chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist.  A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist.  A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist.  A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist.  A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: legs and feet did hurt; Muscle aches are not from flu like; This is a spontaneous report from a contactable nurse reporting for self. This (Age-44, unit-unknown) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included fatigue, she felt fatigue every Friday. Concomitant medications were not reported. The patient stated she got her 2nd vaccine on 08Jan2021, stated "I haven't experienced any side effects, does that mean the vaccine isn't working? " Patient had little fatigue, and stated it's the same fatigue she felt every Friday baseline fatigue. Her legs and feet did hurt, but she had been walking from one end of the hospital to the other. Muscle aches were not from flu like. The outcome of events was unknown.    Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: legs and feet did hurt; Muscle aches are not from flu like; This is a spontaneous report from a contactable nurse reporting for self. This (Age-44, unit-unknown) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included fatigue, she felt fatigue every Friday. Concomitant medications were not reported. The patient stated she got her 2nd vaccine on 08Jan2021, stated "I haven't experienced any side effects, does that mean the vaccine isn't working? " Patient had little fatigue, and stated it's the same fatigue she felt every Friday baseline fatigue. Her legs and feet did hurt, but she had been walking from one end of the hospital to the other. Muscle aches were not from flu like. The outcome of events was unknown.    Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: I have redness, swelling and itching at the injection site/pretty red around where she got the shot; I have redness, swelling and itching at the injection site/swollen; I have redness, swelling and itching at the injection site/itches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient stated, "I had the 1st Pfizer COVID vaccine on the 07Jan2021; symptoms began on Saturday, 09Jan2021: I have been putting on peroxide on the area. I have redness, swelling and itching at the injection site. Am I doing the right thing?" Her side effects have subsided some, but she still has redness and itching passing. She had her first shot last Thursday and it is pretty red around where she got the shot. It was swollen and it itches. She wanted to know if that was normal. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Respiratory tract congestion
Clinical narrative: chest congestion; bother in the throat, at the bottom, me raspa; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported she was feeling chest congestion and "bother in the throat, at the bottom, me raspa". The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hangover, Headache
Clinical narrative: pretty bad excruciating, constant headache /constant brain fog headache; pretty bad excruciating, constant headache and fogginess; feeling hung over; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. Medical history included History of migraines. No medication she takes is helping. The patient's concomitant medications were not reported. On Jan2021, the patient has a pretty bad excruciating, constant headache and fogginess, feeling hung over, constant brain fog headache. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Infection, Musculoskeletal chest pain, Neuritis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (Lot number and expiry date were unknown) via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took shingles shot (unspecified medication) about 3 or 4 years ago for immunization. The patient stated "I got the Pfizer Vaccine last Wednesday (30Dec2020), then now that "I am in bed" and four days later (Jan2021) my rib cage started hurting on the left side, the side I got the shot on. I went to the doctor and she thought I was starting to have shingles or Intercostal neuritis. I just wondered if the shot could cause you to have shingles." The patient also stated, "I had the shingles shot (unspecified medication) about 3 or 4 years ago. The doctor thought I might have shingles or Intercostal neuritis which is infection in between the ribs." Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; This is a spontaneous report from a contactable female nurse (patient) via Pfizer sponsored program.  A female patient of an unspecified age received bnt162b2 (BNT162B2) on 26Dec2020 at single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was exposed to Covid-19 4 days after on 30Dec2020 and tested + 9 days after dose #1 on 04Jan2021.  The outcome of 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 products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Neck pain
Clinical narrative: she felt very fatigued with a headache; she felt very fatigued with a headache; neck and shoulder pain; neck and shoulder pain; mild dizziness; This is a spontaneous report from a contactable consumer reporting for self. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated that she received the first dose of vaccine on 30Dec2020 and the next day (31Dec2020) she felt very fatigued with a headache, neck and shoulder pain, and then experienced mild dizziness. Today (11Jan2021) is the first day that she feels better. She was scheduled to receive the second dose of the vaccine on 20Jan2021 and she wanted to know if she should get the second dose considering her reaction after the first dose. She stated that she used ibuprofen (ADVIL) for the headache and it only helped for about an hour and then she drank Theraflu hot tea and that helped her the most. The outcome of events was recovering.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Malaise, SARS-CoV-2 test positive
Clinical narrative: positive for covid19; positive for covid19; got or felt sick; This is a spontaneous report from a contactable physician reported for self and consumer. This 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 at single dose for covid-19 immunisation. As soon as patient got vaccine she got or felt sick  in Dec2020 and had the test and finds out she was positive, so she stays home two weeks and doesn't have no symptom at all and wants to know when has to take a test. The day after the patient developed symptoms thought it was the vaccine, but the symptoms continued for 2-3 days, the 3rd day the patient got herself tested. The patient was positive for covid19 at the time had the shot/ as soon as she got vaccinated she became positive. The patient hasn't had any symptoms for the past 2 weeks. The patient was scheduled to get retested. The patient was scheduled for 2nd dose of vaccine. The patient asked if there are any risks since developed covid the day after getting the vaccine. What if miss today. The patient wanted to know time after having no symptoms past two weeks, when she has to take a test. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Test positive for covid19 found as soon as following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Swelling face
