chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthru; tested positive for COVID; Breakthru; tested positive for COVID; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Lot number: F5KE20) at the age of 45 years as dose 3 (booster), single, administration date 14Apr2021 (Lot number: EP6955) as dose 2, single and administration date 23Mar2021 (Lot number: EP6955) 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: IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "recovering" and all described as "Breakthru; tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Had a metallic taste that lasted about a hour; Had a metallic taste that lasted about a hour, and the smell of it for about 10 mins; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 11Jan2022 at 11:15 (Lot number: FL3198) at the age of 45 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Cold allergy" (unspecified if ongoing), notes: Known allergies: the cold and "Allergy to plants" (unspecified if ongoing), notes: Known allergies: evergreens. Concomitant medication included: PERCOCET.  The following information was reported: DYSGEUSIA (non-serious) with onset 11Jan2022 at 11:15, outcome "recovered" (11Jan2022), described as "Had a metallic taste that lasted about a hour"; PAROSMIA (non-serious) with onset 11Jan2022 at 11:15, outcome "recovered" (11Jan2022), described as "Had a metallic taste that lasted about a hour, and the smell of it for about 10 mins". Therapeutic measures were not taken as a result of dysgeusia and parosmia.  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. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent treatment clinic.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Caller was asking how long he has to wait to get the booster dose because he tested positive for Covid 10 days ago, 29Dec2021. It was unable to provide contact number, gather address and transfer because the call got disconnected. Created Manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: throat tightness approximately 3 minutes post vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: FD0809, Expiration Date: 10Jan2022) 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: THROAT TIGHTNESS (non-serious) with onset 07Jan2022, outcome "unknown", described as "throat tightness approximately 3 minutes post vaccination".  No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Caller had myocarditis and pericarditis; Caller had myocarditis and pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported MYOCARDITIS (medically significant), PERICARDITIS (medically significant), outcome recovered. The event caller had myocarditis and pericarditis and caller had myocarditis and pericarditis was evaluated at the emergency room visit. The caller received the second dose Pfizer Covid Vaccine and had a horrible reaction. The caller ended up in the hospital and had myocarditis and pericarditis. He was transported via ambulance to the emergency room and was in the emergency room for 6 or 7 hours until sorted out.   Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: Caller had myocarditis and pericarditis; Caller had myocarditis and pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported MYOCARDITIS (medically significant), PERICARDITIS (medically significant), outcome recovered. The event caller had myocarditis and pericarditis and caller had myocarditis and pericarditis was evaluated at the emergency room visit. The caller received the second dose Pfizer Covid Vaccine and had a horrible reaction. The caller ended up in the hospital and had myocarditis and pericarditis. He was transported via ambulance to the emergency room and was in the emergency room for 6 or 7 hours until sorted out.   Follow-up attempts have been completed and no further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough COVID -19 infection; breakthrough COVID -19 infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jan2022, outcome "recovered" (Jan2022) and all described as "breakthrough COVID -19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Pain injection site; Headache; Tiredness; Muscle pain pills; Joint pain; Fever; Nausea; Not feeling well; Decreased appetite; Diarrhea; Vomiting; Arm pain; reminisce injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 at 12:00 (Lot number: unknown)at the age of 39 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication included: WELLBUTRIN.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Pain injection site"; HEADACHE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Tiredness"; MYALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Muscle pain pills"; ARTHRALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Joint pain"; PYREXIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Not feeling well"; DECREASED APPETITE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Decreased appetite"; DIARRHOEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Vomiting"; PAIN IN EXTREMITY (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Arm pain"; VACCINATION SITE REACTION (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "reminisce injection site".  Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, myalgia, arthralgia, pyrexia, nausea, malaise, decreased appetite, diarrhoea, vomiting, pain in extremity and vaccination site reaction.  Additional information: 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-19 vaccine. 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 lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain injection site; Headache; Tiredness; Muscle pain pills; Joint pain; Fever; Nausea; Not feeling well; Decreased appetite; Diarrhea; Vomiting; Arm pain; reminisce injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 at 12:00 (Lot number: unknown)at the age of 39 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication included: WELLBUTRIN.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Pain injection site"; HEADACHE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Tiredness"; MYALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Muscle pain pills"; ARTHRALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Joint pain"; PYREXIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Not feeling well"; DECREASED APPETITE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Decreased appetite"; DIARRHOEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Vomiting"; PAIN IN EXTREMITY (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Arm pain"; VACCINATION SITE REACTION (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "reminisce injection site".  Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, myalgia, arthralgia, pyrexia, nausea, malaise, decreased appetite, diarrhoea, vomiting, pain in extremity and vaccination site reaction.  Additional information: 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-19 vaccine. 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 lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction, Vomiting
