chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Drug hypersensitivity, Erythema, Headache, Rash
Clinical narrative: Chest to neck rash= allergic reaction; Chest to neck rash= allergic reaction; Turned bright red from chest to halfway up face; face swelled up; 2 hour dry coughing fit resulting in persistent wet cough; tolerable headache; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown), on 17Apr2021 at 11Am on left Arm as Dose 1 single for covid 19 immunization. Medical history included TBI (Traumatic Brain Injury) and known allergies: mushrooms and Aspirin from an unknown date. Concomitant medications were not reported. Past drug included Aspirin. On 5Apr2021 at 12 PM Patient experienced Chest to neck rash (allergic reaction), Turned bright red from chest to halfway up face, face swelled up, 12 hour dry coughing fit resulting in persistent wet cough, and tolerable headache. No therapeutic treatments were received. On an unspecified date the outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Chest to neck rash= allergic reaction; Chest to neck rash= allergic reaction; Turned bright red from chest to halfway up face; face swelled up; 2 hour dry coughing fit resulting in persistent wet cough; tolerable headache; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown), on 17Apr2021 at 11Am on left Arm as Dose 1 single for covid 19 immunization. Medical history included TBI (Traumatic Brain Injury) and known allergies: mushrooms and Aspirin from an unknown date. Concomitant medications were not reported. Past drug included Aspirin. On 5Apr2021 at 12 PM Patient experienced Chest to neck rash (allergic reaction), Turned bright red from chest to halfway up face, face swelled up, 12 hour dry coughing fit resulting in persistent wet cough, and tolerable headache. No therapeutic treatments were received. On an unspecified date the outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: 6204) via an unspecified route of administration in Arm Left on 18Mar2021 10:45 as DOSE 2, SINGLE for covid-19 immunisation (at pharmacy). Patient didn't had covid prior to vaccination, patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications lisinopril, allopurinol, foltanx, cartia xt, Motrin within 2weeks. Medical history included arthritis from an unknown date and unknown if ongoing, herpes zoster from 04Feb2020 to an unknown date, analgesic therapy from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop date were not reported; calcium levomefolate, mecobalamin, pyridoxal phosphate (FOLTANX RF) taken for an unspecified indication, start and stop date were not reported; diltiazem hydrochloride (CARTIA XT) taken for an unspecified indication, start and stop date were not reported; ibuprofen (MOTRIN [IBUPROFEN]) taken for analgesic therapy, start and stop date were not reported; paracetamol (TYLENOL) taken for analgesic therapy, start and stop date were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection,Batch/Lot Number:EN 6202) via unspecified route of administration on 25Feb2021 15:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced chest pain on 30Mar2021 14:00. Therapeutic measures were taken as a result of chest pain was antiviral and pain prescription. The outcome of the event chest pain was recovering.  No follow-up attempts are possible; No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Consistent elevated blood pressure (150/110); This is a spontaneous report from a contactable consumer (reported for himself). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8731/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 at 15:30 (at the age of 36-years-old) as dose 2, single for covid-19 immunisation at other. The patient medical history and concomitant medications were not reported. 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 previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8727/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021at 15:30 (at the age of 36-years-old) as dose 1, single for covid-19 immunisation at other. On 19Apr2021 at 07:00, the patient experienced consistent elevated blood pressure (150/110). The reporter stated the events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 150/110 on 19Apr2021 (Consistent elevated blood pressure (150/110)). Therapeutic measures were taken as a result of event included treatment with lostartan. The outcome of the event was not resolved.  No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Erythema, Oropharyngeal discomfort, Paraesthesia oral
Clinical narrative: My lips started tingling; my face then became beet red; BP went way up; throat was scratchy; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 51 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 09:45 (Batch/Lot Number: EW0161) as DOSE 2, SINGLE for covid-19 immunisation. Also, received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30 Mar2021 09:30 (Batch/Lot Number: ER2613 ) as DOSE 1, SINGLE for covid-19 immunisation as historical vaccine. Medical history included allergy to arthropod sting from an unknown date and unknown if ongoing. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient states that her lips started tingling on 21Apr2021 with outcome of recovering , her face then became beet red on 21Apr2021 with outcome of recovering , blood pressure went way up leading to blood pressure increased on 21Apr2021 with outcome of recovering, throat was scratchy on 21Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement which went way up. Therapeutic measures were taken as a result of this by taking her in ambulance to medical Center ER and observed after being given Benadryl, famotidine, and prednisone  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Blood test normal, Electromyogram normal, Headache, Hypoaesthesia
