chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Lymphadenopathy, Mammogram
Clinical narrative: She is having swollen lymph nodes showing up on her mammary glands; This is a spontaneous report from a Regulatory Authority. A contactable 67-year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 20Apr2021 (at 67-year-old) in right arm as dose 2, single for COVID-19 immunization. The patient had no medical history. The concomitant medications of the patient included thyroid (Armour thyroid).The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date (at 67-year-old) as dose 1, single for COVID-19 immunization. On 06Jul2021 the patient had swollen lymph nodes showing up on her mammary glands. When paraphrased the above concern, consumer stated that she does not know but think that she had it on both but I does not know if on one or the other particular. The patient underwent colonoscopy and 3D Mammogram for which results were unknown. She had some blood work and they were all pretty normal everything was pretty good at that time, there was no alarming blood work. The patient was going to go to doctor and would know if she had something else or it could be a reaction from the shot.  No follow-up attempts were possible. Information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (son) reported for a female patient (mother). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number and expiration date was not reported, NDC number of was not reported) dose number unknown via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Other products were not given. No investigation assessment was reported. On an unspecified date the patient experienced sore arm after vaccine. Caller stated that he got both doses of the Pfizer Covid vaccine. No further information provided. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Shortly after receiving the first shot I noticed a ringing in my ears, more so in the left ear. The effect worsened after the second shot; Shortly after receiving the first shot I noticed a ringing in my ears, more so in the left ear. The effect worsened after the second shot; This is a spontaneous report from a contactable consumer (patient) via Patient Assistance.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 08Apr2021 as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated I wish to report a side-effect from receiving the Pfizer COVID-19 vaccine. On an unspecified date in Apr2021, patient reported shortly after receiving the first shot, I noticed a ringing in my ears, more so in the left ear. The effect worsened after the second shot. I visited my ENT specialist this week who noted that there has been some evidence of correlation between tinnitus and the COVID vaccine. She advised that I should report the incident here and not through VAERS. The outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hive breakout; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 02Jul2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Other medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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. On 03Jul2021, the patient experienced hive breakout. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of hive breakout was not recovered at the time of this report.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear after second dose, has not stopped for a month and a half; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 28May2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. The patient did not take any other medications within two weeks of vaccination. 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 07May2021 at 14:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was 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 30May2021, the patient experienced tinnitus in left ear after second dose, that had not stopped for a month and a half. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event tinnitus in left ear after second dose, that had not stopped for a month and a half was not resolved at the time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Facial twitch on left side of face; This is a spontaneous report from a contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EV00181) via an unspecified route of administration in the right arm on 21Jun2021 at 14:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer (triple negative). The patient had no known allergies to food, medications, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jun2021 at 15:00, the patient experienced facial twitch on left side of face. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial twitch on left side of face was resolved on an unknown date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Immune system disorder, Insomnia, Oral herpes
Clinical narrative: weight loss (lost 7 pounds); not sleeping; not eating; feels that her immune system is low; fatigued; cold sore; stress related weight loss; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (unable to get age) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on 27Jun2021 as dose 1, single for COVID-19 immunization. Family medical history included renal cancer from Jun2021 and ongoing husband diagnosed with malignant kidney tumor two weeks ago diagnosis came post Pfizer Covid 19 vaccination in April. The patient's concomitant medications were not reported. The patient experienced weight loss (lost 7 pounds), not sleeping, not eating, feels that her immune system is low, fatigued, cold sore and stress related weight loss on an unspecified date in Jun2021. It was reported that, patient she had her first dose of the Pfizer Covid 19 vaccine on 27Jun2021 and was scheduled to complete her series on 18Jul2021. She had experienced weight loss (lost 7 pounds), not sleeping, not eating, feels that her immune system is low, fatigued and currently has a cold sore. Consumer reported that what she was experiencing due to stress surrounding her husband's recent cancer diagnosis. Had not seen HCP since 2019 due to COVID pandemic. Also reported that her daughter had been vaccinated (no details or events provided). Caller further shared that husband diagnosed with malignant kidney tumor two weeks ago. Noted that this diagnosis came post Pfizer Covid 19 vaccination in Apr2021 and will be going through immunotherapy starting tomorrow as caller details. Started to ask if husbands immune system with immunotherapy would affect his vaccine status, but then declined information as they were both going to a doctor appointment this week. Caller wanted to know if she should get second dose of vaccine in the setting of weight loss, lowered immune system and presence of a cold sore (current health status related to stress) and states she will keep her appointment for second dose at the end of call. Patient received first dose, due for second 18Jul2021. Had cold sore and stress related weight loss, asked if this was a reason not to get second dose. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: F
Vaccine: COVID19
Symptoms: Stress, Weight decreased
