 5 minutes after the injection.  Reported a heaviness in her throat.  This has not improved but not worsening.  Reports some difficulty swallowing.  Denies any difficulty breathing.  Denies rash.  Has never had similar symptoms previously.  Denies fever chills nausea vomiting lightheadedness or dizziness.  Symptoms have been constant since onset.  Has not taken anything to alleviate her symptoms.   Review of Systems  Constitutional: Negative for activity change, chills and fever.  HENT: Negative for congestion and rhinorrhea.        Throat swelling trouble swallowing  Eyes: Negative for pain and visual disturbance.  Respiratory: Negative for chest tightness and shortness of breath.   Cardiovascular: Positive for palpitations. Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Endocrine: Negative for polydipsia and polyuria.  Genitourinary: Negative for dysuria and flank pain.  Musculoskeletal: Negative for back pain and myalgias.  Skin: Negative for rash and wound.  Neurological: Negative for weakness and headaches.  Psychiatric/Behavioral: Negative for confusion and suicidal ideas.  All other systems reviewed and are negative.  BP 114/69  | Pulse (!) 106  | Temp 36.9 °C (98.5 °F) (Oral)  | Resp 21  | Ht 162.6 cm (5' 4")  | Wt 84 kg (185 lb 3 oz)  | SpO2 98%  | BMI 31.79 kg/m²   Physical Exam Vitals signs and nursing note reviewed.  Constitutional:      General: She is not in acute distress.    Appearance: She is well-developed.  HENT:        Mouth/Throat:     Comments: Uvula slightly edematous, tongue does not appear swollen, lips are not swollen, no stridor, breathing comfortably and speaking in full sentences Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No stridor.  Abdominal:     Palpations: Abdomen is soft.     Tenderness: There is no abdominal tenderness. There is no guarding or rebound.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.     Findings: No rash.     Comments: No obvious rash  Neurological:     Mental Status: She is alert and oriented to person, place, and time.     Cranial Nerves: No cranial nerve deficit.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Ear pain, Facial paralysis, Lymphadenopathy
Clinical narrative: intermittent tingling in her right arm; lymph node swelling on the ride side of her neck; right sided Bell's Palsy to her face; This is a spontaneous report from a contactable physician. A 44-year-old female patient received single dose of BNT162B2 (Solution for injection, lot number: EJ1685, Expiry Date: Mar2021), via an unspecified route of administration on 18Dec2020 for immunization. The vaccine was given roughly around 4:30PM at the left arm. Vaccination Facility Type: Hospital. Vaccine was not administered at military facility. Medical history included underlying condition of Lymphoma. It was treated in 2017 and she has been off all medications since 2018. Patient had no relevant family medical history. There were no concomitant medications. The patient had no medications in over 2 years. The patient had no prior vaccinations (within 4 weeks). The patient had right sided Bell's Palsy on an unspecified date in Dec2020 (Either Sunday or Monday, so either the 20th or 21st) wherein she got pain in the right ear. She thought she had an ear infection. She treated herself with antibiotics. 7 days later, she noticed weakness. On day 8, which would have been 26Dec2020, she had complete paralysis. It was ongoing. It was stable, but hard to tell. Patient went to the ER on 26Dec2020 for facial droop. She went to Physician office at Urgent Care on 25Dec2020 thinking it was an ear infection. On 23Dec2020 she had lymph node swelling on right side of neck. that was probably after the ear and she didn't worry about it. She thought maybe it was an infection. It started between onset of ear pain and Bell's Palsy. On 26Dec2020, she had intermittent tingling in right arm. She noticed it on the same day as facial paralysis. She doesn't notice any weakness in the arm. Patient had recent blood work (results and date not reported). The patient considered the events as serious: medically significant. The outcome of lymph node swelling on the ride side of her neck was recovering (was also reported to be ongoing at the time of reporting), while the other events was not recovered. The physician considered the events related to the Pfizer product.; Sender's Comments: Based on the temporal relationship, the association between the events facial paralysis, tingling in right arm, and lymph node swelling on right side of her neck with BNT162b2 can not be fully excluded based on the limited information. The medical history of lymphoma might have been contributory to the lymph node swelling as well.  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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paralysis
Clinical narrative: intermittent tingling in her right arm; lymph node swelling on the ride side of her neck; right sided Bell's Palsy to her face; This is a spontaneous report from a contactable physician. A 44-year-old female patient received single dose of BNT162B2 (Solution for injection, lot number: EJ1685, Expiry Date: Mar2021), via an unspecified route of administration on 18Dec2020 for immunization. The vaccine was given roughly around 4:30PM at the left arm. Vaccination Facility Type: Hospital. Vaccine was not administered at military facility. Medical history included underlying condition of Lymphoma. It was treated in 2017 and she has been off all medications since 2018. Patient had no relevant family medical history. There were no concomitant medications. The patient had no medications in over 2 years. The patient had no prior vaccinations (within 4 weeks). The patient had right sided Bell's Palsy on an unspecified date in Dec2020 (Either Sunday or Monday, so either the 20th or 21st) wherein she got pain in the right ear. She thought she had an ear infection. She treated herself with antibiotics. 7 days later, she noticed weakness. On day 8, which would have been 26Dec2020, she had complete paralysis. It was ongoing. It was stable, but hard to tell. Patient went to the ER on 26Dec2020 for facial droop. She went to Physician office at Urgent Care on 25Dec2020 thinking it was an ear infection. On 23Dec2020 she had lymph node swelling on right side of neck. that was probably after the ear and she didn't worry about it. She thought maybe it was an infection. It started between onset of ear pain and Bell's Palsy. On 26Dec2020, she had intermittent tingling in right arm. She noticed it on the same day as facial paralysis. She doesn't notice any weakness in the arm. Patient had recent blood work (results and date not reported). The patient considered the events as serious: medically significant. The outcome of lymph node swelling on the ride side of her neck was recovering (was also reported to be ongoing at the time of reporting), while the other events was not recovered. The physician considered the events related to the Pfizer product.; Sender's Comments: Based on the temporal relationship, the association between the events facial paralysis, tingling in right arm, and lymph node swelling on right side of her neck with BNT162b2 can not be fully excluded based on the limited information. The medical history of lymphoma might have been contributory to the lymph node swelling as well.  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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Difficulty Breathing, fast heartbeat, dizziness and weakness.  Body aches and nausea
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Difficulty Breathing, fast heartbeat, dizziness and weakness.  Body aches and nausea
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Malaise, Nausea, Neck pain
Clinical narrative: She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial assessment.  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.