chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Pain, Spinal pain
Clinical narrative: pain from my navel to my spine on my right side and it was extreme pain; pain from my navel to my spine on my right side and it was extreme pain; I had hurt my back; shingles; This is a spontaneous report from a contactable other healthcare professional (Patient). A 44-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunization. The medical history included HIV undetectable, allergies to peanuts, Spleen removed all from an unknown date and unknown if ongoing, ongoing immune suppressed (not told to the public and especially the immune suppressed). The patient concomitant medications were not reported. The patient previously took toradol for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. It was reported that on 04Apr2021, after the first shot he had pain from his navel to his spine on his right side and it was extreme pain so he went to the ER and he said that he had hurt his back. The days passed and he went to another doctor and they said you indeed have shingles well nothing appeared until after the second shot and then he was covered and shingles overnight and have been dealing with this since the first vaccine. The patient asked why was this not told to the public and especially the immune suppressed. He had his spleen removed if he had known all this, he would not have taken it. He wanted to ask you all did not do clinical trials on these types of people. He was very pissed off. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with acyclovir. The patient was not tested for COVID-19 Since the vaccination. The outcome for the events was reported as not resolved at the time of this report.  Information on the lot/batch number has been requested.  Follow-up (19Jul2021): This is a follow-up spontaneous report from a contactable other healthcare professional (patient). No new information was received.  Information regarding the lot/batch number has been requested.  Follow-up (23Aug2021): 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Very heavy flow for two days; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: en6202, Expiry date was not reported), (at the age of 49-years-old), via unspecified route of administration, administered on Left arm on 05Mar2021 18:30 as dose 1, single for COVID-19 immunization. The medical history includes Multiple sclerosis, Hasimotos, Autoimmune liver disease, I have been menopausal for 9 years was reported. The concomitant medication was Gilenya, Ursodiol, Lipitor and  blood pressure was taken for unknown indication on unspecified date. The known food allergies to Mango. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On an unspecified date in Mar2021, After the first shot I had a period that was very heavy flow for two days and normal flow for three days. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event was Blood transfusion, Tranexamic acid. The outcome of the event was recovered on an unspecified date 2021.   Follow-up attempts completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Palpitations
Clinical narrative: I have been having night heart palpitations with random chest pain that comes and goes.; I have been having night heart palpitations with random chest pain that comes and goes.; This is a spontaneous report from a contactable consumer. A 43-years-old (age at vaccination was a 43-years-old) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 13May2021 15:45 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 22Apr2021 (Batch/Lot Number: EW0171) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced i have been having night heart palpitations with random chest pain that comes and goes on an unspecified date. Reported Event was I have been having night heart palpitations with random chest pain that comes and goes. I am a person who exercises every single day with recent blood tests that showed no health issues. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included blood test: no health issues on an unspecified date. Outcome of the events was Recovered/Resolved with Sequel on an unspecified date.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash all over face/neck/belly; Red rash all over face/neck/belly; Fatigue; Joint pains especially in the thigh and knees; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6204) via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and was unknown if ongoing. The patient did not receive any medication within two weeks of vaccination. The patient was allergic to fruit allergy(pineapple), allergy to animal dander(fur from animals), perfume sensitivity(some perfumes), cosmetic allergy(some powders and some soaps) The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6201) via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 38-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced itchy red rash all over face/neck/belly, fatigue, joint pains especially in the thigh and knees. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events itchy red rash all over face/neck/belly, fatigue and joint pains especially in the thigh and knees were all not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Left axilla pain; Left axilla pain and swelling; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via intramuscular route of administration in the left arm on 17May2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none known. The patient had mild shellfish allergy. Concomitant medications included escitalopram oxalate (LEXAPRO), colecalciferol (VITAMIN D) and oral contraceptive (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via intramuscular route of administration in the left arm on 25Apr2021 at 13:45 (at the age of 40-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 06:00, the following morning of vaccination, the patient woke with left axilla pain and swelling that progressed throughout the day, the pain and swelling persisted 34 hours after the vaccine. The event 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 events and included treatment with tylenol, ice and heat. The clinical outcome of the event left axilla pain and swelling was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in her legs; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness in the legs after she received first dose of covid-19 vaccine. The outcome of the event was unknown.  Batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Tremor
