chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Metabolic function test, Pain, Swelling
Clinical narrative: Thyroiditis subacute; Dysphagia/Difficulty swallowing,; Lymph node pain; Lymphadenopathy/significant lymph node; pain; swelling worsening over a week; This is a spontaneous report from a non-contactable consumer. This is case 11 of 29. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no past medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) for COVID-19 immunization. It was reported that the patient experienced thyroiditis subacute, dysphagia, lymph node pain, lymphadenopathy. She had difficulty swallowing, pain and significant lymph node, swelling worsening over a week. Calculated TTO (Time-to-onset) was reported as 21 days. On an unspecified date in 2021, the patient underwent lab tests and procedures which included Antinuclear antibody, Anti-thyroid antibody, Blood thyroid stimulating hormone, Full blood count, Metabolic function Test, Thyroxine free, Ultrasound thyroid (results were unknown for all). Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis subacute, Thyroxine free, Ultrasound thyroid
Clinical narrative: Thyroiditis subacute; Dysphagia/Difficulty swallowing,; Lymph node pain; Lymphadenopathy/significant lymph node; pain; swelling worsening over a week; This is a spontaneous report from a non-contactable consumer. This is case 11 of 29. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no past medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) for COVID-19 immunization. It was reported that the patient experienced thyroiditis subacute, dysphagia, lymph node pain, lymphadenopathy. She had difficulty swallowing, pain and significant lymph node, swelling worsening over a week. Calculated TTO (Time-to-onset) was reported as 21 days. On an unspecified date in 2021, the patient underwent lab tests and procedures which included Antinuclear antibody, Anti-thyroid antibody, Blood thyroid stimulating hormone, Full blood count, Metabolic function Test, Thyroxine free, Ultrasound thyroid (results were unknown for all). Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis subacute
Clinical narrative: Subacute thyroiditis; This is a spontaneous report from a non-contactable consumer or other non hcp. A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced subacute thyroiditis (SAT). A safety signal of subacute thyroiditis following vaccination with the novel mRNA- and vector-based COVID-19 vaccines was found during a screening of the WHO database of individual case safety reports. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Sex: F
Vaccine: COVID19
Symptoms: Plasma viscosity, Thyroid function test, Thyroiditis subacute
Clinical narrative: Thyroiditis subacute/viral thyroiditis; This is a spontaneous report from a Non-contactable consumer reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and Concomitant medication(s) included ciprofloxacin lactate (CIPROFLOXACIN [CIPROFLOXACIN LACTATE]) taken for an unspecified indication. On an unspecified date, (Calculated Time-to-onset (TTO): 0 days), the patient experienced thyroiditis subacute. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202100974883
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 antibody test, Sinusitis
Clinical narrative: She thought maybe she has a sinus infection; She has been feeling sick; Has Covid and she received both the Pfizer vaccines; Has Covid and she received both the Pfizer vaccines; This is a spontaneous report from a non-contactable consumer (patients parent) via Pfizer Sales Representative. A 23-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 01May2021 (at the age of 23-years-old) (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as DOSE 2, SINGLE for prevention for Covid 19. The patient medical history was not reported. There were no concomitant medications. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation. The patient parent (Pfizer Sales Representative) stated his daughter received her vaccine on 10Apr2021 and 01May2021 but through Pfizer. Today, she just texted that she has Covid. Reporter was not a health care professional he was just sales representative. Reporter further stated, do you need the final result to the report, she just sent me her report that says she is positive? The patient was taking, the doctor just put her on an antibiotic be-cause she thought maybe she had a sinus infection on an unspecified date. She al-so had been feeling sick on an unspecified date. So, she was taking an antibiotic that was Amoxicillin (Intent: Treatment). The patient underwent lab test, which was  nasal swab, it was collected on 27Jul2021 at 11:09:57. Collected 27Jul2021, received 28Jul2021 and Released 28Jul2021 at 11:43 pm, they are not 'Time' (not clear). Her report that says she was positive on 28Jul2021. The patient had no prior vaccination within 4 weeks. The outcome of all events was unknown.  Follow-Up (03Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Blood test, Chills, Feeding disorder, Gait inability
