chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Dizziness; Chills; Fatigue; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and diabetes. The patient had no known allergies to medications, food or other products. Concomitant medication included metformin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 11May2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 02Jun2021 at 12:00, the patient experienced dizziness, chills, fatigue and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of dizziness, chills, fatigue and diarrhea was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Body pins and needles started at 2 am/ tingling arms, hands, feet; fingers and toes numbness/ right heel numbness; tongue tingling; Heavy head; Slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), intramuscular in right arm on 02Jun2021 13:00 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient was not having any known allergies. The patient experienced body pins and needles started at 2 am/ tingling arms, hands, feet, fingers and toes numbness/ right heel numbness, tongue tingling, heavy head and slight headache on 03Jun2021 02:00. The events Body pins and needles started at 2 am/ tingling arms, hands, feet, fingers and toes numbness/ right heel numbness and tongue tingling were considered as medically significant. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. The events were on and off intermittent, patient had right heel numbness every morning for couple hours. Outcome of events was resolving.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Polymenorrhoea
Clinical narrative: Irregular menstruation following vaccine.; Bleeding more frequently than usual - every 12 to 14 days; This is a spontaneous report from a contactable consumer. This 41-Year-old non pregnant female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 31Mar2021 at 10:00AM (at the age of 41 years old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included fluticasone propionate (FLOVENT) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), started on unknown dates and for unknown indications. No relevant past drug history. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 10Mar2021 at 10:00AM (at the age of 40 years old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021, she had irregular menstruation following vaccine. Bleeding more frequently than usual: every 12 to 14 days. Patient visited doctor or other healthcare professional office/clinic. No hospitalization prolongation or treatment received for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Tinnitus and dizziness started 3 days after receiving the second dose; Tinnitus and dizziness started 3 days after receiving the second dose; This is a spontaneous report from a contactable other hcp (patient). A 37-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 17:00 (age at vaccination 37years), as DOSE 2, SINGLE for covid-19 immunisation at facility. Medical history included depression, anxiety from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection), dose 1, administered in Arm Left on 14Jan2021 04:45 (Batch/Lot number: EJ1685) for covid-19 immunisation. On 27Feb2021, the patient experienced tinnitus and dizziness started 3 days after receiving the second dose. The events resulted in physician office visit. Therapeutic measures were taken as a result of events with meclizine. Device Date was 03Jun2021. The clinical outcome of the events was Recovered with Sequel in 2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle soreness; stiffness in the hand; arm feeling heavy; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26May2021 at 17:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. No relevant medical history reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and ethinylestradiol, levonorgestrel (MARLISSA) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 05May2021 at 19:15 as a single dose for COVID-19 immunisation. On 27May2021 at 07:00, the patient experienced muscle soreness, stiffness in the hand and arm feeling heavy which was reported to get worse on 06/03/2021 at 03:00. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events, muscle soreness stiffness in the hand and arm feeling heavy was not resolved at the time of report.   No follow-up attempts are needed. Information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a non-contactable pharmacist, the patient. A 37-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 on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, two weeks post the second vaccination, the patient experienced vertigo. The clinical outcome of the event vertigo 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Feel stiffness all time and fell pain when I move my arm in any direction. I thought it would go away by time and now feel it is worsen by time.; Feel stiffness all time and fell pain when I move my arm in any direction. I thought it would go away by time and now feel it is worsen by time.; Feel stiffness all time and fell pain when I move my arm in any direction. I thought it would go away by time and now feel it is worsen by time.; This is a spontaneous report from contactable consumer (patient). A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:00 (at the age of 59 years old) (Lot Number: EP7533) as dose 2, single for COVID-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergies. Relevant medical history was none. Concomitant medications were not reported. Patient historical vaccine included on 18Mar2021 at 03:00 AM (at the age of 59 years), patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in Left arm (Lot Number: EP7534) for COVID-19 immunization. On 08Apr2021 patient reported that, feel stiffness all time and fell pain when I move my arm in any direction. I thought it would go away by time and now feel it is worsen by time. No therapeutic measures were taken as a result of events. Since the vaccination, patient had not tested for COVID-19. The outcome of the events was not resolved.  Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Heavy debilitating painful period came earlier than usual 8 days after shot.; Heavy debilitating painful period came earlier than usual 8 days after shot.; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 14-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 16:00 (at the age of 14-years-old), (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was not tested positive for covid 19 prior and post vaccination. On 03Jun2021 the patient experienced heavy debilitating painful period came earlier than usual 8 days after shot. Patient did not receive other vaccine in four weeks. Patient did not received treatment. prior vaccination and post vaccination patient did not test for covid. The outcome of the events was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 55-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 26May2021 at 16:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021, the patient experienced fever, chills, nausea, headache, body aches. Therapeutic measures were taken as a result of event and included treatment with Ibuprofen and fluids. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On 31May2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the events fever, chills, nausea, headache, body aches was recovered on an unknown date of 2021.   No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Chills; Nausea; Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 55-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 26May2021 at 16:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021, the patient experienced fever, chills, nausea, headache, body aches. Therapeutic measures were taken as a result of event and included treatment with Ibuprofen and fluids. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On 31May2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the events fever, chills, nausea, headache, body aches was recovered on an unknown date of 2021.   No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Migraine
Clinical narrative: I started having a migrane on the left top side of my head. about a 1hour 30 after vaccine. I have experienced head pain every day since and pain in my left ear.; About a 1hour 30 after vaccine. I have experienced head pain every day since and pain in my left ear.; About a 1hour 30 after vaccine. I have experienced head pain every day since and pain in my left ear.; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of bnt162b2 (BNT162B2; Batch/Lot Number: ER8730), via an unspecified route of administration on Mar2021 as single dose, second dose via an unspecified route of administration, administered in Arm Left on Mar2021 (Batch/Lot Number: EWB153) as single dose for COVID-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. The patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced migraine, headache, ear pain on 24Mar2021 14:00. Clinical course reported as I started having a migrane on the left top side of my head. about a 1hour 30 after vaccine. i have experienced head pain every day since and pain in my left ear. Therapeutic measures were taken as a result of adverse events as Medication, Mri, Nerve block. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling hot, Hyperhidrosis, Hypoacusis, Vision blurred
Clinical narrative: Vision went very blurry; Things became very distant in hearing; Hard to focus; Felt like was burning up; Sweating; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 13May2021 at 17:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to lactose (slightly lactose intolerant) and sever Acetaminophen allergy. The patient did not receive any other concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13May2021 at 17:00, shortly after having the vaccination, the patient vision went very blurry and things became very distant in hearing, these side effects were hard to focus on however as he started sweating and felt like he was burned up. These effects lasted around 10 minutes. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events vision went very blurry, things became very distant in hearing, hard to focus, felt like he was burned up and sweating were resolved on 13May2021 at 17:10 (after the duration of 10 minutes).   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: The same happen to another patient / his fingers went numb; This is a spontaneous report from another manufacturer company from contactable female consumer (patient). A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route on 28Apr2021 as dose 2, single in the left arm for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Medication for blood pressure. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 21May2021 as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced that his fingers went numb. Patient called to report that after having the second dose of the vaccine on 28Apr2021 on the left, non-dominant arm, side effects developed. The same happen to another patient that received another covid19 vaccine. The patient wanted to knew what to do. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650410
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: since having the vaccine she is experiencing more pain with increased frequency; This is a spontaneous report from a sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history included from Oct2019 to current rheumatoid arthritis and she had been experiencing flare ups. The patient concomitant medications were not reported. On an unspecified date, the patient experienced since having the vaccine more pain with increased frequency. Patient reports MD placed her on hold from Xeljanz for 12 days to have the covid vaccines. Patient notes since the hold she had been experiencing flare ups, MD not aware patient advised to contacted MD. Patient restarted Xeljanz a few weeks ago. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: Headaches all day; Extremely tired; No energy; 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 on 22May2021 at 12:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 the patient experienced headaches all day and extremely tired no energy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events headaches all day and extremely tired, no energy were not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Period was two weeks later having both doses of Pfizer; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr2021, the patient was expecting her period within a week after the second dose but she had her period which was two weeks later on 13May2021 (delayed period), after having both doses of Pfizer. The patient's cycle was of 28-33 days long and this one was 55 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event delayed period was resolved on 13May2021.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anorectal discomfort, Chromaturia, Dehydration, Dry mouth, Faeces hard
