chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal disorder, Pain, Pain in extremity, Somnolence
Clinical narrative: arm is hurting so bad; could not move her arm, her left arm; it feels like lead; she got the injection in is like equalizing the pain she has; hurts all over; sleeps every 2 hours; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date), via an unspecified route of administration on the left arm on 13Jan2021 10:35 at a single dose for COVID-19 immunization. Ongoing medical history heart failure, kidney failure, scoliosis and strained hernia (causing pain down her right leg). Other medical history includes patient gave up her car and as a result she went from 5ft 4 inches to 5ft 1 inch and went from 150 pounds to 106 pounds (stated she loves this new weight. She looks fabulous and wonderful in clothes). The patient's concomitant medications were not reported. It was reported that the patient was a retired school teacher, called about the shot, the vaccine, clarified as the COVID Vaccine. She mentioned she has a history of heart failure, kidney failure, scoliosis, and hernias. She was concerned about getting the vaccine and did not think she should get it, but her doctor informed her she should get it so she did. Since getting it she is having a hard time. Stated it feels like lead. She contacted her doctor and was informed to wait it out 24 hours and it would be a lot better. It was reported that the patient got the COVID Vaccine shot yesterday (13Jan2021 10:35). She mentioned her arm is hurting so bad. She contacted her doctor's office and was informed to give it another 24 hours for the pain to go away. It was reported that the patient hurts so bad, she hurts all over. She added she guesses the arm where she got the injection in is like equalizing the pain she has. She stated as soon as she got the injection everything was wonderful. It was afterwards she felt like she could not move her arm, her left arm. She felt like at first she was having a stroke. She did some self testing and was happy she realized she was not having a stroke. It was reported that the patient provided conflicting details of when arm hurting started. She initially stated it started 13Jan2021. She then stated she did not feel it until 8am in the morning of 14Jan2021 (pending clarification) when she could not move her arm and thought she was having a stroke. She commented she sleeps every 2 hours. She would later mention in report she felt the arm pain starting yesterday (as reported). Attempts made to clarify start of arm hurting, but unable to clarify further. She is scheduled to get the second does on 03Feb2021. She commented even with her age she is still very useful. She was told to continue taking acetaminophen. She has the 1000 mg, take two pills every six hours. She was told if she continued to have pain to take Aleve. Treatment was given for the events. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Weight
Clinical narrative: arm is hurting so bad; could not move her arm, her left arm; it feels like lead; she got the injection in is like equalizing the pain she has; hurts all over; sleeps every 2 hours; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date), via an unspecified route of administration on the left arm on 13Jan2021 10:35 at a single dose for COVID-19 immunization. Ongoing medical history heart failure, kidney failure, scoliosis and strained hernia (causing pain down her right leg). Other medical history includes patient gave up her car and as a result she went from 5ft 4 inches to 5ft 1 inch and went from 150 pounds to 106 pounds (stated she loves this new weight. She looks fabulous and wonderful in clothes). The patient's concomitant medications were not reported. It was reported that the patient was a retired school teacher, called about the shot, the vaccine, clarified as the COVID Vaccine. She mentioned she has a history of heart failure, kidney failure, scoliosis, and hernias. She was concerned about getting the vaccine and did not think she should get it, but her doctor informed her she should get it so she did. Since getting it she is having a hard time. Stated it feels like lead. She contacted her doctor and was informed to wait it out 24 hours and it would be a lot better. It was reported that the patient got the COVID Vaccine shot yesterday (13Jan2021 10:35). She mentioned her arm is hurting so bad. She contacted her doctor's office and was informed to give it another 24 hours for the pain to go away. It was reported that the patient hurts so bad, she hurts all over. She added she guesses the arm where she got the injection in is like equalizing the pain she has. She stated as soon as she got the injection everything was wonderful. It was afterwards she felt like she could not move her arm, her left arm. She felt like at first she was having a stroke. She did some self testing and was happy she realized she was not having a stroke. It was reported that the patient provided conflicting details of when arm hurting started. She initially stated it started 13Jan2021. She then stated she did not feel it until 8am in the morning of 14Jan2021 (pending clarification) when she could not move her arm and thought she was having a stroke. She commented she sleeps every 2 hours. She would later mention in report she felt the arm pain starting yesterday (as reported). Attempts made to clarify start of arm hurting, but unable to clarify further. She is scheduled to get the second does on 03Feb2021. She commented even with her age she is still very useful. She was told to continue taking acetaminophen. She has the 1000 mg, take two pills every six hours. She was told if she continued to have pain to take Aleve. Treatment was given for the events. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (left arm) on 12Jan2021 (12:15 PM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) intramuscular (left arm) on 23Dec2020 (03:00 PM) for Covid-19 immunization. The patient's medical history included migraines and anemia; no known allergies. Concomitant medications included spironolactone, frovatriptan succinate, ethinylestradiol, norgestimate (TRI-SPRINTEC), and ferrous sulfate. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, chills, sweating, nausea, tonsil stones, and muscle aches on 13Jan2021 (07:00 AM). There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillolith
Clinical narrative: Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (left arm) on 12Jan2021 (12:15 PM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) intramuscular (left arm) on 23Dec2020 (03:00 PM) for Covid-19 immunization. The patient's medical history included migraines and anemia; no known allergies. Concomitant medications included spironolactone, frovatriptan succinate, ethinylestradiol, norgestimate (TRI-SPRINTEC), and ferrous sulfate. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, chills, sweating, nausea, tonsil stones, and muscle aches on 13Jan2021 (07:00 AM). There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling cold, Headache, Neck pain, Pain in extremity
Clinical narrative: Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD).  Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination.  The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Taste disorder
Clinical narrative: Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD).  Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination.  The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site hypoaesthesia, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Numbness and tingling in left arm; Numbness and tingling in left arm; Strong pain in left forearm; Feels like she had hit her funny-bone and the effect was lasting quite a while.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration on the left arm on 14Jan2021 15:30 at single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. There were no concomitant medications. No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced numbness and tingling in left arm, strong pain in left forearm, feels like she had hit her funny-bone and the effect was lasting quite a while, all on 14Jan2021 17:00. Next day, still tingling and numbness in left arm. No treatment received for the events. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: significant leakage from the sight of injection; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for two patients. This is 2nd of two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after administration of the vaccine, the pharmacist reported that two of their doctors had significant leakage from the sight of injection. This was a clear fluid leaking out of the sight of injection. The pharmacist knew this type of leaking fluid is a common occurrence with the flu vaccine, but the pharmacist wanted to ask if there is any particular guidance on what should be done in the case of this vaccine. The pharmacist asked if the doctors should get titers drawn up to determine if they need to get a 3rd dose or if they should go ahead and get the 3rd dose anyways. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030291 same reporter/drug/event; different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program, Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the second of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the third of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for the virus (COVID-19) based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine.; This is a spontaneous report from a contactable nurse. This nurse reported the same event for 20 patients (15 residents and 5 staff members). This is the fourth of 20 reports.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient has tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if the patient should receive the second dose.   Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse received from Pfizer sponsored program Pfizer First Connect.  This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 5th of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the sixth of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the seventh of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the ninth of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2. ,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the twelfth of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 13th of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient tested positive for the virus (COVID-19) after the first dose of the vaccine; patient tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored Program. This nurse reported the same event for twenty (20) patients (15 residents and 5 staff members). This is the sixteenth (16th) of the twenty (20) reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the seventeenth of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid after 1st dose received on 03Jan2021; Tested positive for covid after 1st dose received on 03Jan2021; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 18th of 20 reports.  A patient of unspecified age and gender receive the first dose bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 03Jan2020 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient was tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for the virus (COVID-19) based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the nineteenth of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 20th of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm  when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fatigue, Formication, Hyperhidrosis, Hypoaesthesia
Clinical narrative: He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; he fell flat on the floor; felt really tired; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; He couldn't hardly move it sore; tingling, kind of like ants crawling up his leg; This is a spontaneous from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via intramuscular route of administration on 13Jan2021 at 19:05 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Hepatitis B vaccine that is supposed to last for 10 years (which was administered for about three years ago) and flu vaccine. On 13Jan2021, patient received the vaccine and felt really tired, his arm feels like it was punched by a gorilla, it was sore. He couldn't hardly move it sore, like a muscle sore, so he went to bed. His arm was really, really sore, he's just kind of avoided using his arm. He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating. He didn't know his legs were numb until he literally got out of bed, and he fell flat on the floor because he could not feel them. He went to bed again and woke up at 7:20. On an unspecified date in Jan2021, he feels the tingling, kind of like ants crawling up his leg. It's not as bad as it was, it's like a feeling one gets when sitting on top of your legs. He wanted to know could these be side effects of the vaccine. The patient took Advil for arm feels like it was punched by a gorilla/his arm was sore/muscle sore. The patient underwent lab test which included COVID-19 PCR test with negative result on 10Jan2021. The outcome of the events arm feels like it was punched by a gorilla/his arm was sore/muscle sore, he couldn't hardly move it sore, numbness in leg was not recovered; sweating was recovered on an unspecified date, while unknown for the other events.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Myalgia, Pain in extremity, SARS-CoV-2 test, Sleep disorder