Clinical narrative: brain fog; shocking; i have terrible fatigue; shaking some; The initial case was missing the following minimum criteria: unspecified drug. Upon receipt of follow-up information on 02Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EJ1686 and expiration date was not reported),via an unspecified route of administration on 26Feb2021 (at the age of 58-years-old) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EJ1686 and expiration date was not reported),via an unspecified route of administration on 05Feb2021 (at the age of 58-years-old) at dose 1, single for covid-19 immunization and had no reaction on exposure to vaccine. The patient experienced brain fog, shocking, had terrible fatigue and had some shaking on 28Feb2021. Further stated that side effects were horrible and missing work at times. The events resulted in emergency room visit. Patient was not hospitalized due to the events. No treatment was given for events. The outcome of the events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles rash; This is a spontaneous report from a non-contactable physician, the patient. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration on 26Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was not allergic to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 05Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient previously received varicella zoster vaccine (MANUFACTURER UNKNOWN) and was reported that the patient never had the chickenpox as a child; however, the patient did receive the vaccine. 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 17May2021, the patient experienced shingles rash. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with valacyclovir (MANUFACTURER UNKNOWN) on 17May2021. The clinical outcome of the event shingles rash was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Feeling hot, Headache, Metabolic function test
Clinical narrative: Headache; Muscle ache; Diarrhea; Sudden feeling of like being really hot like I have a fever without having one; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration on 02Apr2021 as dose 1, single, (Lot Number: EW0169) via an unspecified route of administration on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation Assessment was done. Consumer stated, like many people (Further clarification was unknown) have side effect within the first 48 hours and then they went away but then about a week later the side effect hit him again later and they have been kind of like on and off for a week and then Saturday was the last day he felt them so, it has gone two days now without feeling it anymore but talk to somebody yesterday, he saw a nurse and she said that she has seen this before so, in other words had this same side effect on and off for two weeks now and it was an extreme headache, muscle ache and diarrhoea. He had that after the first shot within 48 hours and after second shot within 48 hours which is a little bit more severe and about a week later he had exact same symptoms even little bit more severe and then on Saturday this past Saturday probably the worst and then it was improved, a day of doing terrible and then he go a day or two doing great and then it again came back and then the only other symptom he could report was just this sudden feeling of like being really hot that was the best he can describe it, like have a fever without having one. Consumer stated that had actually got blood tested on Thursday of this past week. Consumer stated, just like Ibuprofen for the aches and got a Vitamin infusion from his doctor after the second dose. Vitamin C and things like that. Consumer stated that he got a COVID antibody test and then also got antibody and then got a complete metabolic panel. The patient underwent lab tests and procedures which included blood test: no results, metabolic panel: no results and Covid test: no results on 13May2021. Therapeutic measures were taken as a result of headache, muscle ache and diarrhea. The outcome of events headache, muscle ache and diarrhea was resolved on May2021 and event sudden feeling of like being really hot like I have a fever without having one was unknown.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 antibody test
Clinical narrative: Headache; Muscle ache; Diarrhea; Sudden feeling of like being really hot like I have a fever without having one; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration on 02Apr2021 as dose 1, single, (Lot Number: EW0169) via an unspecified route of administration on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation Assessment was done. Consumer stated, like many people (Further clarification was unknown) have side effect within the first 48 hours and then they went away but then about a week later the side effect hit him again later and they have been kind of like on and off for a week and then Saturday was the last day he felt them so, it has gone two days now without feeling it anymore but talk to somebody yesterday, he saw a nurse and she said that she has seen this before so, in other words had this same side effect on and off for two weeks now and it was an