chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Vaccine wasn't good on my body, I am not feeling fine at all; My left hand was swollen and was black in color, I have been going through a series of pain; My whole body is being disorganized; It is making me restless; My left hand was swollen and was black in color, I have been going through a series of pain; My left hand was swollen and was black in color, I have been going through a series of pain; This is a spontaneous report from a contactable consumer or other Non-health care professional (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 704AZ1A), via an unspecified route of administration, administered in left arm on 12May2021 (age at vaccination was 63 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after taking the vaccination the patient experienced that vaccine wasn't good on her body, as she did not feel fine at all and it even' bought her to the hospital, and medication was given to side effect. She was not feeling fine at all. She reported that since I got it, I have not been myself, my skin on the left hand, and her left hand was swollen and was black in color, she did not know, it seemed to black. Had been going through a series of pain, she was not getting any 'relief' at all, went to the hospital and they gave her 'Naproxen'. She inquired about the when the medicine gets off her body her whole system as her body was being disorganized. She did not feel okay with this. So, she was inquired to reduce the effect on my body, it was making her restless. The event wasn't good on her body, as she did not feel fine was serious hospitalization and other events were Unspecified. The patient received treatment for the event pain. It was reported that patient don't want to get another injection, just the medication that will reduce the pain, that remove the one that she already have one in her body already, that's what she am looking for. The outcome of the events was peripheral swelling, skin discoloration was unknown and other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bradyphrenia, Dyspnoea, Gastrointestinal disorder, Headache
Clinical narrative: Shortness of breath; Upper and lower GI side effects; Slowed mentation; Daily severe headaches/Massive headache; This is a spontaneous report from a contactable physician. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:00 (age at the vaccination 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation at Doctor's office/urgent care. Medical history included prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0185), via an intramuscular, administered in Arm Left on 15May2021 12:00 PM date as 1st dose, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath on 05Jun2021 12:45, daily severe headaches /massive headache on 05Jun2021 12:45, upper and lower gi side effects on 05Jun2021 12:45, slowed mentation on 05Jun2021 12:45. Every afternoon patient had massive headache which patient had never before, shortness of breath and had digestive problems every night, digestive problem like patient can have days of digestive problems upper GI and Lower GI. Adverse event (AE) required visit to the Physician Office. It was getting worst. Therapeutic measures were taken as a result of daily severe headaches/massive headache. Patient took Motrin for headache. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Dyspnea cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had pain in his arm/ The arm pain happened after his second dose/ He is still experiencing pain in his arm; This is a spontaneous report from a contactable consumer (wife of the patient). A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not provided), via an unspecified route of administration, administered in Arm on 19Apr2021 (24 days after the first dose) as dose 2, single (age at vaccination: 58 years), for covid-19 immunization. The reason why lot/batch details were not shared is the reporter was unwilling to complete the report. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 (Lot number was not reported, age at vaccination: 58 years), on 26Mar2021 with his wife on the same day, for covid-19 immunization. The wife reported that, her husband had the same shot, on the same days as of her and he had pain in his arm since an unknown date in Apr2021, after his second dose, but the pain was not as severe as her pain. She also stated that, he was still experiencing pain in his arm and she was not sure in what arm he was experiencing the pain. The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chest discomfort, Dehydration, Fatigue, Migraine
Clinical narrative: migraines; nausea; vomiting; pressure around midchest area; feeling of fullness; dehydration; low grade fever; tiredness; lost 38 lbs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0162), via an unspecified route of administration, in arm left, on 12Apr2021 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included sleep apnoea, type 2 diabetes, high blood pressure, high cholesterol, depression from an unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6207), via an unspecified route of administration, in right arm, on 22Mar2021 as single dose for COVID-19 immunisation and reported tiredness. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has been tested with covid-19. It was reported that on 17Apr2021, 5 days after 2nd dose, the patient had experienced severe migraines (which he never had before this), uncontrollable nausea and vomiting causing 2 ER visits due to dehydration; pressure around midchest area and feeling of fullness after eating a few bites of food; sought gastroenterologist help who suspects gastroparesis, low grade fever, tiredness on 15Apr2021 (3 days after injection) and lost 38 lbs on 13Apr2021. The patient reported that she was scheduled for additional gastrointestinal testing and lost 38 lbs between 13Apr - 1Jul not due to diet or exercise. The events lead to the emergency room and physician office visit. The patient underwent lab tests and procedures which included low grade fever: low on 15Apr2021 and COVID-19 NAT Nasal Swab test: negative on 01Jun2021. Therapeutic measures were taken as a result of dehydration, low grade fever, tiredness, migraines, nausea, vomiting, pressure around midchest area that included medications, IV fluids. The outcome of the events dehydration, low grade fever, tiredness, migraines, pressure around midchest area lost 38 lbs was reported as not resolved and the patient recovered from nausea and vomiting on 01Jul2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Vomiting, Weight decreased