Clinical narrative: Dehydration; Dry mouth; Unquenchable thirst; Urine that stayed yellow after drinking a lot of water; Dry stool and anus.; Dry stool and anus.; This is a spontaneous report from a contactable consumer, the patient. A 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 01May2021 at 15:00 (at the age of 18-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 22May2021 at 12:00 (at the age of 18-years-old), both as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included drospirenone (SLYND) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. The clinical course was reported as follows: on 02May2021, the patient experienced dehydration and dry mouth, unquenchable thirst, urine that stayed yellow after drinking a lot of water, dry stool and anus. 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. The clinical outcome of the events dehydration, dry mouth, unquenchable thirst, urine that stayed yellow after drinking a lot of water, dry stool and anus was not recovered at the time of reporting.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Dehydration; Dry mouth; Unquenchable thirst; Urine that stayed yellow after drinking a lot of water; Dry stool and anus.; Dry stool and anus.; This is a spontaneous report from a contactable consumer, the patient. A 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 01May2021 at 15:00 (at the age of 18-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 22May2021 at 12:00 (at the age of 18-years-old), both as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included drospirenone (SLYND) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. The clinical course was reported as follows: on 02May2021, the patient experienced dehydration and dry mouth, unquenchable thirst, urine that stayed yellow after drinking a lot of water, dry stool and anus. 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. The clinical outcome of the events dehydration, dry mouth, unquenchable thirst, urine that stayed yellow after drinking a lot of water, dry stool and anus was not recovered at the time of reporting.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Oligomenorrhoea, Pain
Clinical narrative: I was late starting my menstrual cycle the month of May by 8 days; now been on my cycle for 7 days.  My normal cycle is 4-5 days.; Had bodyaches the entire time.; This is a spontaneous report received from a contactable nurse (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 15:30 (at the age of 42-years) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis, hyperlipidaemia, covid-19 (prior to the vaccination the patient was diagnosed with COVID-19); all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient was not pregnant at the time of vaccination. On 15May2021 at 19:00, the patient reported that it was late starting her menstrual cycle the month of May by 8 days and now been on her cycle for 7 days. Her normal cycle was 4-5 days and had body aches the entire time. The patient did not receive any treatment for the events. Since the vaccination the patient was tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test): negative on an unspecified date in 2021 (post vaccination). The outcome of events menstruation delayed, menstrual cycle prolonged and generalized aching was not resolved.  Follow-up attempts are completed. No further information is expected
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Poor quality sleep, Vaccination site pain
Clinical narrative: tired; moderate headache; left arm pain at injection site; anxious; didn't sleep much that first night; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 09May2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN); all taken for unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09May2021 at 16:15, the patient felt tired, moderate headache, left arm pain at injection site for about 48 hours after the vaccination. The patient was likely more tired the second day because the patient felt that this shot gave her adrenaline and made her anxious so she didn't sleep much that first night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tired, headache, left arm pain at injection site, anxious, didn't sleep much that first night were recovered on an unknown date in May2021  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After first shot stared to hear blood pressure in ears; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0162, first dose) solution for injection intramuscular in the left arm on 14Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis (RA). Concomitant medications included methotrexate sodium, adalimumab (HUMIRA), and folic acid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. After first shot the patient started to hear blood pressure in ears on 14Apr2021 at 15:30. No treatment was provided for the event. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (20Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651479 same patient/drug and different dose, different/similar event
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: After first shot started to hear blood pressure in ears; This is constant and became worse after the second dose; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0161, second dose) solution for injection intramuscular in the left arm on 05May2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis (RA). Concomitant medications included methotrexate sodium, adalimumab (HUMIRA), and folic acid. Historical vaccine included BNT162B2 (first dose, lot EW0161) for COVID-19 vaccination on 14Apr2021 and experienced hear blood pressure in ears. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. After first shot started to hear blood pressure in ears and this was constant and became worse after the second dose on 05May2021. No treatment was provided for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up (20Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651464 same patient/drug and different dose, different/similar event
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Intense shaking; This is a spontaneous report from a contactable consumer, the patient. A 15-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 03Jun2021 at 14:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, psoriasis and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 13May2021 at 14:00 as a single dose for COVID-19 immunisation. The patient had known allergy to tree nuts. On 03Jun2021 at 00:00, 10 hours after injection the patient experienced intense shaking and could not stop and it was continuing at the 11th hour after injection. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intense shaking was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose fluctuation, Chest pain, Headache
