chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site infection, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; It seemed that it had persisted longer and he said it sounded like it was getting infected; it was painful almost immediately/as a site reaction; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 28Dec2020 injected in unknown arm at single dose for precaution as a front line healthcare worker in hospital. The patient's medical history and concomitant medications were not reported. In the last 9 months, she worked in the COVID unit. It was unknown if additional vaccines administered on same date of bnt162b2. Prior vaccinations within 4 weeks was unknown. Patient said she got the bnt162b2 through her hospital on 28Dec2020, and still had a painful lump on arm that had turned red and itches when she pressed it was reported as worsened on 28Dec2020, it was painful almost immediately, like you would normally get with any vaccination. It seemed that it had persisted longer and he (Sales Representative) said it sounded like it was getting infected. She said it was painful when she pressed on it and he told her not to press on it. Compared to when she had gotten other vaccines in the arm, this seemed out of the ordinary for how long it had been painful as a site reaction. No ER or physician's office required. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Muscle aches; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 30Dec2020 (08:45) at a single dose on the left arm, with route of administration and therapy date unspecified, for COVID-19 immunization at a public health clinic. Medical history included COVID-19 prior to vaccination. There were no concomitant medications. On 30Dec2020 (20:00), the patient had fever and muscle aches. The patient had not been tested for COVID-19 post-vaccination, and did not receive any treatment for the reported adverse events. The outcome of the events, fever and muscle aches, was recovered on 31Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the left ear; This is a spontaneous report from a contactable Other HCP. This Other HCP reported same events for himself and other two patients. This is first of three reports, reported for one of two patients. A female patient started to receive started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. She developed a ringing in her left ear in Jan2021. It was assessed as non serious. Outcome of the event was unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021009229 same reporter/drug/event, different patient;US-PFIZER INC-2021009439 same reporter/drug/event, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Heart rate increased
Clinical narrative: chest tightness; palpitations; elevated heart rate; fatigue; This is a spontaneous report from a contactable Other HCP. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Dermatographia. The patient is allergic to Penicillin, lactose, Cephalosporins and Beepen-VK.  There were no concomitant medications. Seventy two hours after the vaccine was given the patient had an elevated heart rate, chest tightness and fatigue. Are this consistent with the vaccine. She does not have a history of elevated heart rate or palpitations. She checked her heart rate with her Apple watch and sent in a strip to the doctor. The doctor is concerned and is asking if this is related. She went to the ER to make sure she was ok but was not admitted. Outcome of event heart rate increased as recovered on 05Jan2021, of fatigue was not recovered, of others was recovering.   Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of elevated heart rate, chest tightness, palpitations and fatigue due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including 12-lead EKG , counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rash
Clinical narrative: rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), intramuscularly on 05Jan2021 injection in left arm at single dose for preventative since she works in nursing home. The patient's medical history and concomitant medications reported as no. The patient was experiencing a rash that started on her face and now it was going everywhere on 05Jan2021. Rash was reported as worsened. She just took diphenhydramine hydrochloride (BENADRYL). Patient stated it was not serious at this point. She just took her temperature before she called and her temperature was 98.2 on 05Jan2021 and stated this was a slight fever since she was normally 97.4. The outcome of the event rash was not recovered, outcome of slight fever was unknown. The report was reported as non-serious.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Face redness; This is a spontaneous report from a contactable consumer. An adult female patient 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. Medical history included COVID-19 prior vaccination.  The patient's concomitant medications were not reported.  The patient experienced face redness on an unspecified date. The outcome of the event was unknown.    Information on batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she does not feel well; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EU9231), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient does not feel well on 06Jan2021. Outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, SARS-CoV-2 test, Urticaria
Clinical narrative: hives; raised papular rash bilateral lower extremity; Pruritic rash; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. 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 patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 14:00, the patient experienced pruritic rash then on 06Jan2021 10:00, the patient experienced hives and raised papular rash bilateral lower extremity. No angioedema. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included nasal swab was negative on 30Dec2020. It was reported that the patient has been tested for COVID-19 on an unspecified date since the vaccination. Outcome of the events was recovering. The events were considered non-serious.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tremor, Vaccination site pain
Clinical narrative: Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Type IV hypersensitivity reaction, Urticaria
