chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Tinnitus
Clinical narrative: Annoyances appeared; ringing in the ear 24 hours; Headaches; Hand arthritis; fatigue; they appeared is a continuous malaise that is changing my way of life and everything; I don't feel good emotionally; I am depressed; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced annoyances appeared, ringing in the ear 24 hours, headaches, hand arthritis, fatigue, patient never had they appeared is a continuous malaise that is changing my way of life and everything, patient don't feel good emotionally, patient depressed. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A co worker who was vaccinated tested positive for COVID; A co worker who was vaccinated tested positive for COVID; This is a spontaneous report from a non-contactable consumer (patient's co-worker).   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the reporter's co-worker who was vaccinated tested positive for covid. The patient had drug ineffective and covid. The Caller confirmed that she was inquiring about the Pfizer COVID-19 vaccine. The caller had not gotten the vaccine yet and with the medications that she takes she is looking for clinical trial information, she has looked at Moderna and is looking for a PDF like page about the results of the trial and at the end of the call the caller stated she needed to leave because she had to go get tested as a co worker who was vaccinated tested positive for COVID so she now has to get tested, the caller has not yet received the vaccine, And then she rushed off the phone and hung up. The patient underwent lab tests and procedures which included Covid-test and result was positive on an unknown date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Hypokinesia, Paraesthesia
Clinical narrative: Pain near elbow through forearm; Tingling near elbow through forearm, tingling had increased and spread down to hand and up through shoulder and upper back on the left side; Pain, discomfort, and tingling have increased and spread down to hand now and up through shoulder and upper back on the left side.; Felt like arm was partially asleep, but no amount of movement; This is a spontaneous report from a contactable healthcare professional. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0179) via an unspecified route of administration in the arm left on 02Aug2021 at 16:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine and chronic diarrhea. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12), ascorbic acid (VITAMIN C), zinc (MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Aug2021, 2 days after vaccine, the patient began noticing pain and tingling near elbow through forearm. Pain, discomfort, and tingling had increased and spread down to hand and up through shoulder and upper back on the left side. Felt like arm was partially asleep, but no amount of movement, stretching, repositioning reliefs the discomfort of these symptoms. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events pain, discomfort and tingling near elbow through forearm and felt like arm was partially asleep were not resolved at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for covid One person was hospitalized for days; tested positive for covid One person was hospitalized for days; This is a spontaneous report from a contactable consumer reporting for a patient.   An adult patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in Feb2021 (at an unspecified age  of vaccination) as dose number unknown, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  On an unspecified date in Jul2021, the patient experienced tested positive for COVID although receiving the pfizer vaccine in Feb. The patient was hospitalized for days (as reported). Treatment received for adverse events was unknown. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included: Nasal Swab (Sars-cov-2 test): positive on an unspecified date in Jul2021 (COVID test post vaccination), Nasal Swab (Sars-cov-2 test): positive an unspecified date in Jul2021 (COVID test post vaccination). The patient has been tested for COVID-19 since the vaccination.  The reporter assessed events as serious with seriousness criteria of Caused/prolonged hospitalization and did not result in death, life threatening, disabling or incapacitating, congenital anomaly or birth defect.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: Very swollen lymph nodes under armpit raised; armpit raised and red lump 2 inch on length and 1 inch in width; This is a spontaneous report from a contactable consumer, the patient. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FC3180) via an unspecified route of administration in the left arm on 03Aug2021 at 16:30 as a single dose for COVID-19 immunisation. Medical history included autism and COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), lithium (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and risperidone (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Aug2021 at 10:00, the patient experienced very swollen lymph nodes under armpit raised and red lump 2 inch on length and 1 inch in width. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No 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 very swollen lymph nodes under armpit and raised and red lump 2 inch on length and 1 inch in width were not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; via an unspecified route of administration on 11Apr2021 Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid, six days later on 17Apr2021. She was told that she needs to wait to receive her second dose. In the interim she moved from one place (where she received her first dose) to other state. Caller reported that she thought her daughter had some lingering effects. She had been told different things, that she should receive the second dose and she need to start the series over. Caller asked for clarification. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Apr2021. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Urticaria
