chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Exposure to SARS-CoV-2, Illness, Influenza, Pyrexia
Clinical narrative: getting sick; flu symptoms; exposed to his brother with covid 19; 38 celcius fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 8-year-old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "getting sick"; INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to his brother with covid 19"; PYREXIA (non-serious), outcome "unknown", described as "38 Celcius fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Kid 8 years old fully vaccinated being exposed to his brother with covid 19 and getting sick, with flu symptoms and 38 Celcius feber, Event took place after the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: Fever; runny nose; feeling poorly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling poorly".  Additional Information: Batch number was Not available or provided to reporter at the time of report completion. Event reported Fever, runny nose, feeling poorly after second dose. Awareness Date reported as 24Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intermenstrual bleeding
Clinical narrative: Very light Spotting; Patient received first dose on 02Oct2021 and second dose on 23NOV2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 (Lot number: FJ1620) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism; "Menstruation stopped" (unspecified if ongoing), notes: Menstruation stopped. Last period 08Sep. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (lot number - EW0196, dose number 1, dose vaccine location - Left arm), administration date: 02Oct2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Patient received first dose on 02Oct2021 and second dose on 23NOV2021"; INTERMENSTRUAL BLEEDING (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Very light Spotting". Therapeutic measures were not taken as a result of intermenstrual bleeding.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: arm got real sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 (Lot number: EL3248) at the age of 71 years as dose 1, single for covid-19 immunization. Relevant medical history included: "alcohol" (unspecified if ongoing), notes: he drank 3-4 alcoholic drinks. Concomitant medication(s) included: TYLENOL taken for premedication. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm got real sore". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The day before patient got his first dose of Pfizer COVID-19 Vaccine he drank 3-4 alcoholic drinks that day. He usually drinks about 1-2 per day. But the day of he didn't drink any because he took a Tylenol to keep his arm from getting sore and he doesn't drink when he takes medicine.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: mild chills; tired feeling; This Initial case was previously missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on 19Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "reaction to antibiotic; Augmentin amoxicillin", start date: 2011 (unspecified if ongoing); "allergic to sulfate medications", start date: 2011 (unspecified if ongoing); "she had cellulitis in her thumb", start date: 2011 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "mild chills"; FATIGUE (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "tired feeling". Therapeutic measures were not taken as a result of fatigue. Additional information: 1st shot 27Feb2021 mid chills and tired feeling. The patient reported feeling fine at the time of reporting  Drug Lot number and Expiration date for 1st dose were reported as Pfizer Biotech EL9266 (May be EL9255 hard to read  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE and Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had anxiety. The patient wanted to know that, she was receiving her second dose of Pfizer's COVID vaccine tomorrow 13Feb2021 at 11 Am and was wondering if she could take Lorazepam (generic Ativan) today or a Tylenol after she gets the vaccine.  Follow-up attempts are completed. No further information is expected.  Follow-up (03Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she is taking ibuprofen all the time for pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "she is taking ibuprofen all the time for pain.". Therapeutic measures were taken as a result of pain.  Additional information included: The patient took Ibuprofen for the treatment of pain.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor, Vaccination site pain
Clinical narrative: R arm pain "as if someone socked me in the arm" at injection site; chills/shaking "as if my internals are trying to come out"; chills/shaking "as if my internals are trying to come out"; Headache; This is a spontaneous report from a non-contactable other healthcare professional. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on an unknown date (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received varicella zoster vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on an unknown date for an unknown indication and experienced adverse reaction, unable to recall what to the chicken pox vaccine. She had only been able to get one shot. She had tolerated other vaccines without issues. On an unknown date, during her 30 minutes waiting period after the injection, the patient began to experience chills/shaking "as if her internals were trying to come out". She also reported of right (R) arm pain "as if someone socked me in the arm" at the injection site. Therapeutic measures were taken as a result of the events she also reports of R arm pain "as if someone socked me in the arm" at injection site, during her 30-minute waiting period after the injection, the patient began to experience chills/shaking "as if her internals are trying to come out" included treatment with water, snacks and ibuprofen (MANUFACTURER UNKNOWN) for headache. The reporter stated follow up response to treatment was excellent. The patient was stable to go home and follow up with PCP. The clinical outcome of the event she also reports of R arm pain "as if someone socked me in the arm" at injection site, during her 30-minute waiting period after the injection, the patient began to experience chills/shaking "as if her internals are trying to come out" and headache was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated Historical vaccine reaction Coding "Adverse drug reaction NOS" to "Adverse event nos", removed onset latency for all events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle rigidity, Musculoskeletal stiffness, Vomiting
