chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Headache; Not feeling very good; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included other 8 medications (unspecified). Patient received the vaccine this morning, on 21Jan2021, and was wondering if he can take his other 8 medications after receiving the vaccine. Patient was asking if he can take aspirin if he has had a headache after receiving the vaccine (21Jan2021). Patient asked if he can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. Patient had his 1st dose of vaccine today and asking if he can take his other prescription drugs including Aspirin for headache. He mentioned he was not feeling very good (21Jan2021). The outcome of the events headache and not feeling very good was unknown.   Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain
Clinical narrative: she was expecting some pain at the injection site, but is experiencing pain in her hip and knee instead; She could hardly walk; Pain on the whole right side of the body/felt new pain on her entire right side of her body; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263, expiry date not reported), via an unspecified route of administration in the right arm on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing Sjogren's syndrome (diagnosed a few decades ago) and ongoing rheumatoid arthritis (diagnosed about 2-3 years ago). There were no concomitant medications. The patient thought that she was getting the Moderna shot. She lived in a disabled elderly building. She felt fine yesterday. She said that it felt like a flu shot and it was fine. She stated that she was expecting some pain at the injection site, but was experiencing pain in her hip and knee instead, and wanted to know if this was normal. She figured she would feel pain at the injection site. When she woke up that morning, the whole right side of her body was in pain. She could hardly walk. The pain went down to her right hip and right knee. She did have rheumatoid arthritis. She was in her chair with a heating pad since that morning. She had never waken up like that. She did pull her left hip the other day, so now she can feel that but she felt new pain on her entire right side of her body. She was calling to report this. Clinical outcome of pain was not recovered while for the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: Had knee issues after taking the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), 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. The consumer stated that her friend had knee issues on an unspecified date after taking the vaccine. She also had knee replacement done. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vision blurred
Clinical narrative: her vision became blurry; her head does not feel clear and is very foggy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age reported as 30 with unknown unit) receivedBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history  and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine on 20Jan2021. On same day at 15:50, the patient's vision became blurry. Her head did not feel clear and was very foggy. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site joint movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Rash; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; This is a spontaneous report from a contactable other healthcare professional (patient).  A 56-year-old female patient receive bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration in the left arm from 12Jan2021 12:30 to 12Jan2021 12:30 as SINGLE DOSE (first dose of the vaccine by injection) for COVID-19 immunisation.  The patient medical history was not reported.  Ongoing concomitant medication included propranolol 80mg once daily by mouth, apixaban (ELIQUIS) 5mg one twice daily by mouth, omeprazole 40mg once daily by mouth, hydrochlorothiazide 12.5mg once daily by mouth, and atorvastatin 80mg once daily by mouth. The patient stated she got the Pfizer COVID 19 vaccine and she experienced tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder but she could use her arm and her hand. She got the shot on Tuesday and still had some symptoms the next Monday. On an unspecified date, the patient experienced rash. The patient also asked, can you take Tylenol or Ibuprofen before or after vaccination?  I have heard it can it lessen the immune response. With the first dose of the vaccine my arm hurt from Tuesday and the last day of it hurting was the following Monday, so about a week. Someone told me with the second vaccine the pain is higher. I am fine and still getting the second dose. The outcome of the event rash was unknown; while the rest of the events was recovered on 18Jan2021.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Nausea, Pain in extremity
Clinical narrative: Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediately after the shot I felt nauseated; lethargic; ache and pain in my arm is tremendous; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; unknown lot number and expiration date), intramuscular left arm on 21Jan2021 11:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in nursing home/senior living facility. The patient reported that she has never had an adverse effect to this degree from any injections or vaccinations. She mentioned that immediately after the shot (21Jan2021 11:30 AM), she felt nauseated then chills began about 1/2 hour later. The chills got continuously worst as the day went on. It has only been about 4 hours since the shot and she was very lethargic and the ache and pain in her arm was tremendous. She was an extremely active athlete and she has not been sick in over 2 years. The patient did not receive treatment for the adverse events. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event chill was not recovered while the outcome of the other events was unknown.  The following information on the batch/lot number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack; 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack; This is a spontaneous report from a non-contactable consumer. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3247), via an unspecified route of administration on 19Jan2021 00:30 at SINGLE DOSE at right arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient previously took amoxicillin and experienced Allergy. On 21Jan2021 05:30, 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack. I was not anxious. I called my doctor. The patient did not receive treatment for the events. The outcome of the events was unknown.     