chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on the injection site, the arm under the armpit and around the heart; I do had the booster shot; Dizzy; I already felt down; pain on the injection site, the arm under the armpit and around the heart; Feeling unwell; Muscle pain; Chills; Nausea; pain on the injection site, the arm under the armpit and around the heart; pain on the injection site, the arm under the armpit and around the heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown, Expiry date: unknown, NDC/UPC number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization; Bnt162b2 (2nd Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "Pain on the injection site, the arm under the armpit and around the heart"; IMMUNISATION (medically significant), outcome "unknown", described as "I do had the booster shot"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I already felt down"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain on the injection site, the arm under the armpit and around the heart".   Clinical information: The patient wanted to know if the booster shot really was the right one or not. The patient was in a little bit in time pressure when requested for further information and was unwilling to complete the report. Regarding the lot number the patient thought of talking about it to medical info department. On request an attempt was made to transfer the call to Pfizer Medical Information Department however it was unsuccessful and call got hung up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm of shot; Whole body chills; Headache; Fever; Third/booster dose of BNT162b2; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administration date 30Nov2021 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication included: SUMATRIPTAN taken for Migraine. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL3247; Anatomical site: unspecified; Route of administration: unspecified), administration date: 25Feb2021, when the patient was 49 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE; Lot number: EL3247; Anatomical site: unspecified; Route of administration: unspecified), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Third/booster dose of BNT162b2"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Pain in arm of shot"; CHILLS (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Whole body chills"; HEADACHE (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Fever". Therapeutic measures were taken as a result of pain in extremity, chills, headache and pyrexia. Additional Information: 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 COVID vaccine. 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, emergency room/department or urgent care. Therapeutic measures included treatment with TYLENOL and ADVIL.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: I got a condition called CIDP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "I got a condition called CIDP". clinical course includes " she got a condition called CIDP. her neurologist said she is 99% sure it came from the vaccine."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Product dose omission issue
Clinical narrative: Misses doses from time to time; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 56-year-old male patient received tofacitinib citrate (XELJANZ), since 15Oct2021 (Batch/Lot number: unknown) at 5 mg; bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "Misses doses from time to time"; HEADACHE (non-serious), outcome "unknown", described as "headache". The action taken for tofacitinib citrate was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: ER8729) at the age of 44 years as dose 2, single and administered in arm left, administration date 07Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 02Dec2021, outcome "recovering" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: All of my lymph nodes in my neck and head swelled and caused a lot of pain; All of my lymph nodes in my neck and head swelled and caused a lot of pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date an unknown date in Sep2021 (Lot number: unknown) at the age of 56 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset an unknown date in Sep2021, outcome "recovered" (an unknown date in 2021), and all described as "All of my lymph nodes in my neck and head swelled and caused a lot of pain". The event "All of my lymph nodes in my neck and head swelled and caused a lot of pain" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy and lymph node pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. She was told to email by her doctor regarding her reaction that she had with her first dose of the COVID-19 vaccine. She needed to know whether or not to take the 2nd dose. All of her lymph nodes in her neck and head swelled and caused a lot of pain. It lasted for about two months. Her doctor even ordered a CT scan to verify it was not anything else. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Immunisation, Influenza like illness, Vaccination site pain
Clinical narrative: Dose received: 3; Injection site hurt for 2 days; Bones ached for approximately 2 days; Flu like symptoms severe enough to miss work 2 days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is a Pfizer colleague.  An adult male patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical site: unspecified, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown, Anatomical site: unspecified, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Injection site hurt for 2 days"; BONE PAIN (non-serious), outcome "recovering", described as "Bones ached for approximately 2 days"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovering", described as "Flu like symptoms severe enough to miss work 2 days". It was unknown whether any therapeutic measures were taken as a result of the events vaccination site pain, bone pain and influenza like illness.  Additional Information: Employee reporting for a friend (patient). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lip blister, Myalgia
