chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperaesthesia teeth
Clinical narrative: 48 hours post vaccine my top teeth became very sensitive pressure feeling. After 1 500 mg Tylenol the pain let up but still tight & sensitive to liquids.; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 38-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 24May2021 at 14:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) taken for unknown indication taken within 2 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 03May2021 at 13:15 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 25May2021 at 14:00 24 hours post vaccine heavy feeling, chills, she took Tylenol 500mg and she started to sweat & feel much better.0n 26May2021 48 hours post vaccine her top teeth became very sensitive pressure feeling. She took 500 mg Tylenol the pain let up but still tight & sensitive to liquids. Therapeutic measures were taken as a result of the events chills, sensitive teeth with Tylenol 500mg. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events heavy feeling, chills, top teeth became very sensitive pressure feeling and the pain let up but still tight & sensitive to liquids were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in hands; numbness in feet; tingling in hands and feet; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via intramuscular route of administration in the right arm on 23May2021 at 15:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021, the patient experienced numbness and tingling in the hands and feet. It was unknown whether the patient received any treatment for the reported events. The events did not result in any doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness and tingling in the hands and feet was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Broke out in a red rash / near arm injection site; Broke out in a itchy rash / near arm injection site; Red itchy rash on legs and partial torso; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO177) via an unspecified route of administration in the left arm on 18May2021 at 09:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included cystic fibrosis, an allergy to strawberries, bee venom and latex. The patient previously received sulfa (sulfonamide) and opiates and experienced a drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 13:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19May2021 at 17:00, few hours after the second vaccine, the patient reported that she "broke out in a red itchy rash / near arm injection site, legs and partial torso." 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 visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events broke out in a red itchy rash / near arm injection site, legs and partial torso were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Headache, Injection site pain, Myalgia
Clinical narrative: Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site/ whole body muscle soreness; Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site/ Achey joints and bone; Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site.; I also have an intense headache,; Achey joint; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 26May2021 at 10:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anemia, plantar fasciitis, COVID-19, allergy to animal (cat), pollen allergy and spice (cinnamon). Concomitant medications were not reported. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, 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 27May2021, after waking up the next morning after the first dose the patient's every muscle and bone in the body had the same pain which she had on the injection site. The patient also had an intense headache, whole body muscle soreness, achy joints and bones and nausea. 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 every muscle and bone in her body had the same pain which she had on the injection site, intense headache, whole body muscle soreness, achy joints and bones and nausea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site/ whole body muscle soreness; Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site/ Achey joints and bone; Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site.; I also have an intense headache,; Achey joint; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 26May2021 at 10:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anemia, plantar fasciitis, COVID-19, allergy to animal (cat), pollen allergy and spice (cinnamon). Concomitant medications were not reported. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, 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 27May2021, after waking up the next morning after the first dose the patient's every muscle and bone in the body had the same pain which she had on the injection site. The patient also had an intense headache, whole body muscle soreness, achy joints and bones and nausea. 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 every muscle and bone in her body had the same pain which she had on the injection site, intense headache, whole body muscle soreness, achy joints and bones and nausea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Could barely feel a little soreness where the needle went in; Rash on area 10 days later; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 18May2021 as dose 1, single (at the age of 79-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she had no problem at all for 24 hours and on May2021, patient could touch her arm and had a little soreness/could barely feel a little soreness where the needle went in. On May2021, 10 days later, patient developed a rash on area and wanted to know if she was allergic to something in the vaccine, specifically mentioning preservative. Patient also asked that should she get her second dose. The outcome of all the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: sweats; This is a spontaneous report from a contactable consumer. This 70-Year-old male consumer reported for himself.  A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 25May2021 (at the age of 70-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 70-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 2 weeks after the vaccination, the patient is experiencing mild sweats. Caller is wondering if he is supposed to get side effects on the 3rd week after both shots were given. The outcome of the events is not recovered at the time of report.  No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: experienced joint pain in opposite arm; a bit of tingling/numbness in my fingers; a bit of tingling/numbness in fingers.; Beginning symptom was just soreness in arm that received the vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO167) via an unspecified route of administration in left arm on 24May2021 at 15:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to regular laundry detergent or chemicals and short haired animal fur. Concomitant medications included vitamins nos (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and diphenhydramine hydrochloride (BENADRYL) from an unknown date for allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24May2021 at 16:00, the patient experienced just soreness in arm that received the vaccine and a bit of tingling/numbness in her fingers. On 25May2021, the day after, the patient experienced joint pain in the opposite arm and vaccinated arm felt fine. All symptoms were no longer continued and the patient felt regular. No therapeutic measures were taken as a result of the reported events. The adverse events 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 events soreness in arm, a bit of tingling/numbness in fingers and joint pain in the opposite arm was recovered on an unknown date in May2021.     No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue
Clinical narrative: Tired; very sad; This is a spontaneous report from a contactable consumer, the patient. A 13-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 18:30 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient had no known allergies to food, medications or other products. 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 26May2021 at 15:30, the patient felt tired and very sad. No previous signs of depression or anxiety ever before. The patient did not receive any treatment for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired and very sad was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on my forearm; got itchy hands and feet; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on 21May2021 (at the age of 20-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for COVID-19 immunization. The patient reported that she got his second dose on 21May2021 and 3-4 hours after he 'got itchy hands and feet'. Then she got a 'rash on her forearm' on 22May2021, but it went away within 30 min. She wanted to know whether it was common and whether was there anything that she could do for it. The outcome of the event itchy was unknown and rash was resolved on 22May2021.  The lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: tired; weak; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 65-years-old male patient received bnt162b2 (BNT162B2, PFZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient stated since the vaccine dose he has felt weak and tired and patient wanted to know how long will it last. He was so tired, he need to rest when he is working. Patient asked for recommendations on any medication he can take for the symptoms. Reported seriousness was reported as non-serious. The outcome for the events was reported as unknown at the time of this report.   Information about batch/lot number has been requested.  Follow-up (23Aug2021): This follow-up is being submitted to notify that 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node above collarbone on the side of vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 41-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 20May2021 at 09:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. medical history was reported as none. The patient did not have allergies to medications, food, or other products. Concomitant medications included loratadine (CLARITIN 10MG), saccharomyces boulardii (FLORASTOR) and magnesium (MANUFACTURER UNKNOWN), all used for unknown indication from unspecified dates, unknown if ongoing. 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. Since the vaccination, the patient had not been tested for COVID-19.On 27May2021 at 11:00, the patient experienced swollen lymph node above collarbone on the side of vaccination. 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 swollen lymph node was not recovered at the time of the report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feeling abnormal; 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: EW0191) via an unspecified route of administration in the left arm on 27May2021 at 08:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient medical history included COVID-19. The patient had no allergies to food, medication or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 06May2021 at 08:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 09:00, the patient stated that magnet sticks to her arm at injection site and there is a strong magnetic pull in other areas of her body/feeling abnormal. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event magnet sticks to her arm at injection site and there is a strong magnetic pull in other areas of her body/feeling abnormal was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster outbreak approx 1 week following second Pfizer dose; This is a spontaneous report from a contactable healthcare professional. A 56-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 May2021 as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26May2021, the patient experienced herpes zoster outbreak approximately one week following second dose of COVID-19 vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of herpes zoster outbreak which included treatment with valaciclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event herpes zoster outbreak was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness for a day on the left arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170/EW0185) via an unspecified route of administration in the left arm on 29Apr2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 20May2021 at 15:00, the patient experienced soreness for a day on the left arm. The event 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 event. The clinical outcome of the event soreness on the left arm was resolved on 21May2021.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Pruritus, Rash, Swelling
Clinical narrative: Full body rash; Hives; Itchy; swollen on chest, arms, hips, legs; swollen on chest, arms, hips, legs; swollen on chest, arms, hips, legs; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 06May2021 at 15:30 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. 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 06May2021, the patient experienced full body rash, looked like hives, itchy, swollen. On chest, arms, hips, legs. 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 events. The clinical outcome of the events full body rash, looked like hives, itchy, swollen on chest, arms, hips, legs were recovered on an unknown date in May2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body rash; Hives; Itchy; swollen on chest, arms, hips, legs; swollen on chest, arms, hips, legs; swollen on chest, arms, hips, legs; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 06May2021 at 15:30 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. 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 06May2021, the patient experienced full body rash, looked like hives, itchy, swollen. On chest, arms, hips, legs. 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 events. The clinical outcome of the events full body rash, looked like hives, itchy, swollen on chest, arms, hips, legs were recovered on an unknown date in May2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Itching and rashes on hands and feet; Red spots on feet, ankle and hands; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male 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 24May2021 at 17:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. 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 25May2021 at 17:45, the patient experienced itching and rashes on hands and feet and red spots on feet, ankle, and hands. It had not gone away for 36 hours. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events that included treatment with unspecified antihistamine 10mg. The clinical outcome of the event itching and rashes on hands and feet and red spots on feet, ankle, and hands was not recovered at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable nurse.   A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08May2021 (lot Number: unknown), (at the age of 21-yearsold), as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced rash on 13May2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with prednisone (manufacturer unknown). The outcome of the event rash was recovered on May2021.   Information on the lot/ batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Within a few hours, had a herpes outbreak.; 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: EW0178) via an unspecified route of administration in the left arm on 24May2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes. The patient did not receive any medication within two weeks of vaccination. 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 03May2021 at 13:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient previously received cefadroxil (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. 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 24May2021 at 18:00, within a few hours, the patient experienced herpes outbreak. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of herpes outbreak and included treatment with VALTREX. The clinical outcome of the event herpes outbreak was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising on the lateral side of lower legs, bilateral.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration on 25May2021 at 10:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 04May2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 26May2021 at 06:00 the patient experienced bruising on the lateral side of lower legs, bilateral. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bruising on the lateral side of lower legs, bilateral was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: . headache; arm swelling; arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26May2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient 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 05May2021 at 14:30 (at the age of 49-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. On 27May2021 at 10:00, the patient experienced headache, arm swelling and soreness. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of  headache, arm swelling and soreness was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site scab