No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: arm pain at the injection site; fever (100 degrees F) later that night lasting into the next day; This is a spontaneous report from a non-contactable consumer. A 26-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EK9231) intramuscularly on 20Jan2021 (at the age of 26-years-old) at 0.3 mL as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received dose 1 of BNT162B2 intramuscularly on 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 00:00, the patient experienced arm pain at the injection site and fever (100 degrees Fahrenheit (F)) later that night lasting into the next day. The patient did not receive any treatment for the events. There was no hospitalization for the events and the reporter assessed the events as non-serious. The clinical outcomes of arm pain at the injection site and fever (100 degrees F) were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Facial pain, Neck pain, Pain in extremity
Clinical narrative: hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; pain went across her face to the left side; pain in the right shoulder to above the neck; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration in the right deltoid on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient informed that the hurting started when she was just talking with someone on 17Jan2021. The patient had taken ibuprofen and tramadol. The patient informed that her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides and wanted to know if there was anything she could do to eliminate that or make it less consuming. The patient informed that she didn't notice any problems for a couple days, then her right shoulder right above on the neck began to ache. This pain went across her face to the left side, it has sort of stayed in this particular area. It has not stopped aching since then. The patient informed that she didn't know what to take. The patient informed that the pain in the right shoulder to above the neck started 3 days after, it went on to the face to left side, it was in the neck mostly, and the top part of the shoulder, it was a dull aching pain, sometimes it shrills, and she really felt like, it was like it really hits her. The neck shoulder pain all started on the same day. The patient informed that it was not quite as bad as before, she took ibuprofen. The patient took Tramadol after the onset of the neck/shoulder pain. The patient informed that the end of the second phase of the vaccine is coming on the 07Feb2021. The outcome of the events pain in arm, facial pain was unknown, while shoulder pain, neck pain was recovering.  Follow-up activities are possible, information on the batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; pain went across her face to the left side; pain in the right shoulder to above the neck; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration in the right deltoid on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient informed that the hurting started when she was just talking with someone on 17Jan2021. The patient had taken ibuprofen and tramadol. The patient informed that her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides and wanted to know if there was anything she could do to eliminate that or make it less consuming. The patient informed that she didn't notice any problems for a couple days, then her right shoulder right above on the neck began to ache. This pain went across her face to the left side, it has sort of stayed in this particular area. It has not stopped aching since then. The patient informed that she didn't know what to take. The patient informed that the pain in the right shoulder to above the neck started 3 days after, it went on to the face to left side, it was in the neck mostly, and the top part of the shoulder, it was a dull aching pain, sometimes it shrills, and she really felt like, it was like it really hits her. The neck shoulder pain all started on the same day. The patient informed that it was not quite as bad as before, she took ibuprofen. The patient took Tramadol after the onset of the neck/shoulder pain. The patient informed that the end of the second phase of the vaccine is coming on the 07Feb2021. The outcome of the events pain in arm, facial pain was unknown, while shoulder pain, neck pain was recovering.  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Facial pain, Neck pain, Pain in extremity
Clinical narrative: right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; This is a spontaneous report from a contactable consumer reporting for self.  An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. After the hurting started on an unspecified date, she had taken ibuprofen and tramadol. , Her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides; she wanted to know if there is anything she could do to eliminate that or make it less consuming. She wanted to know if there was anything she could do to make the hurting less strenuous or if she can lay or walk a certain way to make it feel better. The end of the second phase of the vaccine is coming on 07Feb2021 and she needed to know if she should go ahead and take that. She hadn't been driving a car while this was going on because she was afraid of running into something. The event was reported as non-serious. The outcome of the event right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/hurting was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; This is a spontaneous report from a contactable consumer reporting for self.  An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. After the hurting started on an unspecified date, she had taken ibuprofen and tramadol. , Her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides; she wanted to know if there is anything she could do to eliminate that or make it less consuming. She wanted to know if there was anything she could do to make the hurting less strenuous or if she can lay or walk a certain way to make it feel better. The end of the second phase of the vaccine is coming on 07Feb2021 and she needed to know if she should go ahead and take that. She hadn't been driving a car while this was going on because she was afraid of running into something. The event was reported as non-serious. The outcome of the event right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/hurting was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; mild headache; This is a spontaneous report from a non-contactable consumer. A adult female patient received the second dose of bnt162b2 (lot number: EL3249), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included autoimmune conditions. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Patient indicated that after 12h post 2nd shot, began experiencing fever, chills, and body aches. Symptoms continued for 12 hours and subsided to a mild headache. The events were occurred on 20Jan2021. The outcome of the events fever, chills, and body aches were recovering, the event headache was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: Sore arm; insomnia; headache (mild to moderate); This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. EL3247, expiry date not reported), via an unspecified route of administration on 20Jan2021 01:45 at a single dose on her left arm for covid-19 immunization.  Medical history included hypothyroidism.  Concomitant medication included levothyroxine sodium (LEVOXYL) for hypothyroidism which she received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with covid-19.  The patient was not pregnant at time of vaccination and has not received any other vaccines within 4 weeks prior to the COVID vaccine.  Patient has no known allergies to medications, food, or other products. On 20Jan2021 08:00 PM, patient experienced sore arm, insomnia, headache (mild to moderate). No treatment was received for the reported adverse events. The outcome of events was recovering.  The facility where the most recent COVID-19 vaccine was administered was in workplace clinic. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: had really bad headache on Tuesday; felt very bad the night; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration on 17Jan2021 at single dose for Covid-19 immunization. The patient's age at vaccination was reported as 50 (units unspecified). The patient is not pregnant. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jan2021 17:00, the patient reported that she felt very bad the night she took the vaccine; she could not even get out of bed. Had a horrible day the next day and had really bad headache on Tuesday (19Jan2021). She was going to take Tylenol. The events were assessed as non-serious. The outcome of the events was recovering.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: mild headache; body aches; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient (also reported as age at vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on 29Dec2020 (age: 39 years) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021, the patient experienced body aches. The patient had a mild headache on 20Jan2021. Unknown if treatment was given in response to the events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: RIGHT ARM VERY SORE; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on Right arm from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE (first dose) for covid-19 immunisation.  Medical history included PCOS, hypothyroidism, hyperparathyroidism, hypertension. The patient has allergies with amoxicillin and oxybenzone. The patient experienced right arm very sore on 05Jan2021 with outcome of recovered.  The patient is not pregnant at the time of vaccination. No treatment was received for the event.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Headache centered at back of head and neck; Sore arm at site of shot; Fatigue; Nausea (mild); Slight dizzziness when getting up from bed; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration at the left arm on 17Jan2021 14:15 at a single dose for covid-19 immunization. The patient has no chronic health conditions or diagnosed illnesses; generally good health. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took codeine and experienced allergies: codeine. On 17Jan2021 17: 30, the patient experienced headache centered at back of head and neck, sore arm at site of shot, fatigue, nausea (mild) for about 8 hours, slight dizziness when getting up from bed.  It was reported that it took 36 hrs for all adverse effects to go away. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on 19Jan2021 05:30.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Pain
Clinical narrative: tired; body aches; chills; cold; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. He mentioned that a family member developed Guillain Barre's syndrome after the Flu vaccine, about 30 years ago. The patient reported that he had "no problem" after receiving the first dose of the COVID-19 vaccine, but felt a "little tired and achy, with chills " after the second dose on an unspecified date. He also feels like he has a cold with body aches on an unspecified date. He then asked if it is okay to take Tylenol or Advil after the vaccination, while also referencing the information he read on the matter. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082243 same reporter and drug, similar event, different patient
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: tired; body aches; chills; cold; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. He mentioned that a family member developed Guillain Barre's syndrome after the Flu vaccine, about 30 years ago. The patient reported that he had "no problem" after receiving the first dose of the COVID-19 vaccine, but felt a "little tired and achy, with chills " after the second dose on an unspecified date. He also feels like he has a cold with body aches on an unspecified date. He then asked if it is okay to take Tylenol or Advil after the vaccination, while also referencing the information he read on the matter. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082243 same reporter and drug, similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Heart rate, Heart rate increased
