chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: 04May2021: Dose #1/ 10Sep2021: Dose #2; 04May2021: Dose #1/ 10Sep2021: Dose #2; Seven hours after dose experienced pain; shingles; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 10Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered on 04May2021 as dose 1, single for covid-19 immunisation and got sick with Covid and following symptoms: No fever but extreme chills, no taste, sore, can't really move, GI issues, headache, and slight cough from 06Aug2021. The patient received dose 1 on 04may2021 and dose 2 on 10Sep2021 and seven hours after dose experienced pain and shingles on Sep2021. Therapeutic measure (treated with Valtrex) was taken as a result of pain and shingles. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265495 Same patient and drug, different event and dose
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Got period 12 days after last cycle. 1 day after vaccine irregular period occurred; Super heavy bleeding; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Sep2021 at 19:00 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, gastritis and and known allergy to some food coloring which gave the patient hives. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), loratadine (CLARITIN) and omeprazole (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN) and pethidine hydrochloride (DEMEROL); both for unspecified indication from unknown date experienced drug allergy. On 24Sep2021 at 12:00, the patient got period 12 days after last cycle (The patient's menstruation had started on 08Sep2021). 1 day after vaccine irregular period occurred, super heavy bleeding. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstruation, heavy menstrual bleeding and short menstruation was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Superficial vein thrombosis
Clinical narrative: Superficial thrombophlebitis of Right hand; This is a spontaneous report from a contactable physician, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Sep2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Sep2021, the patient experienced superficial thrombophlebitis of right hand. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with supportive care: warm compress and unspecified NSAID. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event superficial thrombophlebitis of right hand was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: "My" menstrual cycle has increased since the vaccine. Prior to getting the vaccine, "my" cycle was average around 28 days now it has increasedto 32 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: AN6198) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 08Mar2021, since the vaccine, the patient's menstrual cycle had increased. Prior to getting the vaccine, her cycle was average around 28 days and it had increased to 32 days. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle had increased was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 23Mar2021 at 09:30(at the age of 30-years-old)as a single dose for COVID-19 immunisation.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular period; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date in 2021, the patient experienced irregular period. The clinical outcome of the event irregular period was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash to bilateral upper thighs; This is a spontaneous report from a non-contactable pharmacist. A 53-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an intramuscular route of administration in the left arm on 09Mar2021 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced rash to bilateral upper thighs. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the rash to bilateral upper thighs which included treatment with per oral diphenhydramine hydrochloride (BENADRYL) given once & per oral dexamethasone 4mg (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event rash to bilateral upper thighs was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain
Clinical narrative: Sore throat and ear ache only on the side of the vaccine site; Ear ache only on the side of the vaccine site; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Sep2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), gastroparesis, Ehlers Danlos and hashimoto's thyroiditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), naltrexone (MANUFACTURER UNKNOWN) and fludrocortisone (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 21Sep2021, 24 hours after the vaccination, the patient experienced sore throat and ear ache only on the side of the vaccine site and it had been a week at the time of report, with little change. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat and ear ache only on the side of the vaccine site was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Migraine, Myalgia
Clinical narrative: Migraine headache; Intense chills for 36 hours; Fever of 103 for approx 18 hours; Muscles and joint pain; Muscles and joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301458A) via an unspecified route of administration in the left arm on 22Sep2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 23Sep2021 at 07:30, the patient experienced intense chills for 36 hours, migraine headache, fever of 103 (unspecified units) for approx 18 hours, muscle and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event intense chills was resolved on 24Sep2021 at 19:30, after a duration of 36 hours whereas the event fever of 103 (unspecified units) was resolved on 24Sep2021, after a duration of approx 18 hours. The clinical outcome of event migraine headache and muscle and joint pain was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Migraine headache; Intense chills for 36 hours; Fever of 103 for approx 18 hours; Muscles and joint pain; Muscles and joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301458A) via an unspecified route of administration in the left arm on 22Sep2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 23Sep2021 at 07:30, the patient experienced intense chills for 36 hours, migraine headache, fever of 103 (unspecified units) for approx 18 hours, muscle and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event intense chills was resolved on 24Sep2021 at 19:30, after a duration of 36 hours whereas the event fever of 103 (unspecified units) was resolved on 24Sep2021, after a duration of approx 18 hours. The clinical outcome of event migraine headache and muscle and joint pain was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Tonsillar hypertrophy
Clinical narrative: Chills; Fever; Fatigue; Swollen tonsils; Achy body; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Sep2021 at 12:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Sep2021 at 00:00, the patient experienced chills, fever, fatigue, swollen tonsils and achy body. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event chills, fever, fatigue, swollen tonsils and achy body was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Flushing