extreme headache, muscle ache and diarrhoea. He had that after the first shot within 48 hours and after second shot within 48 hours which is a little bit more severe and about a week later he had exact same symptoms even little bit more severe and then on Saturday this past Saturday probably the worst and then it was improved, a day of doing terrible and then he go a day or two doing great and then it again came back and then the only other symptom he could report was just this sudden feeling of like being really hot that was the best he can describe it, like have a fever without having one. Consumer stated that had actually got blood tested on Thursday of this past week. Consumer stated, just like Ibuprofen for the aches and got a Vitamin infusion from his doctor after the second dose. Vitamin C and things like that. Consumer stated that he got a COVID antibody test and then also got antibody and then got a complete metabolic panel. The patient underwent lab tests and procedures which included blood test: no results, metabolic panel: no results and Covid test: no results on 13May2021. Therapeutic measures were taken as a result of headache, muscle ache and diarrhea. The outcome of events headache, muscle ache and diarrhea was resolved on May2021 and event sudden feeling of like being really hot like I have a fever without having one was unknown.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Urinary tract infection
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination.  The patient previously 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 06Apr2021 at 12:30 (at the age of 51-years-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 29Apr2021 at 18:30, after receiving the second dose, the patient experienced urinary tract infection (UTI) and had symptoms of some blood mixed urine. It was reported that the patient called nurse advisory and scheduled an appointment with the doctor. On an unknown date in 2021, the patient underwent urine test with the sample taken in the afternoon and no trace was found with any blood or bacteria. The patient was asked to give fresh sample taken in the morning. On an unknown date in 2021, the patient underwent urine test that showed traces of blood plus some bacteria. The event of urinary tract infection was confirmed. After the duration of 7 days, the urinary tract infection was clean. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with antibiotics prescribed by the doctor. The clinical outcome of the event urinary tract infection was resolved on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: First dose: Slept 14 hours; This is a spontaneous report from a contactable other hcp (patient herself). A 62-years-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172, Expiration date were not reported) via an unspecified route of administration on 23Apr2021 16:30 (age at the vaccination 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypertension, known allergies to penicillin, sulfa and latex from an unknown date and unknown if ongoing. Patient was not pregnant at time of vaccination. Concomitant medications included atorvastatin calcium, ezetimibe (STATIN EZ) taken for an unspecified indication, start and stop date were not reported. On an unspecified Apr2021, the patient had experienced first dose and slept 14 hours. The reporter (health authority) considered the events as non-serious. The patient had not received any other vaccine within 4 weeks. The patient received other medications in two weeks included blood pressure medicine + statin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since post vaccination. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Malaise, Pyrexia, Somnolence
Clinical narrative: Fever of 101; Haven't been feeling good all day; I have been sleeping all day; Not feeling well; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 16May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously 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, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date in May2021, the patient experienced fever of 101, hadn't been feeling good all day, the patient had been sleeping all day and was not feeling well. The patient got second vaccine yesterday and hadn't been feeling good all day, but actually had a fever of 101 and didn't know it was the typical side effect and will be okay tomorrow. The patient just took and about half hour ago, and had a little fever of 101, and had been sleeping all day. The patient didn't experience it till today (17May2021). The patient just didn't know whether should just wait till tomorrow, take temperature again, whether go with the temperature again, see if it was okay or what should be done. The patient was informed about Pfizer Medical Information. The patient underwent lab test which included body temperature: 101 (fever) on an unspecified date in May2021. The outcome of the events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Headache; light headedness; nausea; tired; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 16May2021 at 15:45 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) in the left arm on 18Apr2021 at 15:45 as a single dose for Covid-19 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced headache, lightheadedness, nausea and tired. 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, emergency room/department or urgent care. The clinical outcome of the events headache, lightheadedness, nausea and tired was recovering at the time of this report   No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: Swollen eyes and rashes all on back.; Swollen eyes and rashes all on back.; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 at 16:45 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no known allergies. 