chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: within 2 weeks she came down with Covid; within 2 weeks she came down with Covid; This is a spontaneous report received from a contactable pharmacist. A 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; lot number and Expiry Date was not reported) via an unspecified route of administration  on unspecified date as a single dose for COVID-19 immunization. Patient medical history and concomitant medication were reported as none. It was reported that pharmacist wanted to know when the patient would be able to get the 2nd dose of the BNT162B2. Patient tested positive for COVID after getting the 1st dose around 10-14 days after getting the 1st dose, patient developed COVID 19 symptoms and tested positive. Pharmacist stated that he/she had a patient who received the first dose of the Covid-19 vaccine, within 2 weeks she came down with Covid. Pharmacist stated that he/she did not actually administered it, so not sure for vaccine LOT number. Pharmacist was not sure regarding patient's date of birth and stated that not treated the patient, the practice Nurse try them, know what to do. Pharmacist had no idea regarding the patient's height, weight and ethnicity, Expiration date, NDC# and UPC#. Patient experienced within 2 weeks she came down with Covid as Drug ineffective and COVID-19. Product Complaint was reported. The patient under-went lab test and procedure which included COVID: positive. The patient was quarantined. The causality reported as no. The outcome of the event was unknown.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 16Jan2021 10:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, migraines, inflammatory arthritis, penicillin allergy. Concomitant medications included eszopiclone (LUNESTA) (MANUFACTURER UNKNOWN); valsartan (MANUFACTURER UNKNOWN); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN). On 8Feb2021, the patient experienced coughing, muscle aches, fatigue, sore throat. On 23Feb2021, the patient experienced test positive for covid 19. There was no direct adverse reaction from the vaccine, but I did test positive for COVID 19 on 23Feb2021 (yesterday) with symptoms of coughing, muscle aches, fatigue and sore throat. The patient underwent lab tests which included sars-cov-2 test: negative on 19Feb2021 and sars-cov-2 test: positive on 23Feb2021. The patient did not receive any treatment for the events. The clinical outcomes of the coughing, muscle aches, fatigue, sore throat, test positive for covid 19. No follow-up attempts are possible.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 16Jan2021 10:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, migraines, inflammatory arthritis, penicillin allergy. Concomitant medications included eszopiclone (LUNESTA) (MANUFACTURER UNKNOWN); valsartan (MANUFACTURER UNKNOWN); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN). On 8Feb2021, the patient experienced coughing, muscle aches, fatigue, sore throat. On 23Feb2021, the patient experienced test positive for covid 19. There was no direct adverse reaction from the vaccine, but I did test positive for COVID 19 on 23Feb2021 (yesterday) with symptoms of coughing, muscle aches, fatigue and sore throat. The patient underwent lab tests which included sars-cov-2 test: negative on 19Feb2021 and sars-cov-2 test: positive on 23Feb2021. The patient did not receive any treatment for the events. The clinical outcomes of the coughing, muscle aches, fatigue, sore throat, test positive for covid 19. No follow-up attempts are possible.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nausea, Pain
Clinical narrative: Chills; high fever; Body ache; cough; severe headache; Nausea; This is a spontaneous report from a contactable other hcp. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN5318), dose 2 and via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:15 as SINGLE DOSE for covid-19 immunization. Medical history included, cardiac disorder, angiopathy from an unspecified date. Historical drug included BNT162B2 for COVID-19 immunization. Concomitant medication(s) included dronedarone hydrochloride (MULTAQ); metoprolol tartrate (METOPROLOL TARTRATE); levothyroxine sodium (SYNTHROID) taken for an unspecified indication, an unspecified date. The patient experienced chills, high fever, body ache, cough, severe headache and nausea on 18Feb2021 01:00. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; high fever; Body ache; cough; severe headache; Nausea; This is a spontaneous report from a contactable other hcp. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN5318), dose 2 and via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:15 as SINGLE DOSE for covid-19 immunization. Medical history included, cardiac disorder, angiopathy from an unspecified date. Historical drug included BNT162B2 for COVID-19 immunization. Concomitant medication(s) included dronedarone hydrochloride (MULTAQ); metoprolol tartrate (METOPROLOL TARTRATE); levothyroxine sodium (SYNTHROID) taken for an unspecified indication, an unspecified date. The patient experienced chills, high fever, body ache, cough, severe headache and nausea on 18Feb2021 01:00. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Cough, Dark circles under eyes, Dysphonia
