chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested COVID-19 positive by PCR.  Drawn Tues 03Aug and notified positive Thurs 05Aug/Cold-like URI symptoms so far and s; Tested COVID-19 positive by PCR.  Drawn Tues 03Aug and notified positive Thurs 05Aug/Cold-like URI symptoms so far and some body aches; This is a spontaneous report from a contactable other healthcare professional (hcp). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested COVID-19 positive by PCR which was drawn Tuesday 03Aug2021 and notified positive on Thursday, 05Aug2021. Patient also had cold-like URI symptoms so far and some body aches. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 to the reported drug ineffective / COVID-19 cannot be ruled out.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 positive test results; Covid-19 positive test results; This is a spontaneous report from a contactable consumer. A 51-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8729), via intramuscular route on 09Apr2021 as dose 2, single (at the age of 51 years) and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6203), via intramuscular route on 16Mar2021 as dose 1, single (at the age of 51 years), for covid-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was stated that, on 03Aug2021, the patient had Covid-19 positive test results. The adverse event resulted Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via PCR test via Nasal Swab sample taken on 01Aug2021, which came out to be positive. No treatment was received. The outcome for the event was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Hypersensitivity, Hypersomnia, Vertigo
Clinical narrative: allergic reaction; vertigo; memory loss / He couldn't remember anything.; He's very tired and sleeps all day; He's very tired and sleeps all day; he lost a lot of weight of about 75 pounds; This is a spontaneous report from a contactable consumer reporting on behalf of her husband. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021, at the age of 64 years, lot EN6201, as the first single dose, for COVID-19 immunisation. Prior vaccinations (within 4 weeks): none. Medical history included back pain (taking medicine for his back), deep vein thrombosis before vaccination and was on blood thinner, bleeding disorder (he was on blood thinner), diverticulitis before vaccination, allergy to penicillin and iodine. Both his parents had heart issues. Concomitant medication included tramadol orally, ongoing from an unknown date, 50 mg tablet 1x/day, for back pain and rivaroxaban (XARELTO) as blood thinner for DVT. The patient experienced an allergic reaction of vertigo on 16Apr2021. He was prescribed by the primary doctor with dramamine to calm it down and it worked for a week. From an unspecified date in 2021 he had also memory loss, he lost a lot of weight of about 75 pounds after 16Apr2021. He was 288 now 212. Since he lost the weight, back pain had stabilized. He couldn't remember anything. He was very tired and slept all day. He was not him. On 07May2021 he received the second dose. Allergic reaction of vertigo had not yet resolved. The other events outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101022334 Same Reporter/Patient/Drug, Different AE/Vaccine Dose
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: allergic reaction; vertigo; memory loss / He couldn't remember anything.; He's very tired and sleeps all day; He's very tired and sleeps all day; he lost a lot of weight of about 75 pounds; This is a spontaneous report from a contactable consumer reporting on behalf of her husband. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021, at the age of 64 years, lot EN6201, as the first single dose, for COVID-19 immunisation. Prior vaccinations (within 4 weeks): none. Medical history included back pain (taking medicine for his back), deep vein thrombosis before vaccination and was on blood thinner, bleeding disorder (he was on blood thinner), diverticulitis before vaccination, allergy to penicillin and iodine. Both his parents had heart issues. Concomitant medication included tramadol orally, ongoing from an unknown date, 50 mg tablet 1x/day, for back pain and rivaroxaban (XARELTO) as blood thinner for DVT. The patient experienced an allergic reaction of vertigo on 16Apr2021. He was prescribed by the primary doctor with dramamine to calm it down and it worked for a week. From an unspecified date in 2021 he had also memory loss, he lost a lot of weight of about 75 pounds after 16Apr2021. He was 288 now 212. Since he lost the weight, back pain had stabilized. He couldn't remember anything. He was very tired and slept all day. He was not him. On 07May2021 he received the second dose. Allergic reaction of vertigo had not yet resolved. The other events outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101022334 Same Reporter/Patient/Drug, Different AE/Vaccine Dose
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid 19; Tested positive for covid 19; This is a spontaneous report received from a non-contactable consumer (patient) reported for himself   A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 05Aug2021, the patient had tested positive for covid 19 (Covid test post vaccination). The patient underwent lab tests and procedures which included Nasal Swab: positive on 05Aug2021 Tested positive for covid 19 (Covid test post vaccination). Patient did not received treatment for the adverse events. Outcome of the events was resolving.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Gait disturbance, Lung disorder, Myocarditis, Visual impairment