Clinical narrative: Large hot welt on arm; 3 day migraine; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 23Jun2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID-19 vaccine. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took codeine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 01Jul2021 at 14:30 the patient experienced large hot welt on arm, 3-day migraine. Patient also stated that migraine continued. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with medications in the ER. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large hot welt on arm, 3-day migraine was not recovered at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 on 04Aug2021; tested positive for COVID-19 on 04Aug2021/ Cold symptoms; This is a spontaneous report from a contactable other health professional. A 34-years-old unknown pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot Number ER2613, Expiration date: unknown) intramuscularly, administered in arm left on 31Mar2021 as dose 1, single and received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot Number ER2613, Expiration date: unknown) intramuscularly, administered in arm right on 20Apr2021 as dose 2, single for COVID-19 immunization at workplace clinic (34 years when vaccinated). The patient medical history and concomitant medications were not reported. It was unknown that the patient diagnosed with COVID-19 prior to vaccination. Known allergies was unknown. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. Other medical history was unknown. On 04Aug2021, the patient started experiencing cold symptoms and on the same day the patient was also diagnosed with covid-19. On 04Aug2021, the patient had tested herself for Sars-Cov-2 infection via Nasal Swab and results were positive. The patient was not treated for the events. The outcome of the events was reported as not recovered.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Fever; Itching; Rash; Swollen lymph nodes; Nausea; Injection site pain; Tiredness; Headache; Chills; Dizziness; Blurred vision; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: FA7484) via intramuscular route of administration in the left arm on 28Jul2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis c and allergies to opioids, iodine, shellfish and environmental. 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 COVID vaccine. Concomitant medications included glecaprevir;pibrentasvir (MAVYRET) for unknown indication from an unknown date and unknown if ongoing. Patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 28Jul2021 at 13:30, the patient experienced fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision. Therapeutic measures were taken for the reported events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision was recovering at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rash, Vaccination site pain
Clinical narrative: Fever; Itching; Rash; Swollen lymph nodes; Nausea; Injection site pain; Tiredness; Headache; Chills; Dizziness; Blurred vision; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: FA7484) via intramuscular route of administration in the left arm on 28Jul2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis c and allergies to opioids, iodine, shellfish and environmental. 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 COVID vaccine. Concomitant medications included glecaprevir;pibrentasvir (MAVYRET) for unknown indication from an unknown date and unknown if ongoing. Patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 28Jul2021 at 13:30, the patient experienced fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision. Therapeutic measures were taken for the reported events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision was recovering at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Fever; Itching; Rash; Swollen lymph nodes; Nausea; Injection site pain; Tiredness; Headache; Chills; Dizziness; Blurred vision; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: FA7484) via intramuscular route of administration in the left arm on 28Jul2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis c and allergies to opioids, iodine, shellfish and environmental. 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 COVID vaccine. Concomitant medications included glecaprevir;pibrentasvir (MAVYRET) for unknown indication from an unknown date and unknown if ongoing. Patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 28Jul2021 at 13:30, the patient experienced fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision. Therapeutic measures were taken for the reported events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision was recovering at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got her first dose of COVID-19 vaccine last 25Feb2021 and tested positive for COVID-19 on 17Mar2021/lost smell and got a head cold; got her first dose of COVID-19 vaccine last 25Feb2021 and tested positive for COVID-19 on 17Mar2021/lost smell and got a head cold; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 25Feb2021 (Lot Number: EL3247; Expiration Date: May2021) as dose 1, single for COVID-19 immunization. Medical history included ongoing Factor V Bleeding Disorder from an unknown date, diagnosed in the 2000s (as reported) and had a blood clot diagnosed at age 18 and one blood clot diagnosed in 2000. There were no concomitant medications. The patient previously received a flu shot on an unknown date but reported that it had been more than 4 weeks before the COVID shot for immunization. The patient got her first dose of COVID-19 vaccine last 25Feb2021 and tested positive for COVID-19 on 17Mar2021. Her husband got COVID and they wouldn't let her get tested for seven days. She went to Urgent Care and got rapid test on 17Mar2021. She was shocked that she had COVID, so she believes the shot works. She got a