chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Lip swelling, Peripheral swelling, Throat tightness
Clinical narrative: minor swelling of my lips, hands, feet; minor swelling of my lips, hands, feet; extreme fatigue; a feeling of tightness and some difficulty swallowing in my throat; a feeling of tightness and some difficulty swallowing in my throat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm at the age of 34-year-old on 15May2021 16:30 (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. Medical history included seasonal allergies, asthma, gastrooesophageal reflux disease(GERD). Concomitant medications included spironolactone; fexofenadine hydrochloride (ALLEGRA); mometasone furoate (FLONASE); omeprazole magnesium (PRILOSEC), all the medications received from 2021 (within 2 weeks of vaccination). The patient previously took sulfa and doxycycline. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm at the age of 34-year-old on 17Apr2021 18:00 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient woke up the next day with minor swelling of her lips, hands, feet, and a feeling of tightness and some difficulty swallowing in her throat. The swelling receded with a non drowsy antihistamine but the feeling of extreme fatigue and a histamine reaction continued. No treatment received for events a feeling of tightness and some difficulty swallowing in her throat. The start date of all events was on 16May2021 08:00 and no hospitalization prolonged. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Syncope
Clinical narrative: She fainted; Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer. A female patient of unspecified age 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 on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Reporter stated, "One of my family members had the vaccine, her second dose of vaccine and she today (14May2021) at 4:00 in the morning she started having chills and fever and body ache and then took like, like in less than an hour she fainted. Is that normal or she has to go to the, her doctor or the emergency room?" Reporter confirmed it was the Pfizer Covid19 vaccine. The outcome of the events was unknown.  information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Foetal cystic hygroma, Maternal exposure timing unspecified, Ultrasound scan
Clinical narrative: baby diagnosed with cystic hygroma after the mother received both doses of COVID vaccine; Maternal drug exposure; This is a spontaneous report from a Contactable consumer who reported information for both mother and fetus case. This is the fetus report. The mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 08Apr2021 as single dose, second dose on unknown date at single dose for COVID-19 immunisation. The mother medical history and concomitant medications were not reported. Caller states that this is fetal case. He states that she is recently pregnant but doesn't know how far along she is. In the conversation the colleague informed him of a complication with the baby. They have indicated that the baby has Cystic Hygroma. Caller states that he thinks the baby is in the first trimester but he is not sure. Caller states that the patient has received both vaccines. Caller states that the diagnosis of cystic hygroma was made yesterday on 13May2021, and the patient informed the caller today and states that it is serious, very serious. He states that it is life threatening for the child, not likely life-threatening for the patient. The lab data included Ultrasound on 13May2021 included diagnosed with cystic hygroma. The outcome of Cystic hygroma was not recovered, of other event was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550420 mother case
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter. A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899 and expiry date: unknown), dose 2 via intramuscular, administered in Deltoid Left on 07Jan2021 as 2nd DOSE, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced breakthrough Covid-19 infection on 17Feb2021. The patient underwent lab tests and procedures which included an asymptomatic COVID test (COVID 19 PCR-done of state) prior to visiting elderly family on 17Feb2021 which was positive. The patient was then re-tested using SARS-CoV-2 on 22Feb2021 and 23Feb2021, both of which were negative. The patient was not hospitalized and not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not experience respiratory symptoms like Dyspnea, Tachypnea, Hypoxemia, COVID-pneumonia, Respiratory failure, Acute Respiratory Distress Syndrome (ARDS) and cardiovascular symptoms like Heart failure ,Cardiogenic shock, Acute myocardial infarction, Arrhythmia , Myocarditis and Gastrointestinal/Hepatic   symptoms like Vomiting, Diarrhea ,Abdominal pain, Jaundice, Acute liver failure and vascular symptoms like Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis and  any other thromboembolic events) and renal symptoms like acute kidney injury, Renal failure and Neurological  symptoms like Altered consciousness, Convulsions/seizures, Encephalopathy, Meningitis, cerebrovascular accident and Hematological symptoms like thrombocytopenia, Disseminated intravascular coagulation and dermatological  symptoms like Chillblains, Erythema multiforme and other symptoms like multisystem inflammatory syndrome. The patient did not receive any additional therapies for COVID-19.  On an unknown date in Feb2021 the outcome of the events was recovered.  