Clinical narrative: extremely sick; high fever; shivers; couldn't walk nor eat; couldn't walk nor eat; liver was up and everything went up; just stayed in bed; terrible reaction; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced extremely sick, high fever, shivers, couldnt walk nor eat, liver was up and everything went up, just stayed in bed and terrible reaction. It was reported that after receiving his first dose of the Pfizer COVID-19 vaccine on 09Jul2021 had a terrible reaction and would like to know if it was able to track the batch number and look if anyone else got sick from the same batch. The reporter stated his brother is overall a healthy guy and has his annual medical done yearly. He had blood work done in Apr2021 and everything was perfect. On 09Jul2021, he received the Pfizer COVID-19 vaccine and was extremely sick, he had high fever, shivers, couldnt walk nor eat and just stayed in bed. He went to ER. The hospital gave blood work and the specialist saw him and said it is not Lyme disease, no sepsis and that there is nothing wrong with him. His blood work went wacko after the vaccine, his liver was up and everything went up. He is due to receive his second dose today 30Jul2021, but has not received it yet. The reporter asked if his brother should receive his second dose of the Pfizer COVID-19 vaccine. Should he get it and How should they approach this again. The patient underwent lab tests and procedures which included blood test: went wacko after the vaccine on an unknown date blood work went wacko after the vaccine, blood test: everything was perfect on Apr2021, liver function test: liver was up and everything went up on an unknown date. The outcome of all the events was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Liver disorder, Liver function test, Pyrexia, Vaccination complication
Clinical narrative: extremely sick; high fever; shivers; couldn't walk nor eat; couldn't walk nor eat; liver was up and everything went up; just stayed in bed; terrible reaction; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced extremely sick, high fever, shivers, couldnt walk nor eat, liver was up and everything went up, just stayed in bed and terrible reaction. It was reported that after receiving his first dose of the Pfizer COVID-19 vaccine on 09Jul2021 had a terrible reaction and would like to know if it was able to track the batch number and look if anyone else got sick from the same batch. The reporter stated his brother is overall a healthy guy and has his annual medical done yearly. He had blood work done in Apr2021 and everything was perfect. On 09Jul2021, he received the Pfizer COVID-19 vaccine and was extremely sick, he had high fever, shivers, couldnt walk nor eat and just stayed in bed. He went to ER. The hospital gave blood work and the specialist saw him and said it is not Lyme disease, no sepsis and that there is nothing wrong with him. His blood work went wacko after the vaccine, his liver was up and everything went up. He is due to receive his second dose today 30Jul2021, but has not received it yet. The reporter asked if his brother should receive his second dose of the Pfizer COVID-19 vaccine. Should he get it and How should they approach this again. The patient underwent lab tests and procedures which included blood test: went wacko after the vaccine on an unknown date blood work went wacko after the vaccine, blood test: everything was perfect on Apr2021, liver function test: liver was up and everything went up on an unknown date. The outcome of all the events was unknown. Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: fast heart rate/normally, my heart rate is 60, and now is the 100's/really high heart rate; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 20Jul2021 (age at vaccination was 28-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that "fast heart rate/normally, my heart rate is 60, and now is the 100's/really high heart rate" on 22Jul2021. The patient states that 2 days after receiving the vaccine (22Jul2021) she began to experience a fast heart rate. Normally, the patient's heart rate was 60, and now it was the 100's. The patient called her doctor to ask if this was a common side effect and, he said that the list they did not had it, and patient called Pfizer. She had spoken to other people who had taken it and they say they had the same symptoms. The patient was asking if this was a common side effect, and had the people who called it in, was it because they had an allergic reaction and will it go. The patient did not think she had an allergic reaction. She had experienced a really high heart rate for no reason and was the concerned. She never had that, prior to this her resting heart rate was in the 60s now its in the 100s. The patient lab test included heart rate was 60's (resting heart rate is in the 60s) on an unknown date and heart rate was 100's (fast heart rate) on 22Jul2021. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Positive PCR test shows positive COVID-19 Diagnosis.; Positive PCR test shows positive COVID-19 Diagnosis.; Dose number: 1, Administration date: 02Mar2021/other vaccine same date dose number: 2, other vaccine same date vaccine date: 02Mar2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203), intramuscularly, administered in Left arm on 02Mar2021 10:00 at the age of 42-years-old as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3248) via an unspecified route of administration, administered in Left arm on 02Mar2021 at the age of 42-years-old as dose 2, single for covid-19 immunisation. Medical history included GERD (gastrooesophageal reflux disease). The patient had no known allergies. Concomitant medication included pantoprazole (PANTOPRAZOLE) which received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. On 29Jul2021 at 13:00, the patient had pcr (Nasal Swab) test which shows positive covid-19 diagnosis. The patient did not received treatment for adverse event. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event, Inappropriate schedule of vaccine administered was unknown while other events were recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: He developed shingles; This is a spontaneous report from a contactable consumer (patient, self-reported). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 20Mar2021, as a single dose for COVID-19 immunization. The patient reported that on 10Jul2021, he developed shingles and was seen in the emergency room, where he was diagnosed and encouraged to call you and report it. His vaccination provider said the same thing. He was in the process of recovering from shingles. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/were experiencing. Because your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider was in the best position to advise you about the appropriate action to take. Outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Tachycardia, Vaccination failure
Clinical narrative: Tachycardia on 24Apr2021; Had breakthrough covid infection documented 17Apr2021; Had breakthrough covid infection documented 17Apr2021; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9261), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Age at vaccination 60 years) as dose 2, single, and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Age at vaccination 60 years) as dose 1, single for covid-19 immunisation. Medical history included Known allergies: Sulfa. Concomitant medication(s) included lubiprostone (AMITIZA); estradiol (IMVEXXY); vitamin d3 (VITAMIN D3); fish oil (FISH OIL) and multivitamins. The patient previously took reglan [metoclopramide] and experienced drug hypersensitivity (Known allergies: Regian). Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 14Apr2021, the patient experienced had breakthrough covid infection documented 17apr2021 and experienced tachycardia on 24apr2021. It was reported that patient had to go to emergency room for tachycardia on 24Apr2021. Tachycardia persisted for 2 months. Patient was not received treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Apr2021 COVID test type: Nasal Swab. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient was visited to emergency room and physician office. The outcome of event Tachycardia was recovered on unspecified date in 2021. The outcome of other events were recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got tested again for COVID-19 infection on the 29th at work and on the 30th, his results came as positive; This is a spontaneous report from a contactable consumer or other non hcp.   A 48-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was reported that, the caller is calling on behalf of her husband who received the first dose of the Pfizer covid vaccine on 28Jun2021. The patient is being tested for covid weekly and on 25Jun2021 he was tested for covid and on 26Jun2021 it resulted negative. After the first dose the patient was tested on 29Jun2021 and then on 30Jun2021 his covid test resulted as positive on 30Jun2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 26Jun2021   sars-cov-2 test: positive on 30Jun2021.  Follow up(30Jul2021), This is a follow up spontaneous report from Pfizer sponsored program COVAX US Support. A contactable reporter reported information included.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: Since end of June also noticing similar weakess/pain in both upper arms; severe muscle weakness; moderate pain at hip/thigh (NOT joint or arthritic pain); moderate pain at hip/thigh (NOT joint or arthritic pain);; Affects ability to walk (assistance or cane to help); This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6198), intramuscular, administered in Arm Left on 02Mar2021 11:45 (at the age of 67-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergies to tea tree oil and fragrances used in cosmetics/cleaning products, thyroiditis, non-specified atopic dermatitis. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3247), intramuscular, administered in Arm Left in Feb2021 12:00 as dose 1, single for covid-19 immunisation and experienced prolonged arrhythmia episodes starting after 1st dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Mar2021, (10 days after second shot) patient experienced severe muscle weakness and moderate pain at hip/thigh (NOT joint or arthritic pain), started in right side. After a couple of days, occurred in left side. Some overlap in both R/L and then resolved in right followed by the left. Duration was about 1 week. After a couple of weeks from resolution, occurred again, (both sides) eventually resolving. This AE was ongoing. Intervals of occurrence vary. Affects ability to walk (assistance or cane to help). Since end of June, patient also noticed similar weakness/pain in both upper arms. Serious criteria were reported as no. Treatment was not provided for adverse events. The outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Atrioventricular block, Axillary pain, Lymphadenopathy