Clinical narrative: 9:20 shot  9:30 tingling in fingers on left hand  10:30 tingling, swollen tongue; tingling in chest and right arm  11:00 tingling in head, thirsty 17:00 arm and joints pain chemical odor in urine 3/30 next day:  0700 mild fatigue, thirsty 1300 itchy under skin 1700 upset stomach 3/31 dark circles under eyes; dry cough, hoarse voice, red eyes, sinus congestion, headache shooting from sinuses around the right to back of head 4/3-4/4 migraine, night sweats, periodic hot flashes itching under skin for a few days after shot
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hot flush, Night sweats, Ocular hyperaemia
Clinical narrative: 9:20 shot  9:30 tingling in fingers on left hand  10:30 tingling, swollen tongue; tingling in chest and right arm  11:00 tingling in head, thirsty 17:00 arm and joints pain chemical odor in urine 3/30 next day:  0700 mild fatigue, thirsty 1300 itchy under skin 1700 upset stomach 3/31 dark circles under eyes; dry cough, hoarse voice, red eyes, sinus congestion, headache shooting from sinuses around the right to back of head 4/3-4/4 migraine, night sweats, periodic hot flashes itching under skin for a few days after shot
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Sinus congestion, Swollen tongue, Thirst
Clinical narrative: 9:20 shot  9:30 tingling in fingers on left hand  10:30 tingling, swollen tongue; tingling in chest and right arm  11:00 tingling in head, thirsty 17:00 arm and joints pain chemical odor in urine 3/30 next day:  0700 mild fatigue, thirsty 1300 itchy under skin 1700 upset stomach 3/31 dark circles under eyes; dry cough, hoarse voice, red eyes, sinus congestion, headache shooting from sinuses around the right to back of head 4/3-4/4 migraine, night sweats, periodic hot flashes itching under skin for a few days after shot
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: 9:20 shot  9:30 tingling in fingers on left hand  10:30 tingling, swollen tongue; tingling in chest and right arm  11:00 tingling in head, thirsty 17:00 arm and joints pain chemical odor in urine 3/30 next day:  0700 mild fatigue, thirsty 1300 itchy under skin 1700 upset stomach 3/31 dark circles under eyes; dry cough, hoarse voice, red eyes, sinus congestion, headache shooting from sinuses around the right to back of head 4/3-4/4 migraine, night sweats, periodic hot flashes itching under skin for a few days after shot
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, tenderness, itching, pain on arm surrounding injection site.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Within week started to have excessive hair loss each time it gets brushed, washed, etc.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Covid arm and itching all over body.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Tinnitus. I?ve always had very mild tonight us directly after the first shot of Moderna it increased.  It did not decrease before the second shot and after the second shot it has further increased.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Magnetic resonance imaging heart
Clinical narrative: Patient developed mild chest pain roughly 24 hrs after receiving 2nd Moderna Vaccine injection. He initially managed this with ibuprofen, but pain intensified and he presented to the ED approximately 1.5 days after 2nd injection with severe chest pain, diffuse ST elevations on EKG and elevated Troponin I measurement of 6 ng/ml. Patient transferred to hospital for further management and remains under inpatient care at time of report. Testing initially suggested pericarditis but cardiac MRI consistent with myocarditis. Troponin I peaked @ 75 ng/ml on 4/16/21.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericardial effusion, Troponin I increased
Clinical narrative: Patient developed mild chest pain roughly 24 hrs after receiving 2nd Moderna Vaccine injection. He initially managed this with ibuprofen, but pain intensified and he presented to the ED approximately 1.5 days after 2nd injection with severe chest pain, diffuse ST elevations on EKG and elevated Troponin I measurement of 6 ng/ml. Patient transferred to hospital for further management and remains under inpatient care at time of report. Testing initially suggested pericarditis but cardiac MRI consistent with myocarditis. Troponin I peaked @ 75 ng/ml on 4/16/21.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Magnetic resonance imaging abnormal, Myocarditis
Clinical narrative: Patient developed mild chest pain roughly 24 hrs after receiving 2nd Moderna Vaccine injection. He initially managed this with ibuprofen, but pain intensified and he presented to the ED approximately 1.5 days after 2nd injection with severe chest pain, diffuse ST elevations on EKG and elevated Troponin I measurement of 6 ng/ml. Patient transferred to hospital for further management and remains under inpatient care at time of report. Testing initially suggested pericarditis but cardiac MRI consistent with myocarditis. Troponin I peaked @ 75 ng/ml on 4/16/21.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate increased, Hypoaesthesia
