chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Inappropriate schedule of product administration, Memory impairment, Speech disorder
Clinical narrative: Inability to complete simple wording phrases (knowing what things are but no being able to say the names of regular everyday objects.); Extreme forgetfulness; disorientation; administration date 27Apr2021, dose number: 1/administration date 05May2021, dose number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 12:15 (Lot number: 0542624) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic migraines" (unspecified if ongoing); "known allergies: seafood (shrimp specifically)" (unspecified if ongoing), notes: known allergies: seafood (shrimp specifically). Concomitant medication(s) included: PROPRANOLOL. Vaccination history included: Bnt162b2 (product=COVID 19, brand=pfizer,, lot number=0536131, lot unknown=False, administration date=27Apr2021, administration time=03:30 PM , dose number=1, Vaccine location=Left arm), administration date: 27Apr2021, for Covid 19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "Inability to complete simple wording phrases (knowing what things are but no being able to say the names of regular everyday objects.)"; MEMORY IMPAIRMENT (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "Extreme forgetfulness"; DISORIENTATION (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "disorientation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "administration date 27Apr2021, dose number: 1/administration date 05May2021, dose number: 2". Therapeutic measures were not taken as a result of speech disorder, memory impairment, disorientation, inappropriate schedule of product administration.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event -Inability to complete simple wording phrases (knowing what things are but no being able to say the names of regular everyday objects.) -Extreme forgetfulness and disorientation This went on for about 48hrs. No treatment received.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pain of skin, Testicular pain
Clinical narrative: Extreme testicle pain, along with extreme skin skin, muscle, and bone sensitivity and pain.; Extreme testicle pain, along with extreme skin skin, muscle, and bone sensitivity and pain.; Extreme testicle pain, along with extreme skin skin, muscle, and bone sensitivity and pain.; Extreme testicle pain, along with extreme skin skin, muscle, and bone sensitivity and pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 17:00 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D NOS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot number: UNKNOWNAnatomical site: Left armAdministration time: 17:00), administration date: 22May2021, when the patient was 26 years old, for COVID-19 immunisation. The following information was reported: TESTICULAR PAIN (non-serious), PAIN OF SKIN (non-serious), MYALGIA (non-serious), BONE PAIN (non-serious) all with onset 13Jun2021 12:00, outcome "recovering" and all described as "Extreme testicle pain, along with extreme skin skin, muscle, and bone sensitivity and pain.". Therapeutic measures were not taken as a result of testicular pain, pain of skin, myalgia, bone pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Significant swelling in right arm pit/front of shoulder (pectoral muscle) and right bicep (vaccine arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jun2021 16:30 (Lot number: EW0168) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (COVID vaccine details: product: COVID 19,, Lot number: EW0129,, Lot unknown: False,, Dose number: 1,, Vaccine location: right arm), administration date: 21May2021, when the patient was 14 years old, for COVID-19 Immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 12Jun2021, outcome "not recovered", described as "Significant swelling in right arm pit/front of shoulder (pectoral muscle) and right bicep (vaccine arm)". The event "significant swelling in right arm pit/front of shoulder (pectoral muscle) and right bicep (vaccine arm)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of peripheral swelling.  Additional information: The patient had no COVID prior vaccination. The patient was not tested COVID post vaccination. Patient had no known allergies. The patient was treated with Ibuprofen and Benadryl.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report received from a consumer or other non-HCP (patient), via a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Jan 8, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed myalgia/muscle soreness, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: serve cramping; having irregular periods and clotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21May2021 05:15 (Lot number: 169) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, lot unknown=True.), for COVID-19 immunisation. The following information was reported: DYSMENORRHOEA (non-serious) with onset 01Jun2021, outcome "not recovered", described as "serve cramping"; MENSTRUATION IRREGULAR (non-serious) with onset 01Jun2021, outcome "not recovered", described as "having irregular periods and clotting". The events "serve cramping" and "having irregular periods and clotting" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysmenorrhoea, menstruation irregular.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. She had irregular periods and clotting this has never happened to her and been having periods for 15 years. This did not start until she got the shot. And serve cramping she was in the Army and cannot have complications like this. No treatment was given for the events. The patient did not experienced covid prior vaccination. The patient did not experienced covid post vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Overdose, Product preparation issue, Pyrexia