Clinical narrative: if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine; delayed hyper sensitive reaction; Angioedema; Urticarial rash; This is a spontaneous report from a contactable other hcp. A 47-years-old male patient received first dose of bnt162b2 (BNT162B2), unknown on 18Dec2020 (lot number: EK5730) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a Physician Assistant. Caller states that she is calling about the Covid Vaccine. She had a patient received his first dose of the vaccine on Friday 18Dec2020, 3 days later on 21Dec2020 he had an urticarial rash that persisted, The urticarial rash was treated with prednisone and resolved by 27Dec2020, it has not reoccurred. The allergist said it was a delayed hyper sensitive reaction that was Prompted by the immune simulation from the vaccine. The Patient was treated for the urticaria.  Caller would like to know if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine? Caller is very upset and frustrated and stating she wants to speak to someone that is a clinician with the clinical trial team who can give her recommendations for a specific patient. Caller asks if they should do Prophylaxis with antihistamines for the second dose. He did not have anaphylaxis but he had angioedema. Caller states that she did a Vaers report on 22Dec2020, but no one contacted her. He started taking Zyrtec and Vistaril. The Allergist said it was fine and he will still need the 2nd Booster Dose. The Angioedema started on 22Dec2020, it was also treated with prednisone, in addition to being administered Benadryl IM, and Vistaril. The outcome of the event urticarial rash was recovered on 27Dec2020 and Angioedema was recovered on 22Dec2020.   No follow-up attempts are needed; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and the other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase level and complement panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: little bit of back pain right where her kidney is; 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 number EL1284 ), via an unspecified route of administration on 05Jan2021 07:00 at single dose for covid-19 immunisation .  Medical history included 50 percent of her kidney function.  The patient's concomitant medications were not reported.  The patient experienced little bit of back pain right where her kidney is on 05Jan2021 13:00. The outcome of event was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dose number 1, 05Jan2020 Dose number 2; Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes/Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable nurse. This is the mother report. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El0140), intramuscular on 17Dec2020 18:30 (dose number 1, right arm) and on 05Jan2021 18:30 (dose number 2, right arm) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified prenatal drug, sertraline hydrochloride (ZOLOFT), and acetylcarnitine hydrochloride (NEUROTIN). The patient was pregnant at the time of vaccination. No other vaccines in four weeks was taken. Patient has no COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. The patient experienced Local site pain immediately, headache, chills, fatigue and general body aches next day on 06Jan2021. 09:00. No treatment was given. Event outcome was recovering. The reporter assessed the events as non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Product use issue, Vaccination site pain
Clinical narrative: Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dose number 1, 05Jan2020 Dose number 2; Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes/Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable nurse. This is the mother report. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El0140), intramuscular on 17Dec2020 18:30 (dose number 1, right arm) and on 05Jan2021 18:30 (dose number 2, right arm) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified prenatal drug, sertraline hydrochloride (ZOLOFT), and acetylcarnitine hydrochloride (NEUROTIN). The patient was pregnant at the time of vaccination. No other vaccines in four weeks was taken. Patient has no COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. The patient experienced Local site pain immediately, headache, chills, fatigue and general body aches next day on 06Jan2021. 09:00. No treatment was given. Event outcome was recovering. The reporter assessed the events as non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever (101 F); myalgia; malaise; headache; This is a spontaneous report from a contactable physician (patient).  A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: Arm right) on 05Jan2021 07:00 at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies. It was reported that patient experienced fever (101 F), myalgia, malaise, and headache on 06Jan2021 at 07:00. It was reported that no treatment was provided for the events. It was also mentioned that prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the right arm on 31Dec2020 15:30 at a single dose for COVID-19 immunization at workplace clinic. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included influenza vaccine (FLU) on 17Dec2020 at right arm, and  prednisone received within 2 weeks of vaccination. The patient experienced hives and rashes all over body on 31Dec2020 23:45, eight hours after the shot and lasted for the whole next day. Events were reported as non-serious. The patient received diphenhydramine (BENADRYL) as treatment. The outcome of the events was recovered. Patient was not tested for COVID post vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular from 17Dec2020 07:00 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported.  There were no concomitant medications. On 17Dec2020 18:00, it was reported that the patient experienced fever, chills, aches, HA, stomach pains for first two nights, and only at night. Woke up, fine by morning. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovered.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness, Sensory loss, Speech disorder
Clinical narrative: right arm weakness; loss of sensation intermittently; lightheaded, dizzy; briefly difficult to speak on one occasion; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142, expiry date: unknown), intramuscular on the right arm on 04Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications.  The patient experienced right arm weakness/loss of sensation intermittently lasting <5 minutes on at least 5 occasions on 05Jan2021. Patient also experienced lightheaded, dizzy, and briefly difficult to speak on one occasion on 05Jan2021. The events resulted in an emergency room visit but no treatment was given. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. There were no other vaccine administered within 4 weeks prior to the COVID vaccine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Blood pressure increased, Discomfort, Dry mouth, Flushing
Clinical narrative: extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction, Malaise, Rash
Clinical narrative: extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Crystal urine present, Fatigue
Clinical narrative: crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Impaired work ability, Influenza like illness, Myalgia, Urine analysis abnormal
Clinical narrative: crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Pain
