chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Uncomfortable with covid- had booster--as does family; Uncomfortable with covid- had booster--as does family; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (060820).  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: IBRANCE taken for breast cancer female, start date: 03Jun2021 (ongoing); ANASTROZOLE; XGEVA. The following information was reported: Patient was uncomfortable with COVID- had booster as does family. Pandemic causes her stress. The outcome of events was unknown.    The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Called me and told me that when they had an IUD implanted they passed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "bad allergies in general" (unspecified if ongoing), notes: known allergies: bad allergies in general; "weight issue" (unspecified if ongoing), notes: weight issue, at one point had a higher BP but do not think that is case now; "at one point had a higher BP but do not think that is case now" (unspecified if ongoing), notes: weight issue, at one point had a higher BP but do not think that is case now. The patient took concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "Called me and told me that when they had an IUD implanted they passed out".  Additional information: List of any other medications the patient received within 2 weeks of vaccination: Likely, but unsure what. Patient told that when they had an IUD implanted they passed out. They could not make out clearly the words the doctor was telling them right before it happened. I am not sure when this procedure was - Caller know that they have taken other contraceptive previously. Post-procedure, they said it was only "bad for a day". Received both shots for Pfizer around first half of 2021. It was Unsure if this related to anything with the vaccine but reporting out of caution.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Investigation
Clinical narrative: angina pectoris; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: ANGINA PECTORIS (hospitalization, medically significant), outcome "unknown", described as "angina". The event "angina" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: never had covid, notes: Antigens taken, never had covid. That was a disaster; false positive, notes: False positive, ended up in the covid unit.  Antigens taken, never had covid. That was a disaster. Therapeutic measures were taken as a result of angina pectoris.The patient received treatment with nitrates for the event angina pectoris.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (16Dec2021): Follow-up activities closed. Batch/lot number not available.; Sender's Comments: As there is limited information in the case provided, the causal association between the angina pectoris and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myocardial infarction
Clinical narrative: Booster; I had a MI after the third vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/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: Comirnaty (Dose 1, After the first one, he wound up in the ER and hospitalized for angina. IV nitrates. False positive, ended up in the covid unit. Antigens taken, never had Covid. That was a disaster), administration date: 2021, for COVID-19 immunization, reaction(s): "Angina"; Comirnaty (Dose 2), administration date: 2021, for COVID-19 immunization, reaction(s): "The second I was fine". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "I had a MI after the third vaccine". It was the first ever. The patient wanted to know what they were finding with cardiac effects on patients and if it was anything on coagulation. The patient did not know what needs to be done in the future as it keeps mutating and will be additional vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Heavy menstrual bleeding, Immunisation, Urticaria
Clinical narrative: period bleeding started immediately after the vaccine; Period/bleeding started immediately; hives; Immunisation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, prev dose product=COVID 19, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, prev dose dose number=1), for Covid-19 immunization, reaction(s): "hives in the evening"; Bnt162b2 (Dose 2, prev dose product=COVID 19, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, prev dose dose number=2), for Covid-19 immunization, reaction(s): "After the 2nd dose, it made me skip a period". The following information was reported: HAEMORRHAGE (medically significant) with onset 09Dec2021, outcome "not recovered", described as "period bleeding started immediately after the vaccine"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Period/bleeding started immediately"; URTICARIA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "hives"; IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Immunisation". Therapeutic measures were not taken as a result of haemorrhage, heavy menstrual bleeding, urticaria, immunisation. Additional information: The patient was not received any other vaccines within 4 weeks. Patient was not diagnosed with COVID-19 prior vaccination and not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had COVID after vaccination; Had COVID after vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (169752).  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had COVID after vaccination". Lack of efficacy of COVID vaccine. Also generalized that they'd seen lots of patients who were fully vaccinated but still contracted COVID.  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 information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diabetes mellitus, Drug ineffective, Illness, Influenza like illness
Clinical narrative: he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID; he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID; I'm at the beginning stages of diabetes; He's had flu-like symptoms; He's been sick for the 5 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "I'm at the beginning stages of diabetes"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's had flu-like symptoms"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's been sick for the 5 days.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of influenza like illness, illness.  Additional information: He's taken Tylenol, Advil, and cold medicine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments:  ~~~
