chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Violent diarrhea the following day and contuing; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in right arm on 25Feb2021 (age at vaccination: 72-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EL9265) via unspecified route in right arm on 03Feb2021 1:00 PM (age at vaccination: 72-years) as dose 1, single for covid-19 immunisation. Patient medical history included high blood pressure from an unspecified date and unknown if ongoing. Patient experienced violent diarrhea the following day on 26Feb2021 and is continuing. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Treatment was given as a result of the adverse events, and was still in process. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Device date was reported as 19May2021. The outcome of event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Insomnia, Pyrexia
Clinical narrative: Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia.; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia.; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; This is a spontaneous report from a non-contactable pharmacist.     A 39-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6199), dose 1 intramuscular, administered in Arm Left on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. The patient receive other vaccine previously. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia. Patient consented to receiving second dose after education with RN on an unspecified date with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable Other Healthcare Professional. A 92-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 92-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on an unspecified date. The patient experienced fever and chills on 18Mar2021 for 24 hours. It was reported that the MD was aware. Outcome of events were recovered on 19Mar2021.   No follow-up attempts are needed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Nausea; Cold; soreness at injection; itching at injection site; woke with a sweaty neck; Dizziness; He experienced weakness 1-2 hours after he received the first dose.; Drowsiness; Fever; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Right arm on 11Feb2021 (at the age of 60 year) as dose 1, single for COVID-19 immunisation.  Medical history included itching and soreness from allergy shot from 29Jan2021 to 01Feb2021.He gets an allergy shot every 2 weeks. His last allergy shot was on 29Jan2021. He didn't take it for 14 days prior to getting the Covid-19 vaccine. He doesn't know the name of the medication that he gets with the allergy shot. There were no concomitant medications. On 11Feb2021, 1-2 hours after he received the first dose, the patient experienced weakness. He also was drowsy. The dizziness lasted about three hours. When he went to bed he had a fever and nausea. He was cold for a few hours. He felt like he wanted to throw up. He got under the covers and a hour to two later it subsided. He started drinking water to help with the nausea. The fever lasted about two hours. He woke with a sweaty neck. He was cold for 35-40 minutes. No relevant tests were done. The outcome of the events was Drowsiness, pyrexia, nausea, cold was recovered; dizziness was recovered with sequel; sweating was unknown and of other events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test, Skin depigmentation, Vitiligo
Clinical narrative: 2 weeks after getting second shot I started getting white spots on hands and face.; 2 weeks after getting second shot I started getting white spots on hands and face.; Vitiligo; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 60-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EN6208; Expiration Date: 30Jun2021), dose 2 via an intramuscular route of administration, administered in arm left on 15Mar2021 at 09:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunisation. Medical history included ongoing high blood pressure and ongoing cholesterol from an unknown date. Historical vaccine included first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EN6201, Expiration Date: 30Jun2021) via an intramuscularly administered in left arm on 22Feb2021 at 09.00 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation and received two doses of chicken pox vaccine, dose 1 on 01Aug2021 and dose 2 on 02Aug2021 (Formulation: injection) in left arm (at the age of 61-year-old) for chicken pox. Concomitant medications included pravastatin 20 mg via oral taken for cholesterol from Feb2021 and ongoing and amlodipine 5mg via oral taken for blood pressure from an unspecified start date and ongoing. The patient was not received other medications within 2 weeks of vaccination. No any other prior vaccinations within 4 Weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced 2 weeks after getting second shot he started getting white spots on hands and face on 05Apr2021 at 08:00 and vitiligo on 30Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 03May2021. The patient received treatment for the adverse events with cream to put on spots/ hands (2x day). The outcome of events reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 72, via an unspecified route of administration, in right arm, on Apr 14, 2021, at 17:30, single dose, for COVID-19 immunisation. The patient's medical history included known allergies to fruits and dairy; all from an unknown date and unknown if ongoing. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced palpitations, PAC (premature atrial contraction), PVC (premature ventricular contractions) and atrial trigeminy on May 14, 2021, 12:30 pm. Treatment received as a result of events: Propranolol. The outcome of the events: not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No follow-up attempts possible.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, SARS-CoV-2 test