Clinical narrative: migraines; nausea; vomiting; pressure around midchest area; feeling of fullness; dehydration; low grade fever; tiredness; lost 38 lbs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0162), via an unspecified route of administration, in arm left, on 12Apr2021 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included sleep apnoea, type 2 diabetes, high blood pressure, high cholesterol, depression from an unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6207), via an unspecified route of administration, in right arm, on 22Mar2021 as single dose for COVID-19 immunisation and reported tiredness. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has been tested with covid-19. It was reported that on 17Apr2021, 5 days after 2nd dose, the patient had experienced severe migraines (which he never had before this), uncontrollable nausea and vomiting causing 2 ER visits due to dehydration; pressure around midchest area and feeling of fullness after eating a few bites of food; sought gastroenterologist help who suspects gastroparesis, low grade fever, tiredness on 15Apr2021 (3 days after injection) and lost 38 lbs on 13Apr2021. The patient reported that she was scheduled for additional gastrointestinal testing and lost 38 lbs between 13Apr - 1Jul not due to diet or exercise. The events lead to the emergency room and physician office visit. The patient underwent lab tests and procedures which included low grade fever: low on 15Apr2021 and COVID-19 NAT Nasal Swab test: negative on 01Jun2021. Therapeutic measures were taken as a result of dehydration, low grade fever, tiredness, migraines, nausea, vomiting, pressure around midchest area that included medications, IV fluids. The outcome of the events dehydration, low grade fever, tiredness, migraines, pressure around midchest area lost 38 lbs was reported as not resolved and the patient recovered from nausea and vomiting on 01Jul2021.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Discomfort, Illness
Clinical narrative: couldn't even get a blood pressure reading because it was so low; got very weak and sick; got very weak and sick; could catch her breath her body was shutting down; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21May2021 (ten days to the day of taking the shot), the patient got very weak and sick. Her fiance had to call emergency medical service (EMS), because she could catch her breath her body was shutting down and the EMS couldn't even get a blood pressure reading because it was so low. The doctors trying to tell her it wasn't the shot, she took a total parenteral nutrition (TPN) 12 hours a day and hadn't changed anything. The patient was trying to figure out why the doctors were trying to lie about these shots and pushing everyone to get it. What she would like to know was they getting a kick back from all this and just didn't care what happened to the patients and could less if patients die or get deathly sick like her. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Dyspnoea, Limb discomfort, Myocardial infarction
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 41-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in left arm on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot: ER8727)via an unspecified route of administration on 18Mar2021 at 12:00 PM in left arm for COVID-19 Immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient was not covid tested post vaccination. Patient received vaccine facility in Public Health Clinic/Veterans Administration facility. The patient reported that she had heart pain daily, felt like I have heart attacks, I have shortness of breath, my chest feels tight, get paralyzed in the moment and it's hard to breath, I have a hard time moving my left arm to my right side. The events Heart pain daily, myocardial reinfarction, paralyzed assessed as serious (Medically Significant) and while other event was non-serious. Patient had no insurance. Patient has not visited the doctor. No treatment was received for the events. The outcome of the events was reported as not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 41-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in left arm on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot: ER8727)via an unspecified route of administration on 18Mar2021 at 12:00 PM in left arm for COVID-19 Immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient was not covid tested post vaccination. Patient received vaccine facility in Public Health Clinic/Veterans Administration facility. The patient reported that she had heart pain daily, felt like I have heart attacks, I have shortness of breath, my chest feels tight, get paralyzed in the moment and it's hard to breath, I have a hard time moving my left arm to my right side. The events Heart pain daily, myocardial reinfarction, paralyzed assessed as serious (Medically Significant) and while other event was non-serious. Patient had no insurance. Patient has not visited the doctor. No treatment was received for the events. The outcome of the events was reported as not recovered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nausea, Taste disorder