Clinical narrative: fever (101.1); chills; fatigue; resting heart rate 125; This is a spontaneous report received from a non-contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 15Jan2021 19:00, at single dose, for COVID-19 immunization, at the hospital. The patient medical history and concomitant medications were not reported. The patient has no known allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient received his second dose on 15Jan2021 (Friday) at 19:00 and felt okay. On 16Jan2021 (Saturday) at 10:00, the patient experienced fever (101.1) and chills, fatigue, resting heart rate 125. The patient took acetaminophen and went to bed. On 17Jan2021 (Sunday), the patient woke up feeling normal (as if nothing happened) and he has been feeling normal since then. The patient underwent COVID test since vaccination in Jan2021 with unknown results. The outcome of the events was recovered on 17Jan2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: fever (101.1); chills; fatigue; resting heart rate 125; This is a spontaneous report received from a non-contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 15Jan2021 19:00, at single dose, for COVID-19 immunization, at the hospital. The patient medical history and concomitant medications were not reported. The patient has no known allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient received his second dose on 15Jan2021 (Friday) at 19:00 and felt okay. On 16Jan2021 (Saturday) at 10:00, the patient experienced fever (101.1) and chills, fatigue, resting heart rate 125. The patient took acetaminophen and went to bed. On 17Jan2021 (Sunday), the patient woke up feeling normal (as if nothing happened) and he has been feeling normal since then. The patient underwent COVID test since vaccination in Jan2021 with unknown results. The outcome of the events was recovered on 17Jan2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Clumsiness
Clinical narrative: Clumsiness; This is a spontaneous report from a non-contactable consumer. An adult male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: unknown) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within the 4 weeks prior to the COVID vaccine. On an unspecified date in Jan2021, the patient experienced clumsiness. There was no hospitalization for the event. The event was reported as non-serious. It was unknown if the patient received treatment for the adverse event. The clinical outcome of clumsiness was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe muscle pain in left arm and body; This is a spontaneous report from a non-contactable consumer. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior and was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. The vaccine was administered at a hospital. On an unspecified date, the patient experienced severe muscle pain in left arm and body. No treatment was received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pharyngeal swelling, Throat tightness
Clinical narrative: throat was getting somewhat tight, some swelling; throat was getting somewhat tight, some swelling; slightly lightheaded; mild headache; This is a spontaneous report from a contactable other health professional (patient).  A 52-year-old female patient received first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration into left arm on 20Jan2021 13:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included allergies to shrimp and lobster, mild asthma and high blood pressure. Concomitant medication included diltiazem, benzoyl peroxide (BP), cetirizine hydrochloride (ZYRTEC), loratadine, paracetamol (TYLENOL) and vitamins. The patient had allergies to past blood pressure medications which included amlodipine besilate (NORVASC), irbesartan (AVAPRO) and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After taking first dose about 20 minutes on 20Jan2021 at 13:50 the patient felt slightly lightheaded and had mild headache, no real concern. Left observation area to go home after 45 minutes. No other symptoms at that point. Light headedness went away. While driving and running errands a few hours later the patient noticed her throat was getting somewhat tight, some swelling on 20Jan2021 at 16:30; this is similar to when she used to have shrimp/lobster allergic reactions. The patient took 1 tab of Benadryl before it got too bad and it subsided after about 30 min. No shortness of breath or any more symptoms so she went home and went to sleep after a few hours. She woke up and her throat had still some swelling. She called her doctor and she was recommended to take more allergy meds throught out the day and to report event to facility and to monitor. The swelling has not gone but much better. She was concerned about 2nd shot if it can be given where she was observed and monitored for a day. The patient recovered from slightly lightheaded on unspecified date. The outcome of headache was unknown and the remaining events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events throat tightness and throat swelling are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache, Pain in extremity
Clinical narrative: Arm was sore; Chest feels tight and very ache; Chest feels tight and very ache; Terrible headache; This is a spontaneous report from a contactable consumer, the patient. This 20 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 09:15 AM (at the age of 20 years-old) for COVID-19 vaccination.  There was no relevant medical history reported.  Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included sertraline and buspirone. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient did a workout and "my arm was sore." About 4 hours after the injection "my chest feels tight" and very ache and had a terrible headache. The events, arm was sore, chest feels tight and very ache and headache were reported as non-serious. There was no treatment received for the events. The clinical outcome of arm was sore, chest feels tight and very ache and headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Gastrointestinal pain, Nausea
Clinical narrative: Severe nausea; Bowel pain; Constipation; Diarrhea 5 times in 24 hours; This is a spontaneous report from a non-contactable other hcp. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), intramuscular on the right arm on 20Jan2021 15:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to sulfa from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced severe nausea, bowel pain, constipation followed by diarrhea 5 times in 24 hours following vaccine administration on 20Jan2021 22:30. No treatment was received for the events. The outcome of the events was recovering.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Malaise