mild case. She lost smell and got a head cold. She was due for second shot on 16Mar2021. She reached out to Pfizer to say she potentially had COVID because her husband had COVID. She got the positive results of COVID on 17Mar2021. The patient had not received her second shot because she waited for her quarantine period to be over before she could get her second dose but when it was time for her to get the second dose, she mentioned that her dose is no longer available at their company. The patient added that she read in a journal that she has more antibodies since she got the shot and got COVID and mentioned that her medical doctor advised her not to get the second shot since she would have many antibodies from the first dose and her COVID-19 infection. She wanted to know if she should still get the second dose of the vaccine or if the information provided to her by her doctor and the journal she read were true. The patient added that Pfizer said they had no idea where her second shot went. She tried to get her second dose of the Pfizer COVID-19 vaccine after her quarantine period but it was no longer available. They told her she missed the opportunity and they didn't have any more shots. Now they are doing kids and she doesn't qualify to come in with the kids. She doesn't know where her shot went. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Was vaccinated with your covid 19 vaccine, receiving my final shot back in May. I recently was diagnosed with covid 19; Was vaccinated with your covid 19 vaccine, receiving my final shot back in May. I recently was diagnosed with covid 19; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration in May2021 as dose 2, single; and received first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single; both for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient was vaccinated with COVID-19 vaccine, and received final shot back in May. Patient recently was diagnosed with COVID-19 on an unspecified date in 2021. Treatment received for event was unknown. Patient was unsure if there are any studies or anything that patient may be able to donate blood samples or anything similar to in order to help better the vaccine or any potential boosters. The patient underwent lab tests and procedures which included sars-cov-2 test, resulted as diagnosed with COVID-19 on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Last night she had a severe asthma attach; This is a spontaneous report from a contactable consumer (patient's mother).  An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 18:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included sports induced asthma from Jan2021 and ongoing. Concomitant medications were not reported. The patient experienced that last night she had a severe asthma attach on 04Aug2021 with outcome of recovered on 04Aug2021. The paramedics were called. They gave her a breathing treatment and they have a doctors appointment scheduled for this afternoon. Therapeutic measures were taken as a result of asthma included Albuterol oxygen.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mildly sore arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 26Apr2021 at 10:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in 2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the patient experienced mildly sore arm. No therapeutic measures were taken as a result of the reported events. The event did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mildly sore arm was resolved on an unknown date in 2021.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypertension, Inappropriate schedule of product administration, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: 4 wks cluster h/a then multiple strokes HTN; 4 wks cluster h/a then multiple strokes HTN; 4 wks cluster h/a then multiple strokes HTN; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable physician. A 36-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 12Apr2021 10:45 (Batch/Lot Number: en6206) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: er8729) as single dose for covid-19 immunisation at the age of 36-year-old. Medical history included HTN (hypertension, ongoing) and migraine with aura. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 4 weeks cluster h/a (Heart attack) then multiple strokes HTN on 13Apr2021 03:00 with outcome of recovered with sequelae on unspecified date in 2021. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included COVID-19 test via Nasal Swab: negative on 17Jul2021. Therapeutic measures were taken as a result of 4 wks cluster h/a then multiple strokes HTN. The event result in visit of Emergency room/department or urgent care, Hospitalization, Life threatening. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: A causal relationship between BNT162B2 and the reported serious events cannot be excluded based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Vertigo; Tinnitus; Numbness on left side of face; Numbness in some toes on left foot.; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had not taken any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies. On 20Mar2021, the patient experienced vertigo, tinnitus, numbness on the left side of the face and numbness in some toes on the left foot. The event resulted in a doctor or other healthcare professional office/clinic visits and in the emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent a nasal swab test and the result was negative. The clinical outcome of the events vertigo, tinnitus, numbness on the left side of the face and numbness in some toes on the left foot 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Covid Positive on 02Aug2021; Covid Positive on 02Aug2021; Colleague developed sore throat; runny nose; This is a spontaneous report from a contactable Nurse. A 44-year-old female patient (pregnant: unknown) received second dose bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Lot Number: EN6199), via intramuscular on an unspecified date as DOSE 2, SINGLE and first dose bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route on 24Feb2021 as DOSE 1, SINGLE for COVID-19 Immunization (at the age of 44 years). Medical history and concomitant medications were not reported. It was reported unknown if other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient on 02Aug2021 experienced Positive on 02Aug2021 and colleague developed sore throat, runny nose. The patient underwent lab tests included SARS-CoV-2 test: positive on 02Aug2021. The patient received any treatment for adverse event as unknown. The patient adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were recovering.