chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Toxicity to various agents
Clinical narrative: Problems with Sleep; can't sleep the required hours; Horrible Extreme Fatigue; had 2 blood tests done and both were abnormal with no answers from the doctors; poisoned by the vaccine; developed a tick in her right eye; neurological problems; last February or March but she could not remember the date; This is a spontaneous report from a Pfizer- COVAX. A contactable 82-year-old female consumer(patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date, NDC number: not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 14:00-15:00 (did not exactly remember) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that it had been many years since she had taken vaccines. She stated that she got her first dose last February or March but she could not remember the date. She stated that she experienced side effects from the vaccine, and she had problems with sleep, she could not sleep the required hours. Her blood tests, 2 of them, were abnormal. The doctors said that they did not know whether they were abnormal. She had horrible extreme fatigue. She reported that she wasn't going to take the vaccine but every doctor pushed her to take the vaccine and so she took it, and now this company had destroyed her health. She reported that she was 82 and she was in good health. She just heard about the extreme fatigue, she didn't know that was from the vaccine also. She assumed that the vaccine caused her neurological problems. She developed, about month and a half ago, she developed a tick in her right eye and she didn't know what it was from. Her side effects started in the early Spring, probably March. She knew something was different but she didn't put it together with the shot and she didn't think about it. She did not visit emergency room as wasn't smart enough to go to the ER, she never thought it was from the vaccine. She went to doctor with the extreme fatigue and that was how found out about abnormal bloodwork and then she had more blood work done and it was abnormal too. These were things she had never had before. She was not sure if she went to the doctor in March or April. She knew that she had 2 blood tests done and both were abnormal with no answers from the doctors. She had not received her second vaccine. Also, stated that she was poisoned by the vaccine. No treatment taken as nobody knew what to do. She stated that like an idiot, she took it. The outcome of all events were not recovered except the outcome of event short-term memory impairment was unknown.  Follow-up attempts were needed. Further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Rash, Swelling
Clinical narrative: rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; This is a spontaneous report from a contactable consumer. A adult non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was diagnosed with COVID-19, prior to vaccination. On an unspecified date, patient had rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose. No additional treatment for all the events. It was unknown if patient had been tested for COVID-19, since the vaccination. The outcome of all the events was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dermatitis contact, Full blood count, Platelet count, Platelet count decreased
Clinical narrative: 7 days after to see my platelets drops; A very mild case of Poison Ivy/started and got little worse; A very mild case of Poison Ivy/started and got little worse; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported for herself that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in left arm on 27May2021 as single dose for COVID-19 immunisation. Medical history included Idiopathic thrombocytopenic purpura (ITP), ongoing poison Ivy (got this last year). Concomitant medications included vitamins and supplements (unspecified). Patient was supposed to get the second dose of the Pfizer Covid-19 Vaccine 18Jun2021 or 19Jun2021 (today or tomorrow) but she has a very mild case of poison ivy and she was asking if she could still get the second dose or if that will matter to get the second dose. She has it now, probably Poison Ivy started maybe 3-4 days ago in Jun2021. She said it started and got little worse, she did put some cream on it but she got this (case of Poison Ivy) last year too. Started with the same cream that the Doctor gave her and it was little better now. She had platelet check for her ITP before she got the first shot and 7 days after to see her platelets drops in Jun2021. Also tested Complete blood count (unknown results) on an unspecified date. The outcome of the event very mild case of poison ivy/ started and got little worse was reported as recovering; unknown for another event.  