Follow up attempts are needed. Further information has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid test; Positive Covid test; This is a spontaneous report from a contactable other health care professional. A 64-year-old female patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EH9899), via Intramuscular route of administration, on 17Dec2020 and on 07Jan2021 respectively, as single dose in Deltoid Right, for Covid-19 immunization. The patient's medical history included asplenia and she was former smoker. The patient's concomitant medications were not reported. On 17Mar2021, the patient had positive covid test. During COVID-19 illness she experienced congestion, cough, and headaches. It was unknown if the patient taking any medications routinely prior to the event or not and unknown if the patient received any treatment for the events or not. The patient visited the physician office. The patient also provided the information regarding the reported adverse events with the use of the product. The patient underwent lab tests which included Covid-19 PCR with positive result on 17Mar2021. The outcome of the event was resolved on 02Apr2021 while the outcome of the other event vaccination failure was unknown.   No follow up attempts are needed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between Vaccination Failure, COVID-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She developed symptoms 4 days later and tested positive and positive test after completion of series; She developed symptoms 4 days later and tested positive and positive test after completion of series; This is a spontaneous report from a contactable Nurse. This contactable nurse reported for a 38-year-old female (patient 4 of 11) consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EH9899), via intramuscular route of administration, administered in deltoid left on 08Jan2021 (at the age of 38-year-old) at a 2nd dose, single for COVID-19 immunisation. Medical history included immunosuppressive disorder rheumatoid arthritis from 2020 to an unknown date (Onset Date: Spring 2020) and She was exposed to a COVID 19 patient during the course of her work. Concomitant medication included methotrexate (METHOTREXATE) at an unknown dose weekly via oral route of administration taken for rheumatoid arthritis from an unspecified start date and ongoing. The patient did not receive any other vaccines prior to the COVID-19 vaccine within 4 weeks. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EK9231) via intramuscular route of administration, administered in deltoid left on 18Dec2020 at a 1st dose, single for COVID-19 immunisation. Patient had completed the vaccine series on 1/8/2021. She was exposed to a COVID 19 patient during her work. She developed symptoms 4 days later and tested positive and positive test after completion of series on 19Mar2021. A repeat test was performed > 24 later and was also positive on 22Mar2021. Patient experienced respiratory: congestion, cough, rhinitis during the COVID-19 illness. The patient was not hospitalized, not admitted to an intensive care unit, and did not receive supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation for the events. The patient underwent lab tests and procedures which included COVID-19 PCR/Nasal PCR/ SARS-CoV-2 by PCR, or other commercial or public health assay: positive on 19Mar2021 abnormal, SARS-COV-2 test: positive on 22Mar2021 (abnormal, retest for confirmation). Patient did not receive any additional therapies, new medication or other treatment or procedure for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: nasal PCR positive; nasal PCR positive; This is a spontaneous report received from a contactable Nurse and a contactable physician. This is the 5th of the 11 reports.  A 28-year-old female patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Dec2020 and 14Jan2021 separately, both at single dose for COVID-19 immunization. Medical history included ongoing seizures. Concomitant medication included ongoing lamotrigine (LAMICTAL) for seizure disorder. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient had nasal PCR positive on both 30Mar2021 and 02Apr2021. The patient did not have SARS-CoV2 antibodies at diagnosis. The outcome of the events was resolved in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.  Case will be re-assessed upon the additional information provided.,Linked Report(s) : US-PFIZER INC-2021389615 Same reporter/ drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Tonsillar hypertrophy
Clinical narrative: his tonsils are still swollen and he went back to urgent care because his tonsils are so swollen that he can barely swallow.; his tonsils are still swollen and he went back to urgent care because his tonsils are so swollen that he can barely swallow.; This is a spontaneous report from a contactable consumer (patient's mother).  