Clinical narrative: Per husband, patient had right-sided stiffness. Arm and hand rigid. She threw-up once, then napped for about 2 hours. She was back to normal after her nap. Patient encouraged to go to  doctor. I am not sure if she went.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, Heart rate increased, Myalgia, Sluggishness
Clinical narrative: Feeling like a brick of concrete. Elevated pulse. Balance off, feeling like vertigo, Sore muscles low back and neck
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Feeling like a brick of concrete. Elevated pulse. Balance off, feeling like vertigo, Sore muscles low back and neck
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Feeling abnormal, Myalgia, Urinary incontinence
Clinical narrative: Feeling like a brick of concrete. Elevated pulse. Balance off, feeling like vertigo, Sore muscles low back and neck
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Loss of consciousness, Musculoskeletal discomfort
Clinical narrative: On 3/11/22 @1415 I received the Moderna first dose. After about 10  minutes, my throat starting feeling really tight and I lost consciousness. Felt discomfort and pain in chest, neck and lower back.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Throat tightness
Clinical narrative: On 3/11/22 @1415 I received the Moderna first dose. After about 10  minutes, my throat starting feeling really tight and I lost consciousness. Felt discomfort and pain in chest, neck and lower back.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: Heart attack. Stent placed in circumflex artery
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Rash, Rash pruritic, Rash vesicular
Clinical narrative: A few days later, I developed a rash on my chest. It started as a few pimples, then turned into a painful and itchy rash (similar to chicken pox). I used Benadryl cream on it. The itching stopped after about a week.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Headache and swollen, painful lymph nodes on neck.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus began within approximately 48 hours after second dose; very pronounced in left ear; unresolved after 10 months
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Headache
Clinical narrative: Headache; Has improvement of bp on observation along with headache has subsided; This is a spontaneous report from a non-contactable healthcare professional. An 88-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on an unknown date in 2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, 15 minutes after the vaccination, the patient experienced a headache and "Has improvement of bp on observation along with headache has subsided". The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling, tongue swelling and weakness face, arms/legs. Therapeutic measures were taken as result of the event headache. It was reported that treatment for the patient included only water and follow up response to the treatment was excellent. The patient was discharged in stable condition to go home and was advised to follow up with a primary care physician. The differential diagnosis was reported as red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). It was reported that the patient was monitored for approximately 30 minutes and there was an improvement of blood pressure on observation along with headache had subsided. The patient was encouraged to monitor her blood pressure at home and follow up with a primary-care physician if blood pressure stays above 140/90. The patient's granddaughter had requested the patient to be evaluated and was appreciative of this evaluation. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information:  1 New AE 'Has improvement of bp on observation along with headache has subsided' added. 2 Age at vaccination removed. 3 Biological product captured as vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Feeling abnormal, Lacrimation increased
Clinical narrative: Strange feeling in the eyes over several hours.; Dry eyes.; Watery eyes; This is a spontaneous report from a non-contactable consumer.   A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 04Mar2021, the patient experienced strange feeling in the eyes over several hours. Dry and watery eyes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the therapeutic measures were taken as a result of the events. The clinical outcome of the events strange feeling in eyes, dry eyes and watery eyes were recovered on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient initial updated from PRIVACY to UNKNOWN, Treatment Received updated in event tab, Narrative "The patient did not receive any other vaccines within four weeks prior to the vaccination" should be removed since it was provided in source document and Final sentence should be updated as : No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Dizziness