Clinical narrative: AV block; Patient having pains on the armpit where, the vaccination was done like; swollen up like, my lymph nodes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient ended up in an emergency yesterday and was being diagnosed with first, with the AV block and now problem is, patient having pains on the armpit where, the vaccination was done like, I was swollen up like, lymph nodes and have been very-very unlet, do not know what to do. Patient visited emergency room for the events. The outcome for the events was reported as unknown.   Follow-up (04Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pain in extremity
Clinical narrative: direct exposure to COVID 19 and did not get COVID; sore arm; This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a 50-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 21Mar2021 (at age of 50-year-old) as dose 1, single and patient had received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 13Apr2021 as dose 2, single both for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and unknown if ongoing. Family medical history relevant to AE(s) was none. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder from an unspecified start date and ongoing. Patient did not have any other vaccination, prior (within 4 weeks) of COVID-19 vaccination. The reporter stated she was just reporting something positively. Both she and her husband had received full vaccination and then had an exposure to COVID and on an did not contract the COVID-19 infection. Mentioned that, the incubation was 10 to 14 days and they were on day 12 taking care of COVID kid. She added as far as awareness, she was unsure what that would be, but as of today she knew that she has not gotten COVID. This was a clone report and created to document the husband's experience. Later on she mentioned her husband got his vaccination before her because they had a cancellation at the pharmacy. She could not remember if she reported anything about her husband before. Added his arm was sore after both doses but it completely cleared up. Confirmed awareness of the sore arm was on the day he got the first shot 21Mar2021. She added they had her son sleeping in a palette in their bedroom; they did not mask but did wash hands really good; and used Lysol in the home. The adverse event did not resulted in any emergency room or physician office visit. Relevant tests were not recently done, he had been tested in the past and it was negative. The outcome of sore arm was recovered on an unspecified date in 2021 while outcome of event direct exposure to COVID 19 and did not get COVID was unknown.  Information on lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 01Aug2021 she took him to be tested and he tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient' mother). A 19-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jul2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 on 01Aug2021 and he was due for the second dose on 11Aug2021. The reporter would like to know if it was possible the vaccine was still in him and was causing a false positive result. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 (at the age of 54-years-old), as a DOSE 2, SINGLE, and dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: EP6955) as a DOSE 1, SINGLE for covid-19 immunization. The patient medical history included was none. The patient's concomitant medications were not reported. The patient had no Known allergies and other relevant medical history. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient experienced covid-19 on 26Jul2021; Received a positive COVID-19 test result. The event was serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on 27Jul2021 by Rapid test. Treatment received for the event was none. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 intramuscular, administered in the left arm on 15Mar2021 at 14:00 (Bath/Lot Number: EP7534) as a single dose, and dose 1 intramuscular, administered in the left arm on 22Feb2021 at 14:00 (Batch/Lot Number: EL9262) as a single dose (at the age of 34-years-old) for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested positive for COVID on 15Jul2021.  The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 15Jul2021 Nasal Swab. No treatment was received.  The patient recovered from the event on an unknown date.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain
Clinical narrative: contracted COVID19 last month even though I was vaccinated; contracted COVID19 last month even though I was vaccinated; My Pain is greater than 10 ever since I contracted COVID19 last month even though I was vaccinated; This is a spontaneous report from a contactable Healthcare Professional and a consumer (patient). A 59-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (dose number not provided), via an unspecified route of administration on an unspecified date, at 59 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included essential primary hypertension, gastrooesophageal reflux disease without esophagitis, arthritis enteropathic and myositis, all from an unknown date. The patient was not pregnant at the time of the event. The patient's concomitant medications included tofacitinib citrate (XELJANZ) 11 mg tablet once daily from May2021 for Rheumatoid arthritis with rheumatoid factor. The patient reported she contracted COVID-19 the month before (Jun2021), even though she was vaccinated (number of doses unspecified), and her pain has been greater than 10 ever since when she contracted COVID-19 the month before (Jun2021). Her doctor has given her steroids pack to help. The outcome of the reported events was unknown at the time of the report.  