Clinical narrative: very bad joint pain; headache; chills; body pain/body aches; back pain; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, 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 received the vaccine on 28Dec2020. On 01Jan2021, she had very bad joint pain, headache, body pain/ body aches and chills; but no fever, most have gone away but still have back pain. She doesn't have any shortness of breath or fever. She added that she was confused if this was from the vaccine or from Coronavirus and queried what she should I do. She confirmed that she did not get tested for corona virus. She did read that her symptoms could be from vaccine. She also asked that, since she received the vaccine, if it will affect the results of test for corona virus i.e. false positive. The outcome of the events very bad joint pain, headache, body pain/ body aches and chills was recovered on an unknown date in Jan2021 while not recovered for back pain.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: pain at the administration site; joint pain "everywhere", mainly on her hands, legs, arms and back; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced joint pain and pain at the administration site, asked how long it was expected to last. Patient experienced joint pain "everywhere", mainly on her hands, legs, arms and back. Patient was taking acetaminophen for pain relief, but was not getting any better. Outcome of the events was unknown. The events were reported as non-serious.  Information about Lot/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza A virus test, Influenza B virus test, Influenza B virus test positive
Clinical narrative: Patient tested positive today for influenza b; This is a spontaneous report from a contactable physician. A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EH9899), via an unspecified route of administration in the left arm on 22Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included hypothyroidism, tobacco user to 2017. Patient did get the Influenza vaccine on 20Oct2020. Concomitant medication included levothyroxine. Physician calling regarding the Pfizer COVID 19 vaccine. Reports she has a patient who received the first dose of the vaccine two weeks ago. The patient is scheduled to receive the second dose on Tuesday but today she tested positive for Influenza B. The patient then tested positive for influenza B today 06Jan2021. She was tested using the Sofia test and states the Influenza A part was negative; and COVID 19 not detected. Relevant Tests Sofia -states the Influenza B was positive; Influenza A was negative; and COVID 19 not detected. Outcome of event was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right ear feeling blocked 2 weeks post vaccine; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 at a single dose for covid-19 vaccination. Medical history included migraine. The patient has no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received her most recent COVID-19 vaccine in a hospital. The patient had right sided face numb/tingling with no drooping or asymmetry and right ear feeling blocked 2 weeks post vaccine (30Dec2020). The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the adverse event. The adverse event result in emergency room/department or urgent care. The event was considered as non-serious. The outcome of the events was recovering.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Vaccination site pain
Clinical narrative: Intermittent headaches for 48 hours; general malaise; chills without fever; Sore injection site; This is a spontaneous report from a contactable Physician reporting for himself. A 33-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular Right arm on 16Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergy to Shellfish. The patient's concomitant medications were none (None medication the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intermittent headaches for 48 hours, general malaise and intermittent chills without fever, Sore injection site on 16Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Intermittent headaches was recovered on 18Dec2020 13:00, the outcome of the other events was recovered on an unknown date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperaesthesia, Myalgia, Pain assessment, Vaccination site pain
Clinical narrative: severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain (worse than prior dose); This is a spontaneous report from a contactable physician (patient herself). A 35-year-old female patient received second dose of PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm) on 05Jan2021 at 11:45 a.m., at a single dose, for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD) and allergic rhinitis. Concomitant medications included loratadine (CLARITIN), methylphenidate hydrochloride (CONCERTA), fluticasone propionate (FLONASE), and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 for COVID-19 immunization and experienced injection site pain; and isoniazid and experienced rash. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 06Jan2021, at 12:00 a.m., the patient experienced severe myalgia 10/10 entire body affected, hyperesthesia, violent chills/rigors, and injection site pain (worse than prior dose), peaked approximately 12 hours after dose. Patient has no fever. It was reported that first dose side effect of moderate 6/10 injection site pain in Dec2020, responded well to naproxen. The patient did not receive treatment for the events. Patient did not seek medical care, because she and her husband are both intensive care unit (ICU) physicians. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling hot, Flushing, Heart rate
Clinical narrative: Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; pulse and BP both were elevated (HR 122 BP 155/80); pulse and BP both were elevated (HR 122 BP 155/80); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (lot number: EL0140), intramuscular on 21Dec2020 10:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 21Dec2020 10:30, it was reported that shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby, the patient started to feel flushed in her face and very warm, and felt her heart racing. The nurse came and took her pulse and BP both were elevated (HR 122 BP 155/80), after three minutes her heart rate and BP came down and normalized again (HR 70 and BP 115/60). Stated that she has never had a similar experience. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The with outcome of recovered on unspecified dates.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; pulse and BP both were elevated (HR 122 BP 155/80); pulse and BP both were elevated (HR 122 BP 155/80); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (lot number: EL0140), intramuscular on 21Dec2020 10:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 21Dec2020 10:30, it was reported that shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby, the patient started to feel flushed in her face and very warm, and felt her heart racing. The nurse came and took her pulse and BP both were elevated (HR 122 BP 155/80), after three minutes her heart rate and BP came down and normalized again (HR 70 and BP 115/60). Stated that she has never had a similar experience. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The with outcome of recovered on unspecified dates.