Clinical narrative: He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; he fell flat on the floor; felt really tired; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; He couldn't hardly move it sore; tingling, kind of like ants crawling up his leg; This is a spontaneous from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via intramuscular route of administration on 13Jan2021 at 19:05 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Hepatitis B vaccine that is supposed to last for 10 years (which was administered for about three years ago) and flu vaccine. On 13Jan2021, patient received the vaccine and felt really tired, his arm feels like it was punched by a gorilla, it was sore. He couldn't hardly move it sore, like a muscle sore, so he went to bed. His arm was really, really sore, he's just kind of avoided using his arm. He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating. He didn't know his legs were numb until he literally got out of bed, and he fell flat on the floor because he could not feel them. He went to bed again and woke up at 7:20. On an unspecified date in Jan2021, he feels the tingling, kind of like ants crawling up his leg. It's not as bad as it was, it's like a feeling one gets when sitting on top of your legs. He wanted to know could these be side effects of the vaccine. The patient took Advil for arm feels like it was punched by a gorilla/his arm was sore/muscle sore. The patient underwent lab test which included COVID-19 PCR test with negative result on 10Jan2021. The outcome of the events arm feels like it was punched by a gorilla/his arm was sore/muscle sore, he couldn't hardly move it sore, numbness in leg was not recovered; sweating was recovered on an unspecified date, while unknown for the other events.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia, Pyrexia, Swelling face
Clinical narrative: fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); numbness in both hands; This is a spontaneous report from a contactable pharmacist (patient).  A 50-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176, expiration date not reported), intramuscular on the left arm, on 07Jan2021, at 11:30 at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies . There were no concomitant medications. The patient previously took the first vaccine of bnt162b2 on 18Dec2020, at 12:00 PM, Intramuscular, on the Right arm for Covid-19 immunization, he had numbness in his right hand x2 days. On 09Jan2021, following second dose, he has had numbness in both hands x2 days and on 10Jan2021, day 2, he ran a fever and his lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers). His eyes have a mix of Juvaderm products. It spontaneously resolved after 1 day with a subjective loss in overall volume. Density of the product used seemed to be a factor in the response. He knows this has been reported with the Moderna product, but he does not believe is has been reported with our product. It appears the response may not be product specific, but more specific to the type of vaccine. The patient has no Covid prior vaccination and not covid tested post vaccination. No treatment was received for the events. Outcome of the events was recovered in Jan2020.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Investigation, Pain
Clinical narrative: body aches increased; headache worse; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (reported as injection) in the left arm on 08Jan2021 at a single dose for COVID vaccine due to the patient's age and lives in continued care retirement community. Medical history included ongoing pain and ongoing persistent headaches, both since 2009. Concomitant medication included erenumab aooe (AIMOVIG) from an unspecified date in 2020 (started taking it 3 months ago). The patient reported side effect from the vaccine received on 08Jan2021. She has had body aches and headaches since 2009, so she figured after reading about the side effects, she would probably have worse body and headaches, but the body aches lasted maybe 4-5 days, from the time of vaccination, she has what was called new daily persistent headaches, which was a rare form of headache. They didn't have meds for it, because not many people have it, it was not a money maker to try to find something that works. She figured this would make headache worse and that was what it did, they were normally a level 7 or 8 on an unspecified date, and they increased to a level 9 on Jan2021, and she couldn't find a way to get it back down. The patient called her headache specialist and she thought steroid injections might help but wanted her to talk to someone to let them know the side effect the patient was having, with the headaches. Her body aches never go away, headaches never go away, and the day of the vaccine, she still had them both as normal, but after receiving the vaccine, her body aches increased, they went up a level, they were normally, a level 7 on an unspecified date, and after the vaccine, they went up to an 8.5 on Jan2021. She took Tylenol, regularly, every 4 to 6 hours, and after about 4 days, the body aches were down to the normal ache. But, the headache did not. The headache was starting to get worse. The outcome of the event body aches increased was recovering while the other event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Respiration abnormal
Clinical narrative: headache; fatigue; sore arm; breathing problems when she is walking fast.; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 15Jan2021, at the time of report, the patient experienced headache, major fatigue, sore arm and breathing problems when she is walking fast. She was told to sit down and report the issues according to the instructions provided to her. She said she was going to do that when she got home and will rest up for the day. She did not sound winded when and had good speech. She calmed down and she was ok. Outcome of the events was unknown.   Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: hot flashes; This is a spontaneous report based on the information received by Pfizer from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration at a single dose on 29Dec2020 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Dec2020, it was reported that the patient received the COVID vaccine "yesterday" and was having hot flashes that went away after 2 hours. Event onset date was unknown. The event resolved on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.