Information on the lot/batch number 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 drug ineffective and covid-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sales Representative. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced severe allergic reaction after receiving the Pfizer-Biontech Covid19 vaccine. The patient visited the ER due to the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Arthralgia, Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: Severe migraine; severe joint and flank pain; severe joint and flank pain; severe dizziness/vertigo; severe dizziness/vertigo; electric shock sensations throughout body; nausea; Vomiting; tachycardia; elevated BP; Angry; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 28Jan2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 39-years-old). The most recent COVID-19 vaccine was administered at Workplace clinic. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. There were no known allergies. Historical vaccine included flu vaccine and shingles vaccine and never had any reaction. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Jan2021, the patient experienced severe migraine, severe joint and flank pain, severe dizziness/vertigo, electric shock sensations throughout body, nausea, vomiting, tachychardia, elevated BP, and she was angry and will not get a second dose. Fix that. The media should be talking more about this because it was happening to a lot of people, but they were not because vaccines. Patient also stated that stop trying to normalize these effects, she got the flu vaccine every goddamn year and had never had any reaction, not even to her Shingles vaccine, that was poison. Events were assessed as non-serious as per reporter. Events resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 29Jan2021. Treatment included Advil, Oxycodone, Zofran, Phenergan (rectal), bena. The clinical outcome for the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Flank pain, Migraine, Nausea, Tachycardia
Clinical narrative: Severe migraine; severe joint and flank pain; severe joint and flank pain; severe dizziness/vertigo; severe dizziness/vertigo; electric shock sensations throughout body; nausea; Vomiting; tachycardia; elevated BP; Angry; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 28Jan2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 39-years-old). The most recent COVID-19 vaccine was administered at Workplace clinic. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. There were no known allergies. Historical vaccine included flu vaccine and shingles vaccine and never had any reaction. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Jan2021, the patient experienced severe migraine, severe joint and flank pain, severe dizziness/vertigo, electric shock sensations throughout body, nausea, vomiting, tachychardia, elevated BP, and she was angry and will not get a second dose. Fix that. The media should be talking more about this because it was happening to a lot of people, but they were not because vaccines. Patient also stated that stop trying to normalize these effects, she got the flu vaccine every goddamn year and had never had any reaction, not even to her Shingles vaccine, that was poison. Events were assessed as non-serious as per reporter. Events resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 29Jan2021. Treatment included Advil, Oxycodone, Zofran, Phenergan (rectal), bena. The clinical outcome for the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Severe migraine; severe joint and flank pain; severe joint and flank pain; severe dizziness/vertigo; severe dizziness/vertigo; electric shock sensations throughout body; nausea; Vomiting; tachycardia; elevated BP; Angry; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 28Jan2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 39-years-old). The most recent COVID-19 vaccine was administered at Workplace clinic. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. There were no known allergies. Historical vaccine included flu vaccine and shingles vaccine and never had any reaction. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Jan2021, the patient experienced severe migraine, severe joint and flank pain, severe dizziness/vertigo, electric shock sensations throughout body, nausea, vomiting, tachychardia, elevated BP, and she was angry and will not get a second dose. Fix that. The media should be talking more about this because it was happening to a lot of people, but they were not because vaccines. Patient also stated that stop trying to normalize these effects, she got the flu vaccine every goddamn year and had never had any reaction, not even to her Shingles vaccine, that was poison. Events were assessed as non-serious as per reporter. Events resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 29Jan2021. Treatment included Advil, Oxycodone, Zofran, Phenergan (rectal), bena. The clinical outcome for the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fibromyalgia, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever; Headache; whole body pain; sore arm; chills; This is a spontaneous report from a contactable consumer. This 55-Years-Old female consumer reported that.  A 55-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3247, Expiration date: unknown), via unspecified route, administered on 27Jan2021 at 02:45 PM (at the age of 55-year-old) as dose number unknown, single for COVID-19 immunization from Workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccines received within 4 weeks of vaccination. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Allergies to medications, food, or other products were not reported.  On 27Jan2021 at 10:00 PM, 7 hrs 15 min after the vaccination, the patient experienced fever/chills, headache, whole body pain(light), sour arm. The events assessed as non-serious. The outcome of the events was recovered on 29Jan2021 morning.  Follow-up (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected   No follow-up attempts possible. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Hyperhidrosis, Maternal exposure during pregnancy, Tachycardia