Clinical narrative: Pain injection site; Headache; Tiredness; Muscle pain pills; Joint pain; Fever; Nausea; Not feeling well; Decreased appetite; Diarrhea; Vomiting; Arm pain; reminisce injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 at 12:00 (Lot number: unknown)at the age of 39 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication included: WELLBUTRIN.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Pain injection site"; HEADACHE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Tiredness"; MYALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Muscle pain pills"; ARTHRALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Joint pain"; PYREXIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Not feeling well"; DECREASED APPETITE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Decreased appetite"; DIARRHOEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Vomiting"; PAIN IN EXTREMITY (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Arm pain"; VACCINATION SITE REACTION (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "reminisce injection site".  Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, myalgia, arthralgia, pyrexia, nausea, malaise, decreased appetite, diarrhoea, vomiting, pain in extremity and vaccination site reaction.  Additional information: 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-19 vaccine. 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 lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Vaccination site pain
Clinical narrative: After the third dose, the patient experienced pain in the arm and lymph nodes near the injection site for four days; After the third dose, the patient experienced pain in the arm and lymph nodes near the injection site for four days; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 at 11:00 (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; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 11:00, outcome "unknown", described as "Dose number: 3"; LYMPH NODE PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Dec2021 at 01:00, outcome "recovered" (20Dec2021), and all described as "After the third dose, the patient experienced pain in the arm and lymph nodes near the injection site for four days". Therapeutic measures were not taken as a result of lymph node pain and vaccination site pain.  Additional information: It was reported that the patient had no fever. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. 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; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Fatigue; Sore throat; Congestion; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 10Dec2021 (Lot number: FJ8757)at the age of 22 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing).Concomitant medications included unspecified birth control pills. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8732, Route of administration: Unspecified, Anatomical location: left arm), administration date: 19Apr2021, when the patient was 22 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0161, Route of administration: Unspecified, Anatomical location: left arm), administration date: 10May2021, when the patient was 22 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Dose number: 3"; FATIGUE (non-serious) with onset 05Jan2022 at 22:00, outcome "recovering", described as "Fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 05Jan2022 at 22:00, outcome "recovering", described as "Sore throat"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 05Jan2022 at 22:00, outcome "recovering", described as "Congestion". Therapeutic measures were taken as a result of fatigue, oropharyngeal pain and respiratory tract congestion.  Additional information: The patient's known allergies were reported as none. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. The patient received Mucisinex as treatment for the reported events. 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: I got rashes dime size; Quarter size red rashes all throughout my body. Especially my stomach and legs.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 33-year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration time at 16:00 (Lot number: unknown) at the age of 33 years as dose 1, 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. Concomitant medication included: ADDERALL.  The following information was reported: RASH (non-serious) with onset 28Dec2021 at 16:00, outcome "recovered", described as "I got rashes dime size"; RASH ERYTHEMATOUS (non-serious) with onset 28Dec2021 at 16:00, outcome "recovered", described as "Quarter size red rashes all throughout my body. Especially my stomach and legs". Therapeutic measures were taken as a result of rash and rash erythematous.  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 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, emergency room/department or urgent care. The patient drank a lot of Benadryl as treatment for rash and rash erythematous.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstruation delayed
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Jan2022 at 12:00 (Lot number: unknown) at the age of 20 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history and no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Left arm, Vaccine administration time: 12:00), administration date: 05Jun2021, when the patient was 20 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Left arm, Vaccine administration time: 12:00), administration date: 26Jun2021, when the patient was 20 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Jan2022 at 12:00, outcome "unknown", described as "Dose number: 3"; MENSTRUATION DELAYED (non-serious) with onset 04Jan2022 at 12:00, outcome "unknown", described as "Menstural Cycle delayed by 7 days". Therapeutic measures were not taken as a result of menstruation delayed.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.The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Oral herpes, SARS-CoV-2 test