Clinical narrative: My lips started tingling; my face then became beet red; BP went way up; throat was scratchy; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 51 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 09:45 (Batch/Lot Number: EW0161) as DOSE 2, SINGLE for covid-19 immunisation. Also, received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30 Mar2021 09:30 (Batch/Lot Number: ER2613 ) as DOSE 1, SINGLE for covid-19 immunisation as historical vaccine. Medical history included allergy to arthropod sting from an unknown date and unknown if ongoing. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient states that her lips started tingling on 21Apr2021 with outcome of recovering , her face then became beet red on 21Apr2021 with outcome of recovering , blood pressure went way up leading to blood pressure increased on 21Apr2021 with outcome of recovering, throat was scratchy on 21Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement which went way up. Therapeutic measures were taken as a result of this by taking her in ambulance to medical Center ER and observed after being given Benadryl, famotidine, and prednisone  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Pain, Pain in extremity, Palpitations, Visual impairment
Clinical narrative: My lips started tingling; my face then became beet red; BP went way up; throat was scratchy; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 51 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 09:45 (Batch/Lot Number: EW0161) as DOSE 2, SINGLE for covid-19 immunisation. Also, received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30 Mar2021 09:30 (Batch/Lot Number: ER2613 ) as DOSE 1, SINGLE for covid-19 immunisation as historical vaccine. Medical history included allergy to arthropod sting from an unknown date and unknown if ongoing. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient states that her lips started tingling on 21Apr2021 with outcome of recovering , her face then became beet red on 21Apr2021 with outcome of recovering , blood pressure went way up leading to blood pressure increased on 21Apr2021 with outcome of recovering, throat was scratchy on 21Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement which went way up. Therapeutic measures were taken as a result of this by taking her in ambulance to medical Center ER and observed after being given Benadryl, famotidine, and prednisone  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy
Clinical narrative: Pleurisy like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfur (MANUFACTURER UNKNOWN) for an unknown indication on unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid (MANUFACTURER UNKNOWN) and probiotic nos (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates and unknown if ongoing. On 02Apr2021 at 14:00, the patient experienced pleurisy like symptoms. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pleurisy like symptoms was recovered with sequelae on an unknown in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 25-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 16Apr2021(at the age of 25-years-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19.  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 vaccination. The concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced arthralgia and muscle soreness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arthralgia and muscle soreness was not recovered at the time of this report.    No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Headache; Sore muscles; Sore joints; Nausea; Intense pain at injection site; Redness at injection site; Swelling at injection site; Patchiness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on 14Apr2021 at 19:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, shellfish allergy and egg allergy(raw egg). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), Montelukast sodium (SINGULAR) and levocetirizine dihydrochloride (XYZAL); all taken from unknown dates for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER2613) via an unspecified route of administration on 24Mar2021 at 08:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 11:00 the patient experienced fever, headache, sore muscles, sore joints, nausea, intense pain at injection site, redness and swelling, and patchiness at injection site. Therapeutic measures were not taken as a result of the events. 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. The clinical outcome of the events fever, headache, sore muscles, sore joints, nausea, intense pain at injection site, redness and swelling, and patchiness at injection site were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Fever; Headache; Sore muscles; Sore joints; Nausea; Intense pain at injection site; Redness at injection site; Swelling at injection site; Patchiness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on 14Apr2021 at 19:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, shellfish allergy and egg allergy(raw egg). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), Montelukast sodium (SINGULAR) and levocetirizine dihydrochloride (XYZAL); all taken from unknown dates for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER2613) via an unspecified route of administration on 24Mar2021 at 08:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 11:00 the patient experienced fever, headache, sore muscles, sore joints, nausea, intense pain at injection site, redness and swelling, and patchiness at injection site. Therapeutic measures were not taken as a result of the events. 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. The clinical outcome of the events fever, headache, sore muscles, sore joints, nausea, intense pain at injection site, redness and swelling, and patchiness at injection site were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Breast pain, Pain, Pain in extremity
