chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Musculoskeletal stiffness, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; This is a spontaneous report from a non-contactable other healthcare professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) 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 is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced headache, right hand numbing and tingling, and stiff neck. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient underwent post vaccination nasal swab with an unknown result.   No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: developed active Covid within 24 hours of receiving vaccine; developed active Covid within 24 hours of receiving vaccine; This is a spontaneous report from a contactable physician received via a Pfizer sales Representative. A female patient (physician) of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history included exposed to COVID-19 a few days prior to receiving the COVID-19 vaccine (works within a hospital and had been exposed to COVID-19 active infected patients). Concomitant medications were not reported. A physician reported that a female physician developed active Covid within 24 hours of receiving vaccine (also reported as received the vaccine and within 24 hours developed active symptoms of Covid) on an unspecified date. Requested information on whether to receive the second vaccine at this point. Unsure of the need or complications that could potentially rise from receiving a second vaccine in the series. The events took place after use of product. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported "active Covid" is related to BNT162B2 vaccine.  Event occurred within 24 hours of receiving vaccination, when the vaccine is not expected to achieve the effect.  The event is most likely intercurrent medical condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported.  The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event.   Information on the lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: the consumer experienced inflamed lymph nodes in the axilla area of the arm that was injected (left arm).; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer Sales Representative.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on unknown date at SINGLE DOSE for COVID-19 immunization. It was reported that the patient was a cancer survivor. The patient's concomitant medications were not reported.  On an unknown date shortly after receiving the vaccine, the patient experienced inflamed lymph nodes in the axilla area of the arm that was injected (left arm). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Neck pain
Clinical narrative: Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; This is a spontaneous report from a contactable nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 03Dec2020 at 16:00, at a single dose, for COVID-19 immunization. Medical history included hypertension (HTN). The patient has no known allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a facility. On 04Dec2020, at 05:00 a.m., the patient initially experienced soreness at the injection site. Over the next 4 days (today is day 4), patient experienced pain in left shoulder, back, and up the back of head/neck which was getting progressively worse - now excruciating. Ibuprofen managed the pain for the first two days, but the soreness/pain was no longer managed with NSAID's and other comfort measures. Patient was hoping that these are normal and was hoping they will get better. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint and muscle pain; Joint and muscle pain; This is a spontaneous report from a contactable physician.  A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on the left arm on 28Dec2020 08:45 at single dose for COVID-19 immunisation.  The patient had no medical history.  Concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRIN) and naproxen sodium (ALEVE).  The patient experienced joint and muscle pain on 28Dec2020 20:00. The patient received no treatment. The outcome of the events was recovered on an unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received a covid positive diagnosis; received a covid positive diagnosis; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 21Dec2020 09:45 at a single dose for COVID-19 immunization at the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and did not received other medications within 2 weeks of vaccination. The patient received a COVID positive diagnosis on 29Dec2020, 8 days later. The events led to a doctor or other healthcare professional office/clinic visit. The patient underwent COVID tests post vaccination on 29Dec2020 - Nasal Swab (NAA nasal swab) and Rapid COVID test, both showed positive test results. The patient was not diagnosed with COVID-19 prior to vaccination. Outcome of the events was recovering. No treatment was given for the events. The events were assessed as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Malaise, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; nausea; Since then, it just doesn't feel right; since the vaccine have stiffness when turning my neck; a few headaches; This is a spontaneous report from a contactable nurse (patient)  A 41-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 21-DEC-2020 09:30 (at the age of 41-years-old) as a single dose in the right arm  for COVID-19 immunization.  Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. Soon after receiving the vaccine in my right arm, she felt a strange feeling in the right-side of the neck that ended around the base of the head and nausea on 21Dec2020. Since then, it just doesn't feel right and still have the nausea and since the vaccine have stiffness when turning my neck on 21Dec2020. "I can't really describe it much more than it feels strange and hasn't gotten better". The patient had a few headaches on 21Dec2020 but am unsure if that's related to the vaccine as they didn't occur immediately after receiving it. The events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches  did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect.  