Clinical narrative: Large blister on lower lip-never occurred before; Fever; Chills; Muscle aches in legs; Headache; Tiredness; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: FK5127) at the age of 10 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE ; Lot Number: FK5127; Anatomical site: left arm; Route of administration: unspecified), administration date: an unknown date in Nov2021, when the patient was 10 years old, for COVID-19 immunisation.  The following information was reported: LIP BLISTER (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Large blister on lower lip-never occurred before"; PYREXIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Muscle aches in legs"; HEADACHE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tiredness". The events "Large blister on lower lip-never occurred before", "Fever", "Chills", "Muscle aches in legs", "Headache" and "Tiredness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lip blister, pyrexia, chills, myalgia, headache and fatigue.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient also had a fever, chills, muscle aches in legs, headache, and tiredness which are already known side effects. It was not sure if the challenge to the immune system allowed a previous exposure to a virus causing lip blisters to surface. Therapeutic measures included unspecified over-the-counter (OTC) cold sore medicine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Large blister on lower lip-never occurred before; Fever; Chills; Muscle aches in legs; Headache; Tiredness; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: FK5127) at the age of 10 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE ; Lot Number: FK5127; Anatomical site: left arm; Route of administration: unspecified), administration date: an unknown date in Nov2021, when the patient was 10 years old, for COVID-19 immunisation.  The following information was reported: LIP BLISTER (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Large blister on lower lip-never occurred before"; PYREXIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Muscle aches in legs"; HEADACHE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tiredness". The events "Large blister on lower lip-never occurred before", "Fever", "Chills", "Muscle aches in legs", "Headache" and "Tiredness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lip blister, pyrexia, chills, myalgia, headache and fatigue.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient also had a fever, chills, muscle aches in legs, headache, and tiredness which are already known side effects. It was not sure if the challenge to the immune system allowed a previous exposure to a virus causing lip blisters to surface. Therapeutic measures included unspecified over-the-counter (OTC) cold sore medicine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: Gall bladder attack; This is a spontaneous report received from a contactable reporter (consumer or other non hcp). The reporter is the patient.   A 41-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22May2021 at 09:30 (Lot number: UNKNOWN) at the age of 41 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: CITALOPRAM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Route of administration: unspecified), administration date: unknown, for COVID-19 immunisation.  The following information was reported: GALLBLADDER DISORDER (non-serious) with onset 22May2021 at 14:45, outcome "unknown", described as "Gall bladder attack". Therapeutic measures were taken as a result of gallbladder disorder.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of gallbladder disorder which included treatment with muscle relaxants.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: He came in close contact with someone who tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "He came in close contact with someone who tested positive for Covid-19".  Additional information: Pharmacist said patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine (orange cap) 3 weeks ago, came in close contact with someone who was positive for COVID about 5 days after he had the vaccine. HCP said the patient was scheduled to receive the 2nd dose tomorrow, 04Dec2021. She also wants to know if the patient needs to hold off with the 2nd dose even if he was asymptomatic, and tests negative. She also mentioned that it was still too early for the patient to get tested so they do not know whether he has contracted the virus of not. HCP also wants to know how long the quarantine period should be. According to the CDC, people in the community or in outpatient settings who have had a known COVID-19 exposure should not seek vaccination until their quarantine period has ended to avoid potentially exposing healthcare personnel and others during the vaccination visit. This also avoids causing diagnostic confusion between possible adverse effects of vaccination and symptoms of a new COVID-19 diagnosis. This recommendation also applies to people with a known COVID-19 exposure before receipt of the second mRNA vaccine dose. Investigation Assessment: No.  Description of Product Complaint: Description of complaint: pharmacist, reporting on behalf of a patient mentioned that he came in close contact with someone who is positive for COVID about 5 days after he had the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Facial paralysis, Inflammation, Vascular malformation
Clinical narrative: Partial facial paralysis/paralysis happened on your right side of my face; Paralysis got worse; Vascular malformation of the seventh cranial nerve (a mass); Inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 25 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 02May2021 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot #: EW0153), administration date: 11Apr2021, for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 2021, outcome "recovering", described as "Partial facial paralysis/paralysis happened on your right side of my face"; CONDITION AGGRAVATED (medically significant) with onset 2021, outcome "recovering", described as "Paralysis got worse"; VASCULAR MALFORMATION (non-serious) with onset 2021, outcome "unknown", described as "Vascular malformation of the seventh cranial nerve (a mass)"; INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Inflammation". Therapeutic measures were taken as a result of facial paralysis, condition aggravated. It was reported that, the paralysis happened on right side of the face, the patient  increased therapy in order to counteract the increased paralysis, and it has mostly improved, but some still remains. The case was reported as non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Rash