Clinical narrative: About 20 minutes: Heart beating faster or louder.  I Felt like I got paralysis on my middle finger. Feeling numb.  20 - 30mins: Felt a little drowsy, dizzy? Heart beating faster or louder.  1hour: Tiredness and drowsy.  1st day - 2nd~3rd day: Muscle pain (pretty bad on the arm) and all over the body. Middle finger feeling numb.  Evening, April 13th - 16th: Slight shortness of breath. It got much better, but I still feel very very minor shortness of breath.  Evening, April  15 - till now: Hives on neck, under eyes(Right side), Between front of my left eye and nose, near mouth, Forehead. Very itchy.   Hives keep appearing and disappearing. It gets better and then all the sudden gets bad.  I am planning to call the place where I got the vaccine today and visit the pharmacy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Myalgia, Pain, Palpitations, Pruritus
Clinical narrative: About 20 minutes: Heart beating faster or louder.  I Felt like I got paralysis on my middle finger. Feeling numb.  20 - 30mins: Felt a little drowsy, dizzy? Heart beating faster or louder.  1hour: Tiredness and drowsy.  1st day - 2nd~3rd day: Muscle pain (pretty bad on the arm) and all over the body. Middle finger feeling numb.  Evening, April 13th - 16th: Slight shortness of breath. It got much better, but I still feel very very minor shortness of breath.  Evening, April  15 - till now: Hives on neck, under eyes(Right side), Between front of my left eye and nose, near mouth, Forehead. Very itchy.   Hives keep appearing and disappearing. It gets better and then all the sudden gets bad.  I am planning to call the place where I got the vaccine today and visit the pharmacy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urticaria
Clinical narrative: About 20 minutes: Heart beating faster or louder.  I Felt like I got paralysis on my middle finger. Feeling numb.  20 - 30mins: Felt a little drowsy, dizzy? Heart beating faster or louder.  1hour: Tiredness and drowsy.  1st day - 2nd~3rd day: Muscle pain (pretty bad on the arm) and all over the body. Middle finger feeling numb.  Evening, April 13th - 16th: Slight shortness of breath. It got much better, but I still feel very very minor shortness of breath.  Evening, April  15 - till now: Hives on neck, under eyes(Right side), Between front of my left eye and nose, near mouth, Forehead. Very itchy.   Hives keep appearing and disappearing. It gets better and then all the sudden gets bad.  I am planning to call the place where I got the vaccine today and visit the pharmacy.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever. 101.3 Drank ibuprofen
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, COVID-19
Clinical narrative: Had covid after 1st vaccine and received second vaccine after. Sis antibody IGG test and I have 1.40 negative for antibodies; This is a spontaneous report from a contactable Other HCP. A 41-years-old non pregnant female patient received second dose of bnt162b2 (COMIRNATY, Lot number: unknown), intramuscularly on left arm 08 Feb2021 15:00 (at the age of 41-year-old) as a single dose as Covid-19 immunisation. It was reported that the patient received first dose of bnt162b2 (COMIRNATY, Lot number: unknown), intramuscularly on left arm 04 Jan2021 15:00 as a single dose as Covid-19 immunisation. Reason why batch/lot is Unknown: misplaced/discarded. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks, was not diagnosed with COVID-19 prior to vaccination and has not tested for COVID-19 since vaccination. On 25Feb2021 12:00 the patient had covid after 1st vaccine and received second vaccine after. The patient underwent lab test included Sis antibody IGG test and resulted 1.40 negative for antibodies. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: stated that she was with her daughter and husband, nonstop and unable to quarantine including close face to face contact with both; This is a spontaneous report from a contactable Nurse (Patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously took historical vaccine first dose of BNT162B2 for Covid-19 immunisation. It was reported that patient husband started to show very mild symptoms of covid on 04Feb2021, but he never got tested. The patient daughter had symptoms of fever and headache on 15Feb2021 and tested positive that day for covid. The patient stated that she was with her daughter and husband, nonstop and unable to quarantine including close face to face contact with both on an unknown date in Feb2021. On 18Feb2021, patient was tested for COVID-19 and resulted in negative. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Tremor