Clinical narrative: Ever since I got the vaccine I have been having cold sore breakouts once a month; Ever since I got the vaccine I have been having cold sore breakouts once a month; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex and "Cold sores" (ongoing), notes: Before the vaccine it was less than twice a year. Concomitant medications included: ABILIFY and ZOLOFT. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number unknown; Anatomical site: left arm; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: ORAL HERPES (non-serious), CONDITION AGGRAVATED (non-serious) all with, outcome "not recovered", and all described as "Ever since I got the vaccine I have been having cold sore breakouts once a month". The event "Ever since I got the vaccine I have been having cold sore breakouts once a month" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether any therapeutic measures were taken as a result of the event oral herpes and condition aggravated.  Additional information: 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-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: Dose number: 3; Fever; Nausea; This is a spontaneous report received from a non-contactable reporter (Pharmacist).   A 46-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 46 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: Covid19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Covid19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Myalgia
Clinical narrative: Increased joint and muscle pain; Increased joint and muscle pain; Also confusion; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 54-year-old male patient received bnt162b2 (BNT162B2), administration date 12Jan2022 at 12:00 (Lot number: unknown) at the age of 54 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: RA - Severe Scoliosis; "Scoliosis" (unspecified if ongoing), notes: RA - Severe Scoliosis; "Joint pain" (unspecified if ongoing) and "Muscle pain" (unspecified if ongoing). Concomitant medications included: FENTYL and VIAGRA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Administration time: 12:00), administration date: 22Dec2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious), all with onset 12Jan2022 at 20:00, outcome "recovering", and all described as "Increased joint and muscle pain"; CONFUSIONAL STATE (non-serious) with onset 12Jan2022 at 20:00, outcome "recovering", described as "Also confusion". Therapeutic measures were not taken as a result of arthralgia, myalgia and confusional state.  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 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 lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Confusional state, Immunisation, Insomnia
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 18:00 (Lot number: FL3209) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: Factor IV and "Fruit allergy" (unspecified if ongoing), notes: Mango (skin contact only). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FL3209,  Route of Administration: unspecified, Administration Time: 05:30, Anatomical Location: Left arm), administration date: 16Apr2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0170,  Route of Administration: unspecified, Administration Time: 17:30, Anatomical Location: Left arm), administration date: 07May2021, when the patient was 52 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 18:00, outcome "unknown", described as "Dose number: 3"; ANXIETY (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "24 hours after the shot, began feeling anxiety. Continued so far for 5 days (better on day 5 (today is day 5), not great)"; INSOMNIA (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Sleeplessness"; PALPITATIONS (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Heart palpitations"; CONFUSIONAL STATE (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Mind going wild"; CHEST DISCOMFORT (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Tightness in chest"; WEIGHT DECREASED (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Resulted in weight loss"; STRESS (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Very stressful". Therapeutic measures were not taken as a result of anxiety, insomnia, palpitations, confusional state, chest discomfort, weight decreased and stress.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. : It was reported that the patient had not recovered yet and will probably seek medical treatment if continues or worsens The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Stress, Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 18:00 (Lot number: FL3209) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: Factor IV and "Fruit allergy" (unspecified if ongoing), notes: Mango (skin contact only). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FL3209,  Route of Administration: unspecified, Administration Time: 05:30, Anatomical Location: Left arm), administration date: 16Apr2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0170,  Route of Administration: unspecified, Administration Time: 17:30, Anatomical Location: Left arm), administration date: 07May2021, when the patient was 52 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 18:00, outcome "unknown", described as "Dose number: 3"; ANXIETY (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "24 hours after the shot, began feeling anxiety. Continued so far for 5 days (better on day 5 (today is day 5), not great)"; INSOMNIA (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Sleeplessness"; PALPITATIONS (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Heart palpitations"; CONFUSIONAL STATE (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Mind going wild"; CHEST DISCOMFORT (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Tightness in chest"; WEIGHT DECREASED (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Resulted in weight loss"; STRESS (non-serious) with onset 09Jan2022 at 18:00, outcome "recovering", described as "Very stressful". Therapeutic measures were not taken as a result of anxiety, insomnia, palpitations, confusional state, chest discomfort, weight decreased and stress.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. : It was reported that the patient had not recovered yet and will probably seek medical treatment if continues or worsens The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Fatigue, Immunisation, Pain