A 18-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) on 09Apr2021 for covid-19 Vaccination. Caller states she is not sure if her son is having a reaction to the Pfizer COVID vaccine. Caller states he received the first dose on 09Apr2021 and then on 10Apr2021 she took him to urgent care because his tonsils were swollen, enlarged, he couldn't swallow and his tonsils were touching each other. Caller states urgent care did a strep test and it was positive so they prescribed him Amoxicillin and he finished the course of antibiotics and then on 04May his tonsils were swollen again and he went to convenient care and he was prescribed Zithromycin and Methylprednisolone. Caller states he finished the course of those antibiotics and medications as well. Caller states he received his second dose of the vaccine on 07May2021 four weeks apart instead of three weeks at . Caller states now he is saying that his tonsils are still swollen and he went back to urgent care because his tonsils are so swollen that he can barely swallow. Caller states her son does not have a primary care doctor and it would be until June before he can be seen there. Caller states he has been to urgent care three times and they don't know what to do to treat her son. Caller states he has not had any other symptoms such as a cough, fever, or tiredness. Caller states he is a healthy student athlete with no underlying conditions and no history of having tonsillitis or strep. Caller would like to know if the Pfizer COVID vaccine could have caused her sons symptoms and what treatment recommendations are there for him. Caller would like to know if it is possible for her son to already have had strep prior to receiving the Pfizer COVID vaccine and then the vaccine caused an immune response to make his symptoms worse after the vaccine. Caller states this issue has been going on for a month. Caller states I have not provided her any information that can help him and hopefully he doesn't die she will just have to figure it out. Caller disconnected call unable to offer survey. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: Breakthrough covid infection; Breakthrough covid infection; Stuffy nose; Fatigue; Headache; This is a spontaneous report was received from a contactable nurse reporting same event under the same suspect product for 11 patients. This is 8th one of 11 reports. A 29-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: EH9899, Expiration date: not reported), on 07Jan2021 at 2nd dose, single administered via intramuscular route, administered in deltoid left for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. On 17Dec2020, the patient had received 1st dose of vaccination. On 31Mar2021, the patient experienced breakthrough covid infection, stuffy nose, low grade fever 100.6, fatigue and headache. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient underwent lab tests and procedures which included Low grade fever 100.6, Nasal swab PCR: positive (Comments: 1st test nasal PCR) on 31Mar2021, SARS CoV2 by PCR: positive on 04Feb2021, Nasophx: positive on 02Apr2021. Patient did not have any medication prior vaccination within 4weeks. The patient had no multiorgan failure, no cardiovascular symptoms and no gastrointestinal/hepatic symptoms. It was unknown whether the patient have SARS CoV2 antibodies at diagnosis. The patient did not display clinical signs at rest indicative of severe systemic illness, the patient did not require supplemental oxygen or receive mechanic ventilation. The event did not require the initiation of new medication or other treatment or procedure. The information about the patient was taking any medications routinely prior to the event was not reported. Patient did not have any pre-existing diseases worsened during the SARS-CoV2 infection. Patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. On 14Apr2021, the patient was recovered from all the events.   Vaccine facility information is available. Follow-up attempts are needed. Further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however,lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough covid infection; Breakthrough covid infection; Stuffy nose; Fatigue; Headache; This is a spontaneous report was received from a contactable nurse reporting same event under the same suspect product for 11 patients. This is 8th one of 11 reports. A 29-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: EH9899, Expiration date: not reported), on 07Jan2021 at 2nd dose, single administered via intramuscular route, administered in deltoid left for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. On 17Dec2020, the patient had received 1st dose of vaccination. On 31Mar2021, the patient experienced breakthrough covid infection, stuffy nose, low grade fever 100.6, fatigue and headache. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient underwent lab tests and procedures which included Low grade fever 100.6, Nasal swab PCR: positive (Comments: 1st test nasal PCR) on 31Mar2021, SARS CoV2 by PCR: positive on 04Feb2021, Nasophx: positive on 02Apr2021. Patient did not have any medication prior vaccination within 4weeks. The patient had no multiorgan failure, no cardiovascular symptoms and no gastrointestinal/hepatic symptoms. It was unknown whether the patient have SARS CoV2 antibodies at diagnosis. The patient did not display clinical signs at rest indicative of severe systemic illness, the patient did not require supplemental oxygen or receive mechanic ventilation. The event did not require the initiation of new medication or other treatment or procedure. The information about the patient was taking any medications routinely prior to the event was not reported. Patient did not have any pre-existing diseases worsened during the SARS-CoV2 infection. Patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. On 14Apr2021, the patient was recovered from all the events.   