chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated, Immunisation, Magnetic resonance imaging
Clinical narrative: booster; Arthritic pain; Knee/hip arthritis; worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "torn meniscus" (unspecified if ongoing), notes: I did have a torn meniscus 10 yrs ago. Concomitant medication(s) included: GABAPENTIN taken for insomnia (ongoing). Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "Painful knee pain"; Bnt162b2 (DOSE 1, Note: AE term: Joint inflammation, Onset date: 02Apr2021, Seriousness criteria: Persistent/ Significant disability/Incapacity, AE required visit to: Physician office visit checked, AE outcome: not recovered, Treatment: Yes checked, If yes details: Rx Taking Pain and Cortisone shots), for Covid-19 immunization, reaction(s): "Joint Inflammation"; Covid-19 vaccine (Dose:2, Manufacture Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "booster"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Arthritic pain"; ARTHRITIS (non-serious) with onset 2021, outcome "not recovered", described as "Knee/hip arthritis"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "worse". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccinations was none. Vaccination Facility Type was reported as Pharmacy or Drug Store. 2 days after patient first vaccination for COVID 19 developed painful knee pain. It got worse after the booster in Oct. Patient never had persistent arthritic pain before this year and have a torn meniscus 10 years ago but it healed it seems that patent developed acute knee/hip arthritis after the vaccination and it persists.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Rapid antigen test was performed and it came out positive for Covid-19; Rapid antigen test was performed and it came out positive for Covid-19; chills; fatigue; sore throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from quality group.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18May2021 (Lot number: EW0168) at the age of 29 years as dose 2, single and intramuscular, administered in arm left, administration date 26Apr2021 (Lot number: EW0176) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Dec2021 17:00, outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021 17:00, outcome "recovering" and all described as "Rapid antigen test was performed and it came out positive for Covid-19"; CHILLS (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, chills, fatigue, oropharyngeal pain.  Clinical course: The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The reporter was Pfizer employee and also a pharmacist. He was reporting for his wife. She did not experience an AE for first or second dose of the Pfizer Covid vaccine. But on 21Dec2021, she experienced chills, fatigue and a sore throat. Rapid antigen test was performed, and it came out positive for Covid-19. She will follow up with a PCR test to confirm Covid-19 diagnosis. No known allergies were reported.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Rapid antigen test was performed and it came out positive for Covid-19; Rapid antigen test was performed and it came out positive for Covid-19; chills; fatigue; sore throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from quality group.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18May2021 (Lot number: EW0168) at the age of 29 years as dose 2, single and intramuscular, administered in arm left, administration date 26Apr2021 (Lot number: EW0176) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Dec2021 17:00, outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021 17:00, outcome "recovering" and all described as "Rapid antigen test was performed and it came out positive for Covid-19"; CHILLS (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, chills, fatigue, oropharyngeal pain.  Clinical course: The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The reporter was Pfizer employee and also a pharmacist. He was reporting for his wife. She did not experience an AE for first or second dose of the Pfizer Covid vaccine. But on 21Dec2021, she experienced chills, fatigue and a sore throat. Rapid antigen test was performed, and it came out positive for Covid-19. She will follow up with a PCR test to confirm Covid-19 diagnosis. No known allergies were reported.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Flatulence
Clinical narrative: Development of bloating and gassiness after she received vaccine; Development of bloating and gassiness after she received vaccine; This is a spontaneous report from a contactable reporter (physician).  A 62-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 (Lot number: 001B21A) at the age of 62 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none: Known allergies: none. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: 031M20A; Anatomical location: left arm; Route of administration: intramuscular), administration date: 12Feb2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset 14Mar2021, outcome "recovered with sequelae" (18Mar2021), described as "Development of bloating and gassiness after she received vaccine", FLATULENCE (non-serious) with onset 14Mar2021, outcome "recovered with sequelae" (18Mar2021), described as "Development of bloating and gassiness after she received vaccine". Therapeutic measures were not taken as a result of abdominal distension and flatulence.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The symptoms continued for 4 days before resolution. She still had occasional symptoms like that (at the time of the report). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Immunisation
Clinical narrative: booster vaccination; crohn's disease symptoms flare with booster vaccination; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4202674-00.  A 15 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as cf for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN (number unknown)), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster vaccination"; CROHN'S DISEASE (medically significant), outcome "recovered" (2021), described as "crohn's disease symptoms flare with booster vaccination". The action taken for adalimumab was unknown.  The reporter considered "crohn's disease symptoms flare with booster vaccination" related to bnt162b2. The reporter considered "crohn's disease symptoms flare with Humira" as no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 information in the case provided, the causal association between the event Crohn's disease flare up and the booster dose of 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.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Dizziness, Loss of consciousness, Vomiting