Clinical narrative: Facial flushing; Weakness; Fatigue; This is a spontaneous report from a non-contactable pharmacist. A 52-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an intramuscular route of administration in the left arm on 21Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient had facial flushing, weakness and fatigue, monitored for 2 hours before leaving. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events facial flushing, weakness and fatigue was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report from a non-contactable healthcare professional. A 72-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via intramuscular route of administration in the left arm on 24Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced mild headache for which he took Tylenol 650mg and symptoms went away in 30 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with paracetamol 650 mg (TYLENOL). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event mild headache was resolved on an unknown date in 2021, after the duration of 30 minutes.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat irritation
Clinical narrative: Throat itching; Trouble breathing; This is a spontaneous report from a non-contactable pharmacist. A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via intramuscular route of administration in the right arm on 24Feb2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced throat itching and trouble breathing. It was reported that the patient was assessed and water was given, and the patient felt better in 20 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events throat itching and trouble breathing was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Burning sensation, Chills, Dyspepsia, Gastrointestinal disorder
Clinical narrative: Weakness of the arms; chills; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation); irregular menstruation (spotting); irregular menstruation (spotting); pains and aches; tightness at injection site; stiff neck; pain in back of head; sore throat; burning/tingling in upper back; burning/tingling in upper back; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jul2021 at 14:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included ocular migraines and known allergies to penicillin and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received metronidazole (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 31Jul2021, the patient experienced weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting. On 23Sep2021, the patient underwent PCR test via nasal swab and the result was negative. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Intermenstrual bleeding, Menstruation irregular, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Weakness of the arms; chills; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation); irregular menstruation (spotting); irregular menstruation (spotting); pains and aches; tightness at injection site; stiff neck; pain in back of head; sore throat; burning/tingling in upper back; burning/tingling in upper back; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jul2021 at 14:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included ocular migraines and known allergies to penicillin and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received metronidazole (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 31Jul2021, the patient experienced weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting. On 23Sep2021, the patient underwent PCR test via nasal swab and the result was negative. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Paraesthesia, Proctitis, SARS-CoV-2 test
Clinical narrative: Weakness of the arms; chills; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation); irregular menstruation (spotting); irregular menstruation (spotting); pains and aches; tightness at injection site; stiff neck; pain in back of head; sore throat; burning/tingling in upper back; burning/tingling in upper back; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jul2021 at 14:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included ocular migraines and known allergies to penicillin and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received metronidazole (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 31Jul2021, the patient experienced weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting. On 23Sep2021, the patient underwent PCR test via nasal swab and the result was negative. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Weakness of the arms; chills; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation),; digestive issues (bloating, discomfort, rectal inflammation); irregular menstruation (spotting); irregular menstruation (spotting); pains and aches; tightness at injection site; stiff neck; pain in back of head; sore throat; burning/tingling in upper back; burning/tingling in upper back; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jul2021 at 14:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included ocular migraines and known allergies to penicillin and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received metronidazole (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 31Jul2021, the patient experienced weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting. On 23Sep2021, the patient underwent PCR test via nasal swab and the result was negative. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events weakness of the arms, chills, lymph nodes, digestive issues (bloating, discomfort, rectal inflammation), irregular menstruation (spotting), pains and aches, tightness at injection sight, stiff neck, pain in back of head, sore throat, burning and tingling in upper back and all lasting for over a month and counting was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: SOB; Dizzy/ Lightheaded; This is a spontaneous report from a non-contactable pharmacist. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration in the left arm on 05Jun2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced shortness of breath (SOB) and dizzy/ lightheaded that were resolved in 1 hour. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events shortness of breath (SOB) and dizzy/ lightheaded was resolved on an unknown date in 2021, after the duration of 1 hour.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness on arms and neck.; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via intramuscular route of administration in the right arm on 25Feb2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Feb2021, the patient experienced itchiness on arms and neck. It was reported that BENADRYL  and water was offered to the patient but was refused. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event itchiness on arms and neck was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizzy; Episode of vertigo; This is a spontaneous report from a non-contactable pharmacist. A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 21Apr2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient was dizzy and experienced episode of vertigo that lasted 20 minutes. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event dizzy and episode of vertigo was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site erythema