Vaccine facility information is available. Follow-up attempts are needed. Further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however,lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR nasopharyngeal swab positive; PCR nasopharyngeal swab positive; This is a spontaneous report from a contactable nurse. A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 30Dec2020 (Lot Number: EH9899) as first single dose, dose 2 intramuscular, administered in deltoid left on 20Jan2021 (Lot Number: EK9231) as second single dose for covid-19 immunization. Medical history included lung disease. The patient's concomitant medications was none. The patient was not taking any medications routinely prior to the event being reported. No prior vaccination. The patient experienced PCR nasopharyngeal swab positive on 29Mar2021 with outcome of recovered on 01Apr2021. Seriousness criteria was reported as not serious. On 29Mar2021 PCR nasopharyngeal swab positive at CVS- results back 31Mar2021, on 31Mar2021 negative PCR nasopharyngeal swab, on 01Apr2021 negative PCR nasopharyngeal swab. The patient was not hospitalized or admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination.   The reporter consider the bnt162b2 had a causal effect to the adverse event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Vaccination Failure and Covid-19.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had a household member who was ill at home for several days preceding this patient's onset of symptoms; Headaches; Developed symptomatic COVID infection; Developed symptomatic COVID infection; This is a spontaneous report from a contactable other hcp. A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK9231; Expiry date Unknown), dose 2 via intramuscular route of administration, administered in Deltoid Left on 14Jan2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient had received first dose of PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EH9899; Expiry date Unknown) dose 1 via intramuscular route of administration, administered in Deltoid Left on 22Dec2020 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. From an unknown date, the patient had a household member who was ill at home for several days preceding this patient's onset of symptoms in Apr2021. The household member was tested positive for COVID 19. On 07Apr2021, (at the age of 61-year-old) the patient developed symptomatic covid infection. The patient had headaches throughout the course of illness, for which the patient responded to OTC pain reliever. On 08Apr2021 and 09Apr2021, the patient underwent Test for SARS-CoV-2 by PCR, which was revealed to be positive. Therapeutic measures were taken as a result of headaches. The outcome of the event symptomatic COVID infection was recovered. The outcome of the events vaccination failure, exposure to SARS-Cov-2 and headache was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Tinnitus
Clinical narrative: tinnitus constant, severe has not ceased as of 14May2021; This is a spontaneous report from a Non-contactable consumer (patient). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) at the age of 25-year-old, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced tinnitus constant, severe has not ceased as of 14May2021 (serious as disability, medically significant). Event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on 2021. Treatment received for the adverse event included steroid (did not resolve tinnitus), MRIs. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pyrexia, Rash, Suspected COVID-19
Clinical narrative: COVID; could not breathe; rash from head to toe; high fever; Dizziness; Vomiting; This is a spontaneous report from a contactable consumer (mother). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 13:55 (Lot Number: EW0171) at the age of 24-year-old as 1st dose, single, at right arm for covid-19 immunisation. Medical history included ongoing chronic bronchitis(so it was important that she was vaccinated), admitted to the hospital for pneumonia and chronic bronchitis. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Family medical history relevant to events reported as no. Relevant tests reported as none. 4 days after the first dose the patient received she had a rash from head to toe on 26Apr2021. After that the patient was rushed to the hospital because she could not breathe on 28Apr2021 and turned out the patient had COVID. The patient went to the pharmacy yesterday to get the second dose of the vaccine and showed her rash, the pharmacist would not give the vaccine to the patient until they spoke with Pfizer. Event rash from head to toe had gotten worse as it was down to her feet and hands and everything. Rash started off so small. The patient stopped experiencing event could not breathe around 5 days before. In the past the patient was admitted to the hospital for pneumonia and chronic bronchitis. This time that the patient went to the hospital after getting the first dose of the vaccine she was released from the emergency room. The patient was released with a pulse ox machine. Treatment received included paracetamol (TYLENOL) and guaifenesin (MUCINEX). The patient also experienced some dizziness on 22Apr2021, vomiting on 22Apr2021, and a high fever on 23Apr2021. The patient was diagnosed with COVID on 28Apr2021. The patient stopped experiencing dizziness around 01May2021 or 02May2021. Events require a visit to emergency room, no physician office visit. The outcome of event rash from head to toe was not recovered, of could not breathe, dizziness was recovered in May2021, of vomiting was recovered on 04May2021, of high fever was recovered on 05May2021, of COVID was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: COVID; could not breathe; rash from head to toe; high fever; Dizziness; Vomiting; This is a spontaneous report from a contactable consumer (mother). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 13:55 (Lot Number: EW0171) at the age of 24-year-old as 1st dose, single, at right arm for covid-19 immunisation. Medical history included ongoing chronic bronchitis(so it was important that she was vaccinated), admitted to the hospital for pneumonia and chronic bronchitis. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Family medical history relevant to events reported as no. Relevant tests reported as none. 4 days after the first dose the patient received she had a rash from head to toe on 26Apr2021. After that the patient was rushed to the hospital because she could not breathe on 28Apr2021 and turned out the patient had COVID. The patient went to the pharmacy yesterday to get the second dose of the vaccine and showed her rash, the pharmacist would not give the vaccine to the patient until they spoke with Pfizer. Event rash from head to toe had gotten worse as it was down to her feet and hands and everything. Rash started off so small. The patient stopped experiencing event could not breathe around 5 days before. In the past the patient was admitted to the hospital for pneumonia and chronic bronchitis. This time that the patient went to the hospital after getting the first dose of the vaccine she was released from the emergency room. The patient was released with a pulse ox machine. Treatment received included paracetamol (TYLENOL) and guaifenesin (MUCINEX). The patient also experienced some dizziness on 22Apr2021, vomiting on 22Apr2021, and a high fever on 23Apr2021. The patient was diagnosed with COVID on 28Apr2021. The patient stopped experiencing dizziness around 01May2021 or 02May2021. Events require a visit to emergency room, no physician office visit. The outcome of event rash from head to toe was not recovered, of could not breathe, dizziness was recovered in May2021, of vomiting was recovered on 04May2021, of high fever was recovered on 05May2021, of COVID was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Suspected COVID-19, Weight
Clinical narrative: Bloating; Covid like symptoms; This is a spontaneous report from a contactable consumer. A 29-year-old male patient (reporter's grandson) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 29Apr2021 15:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included allergy; allergies to penicillin and Ibuprofen; reaction to Ibuprofen is lip swelling;  patient hasn't taken Penicillin in years but believes the it is like a rash; localised infection (Was taking it for his finger). Concomitant products included unknown antibiotic, which was taking for a short time, temporary; it was taking at the time of the vaccine but is not taking anymore; He didn't finish it, he just stopped taking it; it was taking it for his finger. The patient experienced bloating in May2021 with outcome of recovered in May2021, covid like symptoms on 30Apr2021 with outcome of recovered on 01May2021. The seriousness cirteria for event bloating was disability. It was reported the day after the vaccine, he got side effects. He had Covid like symptoms for like 1 day, until the day after. After about 7 days or so after, he felt like his stomach was bloating. It was all right now. Lasted less than a week. The patient underwent lab tests and procedures which included weight: 280 or something.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, White blood cell count, White blood cell count increased
Clinical narrative: WBC "little elevated; Received first dose 08MAR2021, 21MAR2021 has symptoms of SARs-COV-2 and COVID-19 Virus tested positive; Received first dose 08MAR2021, 21MAR2021 has symptoms of SARs-COV-2 and COVID-19 Virus tested positive/ she got sick; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Mar2021 (lot number: EV6205) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose on 08Mar2021, on 21Mar2021 had symptoms of SARs-COV-2 and COVID-19 Virus tested positive on an unknown date in Mar2021. The patient also reported greater than 3 weeks since getting the first dose of the vaccine. The patient had a blood test last week in May2021 (based on 17May2021) white blood cell count (WBC) "little elevated". The patient stated she was calling about the COVID vaccination. She stated she got the first vaccine on 08Mar2021 and then two weeks later on Sunday 21Mar2021 she got sick and she started getting symptoms which turned out to be COVID symptoms which had started 2 weeks after the vaccine and symptoms ended around 06Apr2021 or 07Apr2021. The events outcome for "Received first dose 08Mar2021, 21Mar2021 has symptoms of SARs-COV-2 and COVID-19 Virus tested positive" was recovered in Arp2021, for WBC "little elevated" was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cardiac flutter, Chest discomfort, Diarrhoea, Feeling abnormal