Clinical narrative: vomited; could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they KILL ME OR POISON; could not see, walk and having trouble at every level; MYOCARDITIS; LUNGS AND HEART FAILING; LUNGS AND HEART FAILING; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 10:30 AM (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was hospital. Medical history included Allergies to little milk (Known allergies: Some food the patient think they don't test you here. when little milk), sinus, concussion, trigeminal neuralgia, had covid prior vaccination. No other vaccine in four weeks. Other medications in two weeks: take low dose of Nuerontinin. Concomitant medication included gabapentin (NEURONTIN). The patient previously took Sulphur and experienced allergy, motrin experienced allergy, penicillin and experienced allergy. The reported event started on 26Mar2021 10:00 AM, the course was reported as that nurse laughed I did nothing while I vomited, could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they kill me or poison me. I am sick...getting worse...I have myocarditis now and lungs and heart failing...going to lose my job my health care everything cause you all lied you are liars. I asked what was in it I did not want it but from media pressure and my job got it. now I am about to die and lose everything I worked for cdc is liars and Dr. you all a bunch of liars killed me or it will. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received and was reported as medical clinic did it said. The event outcome was not recovered. No covid tested post vaccination.  Follow-up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited; could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they KILL ME OR POISON; could not see, walk and having trouble at every level; MYOCARDITIS; LUNGS AND HEART FAILING; LUNGS AND HEART FAILING; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 10:30 AM (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was hospital. Medical history included Allergies to little milk (Known allergies: Some food the patient think they don't test you here. when little milk), sinus, concussion, trigeminal neuralgia, had covid prior vaccination. No other vaccine in four weeks. Other medications in two weeks: take low dose of Nuerontinin. Concomitant medication included gabapentin (NEURONTIN). The patient previously took Sulphur and experienced allergy, motrin experienced allergy, penicillin and experienced allergy. The reported event started on 26Mar2021 10:00 AM, the course was reported as that nurse laughed I did nothing while I vomited, could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they kill me or poison me. I am sick...getting worse...I have myocarditis now and lungs and heart failing...going to lose my job my health care everything cause you all lied you are liars. I asked what was in it I did not want it but from media pressure and my job got it. now I am about to die and lose everything I worked for cdc is liars and Dr. you all a bunch of liars killed me or it will. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received and was reported as medical clinic did it said. The event outcome was not recovered. No covid tested post vaccination.  Follow-up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: got covid and got visibly sick from it.; got covid and got visibly sick from it.; got covid and got visibly sick from it.; This is a spontaneous report received from a Pfizer employee reported for a female patient. A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0173), via an unspecified route of administration on 08May2021 (at the age of 26-year-old), DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. It was unknown Prior to vaccination the patient diagnosed with COVID-19. It was unknown if the patient received list of any other medications within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 03Aug2021, the patient got covid and got visibly sick from it. Post vaccination, the patient underwent lab test which included sars-cov-2 test (nasal swab): positive on 03Aug2021. The event resulted into to doctor or other healthcare professional office/clinic visit. it was unknown if the patient received treatment for the event. The patient outcome of the events got covid and got visibly sick from it (covid-19 and sickness) was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration on 17May2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown If patient had covid prior to vaccination. It was unknown if patient received other vaccine in four weeks. On 03Aug2021, patient experienced contracted COVID. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient had COVID tested Rapid PCR post vaccination via, nasal swab on 03Aug2021. It was unknown if patient received treatment. Seriousness was reported as no. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.  .