Clinical narrative: Scab at injection site; This is a spontaneous report from a contactable consumer, the patient. A 77-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 an unknown date in 2021(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 02Mar2021 at 13:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not tested for COVID-19. On 23Apr2021, the patient experienced scab at injection site. The event 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 event. The clinical outcome of scab at the injection site was not recovered at the time of report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Stomach problem she has been having. She stated that it was not related to the vaccine; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced stomach problem. It was reported that patient for the second dose had to cancel her appointment due to a stomach problem she has been having. She stated that it was not related to the vaccine. She wanted to know how long will need to restart the vacation process all over again. The outcome of event was not recovered at the time of report.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events abdominal discomfort and suspect drug BNT162B2 cannot be excluded
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Headache, Neck pain, Tenderness
Clinical narrative: Pain and tenderness left armpit; Tenderness left armpit, outer side of breast and neck; Pain and tenderness left armpit, outer side of breast; Pain and tenderness left armpit, outerside of breast and neck.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 49-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 10May2021(at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included famotidine (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. 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 12May2021, the patient experienced pain and tenderness left armpit, outer side of breast and neck, headache. Therapeutic measures were not 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. The clinical outcome of the events pain and tenderness left armpit, outer side of breast and neck, headache were not resolved at the time of reporting.   Information on lot/batch number has been requested
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Major swelling; body pain; This is a spontaneous report from a contactable consumer, the patient. A 52-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 05Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Patient had no allergies to food, medication or other products. The patient did not receive any other 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 COVID vaccine. On 06Apr2021 at 12:00, the patient experienced major swelling and body pain. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event major swelling and body pain were not resolved at the time of this report.   Information about lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Limb discomfort, Lymphadenopathy
Clinical narrative: armpit area and under the arm, patient havea lot of pain and discomfort; armpit area and under the arm, patient havea lot of pain and discomfort; lymph nodes were compromised and patient have swelling in the armpit area and under the arm; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on an 03May2021 at 10:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient not had any known allergies to medication, food or any other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on an unknown date (at the age of 38-year-old) as a single dose 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.  Since the vaccination, the patient had not been tested for COVID-19. On 25May2021 at 02:00 after receiving the second Pfizer vaccine, the patient experienced lymph nodes were compromised, patient had swelling in the armpit area and under the arm, the patient had a lot of pain and discomfort in that area, it was the side where patient received his vaccinated. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included cold water compress, ibuprofen and patient took rest. The clinical outcome of the events swelling in the armpit area and under the arm, patient had a lot of pain and discomfort in that area were not recovered at the time of this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have had a rash from the vaccine since i taken the second dose; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on an unknown date in 2021(at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included seizures. Concomitant medications were not reported. The patient had known allergies to penicillin and sulfur. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 08Apr2021(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 COVID vaccine. On 29Apr2021 at 09:30 the patient had a rash from vaccine since the second dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with some medication to resolve the issue. The clinical outcome of the event had a rash from vaccine since the second dose was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: have had varying degrees of unexpected vaginal bleeding since a day or two after my second vaccine. This ranges from light spotting to a regular menstrual flow.  It has not stopped, although some days it is much less than others.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the arm left on 12May2021 at 17:00(at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and ethinylestradiol, levonorgestrel (ETHINYLESTRADIOL/LEVONORGESTREL); from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 21Apr2021 at 17:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. 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 four weeks prior to the vaccination. On 14May2021, the patient experienced varying degrees of unexpected vaginal bleeding since a day or two after her second vaccine. This ranges from light spotting to a regular menstrual flow.  It has not stopped, although some days it is much less than others. 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 event vaginal bleeding was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Axillary mass, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: Felt a lump in my left armpit; I had gotten shortness of breath feeling; I had gotten feeling tired; I had gotten feeling weak; I felt hot; Sides felt like it had getting tight; I felt dizzy; My body had tensing up; Feel my body or hardly breath.; Through out the day I was getting worse; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8736) via an unspecified route of administration in the left arm on 24May2021 at 16:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The relevant medical history was not reported. The patient had no allergies to medications, food or other products. The patient did not receive any 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 25May2021 the patient experienced felt a lump in left armpit, worse, shortness of breath, feeling tired, feeling weak, felt hot, sides felt like it had getting tight, felt dizzy, body had tensing up and feel body or hardly breath. It's reported that the patient had a lump in left armpit throughout the day had worse, shortness of breath feeling tired, and weak. He felt hot so drinking Gatorade then a couple of minutes later sides felt like it had to get tight and felt dizzy then when an inside body had to tense up and he couldn't feel the body or hardly breath. No therapeutic measures were taken as a result of reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of felt a lump in left armpit, worse, shortness of breath, feeling tired, feeling weak, felt hot, sides felt like it had getting tight, felt dizzy, body had tensing up and feel body or hardly breath was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.