Clinical narrative: fatigue; fever; Caller is a pharmacist who is reporting administration of undiluted doses of the Pfizer-Biontech Covid19 vaccine to 4 total patients; Caller is a pharmacist who is reporting administration of undiluted doses of the Pfizer-Biontech Covid19 vaccine to 4 total patients; This is a spontaneous report from a Pfizer sponsored program (RA). A contactable pharmacist reported for a 22-year-old female patient that: A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0180; Expiration Date: 31Aug2021), via an Intramuscular route of administration in right deltoid on 02Jul2021 at 09:00 (at the age of 22-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation in pharmacy. The patient medical history and concomitant medications were not reported. The patient's medical history (including any illness at time of vaccination) was unknown. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), via an unspecified route of administration on an unknown date (at the age of 22-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Additional vaccines administered on same date of the Pfizer suspect was unknown. Adverse events following prior vaccinations was unknown. The reporter was a pharmacist reporting higher than the recommended dose of the Pfizer COVID 19 vaccine. On 02Jul2021 (before 10:00), the product was not diluted before being given and was given to 4 patients. Did not confirm whether these were first or second doses. The reporter was asked if this has been studied before and what adverse events to anticipate. The reporter stated that she does not have all of the information, as she was not the one that administered the vaccines. She could forward it on to whoever needs to get it, as far as that goes. Upon follow-up on 09Aug2021, Reporter stated that Patient experienced Fatigue and Fever on 02Jul2021 at 12:00. The adverse event did not result in a visit to emergency room and physician office. AE resolved with the use of Tylenol /Advil. The events were reported as non-serious. The outcome of the events Fatigue and Fever was recovered on an unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.   Follow-up (09Aug2021): This is a follow-up spontaneous report from a contactable pharmacist. This pharmacist reported for a female patient in response to HCP letter via follow-up letter which included that: vaccination time and route of administration was updated. New event added.   Follow-up (18Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021830001 same reporter/drug/AE with different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Oligomenorrhoea
Clinical narrative: Late menstrual cycle not due to pregnancy  with extreme bloating and tiredness./ No chance of pregnancy; Late menstrual cycle not due to pregnancy  with extreme bloating and tiredness./ No chance of pregnancy; tiredness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 05Jun2021 12:00 (Lot number: UNKNOWN) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OLIGOMENORRHOEA (non-serious), ABDOMINAL DISTENSION (non-serious) all with onset 27Jun2021, outcome "recovering" and all described as "Late menstrual cycle not due to pregnancy  with extreme bloating and tiredness./ No chance of pregnancy"; FATIGUE (non-serious) with onset 27Jun2021, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of oligomenorrhoea, abdominal distension, fatigue.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.  Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph node in left armpit the day after vaccination; Dose number 3; This is a spontaneous report from a 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 29Dec2021 at 12:00 (Lot number: unknown) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 14:30), administration date: 18Mar2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 12:45), administration date: 08Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 12:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph node in left armpit the day after vaccination". Therapeutic measures were not taken as a result of lymphadenopathy.  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 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 lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: Mild body aches; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 20-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 31Dec2021 (Lot number: 33030BD) at the age of 20 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EP6955; Route of administration: Unspecified), administration date: 27Mar2021, when the patient was 20 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EP6955; Route of administration: Unspecified), administration date: 17Apr2021, when the patient was 20 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021, outcome "unknown", described as "Dose number 3"; PAIN (non-serious) with onset 01Jan2022, outcome "recovering", described as "Mild body aches". Therapeutic measures were not taken as a result of 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. 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 28-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 28, in left arm, on Dec 16, 2021, single dose, for COVID-19 immunisation. 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. The patient reported alopecia/have been losing hair by the fistfuls/every shower and every hair brush resulted in a softball size wads of hair loosened from scalp, onset Dec 20, 2021, outcome of not recovered. No therapeutic measures taken as a result of alopecia. Additional information: The patient has no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not 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 not provided and will be requested during follow-up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Rash, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result: Positive; Covid test result: Positive; body rash; shortness of breath; This is a spontaneous report received from a contactable reporter Other HCP (Nurse) from product quality group. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jan2021 (Lot number: EL0142) at the age of 48 years as dose 2, single and administered in arm right, administration date 26Dec2020 (Lot number: EL1284) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies: Penicillin" (unspecified if ongoing). There was no covid prior vaccination. Concomitant medication(s) included: TYLENOL; BENADRYL in two weeks. There was no other vaccine in four weeks. Past drug history included: Carrot, reaction(s): "Allergy"; Morphine, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Oct2021, outcome "unknown" and all described as "Covid test result: Positive"; RASH (non-serious) with onset 16Jan2021, outcome "unknown", described as "body rash"; DYSPNOEA (non-serious) with onset 16Jan2021, outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Oct2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, rash, dyspnoea. Clinical course: full body red rash with slight shortness of breath on first dose when he got the 2nd dose a month later he took 1000mg tyl and 50 mg Benadryl 1 hour prior to vaccine and still ended up with body rash and shortness of breath. both time this was with in less then 5 minutes of getting the Pfizer vaccine. Facility type vaccine was reported as in Hospital.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Immunisation, Mass, Myalgia, Pain in extremity
Clinical narrative: I noticed a lump under my shoulder area leading to my breast; I had muscle and bone pain the next day; I had muscle and bone pain the next day, my knee caps were even hurting; My heart was throbbing; There was pain on the arm that I got the vaccine on. On Saturday the pain in the arm where I received the vaccine had progressed.; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Dec2021 at 19:45 (Lot number: unknown) at the age of 50 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: Unspecified), administration date: an unknown date in May2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of Administration: Unspecified), administration date: an unknown date in Jun2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 at 19:45, outcome "unknown", described as "Dose received 3"; MYALGIA (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "I had muscle and bone pain the next day"; BONE PAIN (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "I had muscle and bone pain the next day, my knee caps were even hurting"; PALPITATIONS (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "My heart was throbbing"; PAIN IN EXTREMITY (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "There was pain on the arm that I got the vaccine on. On Saturday the pain in the arm where I received the vaccine had progressed"; MASS (non-serious) with onset 01Jan2022, outcome "not recovered", described as "I noticed a lump under my shoulder area leading to my breast". Therapeutic measures were not taken as a result of myalgia, bone pain, palpitations, pain in extremity and mass.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the 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 did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I noticed a lump under my shoulder area leading to my breast; I had muscle and bone pain the next day; I had muscle and bone pain the next day, my knee caps were even hurting; My heart was throbbing; There was pain on the arm that I got the vaccine on. On Saturday the pain in the arm where I received the vaccine had progressed.; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Dec2021 at 19:45 (Lot number: unknown) at the age of 50 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: Unspecified), administration date: an unknown date in May2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of Administration: Unspecified), administration date: an unknown date in Jun2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 at 19:45, outcome "unknown", described as "Dose received 3"; MYALGIA (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "I had muscle and bone pain the next day"; BONE PAIN (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "I had muscle and bone pain the next day, my knee caps were even hurting"; PALPITATIONS (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "My heart was throbbing"; PAIN IN EXTREMITY (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "There was pain on the arm that I got the vaccine on. On Saturday the pain in the arm where I received the vaccine had progressed"; MASS (non-serious) with onset 01Jan2022, outcome "not recovered", described as "I noticed a lump under my shoulder area leading to my breast". Therapeutic measures were not taken as a result of myalgia, bone pain, palpitations, pain in extremity and mass.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the 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 did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Asymptomatic COVID-19 infection; Asymptomatic COVID-19 infection; dose 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 27Oct2021 15:30 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single, via an unspecified route of administration, administered in arm left, administration date 13Apr2021 16:00 (Lot number: EW0161) at the age of 47 years as dose 2, single and via an unspecified route of administration, administered in arm left, administration date 23Mar2021 16:30 (Lot number: EN6207) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was not pregnant at the time of vaccination. The patient has no history of COVID-19 infection and has no known allergies. There were no concomitant medications. The patient received no other vaccines within 4 weeks.  The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021 15:30, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Asymptomatic COVID-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal Swab): (26Dec2021) positive; (PCR) (22Dec2021) negative. Therapeutic measures were not taken as a result of vaccination failure, asymptomatic covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain in extremity