Clinical narrative: Extreme whole body shaking; had fatigue; nap the afternoon; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EN10200; Expiration Date: unknown), dose 2 via an unspecified route of administration, in Arm Left on 23Feb2021 10:30 as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient didn't take any other vaccine in four weeks prior to 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.Concomitant medications included atorvastatin (ATORVASTATIN), protandim (LIFEVANTAGE PROTANDIM) taken for an unspecified indication, start and stop date were not reported. On 23Feb2021 22:30 the patient experienced extreme whole body shaking lasted for 4-5 minutes and shaking finally stopped and has not happened. On 23Feb2021,the patient experienced fatigue, nap the afternoon(slept 10.5 hours plus a 2 hour nap the afternoon). Now 2 days post injection feeling back to normal.The outcome of the events was recovered. No follow up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted covid 19 infection 2 days after their first dose; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (at the time of 78-years-old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that patient and her husband (both 78 years old) were due for their second doses of Pfizer-Biontech Covid19 vaccine this Saturday, which is 3 weeks after their first dose. Caller reports that they contracted covid -19 infection 2 days after their first dose, and their HCP (healthcare professional) suggested they go ahead and receive their second dose as scheduled, but she wanted to check with Pfizer as well. Outcome of the event was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: they've tested positive on Covid-19 last 14Feb2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is the 1st of 2 reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Feb2021 (Lot number and expiration date was not reported) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient reported they've tested positive on covid-19 on 14Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Feb2021. The 2nd dose will be scheduled on 04Mar2021. They are asking if they still need to take the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214003 Same reporter/ product/event and Different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: They've tested positive on Covid-19 last 14Feb2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Feb2021 (Lot number and expiration date was not reported) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient reported they've tested positive on covid-19 on 14Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Feb2021. The 2nd dose will be scheduled on 04Mar2021. They are asking if they still need to take the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214002 different patient, same event and drug.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Caller tested positive for covid 19; mild cold symptoms; This is a spontaneous report from a contactable consumer (patient himself). A male patient of (age: 63, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration on 19Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 on 25Feb2021. The patient stated that he had mild cold symptoms the day he got the shot on 19Feb2021. Second dose of vaccine was due in two weeks. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: tested positive for COVID; unintended benefit from the vaccine; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), dose 1 via an unspecified route of administration on 04Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included general physical health deterioration, cardiac effusion from an unknown date and unknown if ongoing. The patient is not pregnant at the time. The patient was vaccinated at a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was recovering from a cardiac effusion prior to being administered the vaccine, was extremely weak and on 2 liters of oxygen. Within a month of receiving her first vaccine on 04Jan2021, she has significantly improved. She also tested positive for COVID on 08Jan2021 we believe she was exposed prior to receiving the vaccine. She did not have serious symptoms. She received her second dose of the vaccine on 15Feb2021, after testing negative for the virus. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021. The outcome of the event Unexpected therapeutic benefit was unknown, and another event SARS-CoV-2 infection was recovered. No treatment was received for the adverse events.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Hypersensitivity, Oropharyngeal pain
Clinical narrative: was in contact with someone that had Covid-19; sore throat; allergies; This is a spontaneous report from a Pfizer-sponsored program via a medical information team. A contactable consumer reported that a male patient of unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. It was reported receiving both doses of the vaccine and was in contact with someone that had Covid-19. He was going to get tested for the virus since he was in contact with vulnerable individuals and asked if the vaccine will affect the results of the test. Stated he has a little bit of a sore throat and allergies but nothing out of the ordinary on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: possible exposure to COVID-19; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 06Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She reported that she was scheduled today at 2 pm for her second dose, however she asked if she should get second dose today after a possible exposure to COVID-19. She stated that her brother tested positive for COVID-19 and both wore their masks when she drove him to the Doctor. Outcome of the event was unknown.   