Clinical narrative: Shingles; itching around the nipple area at that time.; a pain under her arm and on her back; 2 bouts of diarrhea; palpating and fluttering; felt like she got hit by a truck/was feeling miserable; sore arm; stuffy nose; sweating really bad; chest was fluttering on and off; hearing was muffled; headache; restless night.; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0165; Expiration Date: 31Aug2021), via an unspecified route of administration on 05May2021 (at the age of 64-years) as 1st, single dose for COVID-19 immunization. Medical history included unspecified allergies. The patient concomitant medications were not reported. On 05May2021 (same day after vaccination), patient developed a headache within the first 15 minutes. She stayed 30 minutes after the COVID vaccine because she has a history of allergies and then she went home and took Tylenol. She was resting that whole day and then she had a restless night. On 06May2021 (one day after vaccination), when woke up, patient felt like she got hit by a truck and had a headache, sore arm, stuffy nose, she was sweating really bad but there was no fever, and her chest was fluttering on and off. Patient ears felt like they were blocked because her hearing was muffled. On 07May2021, patient woke up with a really bad headache, worse than the day before, she had heavy sweating, her hearing was muffled, she had a stuffy nose, and she had the palpating and fluttering that continued. She had no fever. On 08May2021, she woke up with no sweating finally, but she had a real bad headache, her nose still felt congested, her hearing was still muffled, and she was feeling miserable. She had 2 bouts of diarrhea. She was basically nursing with Tylenol at that time. On 09May2021, patient had a slight headache, no sweating and she felt a little bit better in the morning but not 100%. Then she developed a pain under her arm and on her back and she could not lay on her left side. The pain was radiating from the front to the back. She took Tylenol and that did not help, and she could not sleep. On 10May2021, patient had a doctor appointment that was already scheduled so she went to see the doctor. Before she went, when she woke up her ears were still blocked, she had pain on her left side and itching around the nipple area at that time. When she saw the doctor, she was diagnosed with shingles and gave her medicine. Patient received unspecified treatment for the event Shingles and before that patient took Tylenol. The Tylenol she took was only 325 mg because she was sensitive to chemicals in medicines. The lowest dose was usually all she has taken, and it will be enough to relax her to fall asleep, but it did not touch the pain on Sunday night. Patient was worried about the second shot. The outcome of all the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Hyperhidrosis, Hypoacusis, Insomnia
Clinical narrative: Shingles; itching around the nipple area at that time.; a pain under her arm and on her back; 2 bouts of diarrhea; palpating and fluttering; felt like she got hit by a truck/was feeling miserable; sore arm; stuffy nose; sweating really bad; chest was fluttering on and off; hearing was muffled; headache; restless night.; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0165; Expiration Date: 31Aug2021), via an unspecified route of administration on 05May2021 (at the age of 64-years) as 1st, single dose for COVID-19 immunization. Medical history included unspecified allergies. The patient concomitant medications were not reported. On 05May2021 (same day after vaccination), patient developed a headache within the first 15 minutes. She stayed 30 minutes after the COVID vaccine because she has a history of allergies and then she went home and took Tylenol. She was resting that whole day and then she had a restless night. On 06May2021 (one day after vaccination), when woke up, patient felt like she got hit by a truck and had a headache, sore arm, stuffy nose, she was sweating really bad but there was no fever, and her chest was fluttering on and off. Patient ears felt like they were blocked because her hearing was muffled. On 07May2021, patient woke up with a really bad headache, worse than the day before, she had heavy sweating, her hearing was muffled, she had a stuffy nose, and she had the palpating and fluttering that continued. She had no fever. On 08May2021, she woke up with no sweating finally, but she had a real bad headache, her nose still felt congested, her hearing was still muffled, and she was feeling miserable. She had 2 bouts of diarrhea. She was basically nursing with Tylenol at that time. On 09May2021, patient had a slight headache, no sweating and she felt a little bit better in the morning but not 100%. Then she developed a pain under her arm and on her back and she could not lay on her left side. The pain was radiating from the front to the back. She took Tylenol and that did not help, and she could not sleep. On 10May2021, patient had a doctor appointment that was already scheduled so she went to see the doctor. Before she went, when she woke up her ears were still blocked, she had pain on her left side and itching around the nipple area at that time. When she saw the doctor, she was diagnosed with shingles and gave her medicine. Patient received unspecified treatment for the event Shingles and before that patient took Tylenol. The Tylenol she took was only 325 mg because she was sensitive to chemicals in medicines. The lowest dose was usually all she has taken, and it will be enough to relax her to fall asleep, but it did not touch the pain on Sunday night. Patient was worried about the second shot. The outcome of all the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Pruritus