Clinical narrative: weight loss (lost 7 pounds); not sleeping; not eating; feels that her immune system is low; fatigued; cold sore; stress related weight loss; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (unable to get age) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on 27Jun2021 as dose 1, single for COVID-19 immunization. Family medical history included renal cancer from Jun2021 and ongoing husband diagnosed with malignant kidney tumor two weeks ago diagnosis came post Pfizer Covid 19 vaccination in April. The patient's concomitant medications were not reported. The patient experienced weight loss (lost 7 pounds), not sleeping, not eating, feels that her immune system is low, fatigued, cold sore and stress related weight loss on an unspecified date in Jun2021. It was reported that, patient she had her first dose of the Pfizer Covid 19 vaccine on 27Jun2021 and was scheduled to complete her series on 18Jul2021. She had experienced weight loss (lost 7 pounds), not sleeping, not eating, feels that her immune system is low, fatigued and currently has a cold sore. Consumer reported that what she was experiencing due to stress surrounding her husband's recent cancer diagnosis. Had not seen HCP since 2019 due to COVID pandemic. Also reported that her daughter had been vaccinated (no details or events provided). Caller further shared that husband diagnosed with malignant kidney tumor two weeks ago. Noted that this diagnosis came post Pfizer Covid 19 vaccination in Apr2021 and will be going through immunotherapy starting tomorrow as caller details. Started to ask if husbands immune system with immunotherapy would affect his vaccine status, but then declined information as they were both going to a doctor appointment this week. Caller wanted to know if she should get second dose of vaccine in the setting of weight loss, lowered immune system and presence of a cold sore (current health status related to stress) and states she will keep her appointment for second dose at the end of call. Patient received first dose, due for second 18Jul2021. Had cold sore and stress related weight loss, asked if this was a reason not to get second dose. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 45, via an unspecified route of administration, left arm, Jun 18, 2021, at 09:30, single dose, for COVID-19 immunisation. The patient did not have any reported medical history. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 45, via an unspecified route of administration, left arm, on May 7, 2021, at 09:45, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Jun 18, 2021, patient had a strange rash on trunk and legs for several weeks. No therapeutic measures taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has tested for COVID-19. On Jun 28, 2021, patient underwent COVID-19 virus test (nasal swab) with negative result. The outcome of had a strange rash on trunk and legs for several weeks: unknown (at the time of this report). The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Sore injection site; 100 fever; Aches; This is a spontaneous report from a contactable consumer. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 06Jul2021 15:45 (at the age of 14-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Right on 01Jun2021 (at the age of 14-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 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. On 07Jul2021 12:00, the patient experienced sore injection site, 100 fever, aches. The patient did not receive any treatment. The seriousness of the event was considered as non-serious. Outcome of the event was recovering, at the time of this report. Device Date was 07Jul2021. Information on Lot/Batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Menstruation delayed, SARS-CoV-2 test, Tinnitus, Ultrasound scan
Clinical narrative: No menstrual cycle since first injection; Tinnitus (constant ringing in both ears); Eczema flair ups (face); 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: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously took promethazine (PHENERGAN) and experienced drug allergy. Prior to the vaccination, the patient was not 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 COVID vaccine. On 26Mar2021, since the first injection, the patient experienced no menstrual cycle, tinnitus (constant ringing in both ears), and eczema flair ups (face). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of no menstrual cycle since first injection, tinnitus (constant ringing in both ears), eczema flair ups (face) and included treatment with unspecified medication from an unknown date, GP check up and OBGYN check up (ultrasound). On 24Jun2021, the patient underwent a nasal swab for Curative (PCR) test and the result was negative and on an unknown date the patient underwent an ultrasound and the result was unknown. The clinical outcome of the event no menstrual cycle since first injection, tinnitus (constant ringing in both ears), eczema flair ups (face) was not resolved at the time of this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chills, Feeling hot, Headache, Pyrexia
Clinical narrative: have been feeling like a little warm; Chills; Headache; second time she took her temperature it was 101; This is a spontaneous report. A contactable consumer reported for a female patient (daughter). A female patient of an unspecified age received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0170), via an unspecified route of administration on 06Jul2021 as single dose for COVID-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of bnt162b2 on 11Jun2021 for COVID-19 immunisation. Parent stated, her and her daughter had received second dose yesterday the Pfizer vaccine which was 06Jul and her daughter have been feeling like a little warm, she had been having chills and she also been having headache and she also had taken her temperature the first time it was 96.1 and second time she took her temperature it was 101 and they wanted to report that. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature: 96.1 on 06Jul2021, body temperature: 101 on 06Jul2021. The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Periorbital swelling, Swelling face, Tuberculin test