Clinical narrative: dizziness; swelling in the left cheek in the face; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), 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, a Consumer calls for information about if she should receive the second dose of the Pfizer's COVID-19 vaccine considering that she developed side effects after the administration of the first dose. The Consumer reported that she had dizziness and swelling in the left cheek in the face. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: I've got the 1st dose of vaccine and then unfortunately, in the interim, I started feeling sick and tested positive for Covid.; I've got the 1st dose of vaccine and then unfortunately, in the interim, I started feeling sick and tested positive for Covid.; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he got the 1st dose of the vaccine and then unfortunately, in the interim, he started feeling sick and tested positive for Covid. The patient underwent Covid test and resulted positive on an unknown date. Outcome of the event was unknown.  No follow-up activities are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 12th of 13 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. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, Cough, Dizziness
Clinical narrative: Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020).  On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020).  On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020).  On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia
Clinical narrative: Chills, myalgia, axillary lymphadenopathy; Chills, myalgia, axillary lymphadenopathy; Chills, myalgia, axillary lymphadenopathy; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (anatomical location: arm right) from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunisation. Medical history was reported as none. The patient had first vaccine on 18Dec2020 to 18Dec2020 for COVID-19 immunisation. The patient's concomitant medications were not reported. On 09Jan2021, the patient experienced chills, myalgia, axillary lymphadenopathy. The patient did not received any treatment for the events. Outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Ear pain, Neck pain, Pain in extremity
Clinical narrative: neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Received Covid vaccine and tested positive for Covid 10 days after; Received Covid vaccine and tested positive for Covid 10 days after; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), 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 patient received COVID vaccine and tested positive for COVID, 10 days after on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; This is a spontaneous report from a contactable other HCP. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 08Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (anatomical Location: Arm Left) on 18Dec2020 09:30 and experienced headache, arm pain. Concomitant medication included spironolactone and metoprolol. The patient experienced events after the second dose: fever, chills, muscle and joint pain, headache, fatigue on 08Jan2021 21:00. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; This is a spontaneous report from a contactable other HCP. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 08Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (anatomical Location: Arm Left) on 18Dec2020 09:30 and experienced headache, arm pain. Concomitant medication included spironolactone and metoprolol. The patient experienced events after the second dose: fever, chills, muscle and joint pain, headache, fatigue on 08Jan2021 21:00. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: soreness in her arm at the injection site in the left arm; bruising at injection site; injection site that is red and hot; itching and redness at injection site; itching and redness at injection site; This is a spontaneous report from a contactable consumer (patient). A 94-year-old female patient received BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration from 30Dec2020 to 30Dec2020 at SINGLE DOSE in the left arm for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated that she got the Covid vaccine a week ago on Wednesday, 30Dec2020, 9 days ago, stated she did not seem to have any problems or side effects after, then she felt some soreness in her arm at the injection site in the left arm. States that last night on 07Jan2021, she woke up itching and redness at injection site and when she looked at her arm this morning, there is a really bad 2 1/2 to 3 inches at the injection site that is red and hot. Also she experienced bruising at injection site. She wants to know if this is a common thing. The outcome of the event "bruising at injection site" was recovering; for events Vaccination site pruritus and Vaccination site erythema was recovered on unknown dates; while unknown for the other events.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 (reported as three weeks ago from 07Jan2021) for COVID-19 immunization and she was fine. The patient got the second COVID vaccine on 07Jan2021 afternoon. The pain at the injection site to left arm started on 07Jan2021 20:00. On 07Jan2021, in the middle of the night, the fever, headache, and legs hurting started. She has been sleeping all day on 08Jan2021 and she does not do this normally. Outcome of the sleeping all day was unknown, of the headache was recovering, of the pain at the injection site to left arm was recovered on 07Jan2021, of the legs hurting and fever was recovered on 08Jan2021.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1283, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 17:00 at a single dose for COVID-19 immunization. The patient received her first dose of bnt162b2, via an unspecified route of administration on the left arm on 19Dec2020 at 13:00. Both doses were administered at the hospital. The patient had no medical history. The patient had no known allergies; she had no allergies to medications, food, or other products. Concomitant medication included unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness on 10Jan2021 at 20:00, or 24 hours after the shot had been given. At the time of the report, at the 12 hour mark, she was still being dizzy. The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event (AE). The patient was not recovered from the event.