Clinical narrative: Booster dose; The lymph swelling in my breast and under arm area/ lymph node swelling under her arm; Arm pain; 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 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "The lymph swelling in my breast and under arm area/ lymph node swelling under her arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Reporter Subtype: Patient. PQC Present: No. AE Present: Yes. Caller received her Pfizer BTC vaccine (purple cap formula) Booster dose and experienced lymph node swelling under her arm and also arm pain. Wanted to know if this was normal. Caller stated she "did exercises to drain her lymphatic system and her mother said to put a hot compress on it and the next morning it was gone." Caller was asking if she needed to worry about getting breast cancer now, because of "the lymph swelling in her breast and under arm area. A review of the Prescribing Information for Pfizer BTC vaccine (purple cap formula) failed to find any information regarding breast cancer. Please consult with your doctor or health care provider for further guidance, as your doctor/healthcare provider is the most familiar with your medical condition.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Booster dose; The lymph swelling in my breast and under arm area/ lymph node swelling under her arm; Arm pain; 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 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "The lymph swelling in my breast and under arm area/ lymph node swelling under her arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Reporter Subtype: Patient. PQC Present: No. AE Present: Yes. Caller received her Pfizer BTC vaccine (purple cap formula) Booster dose and experienced lymph node swelling under her arm and also arm pain. Wanted to know if this was normal. Caller stated she "did exercises to drain her lymphatic system and her mother said to put a hot compress on it and the next morning it was gone." Caller was asking if she needed to worry about getting breast cancer now, because of "the lymph swelling in her breast and under arm area. A review of the Prescribing Information for Pfizer BTC vaccine (purple cap formula) failed to find any information regarding breast cancer. Please consult with your doctor or health care provider for further guidance, as your doctor/healthcare provider is the most familiar with your medical condition.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID-19; Contracted COVID-19; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 (Lot number: EW0217) at the age of 48 years as dose 3 (booster), single, administered in arm left, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: Known allergies: No. Concomitant medication(s) included: PEPCID AC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering" and all described as "Contracted COVID-19"; IMMUNISATION (medically significant) with onset 27Oct2021, outcome "unknown", described as "Dose number = 3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Post vaccination: Nasal Swab; (31Dec2021) positive, notes: Post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation, Pneumonia
Clinical narrative: Booster; Pneumonia worsened; This is a solicited report received from contactable reporter for a sponsored program. Other Case identifier(s): 21K-163-4191816-00.  Solicited report from the USA by a consumer of a 74-year-old elderly male with an event of fatal PNEUMONIA WORSENED with HUMIRA 40MG/0.4ML (ADALIMUMAB). There was no reported medical history. On an unknown date (2021), the patient experienced PNEUMONIA WORSENED. In 2021, the patient died. The cause of death was reported as PNEUMONIA WORSENED. It is unknown if an autopsy was performed. PFIZER BIONTECH COVID-19 VACCINE and COVID-19 VACCINE were also considered suspect. The patient died due to pneumonia. He did not take last scheduled dose due to failing health. He had taken Flu shot as well as COVID vaccines and booster. His pneumonia seemed to worsened as he took Humira. He was not taking any concomitant drugs. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. On 25Feb2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 25Mar2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 2021, he received COVID-19 booster shot.  Causality for HUMIRA 40MG/0.4ML: The reporter's causality for the event(s) of PNEUMONIA WORSENED with HUMIRA 40MG/0.4ML was a reasonable possibility.  RA opinion is that there is a reasonable possibility that the event of PNEUMONIA WORSENED is related to HUMIRA 40MG/0.4ML. Causality for Pfizer Biontech Covid-19 Vaccine with pneumonia aggravated (Pneumonia) was possible as per reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and pneumonia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia worsened
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Immunisation