Clinical narrative: After the first injection, I noticed that I can barely move my arm. Lots of pain and hard join movement.; After the first injection, I noticed that I can barely move my arm. Lots of pain and hard join movement.; This is a spontaneous report from a contactable consumer or other non hcp. A 55-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not re-ported. On an unknown date, it was reported that after the first injection, he noticed that he can barely move his arm. Lots of pain and hard join movement. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab as Covid test type post vaccination: Nasal Swab  Covid test result: Negative on an unknown date.  The outcome of all events reported as an unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021634370 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: low-grade fever; Injection site tenderness; Chills; Feeling unwell; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as in her middle of 20s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 06Jan2021, as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low-grade fever, injection site tenderness, chills, feeling unwell on an unspecified date. 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in arm; Tiredness; This is a Spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received  bnt162b2 (PFIZER BIONTECH COVID19 VACCINE, Lot#:Ew0187), via an unspecified route of administration in arm left on 04Jun2021 12:30 at age of 49-year-old as dose 1, single for COVID-19 immunisation. The patient had no known allergies. Prior to vaccination, the patient was diagnosed as COVID-19. The patient was not preganant at time of the vaccination. Other vaccine in four weeks and other medications in two weeks were none. On 05Jun2021, the patient experienced pain in arm,tiredness and swallowed though. The events did not resulted in emergency room visit or physician office visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. In 2021, the outcome of adverse events pain in arm,tiredness and swallowed though was resolved.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Scar
Clinical narrative: Very bad itching on arms, legs, back, check, stomach.; Bumps that would in same cases stay or others that would come and go. Only one filled with fluid.; Some left scarring.; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 49-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, expiration date: not reported) via an unspecified route of administration, administered in left arm on Mar2021 (at the age of 49-years-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, expiration date: not reported) via an unspecified route of administration, administered in left arm on Mar2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunization. Medical history included depression and anxiety start and stop date was unknown. Patient had no known allergies. Concomitant medication(s) included hydroxyzine (HYDROXYZINE), montelukast (MONTELUKAST), fexofenadine hydrochloride (ALLEGRA) and sertraline (SERTRALINE and Montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. I saw the family physician twice and and then they sent me to the allergist. The allergist said it was not hives. It has gone with the exception of my chest still itching from time to time. Prior vaccination, Patient had not covid since tested no covid. On 24Mar2021, patient experienced very bad itching on arms, legs, back, check, stomach, bumps that would in same cases stay or others that would come and go. only one filled with fluid, some Therapeutic measures were taken as a result of very bad itching on arms, legs, back, check, stomach, bumps that would in same cases stay or others that would come and go. only one filled with fluid, some left scarring. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Oral and topical treatments. The outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Diarrhoea, Headache, Pain, Protein urine present
Clinical narrative: presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; Persistent Fever for 2 weeks and 5 days after the 2nd dose of the vaccination; Some body aches; headache; throwing up; diarrhea; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient).   A 46-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021(at 46-years of age) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did don't had COVID prior vaccination and not COVID tested post vaccination. And patient had no Known allergies. On 20May2021 the patient experienced persistent fever for 2 weeks and 5 days after the 2nd dose of the vaccination, some body aches, headache, throwing up (vomiting) and diarrhoea. The patient presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein on 08Jun2021. Patient visited Doctor or other healthcare professional office/clinic visit. Therapeutic measures include Nitrofurantoin mono mcr 100 mg. The events outcome was reported as not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis, Vomiting, White blood cells urine