Clinical narrative: chest pain; severe headaches; SI joint pain; swollen lymph nodes; panic attacks; glucose levels fluctuating; This is a spontaneous report from a contactable healthcare professional reported for herself. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiration date was not reported) via an unspecified route of administration on 18May2021 at 16:15 (at the age of 39-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chest pain, Sacroiliac (SI) joint pain, severe headaches, swollen lymph nodes, panic attacks and glucose levels were fluctuating on unspecified date in 2021. The patient underwent lab tests and procedures which included blood glucose: fluctuating on unspecified date in 2021. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Augmentin and flexril. The clinical outcome of the events was recovering at the time of this report.  Information about lot/batch number will be obtained during follow-up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Panic attack
Clinical narrative: chest pain; severe headaches; SI joint pain; swollen lymph nodes; panic attacks; glucose levels fluctuating; This is a spontaneous report from a contactable healthcare professional reported for herself. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiration date was not reported) via an unspecified route of administration on 18May2021 at 16:15 (at the age of 39-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chest pain, Sacroiliac (SI) joint pain, severe headaches, swollen lymph nodes, panic attacks and glucose levels were fluctuating on unspecified date in 2021. The patient underwent lab tests and procedures which included blood glucose: fluctuating on unspecified date in 2021. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Augmentin and flexril. The clinical outcome of the events was recovering at the time of this report.  Information about lot/batch number will be obtained during follow-up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding
Clinical narrative: I have not had a minstral cycle since 2015 but after taking the second Pfizer dose Im experiencing minstral cramps and spotting.; I have not had a minstral cycle since 2015 but after taking the second Pfizer dose Im experiencing minstral cramps and spotting.; This is a spontaneous report received from a contactable consumer or other non-health care professional.  A 54-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration on 01May2021 as dose 1, single and received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient's medical history included none. No past drug events. No known allergies. Concomitant medication(s) were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021, the patient experinced I have not had a menstral cycle since 2015 but after taking the second Pfizer dose I am experiencing menstral cramps and spotting. All the events were non-serious. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: huge area of discoloration behind my right knee and up the back of my thigh.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration in the arm left on 02Apr2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history included migraine and anxiety. Concomitant medications included rizatriptan benzoate (MAXALT) from unknown date for migraine, an unknown if on going and sambucus nigra (ELDERBERRY GUMMIES) from unknown date for an unknown indication, unknown if on going. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient  had no known allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced, huge area of discoloration behind her right knee and up the back of her thigh. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event huge area of discoloration behind  right knee and up the back of  thigh was recovering at time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bladder pain, Burning sensation, Chills, Diarrhoea
Clinical narrative: Fever; Chills; Aches in joints; Aches in kidney; Aches in bladder area; Headaches; Nausea; Diarrhea; Burning in nail beds of big toes; This is a spontaneous report from a contactable consumer, the patient. A 62-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 21May2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none, the patient reported that she was healthy and was not on medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the vaccination. The patient previously took FLAGYL and and codeine and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21May2021 at 10:15, with in an hour, the patient experienced fever, chills, aches in joints and kidneys and bladder area, headaches, nausea, diarrhea and burning in nail beds of big toes. "All side effects lasted 4 days except the toes." Since the vaccination, the patient had not been tested for COVID-19. The events 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 events. The clinical outcome of the events fever, chills, aches in joints and kidneys and bladder area, headaches, nausea, diarrhea was resolved on 25May2021. The clinical outcome of the event burning in nail beds of big toes was resolved on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Renal pain
Clinical narrative: Fever; Chills; Aches in joints; Aches in kidney; Aches in bladder area; Headaches; Nausea; Diarrhea; Burning in nail beds of big toes; This is a spontaneous report from a contactable consumer, the patient. A 62-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 21May2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none, the patient reported that she was healthy and was not on medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the vaccination. The patient previously took FLAGYL and and codeine and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21May2021 at 10:15, with in an hour, the patient experienced fever, chills, aches in joints and kidneys and bladder area, headaches, nausea, diarrhea and burning in nail beds of big toes. "All side effects lasted 4 days except the toes." Since the vaccination, the patient had not been tested for COVID-19. The events 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 events. The clinical outcome of the events fever, chills, aches in joints and kidneys and bladder area, headaches, nausea, diarrhea was resolved on 25May2021. The clinical outcome of the event burning in nail beds of big toes was resolved on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.