Information regarding the Lot/Batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat itching; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: ER8733) via unknown route of administration on 17Jun2021 as dose 2 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) on 27May2021 for COVID-19 Immunization and had no reaction. Patient went to get her second shot yesterday but today she was saying her throat was itching on 18Jun2021. No treatment for adverse event. The outcome of event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: It was more painful than the 1st time; This is a spontaneous report from a contactable nurse (patient herself) via a medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history included chronic pain. Concomitant medications were not reported. The patient previously received influenza shot (FLU) shots for immunisation and experienced reactions to flu shots, pethidine hydrochloride (DEMEROL) and experienced allergic reactions to Demerol, OCPs (oral contraceptive pills). She mentioned that she had prior reactions to flu shots where she got the flu afterwards, allergic reactions to Demerol where her through closed up, and reactions to OCPs. Patient mentioned that it was more painful than the 1st time. She mentioned that she initially did not want to get vaccinated due to her complications but was convinced by her doctor. She was calling to report this event and to see if this has been reported as a side effect because she did not see this as a side effect. She also had chronic pain, that was why she was unsure with associating the pain to the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Joint pain was reported as worsened; range of movement is kind of restricting when she lifts her arm up and it does hurt a lot; This is a spontaneous report from a contactable Pharmacist (patient) via Pfizer Sponsored Program . A 31-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 13May2021 in right arm as dose 2, single (at age of 31-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0172) via an unspecified route of administration in right arm on 22Apr2021 as dose 1, single (at age of 31-year-old) for COVID-19 immunization. After second dose, patient experienced joint pain probably a week later (in May2021). It did not seem like it was going away so that was why she was calling. She felt like it was getting worse. Patient stated it was not life threatening but it was her shoulder, so like the range of movement is kind of restricting when she lifts her arm up and it does hurt a lot on an unspecified date in 2021. Just like the side she received the vaccine in is where it is, her right arm. If she stretches a certain way, it hurts a lot of she is sweeping and raises her arm. Patient stated it sucks. She wanted it to go away. she had been taking Tylenol and Ibuprofen as treatment. She was hoping it would go away the longer she waited but it does not seem like it is going away. Patient stated that she would say yes for causality but was wondering if she would go to see a doctor's office. Patient stated she just wanted to report the joint pain and get information. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for a few days; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient Historical Vaccine was reported as BNT162B2 DOSE 1 for COVID-19 immunization.The patient experienced sick for a few on an unspecified date. Outcome of event was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Escherichia infection, Urinary tract infection, Urine analysis
Clinical narrative: Urinary tract infection; Escherichia coli infection; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6208), intramuscularly, on 09Mar2021, as a single dose for COVID-19 immunisation. The patient received Adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen) at an unknown dose subcutaneously from an unspecified date in May2021 for rheumatoid arthritis. Medical history included ear infection (started Jan2021), non-tobacco user, non alcohol user and sulfa drugs allergy manifested as rash. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot Number: EN6201), intramuscularly, on 16Feb2021 as single dose for COVID-19 immunisation with no reaction on previous exposure to vaccine. The patient's past medications include SULFA and Etanercept (ENBREL). In Jun2021, the patient experienced urinary tract infection and Escherichia coli infection. The patient went to an urgent care due to urinary tract infection on 09Jun2021. Physician asked her to skip Adalimumab when was informed about the infection. On 04Jun2021, therapy with Adalimumab was discontinued. She had a shot of COVID 19 vaccine before at least one symptom happened therefore COVID-19 VACCINE was considered as co-suspect product. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with Clarithromycin (MACROBID). Relevant Laboratory & Other Diagnostic Tests included Dipstick culture performed in Jun2021 that confirmed there was Escherichia coli and urinary tract infection. Outcome of the events was unknown. The reporter's causality for the events of urinary tract infection and Escherichia coli infection with BNT162B2 was not related and with Adalimumab was no reasonable possibility.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Chills, Erythema, Fatigue
Clinical narrative: cellulitis; swollen glands; muscle aches; fever 102 degrees; left biceps swelling; pain; redness; neck stiffness; elevated WBC; throat ache; chills; high fever; body aches; groin pain and swelling; groin pain and swelling; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 16-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08May2021 as single dose for covid-19 immunization. (Vaccination facility: Public Health Clinic). Medical history included eczema, myositis during childhood from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: All nuts from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not receive any other medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 in left arm on 16Apr2021 for covid-19 immunization. Patient was not diagnosed with COVID-19 Prior to vaccination. It was reported on 31May2021 04:30 PM he had high fever, chills and body aches. Tested for COVID rapid and PCR came out negative. Then a week after he started c/o groin pain and swelling followed by throat ache and swollen glands. It lasted for few days. As He c/o fatigue and neck stiffness he took to urgent care on June 12th 8;30 pm and did the blood work and found to have elevated WBC. Sent him home requesting to hydrate and take fluids. On 15Jun2021 morning he had muscle aches and left biceps swelling, pain and redness as well as fever 102 degrees. Took him to the doctor and they suspected cellulitis and started on 10 days dose of Cephalexin. The swelling started going down within 24 hrs. He is still on antibiotics. Slowly feeling better. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021 (test name: Rapid and PCR, test type: Nasal Swab), Body temperature measurement: fever 102 degrees on 15Jun2021. Therapeutic measures were taken as a result of cellulitis, high fever, chills, body aches, groin pain and swelling, groin pain and swelling, throat ache, swollen glands, fatigue, neck stiffness, muscle aches, left biceps swelling, pain, redness, fever 102 degrees. The outcome for the event was reported as resolving.    Information regarding the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Groin pain, Lymphadenopathy, Muscle swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: cellulitis; swollen glands; muscle aches; fever 102 degrees; left biceps swelling; pain; redness; neck stiffness; elevated WBC; throat ache; chills; high fever; body aches; groin pain and swelling; groin pain and swelling; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 16-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08May2021 as single dose for covid-19 immunization. (Vaccination facility: Public Health Clinic). Medical history included eczema, myositis during childhood from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: All nuts from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not receive any other medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 in left arm on 16Apr2021 for covid-19 immunization. Patient was not diagnosed with COVID-19 Prior to vaccination. It was reported on 31May2021 04:30 PM he had high fever, chills and body aches. Tested for COVID rapid and PCR came out negative. Then a week after he started c/o groin pain and swelling followed by throat ache and swollen glands. It lasted for few days. As He c/o fatigue and neck stiffness he took to urgent care on June 12th 8;30 pm and did the blood work and found to have elevated WBC. Sent him home requesting to hydrate and take fluids. On 15Jun2021 morning he had muscle aches and left biceps swelling, pain and redness as well as fever 102 degrees. Took him to the doctor and they suspected cellulitis and started on 10 days dose of Cephalexin. The swelling started going down within 24 hrs. He is still on antibiotics. Slowly feeling better. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021 (test name: Rapid and PCR, test type: Nasal Swab), Body temperature measurement: fever 102 degrees on 15Jun2021. Therapeutic measures were taken as a result of cellulitis, high fever, chills, body aches, groin pain and swelling, groin pain and swelling, throat ache, swollen glands, fatigue, neck stiffness, muscle aches, left biceps swelling, pain, redness, fever 102 degrees. The outcome for the event was reported as resolving.    Information regarding the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test, Swelling
Clinical narrative: cellulitis; swollen glands; muscle aches; fever 102 degrees; left biceps swelling; pain; redness; neck stiffness; elevated WBC; throat ache; chills; high fever; body aches; groin pain and swelling; groin pain and swelling; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 16-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08May2021 as single dose for covid-19 immunization. (Vaccination facility: Public Health Clinic). Medical history included eczema, myositis during childhood from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: All nuts from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not receive any other medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 in left arm on 16Apr2021 for covid-19 immunization. Patient was not diagnosed with COVID-19 Prior to vaccination. It was reported on 31May2021 04:30 PM he had high fever, chills and body aches. Tested for COVID rapid and PCR came out negative. Then a week after he started c/o groin pain and swelling followed by throat ache and swollen glands. It lasted for few days. As He c/o fatigue and neck stiffness he took to urgent care on June 12th 8;30 pm and did the blood work and found to have elevated WBC. Sent him home requesting to hydrate and take fluids. On 15Jun2021 morning he had muscle aches and left biceps swelling, pain and redness as well as fever 102 degrees. Took him to the doctor and they suspected cellulitis and started on 10 days dose of Cephalexin. The swelling started going down within 24 hrs. He is still on antibiotics. Slowly feeling better. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021 (test name: Rapid and PCR, test type: Nasal Swab), Body temperature measurement: fever 102 degrees on 15Jun2021. Therapeutic measures were taken as a result of cellulitis, high fever, chills, body aches, groin pain and swelling, groin pain and swelling, throat ache, swollen glands, fatigue, neck stiffness, muscle aches, left biceps swelling, pain, redness, fever 102 degrees. The outcome for the event was reported as resolving.    