Clinical narrative: Throat itching; Injection site redness; This is a spontaneous report from a non-contactable pharmacist. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 13Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced throat itching and injection site redness and was resolved by BENADRYL po. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event throat itching and injection site redness was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Pruritus, Tenderness
Clinical narrative: Redness spread down arm; Heat; Tenderness; Numbing; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Sep2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose COVID-19 immunisation. On 26Sep2021 at 00:00, the patient experienced redness spreading down arm, heat, tenderness, numbing and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness spreading down arm, heat, tenderness, numbing and itchy was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Injection site induration, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: Redness spread down arm; Heat; Tenderness; Numbing; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Sep2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose COVID-19 immunisation. On 26Sep2021 at 00:00, the patient experienced redness spreading down arm, heat, tenderness, numbing and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness spreading down arm, heat, tenderness, numbing and itchy was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus
Clinical narrative: Itching; Nausea; Headache; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on 27Sep2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), famotidine (MANUFACTURER UNKNOWN) and riboflavin (VITAMIN B2); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021, the patient experienced itching, nausea and headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itching, nausea and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness for 30 minutes; This is a spontaneous report from a non-contactable pharmacist. An 18-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an intramuscular route of administration in the left arm on 30Mar2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient reported dizziness for 30 minutes, symptoms resolved and patient was able to leave. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, it was unknown whether the patient had not been tested for COVID-19. The clinical outcome of the event dizziness for 30 minutes was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headedness; This is a spontaneous report from a non-contactable pharmacist. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 24May2021 as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 24May2021, the patient experienced light headedness. She had relaxed for 30 minutes and felt better. Therapeutic measures were not taken as a result of the reported event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event light headedness was resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Light headed, dizziness; Nausea; This is a spontaneous report from a non-contactable pharmacist. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an intramuscular route of administration in the left arm on 05May2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced light headed, dizziness and nausea, symptoms resolved in 1 hour. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events light headed, dizziness and nausea was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: Right eye and cheek area swelling; Right eye and cheek area swelling; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Sep2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, cardiomyopathy, multiple sclerosis, thyroid disorder and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included carvedilol (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and spironolactone (SPIRONOLACTON); all from unknown date for unknown indication and unknown if ongoing. On 17Sep2021 at 17:00, the patient experienced right eye and cheek area swelling. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with short course of 40 mg prednisone for 5 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right eye and cheek area swelling was not resolved at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, SARS-CoV-2 test
Clinical narrative: Menstrual cycles completely stopped; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021(at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 01Jun2021, the patient's menstrual cycles completely stopped. Her cycles had now vanished. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date, the patient underwent nasal swab test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event menstrual cycles completely stopped was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Rash pruritic
Clinical narrative: I experienced irregular menstrual bleeding the day after receiving the vaccine; It was very light spotting and only happened once but that is extremely rare for me.; I received the vaccine in my left arm and also woke up the next day with a very itchy rash on my right shoulder.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 21Sep2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Sep2021, the day after receiving the vaccine around 16:00, the patient experienced irregular menstrual bleeding, it was very light spotting and only happened once but that was extremely rare for the patient. The patient reported that her period was not expected for 2 weeks after that and it was impossible for her to be pregnant. On 22Sep2021, the patient also experienced a very itchy rash on the right shoulder which looked like 6 swollen mosquito bites. The patient was not sure if the rash was related but didn't know what else it could be. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstrual bleeding, it was very light spotting and only happened once but that was extremely rare for the patient and a very itchy rash on the right shoulder which looked like 6 swollen mosquito bites was resolved on an unknown date in Sep2021.  No follow-up attempts are possible. No further information is expected.