Clinical narrative: Body aches all over; Body aches all over. Arms, lower back, breasts; Body aches all over. Arms, lower back, breasts; Body aches all over. Arms, lower back, breasts; Fever up to 103.1/ Fever for over 24 hours.; This is a spontaneous report from a 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: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. 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: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 21:00, the patient experienced body aches all over in arms, lower back and breasts and fever for up to 103.1 (unknown units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches all over in arms, lower back and breasts and fever were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches all over; Body aches all over. Arms, lower back, breasts; Body aches all over. Arms, lower back, breasts; Body aches all over. Arms, lower back, breasts; Fever up to 103.1/ Fever for over 24 hours.; This is a spontaneous report from a 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: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. 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: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 21:00, the patient experienced body aches all over in arms, lower back and breasts and fever for up to 103.1 (unknown units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches all over in arms, lower back and breasts and fever were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Oropharyngeal pain
Clinical narrative: Sore throat; Very tender lymph node under right arm; This is a spontaneous report from a contactable consumer, the patient. A 43-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 arm right on 15Apr2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, ADD (attention deficit disorder), eczema, COVID-19 and sulfonamide allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), olmesartan medoxomil (BENICAR) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) all for unknown indication from an unknown date. 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 arm left on 25Mar2021 at 14:00 (at the age of 43-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 17Apr2021 at 07:00, second day after injection, the patient experienced sore throat and very tender lymph node under right arm. 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 sore throat and very tender lymph node under right arm were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching at the injection site and around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old 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 08Apr2021 at 15:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. It was unknown whether the patient was pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) for unknown indication from an unknown date.  Allergies to medications, food or other products was reported as not aware of. 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 14Apr2021, the patient experienced itching at the vaccination site and around the vaccination site  (reported as nothing serious). 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, the patient had not been tested for COVID-19. The clinical outcome of the event itching at the vaccination site and around the vaccination site was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Hypoaesthesia, Pain in extremity
Clinical narrative: right arm went numb; the back of arm was sore; irregular heart beat; 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: FP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications or other products. The patient did not take any concomitant medications. 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 07Apr2021 at 16:00, the patient experienced irregular heart beat and on 10Apr2021 her right arm went numb and the back of her arm was sore. The right arm was not the arm that the patient got the injection, so she thought that was strange. 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. 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 irregular heartbeat, right arm went numb and back of arm was sore was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular, Ultrasound scan