Clinical narrative: presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; Persistent Fever for 2 weeks and 5 days after the 2nd dose of the vaccination; Some body aches; headache; throwing up; diarrhea; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient).   A 46-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021(at 46-years of age) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did don't had COVID prior vaccination and not COVID tested post vaccination. And patient had no Known allergies. On 20May2021 the patient experienced persistent fever for 2 weeks and 5 days after the 2nd dose of the vaccination, some body aches, headache, throwing up (vomiting) and diarrhoea. The patient presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein on 08Jun2021. Patient visited Doctor or other healthcare professional office/clinic visit. Therapeutic measures include Nitrofurantoin mono mcr 100 mg. The events outcome was reported as not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cholelithiasis
Clinical narrative: My mom also received the Pfizer vaccine and had gallstones after as well; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that I'm not sure if this was caused by the vacccine or not, but I got gallstones and had gallbladder removal surgery after. My mom also received the Pfizer vaccine and had gallstones after as well (cholelithiasis) (non-serious) 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.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Electrocardiogram, Fatigue, Local reaction
Clinical narrative: Vaccination related malaise; fatigue; local reaction/ sore arm; Fever; local reaction/ sore arm; undiluted second dose of pfizer-biontech covid-19 vaccine; Administered undiluted second dose of Pfizer-BioNTech Covid-19 Vaccine; Paronychia; This is a spontaneous report from a contactable other health care professional. A 14-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191 and expiration date: 30Sep2021) via an intramuscular route of administration in right deltoid on 11Jun2021 at 11:55 AM (age at vaccination 14-year-old) as DOSE 2, 0.3 ml, SINGLE for covid-19 immunisation at physician's office. The patient's medical history included GERD from Dec 2020 to Feb 2021, ongoing paronychia from Jun2021, ongoing obesity from Mar2019, ongoing allergic rhinitis from Jun2016. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0177) on 19May2021 10:55 AM (age at vaccination 14-year-old) at via intramuscular route of administration in left deltoid as DOSE 1, SINGLE for covid-19 immunization. On 11Jun2021, a 14-year-old male patient administered undiluted second dose of Pfizer-Biontech covid-19 vaccine. On 19Jun2021, the patient experienced local reaction/ sore arm, fatigue, fever. On an unknown date, the patient experienced vaccination related malaise and paronychia. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures, which included on 18Jun2021 Brain natriuretic peptide: 21 pg/mL (normal low: 0, normal high: 99), C-reactive protein: less than 0.5 mg/dl (normal high: 0.5), electrocardiogram: normal, ESR (red blood cell sedimentation rate): 10 mm/hr (normal low: 0, normal high: 15), troponin I: less than 3 ng/l (normal high: 45). The NDC number of Pfizer-BioNTech Covid-19 Vaccine: 59267-1000-1. These events local reaction/ sore arm, fatigue, fever were considered non-serious. The outcome of the events local reaction/ sore arm, fatigue, fever was recovered in 2021 and unknown for other events. The physician considers the Pfizer product had a causal effect to the adverse event.  Information on Lot/Batch number was available. Additional information has been requested.  Follow up (06Jul2021 and 09Jul2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to the HCP letter sent that included: The physician considers the Pfizer product had a causal effect to the adverse event. Added new events local reaction/ sore arm, fatigue, fever, vaccination related malaise and paronychia. Added all lab data. Added all medical history.  Follow-up attempts are completed. No further information was expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Paronychia, Product preparation error, Pyrexia
Clinical narrative: Vaccination related malaise; fatigue; local reaction/ sore arm; Fever; local reaction/ sore arm; undiluted second dose of pfizer-biontech covid-19 vaccine; Administered undiluted second dose of Pfizer-BioNTech Covid-19 Vaccine; Paronychia; This is a spontaneous report from a contactable other health care professional. A 14-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191 and expiration date: 30Sep2021) via an intramuscular route of administration in right deltoid on 11Jun2021 at 11:55 AM (age at vaccination 14-year-old) as DOSE 2, 0.3 ml, SINGLE for covid-19 immunisation at physician's office. The patient's medical history included GERD from Dec 2020 to Feb 2021, ongoing paronychia from Jun2021, ongoing obesity from Mar2019, ongoing allergic rhinitis from Jun2016. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0177) on 19May2021 10:55 AM (age at vaccination 14-year-old) at via intramuscular route of administration in left deltoid as DOSE 1, SINGLE for covid-19 immunization. On 11Jun2021, a 14-year-old male patient administered undiluted second dose of Pfizer-Biontech covid-19 vaccine. On 19Jun2021, the patient experienced local reaction/ sore arm, fatigue, fever. On an unknown date, the patient experienced vaccination related malaise and paronychia. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures, which included on 18Jun2021 Brain natriuretic peptide: 21 pg/mL (normal low: 0, normal high: 99), C-reactive protein: less than 0.5 mg/dl (normal high: 0.5), electrocardiogram: normal, ESR (red blood cell sedimentation rate): 10 mm/hr (normal low: 0, normal high: 15), troponin I: less than 3 ng/l (normal high: 45). The NDC number of Pfizer-BioNTech Covid-19 Vaccine: 59267-1000-1. These events local reaction/ sore arm, fatigue, fever were considered non-serious. The outcome of the events local reaction/ sore arm, fatigue, fever was recovered in 2021 and unknown for other events. The physician considers the Pfizer product had a causal effect to the adverse event.  