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID; he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID; I'm at the beginning stages of diabetes; He's had flu-like symptoms; He's been sick for the 5 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "I'm at the beginning stages of diabetes"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's had flu-like symptoms"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's been sick for the 5 days.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of influenza like illness, illness.  Additional information: He's taken Tylenol, Advil, and cold medicine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments:  ~~~
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Malaise, Nausea
Clinical narrative: Low grade fever; Chills; Nausea; Body aches; Malaise for about 6 hours; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in left arm, administration date 14Dec2021 at 16:30 (Lot number: FD7218) at the age of 40 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: Comirnaty (DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 26Mar2021, when the patient was 39 years old, and Comirnaty (DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 05Mar2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 16:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Low grade fever"; CHILLS (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Chills"; NAUSEA (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Nausea"; PAIN (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Body aches"; MALAISE (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Malaise for about 6 hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Duration of the event of Malaise was reported as 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever; Chills; Nausea; Body aches; Malaise for about 6 hours; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in left arm, administration date 14Dec2021 at 16:30 (Lot number: FD7218) at the age of 40 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: Comirnaty (DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 26Mar2021, when the patient was 39 years old, and Comirnaty (DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 05Mar2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 16:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Low grade fever"; CHILLS (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Chills"; NAUSEA (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Nausea"; PAIN (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Body aches"; MALAISE (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Malaise for about 6 hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Duration of the event of Malaise was reported as 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: exposed with Covid-19 and she mentioned that she only got mild symptoms; exposed with Covid-19 and she mentioned that she only got mild symptoms; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "exposed with Covid-19 and she mentioned that she only got mild symptoms".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Pain, Pyrexia
Clinical narrative: Shortness of breath; Fever; Body aches; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 15Dec2021 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Clear cell renal cell carcinoma" (unspecified if ongoing), notes: Clear cell renal cell carcinoma surgery and "Carcinoma excision" (unspecified if ongoing), notes: Clear cell renal cell carcinoma surgery. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0161, Anatomical location: Left arm), administration date: 10Apr2021, when the patient was 31 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: ER2613, Anatomical location: Left arm), administration date: 20Mar2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose received: 3"; DYSPNOEA (non-serious) with onset 16Dec2021 at 01:00, outcome "recovering", described as "Shortness of breath"; PYREXIA (non-serious) with onset 16Dec2021 at 01:00, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 16Dec2021 at 01:00, outcome "recovering", described as "Body aches". Therapeutic measures were not taken as a result of dyspnoea, pyrexia and pain.  Additional information: It was unknown whether the patient had any 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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Feeling cold, Feeling hot
Clinical narrative: myocarditis; pericarditis; hard time breathing; he felt toasty and warm; chills; cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 22 year-old male patient received bnt162b2 (COMIRNATY), administration date May2021 (Batch/Lot number: unknown) at the age of 22 years 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: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant) with onset 2021, outcome "unknown", described as "pericarditis"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "hard time breathing"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "he felt toasty and warm"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: body temperature: unknown results.  Additional Information: The patient received the first dose of the purple cap Pfizer Covid-19 vaccine back in May2021 when he was 21 years-old.  He reports that him and his mom got the first dose at the same time.  He also reported that he had a pain in his heart.  He denies having a reaction to the second dose of the Pfizer Covid-19 vaccine.  He is asking the following: if he should get the booster dose of the purple cap Pfizer Covid-19 vaccine after experiencing what he did with the first dose.  What information is there on the cardiac symptoms that he felt with the Pfizer Covid-19 vaccine. What are the side effects of the booster dose of the purple cap Pfizer Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; hard time breathing; he felt toasty and warm; chills; cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 22 year-old male patient received bnt162b2 (COMIRNATY), administration date May2021 (Batch/Lot number: unknown) at the age of 22 years 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: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant) with onset 2021, outcome "unknown", described as "pericarditis"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "hard time breathing"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "he felt toasty and warm"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: body temperature: unknown results.  