Clinical narrative: Lightheadedness; Anxiety; This is a spontaneous report from a non-contactable healthcare professional. A 69-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on an unknown date (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling of double mask for a brief moment. Follow up response to treatment was excellent. The patient was discharged and was stable to go home and follow up with PCP (primary care physician). It was reported that differential diagnosis as Vaccine-Related Anxiety (include misc mental health). On an unknown date in 2021, Blood pressure was checked and the patient was evaluated. The patient was doing well and she felt better knowing her blood pressure was okay and not high. The patient was pleased with care and denied any concerns and she was able to ambulate out of the facility without assistance. Therapeutic measures were taken as a result of the event which was not specified. The clinical outcome of the events lightheadedness and Anxiety was unknown at the time of the report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: AE "Anxiety" was added and coded as such.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Body temperature, Chills, Headache
Clinical narrative: No side effects 1st shot but slight headach; severe chills; Fever; lack of energy; hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: Nov2020, stop date: Nov2020, notes: in November of 2020; "chronic obstructive pulmonary disease", start date: 2015 (ongoing), notes: 2015 and ongoing; "non-tobacco user", start date: 2015 (ongoing), notes: 2015 and ongoing; "sinus headache" (ongoing), notes: ongoing sinus headache teen/adult all my life/Ongoing. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "No side effects 1st shot but slight headach"; CHILLS (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "Fever"; ASTHENIA (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "lack of energy"; ALOPECIA (non-serious) with onset Feb2021, outcome "recovering", described as "hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: (To update patient details, suspect product details, events and lead line of narrative.)
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: No side effects 1st shot but slight headach; severe chills; Fever; lack of energy; hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: Nov2020, stop date: Nov2020, notes: in November of 2020; "chronic obstructive pulmonary disease", start date: 2015 (ongoing), notes: 2015 and ongoing; "non-tobacco user", start date: 2015 (ongoing), notes: 2015 and ongoing; "sinus headache" (ongoing), notes: ongoing sinus headache teen/adult all my life/Ongoing. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "No side effects 1st shot but slight headach"; CHILLS (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "Fever"; ASTHENIA (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "lack of energy"; ALOPECIA (non-serious) with onset Feb2021, outcome "recovering", described as "hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: (To update patient details, suspect product details, events and lead line of narrative.)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Vaccination site pain, Vaccination site swelling
Clinical narrative: approximately 16 hours after injection started experiencing soreness and swelling at the injection site.; approximately 16 hours after injection started experiencing soreness and swelling at the injection site.; Approximately 4 hours after injection was struck with a wave of exhaustion; Head felt very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP 7533) via an unspecified route of administration in the right arm on 08Apr2021 at 09:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications include escitalopram (MANUFACTURER UNKNOWN); norethisterone acetate, ethinylestradiol, ferrous fumarate (Blisovi/FE); both for unknown indications and since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not have any allergies to medications, food, or other products. On 08Apr2021 at 14:00, Approximately 4 hours after injection the patient was struck with a wave of exhaustion and her head felt very heavy. It took approximately 3 hours of laying in bed for the feeling to pass. Additionally, on 09Apr2021, approximately 16 hours after injection, the patient started experiencing soreness and swelling at the injection site. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. The clinical outcome of the events head felt very heavy, soreness at the injection site and swelling at the injection site were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Country added. 2. The onset date for event 'approximately 16 hours after injection started experiencing soreness and swelling at the injection site.' update. 3. Narrative 'Approximately 4 hours after injection the patient was struck with a wave of exhaustion' added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and mefenamic acid (ADVIL) from an unknown date for unknown indication. The patient previously took aspirin and doxycycline, and experienced allergy to the medications. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021, (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021, the patient experienced diarrhea 56 hours after vaccine. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event diarrhea was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added country in patient tab and Vaccination Facility Country. Recoded Concomitant drug Advil
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Pain in jaw