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Gingival pain, Headache
Clinical narrative: Constant Headaches; light and loud noise sensitivity; light and loud noise sensitivity; sore throat; extreme fatigue; nausea; grapefruit size knot at injection site; gum and teeth soreness and sensitivity; gum and teeth soreness and sensitivity; teeth soreness and sensitivity; pain in joints, knees, back and elbows; pain in joints, knees, back and elbows; vomiting; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Jul2021 14:00 (at the age of 45-years; Lot Number: EW0198) as DOSE 1, SINGLE for COVID-19 immunization (also reported as dose 2 (Lot Number: FC3180)). Medical history included degenerative disc disease and herniated discs. Concomitant medications included pregabalin (LYRICA) and hydrocodone. 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 was not pregnant at the time of vaccination. On 18Jul2021 14:45, the patient experienced constant headaches, light and loud noise sensitivity, sore throat, extreme fatigue, nausea, grapefruit size knot at injection site, gum and teeth soreness and sensitivity, pain in joints, knees, back and elbows, and vomiting. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of the events. The events were assessed as serious (disabling/incapacitating). Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Hyperaesthesia teeth, Nausea, Oropharyngeal pain, Photophobia
Clinical narrative: Constant Headaches; light and loud noise sensitivity; light and loud noise sensitivity; sore throat; extreme fatigue; nausea; grapefruit size knot at injection site; gum and teeth soreness and sensitivity; gum and teeth soreness and sensitivity; teeth soreness and sensitivity; pain in joints, knees, back and elbows; pain in joints, knees, back and elbows; vomiting; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Jul2021 14:00 (at the age of 45-years; Lot Number: EW0198) as DOSE 1, SINGLE for COVID-19 immunization (also reported as dose 2 (Lot Number: FC3180)). Medical history included degenerative disc disease and herniated discs. Concomitant medications included pregabalin (LYRICA) and hydrocodone. 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 was not pregnant at the time of vaccination. On 18Jul2021 14:45, the patient experienced constant headaches, light and loud noise sensitivity, sore throat, extreme fatigue, nausea, grapefruit size knot at injection site, gum and teeth soreness and sensitivity, pain in joints, knees, back and elbows, and vomiting. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of the events. The events were assessed as serious (disabling/incapacitating). Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache, Vaccination site mass, Vomiting
Clinical narrative: Constant Headaches; light and loud noise sensitivity; light and loud noise sensitivity; sore throat; extreme fatigue; nausea; grapefruit size knot at injection site; gum and teeth soreness and sensitivity; gum and teeth soreness and sensitivity; teeth soreness and sensitivity; pain in joints, knees, back and elbows; pain in joints, knees, back and elbows; vomiting; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Jul2021 14:00 (at the age of 45-years; Lot Number: EW0198) as DOSE 1, SINGLE for COVID-19 immunization (also reported as dose 2 (Lot Number: FC3180)). Medical history included degenerative disc disease and herniated discs. Concomitant medications included pregabalin (LYRICA) and hydrocodone. 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 was not pregnant at the time of vaccination. On 18Jul2021 14:45, the patient experienced constant headaches, light and loud noise sensitivity, sore throat, extreme fatigue, nausea, grapefruit size knot at injection site, gum and teeth soreness and sensitivity, pain in joints, knees, back and elbows, and vomiting. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of the events. The events were assessed as serious (disabling/incapacitating). Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Today she is scheduled for her 2nd dose but she is tested positive; on Monday when I went to Covid test,  I needed to take it they said that I am positive for Covid-2; This is a spontaneous report received from a contactable consumer or other non hcp (patient) via a Pfizer-sponsored program COVAX US Support. A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0178) via an unspecified route of administration, administered in arm left on 15Jul2021 at 14:00 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included had sinuses and allergies from an unknown date and unknown if ongoing. Concomitant medications included tramadol, gabapentin taken for an unspecified indication, unknown start and stop dates. The patient got her 1st Covid-19 vaccine on 15Jul2021 and she was scheduled for the 2nd shot but on monday when she went to covid test, she needed to take it they said that she was positive (be-fore taking her 2nd dose) for Covid-2 on 21Jul2021. The patient did not receive any treatment for the adverse events but quarantined. The patient underwent lab tests and procedures which in-cluded sars-cov-2 test: positive on 21Jul2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the Covid19; Got the Covid19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's sister) reported that a male patient (reporter's brother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), on Feb2021 as dose 1, single and then on Mar2021 as dose 2, single, both via an unspecified route of administration for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Jul2021, patient got the COVID-19 virus. The consumer was calling on behalf of her brother and took both doses of the vaccine. Consumer mentioned the first dose was Feb2021 and the second dose was Mar2021. The patient got the Covid19 virus in Jul2021 and he needs to travel in Sep2021. The consumer wants to know if her brother will be tested in Covid19 test if it will have a negative result. She wants to know as well if you're trying to travel how many days you should turn negative to Covid19 test, is it 90, 60, 30 days. Outcome of the event of COVID-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Suspected COVID-19
Clinical narrative: positive covid test; Inappropriate schedule of vaccine administered; positive covid test; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via an unspecified route of administration, on 09Mar2021, as a single dose for COVID-19 immunization and 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 23Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had sore throat, body aches, low grade fever, cough, nose congestion, and nausea and these symptoms were first noticed the night of 04Aug2021. On 07Aug2021, the patient had positive covid test and inappropriate schedule of vaccine administered. Event took place after use of product. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal oedema, Rash
Clinical narrative: swollen throat; rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on 06Aug2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Two days later, on 08Aug2021, she mentioned that she could breath but had a swollen throat and a rash. She would like to know when the rash would go away. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer  The same reporter reported  for four  different patients   A 9-decade-old patient of an unspecified gender received bnt162b2 (BNT162B2) unknown dose number , via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was tested positive for covid-19 (medically significant) on an unspecified date and ended up quite sick with outcome of unknown.  Course of the event. I received a phone call from my friend that her 2 yr old granddaughter tested positive for Covid. They visited me on 27Jul2021. Her, and the mother had both been vaccinated with the Pfizer vaccine in Feb2021. However they both tested positive for COVID. I then self-quarantined until I tested 5 days later on 01Aug2021. My test came out Negative. My friend also reported to me that another in their family who is in their 80's also Pfizer vaccinated, tested positive covid and ended up quite sick.  Information about the Lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Periarthritis
Clinical narrative: Frozen left shoulder; Pain in left arm.; Worst pain after waking up in the morning; This is a spontaneous report received from a contactable consumer.  A 66-years-old male patient reported that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 23Mar2021 at 10:30 am (Batch/Lot Number ER8727) (at the age of 66-years-old ) as single dose for covid-19 immunisation.  Medical history was none. The patient had no allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Apr2021 the patient experienced frozen left shoulder, pain in left arm. Unlike most injuries worst pain after waking up in the morning. The events resulted in 'dr. visit and PT'.  Treatment for the events was received. Seriousness criteria reported as disabling. Since the vaccination, has the patient been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Fatigue, Nasal congestion, Pyrexia
Clinical narrative: had his 1st dose of the vaccine 3 weeks ago/due for 2nd shot that day but he developed symptoms of Covid19; had his 1st dose of the vaccine 3 weeks ago/due for 2nd shot that day but he developed symptoms of Covid19; he felt congested/congestion; Fever; cough; little bit of tiredness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient called regarding the Pfizer BioNTech Covid19 Vaccine. Per report, he had his 1st dose of the vaccine 3 weeks ago (on unspecified date) and is due for 2nd shot that day but he developed symptoms of Covid19 such as congestion, cough and a little bit of tiredness; all on unspecified date. He did COVID home test and the results were inconclusive. He was asking if he could still take the 2nd dose of the vaccine that day. Further reported that he felt congested on unspecified date. He already received his first dose of the Pfizer COVID vaccine and he felt congested and he also had a fever and he did take MOTRIN as treatment for his fever and then he also took the COVID home test and it was inconclusive and he wanted to know if its still okay to get the second dose. The patient underwent lab tests and procedures which included COVID-19 test: inconclusive on unspecified date. Therapeutic measures were taken as a result of he felt congested/congestion and fever. The outcome of the events was unknown.  Information about Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: had his 1st dose of the vaccine 3 weeks ago/due for 2nd shot that day but he developed symptoms of Covid19; had his 1st dose of the vaccine 3 weeks ago/due for 2nd shot that day but he developed symptoms of Covid19; he felt congested/congestion; Fever; cough; little bit of tiredness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient called regarding the Pfizer BioNTech Covid19 Vaccine. Per report, he had his 1st dose of the vaccine 3 weeks ago (on unspecified date) and is due for 2nd shot that day but he developed symptoms of Covid19 such as congestion, cough and a little bit of tiredness; all on unspecified date. He did COVID home test and the results were inconclusive. He was asking if he could still take the 2nd dose of the vaccine that day. Further reported that he felt congested on unspecified date. He already received his first dose of the Pfizer COVID vaccine and he felt congested and he also had a fever and he did take MOTRIN as treatment for his fever and then he also took the COVID home test and it was inconclusive and he wanted to know if its still okay to get the second dose. The patient underwent lab tests and procedures which included COVID-19 test: inconclusive on unspecified date. Therapeutic measures were taken as a result of he felt congested/congestion and fever. The outcome of the events was unknown.  Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity, Arthralgia, Dyspnoea, Fatigue, Headache