Additional Information: The patient received the first dose of the purple cap Pfizer Covid-19 vaccine back in May2021 when he was 21 years-old.  He reports that him and his mom got the first dose at the same time.  He also reported that he had a pain in his heart.  He denies having a reaction to the second dose of the Pfizer Covid-19 vaccine.  He is asking the following: if he should get the booster dose of the purple cap Pfizer Covid-19 vaccine after experiencing what he did with the first dose.  What information is there on the cardiac symptoms that he felt with the Pfizer Covid-19 vaccine. What are the side effects of the booster dose of the purple cap Pfizer Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Swelling
Clinical narrative: Swelling and a lot of pain in the underarm area; Swelling and a lot of pain in the underarm area; The patient previously received COVID-19 VACCINE MODERNA and then third (booster) dose of BNT162B2; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 14Dec2021 at 14:00 (Lot number: unknown) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergic reaction to analgesics" (unspecified if ongoing), notes: Known allergies: Narcotics/opioids and "Drug allergy" (unspecified if ongoing), notes: Known allergies: Narcotics/opioids. Concomitant medications included: IBUPROFEN. Vaccination history included: Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 11:00), administration date: an unknown date in May2021, when the patient was 40 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: an unknown date in Apr2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Dec2021 at 14:00, outcome "unknown", described as "The patient previously received COVID-19 VACCINE MODERNA and then third (booster) dose of BNT162B2"; IMMUNISATION (non-serious) with onset 14Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 15Dec2021, outcome "not recovered", and all described as "Swelling and a lot of pain in the underarm area". Therapeutic measures were not taken as a result of swelling and axillary pain. Additional Information: It had been 52 hours since receiving the injection and pain and swelling persisted. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination was reported as may be Ibuprofen, but not sure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The 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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia, Vaccination site pain
Clinical narrative: Dose received:3; Low grade fever; Soreness at injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 44-year-old male patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Lot number: FF2587) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Route of administration: unknown), administration date: 22Mar2021, when the patient was 43 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955, Route of administration: unknown), administration date: 12Apr2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose received:3"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Low grade fever"; VACCINATION SITE PAIN (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Soreness at injection site".  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Immunisation, Swelling, Vaccination site pain
Clinical narrative: Swelling and tenderness under left arm; Tenderness under left arm; Fatigue; Itching and soreness at injection site; Soreness at injection site; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 14Dec2021 at 15:00 (Lot number: ED7218) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER9735, Anatomical location: Left arm, Administration time: 10:30, Route of administration: Intramuscular), administration date: 12Apr2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0182, Anatomical location: Left arm, Administration time: 10:30, Route of administration: Intramuscular), administration date: 03May2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 15:00, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Swelling and tenderness under left arm"; AXILLARY PAIN (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Tenderness under left arm"; FATIGUE (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Fatigue"; VACCINATION SITE PRURITUS (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Itching and soreness at injection site"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of swelling, axillary pain, fatigue, vaccination site pruritus and vaccination site pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the 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.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Swelling and tenderness under left arm; Tenderness under left arm; Fatigue; Itching and soreness at injection site; Soreness at injection site; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 14Dec2021 at 15:00 (Lot number: ED7218) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER9735, Anatomical location: Left arm, Administration time: 10:30, Route of administration: Intramuscular), administration date: 12Apr2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0182, Anatomical location: Left arm, Administration time: 10:30, Route of administration: Intramuscular), administration date: 03May2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 15:00, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Swelling and tenderness under left arm"; AXILLARY PAIN (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Tenderness under left arm"; FATIGUE (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Fatigue"; VACCINATION SITE PRURITUS (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Itching and soreness at injection site"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of swelling, axillary pain, fatigue, vaccination site pruritus and vaccination site pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the 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.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Breast pain, Headache, Immunisation, Lymphadenopathy