Clinical narrative: Fever; Chills; Tiredness; Headaches; feeling unwell; Minor cough; This is a spontaneous report from a non-contactable consumer.  A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL2437, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Jan2021, the patient experienced fever, chills, tiredness, headaches, and feeling unwell but I had developed a minor cough. Patient had a covid test done two days ago and it came back negative, same day as the side effects started; post vaccination nasal swab was done on 19Jan2021 was negative. The events reported resulted in doctor or other healthcare professional office/clinic visit. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the events reported. The outcome of the events fever, chills, tiredness, headaches, feeling unwell and a minor cough was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Tiredness; Headaches; feeling unwell; Minor cough; This is a spontaneous report from a non-contactable consumer.  A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL2437, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Jan2021, the patient experienced fever, chills, tiredness, headaches, and feeling unwell but I had developed a minor cough. Patient had a covid test done two days ago and it came back negative, same day as the side effects started; post vaccination nasal swab was done on 19Jan2021 was negative. The events reported resulted in doctor or other healthcare professional office/clinic visit. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the events reported. The outcome of the events fever, chills, tiredness, headaches, feeling unwell and a minor cough was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Night sweats, Pyrexia, Seasonal allergy, Sluggishness
Clinical narrative: little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night; allergies due to the pollen; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer reporting for himself.  A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for COVID-19 immunisation.  Medical history reported as none. Family history included wife who passed away 2.5 years before, on an unspecified date and his daughter and her (daughter) son, who lives with the patient, tested positive for COVID virus. There were no concomitant medications. The patient experienced little bit of fever, allergies, and feeling unwell, but described as not horribly bad. Patient stated he is ok and doesn't think it has anything to do with the COVID-19 Vaccine. He stated that he thinks it is just allergies due to the pollen. Patient was taking two to three Ibuprofen once or twice a day when he goes to sleep. He has been perspiring quite a bit at night, which he stated was ok. Aside from that he was pretty much ok. He doesn't get second dose until 15Feb2021. Stated we have come a long way from beginnings of time where people would just die. He asked if he should get tested. Patient was advised to follow up with his primary care physician. He stated his symptoms began in the evening of 16Jan2021 at 8pm. He started getting a little feverish and sluggish. He took three Ibuprofen. He thought he lost some weight with the COVID-19 Vaccine. Weight was between 169-170lbs on 16Jan2021. The patient operates a daycare center with children. He was not taking any medication except for the Ibuprofen. He is very active and runs a business. Only thing is, he is sad because he does not have his wife with him. He stated everything was fine. He wanted to know if it was possible one can get the COVID virus even with the injection. He asked about the second COVID-19 Vaccine and what does the first dose do. Treatment included ibuprofen for little bit of fever, sluggish, and Feeling unwell. 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 the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of fever, sluggish, weight decreased, night sweats and feeling unwell  due to temporal relationship  Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of pollen allergy, which likely represent intercurrent medical condition.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night; allergies due to the pollen; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer reporting for himself.  A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for COVID-19 immunisation.  Medical history reported as none. Family history included wife who passed away 2.5 years before, on an unspecified date and his daughter and her (daughter) son, who lives with the patient, tested positive for COVID virus. There were no concomitant medications. The patient experienced little bit of fever, allergies, and feeling unwell, but described as not horribly bad. Patient stated he is ok and doesn't think it has anything to do with the COVID-19 Vaccine. He stated that he thinks it is just allergies due to the pollen. Patient was taking two to three Ibuprofen once or twice a day when he goes to sleep. He has been perspiring quite a bit at night, which he stated was ok. Aside from that he was pretty much ok. He doesn't get second dose until 15Feb2021. Stated we have come a long way from beginnings of time where people would just die. He asked if he should get tested. Patient was advised to follow up with his primary care physician. He stated his symptoms began in the evening of 16Jan2021 at 8pm. He started getting a little feverish and sluggish. He took three Ibuprofen. He thought he lost some weight with the COVID-19 Vaccine. Weight was between 169-170lbs on 16Jan2021. The patient operates a daycare center with children. He was not taking any medication except for the Ibuprofen. He is very active and runs a business. Only thing is, he is sad because he does not have his wife with him. He stated everything was fine. He wanted to know if it was possible one can get the COVID virus even with the injection. He asked about the second COVID-19 Vaccine and what does the first dose do. Treatment included ibuprofen for little bit of fever, sluggish, and Feeling unwell. 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 the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of fever, sluggish, weight decreased, night sweats and feeling unwell  due to temporal relationship  Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of pollen allergy, which likely represent intercurrent medical condition.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.