No follow-up attempts possible. No furthermore information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid19; tested positive for Covid19; This is a spontaneous report from a Pfizer-sponsored program . A contactable male consumer (patient) reported that a male patient of an unspecified age received first dose bnt162b2 (Solution for injection), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller got the first dose of the Covid19 vaccine last 01Feb2021. He went to the doctor the next Friday and he got tested positive for Covid19 in 2021. He is scheduled to take the second dose of the Covid19 vaccine on 22Feb2021. He wants to know if he can get the second dose since he is already positive for Covid19.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: On the third day, I had swollen gland in my right side of neck and back of head. It continued for over a week; This is a spontaneous report from a contactable consumer or other non-healthcare professional (reported for herself). A 70-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9269) administered in right arm via an unknown route of administration on 11Feb2021 at 15:45pm as SINGLE DOSE for covid-19 immunization. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL8982) administered in left arm on 21Jan2021 at 03:45pm. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The patient did not have any other vaccine in four weeks and other medications in two weeks. On 14Feb2021 at 09:00 pm (3 days after vaccination), the patient had swollen gland in right side of neck and back of head. It continued for over a week. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: She explained she had dinner at a friend's house where she was in contact with a person who tested positive to COVID-19.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not pregnant at the time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller stated that she was scheduled to receive the second dose of the second dose of the Pfizer-BioNTech COVID-19 vaccine on 02Mar2021. She explained she had dinner at a friend's house where she was in contact with a person who tested positive to COVID-19. She specified this person was informed this morning that she was exposed to a confirmed positive case at work home and thus got tested. Caller added she doesn't have any symptoms and asked if she can receive her second dose as planned. She then explained a nurse at (Hospital name withheld) recommended her to get tested for COVID-19 in 5-7 days. Caller stated she doesn't have the number to her vaccination provider. She explained she will not be able to call them to reschedule the second dose of the COVID-19 vaccine and asked if we can assist her. While on hold, caller stated she was able to find a phone number to call for questions / to reschedule her appointment, and therefore she will not need our references. Outcome of the event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: tired; Chills; temperature going up and down many times, the most it went to was 100.5F then went to normal; puking/throwing up; Nauseous; Headache; This is a spontaneous report received from contactable Nurse. A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262 and expiration date: 31May2021), via an unspecified route of administration at the left arm on 17Feb2021 at single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Lot: Lot 1283) on 27Jan2021 for COVID-19 immunization. The patient's medical history included immune system disorder. Concomitant medications included promethazine (PHENERGAN) and loratadine (IMMUNIX). It was reported that patient experienced the headache a couple days after second dose. The patient first got tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal. The patient kept taking tylenol for 4 days then after she was nauseous and kept puking. The patient took ondansetron and stopped puking and reported sometimes it works sometimes it doesn't get in system fast enough and then the patient had dry eating and hydrated. The patient feels nauseous and sick still and still has a headache. It was reported that the patient called the doctor wanting a refill on her Phenergan, but the doctor told her no and said that she has to call Pfizer. It was reported that she doesn't understand why the doctor would say that when he knows Pfizer has nothing to do with her receiving her Phenergan. It was stated that he doesn't understand, this is not a new medication for her, she's just getting a refill for something that she's had before. The doctor said that they couldn't do anything. Outcome of puking was reported as recovered and outcome of tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal and nauseous was reported as unknown.  Follow-up information has been requested and pending to receive.