chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Throat irritation
Clinical narrative: choking; scratchy throat; the muscles in her throat started seizing up completely within minutes; couldn't swallow whatsoever/no muscle control with swallowing; she couldn't control her spit; fingertips started turning blue; anaphylactic shock; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in right arm (reported: right upper arm) on 19Mar2021 12:30 (at the age of 48 years old) as dose 1, single for COVID-19 immunization. Medical history included triple negative breast cancer from 2017 to an unknown date, CREST (an autoimmune disorder that affects the scleroderma), and asthma from an unknown date. Concomitant medications include unspecified blood pressure and asthma medications. The patient received her 1st dose of COVID vaccine on 19Mar2021 and on the same day had anaphylactic shock. She reported she got the shot and within 10 minutes she had a really scratchy throat and she reported it to the nurse. The muscles in her throat started seizing up completely within minutes. She stated she did not have trouble breathing but she couldn't swallow whatsoever, she couldn't control her spit, when she tried to swallow, she was choking as she had no muscle control with swallowing. She also relayed her fingertips started turning blue. She was given an epi pen for the events. She was transported in the emergency room (ER) for 8 hours but was not admitted. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Finger deformity, Peripheral swelling, Tendon disorder, Ultrasound scan
Clinical narrative: his fingers looked like sausages especially from the first knuckle in his hands to the next closest joint in his fingers/ fingers just don't work, he cannot make a fist; has angry tendons; hands swell up; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization. Medical history included psoriatic arthritis. The patient's concomitant medications were not reported. The patient has been prescribed XELJANZ 11 mg for psoriatic arthritis but has not started it yet. Before starting the medication for his psoriatic arthritis, on an unspecified date, his fingers looked like sausages especially from the first knuckle in his hands to the next closest joint in his fingers. His doctor did an ultrasound on an unspecified date and said he has angry tendons. It was difficult to use his hands. He tried REMICADE but that did absolutely nothing but made him tired and now he was on leflunomide (ARAVA). When he wakes up, his hands were worse than they were an hour after he takes the ARAVA.  His hands swelled up, the fingers just didn't work, he could not make a fist. He has tried several things. Since psoriatic arthritis was due to an overactive immune system, and XELJANZ works to stop that, he has read he would be at risk for infections and now with COVID, even though he received the Pfizer vaccine, he was concerned. The outcome of the events was not recovered. The events were reported as non-serious.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a non-contactable pharmacist. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On an unknown date in Jun2021, the patient experienced vertigo. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event vertigo was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his wife was just diagnosed with COVID with flu-like symptoms and that she had the Pfizer Vaccine; his wife was just diagnosed with COVID with flu-like symptoms and that she had the Pfizer Vaccine; This is a spontaneous report from a contactable consumer (patient's husband). This report was received via a sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that his wife was just diagnosed with COVID and that she had the Pfizer vaccine. He said she was in bed with flu-like symptoms. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 infection; a little over a week later tested positive for Covid-19 infection; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for 25-year-old Patient  that received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced tested positive for covid-19 infection, a little over a week later tested positive for covid-19 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 2021. Caller asked when can he get his second dose. Caller states we heard 3 months and then the pharmacy said 2 weeks after positive test and has no more symptoms so we're confused and concerned and just want to know when he can get it. Response: Provided disclaimer and spoke from the attached document. Will send attached document in fulfillment via email to the email address caller provided. Referred to HCP for further guidance. Survey offered. Caller asked if he gets up and around and goes to a different state, is he able to get the second dose anywhere as long as he has his vaccination card. Caller stated the place he got his first dose is no longer there. Response: Explained that the doses were the same and he could receive second dose as long as it was the Pfizer Covid-19 vaccine. He did not get any additional shots on the day he got the vaccine; he did not go to the doctor's office or emergency room related to this other than to test for COVID. No treatments, he has just quarantine at home with his symptoms. Description of Product complaint: Warm transfer of a mom calling for son and who explained that he got his first dose of the Pfizer COVID vaccine then 1 week after getting it he came down with COVID. She would like to know when he can get the second dose. The outcome for both events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immobile
Clinical narrative: cannot get up to answer the door; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated, " the workers were supposed to come today and give me my second shot today nobody showed up, yet they were supposed to be here at 1230 supposed to be here before my nurse go home because I cannot get up to answer the door." A nurse was supposed to come to the residence to give second dose to caller and had not shown up yet. Indicated called number on the paper. "I did not have that what was on the card, they put it in the mail. Gave it to me on the street. Ya would be giving out the shots, they supposed to be late, and the medicine is already messing people up." So, who do I get in contact with to let them know they were supposed to. The clinical outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test
