chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Stomatitis, Vomiting
Clinical narrative: mouth sores; Nausea; vomiting; stomach cramps; sweats; joint pain; elevated heart rate; This is a spontaneous report from a contactable other HCP (Patient).  A 21-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot #EL0140, via an unspecified route of administration on 29Dec2020 12:00 at single dose at Left arm for COVID-19 immunisation.  Medical history included Behcets, dysautonomia, Irritable bowel syndrome (IBS), and COVID-19.  The patient's concomitant medications included unspecified products within two weeks of vaccination.  The patient previously took amoxicillin, MELOXICAM (MOBIC) minocycline and all experienced drug hypersensitivity.  On 30Dec2020 12:00 the patient experienced mouth sores, nausea, vomiting, stomach cramps, sweats, joint pain and elevated heart rate. There was no other vaccine in four weeks. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19 and  since the vaccination, the patient has not been tested for COVID-19. The reporter considered all the events are non-serious and stated no treatment was received. The events outcome was not resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous report from a contactable other-HCP.   A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899), via an unspecified route of administration on 29Dec2020 11:15 at single dose for covid-19 immunisation.  Medical history was none.  Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC).  The patient experienced Chills, light headed, body aches, headache, fatigue, injection site pain on 30Dec2020 02:00. All events were non serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous report from a contactable other-HCP.   A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899), via an unspecified route of administration on 29Dec2020 11:15 at single dose for covid-19 immunisation.  Medical history was none.  Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC).  The patient experienced Chills, light headed, body aches, headache, fatigue, injection site pain on 30Dec2020 02:00. All events were non serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: severe headache; Fever to 103 Fahrenheit; myalgias; chills; This is a spontaneous report from a contactable Physician (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 Intramuscular at single dose on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020. The patient experienced Fever to 103 Fahrenheit, severe headache, chills, myalgias on 05Jan2021. No treatment was received for all events. There was no covid prior vaccination. There was no covid tested post vaccination. He had no Allergies to medications, food, or other products. The outcome of all events was resolved.  information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills; fever; body aches; headache; fatigue; This is a spontaneous report from a non-contactable pharmacist, the patient. This 27-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), dose  2, single dose via an unspecified route of administration in the right arm on 04Jan2021 at 06:15 PM (at the age of 27 years-old) for COVID-19 vaccination. There was no relevant medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), single dose, dose 1 in the left arm on 17Dec2020 at 12:00 PM and had injection site pain. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oral contraceptives.  The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 04:00 AM, the patient had chills, fever, body aches, headache, fatigue. The events were reported as non-serious. The onset was roughly 10 hours after dose. All symptoms apart from fatigue resolved between 36 and 48 hours after dose. The patient was treated for fever and muscle aches with over the counter (OTC) ibuprofen. The clinical outcome of chills, fever, body aches, headache was recovering and not recovered from fatigue.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: experienced redness and itching at the injection site (localized to the arm).; experienced redness and itching at the injection site (localized to the arm).; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness and itching at the injection site (localized to the arm) after she received the first dose of the vaccine. She received Benadryl. The reporter was asking if her employee should receive the 2nd dose if she developed a site injection reaction following the first dose and any premedication to give. Outcome of events was unknown.  Information on Lot/Batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Lymphadenopathy, Muscular weakness, Nausea
Clinical narrative: acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paraesthesia, Presyncope
Clinical narrative: acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain
Clinical narrative: almost fainted; body pain and chills; body pain and chills; This is a spontaneous report from a non-contactable other health professional (patient). A 21-year-old female patient (pregnant: No) received first dose of BNT162B2 (Batch/lot number: EUA), intramuscularly in left arm on 06Jan2021 12:00 PM at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), celecoxib (CELEXA). The patient experienced almost fainted, body pain and chills all on 07Jan2021 03:30 AM. About 15 hours the vaccine, the patient woke up at 3 am with extreme body pain and chills and almost fainted when trying to get paracetamol (TYLENOL). The events were reported as non-serious. The adverse event was not resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of events was unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Oxygen saturation, Pain in extremity
Clinical narrative: felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site erythema, Vaccination site induration, Vaccination site nodule, Vaccination site pain