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: tired; Chills; temperature going up and down many times, the most it went to was 100.5F then went to normal; puking/throwing up; Nauseous; Headache; This is a spontaneous report received from contactable Nurse. A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262 and expiration date: 31May2021), via an unspecified route of administration at the left arm on 17Feb2021 at single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Lot: Lot 1283) on 27Jan2021 for COVID-19 immunization. The patient's medical history included immune system disorder. Concomitant medications included promethazine (PHENERGAN) and loratadine (IMMUNIX). It was reported that patient experienced the headache a couple days after second dose. The patient first got tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal. The patient kept taking tylenol for 4 days then after she was nauseous and kept puking. The patient took ondansetron and stopped puking and reported sometimes it works sometimes it doesn't get in system fast enough and then the patient had dry eating and hydrated. The patient feels nauseous and sick still and still has a headache. It was reported that the patient called the doctor wanting a refill on her Phenergan, but the doctor told her no and said that she has to call Pfizer. It was reported that she doesn't understand why the doctor would say that when he knows Pfizer has nothing to do with her receiving her Phenergan. It was stated that he doesn't understand, this is not a new medication for her, she's just getting a refill for something that she's had before. The doctor said that they couldn't do anything. Outcome of puking was reported as recovered and outcome of tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal and nauseous was reported as unknown.  Follow-up information has been requested and pending to receive.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blood cholesterol, Burning sensation, Erythema, Hypersensitivity
Clinical narrative: It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's from below where the shot was; Going around the arm and it's kind of like a burning itch; it is annoying; little redness on my arm; allergic to the preservatives in the vaccine; Going around the arm and it's kind of like a burning itch; it is annoying; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing cholesterol. Concomitant medication included rosuvastatin taken for cholesterol, start and stop date were not reported. Historical vaccine included FLU for patient had a Flu Shot but it only got little red, little redness on my arm and first dose of BNT162B2 (Lot number: EN6200, Expiration date: Jun2021) via an unspecified route of administration on 27Jan2021 for Covid-19 immunization. Patient stated, "patient got the Pfizer second shot on Wednesday (Clarified as 17Feb2021) patient arm didn't start to bother me or it was very sore (Further clarification was unknown if consumer's arm was sore or not, hence captured as event) but then on Friday patient noticed patient was getting a reaction and it started to turn red so patient had an allergic reaction to it, except that it keeps spreading on patient arm it's from below where the shot was, it didn't hit the elbow yet but it is going around the arm and it's kind of like a burning itch it's not something terrible it's not something patient cannot deal with but patient was concerned about it and patient wondering if there is something patient can take or do because it is annoying on 19Feb2021" Patient believe because patient had a Flu Shot (Captured as provided) but it only got little red. patient think patient was allergic to the preservatives in the vaccine (COVID-19 Vaccine) because a friends of my works in a doctor's office and she was with me and she said I am probably allergic to, what you call the preservatives in the vaccine." Patient stated, "No it's been a while, it's been, you know it was just a little redness on my arm on 19Feb2021." Patient received a treatment that put some Ice on its last night and then patient took a Benadryl, you know generic Benadryl from a Walmart. The patient underwent lab tests and procedures which included Cholesterol and Urine: unknown results on an unspecified date in 2021. The outcome of the events was unknown.  Information on Batch/Lot number has been requested
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urine analysis
Clinical narrative: It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's from below where the shot was; Going around the arm and it's kind of like a burning itch; it is annoying; little redness on my arm; allergic to the preservatives in the vaccine; Going around the arm and it's kind of like a burning itch; it is annoying; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing cholesterol. Concomitant medication included rosuvastatin taken for cholesterol, start and stop date were not reported. Historical vaccine included FLU for patient had a Flu Shot but it only got little red, little redness on my arm and first dose of BNT162B2 (Lot number: EN6200, Expiration date: Jun2021) via an unspecified route of administration on 27Jan2021 for Covid-19 immunization. Patient stated, "patient got the Pfizer second shot on Wednesday (Clarified as 17Feb2021) patient arm didn't start to bother me or it was very sore (Further clarification was unknown if consumer's arm was sore or not, hence captured as event) but then on Friday patient noticed patient was getting a reaction and it started to turn red so patient had an allergic reaction to it, except that it keeps spreading on patient arm it's from below where the shot was, it didn't hit the elbow yet but it is going around the arm and it's kind of like a burning itch it's not something terrible it's not something patient cannot deal with but patient was concerned about it and patient wondering if there is something patient can take or do because it is annoying