Clinical narrative: Shingles; itching around the nipple area at that time.; a pain under her arm and on her back; 2 bouts of diarrhea; palpating and fluttering; felt like she got hit by a truck/was feeling miserable; sore arm; stuffy nose; sweating really bad; chest was fluttering on and off; hearing was muffled; headache; restless night.; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0165; Expiration Date: 31Aug2021), via an unspecified route of administration on 05May2021 (at the age of 64-years) as 1st, single dose for COVID-19 immunization. Medical history included unspecified allergies. The patient concomitant medications were not reported. On 05May2021 (same day after vaccination), patient developed a headache within the first 15 minutes. She stayed 30 minutes after the COVID vaccine because she has a history of allergies and then she went home and took Tylenol. She was resting that whole day and then she had a restless night. On 06May2021 (one day after vaccination), when woke up, patient felt like she got hit by a truck and had a headache, sore arm, stuffy nose, she was sweating really bad but there was no fever, and her chest was fluttering on and off. Patient ears felt like they were blocked because her hearing was muffled. On 07May2021, patient woke up with a really bad headache, worse than the day before, she had heavy sweating, her hearing was muffled, she had a stuffy nose, and she had the palpating and fluttering that continued. She had no fever. On 08May2021, she woke up with no sweating finally, but she had a real bad headache, her nose still felt congested, her hearing was still muffled, and she was feeling miserable. She had 2 bouts of diarrhea. She was basically nursing with Tylenol at that time. On 09May2021, patient had a slight headache, no sweating and she felt a little bit better in the morning but not 100%. Then she developed a pain under her arm and on her back and she could not lay on her left side. The pain was radiating from the front to the back. She took Tylenol and that did not help, and she could not sleep. On 10May2021, patient had a doctor appointment that was already scheduled so she went to see the doctor. Before she went, when she woke up her ears were still blocked, she had pain on her left side and itching around the nipple area at that time. When she saw the doctor, she was diagnosed with shingles and gave her medicine. Patient received unspecified treatment for the event Shingles and before that patient took Tylenol. The Tylenol she took was only 325 mg because she was sensitive to chemicals in medicines. The lowest dose was usually all she has taken, and it will be enough to relax her to fall asleep, but it did not touch the pain on Sunday night. Patient was worried about the second shot. The outcome of all the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis, Chills, Computerised tomogram, Fatigue
Clinical narrative: appendicitis; Sunday morning: wake with mild stomach pain; pain increasing consistently/considerable and unbearable pain; Vomiting; Saturday: largely symptom free, though tired and lethargic; Saturday: largely symptom free, though tired and lethargic; moderate headache; Wednesday morning: developed mild to moderate fever and chills; Wednesday morning: developed mild to moderate fever and chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:45 at the age of 41-years-old (Batch/Lot Number: FIL30161) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Surgery for pinned broken thumb. surgical repair of achilles tendon.  The patient previously took erythromycin and experienced known allergies: Erythromycin (Nausea). The patient received first dose of BNT162B2 administered in Arm Left on 03Apr2021 04:00 PM at the age of 41-years-old (Batch/Lot Number: ER8737) for covid-19 immunisation. The patient did not take other vaccine in four weeks. Other medications in two weeks included only post-surgery pain meds after vaccine. The patient did not get covid prior vaccination. On Tuesday evening 27Apr2021, Pfizer second dose administered. On Wednesday morning 28Apr2021 10:30 AM: developed mild to moderate fever and chills. On Thursday 29Apr2021: mild to moderate fever and chills continue, new symptoms include a moderate headache. On Friday 30Apr2021: fever and chills begin to subside, headache remained. On Saturday 01May2021: largely symptom free, though tired and lethargic. On Sunday morning 02May2021: wake with mild stomach pain. On Sunday noon 02May2021: pain increasing consistently. On Sunday early afternoon 02May2021: considerable and unbearable pain. Vomiting. The patient was transport to Urgent Care. Urgent Care recommended Emergency Room. On Sunday early evening 02May2021: admitted to ER, administered pain medication. Vomiting ensues. CT Scan administered and showed positive for appendicitis. On Sunday Evening 02May2021: transported to surgical center, prepped for surgery. On Sunday Night 02May2021: emergency surgery performed, appendectomy. Overnight hospital stay was required. On Monday morning 03May2021: discharged from hospital. The adverse events appendicitis, stomach pain, pain and Vomiting resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Pain medications and Surgery (appendectomy). The patient underwent lab tests and procedures which included computerised tomogram: positive for appendicitis on 02May2021, CT Scan administered and shows positive for appendicitis, Nasal Swab: negative on 02May2021.  The outcome of the events was resolving. The case was reported as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage.