chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gene mutation identification test, Investigation, Polymerase chain reaction, Vaccination failure
Clinical narrative: fatigue, sinus congestion, and a headache developed, tested positive for SARS-CoV-2 RNA; fatigue, sinus congestion, and a headache developed, tested positive for SARS-CoV-2 RNA; This is a literature report. The full publication has been requested.  Follow-up (14Jul2021): The initial case was missing the following minimum criteria: [unspecified product]. Upon receipt of follow-up information on (14Jul2021), this case now contains all required information to be considered valid. This is a literature report. The authors describe two fully vaccinated persons in whom subsequent breakthrough infections with SARS-CoV-2 variants harboring a number of substitutions of interest developed.   A 65-year-old female patient received BNT162B2, dose 1 intramuscular on 19Jan2021 (Batch/Lot number was not reported) as single dose, dose 2 intramuscular on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was healthy previously with no risk factors for severe Covid-19 who received the first dose of BNT162b2 vaccine on 19Jan2021 and the second dose on February 9. Pain that developed in the inoculated arm lasted for 2 days. On 03Mar2021, her unvaccinated partner tested positive for SARS-CoV-2, and on 16Mar2021, fatigue, sinus congestion, and a headache developed in Patient. On 17Mar2021, she felt worse and tested positive for SARS-CoV-2 RNA, 36 days after completing vaccination. Her symptoms plateaued and began to resolve on 20Mar2021.  The patient underwent other lab tests and procedures in 2021 which included 69/70 deletion,  A570D, D138Y, D215G, D253G, D80A, delta 242-244, H655Y, all Not detected; A701V: Undetermined; D614G: Detected; D796H: Undetermined; del142-145: Detected (G142V, del144); E484K: Undetermined; F220I: Detected; K417T: Undetermined; L452R: Undetermined; N501Y: Undetermined; P681H: partial heterozygosity; R190T: Detected; R237K: Detected; R246T: Detected; S477N: partial heterozygosity; T95I: Detected; Historical examination: These data, together with the clinical history, provide strong evidence that this  patient probably had neutralizing antibodies  elicited by vaccination; pseudotype neutralization assay: Unknown result; RT-PCR: to determine the corresponding Ct values for each dilution approximately 400 copies per milliliter. The action taken in response to the event for bnt162b2 was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Headache, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets; Body aches; Chills; Got the second dose 2 weeks after the first dose; Could not function correctly; Headache; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, in Left Arm on 03May2021 at 11:30 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Left Arm on 19APr2021 at 11:30 as dose 1, single dose for COVID-19 immunization and experienced Could not function correctly, Headaches, Body aches, and chills. On 03May2021, the patient got the second dose 2 weeks after the first dose and experienced Could not function correctly pain , muscle aches, Body aches, swelling, Chills, Pain was all over the body on the right side. on 13May21 patient experienced Shingles, pain, Swollen, Low platelets caller stated that now she can't even use one of her arms. She had muscle aches and her nerves are acting up. She had nerve pain. patient visited physician office for adverse event. The patient underwent lab tests and procedures which included blood test: positive on 23May2021 Positive for shingles, blood test: decreased on 23May2021 low platelets. Therapeutic measures were taken as a result of all the events where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg. The outcome for the events was not recovered.  Information on the lot/batch number has been requested.  Amendment: (06Jun2021) This follow-up report is being submitted to amend previously reported information: To recode LLT from Loss of personal independence in daily activities to LLT General malaise, to delete LLT off label use.  Follow-up (21JUL2021): 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Malaise, Myalgia, Neuralgia, Pain
Clinical narrative: Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets; Body aches; Chills; Got the second dose 2 weeks after the first dose; Could not function correctly; Headache; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, in Left Arm on 03May2021 at 11:30 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Left Arm on 19APr2021 at 11:30 as dose 1, single dose for COVID-19 immunization and experienced Could not function correctly, Headaches, Body aches, and chills. On 03May2021, the patient got the second dose 2 weeks after the first dose and experienced Could not function correctly pain , muscle aches, Body aches, swelling, Chills, Pain was all over the body on the right side. on 13May21 patient experienced Shingles, pain, Swollen, Low platelets caller stated that now she can't even use one of her arms. She had muscle aches and her nerves are acting up. She had nerve pain. patient visited physician office for adverse event. The patient underwent lab tests and procedures which included blood test: positive on 23May2021 Positive for shingles, blood test: decreased on 23May2021 low platelets. Therapeutic measures were taken as a result of all the events where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg. The outcome for the events was not recovered.  Information on the lot/batch number has been requested.  Amendment: (06Jun2021) This follow-up report is being submitted to amend previously reported information: To recode LLT from Loss of personal independence in daily activities to LLT General malaise, to delete LLT off label use.  Follow-up (21JUL2021): 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Swelling
Clinical narrative: Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets; Body aches; Chills; Got the second dose 2 weeks after the first dose; Could not function correctly; Headache; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, in Left Arm on 03May2021 at 11:30 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Left Arm on 19APr2021 at 11:30 as dose 1, single dose for COVID-19 immunization and experienced Could not function correctly, Headaches, Body aches, and chills. On 03May2021, the patient got the second dose 2 weeks after the first dose and experienced Could not function correctly pain , muscle aches, Body aches, swelling, Chills, Pain was all over the body on the right side. on 13May21 patient experienced Shingles, pain, Swollen, Low platelets caller stated that now she can't even use one of her arms. She had muscle aches and her nerves are acting up. She had nerve pain. patient visited physician office for adverse event. The patient underwent lab tests and procedures which included blood test: positive on 23May2021 Positive for shingles, blood test: decreased on 23May2021 low platelets. Therapeutic measures were taken as a result of all the events where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg. The outcome for the events was not recovered.  Information on the lot/batch number has been requested.  Amendment: (06Jun2021) This follow-up report is being submitted to amend previously reported information: To recode LLT from Loss of personal independence in daily activities to LLT General malaise, to delete LLT off label use.  Follow-up (21JUL2021): 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test, Tachycardia
Clinical narrative: Tachycardia; Difficulty breathing while Lying down; This is a spontaneous report from a contactable consumer Other HCP nurse (patient). A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ewo0183), via an unspecified route of administration in Arm Left on 17May2021 16:00 (age at the time of vaccination 33-years-old), single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ew0162), via an unspecified route of administration on 18Apr2021 03:00 PM (age at the time of vaccination 33-years-old), single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive within 2 weeks of vaccination. On 18May2021 22:00 the patient experienced Tachycardia, and Difficulty breathing while Lying down. On 25Jan2021, the patient underwent lab tests and procedures which included Nasal Swab, SARS-CoV-2 test: Pending. Patient received Tylenol treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date 2021.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood pressure increased, Blood pressure measurement, Cardiac disorder, Cardiac stress test
Clinical narrative: Ringing in both ears; Ear pressure, clogging and the feeling of water in the ears; Chest tightness; Sternum pain; Aches and pains throughout my upper body, exacerbated by exercise; Transthoracic Echo showed some abnormalities.; Blood pressure elevated; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 49-year-old male patient received first dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6202), via an unspecified route in the left arm on 27Feb2021 at 14:15 (age at vaccination: 49-year-old), as a single dose for covid-19 immunization. Medical history included high cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 01Mar2021, 36 hours after vaccination, patient woke up at 03:00 am with ringing in both ears for the first time in his life. Patient have seen two ENTs and a chiropractor. Patient have had periods of ear pressure, clogging and the feeling of water in the ears. In addition, 13 days after vaccination on an unknown date, patient started experienced chest tightness, sternum pain, aches and pains throughout his upper body, exacerbated by exercise, transthoracic echo showed some abnormalities and blood pressure elevated, still. Therapeutic measures taken as a result of the events included nasal spray, allegra, chiropractor and acupuncture. Patient has received second dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6206), via an unspecified route in the left arm on 20Mar2021 at 12:45, as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included hearing test was normal and showed no loss of hearing, pressure test was normal, Chest xray and stress test was normal, transthoracic echo showed some abnormalities, blood pressure elevated, PCR (SARS-CoV-2 test) nasal swab: negative on 10Mar2021 and 20Mar2021. The clinical outcome of periods of ear pressure, clogging and the feeling of water in the ears have diminished over the past 12 weeks and only now happen a few times a week, but the ringing in the ears persists. It was constant but he has gotten more used to it, and there are times when it is louder and times when it is less loud, chest symptoms have mostly resolved, blood pressure elevated, still, sternum pain, aches and pains throughout upper body, exacerbated by exercise was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Ear discomfort, Echocardiogram, Investigation
Clinical narrative: Ringing in both ears; Ear pressure, clogging and the feeling of water in the ears; Chest tightness; Sternum pain; Aches and pains throughout my upper body, exacerbated by exercise; Transthoracic Echo showed some abnormalities.; Blood pressure elevated; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 49-year-old male patient received first dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6202), via an unspecified route in the left arm on 27Feb2021 at 14:15 (age at vaccination: 49-year-old), as a single dose for covid-19 immunization. Medical history included high cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 01Mar2021, 36 hours after vaccination, patient woke up at 03:00 am with ringing in both ears for the first time in his life. Patient have seen two ENTs and a chiropractor. Patient have had periods of ear pressure, clogging and the feeling of water in the ears. In addition, 13 days after vaccination on an unknown date, patient started experienced chest tightness, sternum pain, aches and pains throughout his upper body, exacerbated by exercise, transthoracic echo showed some abnormalities and blood pressure elevated, still. Therapeutic measures taken as a result of the events included nasal spray, allegra, chiropractor and acupuncture. Patient has received second dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6206), via an unspecified route in the left arm on 20Mar2021 at 12:45, as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included hearing test was normal and showed no loss of hearing, pressure test was normal, Chest xray and stress test was normal, transthoracic echo showed some abnormalities, blood pressure elevated, PCR (SARS-CoV-2 test) nasal swab: negative on 10Mar2021 and 20Mar2021. The clinical outcome of periods of ear pressure, clogging and the feeling of water in the ears have diminished over the past 12 weeks and only now happen a few times a week, but the ringing in the ears persists. It was constant but he has gotten more used to it, and there are times when it is louder and times when it is less loud, chest symptoms have mostly resolved, blood pressure elevated, still, sternum pain, aches and pains throughout upper body, exacerbated by exercise was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Ligament sprain, Pain, SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in both ears; Ear pressure, clogging and the feeling of water in the ears; Chest tightness; Sternum pain; Aches and pains throughout my upper body, exacerbated by exercise; Transthoracic Echo showed some abnormalities.; Blood pressure elevated; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 49-year-old male patient received first dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6202), via an unspecified route in the left arm on 27Feb2021 at 14:15 (age at vaccination: 49-year-old), as a single dose for covid-19 immunization. Medical history included high cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 01Mar2021, 36 hours after vaccination, patient woke up at 03:00 am with ringing in both ears for the first time in his life. Patient have seen two ENTs and a chiropractor. Patient have had periods of ear pressure, clogging and the feeling of water in the ears. In addition, 13 days after vaccination on an unknown date, patient started experienced chest tightness, sternum pain, aches and pains throughout his upper body, exacerbated by exercise, transthoracic echo showed some abnormalities and blood pressure elevated, still. Therapeutic measures taken as a result of the events included nasal spray, allegra, chiropractor and acupuncture. Patient has received second dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6206), via an unspecified route in the left arm on 20Mar2021 at 12:45, as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included hearing test was normal and showed no loss of hearing, pressure test was normal, Chest xray and stress test was normal, transthoracic echo showed some abnormalities, blood pressure elevated, PCR (SARS-CoV-2 test) nasal swab: negative on 10Mar2021 and 20Mar2021. The clinical outcome of periods of ear pressure, clogging and the feeling of water in the ears have diminished over the past 12 weeks and only now happen a few times a week, but the ringing in the ears persists. It was constant but he has gotten more used to it, and there are times when it is louder and times when it is less loud, chest symptoms have mostly resolved, blood pressure elevated, still, sternum pain, aches and pains throughout upper body, exacerbated by exercise was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Herpes zoster, Inappropriate schedule of product administration, Rash
Clinical narrative: Shingles lower back rashFacial filler edema; Shingles lower back rashFacial filler edema; Shingles lower back rashFacial filler edema; dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EW0162); This is a spontaneous report from a contactable consumer. A 41-years old non-pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00 (at the age of 41 year old )as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EW0162) as dose 2, single for covid-19 immunisation. Medical history included eczema, psoriasis. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced shingles lower back rash facial filler edema on 21Apr2021 14:00. The outcome of events was recovered with sequelae.  Follow-up (12Jul2021): Follow-up attempts are completed. No further information is expected  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak after first dose; This is a spontaneous report from a contactable consumer (reported for himself). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0179, Expiration date: Unknown), dose 1 via an unspecified route of administration, in Arm Left on 18May2021 09:45 (at the age of 33-years-old) as a single dose for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0185), via an unspecified route of administration, in Arm Left on 10Jun2021 10:30 (at the age of 33-years-old) as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 12:00, the patient experienced shingles outbreak after first dose. No Health issues prior. The adverse event resulted in emergency room/department or urgent care visit. The patient received treatment with Valacyclovir. The outcome of the event was not recovered, at the time of this report.  Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nodule, Pruritus, Vaccination site hypersensitivity
Clinical narrative: An allergic reaction in the left arm.; Golf ball size knot; Warm to the touch; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ew0217), via an unspecified route of administration, administered in Arm Left on 17Jun2021 at 16:30 (at the age of 43-years-old) as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history was not reported. Concomitant medications included oxcarbazepine (Trileptal) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall): both for an unspecified indication, start and stop dates were not reported. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient stated she developed an allergic reaction in the left arm. Golf ball size knot, warm to the touch, read at times itchy on 19Jun2021. 5 days later still there. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered at the time of this report.  Information on batch/lot numbers are available. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Food allergy
Clinical narrative: can't handle antibiotics or seafood, is now allergic to them; can't handle antibiotics or seafood, is now allergic to them; This is a spontaneous report from a contactable consumer (patient) from a. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), second dose via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, first dose 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 medical history and concomitant medications were not reported. The patient couldn't handle antibiotics or seafood, was then allergic to them on an unspecified date. Patient got both doses of the Covid vaccine and since then can't handle antibiotics or seafood. Patient stated he was then allergic to them. Caller stated his cousin was the same way. Provided PMI number and then because caller could understand what support team was saying interpreter hung up. Patient was about to transfer to the hospital for AE, but caller hung up while holding since they were having side effects after both doses. Clinical outcome of the events was unknown.  Follow-up attempts are possible. Information on Batch/Lot no. has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: I still see like headache, chills, fever and cold so strong and this comes and goes between this; I still see like headache, chills, fever and cold so strong and this comes and goes between this; I still see like headache, chills, fever and cold so strong and this comes and goes between this; I still see like headache, chills, fever and cold so strong and this comes and goes between this; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 25Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that the patient taken that second shot from Pfizer "yesterday" (25Jun2021) and (on an unknown date) still seen like headache, chills, fever and cold so strong and this comes and goes between this, was this normal or patient taken medicine and need to know, was there any way can "you" tell patient just some question which patient have, like Vitamin C, was that work if the patient take Vitamin C. The outcome of the events was known.  Information on the Batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in Arm on 12May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 for covid-19 immunization. It was reported that patient had the shot right in hand, the second shot was 12May2021 and patient did not know all of a sudden patient had, for a week or so, patient have been having a runny nose. patient wanted to know Is that anything to do with the shot. Patient wanted to know what do you advice on my runny nose. The outcome for the event was reported as not resolved at the time of this report.   Information related to batch/Lot no. was requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia, Hypoaesthesia oral, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Her feet and hands felt numb; Having a bit of anxiety attack; her hands feel like she can't open them all the way."; her lip is feeling numb; Having some face twitching; her hands are trembling and feeling numb; This is a spontaneous report received from a contactable consumer reported for his girlfriend (patient). A female patient of unspecified age received first dose of bnt162b2 (Pfizer COVID Vaccine, Solution for Injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced her feet and hands felt numb, then she has anxiety so she was having a bit of anxiety attack but now she says that they like, her hands are trembling and feeling numb, and her lip is feeling numb, and she is having some face twitching and she is having some, her hands feel like she can't open them all the way. The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Her feet and hands felt numb; Having a bit of anxiety attack; her hands feel like she can't open them all the way."; her lip is feeling numb; Having some face twitching; her hands are trembling and feeling numb; This is a spontaneous report received from a contactable consumer reported for his girlfriend (patient). A female patient of unspecified age received first dose of bnt162b2 (Pfizer COVID Vaccine, Solution for Injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced her feet and hands felt numb, then she has anxiety so she was having a bit of anxiety attack but now she says that they like, her hands are trembling and feeling numb, and her lip is feeling numb, and she is having some face twitching and she is having some, her hands feel like she can't open them all the way. The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back pain, Pain
Clinical narrative: He is having pain in his back; Pain; This is a spontaneous report from a contactable consumer (patient parent). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as single for covid-19 immunization. The patient received paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. Reporter stated patient got the second shot on Saturday and he was having pain in his back. When asked for further probing, reporter stated, want to know what could be done with the pain that all need to know. Treatment received in regard to events was aspirin. The outcome of events was unknown.  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: Drug intolerance
Clinical narrative: My boys and I get the same dose and it's toxic; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for 13-year-old male patient that:  A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She mentioned that she does not want to get the full dose of 30 mcg shot because she feels weird after getting the first shot, she feels shaky and quavering inside." My boys are small. My 13-year-old is only 89 pounds". They will get their second shot on 21July2021. The caller wants to get the smaller dose for the second one instead of full 30 mcg.  She thought it was too much and it was too toxic. She read that there are people having heart issues. She knows that there was a small risk but every day, she was just reading stuff. It was toxic and we need a smaller dose. She read that it does not take much to get an immune response. The vaccines are not only based on people's weight, but they are also based on people's age. She was a small person and receiving the same dose my husband was "4x" at. He has no side effects. Her boys and she get the same dose and it was toxic. It was a poison. There are "15M" that are sick on that shot. We are freaked out. She was a super healthy person, exercise couple miles a day and did not felt how she used to feel. She regrets the first shot, she did not want to do further damage. She wants to know if she can get the second dose and not the full shot of the dose, if not if she can just get one dose of the vaccines since she cannot tolerate the side effects. She mentioned that women are sometimes responding stronger to the shot because of their inflammatory response because of estrogens compared to testosterone in men and stuff. Would it be beneficial to take Ibuprofen if she starts feeling symptoms to help reduce the inflammation after getting the shot which can cause the spinal neurological symptoms. She was worried about neurological symptoms. The outcome of the event was unknown.  Information about lot/batch number is requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Hypersensitivity, Paraesthesia, Pruritus
Clinical narrative: Rash; itching; hives; Tingling in legs and feet; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 73-Year-old female patient first dose of BNT162B2 (PFIZER BIOTECH, COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration in upper right arm in the muscle on 05Jul2021 09:15 (age at the time of vaccination 12-years-old), as a single dose for COVID-19 immunization. The patient's medical history included she had 2 heart surgeries, irritable bowel syndrome, she took Fosamax for osteopenia and she had muscle cramps in her legs and feet and an upset stomach and nausea, osteopenia, Lipitor causes her muscle cramps and stomach pain, Dicyclomine for irritable bowel syndrome it was 10 mg that one she only took for a couple of days, she had the first shingles vaccine quite a few years ago and she had no side effects from that, and She has flu vaccines every year. Other relevant medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medication included vitamin D. Patient has trouble with the statins and She does take a statin now, is okay with it. On an unspecified date 2021, patient experienced allergic reaction; on 05Jul2021 Tiredness; on 05Jul2021 14:00 Tingling in legs and feet; on 05Jul2021 18:00 rash, itching, and hives. On an unspecified date, the patient underwent lab tests and procedures which included bloodwork, blood test: Unknown result. Patient did not visit emergency room or physician office. Upon consultation with her family doctor, she was advised not to get the second dose of vaccine and that she is "80% protected" already. Caller wanted to verify the information that her family doctor said, she asks if that is correct. The outcome of the evets allergic reaction was unknown; and all other events were recovered on 05Jul2021.  Information about batch/lot number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash; itching; hives; Tingling in legs and feet; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 73-Year-old female patient first dose of BNT162B2 (PFIZER BIOTECH, COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration in upper right arm in the muscle on 05Jul2021 09:15 (age at the time of vaccination 12-years-old), as a single dose for COVID-19 immunization. The patient's medical history included she had 2 heart surgeries, irritable bowel syndrome, she took Fosamax for osteopenia and she had muscle cramps in her legs and feet and an upset stomach and nausea, osteopenia, Lipitor causes her muscle cramps and stomach pain, Dicyclomine for irritable bowel syndrome it was 10 mg that one she only took for a couple of days, she had the first shingles vaccine quite a few years ago and she had no side effects from that, and She has flu vaccines every year. Other relevant medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medication included vitamin D. Patient has trouble with the statins and She does take a statin now, is okay with it. On an unspecified date 2021, patient experienced allergic reaction; on 05Jul2021 Tiredness; on 05Jul2021 14:00 Tingling in legs and feet; on 05Jul2021 18:00 rash, itching, and hives. On an unspecified date, the patient underwent lab tests and procedures which included bloodwork, blood test: Unknown result. Patient did not visit emergency room or physician office. Upon consultation with her family doctor, she was advised not to get the second dose of vaccine and that she is "80% protected" already. Caller wanted to verify the information that her family doctor said, she asks if that is correct. The outcome of the evets allergic reaction was unknown; and all other events were recovered on 05Jul2021.  Information about batch/lot number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Dysuria, Micturition urgency, Pain, Urinary tract infection
Clinical narrative: she went to bathroom to pee, it was cloudy and had blood in it; she has pain and has urge; she has pain and has urge; Not able to pee; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; Left arm was swollen at injection site.; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198), via an unspecified route of administration, administered in left arm (unable to confirm if given in the muscle) on 12Jul2021 at 20:20 (at the age of 19 years old) as single for covid-19 immunisation. Medical history included ongoing peanut allergy diagnosed when she was 1 year old. Concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRAN), 1 tablet daily in the morning for 28 days for contraception from Jan2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. She began to be experienced unconfirmed urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating on 13Jul2021. She asking have this been reported after receiving the Pfizer Covid-19 Vaccine? She just took it two days ago and woke up not being able to pee and peeing blood and stated that it caused a UTI on 13Jul2021. She has never had one before in her life. This happened the night after she got the vaccine and it may be just a coincidence. Her left arm was also swollen and when she went to bathroom to pee, it was cloudy and had blood in it. She knew it had to be the vaccine because she never had that before. A couple of hours after the vaccine she noticed her left arm was swollen at injection site on 12Jul2021 at 22:00. Yesterday morning on 13Jul2021 at 08:00 she was not able to pee. It improved a bit, but she has pain and has urge. It feels like she just has to pee even though she just peed. She googled it and it said it was a UTI. She has not been formally diagnosed yet. She first stated the peeing blood started on 13Jul2021. At around 1:00 am, there was a little bit of blood when she got up to pee. She did not see any this morning, but does not know how it will be throughout the day. It has improved for now. She would like to find out if this has been reported before. The patient did not visit emergency room or physician office. No relevant tests were performed. The outcome of events was she went to bathroom to pee, it was cloudy and had blood in it, she has pain and has urge was unknown, while with other events recovering.  Follow-up attempts are completed; no further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urine abnormality, Vaccination site swelling
Clinical narrative: she went to bathroom to pee, it was cloudy and had blood in it; she has pain and has urge; she has pain and has urge; Not able to pee; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; Left arm was swollen at injection site.; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198), via an unspecified route of administration, administered in left arm (unable to confirm if given in the muscle) on 12Jul2021 at 20:20 (at the age of 19 years old) as single for covid-19 immunisation. Medical history included ongoing peanut allergy diagnosed when she was 1 year old. Concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRAN), 1 tablet daily in the morning for 28 days for contraception from Jan2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. She began to be experienced unconfirmed urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating on 13Jul2021. She asking have this been reported after receiving the Pfizer Covid-19 Vaccine? She just took it two days ago and woke up not being able to pee and peeing blood and stated that it caused a UTI on 13Jul2021. She has never had one before in her life. This happened the night after she got the vaccine and it may be just a coincidence. Her left arm was also swollen and when she went to bathroom to pee, it was cloudy and had blood in it. She knew it had to be the vaccine because she never had that before. A couple of hours after the vaccine she noticed her left arm was swollen at injection site on 12Jul2021 at 22:00. Yesterday morning on 13Jul2021 at 08:00 she was not able to pee. It improved a bit, but she has pain and has urge. It feels like she just has to pee even though she just peed. She googled it and it said it was a UTI. She has not been formally diagnosed yet. She first stated the peeing blood started on 13Jul2021. At around 1:00 am, there was a little bit of blood when she got up to pee. She did not see any this morning, but does not know how it will be throughout the day. It has improved for now. She would like to find out if this has been reported before. The patient did not visit emergency room or physician office. No relevant tests were performed. The outcome of events was she went to bathroom to pee, it was cloudy and had blood in it, she has pain and has urge was unknown, while with other events recovering.  Follow-up attempts are completed; no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: could not walk properly and it's getting worse; This is a spontaneous report from a contactable physician. A 36-years-old female 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 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, 5minutes after receiving the vaccine, the patient could not walk properly and it's getting worse. The reporter stated he believes it may be either a neurological problem or osteoarthritis as it affects only half of her body. When she relaxes she's fine but when she starts walking and moving, it comes back viciously. She's crippled. The outcome of the event was not recovered. There was no product quality complaint (PQC) present.  Information about Lot/ Batch number has been requested.