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1283, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 17:00 at a single dose for COVID-19 immunization. The patient received her first dose of bnt162b2, via an unspecified route of administration on the left arm on 19Dec2020 at 13:00. Both doses were administered at the hospital. The patient had no medical history. The patient had no known allergies; she had no allergies to medications, food, or other products. Concomitant medication included unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness on 10Jan2021 at 20:00, or 24 hours after the shot had been given. At the time of the report, at the 12 hour mark, she was still being dizzy. The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event (AE). The patient was not recovered from the event.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Light headache ( first day); nausea ( 3 days); severe fatigue (2 days); This is a spontaneous report from a contactable healthcare professional (patient). A 53-years-old female patient received first dose on bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number Bj1685, expiration date not reported), intramuscular, on the left arm, on 07Jan2021 at 15:00 at a single dose for Covid-19 immunization. Medical history included scleroderma, interstitial lung disease (ILD), and Raynauds. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant. On 06Jan2021, the patient had a nasal swab with negative result. On 07Jan2021, the patient experienced light headache (first day), nausea (3 days) and severe fatigue (2 days). The patient had a nasal swab with negative result on 06Jan2021. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Malaise
Clinical narrative: Not feeling well; Slight flu; Fatigue; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 07Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was not feeling well; had a slight flu; and fatigue. The outcome of the events, 'not feeling well', 'slight flu' and 'fatigue', was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, SARS-CoV-2 test negative
Clinical narrative: started with left sided lower back pain; This is a spontaneous report from a contactable Nurse (patient). A 22-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration at left arm on 16Dec2020 13:45 at single dose for covid-19 immunization. Medical history included allergies for All fish. The patient's concomitant medications were not reported. The patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days), Life threatening illness (immediate risk of death from the event). The patient received the Heparin drip and xarelto at home for the event. The patient was not pregnant. The patient received the covid test post vaccination on 09Jan2021. Test type was Nasal Swab. The result was negative. The outcome of the event was recovered with sequel on unspecified date.; Sender's Comments: From the information provided it is unclear what is the nature of the reported event and what are the reasons that have put the subject at immediate risk of death. The event is considered possibly related to the suspect product based on the positive temporal association.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Pain at injection site; Headache; Nausea; Vomiting; Loss of appetite; Fatigue; Chills; This is a spontaneous report from a non-contactable nurse (patient herself).  This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248), via intramuscular, on 09Jan2021 at 10:30, at single dose in the left arm, for COVID-19 immunisation. The patient was not pregnant. She was vaccinated at hospital, age at vaccination was 35-year-old. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL5730), via intramuscular, on 19Dec2020 at 13:00 at single dose in the right arm. Historical vaccine includes Hepatitis A vaccine (single dose, via an unknown route in the arm left) on 18Dec2020. No medical history was provided. No known allergies. No relevant concomitant medications were provided. The patient was vaccinated at hospital, age at vaccination was 35-year-old. Pre-vaccination and post-vaccination COVID tests were not performed. On 09Jan2021 at 18:00, the patient developed pain at injection site, headache, nausea, vomiting, loss of appetite, fatigue, and chills. The patient was not treated for the events. The patient had recovered from the events on unknown date in Jan2021.  No follow-up attempts are possible. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Pain at injection site; Headache; Nausea; Vomiting; Loss of appetite; Fatigue; Chills; This is a spontaneous report from a non-contactable nurse (patient herself).  This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248), via intramuscular, on 09Jan2021 at 10:30, at single dose in the left arm, for COVID-19 immunisation. The patient was not pregnant. She was vaccinated at hospital, age at vaccination was 35-year-old. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL5730), via intramuscular, on 19Dec2020 at 13:00 at single dose in the right arm. Historical vaccine includes Hepatitis A vaccine (single dose, via an unknown route in the arm left) on 18Dec2020. No medical history was provided. No known allergies. No relevant concomitant medications were provided. The patient was vaccinated at hospital, age at vaccination was 35-year-old. Pre-vaccination and post-vaccination COVID tests were not performed. On 09Jan2021 at 18:00, the patient developed pain at injection site, headache, nausea, vomiting, loss of appetite, fatigue, and chills. The patient was not treated for the events. The patient had recovered from the events on unknown date in Jan2021.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Maternal exposure during pregnancy
Clinical narrative: Lymphadenopathy; Patient that was 13 weeks pregnant did receive the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was 13-week pregnant when the first dose of the vaccination was received. On an unspecified date, the patient had lymphadenopathy. The outcome of the events, '13-week pregnant when the first dose of the vaccination was received' and 'lymphadenopathy', was unknown. The patient was asking about the second dose of the vaccine.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: the spot itched like crazy; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), 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 patient experienced "the spot itched like crazy" on an unspecified date. The outcome of the event was unknown.  Information about lot/batch has been requested.