Information regarding the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: cellulitis; swollen glands; muscle aches; fever 102 degrees; left biceps swelling; pain; redness; neck stiffness; elevated WBC; throat ache; chills; high fever; body aches; groin pain and swelling; groin pain and swelling; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 16-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08May2021 as single dose for covid-19 immunization. (Vaccination facility: Public Health Clinic). Medical history included eczema, myositis during childhood from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: All nuts from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not receive any other medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 in left arm on 16Apr2021 for covid-19 immunization. Patient was not diagnosed with COVID-19 Prior to vaccination. It was reported on 31May2021 04:30 PM he had high fever, chills and body aches. Tested for COVID rapid and PCR came out negative. Then a week after he started c/o groin pain and swelling followed by throat ache and swollen glands. It lasted for few days. As He c/o fatigue and neck stiffness he took to urgent care on June 12th 8;30 pm and did the blood work and found to have elevated WBC. Sent him home requesting to hydrate and take fluids. On 15Jun2021 morning he had muscle aches and left biceps swelling, pain and redness as well as fever 102 degrees. Took him to the doctor and they suspected cellulitis and started on 10 days dose of Cephalexin. The swelling started going down within 24 hrs. He is still on antibiotics. Slowly feeling better. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021 (test name: Rapid and PCR, test type: Nasal Swab), Body temperature measurement: fever 102 degrees on 15Jun2021. Therapeutic measures were taken as a result of cellulitis, high fever, chills, body aches, groin pain and swelling, groin pain and swelling, throat ache, swollen glands, fatigue, neck stiffness, muscle aches, left biceps swelling, pain, redness, fever 102 degrees. The outcome for the event was reported as resolving.    Information regarding the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Night sweats, Pericardial effusion
Clinical narrative: Had a CT chest which revealed pleural effusion, and pericardial effusion.; Had a CT chest which revealed pleural effusion, and pericardial effusion.; I started having left-sided chest pains.; chills; night sweats; I had an increase in joint pains.; This is a spontaneous report from a contactable consumer reported herself. A 50-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: ELO140), via an intramuscular route on left arm 21Dec2020 at 13:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. the patient does not have any medical illness. No known allergies have been reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On an unknown date, during the month of December, after taking the first covid shot, patient experienced an increase in joint pains which continued throughout the month of January. In Feb2021, she started having chills at sundown with night sweats. But no fever, no cough. On 28May2021 at 15:00, she started having left-sided chest pains. No cough, no fever, no chills. On 03Jun2021, patient went to the emergency room at work and had a CT chest which revealed pleural effusion, and pericardial effusion. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included admission to emergency room/department or urgent care for 3 days and received IV Doxycycline, IV Rocephin, Toradol, Losartan, Pepcid and Colchine. On an unknown date, patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: EL 3302) on the left arm as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included post vaccination covid tests, nasal swab rapid test on 03Jun2021, test result: negative and covid PCR test on 04Jun2021, test result: negative. The clinical outcome of the events was recovered on an unknown date.  Information on batch/lot numbers are available. Further information has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: Had a CT chest which revealed pleural effusion, and pericardial effusion.; Had a CT chest which revealed pleural effusion, and pericardial effusion.; I started having left-sided chest pains.; chills; night sweats; I had an increase in joint pains.; This is a spontaneous report from a contactable consumer reported herself. A 50-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: ELO140), via an intramuscular route on left arm 21Dec2020 at 13:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. the patient does not have any medical illness. No known allergies have been reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On an unknown date, during the month of December, after taking the first covid shot, patient experienced an increase in joint pains which continued throughout the month of January. In Feb2021, she started having chills at sundown with night sweats. But no fever, no cough. On 28May2021 at 15:00, she started having left-sided chest pains. No cough, no fever, no chills. On 03Jun2021, patient went to the emergency room at work and had a CT chest which revealed pleural effusion, and pericardial effusion. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included admission to emergency room/department or urgent care for 3 days and received IV Doxycycline, IV Rocephin, Toradol, Losartan, Pepcid and Colchine. On an unknown date, patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: EL 3302) on the left arm as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included post vaccination covid tests, nasal swab rapid test on 03Jun2021, test result: negative and covid PCR test on 04Jun2021, test result: negative. The clinical outcome of the events was recovered on an unknown date.  Information on batch/lot numbers are available. Further information has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm started to hurt; This is a spontaneous report from a contactable consumer (patient). A 62-year-old-male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an intramuscular route of administration, administered in Arm Right on an unspecified date in Apr2021 (the day after Easter, so April 6th or 5th), at 09:15 in the morning (at the age of 62-year-old), as single dose, for Covid-19 immunization. The patient's medical history was none.The patient did not receive any other vaccine prior to this vaccination and no family medical history. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via unspecified route of administration, administered in Arm Right on an unspecified date in Mar2021, (3 weeks before like on March 15th or something like that), at 09:15 in the morning (3 weeks before that, so it's like March 15th or something like that) as a single dose, for Covid-19 immunization. The patient's concomitant medications were not reported. The patient got his second shot on the day after Easter and just two days ago his arm started to hurt, on an unspecified date in 2021. It didn't hurt when he got the shot in April, but it just started hurting two days ago (date unspecified). While probing, the patient stated that he was still having the problem and the outcome was not the same. The patient did not receive any treatment for the event. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: The patient stated that recently tested positive for COVID (coronavirus disease) and had lost his sense of smell.; tested positive for COVID; inappropriate schedule of vaccine administered; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer based on information received by Pfizer. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing psoriasis. Concomitant medication included etanercept (ENBREL) taken for Plaque psoriasis 50 milligram, weekly on an unknown start date and stopped in Apr2021 and again started on an unspecified date in 2021. In 2021, the patient experienced the patient stated that recently tested positive for covid (coronavirus disease) and had lost his sense of smell, tested positive for covid, inappropriate schedule of vaccine administered. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath; Severe chest pressure; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe chest pressure and shortness of breath after 8-10 days post vaccination on an unspecified date. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021739776 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report from a Pfizer sponsored program via consumer or other non-health professional (Patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) 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 was tired after the first vaccine on an unspecified date. The clinical outcome of the event was unknown.   Follow-up attempts are possible. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain in arm after COVID 19 vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date, as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient experienced injection site pain in arm after COVID-19 vaccine. The outcome of the event was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Received the second dose, all of pain was completely gone; No longer pain in body; not get tired anymore; body jump out just like from wow, have lot of energy, feel like he go back 10 years younger; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: unknown [number provided as 8726 but was not clarified further]) via unspecified route of administration on an unspecified date (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: unknown) via unspecified route of administration on an unspecified date (at the age of 52-year-old), as single dose, for COVID-19 immunization and felt tired. Reportedly on an unspecified date in 2021, after receiving second dose of vaccination, all of patient's pain was completely gone. Patient stated that "he had no longer pain in his body anymore like he was 52-year-old and he used to have little pain here and there and when he used to leave his car, when go outside in his car he use legs, when he take the stares, his legs will be hurting, 'you'll feel it's not enough to stand by own body and all', all this he don't have this anymore, he was free of pain since he got the vaccine, the second one, his body just jump out just like from wow, he had lot of energy and he feel like he just go back 10 years younger, patient just feel like". Patient was giving an example that "when you are driving a car for couple of hours, when you come outside your car and you are walking, your legs hurt because you use them in the car while driving, you get the idea it's normal". Further patient stated that "Now, he doesn't have this anymore and mentioned like let's say when you are working you get tired of your body, he doesn't get this anymore, he doesn't get tired anymore. So, the vaccine gave him good benefit, he doesn't know what kind of side effects he has in his body, but they have very good results". The patient mentioned that he did not need any assistance as he did not have any problem. Further probing was not done as the caller ended the call abruptly hence limited information was available. The outcome of the event was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 antibody test