Clinical narrative: neuropathy; tinnitus; joint tightness; headache; blurry vision; abdominal spasms; Numbness of the left side of her body from under the Breast to her Toes; joint pain; body exhaustion; forced breathing; heart palpitations; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age 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. Since an unknown date, the patient was suffering from long-term effects of Covid-19 vaccine which include neuropathy, tinnitus, joint tightness, headache, blurry vision, abdominal spasms, numbness of the left side of her body from under the breast to her toes, joint pain, body exhaustion, forced breathing, heart palpitations while performing small activities or going up the stairs to 2nd floor. The reporter is asking to provide an action plan to alleviate the symptoms as they have deteriorated there way of life. The outcome of all events was unknown.  Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101023095 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint stiffness, Neuropathy peripheral, Palpitations, Tinnitus
Clinical narrative: neuropathy; tinnitus; joint tightness; headache; blurry vision; abdominal spasms; Numbness of the left side of her body from under the Breast to her Toes; joint pain; body exhaustion; forced breathing; heart palpitations; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age 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. Since an unknown date, the patient was suffering from long-term effects of Covid-19 vaccine which include neuropathy, tinnitus, joint tightness, headache, blurry vision, abdominal spasms, numbness of the left side of her body from under the breast to her toes, joint pain, body exhaustion, forced breathing, heart palpitations while performing small activities or going up the stairs to 2nd floor. The reporter is asking to provide an action plan to alleviate the symptoms as they have deteriorated there way of life. The outcome of all events was unknown.  Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101023095 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: neuropathy; tinnitus; joint tightness; headache; blurry vision; abdominal spasms; Numbness of the left side of her body from under the Breast to her Toes; joint pain; body exhaustion; forced breathing; heart palpitations; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age 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. Since an unknown date, the patient was suffering from long-term effects of Covid-19 vaccine which include neuropathy, tinnitus, joint tightness, headache, blurry vision, abdominal spasms, numbness of the left side of her body from under the breast to her toes, joint pain, body exhaustion, forced breathing, heart palpitations while performing small activities or going up the stairs to 2nd floor. The reporter is asking to provide an action plan to alleviate the symptoms as they have deteriorated there way of life. The outcome of all events was unknown.  Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101023095 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID week of 05Aug2021 and is symptomatic.; Patient tested positive for COVID week of 05Aug2021 and is symptomatic.; This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot no: EP7534) via intramuscular route of administration, administered on 21Mar2021 as single dose for covid-19 immunisation. The patient was not pregnant at the time vaccination. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was diagnosed with covid-19 was unknown. The patient receives any other vaccines within 4 weeks prior to the covid vaccine was unknown. It was reported that the patient was symptomatic to covid in the week of 05Aug2021. On an unspecified date in Aug2021 the patient tested positive for covid. On an unspecified date in Aug2021 the patient underwent lab tests and procedures which included Covid-19 test which was resulted positive. The patient was recovering from the covid.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 by Antibodies test on Monday 02Aug and by PCR on 04Aug; positive COVID-19 test with symptom; This is a spontaneous report from a contactable other hcp.    A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. The patient's concomitant medications were not reported.  The patient tested positive for covid-19 by antibodies test on 02aug2021 and positive by PCR on 04aug2021. Symptoms was mild flu-like so far. The patient was exposed to virus around 30Jul2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 to the reported drug ineffective / COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: My husband is dying right now from your vaccine.; This is a spontaneous report from Pfizer-sponsored program - via a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, expiration date not provide) as a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient's (reporter's husband) was dying right now from the vaccine  (life threatening) on an unspecified date with outcome of unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Tested positive for COVID19 within 5 days of being exposed to another COVID positive person who also received both doses of the BioNTech vaccine.; Tested positive for COVID19 within 5 days of being exposed to another COVID positive person who also received both doses of the BioNTech vaccine.; This is a spontaneous report from a contactable consumer or other non hcp.  A 60-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date in March2021 as dose 1, single and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 2 single, both for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient known allergies were reported as unknown. Patient did not have covid prior vaccination. Patient did not receive other vaccine in four weeks. Patient had tested for covid post vaccination. On 08Aug2021 the patient experienced tested positive for covid19 within 5 days of being exposed to another covid positive person who also received both doses of the biontech vaccine. On 07Aug2021 the patient underwent lab tests and procedures which included Nasal Swab, covid test name post vaccination-Rapid test (sars-cov-2 antibody test): positive. Patient did not receive treatment for the events. Outcome of the events was not resolved.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest X-ray, Chest pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for patient (mother). A 57-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# SC3180), at age 57, via an unspecified route of administration, left arm, on Aug 4, 2021, 17:45, single dose, for COVID-19 immunisation. The patient's medical history reported as none. The concomitant medications not reported. On Aug 4, 2021 at 22:00, patient experienced leg pain, back pain and body aches all over. On Aug 5, 2021 at 01:00, patient experienced chest pain. The caller stated patient was taken to the emergency room at 2:00 am on Thursday, Aug 5, 2021 because of chest pain. The caller stated prior to receiving the vaccine, her mother did not have any of these symptoms and did not have chest pain. The caller also reported her mother improving a little bit at home with pain killers. She was instructed by the emergency room doctor to follow up with her primary care provider. Her mother treated and released from the emergency room; and that day her mother's lower back pain was nothing like she had previous week. The back pain was part of her body aches. Caller stated her mother got the vaccine, at her recommendation. Now that she got the first dose, her mother said, she will not be getting the second dose of vaccine. They ran lab tests at the ER. Everything came back okay. The patient underwent lab tests and procedures, which included a blood test (came back okay on an unspecified date in Aug 2021); and a chest X-ray (came back okay on an unspecified date in Aug 2021). The outcome of the events reported: resolving.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reported for patient (mother). A 57-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# SC3180), at age 57, via an unspecified route of administration, left arm, on Aug 4, 2021, 17:45, single dose, for COVID-19 immunisation. The patient's medical history reported as none. The concomitant medications not reported. On Aug 4, 2021 at 22:00, patient experienced leg pain, back pain and body aches all over. On Aug 5, 2021 at 01:00, patient experienced chest pain. The caller stated patient was taken to the emergency room at 2:00 am on Thursday, Aug 5, 2021 because of chest pain. The caller stated prior to receiving the vaccine, her mother did not have any of these symptoms and did not have chest pain. The caller also reported her mother improving a little bit at home with pain killers. She was instructed by the emergency room doctor to follow up with her primary care provider. Her mother treated and released from the emergency room; and that day her mother's lower back pain was nothing like she had previous week. The back pain was part of her body aches. Caller stated her mother got the vaccine, at her recommendation. Now that she got the first dose, her mother said, she will not be getting the second dose of vaccine. They ran lab tests at the ER. Everything came back okay. The patient underwent lab tests and procedures, which included a blood test (came back okay on an unspecified date in Aug 2021); and a chest X-ray (came back okay on an unspecified date in Aug 2021). The outcome of the events reported: resolving.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Influenza like illness, Nasopharyngitis, Rhinorrhoea
Clinical narrative: she felt like she was having a very bad cold, or like she was getting the flu; she thought it was a combination of flu and allergies; she only had a runny nose; pain in her joints, her knees and elbows hurt; she noticed a big red circle in the injection site; she felt like she was having a very bad cold, or like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the Pfizer Covid 19 vaccine at the pharmacy and the next day she felt like she was having a very bad cold, or like she was getting the flu. At first she thought it was a combination of flu and allergies, but she also experienced pain in her joints, her knees and elbows hurt and she noticed a big red circle in the injection site. The following day she felt okay, she only had a runny nose but she was not sure if it was a reaction to the vaccine or the weather. The patient wanted to know if these symptoms are normal after receiving the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: she felt like she was having a very bad cold, or like she was getting the flu; she thought it was a combination of flu and allergies; she only had a runny nose; pain in her joints, her knees and elbows hurt; she noticed a big red circle in the injection site; she felt like she was having a very bad cold, or like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the Pfizer Covid 19 vaccine at the pharmacy and the next day she felt like she was having a very bad cold, or like she was getting the flu. At first she thought it was a combination of flu and allergies, but she also experienced pain in her joints, her knees and elbows hurt and she noticed a big red circle in the injection site. The following day she felt okay, she only had a runny nose but she was not sure if it was a reaction to the vaccine or the weather. The patient wanted to know if these symptoms are normal after receiving the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died; Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (aunt) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported her aunt just had the PFIZER covid vaccine but ended up getting the delta variant then died. The patient died on 06Aug2021. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died; Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died