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 at 15:15 (Lot number: FD7218) at the age of 12 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none; Known allergies: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0185; Administration time: 16:15; Anatomical site: left arm; Route of administration: unspecified), administration date: 13May2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0191; Administration time: 16:00; Anatomical site: left arm; Route of administration: unspecified), administration date: 03Jun2021, when the patient was 12 years old, for COVID-19 immunisation.The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 15:15, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 08Jan2022 at 04:15, outcome "recovered" (09Jan2022 at 04:15), described as "Fever (101.5)"; FATIGUE (non-serious) with onset 08Jan2022 at 04:15, outcome "recovered" (09Jan2022 at 04:15), described as "Fatigue"; VULVAL ULCERATION (non-serious) with onset 09Jan2022 at 20:00, outcome "recovering", described as "48 hours post vaccination, developed painful vulvar ulcer"; BURNING SENSATION (non-serious), PAIN (non-serious) all with onset 09Jan2022 at 20:00, outcome "recovering", and all described as "Burning/stinging sensation". The events "Fever (101.5)", "Fatigue", "48 hours post vaccination, developed painful vulvar ulcer" and "Burning/stinging sensation" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vulval ulceration, burning sensation and pain.Additional information: 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-19 vaccine. The patient was not sexually active. Treatment included topical ointment (Lidocaine and Triamcinolone acet) for vulval ulceration, burning sensation and pain. Since the vaccination, the patient had been tested for COVID-19.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vulval ulceration
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 at 15:15 (Lot number: FD7218) at the age of 12 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none; Known allergies: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0185; Administration time: 16:15; Anatomical site: left arm; Route of administration: unspecified), administration date: 13May2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0191; Administration time: 16:00; Anatomical site: left arm; Route of administration: unspecified), administration date: 03Jun2021, when the patient was 12 years old, for COVID-19 immunisation.The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 15:15, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 08Jan2022 at 04:15, outcome "recovered" (09Jan2022 at 04:15), described as "Fever (101.5)"; FATIGUE (non-serious) with onset 08Jan2022 at 04:15, outcome "recovered" (09Jan2022 at 04:15), described as "Fatigue"; VULVAL ULCERATION (non-serious) with onset 09Jan2022 at 20:00, outcome "recovering", described as "48 hours post vaccination, developed painful vulvar ulcer"; BURNING SENSATION (non-serious), PAIN (non-serious) all with onset 09Jan2022 at 20:00, outcome "recovering", and all described as "Burning/stinging sensation". The events "Fever (101.5)", "Fatigue", "48 hours post vaccination, developed painful vulvar ulcer" and "Burning/stinging sensation" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vulval ulceration, burning sensation and pain.Additional information: 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-19 vaccine. The patient was not sexually active. Treatment included topical ointment (Lidocaine and Triamcinolone acet) for vulval ulceration, burning sensation and pain. Since the vaccination, the patient had been tested for COVID-19.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an unknown age and unknown gender patient who got the flu and a horrible one at that while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In 1997, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. In 1997, the patient developed a non-serious event 'got the flu and a horrible one at that' (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I got one flu shot 25 years ago and that was the only year I got the flu and a horrible one at that. Hard pass." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got the flu and a horrible one at that). At time of reporting, the outcome was Unknown for the event 'got the flu and a horrible one at that'.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an unknown age male patient who had flu shot a week later he had the flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE unknown formulation and strength produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event, "had flu shot a week later he had the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (had flu shot a week later he had the flu). At time of reporting, the outcome was Unknown for the event had flu shot a week later he had the flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: This case involves Adult and unknown gender patient who caught the flu few weeks after sick as a dog for 2 weeks after, while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event, "caught the flu few weeks after sick as a dog for 2 weeks after" (influenza) (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported, " I got a flu shot about 30 years ago, caught the flu few weeks after sick as a dog for 2 weeks after,,,, haven't had a flu shot since and haven't had the flu either." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (caught the flu few weeks after sick as a dog for 2 weeks afte, caught the flu few weeks after sick as a dog for 2 weeks after). At time of reporting, the outcome was Unknown for the event caught the flu few weeks after sick as a dog for 2 weeks afte and was Unknown for the event caught the flu few weeks after sick as a dog for 2 weeks after.
Age: 55.0
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I had the flu; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves a 55 years old patient of unknown gender who reported ihad the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, frequency, administration site, lot number and expiry date was unknown) for flu vaccine.  On an unknown date the patient developed a non-serious event " i had the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"I had the flu 32 years ago two days after getting a flu shot."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I had the flu).  At time of reporting, the outcome was Unknown for the event i had the flu.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: today feel sickly; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an Adult patient (unknown gender and age) who today feel sickly, after receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date in Dec-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; route, dose, formulation: unknown) in unknown administration site for Immunisation.  On 07-Jan-2022 the patient developed a non-serious "today feel sickly (malaise)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The following potential adverse event has been found on a public post. Author/Reporter Name:  Author/Reporter Location: Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: Got mine 3 weeks ago today feel sickly gonna stay in bed".   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was Not Applicable.  It was not reported if the patient received a corrective treatment for the event (today feel sickly).  At time of reporting, the outcome was Unknown for the event today feel sickly.