Information on Lot/Batch number was available. Additional information has been requested.  Follow up (06Jul2021 and 09Jul2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to the HCP letter sent that included: The physician considers the Pfizer product had a causal effect to the adverse event. Added new events local reaction/ sore arm, fatigue, fever, vaccination related malaise and paronychia. Added all lab data. Added all medical history.  Follow-up attempts are completed. No further information was expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Troponin I, Vaccination complication
Clinical narrative: Vaccination related malaise; fatigue; local reaction/ sore arm; Fever; local reaction/ sore arm; undiluted second dose of pfizer-biontech covid-19 vaccine; Administered undiluted second dose of Pfizer-BioNTech Covid-19 Vaccine; Paronychia; This is a spontaneous report from a contactable other health care professional. A 14-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191 and expiration date: 30Sep2021) via an intramuscular route of administration in right deltoid on 11Jun2021 at 11:55 AM (age at vaccination 14-year-old) as DOSE 2, 0.3 ml, SINGLE for covid-19 immunisation at physician's office. The patient's medical history included GERD from Dec 2020 to Feb 2021, ongoing paronychia from Jun2021, ongoing obesity from Mar2019, ongoing allergic rhinitis from Jun2016. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0177) on 19May2021 10:55 AM (age at vaccination 14-year-old) at via intramuscular route of administration in left deltoid as DOSE 1, SINGLE for covid-19 immunization. On 11Jun2021, a 14-year-old male patient administered undiluted second dose of Pfizer-Biontech covid-19 vaccine. On 19Jun2021, the patient experienced local reaction/ sore arm, fatigue, fever. On an unknown date, the patient experienced vaccination related malaise and paronychia. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures, which included on 18Jun2021 Brain natriuretic peptide: 21 pg/mL (normal low: 0, normal high: 99), C-reactive protein: less than 0.5 mg/dl (normal high: 0.5), electrocardiogram: normal, ESR (red blood cell sedimentation rate): 10 mm/hr (normal low: 0, normal high: 15), troponin I: less than 3 ng/l (normal high: 45). The NDC number of Pfizer-BioNTech Covid-19 Vaccine: 59267-1000-1. These events local reaction/ sore arm, fatigue, fever were considered non-serious. The outcome of the events local reaction/ sore arm, fatigue, fever was recovered in 2021 and unknown for other events. The physician considers the Pfizer product had a causal effect to the adverse event.  Information on Lot/Batch number was available. Additional information has been requested.  Follow up (06Jul2021 and 09Jul2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to the HCP letter sent that included: The physician considers the Pfizer product had a causal effect to the adverse event. Added new events local reaction/ sore arm, fatigue, fever, vaccination related malaise and paronychia. Added all lab data. Added all medical history.  Follow-up attempts are completed. No further information was expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Muscle spasms, Myalgia, Nausea
Clinical narrative: Extreme pharyngitis with swelling making it difficult to breathe; Extreme pharyngitis with swelling making it difficult to breathe; Extreme pharyngitis with swelling making it difficult to breathe; 6 days later arm is still swollen with muscle spasms.; 6 days later arm is still swollen with muscle spasms.; Nausea; diarrhea; myalgia; This is a spontaneous report from a contactable Nurse. An 18-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via unspecified route administered in Arm Left on 18Jun2021 (at the age of 18-years-old) as single dose for covid-19 immunisation. Medical history included periodic fever syndrome. Patient had no known drug allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid tested post vaccination. On 18Jun2021 20:00, patient experienced extreme pharyngitis with swelling making it difficult to breathe, 6 days later arm is still swollen with muscle spasms, nausea, diarrhea and myalgia. Therapeutic measures were not taken due to the events. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 24Jun2021. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pharyngeal swelling, Pharyngitis, SARS-CoV-2 test
Clinical narrative: Extreme pharyngitis with swelling making it difficult to breathe; Extreme pharyngitis with swelling making it difficult to breathe; Extreme pharyngitis with swelling making it difficult to breathe; 6 days later arm is still swollen with muscle spasms.; 6 days later arm is still swollen with muscle spasms.; Nausea; diarrhea; myalgia; This is a spontaneous report from a contactable Nurse. An 18-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via unspecified route administered in Arm Left on 18Jun2021 (at the age of 18-years-old) as single dose for covid-19 immunisation. Medical history included periodic fever syndrome. Patient had no known drug allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid tested post vaccination. On 18Jun2021 20:00, patient experienced extreme pharyngitis with swelling making it difficult to breathe, 6 days later arm is still swollen with muscle spasms, nausea, diarrhea and myalgia. Therapeutic measures were not taken due to the events. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 24Jun2021. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure increased, Blood pressure measurement