Clinical narrative: Stiffness in jaw; aching jaw; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00(at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included gliclazide (CLARITIN) and multivitamin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 12:00 the patient experienced stiffness in jaw and aching jaw. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events stiffness in jaw and aching jaw were not resolved at the time of this report   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: To amend 1. Vaccine Facility Information added.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Icy hot, burning, sunburn feeling intermittently all over body. Mostly arms, legs and shoulders; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Apr2021 at 13:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 20:00, about 30 hours after first vaccine, the patient started to get an icy hot, burning - sunburn feeling intermittently all over her body. Mostly arms and legs and shoulders. It was day 10 and still continuing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and was asked to take antihistamines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event icy hot, burning, sunburn feeling intermittently all over body, mostly arms, legs and shoulders was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (16Aug2021): Amendment: This follow-up report is being submitted to amend previously reported information: Patient's initials field updated. Narrative was updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain
Clinical narrative: chills; body pain; lethargy; This is a spontaneous report from a contactable consumer, the patient.   A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the arm left on 12Mar2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma and allergy to certain poultry. Concomitant medications included losartan (MANUFACTURER UNKNOWN) , ascorbic acid (VITAMIN C) and cyanocobalamin (B12), all from unknown dates and for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in  Mar2021, the patient experienced chills, body pain and lethargy. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with motrin. The clinical outcome of the events chills, body pain and lethargy was recovered on unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the arm left on 02Apr2021 at 09:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation.    No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility information was added in vaccine sub-tab.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Arm hurts; Nausea; Tired; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021(at the age of 53-year-old) as a dose number unknown, single for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On an unknown date in 2021 the patient experienced arm hurts, nausea, tired and headache. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm hurts, nausea, tired and headache was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (18Aug2021) Amendment: This follow-up report was submitted to amend previously reported information: Regulatory Authority added as country in the patient information field, Relevant medical history was not reported was added in narrative, Event onset date as added as 2021. Closer sentence No follow-up attempts are possible; information about lot/batch number cannot be obtained' was updated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN2613) via an unspecified route of administration in the left arm on 25Mar2021 at 18:00 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. Vaccination facility type was reported as Pharmacy/Drug store. Patient medical history was not reported. The patient had no known allergies to medications, food or other products. The concomitant medications included rosuvastatin calcium (CRESTOR) taking 5mg every other day, with a daily dosage of 2.5 mg/alternate day, Cyanocobalamin (VITAMIN B12) (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3) (MANUFACTURER UNKNOWN) for unknown indications, from unknown start dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 19:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021 the patient experienced ringing in ears. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of ringing in ears and included treatment with ear wax removal from an unknown start date to an unknown stop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was not recovered at the time of report.   No follow-up attempts are needed; No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information which included Lot number updated from unknown to EN6199 in Historical vaccine notes, Vaccine Facility Information added, 5mg every other day added in narrative for Crestor, Narrative Dose 1 and dose 2 order updated.  No follow-up attempts are needed, No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Ear ringing; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6202) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 58-years-old) as a dose 2, single for COVID-19 immunisation. Medical history included breast cancer. It was reported that the patient was a Breast cancer survivor. The patient previously had Cephalosporin on unknown date for unknown indication and experienced allergy to antibiotic. Concomitant medications taken within two weeks of vaccination included rosuvastatin calcium (CRESTOR) and thyroid (MANUFACTURER UNKNOWN); both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9265) via an unspecified route of administration in the left arm on 04Feb2021 at 08:00 (at the age of 58-years-old) as a dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 17:00, the patient experienced ear ringing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of ear ringing and included sinus treatment, ear testing. Since the vaccination, the patient had been tested for COVID-19. On 16Apr2021, the patient underwent COVID- 19 test and the result was negative. The clinical outcome of the event ear ringing was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Type, Name, City, State and Country added. Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Type, Name, City, State and Country added.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Pain in extremity, Parosmia