Clinical narrative: severe joint pain/left knee, then left shoulder,then left hip, now it is my right shoulder; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, then 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 experienced "severe joint pain/left knee, then left shoulder,then left hip, now it is my right shoulder" on an unspecified date. Ever since receiving both Pfizer doses, patient has been dealing with severe joint pain. That pain has randomly moved from one major joint to the other (left knee,then left shoulder,then left hip, now it is his right shoulder). He had never dealt with anything like that before. He would like to know if anyone else was complaining of that type of side effect. He had gone for blood work and everything comes up normal. The patient underwent lab tests and procedures which included blood work: everything comes up normal on unspecified date. The outcome of the event was not recovered.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 antibody test
Clinical narrative: cough; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her son received his first dose on 12Jul2021 and on 20Jul2021 they both tested positive for Covid and experienced cough on an unspecified date. Her son was scheduled for his second dose today. The reporter asked if the patient could receive his second dose today if he still has a cough and asked if someone gets Covid after their first dose do they still have to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 20Jul2021. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough case of COVID-19 after being fully vaccinated; Breakthrough case of COVID-19 after being fully vaccinated; This is a spontaneous report from a contactable consumer.  An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 both intramuscular, in Arm Right in Apr2021 at 09:00 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation in clinic. The patient medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced breakthrough case of covid-19 after being fully vaccinated on 19Jul2021 with outcome of recovered on 30Jul2021. The patient was not treated due to the event. The patient underwent lab tests and procedures which included SARS-CoV-2 Rapid Ag: Positive on 22Jul2021 (Nasal Swab), negative on 30Jul2021 (Nasal Swab), PCR: negative on 30Jul2021 (Nasal Swab). The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: A Puffy swelling filling on both sides of head.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the arm left on 28Jul2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021 at 00:45, the patient experienced a puffy swelling filling on both sides of head. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a puffy swelling filling on both sides of head was not recovered at the time of this report.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report from a contactable consumer (patient's mother). A 28-year-old male patient (reporter's son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 28 years old, on 01Aug2021 (Sunday) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) at single dose for COVID-19 immunisation. After the second vaccination, the patient experienced dizzy all day long on 01Aug2021, yesterday (02Aug2021) too and today (03Aug2021). The reporter asked if this was normal. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for Covid-19; Positive for Covid-19; This is a spontaneous report from a contactable other healthcare professional (nurse). A 33-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021), via intramuscular route, administered in Left arm on 04May2021 at 06:30 as dose 2, single (at the age of 32 years) and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021) via intramuscular, administered in Left arm on an unspecified date in Apr2021 at 06:30 as dose 1, single (at the age of 32 years), for covid-19 immunization, at clinic. Relevant medical history, concurrent conditions and relevant past drug history was unknown. It was unknown if the patient had received any other medications within 2 weeks of vaccination (concomitant medications unknown). It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was stated that, on 30Jul2021, the patient was positive for Covid-19. The event was reported as non-serious. The event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no hospitalization. No treatment was received. The outcome of the event covid-19 was recovering at the time of report.  Product complaint investigation conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to someone who is covid positive; This is a spontaneous report from a non-contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history concomitant medications were not reported. It was reported that, the patient experienced exposed to someone who is covid positive on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp. A adult patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of ad-ministration on an unspecified date (Batch/Lot number and Expiry date was unknown) as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have Covid prior vaccination. On an unspecified date, the patient tested positive for covid. No treatment was received for event. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Rash, Swelling