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was diagnosed with COVID-19; Patient was diagnosed with COVID-19; This is a spontaneous report from a non-contactable pharmacist.  A 25-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 30Apr2021 at the age of 25-years-old as dose 2, single, dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine.The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has been tested for Covid-19 Since the vaccination. On 01Aug2021 the patient experienced patient was diagnosed with covid-19, experiencing loss of smell, loss of taste, sore throat, cough, mild congestion, similar to seasonal allergies. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Au g2021. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided the lack of efficacy of the vaccine BNT162B2 cannot be excluded. The case will be reassessed if any new information is reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fall, Fear of death, Insomnia
Clinical narrative: been in bed for 3 days; has no desire to eat/drink anything; has fallen twice; has not slept in 3 days; nauseated; concerned she might be dead in the next two days with sleep status/not eating; her legs wouldn't hold her up; shoulder is very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) Dose 1 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FA7485) as a single dose for COVID-19 immunisation. Medical history included pneumonia from an unknown date and unknown if ongoing , COVID-19 from Jan2021 to an unknown date (Notes: had COVID and was given the antibodies in Jan2021 and was in the hospital). The patient's concomitant medications were not reported. On 02Aug2021, the patient experienced has been in bed for 3 days (medically significant), has no desire to eat/drink anything, has fallen twice (medically significant), has not slept in 3 days (medically significant, nauseated (medically significant), concerned she might be dead in the next two days with sleep status/not eating, her legs wouldn't hold her up, and shoulder is very sore. Consumer received 1st dose of Pfizer Covid 19 vaccine on 02Aug2021. Since then she has been in bed for 3 days, has no desire to eat/drink anything, has fallen twice because her legs wouldn't hold her up (fall happened the first two days), has not slept in 3 days or night. The caller hasn't slept not even 20 minutes. When the caller fell she couldn't get up without help. The caller feels nauseous like she is going to throw up. Patient stated she does not know what to do and thinks she should go to the hospital. It was noted that she is scheduled for her second dose of Pfizer Covid 19 vaccine in two weeks and unsure of guidance. The patient was concerned she might be dead in the next two days with sleep status/not eating and explains that her HCP will not be able to see her. It takes a week to get in. The caller is getting weaker and weaker. The caller is concerned about whether to take the second dose and if she does not get any better then she is going to have to go to the hospital. The caller had to take the nausea pill and that helped. The caller has to walk with help. The patients shoulder is very sore. The patient was recovering from the events, been in bed for 3 days, nauseated, her legs wouldn't hold her up, and shoulder is very sore. The patient had not recovered from the events, has no desire to eat/drink anything, has no desire to eat/drink, has no desire to eat/drink anything, and has not slept in 3 days. The outcome of the events, has fallen twice, and concerned she might be dead in the next two days with sleep status/not eating was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Nausea
Clinical narrative: been in bed for 3 days; has no desire to eat/drink anything; has fallen twice; has not slept in 3 days; nauseated; concerned she might be dead in the next two days with sleep status/not eating; her legs wouldn't hold her up; shoulder is very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) Dose 1 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FA7485) as a single dose for COVID-19 immunisation. Medical history included pneumonia from an unknown date and unknown if ongoing , COVID-19 from Jan2021 to an unknown date (Notes: had COVID and was given the antibodies in Jan2021 and was in the hospital). The patient's concomitant medications were not reported. On 02Aug2021, the patient experienced has been in bed for 3 days (medically significant), has no desire to eat/drink anything, has fallen twice (medically significant), has not slept in 3 days (medically significant, nauseated (medically significant), concerned she might be dead in the next two days with sleep status/not eating, her legs wouldn't hold her up, and shoulder is very sore. Consumer received 1st dose of Pfizer Covid 19 vaccine on 02Aug2021. Since then she has been in bed for 3 days, has no desire to eat/drink anything, has fallen twice because her legs wouldn't hold her up (fall happened the first two days), has not slept in 3 days or night. The caller hasn't slept not even 20 minutes. When the caller fell she couldn't get up without help. The caller feels nauseous like she is going to throw up. Patient stated she does not know what to do and thinks she should go to the hospital. It was noted that