Clinical narrative: Taste was different and still hasn't gone away; Really nauseous; metallic taste; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left 13May2021 (Age at Vaccination: 17 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations was reported as none. Family Medical History Relevant to Adverse events was reported as none.  The patient Concomitant medications were not reported. Historical Vaccine included She received allergy shots. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 22Apr2021 (at the age of 17 years) as DOSE 2, SINGLE for COVID-19 immunisation. She got her second dose 6 weeks ago and on 15May2021, the patient experienced taste was different and still hasn't gone away. She was reading that it is kind of uncommon to still get a metallic taste. On an unspecified date in May2021, after the second dose, the patient experienced really nauseous and then started noticing her taste was different and she just stopped eating things that taste weird mainly meat. Treatment received for Taste was different and still hasn't gone away was reported as no. The Relevant Tests was reported as none. The outcome of the event nausea was unknown, while other events was not recovered.  Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Anticoagulation drug level above therapeutic, International normalised ratio
Clinical narrative: supratherapeutic INRs/ INR increased; This is a spontaneous report from a contactable health care professional (nurse), via Pfizer sales representative. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and  expiration date: not reported,) via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not specified, RN did not elaborate on what concomitant medications patients were on. On an unspecified date, the patient experienced supratherapeutic INRs. The nurse mentioned that they have seen many more supratherapeutic INRs due to the Covid vaccine. Within 5-7 days of vaccination, INR appears to increase in patients on warfarin. The nurse stated that this is a very common occurrence. The patient underwent lab tests and procedures which included international normalized ratio: increased on an unspecified date. The outcome of the event is unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Limb discomfort, Muscle rigidity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 59-year-old-female (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186, Expiration date: unknown) via unspecified route of administration in the right arm, on an unknown date, as dose 2, single for COVID-19 Immunisation. Medical history included asthma and allergies. Concomitant medications included epinephrine bitartrate (ASTHMAHALER), taken for unspecified indication start and stop date were not reported, allergy medication. The patient was allergic to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0173) via unspecified route of administration in the left arm, on 07May2021 at 01:30 PM, (at the age of 59-year-old) as dose 1, single for COVID-19 Immunisation. The patient was not a pregnant at time of Vaccination. On 28May2021, the patient experienced chronic diarrhea and also chronic heaviness, muscle aches, soreness, pain, rigidity and tight muscles in both legs from hips to toes, all right after 2nd dose. In addition, shortly after second dose, she experienced low grade fever and vomiting. The patient was concerned about diarrhea and leg issues. The patient did not received 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. The patient did not received any treatment for event. The outcome of the events was not recovered.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 59-year-old-female (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186, Expiration date: unknown) via unspecified route of administration in the right arm, on an unknown date, as dose 2, single for COVID-19 Immunisation. Medical history included asthma and allergies. Concomitant medications included epinephrine bitartrate (ASTHMAHALER), taken for unspecified indication start and stop date were not reported, allergy medication. The patient was allergic to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0173) via unspecified route of administration in the left arm, on 07May2021 at 01:30 PM, (at the age of 59-year-old) as dose 1, single for COVID-19 Immunisation. The patient was not a pregnant at time of Vaccination. On 28May2021, the patient experienced chronic diarrhea and also chronic heaviness, muscle aches, soreness, pain, rigidity and tight muscles in both legs from hips to toes, all right after 2nd dose. In addition, shortly after second dose, she experienced low grade fever and vomiting. The patient was concerned about diarrhea and leg issues. The patient did not received 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. The patient did not received any treatment for event. The outcome of the events was not recovered.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pneumonia
Clinical narrative: Diagnosed with pneumonia.; Chest and back pain; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female 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, administered in left arm on 24Jun2021 (at the age of 72-years-old) as dose 2, single for COVID-19 immunization in hospital. No other vaccine was administered in four weeks. No other medications were administered in two weeks. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination. Medical history included, eczema, heart rate irregular. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 03Jun2021 (at the age of 72-years-old) as dose 1, single for covid-19 immunisation in hospital. The patient previously took erythromycin and claritin [clarithromycin] and experienced allergy. On 24Jun2021, the patient was diagnosed with pneumonia and experienced chest and back pain and shortness of breath. The events resulted in physician office visit. Therapeutic measures were taken as a result of the events with antibiotics. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a Pfizer sponsored program Pfizer RxPathways via a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; and varenicline tartrate (CHANTIX), route of administration, start and stop date, batch/lot number and dose were not reported to quit smoking. The patient medical history and concomitant medications were not reported. The patient experienced heart attack in Feb2021 with outcome of unknown. Caller called in seeking assistance with the medication Chantix. During the call caller stated."I had a heart attack in February and the patient was trying to quit smoking and trying but it was pretty hard to do. The action taken in response to the event(s) for varenicline tartrate was dose not changed.   Information about batch/lot number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sleep disorder, Vaccination site pain