Clinical narrative: Administration site: Right leg; Major rash and swelling that started with shot and continued.; Major rash and swelling that started with shot and continued.; This is a spontaneous report from a contactable consumer, the patient. An 86-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right leg on an unknown date in Mar2021 (at the age of 86-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and diabetes. The patient had known allergies to procaine hydrochloride (NOVOCAINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified blood pressure and diabetes medicines from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced major rash and swelling that started with shot and continued. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major rash and swelling was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy, Break though case of COVID-19; Lack of efficacy, Break though case of COVID-19; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) intramuscularly in right arm on 03Mar2021 14:00 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FP6955) intramuscularly in right arm on 24Mar2021 14:00 (at the age of 60- years-old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as clinic. 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 and had been tested for COVID-19, since the vaccination. Medical history included none. The patient has no known allergies. The concomitant medications included FLOWMAX, LIPITOR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccines were taken in four weeks. On 27Jul2021, the patient experienced lack of efficacy, break though case of COVID-19. On 01Aug2021, the patient tested positive for PCR. No treatment was received for the adverse events. The adverse event resulted in Doctor or other healthcare professional office or clinic visit. The patient underwent lab tests and procedures which included Sars-Cov-2 (nasal swab, rapid) test with result as positive on 01Aug2021. The outcome of the event COVID-19 was recovering.  Follow-up attempts are completed. No further information is expected.  Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Cough, Delirium, Dyspnoea
Clinical narrative: Cough; Delirious; She woke up with the sweats, which she knew was not normal for her; Difficulty breathing; Laughing at nothing; Flu-like; Feel achy; Low grade fever; Chills; Tingling in the chest; Fatigue feeling; Second dose of vaccination was on 02Jul2021; Congestion; Wheezing; Other respiratory symptoms; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 02Jul2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma since childhood, and anaphylaxis. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15May2021 (at the age of 57 years old) for COVID-19 immunization. On 02Jul2021, the patient had a fatigue feeling. On 05Jul2021, the patient was laughing at nothing; had flu-like; was feeling achy; low grade fever; chills; and tingling in the chest. On 06Jul2021, the patient had woken up with sweats, which she knew was not normal for her; difficulty breathing; and was delirious. On 07Jul2021, the patient had cough that lasted for a long time. On an unspecified date in 2021, the patient had congestion, wheezing and other respiratory symptoms. The patient had received the second dose of vaccination on 02Jul2021, when the first dose was received on 15May2021. The patient was encouraged by her sister to go to the emergency room, but went to the doctor instead (events had resulted into physician office visit). The patient had a chest x-ray on 30Jul2021 (results were not provided). The patient was doing puffs of albuterol as treatment for difficulty breathing, congestion, wheezing and other respiratory symptoms. The outcome of the events was recovering for 'fatigue feeling', 'laughing at nothing', 'flu-like' and 'feeling achy'; was recovered on an unspecified date in 2021 for 'difficulty breathing'; and was unknown for all the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Inappropriate affect, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Cough; Delirious; She woke up with the sweats, which she knew was not normal for her; Difficulty breathing; Laughing at nothing; Flu-like; Feel achy; Low grade fever; Chills; Tingling in the chest; Fatigue feeling; Second dose of vaccination was on 02Jul2021; Congestion; Wheezing; Other respiratory symptoms; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 02Jul2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma since childhood, and anaphylaxis. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15May2021 (at the age of 57 years old) for COVID-19 immunization. On 02Jul2021, the patient had a fatigue feeling. On 05Jul2021, the patient was laughing at nothing; had flu-like; was feeling achy; low grade fever; chills; and tingling in the chest. On 06Jul2021, the patient had woken up with sweats, which she knew was not normal for her; difficulty breathing; and was delirious. On 07Jul2021, the patient had cough that lasted for a long time. On an unspecified date in 2021, the patient had congestion, wheezing and other respiratory symptoms. The patient had received the second dose of vaccination on 02Jul2021, when the first dose was received on 15May2021. The patient was encouraged by her sister to go to the emergency room, but went to the doctor instead (events had resulted into physician office visit). The patient had a chest x-ray on 30Jul2021 (results were not provided). The patient was doing puffs of albuterol as treatment for difficulty breathing, congestion, wheezing and other respiratory symptoms. The outcome of the events was recovering for 'fatigue feeling', 'laughing at nothing', 'flu-like' and 'feeling achy'; was recovered on an unspecified date in 2021 for 'difficulty breathing'; and was unknown for all the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Paraesthesia, Pyrexia, Respiratory symptom