on 19Feb2021" Patient believe because patient had a Flu Shot (Captured as provided) but it only got little red. patient think patient was allergic to the preservatives in the vaccine (COVID-19 Vaccine) because a friends of my works in a doctor's office and she was with me and she said I am probably allergic to, what you call the preservatives in the vaccine." Patient stated, "No it's been a while, it's been, you know it was just a little redness on my arm on 19Feb2021." Patient received a treatment that put some Ice on its last night and then patient took a Benadryl, you know generic Benadryl from a Walmart. The patient underwent lab tests and procedures which included Cholesterol and Urine: unknown results on an unspecified date in 2021. The outcome of the events was unknown.  Information on Batch/Lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: It feels like is I have Covid; Chills; Headache; Tiredness; Aches in my joint; severe pain in my arm that I received the injection in; Had a temperature also; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not pregnant at the time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Consumer stated, I was calling regarding the side effects from the shot from the vaccine (Pfizer Covid Vaccine). I experienced severe pain in my arm that I received the injection in. That was first day and the next day I experience chills, headache, tiredness, and aches in my joint. It feels like is I have Covid. That was from my first injection and that was on Wednesday. I had a temperature also. According to the paperwork they said to notify you guys so you can know that I have side effects and I had major side effects from it. Consumer stated, "Can I ask you a question? Since that was the first vaccine and I had those side effects. Am I going to more with second one? Anything else dealing with this regarding the next shot, I mean I must speak with someone else to stand hold like this again? Are you guys accept an application? Are you guys short of help? I don't understand. The outcome of the events was unknown.   Is there a Product Complaint: Yes  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: It feels like is I have Covid; Chills; Headache; Tiredness; Aches in my joint; severe pain in my arm that I received the injection in; Had a temperature also; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not pregnant at the time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Consumer stated, I was calling regarding the side effects from the shot from the vaccine (Pfizer Covid Vaccine). I experienced severe pain in my arm that I received the injection in. That was first day and the next day I experience chills, headache, tiredness, and aches in my joint. It feels like is I have Covid. That was from my first injection and that was on Wednesday. I had a temperature also. According to the paperwork they said to notify you guys so you can know that I have side effects and I had major side effects from it. Consumer stated, "Can I ask you a question? Since that was the first vaccine and I had those side effects. Am I going to more with second one? Anything else dealing with this regarding the next shot, I mean I must speak with someone else to stand hold like this again? Are you guys accept an application? Are you guys short of help? I don't understand. The outcome of the events was unknown.   Is there a Product Complaint: Yes  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip swelling
Clinical narrative: With the 1st dose, my lips were swollen and cracked; With the 1st dose, my lips were swollen and cracked; This is a spontaneous report from a contactable consumer(patient).   This 74-year old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9262) dose 1 via an unspecified route of administration at right arm on 10Feb2021 at 01:15 am as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 12Feb2021, her lips were swollen and cracked. No treatment received. The event assessed as non-serious with outcome not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Sars-Cov-2 infection; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unknown route of administration on 15Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Feb2021. The patient experienced sars-cov-2 infection (covid-19) on 21Feb2021 and the patient wants to know if she can receive her second dose as scheduled. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 2 patient (Herself and her husband). This is 1 of 2 report. A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got COVID-19 virus (COVID-19) on an unspecified date. The patient underwent lab tests included sars-cov-1 test: positive on an unspecified date. Outcome of the event was unknown. Information on lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223614 same drug and event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid Virus; got covid Virus; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported similar events for 02 patient. This is the 2nd of 02 reports. This consumer reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced got COVID virus after receiving the 1st dose of vaccine. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223614 same drug and event, different patient