Clinical narrative: right arm went numb; the back of arm was sore; irregular heart beat; 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: FP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications or other products. The patient did not take any concomitant medications. 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 07Apr2021 at 16:00, the patient experienced irregular heart beat and on 10Apr2021 her right arm went numb and the back of her arm was sore. The right arm was not the arm that the patient got the injection, so she thought that was strange. 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. 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 irregular heartbeat, right arm went numb and back of arm was sore was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual spotting (which never done before). Spotting was 3/27-4/10. Menstrual spotting has lasted almost two weeks, which took her to  28 day mark of the cycle; Had also started going longer than 4 weeks between periods, but never shorter.; 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: ER8732) via an unspecified route of administration in the right arm on 25Mar2021 at 14:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included mitral valve regurgitation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on 17Feb2021, within four weeks prior to the COVID vaccine. Concomitant medications included nadolol (MANUFACTURER UNKNOWN), cannabidiol (CBD OIL), magnesium oxide (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and phosphoric acid sodium, sodium phosphate dibasic (PHOSPHATE); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 04Mar2021 at 14:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. On 27Mar2021 at 07:00, day after second vaccination, the patient experienced menstrual spotting (which never occurred before). Spotting was from 3/27 to 4/10. Menstrual spotting had lasted almost two weeks, which took the patient to the 28-day mark of the cycle, then moved into a normal period which she had for almost a week now (usually only 4-5 days). Period started 4/11-current as of 4/17. The patient had also started going longer than 4 weeks between periods, but never shorter. 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 menstrual spotting (which never done before) and had started going longer than 4 weeks between periods, but never shorter were resolving 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: Abdominal pain upper, Back pain, Benign neoplasm of cervix uteri, Computerised tomogram, Fatigue
Clinical narrative: Tingling on left side of face 30 min  after vaccine.; Tired; back pain; stomach pain; Swollen lymph nodes in neck, chest and under arm; Swollen lymph nodes in neck, chest and under arm; Ct scan at emergency room shows multiple small benign appearing cervical nodes.; Pain, extreme pain in neck from glands; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: En6207, patient was 51-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 03:45 PM as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. No covid prior vaccination, not tested for covid post vaccination. On 26Mar2021 at 16:15, the patient experienced tingling on left side of face 30 min after vaccine, on 26Mar2021, the patient experienced tired, back pain, stomach pain, swollen lymph nodes in neck, chest and under arm, swollen lymph nodes in neck, chest and under arm, CT scan at emergency room shows multiple small benign appearing cervical nodes., pain, extreme pain in neck from glands. The patient underwent lab tests and procedures which included CT scan: multiple small benign appearing cervical nodes on 26Mar2021. Patient received treatment for events. AE resulted in to visit doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcomes of events were not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Paraesthesia, Peripheral swelling
Clinical narrative: Tingling on left side of face 30 min  after vaccine.; Tired; back pain; stomach pain; Swollen lymph nodes in neck, chest and under arm; Swollen lymph nodes in neck, chest and under arm; Ct scan at emergency room shows multiple small benign appearing cervical nodes.; Pain, extreme pain in neck from glands; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: En6207, patient was 51-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 03:45 PM as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. No covid prior vaccination, not tested for covid post vaccination. On 26Mar2021 at 16:15, the patient experienced tingling on left side of face 30 min after vaccine, on 26Mar2021, the patient experienced tired, back pain, stomach pain, swollen lymph nodes in neck, chest and under arm, swollen lymph nodes in neck, chest and under arm, CT scan at emergency room shows multiple small benign appearing cervical nodes., pain, extreme pain in neck from glands. The patient underwent lab tests and procedures which included CT scan: multiple small benign appearing cervical nodes on 26Mar2021. Patient received treatment for events. AE resulted in to visit doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcomes of events were not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I contracted shingles following my 2nd COVID vaccine.; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 16Feb2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shrimp. The patient did not receive any medication within two weeks of vaccination. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 26Jan2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient had contracted shingles following her second COVID vaccine, the symptoms started on 19Mar2021 and diagnosis was confirmed on 22Mar2021. 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 antiviral medication. The clinical outcome of the event shingles was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, Chest pain, Echocardiogram