Clinical narrative: Cough; Delirious; She woke up with the sweats, which she knew was not normal for her; Difficulty breathing; Laughing at nothing; Flu-like; Feel achy; Low grade fever; Chills; Tingling in the chest; Fatigue feeling; Second dose of vaccination was on 02Jul2021; Congestion; Wheezing; Other respiratory symptoms; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 02Jul2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma since childhood, and anaphylaxis. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15May2021 (at the age of 57 years old) for COVID-19 immunization. On 02Jul2021, the patient had a fatigue feeling. On 05Jul2021, the patient was laughing at nothing; had flu-like; was feeling achy; low grade fever; chills; and tingling in the chest. On 06Jul2021, the patient had woken up with sweats, which she knew was not normal for her; difficulty breathing; and was delirious. On 07Jul2021, the patient had cough that lasted for a long time. On an unspecified date in 2021, the patient had congestion, wheezing and other respiratory symptoms. The patient had received the second dose of vaccination on 02Jul2021, when the first dose was received on 15May2021. The patient was encouraged by her sister to go to the emergency room, but went to the doctor instead (events had resulted into physician office visit). The patient had a chest x-ray on 30Jul2021 (results were not provided). The patient was doing puffs of albuterol as treatment for difficulty breathing, congestion, wheezing and other respiratory symptoms. The outcome of the events was recovering for 'fatigue feeling', 'laughing at nothing', 'flu-like' and 'feeling achy'; was recovered on an unspecified date in 2021 for 'difficulty breathing'; and was unknown for all the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Cough; Delirious; She woke up with the sweats, which she knew was not normal for her; Difficulty breathing; Laughing at nothing; Flu-like; Feel achy; Low grade fever; Chills; Tingling in the chest; Fatigue feeling; Second dose of vaccination was on 02Jul2021; Congestion; Wheezing; Other respiratory symptoms; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 02Jul2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma since childhood, and anaphylaxis. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15May2021 (at the age of 57 years old) for COVID-19 immunization. On 02Jul2021, the patient had a fatigue feeling. On 05Jul2021, the patient was laughing at nothing; had flu-like; was feeling achy; low grade fever; chills; and tingling in the chest. On 06Jul2021, the patient had woken up with sweats, which she knew was not normal for her; difficulty breathing; and was delirious. On 07Jul2021, the patient had cough that lasted for a long time. On an unspecified date in 2021, the patient had congestion, wheezing and other respiratory symptoms. The patient had received the second dose of vaccination on 02Jul2021, when the first dose was received on 15May2021. The patient was encouraged by her sister to go to the emergency room, but went to the doctor instead (events had resulted into physician office visit). The patient had a chest x-ray on 30Jul2021 (results were not provided). The patient was doing puffs of albuterol as treatment for difficulty breathing, congestion, wheezing and other respiratory symptoms. The outcome of the events was recovering for 'fatigue feeling', 'laughing at nothing', 'flu-like' and 'feeling achy'; was recovered on an unspecified date in 2021 for 'difficulty breathing'; and was unknown for all the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: she was on chemo and is immunocompromised that they don't think she has had enough of an immune response to the vaccine.; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EN6202) as dose 1, single, then via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: ER8733) as dose 2, single for covid-19 immunisation. Medical history included ongoing stage 4 cancer and was taking chemotherapy.  The patient's concomitant medications were not reported. Patient had stage 4 cancer and was taking chemotherapy at the time she received both doses. Her primary care physician and oncologist both said that she should get the booster dose and she has called the health department and her local hospital to get more information regarding being able to receive a third dose. The patient's doctors are concerned that since she was on chemo and was immunocompromised that they don't think she has had enough of an immune response to the vaccine on an unspecified date in 2021. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Appendix disorder, Product dose omission issue
Clinical narrative: needed an emergency apendectomy; missed the second dose of vaccine; This is a spontaneous report from a contactable other health care professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. HCP inquiring if a patient that received first dose of vaccine 03Jun20211 then the patient experienced, needed an emergency appendectomy and missed the second dose of vaccine and would like second dose 02Aug2021. Transfer to another hospital - nurse sent paperwork to facility for AE - medical treatment needed after vaccine and second dose beyond 21 days. CoVax US Support CEP 159558. The outcome of event needed an emergency appendectomy was unknown.  Follow up attempts are needed, Information on lot/batch number has been requested. ; Sender's Comments: Based on limited available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of "Emergency appendectomy" due to temporal relationship and current known drug safety profile. 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID-19 test on 29Jul2021; Positive COVID-19 test on 29Jul2021; This is a spontaneous report from a contactable consumer or other non hcp.A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EL3247) via intramuscular route of administration, administered in Arm Left (Age at time of vaccination: 43 years old) on 19Jan2021 as DOSE 1, SINGLE, dose 2 via intramuscular route of administration, administered in Arm Left on 08Feb2021 (Batch/Lot Number: EL3247) as DOSE 2,SINGLE for covid-19 immunisation at clinic. Medical history included migraine. There were no concomitant medications. The patient previously took sesame oil and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced positive covid-19 test on 29Jul2021. The patient did not received treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29Jul2021.The outcome of the events were recovering on unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain, swelling and redness at injection site; Pain, swelling