Clinical narrative: Severe numbness in both hands mostly effecting both thumbs and first 3 digits; Puffiness in face; Puffiness around eyes; This is a spontaneous report from a contactable healthcare professional. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA6780) via an unspecified route of administration in the right arm on 07Jul2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, back pain, hip pain, sinus and allergy issues. 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 allergy shot (MANUFACTURER UNKNOWN) and several other unspecified medications taken for unknown indications on unknown dates and unknown if ongoing. The patient previously took morphine hydrochloride (MORPHINE) for unknown indication on unknown date and experienced drug allergy. On 07Jul2021 at 20:00, the patient experienced severe numbness in both hands mostly effecting both thumbs and first 3 digits, puffiness in face and around eyes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the adverse events. On an unknown date, the patient underwent lab tests and procedures which included PPD tests and the result was found to be unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe numbness in both hands mostly effecting both thumbs and first 3 digits, puffiness in face and around eyes were not recovered at the time of this report.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph nodes in armpit of arm that was vaccinated; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 07Jul2021 at 09:45 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 vaccine. Concomitant medications included vitamin B12 (MANUFACTURER UNKNOWN) and ascorbic acid /pyridoxal phosphate /biotin /folic acid /colecalciferol /calcium pantothenate /ascorbyl palmitate /cocarboxylase /calcium citrate /tocopheryl acid succinate /calcium ascorbate /magnesium aspartate /betacarotene /manganese /molybdenum /chromium /copper /vanadium /iodine /selenium /mecobalamin /magnesium ascorbate /zinc gluconate /bioflavonoids nos /nicotinamide ascorbate /riboflavin phosphate /boron citrate (MULTIVITAMIN); both from unknown dates for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 16Jun2021 (at the age of 12-year-old), as a single dose for COVID-19 immunisation. The patient previously received clotrimazole (LOTRIMIN) on an unknown date for an unspecified indication and experienced drug allergy. On 08Jul2021 at 09:00, the patient experienced swelling of lymph nodes in armpit of arm that was vaccinated. 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 event swelling of lymph nodes in armpit of arm that was vaccinated was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received 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. The patients' medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date, the patient experienced fatigue. Since the vaccination, it was unknown if the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the adverse event fatigue. The clinical outcome of the event fatigue was resolved on an unknown date.   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: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW217) via an unspecified route of administration in the right arm on 07Jul2021 at 10:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included reactive arthritis. 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 were not reported. The patient previously took sulfasalazine and experienced an allergy. On 07Jul2021 at 18:00 the patient experienced a sore arm. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors 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. The clinical outcome of the event sore arm was recovering at the time of the report.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Swelling in legs; Increased pain in joints within a week of shots; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received 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 09Mar2021 at 00:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. 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 ibuprofen (MOTRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on Feb2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 16Mar2021, the patient experienced swelling in legs and increased pain in joints within a week of shots that not only had not gone away but was getting worse as time went on. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in Mar2021, the patient underwent SARS-COV-2 test and the result was negative. On an unknown date in Apr2021, the patient underwent SARS-COV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events swelling in legs and increased pain in joints was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: My left torso and thigh down to my knee including groin area has pins and needles and numb; My left torso and thigh down to myknee including groin area has pinsand needles and numb; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 26Feb2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. 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 did not receive any medication within two weeks of vaccination.  On 15Mar2021, the patient's left torso and thigh down to his knee including groin area had pins and needles and numbness. No therapeutic measures were taken as a result of event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events left torso and thigh down to his knee including groin area had pins and needles and numbness was not recovered at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in unspecified location in 2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever 102 degrees; muscle aches (legs back); Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 13-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 06Jul2021 at 10:00 (at the age of 13-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. 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 right arm on 15Jun2021 at 16:30 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jul2021 at 21:00, the patient experienced fever, muscle aches (legs back) and sore arm, these symptoms lasted for approximately 24 hours. On 06Jul2021, the body temperature was reported as 102 degrees. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measure was taken as a result of events and included treatment with acetaminophen.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102 degrees, muscle aches (legs back) and sore arm was resolved on 07Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 16Jun2021 at 02:00 (at the age of 12-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 07Jul2021 at 04:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any vaccine within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced fever. The clinical outcome of event fever was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vertigo positional
Clinical narrative: Pain at injection site for 2 weeks; Headache; positional Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6119) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease(CAD) and sulfonamide allergy. Concomitant medication included losartan (MANUFACTURER UNKNOWN); from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 for COVID-19 immunisation. 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. On 04Mar2021 at 04:00 AM, the patient experienced pain at injection site for 2 weeks, headache the next day and was still having them and also had positional vertigo. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included Duloxetine for headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, headache and positional vertigo was not recovered at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer. A female patient of unknown age received 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. Medical history was not reported. It was unknown whether the patient received any concomitant medications. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event fatigue was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, SARS-CoV-2 test