Clinical narrative: Upset stomach; Headache; Swollen glands; Breast pain on left side - where shot was given; Dose number 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Dec2021 (Lot number: FJ1620) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8731, Route of administration: Unspecified), administration date: 14Apr2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0176, Route of administration: Unspecified), administration date: 05May2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Dose number 3"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Dec2021, outcome "recovering", described as "Upset stomach"; HEADACHE (non-serious) with onset 14Dec2021, outcome "recovering", described as "Headache"; LYMPHADENOPATHY (non-serious) with onset 14Dec2021, outcome "recovering", described as "Swollen glands", BREAST PAIN (non-serious) with onset 14Dec2021, outcome "recovering", described as "Breast pain on left side - where shot was given". Therapeutic measures were not taken as a result of abdominal discomfort, headache, lymphadenopathy and breast 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 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 and emergency room/department or urgent care.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Feeling heart beat rapidly and regularly in chest. During fast heart beating check the heart rate, it also increases (up to 95 in rest); This is a spontaneous report from a contactable reporter (consumer or non-HCP). The reporter is the patient.   A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Sep2021 at 18:00 (Lot number: unknown) at the age of 40 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Administration Time: 18:15, Anatomical Location: Right arm, Route of Administration: Unspecified), administration date: 26Aug2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Sep2021, outcome "not recovered", described as "Feeling heart beat rapidly and regularly in chest. During fast heart beating check the heart rate, it also increased (up to 95 in rest)". The event "Feeling heart beat rapidly and regularly in chest. During fast heart beating check the heart rate, it also increased (up to 95 in rest)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures taken as a result of heart rate increased was unknown.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, SARS-CoV-2 test
Clinical narrative: Mild headache; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Dec2021 at 14:15 (Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medications included: EFFEXOR and PREMARIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Administration Location: Right Arm; Route of administration: Intramuscular), administration date: 15May2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Administration Location: Right Arm; Route of administration: Intramuscular), administration date: 03Jun2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 14:15, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 17Dec2021 at 16:00, outcome "recovered" (17Dec2021), described as "Mild headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number of BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation, Speech disorder
Clinical narrative: Brain fog; Difficulty with language/sentence formation; Dose number: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 at 10:15 (Lot number: unknown) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Administration Time: 12:00; Anatomical Location: Left Arm; Route of administration: Unspecified), administration date: 08Apr2021, when the patient was 26 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Administration Time: 12:00; Anatomical Location: Left Arm; Route of administration: Unspecified), administration date: 29Apr2021, when the patient was 26 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 10:15, outcome "unknown", described as "Dose number: 3"; FEELING ABNORMAL (non-serious) with onset 15Dec2021 at 18:00, outcome "unknown", described as "Brain fog"; SPEECH DISORDER (non-serious) with onset 15Dec2021 at 18:00, outcome "unknown", described as "Difficulty with language/sentence formation". Additional information: 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; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Irritability, Malaise, Vaccination site pain
Clinical narrative: Dose received: 3; Fatigue; Malaise; Pain at injection site; Irritability; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP).   An adult female patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious), outcome "recovering", described as "Fatigue"; MALAISE (non-serious), outcome "recovering", described as "Malaise"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Pain at injection site"; IRRITABILITY (non-serious), outcome "recovering", described as "Irritability". Therapeutic measures were not taken as a result of fatigue, malaise, vaccination site pain and irritability. Additional information: 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, 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: A few days after third shot, the lymph nodes in right armpit (shot arm) were swollen for about 3-4 days.; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 22Nov2021 at 10:30 (Lot number: F63527) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medications included: CELEXA; CLARITIN and IBUPROFEN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6199, Route of administration: unspecified, Administration time: 16:30, Anatomical site: Left arm), administration date: 06Mar2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN2613, Route of administration: unspecified, Administration time: 17:00, Anatomical site: Left arm), administration date: 29Mar2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 at 10:30, outcome "unknown", described as "Dose received 3"; LYMPHADENOPATHY (non-serious) with onset 24Nov2021 at 06:00, outcome "recovered" (an unknown date in Nov2021), described as "A few days after third shot, the lymph nodes in right armpit (shot arm) were swollen for about 3-4 days". Therapeutic measures were taken as a result of lymphadenopathy.  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 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 and emergency room/department or urgent care. Treatment included ibuprofen for lymphadenopathy.