and redness at injection site.; Pain, swelling and redness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 31Jul2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 20:00, the patient experienced pain, swelling and redness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, swelling and redness at injection site was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19 on 23Jul2021; Tested positive for Covid 19 on 23Jul2021; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), dose 2 via an unspecified route of administration, administered in arm right on 17Mar2021 11:00 (age at vaccination 53-year-old) as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), dose 1 via an unspecified route of administration, administered in arm right on 17Feb2021 as single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history included AFIB (atrial fibrillation) from an unknown date and unknown if ongoing. Concomitant medication included TOPROL XL taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated that tested positive for covid 19 on 23Jul2021 on 21Jul2021 20:00. The patient lab test and procedures which included SARS-COV-2 COVID19 w/ OPTIC (nasal swab) was positive on 23Jul2021. No treatment medications were received for the events. The patient was not hospitalized. The outcome of the event COVID-19 was resolved on an unknown date 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have been diagnosed with COVID-19 via rapid test (non-PCR); I have been diagnosed with COVID-19 via rapid test (non-PCR); This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN 5318), both via an unspecified route of administration, administered in left arm, on 26Jan2021 (pending clarification) at single doses for COVID-19 immunization. Patient had no medical history and no known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. The patient was diagnosed with COVID-19 via rapid test (non-PCR) on 01Aug2021. The events resulted in emergency room/department or urgent care. No treatment was given for the events. The outcome of the events was reported as not recovered
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on Mar2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) in Feb2021 for COVID-19 immunization. On an unspecified date in 2021, the patient had rheumatoid arthritis. The patient was immunosuppressive medication to treat rheumatoid arthritis. The patient had an antibody test which was negative in Jul2021. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Movement disorder, Myalgia, Pain
Clinical narrative: Pains all over body and in joints and muscles; Get up from bed and can't even move because of how joints were hurting; Pains all her body and in joints and muscles; Pains all over body and in joints and muscles; Like she has the flu; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 (at the age of 58 years old) as dose 2, single for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient previously received the dose 1 of BNT162B2 on an unknown date for COVID-19 immunization. The patient reported that after her second shot on 15Jun2021, she experienced pains all over her body and in joints and muscles on an unspecified date in Jun2021. The side effects have been really bad that there's were time she gets up from bed and can't even move because of how joints were hurting and her muscles, like she has the flu, that's how she felt. She went to see a doctor a week and a half ago. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Diagnosed with HSP/ After the second shot of Pfizer it shows on his knees down to his feet. It went away but stayed on the leg.; This is a spontaneous report received from a contactable consumer (parent) by a Pfizer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  Medical history included henoch-schonlein purpura (hospitalized at 10 years old and diagnosed with HSP). The patient's concomitant medications were not reported. On an unspecified date after the second shot of Pfizer COVID vaccine, the patient experienced HSP showed on his knees down to his feet. It went away but stayed on the leg, it didn't go to rest of the body. The outcome of the event was not recovered.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis, Malaise
Clinical narrative: has diverticulitis prior to receiving the COVID-19 vaccine. After the first vaccine, the patient had a bout of diverticulitis; patient got sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included ongoing diverticulitis. The patient's concomitant medications were not reported. The patient mentioned that he received his first dose of COVID-19 vaccine in Jan2021. After that, the patient got sick (in 2021). The patient wanted to know if he could get his second dose. The patient confirmed that he has diverticulitis prior to receiving the COVID-19 vaccine. After the first vaccine, the patient had a bout of diverticulitis (in 2021). The patient was advised to follow up with primary care physician or local health care provider for treatment recommendations and medical advice. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: He had an outbreak of shingles on his face.; This is a spontaneous report from a contactable consumer (patient himself) via medical information team. This 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 14Apr2021 as dose 1 single for COVID-19 immunisation at Hospital/workplace clinic dining room. The patient medical history included started drinking alcohol again and stress at work (He was under stress from work and started drinking alcohol again and was stressed out). The patient's concomitant medications were not reported. The patient experienced outbreak of shingles on his face on 22Apr2021. It continued passed the 3 weeks, so he cancelled his second dose. Patient stated he did not report this following the first dose because he was under stress from work and started drinking alcohol again and was stressed out. He didn't think it was related to the vaccine. The outcome of event was unknown.  Information about lot/batch number has been requested.