Clinical narrative: Ocular sensitivity to light; This is a spontaneous report from a contactable nurse, the parent. A 36-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 on an unknown date (at the age of 36-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on an unknown date (at the age of 36-years-old); both as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021, the patient experienced ocular sensitivity to light. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on 01Jul2021 and tested negative. 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 event. The clinical outcome of the event ocular sensitivity to light was not recovered 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: Pilonidal cyst, SARS-CoV-2 test
Clinical narrative: Pilonidal cyst; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have any allergies to medications, food, or other products. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C) and vitamin d nos (VITAMIN D); taken for an 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: EN6199) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19.  On 12Apr2021, the patient experienced pilonidal cyst. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event and included cyst drained and wound left open to heal. Since the vaccination, the patient had been tested for COVID-19. On unknown date in Mar2021, the patient underwent color test and the result was negative and on an unknown date in Apr2021, May2021, Jun2021 and Jul2021, the patient underwent color test and the result was unknown. The clinical outcome of the event pilonidal cyst was recovered on unknown date in 2021 at this time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain, Ultrasound scan
Clinical narrative: Enlarged lymph node under right arm; Causes sharp pains at times and sore; Causes arm to go numb sometimes; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via intramuscular route of administration in the left arm on 22Jan2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via intramuscular route of administration in the left arm on 23Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as not applicable. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021, a week after the vaccine, the patient experienced enlarged lymph node under right arm which had not gone away at the time of this report. The enlarged lymph node caused sharp pains at times and sore and also caused the patient's arm to go numb sometimes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with antibiotics and ultrasound. On an unknown date, the patient underwent Ultrasound and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events enlarged lymph node under right arm, caused sharp pains at times and sore and caused arm to go numb sometimes was not recovered at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: Fever 101; Chills; Muscle soreness; Weakness; Intense headache; Growing pain in an area that previously had surgery on (in left clavicle); This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0196) via an unspecified route of administration in the left arm on 07Jul2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included surgery in left clavicle. The patient had mild allergy to fruits. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0196) via an unspecified route of administration in the left arm on 17Jun2021 at 12:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Jul2021 at 00:45, the patient experienced fever 101, chills, muscle soreness, weakness, intense headache and growing pain in an area that she previously had surgery on (in her left clavicle). Om 08Jul2021 at 00:45 the patient underwent test which include body temperature and the result was 101 (unspecified units).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 fever 101, chills, muscle soreness, weakness, intense headache and growing pain in an area that previously had surgery on (in left clavicle) were not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 101; Chills; Muscle soreness; Weakness; Intense headache; Growing pain in an area that previously had surgery on (in left clavicle); This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0196) via an unspecified route of administration in the left arm on 07Jul2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included surgery in left clavicle. The patient had mild allergy to fruits. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0196) via an unspecified route of administration in the left arm on 17Jun2021 at 12:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Jul2021 at 00:45, the patient experienced fever 101, chills, muscle soreness, weakness, intense headache and growing pain in an area that she previously had surgery on (in her left clavicle). Om 08Jul2021 at 00:45 the patient underwent test which include body temperature and the result was 101 (unspecified units).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 fever 101, chills, muscle soreness, weakness, intense headache and growing pain in an area that previously had surgery on (in left clavicle) were not resolved at the time of this report.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Feeling itchy; Hives all over her body; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0217) via an unspecified route of administration in the left arm on 08Jul2021 at 19:00 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to coating on pills. 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. Concomitant medications were not reported. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced allergy. On 09Jul2021 at 02:00, around 6 hours after the vaccine, the patient started feeling itchy and got hives all over her body. 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 events. The clinical outcome of the events feeling itchy and hives all over her body was resolved on 09Jul2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Full body muscle soreness; Fatigue; Swollen and tender lymph nodes under left arm (arm of injection site) and left neck; This is a spontaneous report from a non-contactable consumer, the patient. A 24-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 01Jun2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. The patient had known allergies to ceftriaxone sodium (ROCEPHINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, 12 hours after vaccination, the patient experienced full body muscle soreness, fatigue and swollen and tender lymph nodes under left arm (arm of injection site) and left neck for 2-3 weeks post vaccine. The patient's lymph nodes were slightly enlarged but no longer tender at the time of report. 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 full body muscle soreness and fatigue was resolved with sequelae on an unknown date in Jun2021, after the duration of 12 hours; while that of the swollen and tender lymph nodes under left arm (arm of injection site) and left neck was not recovered 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.