she is scheduled for her second dose of Pfizer Covid 19 vaccine in two weeks and unsure of guidance. The patient was concerned she might be dead in the next two days with sleep status/not eating and explains that her HCP will not be able to see her. It takes a week to get in. The caller is getting weaker and weaker. The caller is concerned about whether to take the second dose and if she does not get any better then she is going to have to go to the hospital. The caller had to take the nausea pill and that helped. The caller has to walk with help. The patients shoulder is very sore. The patient was recovering from the events, been in bed for 3 days, nauseated, her legs wouldn't hold her up, and shoulder is very sore. The patient had not recovered from the events, has no desire to eat/drink anything, has no desire to eat/drink, has no desire to eat/drink anything, and has not slept in 3 days. The outcome of the events, has fallen twice, and concerned she might be dead in the next two days with sleep status/not eating was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient has tested positive for COVID-19 via rapid test on 04Aug2021; The patient has tested positive for COVID-19 via rapid test on 04Aug2021; This is a spontaneous report from a non-contactable Other HCP. A 47-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via intramuscularly in right arm on 31May2021 at 07:00 AM as dose number unknown, single (at the age of 47-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. It was unknown, the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that prior to vaccination, the patient was diagnosed with COVID-19. On 04Aug2021, patient had tested positive for COVID-19 via rapid test. It was unknown if patient received treatment. Since the vaccination, the patient had been tested for COVID-19 via Nasal swab resulted positive on 04Aug2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available,The casual association between the reported event Covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Neuralgia
Clinical narrative: Started having nerve pain 3 hours after the second vaccine. It only got worse over time.; the pain has greatly interfered with my daily activities; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications on unknown dates. The patient previously received the first dose of 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. On 07Apr2021 at 17:00, 3 hours after the second vaccine, the patient started having nerve pain. It only got worse over time. The patient was now being treated by her doctor because the pain had greatly interfered with the daily activities. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain that only got worse overtime and had greatly interfered with the daily activities was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Dyspnoea, Ear pain
Clinical narrative: Started having nerve pain 3 hours after the second vaccine. It only got worse over time.; the pain has greatly interfered with my daily activities; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications on unknown dates. The patient previously received the first dose of 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. On 07Apr2021 at 17:00, 3 hours after the second vaccine, the patient started having nerve pain. It only got worse over time. The patient was now being treated by her doctor because the pain had greatly interfered with the daily activities. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain that only got worse overtime and had greatly interfered with the daily activities was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Pain, Rhinorrhoea, Tremor
Clinical narrative: Started having nerve pain 3 hours after the second vaccine. It only got worse over time.; the pain has greatly interfered with my daily activities; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications on unknown dates. The patient previously received the first dose of 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. On 07Apr2021 at 17:00, 3 hours after the second vaccine, the patient started having nerve pain. It only got worse over time. The patient was now being treated by her doctor because the pain had greatly interfered with the daily activities. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain that only got worse overtime and had greatly interfered with the daily activities was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Started having nerve pain 3 hours after the second vaccine. It only got worse over time.; the pain has greatly interfered with my daily activities; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications on unknown dates. The patient previously received the first dose of 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. On 07Apr2021 at 17:00, 3 hours after the second vaccine, the patient started having nerve pain. It only got worse over time. The patient was now being treated by her doctor because the pain had greatly interfered with the daily activities. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain that only got worse overtime and had greatly interfered with the daily activities was not recovered at the time of this report.  The lot number for 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 positive COVID case; Breakthrough positive COVID case; This is a spontaneous report from a contactable consumer or other non-hcp. An adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration; in Mar2021 as dose 2, single; and in 2021 as dose 1, single; both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021, the patient experienced breakthrough positive COVID case. The patient underwent lab tests and procedures which included Breakthrough positive COVID case in Aug2021. It was unknown if the patient received any treatment for the event Breakthrough positive COVID case. The clinical outcome of "Breakthrough positive COVID case" was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.