Clinical narrative: had napped 2-3 different times, which was unusual for her daughter.; Her daughter immediately had right arm injection site pain; Her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards; This is a spontaneous report from a contactable Nurse. This Nurse (patient's mother) reported for a 13-year-old female patient (reporter's daughter) that: A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Right on 24Jun2021 at 13:21 (at the age of 13 year) as single dose for covid-19 immunisation. Medical history included ongoing heart disease congenital diagnosed prior birth, ongoing irregular heart rhythm. Patien''s family history includes her daughter's grandmother (patient's mother's mother) & her daughter's aunt (patient's mother's sister) all have holes in their hearts & they all have implantable defibrillators. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Patient not received additional vaccines on same date of the Pfizer Suspect. Patient was not received any other vaccine four weeks prior vaccination. She stated her daughter (patient) didn't have an implanted defibrillator at this time & her daughter's doctor was waiting until her daughter was older. She reported her daughter's irregular heart rhythm had a genetic component, but she did not know if the irregular heart rhythm was related to her daughter's congenital heart disease. Patient's mother reported her daughter received her first COVID-19 Vaccine dose on 24Jun2021 at 01:21PM in her right arm, and immediately had right arm injection site pain on 24Jun2021. She said her daughter, was really tired and exhausted for 24-36 hours afterwards on unknown date in Jun2021. She said she was not sure if her daughter tiredness and exhaustion started on 24Jun2021, but her daughter took a nap that evening (24Jun2021), and on the next day (25Jun2021) had napped 2-3 different times, which was unusual for her daughter. She reported she offered her daughter Ibuprofen and an ice pack for her right arm injection site pain, and her daughter refused. Patient not visited to physician office or emergency room for the events. The outcome of the events her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards was not recovered and had napped 2-3 different times, which was unusual for her daughter, her daughter immediately had right arm injection site pain was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Erythema, Pruritus, Skin injury
Clinical narrative: Extremely allergic itching reaction; Whole skin is red; I have been ripping my skin apart; Extremely allergic itching reaction; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A patient of unspecified age and gender received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient after got the shot, experienced extremely allergic itching reaction since 08Jun2021, have been ripping the skin apart and the whole of skin was red. Patient went to two doctors and they said that it was probably a reaction and then patient need to call Pfizer that took a medical report figure out to do about itching. Outcome of the event was unknown.  Limited information available over the call.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: My right arm is weak; it's spreading through my entire upper arm, my neck and my other arm; My right arm is painful with limited mobility; My right arm is painful with limited mobility; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration, in Mar2021 as dose 1, single; then second dose of BNT162B2 (Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration, in Apr2021 dose 2, single, both for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had COVID shots in Mar2021 and Apr2021. The patient experienced right arm weak and right arm was painful with limited mobility on an unspecified date in 2021. It was reported that the patient need help. The patient was in so much pain, and it was spreading through entire upper arm, neck and other arm. The patient was seeking help and reported that the doctors couldn't help the patient. The outcome for the events was not recovered.  Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Pruritus
Clinical narrative: Started itching all over, whole body is on fire and is scratching; Annoying; This is a spontaneous report from  Pfizer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left upper arm on 08Jun2021 as dose 2, single dose for covid-19 immunization.  Medical history included hypertension. Concomitant medication included Bystolic (Nebivolol Hydrochloride, strength: 5mg), via an unspecified route of administration on an unspecified date at 5 mg, unknown frequency for hypertension. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: unknown, Expiry Date: unknown), via an unspecified route of administration on an unspecified date for COVID-19 immunization and had no reaction on previous exposure to vaccine. Consumer did not took any vaccination 4 weeks prior to COVID Vaccine. The patient experienced started itching all over, whole body is on fire and is scratching; under in my chest, my abdominal area, around my ribs, below my naval and above my pubis, whole abdominal trunk is itchy/sometimes it will be in my hairline, it's just annoying it's not breaking my skin apart on an unspecified date in Jun2021. Consumer stated, whatever the process normally would be it's fine, I just wanted to know what to do because I'm itchy, it started after the second shot and I never in my entire life had to take Benadryl for anything. But I've been to few doctors who tried to get rid of it and it's not, because they don't know what it is because it is something nobody has experienced apparently. Started itching all over, whole body is on fire and is scratching; Under in my chest, my abdominal area, around my ribs, below my naval and above my pubis, whole abdominal trunk is itchy/sometimes it will be in my hairline and annoying. Therapeutic measures were taken and the patient took hydrocortisone and that didn't work, and I took Benadryl and just nothing is helping. The clinical outcome of event started itching all over, whole body is on fire and is scratching, annoying was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinusitis
Clinical narrative: sinus infection; nasal dripping; sinus infection; nasal dripping; This is a spontaneous report from a non-contactable consumer or other non hcp.A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was 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. On an unknown date, the patient experienced sinus infection and nasal dripping. It was reported that patient had the vaccine almost about 2 days ago and had the sinus infection, knew that had been getting one. Also asked that can patient take Nasonex. The patient did not had any side effects. Had nasal dripping, patient get this a lot nothing new. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Weight increased
Clinical narrative: no period since May 5 (2 weeks after last COVID shot); weight gain; last period now 59 days ago; no period since May 5 (2 weeks after last COVID shot); weight gain; last period now 59 days ago; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 43-years-old female non-pregnant patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ew0153), via an unspecified route of administration, administered in Right arm on 17Apr2021 (43-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included erenumab aooe (AIMOVIG) taken for migraine, start and stop date were not reported and multivitamins. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: en6203), via an unspecified route of administration on 28Mar2021 (43-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. On 05May2021 the patient experienced no period since may 5 (2 weeks after last covid shot); weight gain; last period now 59 days ago. The outcome of events was not resolved.   Follow-Up : Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Hyperpyrexia
Clinical narrative: has got a high temperature of 107; This is a spontaneous report from a contactable consumer (Parent) or other non HCP  A 55-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration (at the age of 55-year-old) on 01Jul2021 as dose 1 single for covid-19 immunization. The patient's medical history and concomitant medications was reported as no. On 02Jul2021 Reporter stated, his/her son received his Pfizer shot yesterday (01Jul2021) and that day he has got a high temperature of 107. The patient did not received any treatment for event. The patient underwent lab tests and procedures which included body temperature increased: 107 on 02Jul2021 (he has got a high temperature of 107). The outcome of event was unknown.  Information on the lot/batch number has been requested
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I received second shot on 17Apr2021 in left arm as first shot, today is 01Jul2021 and i am STILL HAVING SEVERE PAIN IN THE INJECTION ARM. I have responded to the messages I have received askin; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 62 years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302, Expiration date: unknown), via an unspecified route of administration on 17Apr2021 (at the age of 61-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure abnormal. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported, blood thinner (unspecified). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302, Expiration date: unknown), via an unspecified route of administration on 27Mar2021 12:00PM as dose 1, single for covid-19 immunisation. The patient had no allergies.The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021 02:00, the patient experienced Pain in injection arm. Patient reported that he received second shot on 17apr2021 in left arm as first shot, today is 01jul2021 and he still have severe pain in the injection arm. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken as a result of event. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection: Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021 the patient experienced shingles. Reporter is a pharmacist calling on behalf of a patient who received the Pfizer Covid vaccine in Mar2021, developed shingles and was treated and now would like the second dose of the Pfizer Covid vaccine. Is it safe for the patient to receive the Pfizer Covid vaccine after having shingles. a patient of unknow age who developed shingles between 1st and second dose, and now has been greater than 42 days between doses. Spoke from Covid-19 Vaccine use of antivirals and antibiotics at vaccination: Pfizer Medical Information is not aware of any specific information suggesting that you cannot be vaccinated with the Pfizer-BioNTech COVID-19 Vac-cine if you are taking an antiviral (such as acyclovir or valacyclovir) or an antibiotic (such as amoxicillin or azithromycin). Patient received treatment for the adverse event. Outcome of the event of the was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021828823 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: with the second dose got sick; This is a spontaneous report from a contactable nurse and a contactable consumer (Patient). A 50-years-old female patient (Pregnancy unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on unspecified date via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's concomitant medications were not reported. On an unknown date, after second of BNT162B2 patient experienced sickness. The event outcome was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash on her side; This is a spontaneous report from a contactable Pharmacist. An 82-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),  via an unspecified route of administration on an unspecified date, as first dose ,single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Pharmacist called on behalf of an 82-year-old female patient and reported that the patient received her first Pfizer BioNTech COVID 19 vaccine 21 days ago and developed a rash on her side. Pharmacist was now seeking information if it was ok for the patient to receive the second dose of the vaccine today. In response pharmacist was instructed that Pfizer was unable to make treatment recommendations for patients up to HCP decision. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829772 similar report from same reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Peripheral swelling, Rash erythematous
Clinical narrative: reddish rash and swelling on arm, on my left arm; reddish rash and swelling on arm, on my left arm; reddish rash and swelling on arm, on my left arm; This is a spontaneous report from a contactable other HCP.  A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: EW0217), via an unspecified route of administration, administered on 19Jun2021 as single dose for covid-19 immunisation. Medical history included neck pain from an unknown date, (At one time, I was having like neck pain on left side but that subsided), blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included Dyazide 37.5/25 (Hydrochlorothiazide, Triamterene) taken for blood pressure measurement, start and stop date were not reported. Date schedule to receive second shot: Consumer stated, second shot is 10Jul2021.The patient experienced reddish rash and swelling on arm, on my left arm, reddish rash and swelling on arm, on my left arm on 27Jun2021.Consumer stated treatment was not taken. Verbatim event relatedness: COVID-19 Vaccine: reddish rash and swelling on arm, on my left arm - Related. The events reddish rash and swelling on arm, on my left arm was reported as worsened. The outcome of all event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Influenza, Migraine, Nasal congestion, Pain in extremity
Clinical narrative: Arm a little bit sore; I woke up with like a massive migraine; Head feels like it was caved in like really bad sinus; Fever your eyes are kind of bruised; Nose is not flaring now; I got like a real bad flu or fever; I got like a real bad flu or fever; This is a spontaneous report from a contactable consumer or other non hcp.  A patient of an unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated when got the shot, felt like completely normal other than like obvious, arm a little bit sore, the day when patient went to sleep like a few hours later, patient would say like may be five, six hours later, woke up with like a massive migraine means patient head feels like it was caved in like really bad sinus and kind of like you know when you get like a fever your eyes are kind of bruised. It was kind of feeling, patient got like a real bad flu or fever. It was cleared up a bit now like patient sinuses or nose is not flaring now and head does feel like totally caved in that just feels like kind of bruised something like a basketball or something like it and that was think the lasted side effects that patient got. Outcome of the events was unknown.  Product details(LOT#, NDC#, UPC# and Expiration date) and pharmacy details could not be probed as the consumer hung up abruptly. Hence limited information available over the call.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Sinus headache
Clinical narrative: Arm a little bit sore; I woke up with like a massive migraine; Head feels like it was caved in like really bad sinus; Fever your eyes are kind of bruised; Nose is not flaring now; I got like a real bad flu or fever; I got like a real bad flu or fever; This is a spontaneous report from a contactable consumer or other non hcp.  A patient of an unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated when got the shot, felt like completely normal other than like obvious, arm a little bit sore, the day when patient went to sleep like a few hours later, patient would say like may be five, six hours later, woke up with like a massive migraine means patient head feels like it was caved in like really bad sinus and kind of like you know when you get like a fever your eyes are kind of bruised. It was kind of feeling, patient got like a real bad flu or fever. It was cleared up a bit now like patient sinuses or nose is not flaring now and head does feel like totally caved in that just feels like kind of bruised something like a basketball or something like it and that was think the lasted side effects that patient got. Outcome of the events was unknown.  Product details(LOT#, NDC#, UPC# and Expiration date) and pharmacy details could not be probed as the consumer hung up abruptly. Hence limited information available over the call.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: soulders hurt; This is a spontaneous report from a contactable other HCP. A 56-years-old female patient received 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 DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization; tofacitinib citrate (XELJANZ XR, Formulation: unknown, Lot number was not reported; Expiration Date: 28Feb2023), oral from an unspecified to an unspecified date, at 11 mg, daily for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced soulders hurt. The outcome of event was unknown.   Information on the Batch/lot number has been requested.