Clinical narrative: Increased blood pressure and worsened asthmatic symptoms for 2+ months after; Increased blood pressure and worsened asthmatic symptoms for 2+ months after; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0170, Expiration Date: not reported) via an unspecified route of administration in right arm on 28Apr2021 17:00 as dose 2, single for COVID-19 immunization (at the age of 23-year-old, non-pregnant). Historical vaccine included 1st dose of BNT162B2 (Lot number: EP6955, Expiration Date: not reported) via an unspecified route of administration in left arm on 29Mar2021 17:00 as dose 2, single for COVID-19 immunization (at the age of 23-year-old). Medical history included covid-19 from an unknown date and unknown if ongoing prior vaccination, High blood pressure and asthma from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC); Montelukast and norethindrone acetate all taken for an unspecified indication, start and stop date were not reported. Patient did not received other vaccine in four weeks. The patient experienced increased blood pressure and worsened asthmatic symptoms for 2+ months after on 30Apr2021 12:00. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 30Apr2021. Therapeutic measures were taken as a result of increased blood pressure and worsened asthmatic symptoms for 2+ months after with Increased dosage of existing medications. Covid was not tested post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: he had two diarrhea episodes and the third day one episode so far; This is a spontaneous report from a contactable Physician. A 14-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via intramuscular route of administration in left arm on 26Jun2021 at 14:30 (at the age of 14 years old) as dose 1, single for covid-19 immunisation. Medical history included rare epilepsy, developmental delay, hypotonia. The patient had known allergies to penicillin, pneumococcal vaccine. Concomitant medication included ibuprofen (ADVIL 12 HOUR), 200 mg once time. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Jun2021 at 12:00 second day post vaccination he had two diarrhea episodes and the third day one episode so far. Therapeutic measures were taken as a result of he had two diarrhea episodes and the third day one episode so far with pedialyte and probiotics. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), as DOSE 1, SINGLE, then as DOSE 2, SINGLE, both at the age of 31-years-old, via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chest pain on 06Jul2021. There was no treatment received for the event. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: red itchy rash all over torso; red itchy rash all over torso; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 47-year-old intramuscularly administered in left arm on 03Jul2021 11:15 (Lot Number: EW0196; Expiration Date: Sep2021) as dose 1, single for covid-19 immunisation. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications included ascorbic acid, colecalciferol, nicotinamide, panthenol, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTI VITAMIN); cetirizine hydrochloride (ZYRTEC); calcium; and unspecified birth control pills, all indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jul2021 18:00, the patient experienced red itchy rash all over torso. It was further reported that on day 3 after vaccine, she noticed red itchy rash all over torso. It resembles chicken pox. It's been 6 days of rash and it doesn't appear to be getting any better. The patient has not been tested for covid-19 since vaccination. The patient received treatment for the adverse events which included a prescription for prednisone. The reporter considered the case as non-serious. The adverse events resulted in physician office visit. The outcome of the events was recovered on 22Jul2021. The patient received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) dose 2 at vaccination age of 47-year-old intramuscular in the left arm (reported as left bicep) on 24Jul2021 11:45 (Lot Number: FA7484) as dose 2, single for covid-19 immunisation.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missing menstrual cycle; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration, in the left arm, on 25Jun2021 17:00 (at the age of 48-years-old), as dose number unknown, single for COVID-19 immunisation. The patient has no relevant medical history and concomitant medications were not reported. Patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced missing menstrual cycle on 07Jul2021. Event did not result to either physician office visit nor to emergency room visit. No treatment was given as a result of the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: My menstrual cycle has been very altered; period was very abundant; continued spotting till the 22May; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 13May2021 at 16:30 (Batch/Lot Number: EW0168) (at the age of 30 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism. The patient was not pregnant at time of vaccination. The patient had no reported allergies. The patient did not undergo COVID-19 prior to vaccination. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks of COVID-19 vaccine. The patient experienced menstrual cycle had been very altered, period was very abundant and continued spotting on 13May2021 at 18:00. The course of events was as follows: The patient's menstrual cycle had been very altered since her first shot. She had her period the day she had the 1st dose and that months period was very abundant (13May2021) and she continued spotting until the 22May2021 (her period usually lasts max. 5 days). The second period she had after second dose same problem (13Jun until 22Jun). This month she had spotting between cycles for 3 days (ovulation phase she believed) and she was spotting again the last 3 days. She already got an appointment with the doctor for next week. Is this normal? The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the event. The outcome of event spotting was recovered on 22May2021, while outcome of events menstrual cycle had been very altered and period was very abundant was unknown. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jun2021 (Batch/Lot Number: EW0217) administered in left arm for COVID-19 immunisation. The patient underwent laboratory tests and procedures which included PCR COVID test: negative on 10Jun2021 Nasal Swab.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed her period by 11 days; This is a spontaneous report from a non-contactable consumer (patient herself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 28Jun2021 at 17:00 at the age of 19 years old (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The vaccination facility type was a pharmacy or drug store. Relevant medical history included COVID-19 prior vaccination on an unknown date. There were no concomitant medications; no other medications in two weeks. The patient had no other vaccine in four weeks. The patient was not tested for COVID-19 post vaccination. The patient missed her period by 11 days on 28Jun2021. The patient did not receive any treatment for the adverse event (AE). The patient was not recovered from the event at the time of the report.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Extreme fatigue; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old non-pregnant female 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 dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No COVID prior to vaccination. Not been tested post vaccination. The patient experienced extreme fatigue and weakness on an unspecified date. Patient had bed rest. No treatment was given for the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash with itching at the top of her back on both sides, down each of her sides & on her arm; rash with itching at the top of her back on both sides, down each of her sides & on her arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration on 09Jul2021 as dose 2, single for COVID-19 immunization (age at vaccination: 76-years-old). Medical history included, diabetes mellitus, she had a penicillin and had a reaction to it. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 11Jul2021, the patient experienced rash with itching at the top of her back on both sides, down each of her sides and on her arm (rash). It was reported that it was not real severe like all over her body, she did have it with some itching. Patient states her question was she had to hold on so long to her doctor office so she just wanted to know if she could take some benadryl, she did not know if she could take it. The 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.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Chills, Confusional state, Eating disorder, Feeling abnormal
Clinical narrative: experienced headaches; kidneys don't seem like to working properly ; problem in going to bathroom ; both peeing and pooping; kidneys don't seem like to working properly ; problem in going to bathroom ; both peeing and pooping; I am very sick; I can't remember my from taking this shot; I do not feel good/ I feel crazy; Confusion; I eat particulate and then sometimes I don't eat at all; Body ache; I felt like I was strangled in my throat like it was choking and I couldn't get over it; Sweating/sweat; I get hot that all the time in the night and it wakes me up; Feeling hot and cold; Teeth chattering; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 65-years-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 05Jul2021 (at the age of 65 years) as dose 1, single for COVID-19 immunization. Medical history included drug hypersensitivity (allergic to medicines and the patient take no medicines) from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no prior vaccination within 4 weeks. Patient added "he had Headaches, a whole of bunch of confusion. His kidneys don't seem like to working properly. He has a problem in going to bathroom and in both peeing and pooping and he eat particulate and then sometimes he don't eat at all. He was very sick. He drink a lot of water but side effects confusion, body ache, he felt like he was strangled in his throat like it was choking and he couldn't get over it and finally he get whole bunch of water and then finally it went away to an extent. He can still feel it in still feel it in his throat, acting funny. He do not feel good/ he feel crazy. He can't remember his address from taking this shot. He need to see a doctor, what he need to see, all hot and cold, sweat/ sweating, he get hot that all the time in the night and it wakes him up and his teeth starts chattering, they just starts chattering away/ teeth chattering ". The patient experienced Feeling hot and cold. No treatment was received for the events. Clinical outcome of the event was reported as unknown.  The lot number for vaccine was not provided and will be requested during follow up.