Clinical narrative: phantom smells of cigarette smoke; sore arm; hot flashes; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced a sore arm for a couple of days. On an unknown date in Apr2021, within 24 hours of vaccination, the patient experienced hot flashes and chills. On 17Apr2021, 12 days after the vaccination, the patient experienced phantom smells of cigarette smoke many times in a day. It was reported that no one in the patient's house smokes and this had been going on for at least a week. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, hot flashes, chills and phantom smells of cigarette smoke was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment (26Aug2021): This follow-up report is being submitted to amend previously reported information: Patient's initial added in patient tab. Narrative updated.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Head aches; migraines isolated in the back of head; This is a spontaneous report from a non-contactable consumer, the patient. A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 24-years-old) as a dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced headaches and migraines isolated in the back of her head. The patient never had headaches like that before the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headaches and migraines was not recovered at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age at vaccination added as 24 years.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: Left eyelid twitches every once in a while,; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 07:30 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN). On 12Apr2021, the patient experienced that left eyelid twitches every once in a while, which did not happen prior to vaccine. The patient did not receive any treatment for the event left eyelid twitches. The clinical outcome of the event left eyelid twitches every once in a while, was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment (30Aug2021): This follow-up report is being submitted to amend previously reported information that the patient had no known allergies to medications, food, or other products was added in narrative.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Felt younger after vaccination.; This is a spontaneous report from a from a contactable consumer (pfizer colleague). A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) at the age of 57 years via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown, if the patient had received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date, the patient experienced felt younger after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event, felt younger after vaccination was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age at Vaccination added 57 Years.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Hot flush, Vomiting
Clinical narrative: Stomach cramps; Throwing up; Chills; Hot flashes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient received bnt162b2 (BNT162B2) (Lot number: ER8733) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach cramps"; VOMITING (non-serious), outcome "unknown", described as "Throwing up"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes".  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Narrative "The patient did not receive any medication within two weeks of vaccination." was removed. 2. Final sentence was updated.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Multiple family members; grabbed wrong dose for patient. Noted right after injection. Gave adult Pfizer to 9-year-old when should have administered pediatric dose. No adverse reaction noted.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature fluctuation, Chills, Fatigue, Headache
Clinical narrative: Body aches and joint pain: duration ~15 hours starting about 6 hours after vaccination Fever/chills: duration ~12 hours starting about 8 hours after vaccination Mild temperature fluctuations: starting about 20 hours after vaccination and continuing for about 28 = hours Exhaustion: duration 48 hours starting 4 hours after vaccination Headache: duration 24 hours starting 18 hours after vaccination Acetaminophen: first dose of 1000 mg 5 hours after vaccination - last dose, also 1000 mg, 30 hours after vaccination Ibuprofen: first dose of 400 mg 17 hours after vaccination - last dose, also 400 mg, 43 hours after vaccination Symptoms did not require healthcare visit but resulted in inability to work or carry out normal activities
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Body aches and joint pain: duration ~15 hours starting about 6 hours after vaccination Fever/chills: duration ~12 hours starting about 8 hours after vaccination Mild temperature fluctuations: starting about 20 hours after vaccination and continuing for about 28 = hours Exhaustion: duration 48 hours starting 4 hours after vaccination Headache: duration 24 hours starting 18 hours after vaccination Acetaminophen: first dose of 1000 mg 5 hours after vaccination - last dose, also 1000 mg, 30 hours after vaccination Ibuprofen: first dose of 400 mg 17 hours after vaccination - last dose, also 400 mg, 43 hours after vaccination Symptoms did not require healthcare visit but resulted in inability to work or carry out normal activities
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Diagnosed with Pericarditis and having complications. Patient has been admitted into hospital 3 times. She has received colchicine during her visits. As of now colchicine has not worked, so MD added Lasix to her regimen.