Clinical narrative: Rash on torso; Third/booster dose of BNT162b2; Initial immunisation with COVID-19 vaccine moderna and booster dose with BNT162b2; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 01Dec2021 at 09:30 (Lot number: FG3527) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot number: 009021A, Anatomical location: left arm, Administration time: 09:00), administration date: 24Apr2021, when the patient was 38 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot number: HRSA0421A, Anatomical location: left arm, Administration time: 09:00), administration date: 22May2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 09:30, outcome "unknown", described as "Third/booster dose of BNT162b2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 01Dec2021 at 09:30, outcome "unknown", described as "Initial immunisation with COVID-19 vaccine moderna and booster dose with BNT162b2"; RASH (non-serious) with onset 02Dec2021 at 21:30, outcome "not recovered", described as "Rash on torso". Therapeutic measures were not taken as a result of rash. Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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, emergency room/department or urgent care.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Swollen and painful left armpit; Painful left armpit; Swollen and painful left armpit/lymph node; Painful left armpit/lymph node; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 02Dec2021 at 11:15 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing). Concomitant medications included: SYNTHROID. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 15Mar2021, when the patient was 48 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 22Feb2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 11:15, outcome "unknown", described as "The patient received third/booster dose of BNT162b2"; SWELLING (non-serious) with onset 03Dec2021 at 08:00, outcome "recovering", described as "Swollen and painful left armpit"; AXILLARY PAIN (non-serious) with onset 03Dec2021 at 08:00, outcome "recovering", described as "Painful left armpit"; LYMPHADENOPATHY (non-serious) with onset 03Dec2021 at 08:00, outcome "recovering", described as "Swollen and painful left armpit/lymph node"; LYMPH NODE PAIN (non-serious) with onset 03Dec2021 at 08:00, outcome "recovering", described as "Painful left armpit/lymph node". Therapeutic measures were taken as a result of swelling, axillary pain, lymphadenopathy and lymph node pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. 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. Treatment included advil for swelling, axillary pain, lymphadenopathy and lymph node pain.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Dose number:3; Fevers; Headache; Fatigue; Ringing in the ears; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: EW0186) at the age of 45 years, as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Human immunodeficiency virus syndrome", notes: HIV and "Sulfonamide allergy", notes: Known allergy: Sulpha. Concomitant medications included: WELLBUTRIN; BIKTARVY; TOPAMAX; DILT-XR and FLECAINIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot Number: EN6203, Anatomical location: Arm Left, Route of administration: Unspecified), administration date: 23Feb2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE Lot Number: EP7534, Route of administration: Unspecified), administration date: 16Mar2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 13Sep2021, outcome "unknown", described as "Dose number:3"; PYREXIA (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Fevers"; HEADACHE (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Fatigue"; TINNITUS (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Ringing in the ears"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Sep2021 at 03:00, outcome "not recovered", described as "Flu like symptoms". Therapeutic measures were taken as a result of pyrexia, headache, fatigue, tinnitus and influenza like illness which included treatment with antibiotics (unspecified).  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Flu like symptoms; Dose number:3; Fevers; Headache; Fatigue; Ringing in the ears; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: EW0186) at the age of 45 years, as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Human immunodeficiency virus syndrome", notes: HIV and "Sulfonamide allergy", notes: Known allergy: Sulpha. Concomitant medications included: WELLBUTRIN; BIKTARVY; TOPAMAX; DILT-XR and FLECAINIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot Number: EN6203, Anatomical location: Arm Left, Route of administration: Unspecified), administration date: 23Feb2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE Lot Number: EP7534, Route of administration: Unspecified), administration date: 16Mar2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 13Sep2021, outcome "unknown", described as "Dose number:3"; PYREXIA (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Fevers"; HEADACHE (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Fatigue"; TINNITUS (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Ringing in the ears"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Sep2021 at 03:00, outcome "not recovered", described as "Flu like symptoms". Therapeutic measures were taken as a result of pyrexia, headache, fatigue, tinnitus and influenza like illness which included treatment with antibiotics (unspecified).  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: 24 hour delayed swelling at injection site; Swollen lymph node in left armpit; Tenderness, itchiness, red spot at injection site; Itchiness, red spot at injection; Red spot at injection site; Dose 1 and Dose with Moderna COVID 19 vaccine; Dose 3 with Pfizer COVID 19 vaccine; Dose received 3; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 30Nov2021 at 17:00 (Lot number: FD0809) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos and "Gluten intolerance" (unspecified if ongoing), notes: Known allergies: Gluten. Concomitant medication included: SYNTHROID. Past drug history included: Morphine, reaction: "Drug allergy", notes: Known allergies: Morphine. Vaccination history included: Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot number: 024M20A, Anatomical location: Left arm), administration date: 20Feb2021, when the patient was 28 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot number: 037L20A, Anatomical location: Left arm), administration date: 21Jan2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 30Nov2021 at 17:00, outcome "unknown", described as "Dose 1 and Dose with Moderna COVID 19 vaccine; Dose 3 with Pfizer COVID 19 vaccine"; IMMUNISATION (non-serious) with onset 30Nov2021 at 17:00, outcome "unknown", described as "Dose received 3"; VACCINATION SITE SWELLING (non-serious) with onset 01Dec2021, outcome "recovering", described as "24 hour delayed swelling at injection site"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "recovering", described as "Swollen lymph node in left armpit"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021, outcome "recovering", described as "Tenderness, itchiness, red spot at injection site"; VACCINATION SITE PRURITUS (non-serious) with onset 01Dec2021, outcome "recovering", described as "Itchiness, red spot at injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 01Dec2021, outcome "recovering", described as "Red spot at injection site". Therapeutic measures were not taken as a result of vaccination site swelling, lymphadenopathy, vaccination site pain, vaccination site pruritus and vaccination site erythema.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. 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.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: Have developed painful joint pain/inflammation, knees and hip; Have developed painful joint pain/inflammation, knees and hip; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Feb2021 (Lot number: unknown) at the age of 68 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Drug allergy", notes: Known allergy : Cipro.  The following information was reported: ARTHRALGIA (non-serious), ARTHRITIS (non-serious) all with onset 03Feb2021 at 12:30, outcome "not recovered", and all described as "Have developed painful joint pain/inflammation, knees and hip". The event "Have developed painful joint pain/inflammation, knees and hip" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia and arthritis.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures included physical therapy and unspecified medicine for pain/inflammation. The patient also received Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical site: unspecified), administration date: 22Feb2021, when the patient was 68 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: UNKNOWN; Anatomical site: Unspecified; Administration time: 14:00), administration date: 18Oct2021, when the patient was 68 years old, for COVID-19 immunisation.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myopia, Visual acuity reduced, Visual impairment
Clinical narrative: Vision significantly impacted; Both distance and reading vision affected.; Both distance and reading vision affected; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162b2), administered in left arm, administration date 20Nov2021 at 14:00 (Lot number: FG3527) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing) notes: known allergies: Penicillin. Concomitant medications included: ADVIL; VIT E; VIT C, MULTI-VIT and MAGNESIUM. Vaccination history included: bnt162b2 (DOSE 1, SINGLE; Lot number: EW0153; Anatomical site: Right arm; Administration time: 16:00), administration date: 12Apr2021, when the patient was 52 years old, for COVID-19 immunisation and bnt162b2 (DOSE 2, SINGLE; Lot number: ER8735; Anatomical site: Left arm; Administration time: 14:00), administration date: 13May2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 at 14:00, outcome "unknown", described as "Dose received 3/ dose number=3"; VISUAL IMPAIRMENT (non-serious) with onset 22Nov2021 at 09:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Vision significantly impacted"; VISUAL ACUITY REDUCED (non-serious) with onset 22Nov2021 at 09:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Both distance and reading vision affected"; MYOPIA (non-serious) with onset 22Nov2021 at 09:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Both distance and reading vision affected". The events "Vision significantly impacted" and "Both distance and reading vision affected'' were evaluated at the physician office visit. Therapeutic measures were not taken as a result of visual impairment, visual acuity reduced and myopia.  Additional Information: 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 been tested for COVID-19. It was reported that patient needed reading glasses now everyday glasses and stronger new glasses needed for reading.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Pain in extremity
Clinical narrative: Fatigue; Headache; Chills; Left arm sore; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 18:30 (Lot number: 33030BD) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: unspecified), administration date: 18Mar2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: unspecified), administration date: 08Apr2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 18:30, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Left arm sore". Therapeutic measures were not taken as a result of fatigue, headache, chills and pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Fever; Extreme body aches; Extreme headache; Diarrhea; Chest pain; Blue palms; Fatigue; This is a spontaneous report received from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 17Nov2021 at 10:00 (Lot number: FF2593) at the age of 27 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: FH8027, Administration site: Left arm, Administration Time: 09:45), administration date: 27Oct2021, when the patient was 27 years old, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fever"; PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme body aches"; HEADACHE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme headache"; DIARRHOEA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Diarrhea"; CHEST PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Chest pain"; SKIN DISCOLOURATION (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Blue palms"; FATIGUE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fatigue". Therapeutic measures were not taken as a result of pyrexia, pain, headache, diarrhoea, chest pain, skin discolouration and fatigue. Relevant laboratory tests and procedures are available in the appropriate section.   Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: Nasal swab (01Nov2021) negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Skin discolouration
Clinical narrative: Fever; Extreme body aches; Extreme headache; Diarrhea; Chest pain; Blue palms; Fatigue; This is a spontaneous report received from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 17Nov2021 at 10:00 (Lot number: FF2593) at the age of 27 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: FH8027, Administration site: Left arm, Administration Time: 09:45), administration date: 27Oct2021, when the patient was 27 years old, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fever"; PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme body aches"; HEADACHE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme headache"; DIARRHOEA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Diarrhea"; CHEST PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Chest pain"; SKIN DISCOLOURATION (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Blue palms"; FATIGUE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fatigue". Therapeutic measures were not taken as a result of pyrexia, pain, headache, diarrhoea, chest pain, skin discolouration and fatigue. Relevant laboratory tests and procedures are available in the appropriate section.   Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: Nasal swab (01Nov2021) negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.