Clinical narrative: positive Abbott BinaxNOW nasal swab test; positive Abbott BinaxNOW nasal swab test; Cough; Fever; Headache; Chills; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a representative. The reporter is the patient.  A 48 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in arm left, administration date 13Oct2021 (Lot number: EW0180) at the age of 48 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 16Mar2021 (Lot number: EN6199) as dose 2, single and intramuscular, administered in arm left, administration date 23Feb2021 (Lot number: EN5318) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included INFLUENZA taken for immunisation, administration date 29Sep2021. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome unknown; IMMUNISATION (medically significant) with onset 13Oct2021, outcome unknown; COUGH (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); PYREXIA (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); HEADACHE (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); CHILLS (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021). The patient underwent the following laboratory tests and procedures sars-cov-2 test (23Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of COVID-19, cough, pyrexia, headache, and chills.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Abbott BinaxNOW nasal swab test; positive Abbott BinaxNOW nasal swab test; Cough; Fever; Headache; Chills; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a representative. The reporter is the patient.  A 48 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in arm left, administration date 13Oct2021 (Lot number: EW0180) at the age of 48 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 16Mar2021 (Lot number: EN6199) as dose 2, single and intramuscular, administered in arm left, administration date 23Feb2021 (Lot number: EN5318) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included INFLUENZA taken for immunisation, administration date 29Sep2021. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome unknown; IMMUNISATION (medically significant) with onset 13Oct2021, outcome unknown; COUGH (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); PYREXIA (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); HEADACHE (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); CHILLS (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021). The patient underwent the following laboratory tests and procedures sars-cov-2 test (23Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of COVID-19, cough, pyrexia, headache, and chills.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Immunisation, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Cough; Sore throat; Abbott BinaxNOW:  Positive; Abbott BinaxNOW: Positive; Dose received:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Oct2021 (Lot number: FF8839) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Apr2021, when the patient was 48 years old, for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. It was unknown the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Abbott BinaxNOW:  Positive"; IMMUNISATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "Dose received:3"; COUGH (non-serious) with onset 25Dec2021 20:00, outcome "recovered" (25Dec2021), described as "Cough"; OROPHARYNGEAL PAIN (non-serious) with onset 25Dec2021 20:00, outcome "recovered" (25Dec2021), described as "Sore throat". Hospitalization was not prolonged. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: Nasal Swab; (Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of cough, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Cough; Sore throat; Abbott BinaxNOW:  Positive; Abbott BinaxNOW: Positive; Dose received:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Oct2021 (Lot number: FF8839) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Apr2021, when the patient was 48 years old, for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. It was unknown the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Abbott BinaxNOW:  Positive"; IMMUNISATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "Dose received:3"; COUGH (non-serious) with onset 25Dec2021 20:00, outcome "recovered" (25Dec2021), described as "Cough"; OROPHARYNGEAL PAIN (non-serious) with onset 25Dec2021 20:00, outcome "recovered" (25Dec2021), described as "Sore throat". Hospitalization was not prolonged. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: Nasal Swab; (Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of cough, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Jun2021 (Lot number: EP6955) at the age of 13 years as dose 2, single and intramuscular, administered in arm left, administration date 27May2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. Relevant past drug history included name of drug was reported as no and reaction was allergy. There were no concomitant medications. The 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 and since the vaccination the patient has been tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Abbott BinaxNOW : Positive / PCR: Positive"; COVID-19 (medically significant) with onset 25Dec2021 18:00, outcome "unknown", described as "Abbott BinaxNOW : Positive / PCR: Positive/ sore throat/Stuffy nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab; (28Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Swollen lymph nodes; Nausea; Injection site pain; Headache; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 at 09:00 (Lot number: 33025BD) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: 33026BD; Anatomical location: Right arm), administration date: 09Dec2021 at 09:00, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Swollen lymph nodes"; NAUSEA (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Nausea"; VACCINATION SITE PAIN (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Injection site pain"; HEADACHE (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 31Dec2021 at 00:00, outcome "not recovered", and all described as "Muscle and joint pain". The events "Swollen lymph nodes", "Nausea", "Injection site pain", "Headache" and "Muscle and joint pain" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, nausea, vaccination site pain, headache, myalgia and arthralgia.  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 not been tested for COVID-19.