Clinical narrative: felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: antibody test/ no antibodies were in her blood; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Oct2020 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient had a question regarding production of antibodies after receiving Covid vaccine. The received the vaccine last October, had antibody test late October2020 and in January2021, and no antibodies were in her blood. The patient inquired, "Does that mean the shot was not effective and should I get another shot?" The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral discomfort, Oropharyngeal discomfort, Pharyngeal swelling, Swollen tongue
Clinical narrative: funny feeling in her lips/lips; felt funny; funny feeling in her; tongue/tongue; felt funny; funny feeling in her; throat/throat felt funny; lips; swollen; tongue; swollen; throat; swollen; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient informed that she received her first dose of Covid vaccine yesterday (06Jan2021) between 7:30 and 8:00. In Jan2021, the patient had a slight reaction. The patient experienced funny feeling in her lips, tongue and throat and swollen/lips, tongue, and throat felt funny and swollen. The patient didn't tell anyone because she was embarrassed. The patient left and went home. It lasted for two hours and then she felt ok. Wants to know if she should take the second dose, which she was due for on 27Jan2021. The patient informed that her doctor told her to take a Benadryl before taking the second dose and see him after the vaccine. The outcome of the events funny feeling in her lips, tongue and throat and swollen/lips, tongue, and throat felt funny and swollen was recovered  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: funny feeling in her lips/lips; felt funny; funny feeling in her; tongue/tongue; felt funny; funny feeling in her; throat/throat felt funny; lips; swollen; tongue; swollen; throat; swollen; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient informed that she received her first dose of Covid vaccine yesterday (06Jan2021) between 7:30 and 8:00. In Jan2021, the patient had a slight reaction. The patient experienced funny feeling in her lips, tongue and throat and swollen/lips, tongue, and throat felt funny and swollen. The patient didn't tell anyone because she was embarrassed. The patient left and went home. It lasted for two hours and then she felt ok. Wants to know if she should take the second dose, which she was due for on 27Jan2021. The patient informed that her doctor told her to take a Benadryl before taking the second dose and see him after the vaccine. The outcome of the events funny feeling in her lips, tongue and throat and swollen/lips, tongue, and throat felt funny and swollen was recovered  Follow-up activities are possible, information on the batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Influenza like illness, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: he tested positive for COVID-19 / (probably infected by a family member); runny nose; dry cough; flu-like symptoms; he tested positive for COVID-19 / (probably infected by a family member); he tested positive for COVID-19 / (probably infected by a family member); This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that the next dose is scheduled for the time of the report, however he tested positive for COVID-19 on 05Jan2021 (probably infected by a family member). Representatives at the administration site are not sure if he should get the second dose. The patient reported minor symptoms "flu-like symptoms, runny nose, dry cough, no major symptoms". The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: diagnosed with covid 30Dec2020; diagnosed with covid 30dec2020; This is a spontaneous report from a contactable nurse (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration in right deltoid on 21Dec2020 13:45 at single dose for Vaccination.  There were no medical history and concomitant medications.  The patient was diagnosed with covid on 30Dec2020 with outcome of recovering.  The patient underwent lab tests and procedures which included COVID test: positive on 30Dec2020. The patient received the first dose of the covid vaccine on 21Dec2020, and was diagnosed with covid on 30Dec2020. The patient had COVID test on 30Dec2020 and received positive result of COVID test on 31Dec2020. He was scheduled for the second dose between 08Jan2021 and 11Jan2021. He asked if he should continue to get the second dose as scheduled in relation to the diagnosis of COVID. COVID: the patient still had chest congestion, but no fever without medication, no cough anymore. He was having cough, fever, loss of taste and smell, fatigue and malaise. Reporter seriousness for COVID: Not serious. Relatedness of drug to reaction/event:  Reaction assessed: COVID, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Unrelated. Verbatim event relatedness: Pfizer COVID-19 Vaccine: COVID-Unrelated.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and was diagnosed with COVID-19 on 30Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the diagnosed COVID-19 likely represents the pre-existing infection prior to vaccine use, and unrelated to BNT162B2.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: diagnosed with covid 30Dec2020; diagnosed with covid 30dec2020; This is a spontaneous report from a contactable nurse (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration in right deltoid on 21Dec2020 13:45 at single dose for Vaccination.  There were no medical history and concomitant medications.  The patient was diagnosed with covid on 30Dec2020 with outcome of recovering.  The patient underwent lab tests and procedures which included COVID test: positive on 30Dec2020. The patient received the first dose of the covid vaccine on 21Dec2020, and was diagnosed with covid on 30Dec2020. The patient had COVID test on 30Dec2020 and received positive result of COVID test on 31Dec2020. He was scheduled for the second dose between 08Jan2021 and 11Jan2021. He asked if he should continue to get the second dose as scheduled in relation to the diagnosis of COVID. COVID: the patient still had chest congestion, but no fever without medication, no cough anymore. He was having cough, fever, loss of taste and smell, fatigue and malaise. Reporter seriousness for COVID: Not serious. Relatedness of drug to reaction/event:  Reaction assessed: COVID, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Unrelated. Verbatim event relatedness: Pfizer COVID-19 Vaccine: COVID-Unrelated.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and was diagnosed with COVID-19 on 30Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the diagnosed COVID-19 likely represents the pre-existing infection prior to vaccine use, and unrelated to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: she got Covid; she got Covid; This is a spontaneous report from a contactable physician. A female patient (Patient Age: 18; Unit: Unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date t a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse that her first Pfizer Covid 19 vaccine and a couple of days later developed symptoms of Covid and tested positive. Stated that she recovered and had no symptoms.   Information on Lot/Batch number has been requested.; Sender's Comments: The reported symptoms of Covid with tested positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: he had an antibody titer drawn that was negative- no antibodies; This is a spontaneous report from a contactable physician (reporting for himself).  A male patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, bacth/lot no. and expiry date unknown), via an unspecified route of administration on 05Jan2021 (2nd dose) at single dose for COVID-19 immunization. Patient medical history included chronic myelocytic leukemia and was taking dasatinib (SPRYCEL)  and Jak (?). He was taking 30 mg of Jak and 100 mg of dasatinib. Patient first received his first dose of PFIZER vaccine on 16Dec2020. On 05Jan2021, patient received 2nd dose of vaccine. He had an antibody titer drawn that was negative- no antibodies on 05Jan2021. He understands per literature that patients on immunosuppressant therapy can have a diminished response to vaccine. He understands that in the clinical trials, some patients received a higher dose of the vaccine. He wanted to talk to someone about this. Wondering if he should check his antibodies titre in another week or should he get another dose of the vaccine or higher dose of it. Outcome of the event COVID-19 antibody test negative was unknown.   Information on the Lot/Batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report from a contactable other healthcare professional (other HCP reporting for himself).  A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date unknown), via an unspecified route of administration on 16Dec2020 12:45 (1st dose) at a single dose on his left arm for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included hydrochlorothiazide, losartan potassium (HYZAAR), omeprazole, and ibuprofen; all on unspecified dates for unspecified indications. The patient previously took amoxicillin and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, he was also not diagnosed with COVID-19 prior to vaccination. However, since the medication, the patient has been tested positive for COVID-19. Patient had his nasal swab on 22Dec2020, and it turned out positive (COVID test result=positive).  Outcome of the event drug ineffective and COVID-19 virus test positive was unknown. Facility where the most recent COVID-19 vaccine was administered at the hospital.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: covid test result=Positive; covid test result=Positive; nasal congestion; sneezing runny nose; sneezing runny nose; sinus pressure; dry cough; This is a spontaneous report from a contactable Nurse (patient herself).  This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via an unknown route, on 19Dec2020 at 16:15 at single dose for COVID-19 immunisation. Vaccine location was arm left. The patient was not pregnant. The patient was vaccinated at hospital, age at vaccination was 37-year-old. No other vaccine was received in four weeks. No relevant medical history was provided. Relevant concomitant medications included amoxicillin sodium, clavulanate potassium (AUGMENTIN, formulation: tablet) at dose of 875 mg twice daily from an unknown.  Pre-vaccination COVID test was not performed. On 25Dec2020 at 20:00, the patient complained of nasal congestion, sneezing runny nose, sinus pressure, and cough. On 28Dec2020, COVID test Nasal Swab (SOFIA SARS ANTIGEN FIA/QUIDEL) was performed and resulted positive. She was given oral azithromycin 500 mg 1 tab Daily and oral benzonatate (TESSALON PERLES) 1 Capsule three times a day (TID). The symptoms of nasal congestion, sneezing runny nose, sinus pressure, and cough were improving. The outcome of 'COVID test result=Positive' was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: covid test result=Positive; covid test result=Positive; nasal congestion; sneezing runny nose; sneezing runny nose; sinus pressure; dry cough; This is a spontaneous report from a contactable Nurse (patient herself).  This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via an unknown route, on 19Dec2020 at 16:15 at single dose for COVID-19 immunisation. Vaccine location was arm left. The patient was not pregnant. The patient was vaccinated at hospital, age at vaccination was 37-year-old. No other vaccine was received in four weeks. No relevant medical history was provided. Relevant concomitant medications included amoxicillin sodium, clavulanate potassium (AUGMENTIN, formulation: tablet) at dose of 875 mg twice daily from an unknown.  Pre-vaccination COVID test was not performed. On 25Dec2020 at 20:00, the patient complained of nasal congestion, sneezing runny nose, sinus pressure, and cough. On 28Dec2020, COVID test Nasal Swab (SOFIA SARS ANTIGEN FIA/QUIDEL) was performed and resulted positive. She was given oral azithromycin 500 mg 1 tab Daily and oral benzonatate (TESSALON PERLES) 1 Capsule three times a day (TID). The symptoms of nasal congestion, sneezing runny nose, sinus pressure, and cough were improving. The outcome of 'COVID test result=Positive' was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: two staff members who tested positive for covid after receiving the first dose.; two staff members who tested positive for covid after receiving the first dose.; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist reported similar events for 2 patients. This is a first of two reports. A staff member of unknown age and gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date  at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were unknown. The reporter stated that have a staff member took the first shot and afterward got a positive COVID test. He is asking about the recommendation regarding taking the second shot. The reporter explained he is the immunizer and 2.5 weeks ago he gave the employ at the facility the first does of the vaccine. He has very little information to provide on this event. He called to go over the procedure for administering the second dose and that is when in was inform. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021011912 Same reporter/ drug/ event for different patients.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received first dose of the vaccine on 19Dec and tested positive on 30Dec; received first dose of the vaccine on 19Dec and tested positive on 30Dec; This is a spontaneous report from a contactable nurse reported for herself. A female patient on unknown age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not provided. On 30Dec2020 the patient experienced tested positive for COVID-19. It was reported that the patient is scheduled to have her 2nd dose on 09Jan2021however she's been getting roundabout information on what to do in her case. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She tested positive to COVID on 29DEC2020; She tested positive to COVID on 29DEC2020; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, lot no. and expiry date were unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive to COVID on 29Dec2020. She received the 1st dose of the vaccine on 21Dec2020. She is due for the 2nd dose on 11Jan2020. They asked if she should still receive the 2nd dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Irritability, Muscle twitching, Somnolence
Clinical narrative: She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization.  There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Diarrhoea, Dizziness, Headache
Clinical narrative: Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain; Sudden head rush; This is a spontaneous report from a two contactable Other Health Professional (one of which patient) received via Medical Information Team.  A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: 30Apr2021), via an unspecified route of administration in arm left on 30Dec2020 at single dose for COVID-19 immunization. The patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine at 10 mg and rosuvastatin calcium at 20 mg, both from an unknown date and ongoing.  The patient experienced headaches, dizziness, loose stool, upper back pain where the lungs are/upper back pain, all on 02Jan2021. The patient also experienced loose bowels on 03Jan2021 and sudden head rush on 30Dec2020.  The patient underwent lab tests and procedures which included COVID-19 test which resulted negative on 06Jan2021.  The patient outcome of headache, dizziness, loose bowels was recovering, the outcome of loose stools was unknown, the outcome of back pain and sudden head rush was recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; myalgia; malaise; This is a spontaneous report from a contactable Physician (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), intramuscular (vaccination location: left arm) on 18Dec2020 13:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 (reported as prior to vaccination, patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. The patient has not received other vaccines within four weeks prior to COVID vaccine and no other medications received within two weeks of vaccination. The patient's concomitant medications were not reported. The patient has no known allergies. On 19Dec2020, the patient experienced fever, myalgia, and malaise. It was reported that patient received paracetamol (TYLENOL) for fever. It was reported that since vaccination, the patient has been tested for COVID-19 with PCR swab test on 28Dec2020 which had negative results. Outcome of the events was recovered.  Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021/tested positive for COVID-19; had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021/tested positive for COVID-19; This is a spontaneous report from a contactable Nurse (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021. However, last 04Jan2021, the patient tested positive for COVID-19. The patient was looking for recommendations on when he/she can take the COVID-19 vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on 04Jan2021. The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue; Chills; This is a spontaneous report from a contactable Nurse (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 05Jan2021 08:00 in left arm, via an unspecified route of administration at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient experienced fatigue and chills on 05Jan2021 22:00 with outcome of recovering. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the adverse event. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.