Clinical narrative: I have a 24/7 constant chest pain; Intense heart pounding sensation; This is a spontaneous report from a contactable consumer (patient). A (age:39; unit: unknown) non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administrated in Left arm on 06Apr2021, as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included Ritual prenatal vitamins (Prenatal Vitamins [Minerals Nos; Vitamins Nos]). No other vaccine in four weeks. Patient had no known allergies. On 08Apr2021, the patient experienced I have a 24/7 constant chest pain, and Intense heart pounding sensation. On an unspecified date, the patient underwent lab tests and procedures which included laboratory Blood pressure measurement: Normal; Blood test: Normal; Body temperature: Normal; Echocardiogram: Unknown result, Waiting on Echo results; Electrocardiogram: Normal; Heart rate: Normal; and Oxygen saturation: Normal. Patient did not received treatment for adverse events. Patient visited to physician office. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Oxygen saturation, Palpitations
Clinical narrative: I have a 24/7 constant chest pain; Intense heart pounding sensation; This is a spontaneous report from a contactable consumer (patient). A (age:39; unit: unknown) non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administrated in Left arm on 06Apr2021, as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included Ritual prenatal vitamins (Prenatal Vitamins [Minerals Nos; Vitamins Nos]). No other vaccine in four weeks. Patient had no known allergies. On 08Apr2021, the patient experienced I have a 24/7 constant chest pain, and Intense heart pounding sensation. On an unspecified date, the patient underwent lab tests and procedures which included laboratory Blood pressure measurement: Normal; Blood test: Normal; Body temperature: Normal; Echocardiogram: Unknown result, Waiting on Echo results; Electrocardiogram: Normal; Heart rate: Normal; and Oxygen saturation: Normal. Patient did not received treatment for adverse events. Patient visited to physician office. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: 3.5 inch wide red strip from shoulder to elbow; It is warm in the red area.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 13Mar2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced 3.5-inch-wide red strip from his shoulder to his elbow. It was warm in the red area. It had been 7 days since his shot. His understanding was that side effects should last 2 or 3 days. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events 3.5-inch-wide red strip from shoulder to elbow and warm in the red area was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Auxiliary lymph node pain on left side > 5 days.; Auxiliary lymph node welling on left side > 5 days.; This is a spontaneous report from a non-contactable consumer, the patient. An adult male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration in the left arm on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. 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: EN 6206) via an unspecified route of administration in the left arm on 22Mar2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 the patient experienced auxiliary lymph node pain/swelling on left side for more than 5 days. 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 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 auxiliary lymph node pain/swelling on left side for more than 5 days was resolving.  No follow-up attempts are possible. No further information is expected.  .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: left arm and hand started tingling; Throughout the day my arm and legs kept feeling so heavy. Thankfully, the following day I felt a lot better. Even the soreness had stopped in my left arm; Throughout the day my arm and legs kept feeling so heavy. Thankfully, the following day I felt a lot better. Even the soreness had stopped in my left arm; problems breathing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 13Apr2021 at 14:00 (at the age of 63-year-old) as single dose for COVID-19 immunization. Medical history of the patient included blood pressure and asthma. Patient had no known allergies. Concomitant/other medications in two weeks included Losartan 25mg/Albuterol 90mg taken for an unspecified indication. Patient previously received Shingle vaccine in right arm on an unspecified date in Feb2021. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 14Apr2021 at 07:00, patient had problems breathing in the morning, (used Inhalant) within hour was better. On 17Apr2021, Saturday morning, left arm and hand started tingling. Patient flexed her hand and moved her arm up and down to no relief. She took half a Losartan and it stopped within an hour. Throughout the day her arm and legs kept feeling so heavy, the following day she felt a lot better. Even the soreness had stopped in her left arm. Patient received treatment in response to the events. Outcome of the event feeling heavy in arms and legs, soreness in left arm were resolved on 18Apr2021, tingling was resolved on 17Apr2021, breathing difficulty was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Swollen lymph node in L armpit; General malaise; Myalgia; This is a spontaneous report from a contactable pharmacist. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the arm left on 16Apr2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient previously received amoxicillin (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. 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: EP6955) via intramuscular route of administration in the arm left on 26Mar2021 at 15:00 (at the age of 16-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 vaccine. On 17Apr2021 at 10:00, the patient experienced swollen lymph node in left armpit, general malaise and myalgia, noted upon waking the morning. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the events swollen lymph node in left armpit, general malaise and myalgia was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.