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. On 17May2021 at 21:00, the patient experienced swollen eyes and rashes all on back. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events swollen eyes and rashes all on back was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Slight fever; Feeling tired; This is a spontaneous report from a contactable consumer or other non HCP (wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on unspecified date for covid-19 immunisation. The patient experienced slight fever and feeling tired on an unspecified date. The outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Ear sensitivity, hearing issues; This is a spontaneous report from a non-contactable consumer, the patient. A 13-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 in the left arm on 17May2021 at 11:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 07:00, the patient experienced ear sensitivity, hearing issues. 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. The clinical outcome of the event ear sensitivity, hearing issues was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the 2nd shot; Lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the 2nd shot; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient (consumer) received DOSE 2 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Apr2021 at 13:15 (age 39-year-old at the of vaccination) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient had no relevant medical history and concomitant medications. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the dose 1 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Apr2021 at 13:15 (age 39-year-old at the of vaccination) as a DOSE 1, SINGLE 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient experienced lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of events lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the second shot were not recovered at the time of this report. Follow-up received on 20Aug2021, included Reporter comment: Consumer did not give consent for information for follow-up questionnaire.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: Pyrexia around 38.5 degree C; Chill; Headache; Malaise; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as  dose 1, single for COVID-19 immunization and experience muscle pain. On an unspecified date the patient experienced pyrexia around 38.5 degree c, chill, headache and malaise. The patient underwent lab tests and procedures which included pyrexia: 38.5 centigrade. The events outcome 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-2021565024 same reporter/patient different vaccine dose/AE
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Numbness in hands and shoulders; Shoulder blade, in the joints and muscles in deltoid or whatever that muscle is down to the forearm to like the first finger and thumb feel numb, like pricked by needles; Feels like arm is about to fall asleep from shoulder down to thumb; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0161), via an unspecified route of administration, on 06May2021 at 18:00 (at the age of 56-year-old), as dose 1, single, in left arm for COVID-19 immunization at Pharmacy/drug store. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities including diabetes and obesity and allergy to latex or IV needle/butterfly needle plastic material that caused his hands to swell up. The patient's past medications included Bupropion, Simvastatin, Metoprolol, and Xarelto; all taken for unspecified indications. Concomitant medications were not reported. Patient did not receive other shots on the same day of COVID vaccine, or 4 weeks prior. He experienced no problems with shots in the past. On 07May2021, 6 hours after the first dose of vaccine, the patient experienced numbness in hands and shoulders and shoulder blade, in the joints and muscles in deltoid or whatever that muscle was down to the forearm to like the first finger and thumb felt numb, like pricked by needles. On an unspecified date in May2021, after the first dose of vaccine, the patient felt like his arm was about to fall asleep from shoulder down to thumb. The patient was concerned that if this could be a heart condition or something else. The clinical outcome of all the events was not resolved.  Follow up attempts needed. Further information is expected.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: slight fever; malaise; headache; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, on an unspecified date patient experienced malaise, headache, slight fever developed from the afternoon of the day after the 2nd dose vaccination day. The outcome of all events was resolved on the next day (unspecified date).  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Sluggishness
Clinical narrative: Some left shoulder socket pain; Felt sluggish; Woke up with headache; Felt drained; Hip socket pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ZW0177), via an unspecified route of administration in the left arm on 15May2021 at 16:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) 10 mg and famotidine (MANUFACTURER UNKNOWN) 20 mg; both from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736), via an unspecified route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 50-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 07:00, the patient woke up with headache. As day went on felt sluggish, felt drained, some hip socket pain. Sunday (16May2021) night at bed time had chills.  On 17May2021, Monday the patient started feeling normal. Some left shoulder socket pain which was subsided. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, felt sluggish, felt drained, some hip socket pain, chills, and some left shoulder socket pains were resolved on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Pain in extremity, Vaccination site swelling