No treatment was received for the events. Outcome of the events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches was recovering.  Since the vaccination, the patient has not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; nausea; Since then, it just doesn't feel right; since the vaccine have stiffness when turning my neck; a few headaches; This is a spontaneous report from a contactable nurse (patient)  A 41-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 21-DEC-2020 09:30 (at the age of 41-years-old) as a single dose in the right arm  for COVID-19 immunization.  Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. Soon after receiving the vaccine in my right arm, she felt a strange feeling in the right-side of the neck that ended around the base of the head and nausea on 21Dec2020. Since then, it just doesn't feel right and still have the nausea and since the vaccine have stiffness when turning my neck on 21Dec2020. "I can't really describe it much more than it feels strange and hasn't gotten better". The patient had a few headaches on 21Dec2020 but am unsure if that's related to the vaccine as they didn't occur immediately after receiving it. The events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches  did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect.  No treatment was received for the events. Outcome of the events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches was recovering.  Since the vaccination, the patient has not been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; Chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular on 31Dec2020 08:45 in arm (reported as left and right) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, norgestimate (NORGESTIMATE AND ETHINYL ESTRADIOL). It was reported that on 31Dec2020, the patient had chills and headache that started around 11:00 pm on the day the patient received the vaccine. The patient took 400mg of ibuprofen the next morning and had no recurrent symptoms. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: muscle aches, joint aches, sore throat, low grade fever; muscle aches, joint aches, sore throat, low grade fever; muscle aches, joint aches, sore throat, low grade fever; muscle aches, joint aches, sore throat, low grade fever; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 29Dec2020 10:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included anxiety and food allergy from cashews from an unknown date and unknown if ongoing.  Concomitant medication included paroxetine (PAROXETINE), cetirizine (CETIRIZINE), iron (IRON), vitamin d3 (VITAMIN D3) and magnesium (MAGNESIUM). The patient experienced muscle aches, joint aches, sore throat and low grade fever (non-serious) on 29Dec2020 18:00. The patient underwent lab tests and procedures which included body temperature: low grade fever on 29Dec2020. The outcome of event was recovered with sequelae.  Information about lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid pain, Swelling of eyelid
Clinical narrative: left eyelid severely swollen; eye lid or perhaps eyeball under lid sore to touch; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: unknown), via an unspecified route of administration on 29Dec2020 13:00 in left arm at single dose for COVID-19 immunization. Medical history included seasonal allergy and asthma from an unknown date and unknown if ongoing. Concomitant medication included zinc, vitamin C [ascorbic acid], vitamin B3 and Elipta for asthma. The patient had historical vaccine Tetanus and experienced allergies. On 30Dec2020, the patient woke up the next morning with left eyelid severely swollen then took anithistamine Allegra, it got better as the eye lid or perhaps eyeball under lid sore to touch for next 24 hours but getting progressively better. The facility where the most recent COVID-19 vaccine was administered in a nursing home or senior living facility. 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. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: fever of 101.4 and myalgias; fever of 101.4 and myalgias; This is a spontaneous report from a contactable nurse. This 24-Year-old female nurse reported for herself that:  A 24-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) intramuscular at single dose at left arm on 22Dec2020 for Covid-19 immunisation, administered at hospital.  Medical history included anxiety, depression, attention deficit hyperactivity disorder (ADHD), had experienced Covid prior vaccination. She was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced fever of 101.4 and myalgias on 22Dec2020. The patient underwent lab tests and procedures which included body temperature: 101.4 on 10Jan2004 fever of 101.4. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.  Information on Lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; This is a spontaneous report from a contactable other hcp reporting for herself.   This 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose on 15Dec2020 14:00  (Lot # EK5730) in the left arm and the second dose on 04Jan2021 12:45 (Lot # EL1284) in the right arm, both via an unspecified route of administration at single dose for Covid-19 immunisation. Medical history included asthma and allergies to Penicillin and Oxycodone. Concomitant medication included omalizumab (XOLAIR), salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  On 04Jan2021 23:00, the patient experienced injection site soreness, fatigue/chills (day). Bad diarrhea at night. No treatment was performed. The outcome of the events was recovered. The patient underwent lab tests and procedures which included Nasal Swab, Covid test on 28Dec2020 was negative. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Urticaria, Vaccination site pain