Clinical narrative: Very tired for two days; A non stop headache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 11Jun2021 10:15 (Lot number: 59257-1000-1) as dose 2, single for covid-19 immunization at the age of 42-year-old. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing, and COVID-19 in Dec2020. The patient was non-pregnant. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; zinc chloride taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT-C) taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported; biotin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20May2021 11:00 (Lot number: 59257-1000-1) as dose 1, single for covid-19 immunization at the age of 42-year-old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she still tested positive for antibodies in May2021 when she donated platelets. The patient reported that she felt very tired for two days. As of 13Jun2021 she had a non-stop headache and that it lasted all day (as reported). Patient stated that she never got headaches much before, maybe twice a year and that this was driving her crazy. Patient stated she took several ibuprofen (ADVIL) daily and nothing helped. Patient was still continuing to feel tired. The onset of the events was on 13Jun2021 10:00 (as reported). The outcome of the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for her 14-year-old daughter and six female patients. This report is about six female patients.  Six female patients of unspecified ages received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single, for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. On an unspecified date, six of the patients developed shingles within several days of receiving the vaccine. The clinical outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar event for six patients. This is second of six report. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced six of the patients developed shingles within several days of receiving the vaccine. Reported that reporter read on the internet an article published specifically on  The researchers found that six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose. The RA also said that it's triggered by the same virus that causes chickenpox." She is asking if she should take a Shingles shot before getting the vaccine. She is surprised that we don't have any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people have reported these and her daughter also experienced it. The outcome of event was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The researchers found that on an unspecifies date, six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose. The National Institute of Neurological Disorders and Stroke also said that it's triggered by the same virus that causes chickenpox. Caller was asking if she should take a Shingles shot before getting the vaccine. Caller was surprised that we did not have any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people have reported these. Outcome of the event was unknown.  Information about lot/both number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report received from a contactable consumer. This case is for the 4th patient. This consumer reported for an unknown female consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and Expiration date was not provided), via an unspecified route of administration, on an unspecified date, as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that she read on the internet an article published specifically on 21Apr2021, "A Herpes Infection May Be Linked to the COVID Vaccine" from health.com. The researchers found that six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose.  Also said that it's triggered by the same virus that causes chickenpox. Reporter was asking if she should take a Shingles shot before getting the vaccine. reporter was surprised that we don't had any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people had reported these and her daughter also experienced it. The outcome of the event was reported as unknown.  Information about Batch/Lot number requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. The consumer reported similar events for 6 patients including her daughter. This is the 5th of the six reports. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination patient experienced herpes zoster on an unspecified date.  The researchers found that six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose. The Clinic also said that it's triggered by the same virus that causes chickenpox. Caller is asking if she should take a Shingles shot before getting the vaccine. Caller is surprised that we don't have any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people have reported these and her daughter also experienced it. The outcome of event was unknown.   Information on the lot/batch number has been requested.