Clinical narrative: Dizziness; fatigue; difficulty breathing; arm pain; swelling at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 17May2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On 17May2021 at 14:00, the patient experienced dizziness, fatigue, difficulty breathing, arm pain, swelling at injection site. The patient did not receive any treatment for 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 events dizziness, fatigue, difficulty breathing, arm pain, swelling at injection site was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever 100.4; This is a spontaneous report from a contactable consumer or other non hcp.    A 62-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, the patient experienced low grade fever 100.4 on 20Mar2021 with outcome of recovered.    Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant .  Additionally , per 21 CFR 314.80 , post marketing Reporting of Adverse Drug experiences , updated 01Apr2016, the requirements of paragraphs (c)(1) (ii) of this section Concerning the submission of post marketing 15 day alert reports , also apply to any person other than the applicant whose name appears on the label of an approved drug product as manufacturer a Packer distributor non applicant. To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c) (1)(i) and (c)(1)(ii) Off the section, obligations office none applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. Is a non applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days off initial receipt of the information by the non applicant, and the applicant must then comply with the requirements of this section.  VR, therefore, forwarding the information below relating to your product which was obtained by one of our employees during the normal course of business.   follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeding disorder, Headache, Myalgia, Respiration abnormal
Clinical narrative: Major back pain; sore muscles in lower half of body; constant vomiting; Cant eat and barely can breathe; Cant eat and barely can breathe; not able to rest without waking up repetitively; headache; This is a spontaneous report received from a contactable consumer. A 19-year-old non-pregnant female patient (consumer) reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 03May2021 09:00 (Age 19-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 Since the vaccination. The patient experienced major back pain, headache, sore muscles in lower half of body, constant vomiting, not able to rest without waking up repetitively on 03May2021 16:00. She could not eat and barely could breathe on 03May2021 16:00. The outcome of the events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vomiting
Clinical narrative: Major back pain; sore muscles in lower half of body; constant vomiting; Cant eat and barely can breathe; Cant eat and barely can breathe; not able to rest without waking up repetitively; headache; This is a spontaneous report received from a contactable consumer. A 19-year-old non-pregnant female patient (consumer) reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 03May2021 09:00 (Age 19-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 Since the vaccination. The patient experienced major back pain, headache, sore muscles in lower half of body, constant vomiting, not able to rest without waking up repetitively on 03May2021 16:00. She could not eat and barely could breathe on 03May2021 16:00. The outcome of the events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PPV
Symptoms: Blood glucose, Blood sodium, Malaise, Skin burning sensation
Clinical narrative: feel like my skin just like on fire like something inside my side that's burning me; didn't feel well; This is a spontaneous report from a contactable consumer. A 76-year-old patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for immunization. The patient's medical history included blood pressure abnormal (reported as blood pressure), blood cholesterol, gastrooesophageal reflux disease. Patient had cancer twice and had thyroid removed and had both breast removed but was under control as the patient had exams every 6 months my remission (patient's doctor check the patient's sugar and sodium level) and instructed to watch what he/she eat. The patient's concomitant medications were not reported. The patient didn't feel well and felt like his/her skin was just like on fire like something inside side that's burning him/her. It was further reported that the patient couldn't take any even Pneumonia shot (Captured as suspect), "I have anti-vaccines". The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Armpit lymph node major swelling; Chills; Fatigue; Difficulty concentrating; Slept poorly; Brain fog; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 04May2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, foot surgery, blood clotting and penicillin allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 13Apr2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 23:00, Chills night of second dose. Slept poorly. Day after until day 11 after left armpit lymph node major swelling. Went away. Brain fog developed shortly after and was present 2weeks later. Fatigue/brain fog/difficultly concentrating/slight dizziness. Therapeutic measures were taken as a result of the events which included treatment with over-the-counter nose spray. The clinical outcome of armpit lymph node major swelling was recovered on an unknown date in May2021. The clinical outcome of the events chills night of second dose. Slept poorly. Brain fog developed shortly after and was present 2weeks later. Fatigue/brain fog/difficultly concentrating/slight dizziness were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.