Clinical narrative: swollen hives and welts around mouth area; Muscle pain at injection site; extreme fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular from on 31Dec2020 16:30 (04:30 PM) at a single dose on the left arm as Covid vaccine.  The patient had no medical history. It is unknown if the patient had known allergies to medications, food, or other products. Concomitant medication included birth control (other medications within 2 weeks of vaccination). The patient was not pregnant at the time of vaccination. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. The patient experienced muscle pain at injection site, extreme fatigue x 2 days, swollen hives and welts around mouth area x 3 days and still persistent, all on 01Jan2021 12:00. The events did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. No treatment was received for the events. She was not diagnosed with COVID-19 prior to vaccination and did not have Covid tested post vaccination (had not been tested for COVID-19 since the vaccination). The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Tinnitus
Clinical narrative: Current symptoms are ear ringing and tingling all over.; 5 minutes after injection I had ear ringing that has persisted. Additionally, I was woken with  extreme nausea after ~56 hours and was ill for 24 hours. Current symptoms are ear ringing and tingling a; 5 minutes after injection I had ear ringing that has persisted. Additionally, I was woken with  extreme nausea after ~56 hours and was ill for 24 hours. Current symptoms are ear ringing and tingling a; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown ), via an unspecified route of administration (left arm) on 29Dec2020 15:30 at SINGLE DOSE for COVID-19 immunization. Medical history included migraine and allergies to penicillin from an unknown date. No other vaccine was taken in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included rizatriptan benzoate (MAXALT) from an unspecified date. On 29Dec2020 15:35, 5 minutes after injection, the patient had ear ringing that has persisted. Additionally, she was woken with extreme nausea after 56 hours, on 31Dec2020 23:30 (also reported as 29Dec2020 03:45), and was ill for 24 hours. Current symptoms were ear ringing and tingling all over. Treatment was not given. Event outcome was not recovered. The reporter considered the events as non-serious.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeding disorder
Clinical narrative: Injection site beside the little red it's 6 to 8 inch; It's just hurt like too much 4 out of 10/ a lot of pain just 6-8 inch from the injection site; No strength, zero to go do anything/weak; did not eat all day; dizzy; ill; Could not sleep/ being up all night long; fatigued/ tired; headache; Muscle pain; chills; I was cold; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration on 29Dec2020 14:00 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously took flu shot and was goofy for the next 2 days. The patient reported that he/she had all the symptoms, side effects of the vaccine. The patient just got his/her first injection on 29Dec2020, 2 o clock in the PM. The first and the second day he was so much okay. The patient doesn't see any swollen lymph node or fever, but the rest all the things he/she stated to have. The patient stated that he/she is pretty ill, could not sleep, cold, fatigued, and had a big "done" (not clarified) headache where low mount of Tylenol could quite that down. It's just on and on and on. The injection site beside the little red it's 6 to 8 inch. It's just hurt like too much 4 out of 10 and it should not be. The patient has no strength, zero to go do anything. The patient did not eat all day. The patient reported that he/she does not have those severe symptoms of difficulty breathing, swelling of the face, and fast heart rate or thing like that, but he/she has been dizzy and very weak. It was further reported that yesterday (31Dec2020), the patient got very sick with the headache which will not go away. The patient had muscle pain, chills, and was so cold. The patient was not sure if he/she had fever last night, but he/she could not get up from his/her bed. Right now, the patient has a lot of pain just 6-8 inch from the injection site, and he/she just wanted to report all of this to the company. He had to call in sick this morning, because he was so tired being up all night long. The patient's second dose is due on the 19Jan2021. The patient wanted to know if he/she should delay the second vaccine. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Illness, Insomnia, Myalgia
Clinical narrative: Injection site beside the little red it's 6 to 8 inch; It's just hurt like too much 4 out of 10/ a lot of pain just 6-8 inch from the injection site; No strength, zero to go do anything/weak; did not eat all day; dizzy; ill; Could not sleep/ being up all night long; fatigued/ tired; headache; Muscle pain; chills; I was cold; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration on 29Dec2020 14:00 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously took flu shot and was goofy for the next 2 days. The patient reported that he/she had all the symptoms, side effects of the vaccine. The patient just got his/her first injection on 29Dec2020, 2 o clock in the PM. The first and the second day he was so much okay. The patient doesn't see any swollen lymph node or fever, but the rest all the things he/she stated to have. The patient stated that he/she is pretty ill, could not sleep, cold, fatigued, and had a big "done" (not clarified) headache where low mount of