Clinical narrative: Feeling of shortness of breath; Tachycardia; Sweating; Hot; Pregnant/ Gestational period: 16; This is a spontaneous report from a contactable nurse (patient). This is a maternal report. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via intramuscular, administered in left arm on 09Feb2021 14:15 (at the age of 34-year-old) as dose 1, single dose for COVID-19 immunisation. Medical history included pregnant and COVID-19 from an unknown date. Patient had no known allergies. Other vaccine included in two weeks doxylamine succinate, pyridoxine hydrochloride (DICLEGIS). The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On 11Feb2021 at 08:00, patient experienced feeling of shortness of breath, tachycardia, sweating, hot. Treatment was not received in response to the events. The mother reported she became pregnant while taking bnt162b2. The mother was 16 Weeks pregnant at the onset of the event. The mother was due to deliver on 24Aug2021. Outcome of the events was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Rhinorrhoea
Clinical narrative: Runny nose; feeling weekness in the body; This is a spontaneous report from a contactable Consumer (patient). A 45-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in right arm on 09Feb2021 at 15:45 as dose 2 single (at the age of 45-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took Aspirin and experienced known allergies. Patient had no covid prior vaccination. Patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. Facility type vaccine was workplace clinic. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in right arm on 19Jan2021 at 03:45 PM as dose 1 single (at the age of 45-year-old) for COVID-19 immunization. On 10Feb2021, patient experienced runny nose & feeling weakness in the body. Treatment for adverse events was unknown. Patient had not covid tested post vaccination. The outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Asthenopia, Cardiac disorder, Dry eye
Clinical narrative: not being able to sleep last night/couldn't sleep very well; Dry and tired eyes; Dry and tired eyes; Pain around the neck/tight and tired in neck; Feels like her legs are tight/tired and painful in legs; Feet are hot; Trouble walking/hard to walk; Not breathing well/Short of breath; Her heart feels fast; Stomach and head "feel like there is a bump on them''; Stomach and head "feel like there is a bump on them''; Fibromyalgia worsened; Feeling tired; Feels nervous; She has anxiety; Wants to throw up; very weird the way she feels; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 10Feb2021 as dose 2 single for COVID-19 immunization. Medical history included fibromyalgia. Concomitant medications included atenolol, alprazolam (XANAX). The patient reported feeling worse after the second injection compared to after the first. After the second injection, the patient reported experiencing not being able to sleep last night, dry and tired eyes, pain around the neck, feels like her legs are tight, bottom of feet are hot, trouble walking, not breathing well, and like someone is pinching her hands with a nail. The patient reported her stomach and head feel like there is a bump on them and her heart feels fast, feeling tired, feels nervous, she has anxiety. The patient was worried her blood pressure might be high but it had not been measured. Patient was calling because she had her second vaccine yesterday. The first one, she had a little bit of side effects, but after the second one she felt terrible. She was wondering how long this will last in her body. What can she do when she feels like this. Clinical course included she had been feeling tired. She had fibromyalgia, and she thinks this had been worse for her. She felt tight and tired in her neck. Her legs were tired and painful. She feels like tired. She had to call out of work. She also felt very nervous. Last night she could not sleep very well. Her heart was beating very fast. Her head. She had anxiety. She is a custodian at school. She was working this morning, and felt short of breath. She had to stop working. She almost felt like if her blood pressure was up or something like that. It was like when someone feels nervous. It made her uncomfortable. It was very weird the way she feels. She needs to know does she need to do something or take something.  She had a prescription from the doctor for Atenolol. She mentioned her stomach and her heart, and so she took an Atenolol. She also took a half of a Xanax, and she is feeling a little better now. She just wanted to know if this is normal. Should she go to the ER. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.