Tylenol could quite that down. It's just on and on and on. The injection site beside the little red it's 6 to 8 inch. It's just hurt like too much 4 out of 10 and it should not be. The patient has no strength, zero to go do anything. The patient did not eat all day. The patient reported that he/she does not have those severe symptoms of difficulty breathing, swelling of the face, and fast heart rate or thing like that, but he/she has been dizzy and very weak. It was further reported that yesterday (31Dec2020), the patient got very sick with the headache which will not go away. The patient had muscle pain, chills, and was so cold. The patient was not sure if he/she had fever last night, but he/she could not get up from his/her bed. Right now, the patient has a lot of pain just 6-8 inch from the injection site, and he/she just wanted to report all of this to the company. He had to call in sick this morning, because he was so tired being up all night long. The patient's second dose is due on the 19Jan2021. The patient wanted to know if he/she should delay the second vaccine. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site beside the little red it's 6 to 8 inch; It's just hurt like too much 4 out of 10/ a lot of pain just 6-8 inch from the injection site; No strength, zero to go do anything/weak; did not eat all day; dizzy; ill; Could not sleep/ being up all night long; fatigued/ tired; headache; Muscle pain; chills; I was cold; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration on 29Dec2020 14:00 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously took flu shot and was goofy for the next 2 days. The patient reported that he/she had all the symptoms, side effects of the vaccine. The patient just got his/her first injection on 29Dec2020, 2 o clock in the PM. The first and the second day he was so much okay. The patient doesn't see any swollen lymph node or fever, but the rest all the things he/she stated to have. The patient stated that he/she is pretty ill, could not sleep, cold, fatigued, and had a big "done" (not clarified) headache where low mount of Tylenol could quite that down. It's just on and on and on. The injection site beside the little red it's 6 to 8 inch. It's just hurt like too much 4 out of 10 and it should not be. The patient has no strength, zero to go do anything. The patient did not eat all day. The patient reported that he/she does not have those severe symptoms of difficulty breathing, swelling of the face, and fast heart rate or thing like that, but he/she has been dizzy and very weak. It was further reported that yesterday (31Dec2020), the patient got very sick with the headache which will not go away. The patient had muscle pain, chills, and was so cold. The patient was not sure if he/she had fever last night, but he/she could not get up from his/her bed. Right now, the patient has a lot of pain just 6-8 inch from the injection site, and he/she just wanted to report all of this to the company. He had to call in sick this morning, because he was so tired being up all night long. The patient's second dose is due on the 19Jan2021. The patient wanted to know if he/she should delay the second vaccine. The outcome of the events was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: tested positive after taking the first dose of the vaccine; exposed to a family member with the virus/tested positive after taking the first dose of the vaccine; tested positive after taking the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse reported for a 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who tested and was positive for the virus after being exposed to a family member with the virus after taking the first dose of the vaccine. Patient was asymptomatic. The Nurse asking if we have any recommendations for the 2nd dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the events lack of effect (suspected COVID-19, tested and was positive) with BNT162b2 can not be completely excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted covid after getting the vaccine; contracted covid after getting the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported similar events for 4 patients. This is 1st of 4 reports. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, does not have lot number to provide) via an unspecified route of administration on 24Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient contracted COVID after getting the vaccine on 01Jan2021. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested; Sender's Comments: The association between the event lack of effect (contracted COVID) with BNT162b2 can not be completely excluded.,Linked Report(s) : US-PFIZER INC-2021003894 same reporter/drug/event, different patient;US-PFIZER INC-2021003893 same reporter/drug/event, different patient;US-PFIZER INC-2021003895 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted covid after getting the vaccine; Contracted covid after getting the vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A contactable physician reported similar events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), 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 contracted covid after getting the vaccine on an unspecified date. The report was non-serious per the reporter. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: The association between the event lack of effect (contracted COVID) with BNT162b2 can not be completely excluded.,Linked Report(s) : US-PFIZER INC-2021003873 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted covid after getting the vaccine; contracted covid after getting the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported similar events for 4 patients. This is 3rd of 4 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient contracted COVID after getting the vaccine. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003873 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted covid after getting the vaccine; contracted covid after getting the vaccine; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported similar events for 4 patients. This is 4th of 4 reports. A patient of unspecified age and gender received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient contracted COVID after getting the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (contracted COVID) with BNT162b2 can not be fully excluded.,Linked Report(s) : US-PFIZER INC-2021003873 same reporter/drug/event, different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Arm/muscle pain; Arm/muscle pain; Exhaustion lasting two days; This is a spontaneous report from a non-contactable nurse (patient herself). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (arm right), on 17Dec2020 at 06:00, at a single dose, for COVID-19 immunization. Relevant medical history included depression, anxiety, exercise endured asthma, migraines, and allergies to estrogen supplements. Concomitant medications included sertraline hydrochloride (ZOLOFT), galcanezumab (EMGALITY), clarithromycin (CLARITIN), and norethindrone. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced exhaustion lasting two days, and arm/muscle pain. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient showed a negative post vaccination nasal swab result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Headache, Sleep disorder due to a general medical condition
Clinical narrative: severe abdominal pain, waking him from sleep. Pain was periumbilical and supra- public region/Pain has recurred twice (24 and 48 hours post vaccination) waking from sleep each successive night; severe abdominal pain, waking him from sleep. Pain was periumbilical and supra- public region/Pain has recurred twice (24 and 48 hours post vaccination) waking from sleep each successive night; Recurrent events were also associated with a left sided headache, dull and throbbing in nature; This is a spontaneous report from a contactable other healthcare professional. A 68-year-old male patient received bnt162b2n(PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), intramuscular in the right arm on 29Dec2020 19:00 at a single dose for COVID-19 immunization. The patient's medical history included dyslipidaemia and hypothyroidism from an unknown date and unknown if ongoing. the patient has no known allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN 81), levothyroxine sodium (SYNTHROID), and atorvastatin calcium (LIPITOR). On 30Dec2020 (5-6 hours post injection), the patient developed severe abdominal pain, waking him from sleep. Pain was periumbilical and supra- public region. Relieved with analgesia (over the counter analgesia). CT scan the following days negative for appendicitis. Pain has recurred twice (24 and 48 hours post vaccination) waking from sleep each successive night and relieved with analgesia. Recurrent events were also associated with a left sided headache, dull and throbbing in nature, the initial event was not associated with a headache. The outcome of the event was recovering. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient  was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Vaccination site pain
Clinical narrative: arm pain (unspecified) following the injection; shoulder and neck stiffness; Pain was bilateral shoulders earlier; Neck is till sore, midline to posterior; This is a spontaneous report from a non-contactable nurse (patient herself that works at the surgical center of the hospital). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EX9231, expiry date: Apr2021), via an unspecified route of administration on 03Jan2021 at a single dose as Covid-19 vaccine. The patient's medical history and concomitant medications were not reported. Patient received flu vaccine on 29Oct2020. On 03Jan2021, the nurse reported some arm pain (unspecified) following the injection and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day. On 03Jan2021, pain was bilateral shoulders earlier, now subsiding. Neck was till sore, midline to posterior. The event arm pain (unspecified) following the injection was recovered on 04Jan2021. The patient was recovering from shoulder and neck stiffness and "pain was bilateral shoulders earlier". The outcome of the event neck was till sore, midline to posterior was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; This is a spontaneous report from a contactable unspecified Healthcare professional reporting for himself. This 52-year-old male patient received on 20Dec2020 02:30 PM first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) at single dose intramuscular in the left arm for COVID-19 immunization. No allergies to medications, food, or other products. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Concomitant medications (all started on an unknown date and received within 2 weeks of vaccination) included buspirone hydrochloride (BUSPIRON), atorvastatin (manufacturer unknown) and acetylsalicylic acid (BABY ASPIRIN). On 21Dec2020, 10 hours after getting vaccine the patient had body aches, cold and severe left arm pain. 4 days after getting vaccine again the patient had cold, body aches and sore throat for couple of days. On 28Dec2020, covid 19 test (nasal swab) result came up positive. The patient went to Emergency room. Outcome was recovered on an unknown date. It was unknown if a treatment was performed.; Sender's Comments: The association between the event lack of effect (COVID 19 nasal swab test result came up positive) with BNT162b2 can not be fully excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Depressed mood, Headache, Illness, Nasal congestion
Clinical narrative: Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.