Clinical narrative: passed out; upset stomach; vomiting; got dizzy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4201755-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "had boils that formed on her body", start date: Oct2021 (unspecified if ongoing), notes: In Oct2021, the patient had boils /she was prescribed antibiotics in Nov2021. The patient's concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "passed out"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "upset stomach"; VOMITING (non-serious) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "vomiting"; DIZZINESS (non-serious) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "got dizzy". The action taken for upadacitinib was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Reporter's causality was not reported for suspects. The case would be managed as per company assessment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Loss of consciousness, abdominal discomfort, vomiting and dizziness and BNT162B2.  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; Vertigo; This is a spontaneous report from a non-contactable reporter (other healthcare professional). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 at 16:00 (Lot number: EW0186) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN; "Asthma" (unspecified if ongoing); "AFib" (unspecified if ongoing) and "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient received unspecified concomitant medications (unspecified if ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0183; Anatomical site: Left arm; Administration time: 17:00), administration date: 02Sep2021, when the patient was 65 years old, for COVID-19 immunisation.  The following information was reported: DIZZINESS (non-serious) with onset 01Nov2021 at 06:30, outcome "not recovered", described as "Dizziness"; VERTIGO (non-serious) with onset 01Nov2021 at 06:30, outcome "not recovered", described as "Vertigo". Therapeutic measures were not taken as a result of dizziness and vertigo.  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. It was reported that dizziness/vertigo, started roughly 6 weeks after second vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, COVID-19, Disease recurrence, Fatigue, Immunisation
Clinical narrative: In October 2021, the patient experienced COVID-19; ln Jul2020 and Oct2021, the patient experienced COVID-19; felt fatigue; horrible back pain; In 2021, she received booster dose of COVID-19 Vaccine manufactured by Pfizer and Biontech; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4203287-00 (Agency).  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster ), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, cf for rheumatoid arthritis. Relevant medical history included: "COVID-19", start date: Jul2020, stop date: Jul2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Patient route of administration: Intramuscular), administration date: 05May2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (2nd Dose, Patient route of administration: Intramuscular), administration date: 26May2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "In 2021, she received booster dose of COVID-19 Vaccine manufactured by Pfizer and Biontech"; COVID-19 (medically significant) with onset Oct2021, outcome "recovered" (2021), described as "In October 2021, the patient experienced COVID-19"; DISEASE RECURRENCE (medically significant) with onset Oct2021, outcome "unknown", described as "ln Jul2020 and Oct2021, the patient experienced COVID-19"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt fatigue"; BACK PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "horrible back pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. The action taken for adalimumab was unknown.  The reporters causality for the event(s) of felt fatigued and horrible back pain with Humira (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Covid-19 onset in July2020 and COVID-19 onset in October2021 was not provided. The reporter's causality for the event(s) of felt fatigued, horrible back pain and Covid-19 onset in July2020 and COVID-19 onset in October2021 with Pfizer Biontech Covid-19 Vaccine was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events fatigue, back pain, Covid 19, immunisation and disease recurrence and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101837470 same patient, different dose/event
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: In October 2021, the patient experienced COVID-19; ln Jul2020 and Oct2021, the patient experienced COVID-19; felt fatigue; horrible back pain; In 2021, she received booster dose of COVID-19 Vaccine manufactured by Pfizer and Biontech; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4203287-00 (Agency).  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster ), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, cf for rheumatoid arthritis. Relevant medical history included: "COVID-19", start date: Jul2020, stop date: Jul2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Patient route of administration: Intramuscular), administration date: 05May2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (2nd Dose, Patient route of administration: Intramuscular), administration date: 26May2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "In 2021, she received booster dose of COVID-19 Vaccine manufactured by Pfizer and Biontech"; COVID-19 (medically significant) with onset Oct2021, outcome "recovered" (2021), described as "In October 2021, the patient experienced COVID-19"; DISEASE RECURRENCE (medically significant) with onset Oct2021, outcome "unknown", described as "ln Jul2020 and Oct2021, the patient experienced COVID-19"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt fatigue"; BACK PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "horrible back pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. The action taken for adalimumab was unknown.  The reporters causality for the event(s) of felt fatigued and horrible back pain with Humira (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Covid-19 onset in July2020 and COVID-19 onset in October2021 was not provided. The reporter's causality for the event(s) of felt fatigued, horrible back pain and Covid-19 onset in July2020 and COVID-19 onset in October2021 with Pfizer Biontech Covid-19 Vaccine was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events fatigue, back pain, Covid 19, immunisation and disease recurrence and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101837470 same patient, different dose/event
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After my 2nd dose, I still feel the pain from the injection in my left arm occasionally.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 41-year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 23Aug2021 (Lot number: unknown) at the age of 41 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not take any concomitant medications. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Left arm), administration date: 02Aug2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Aug2021, outcome "not recovered", described as "After my 2nd dose, I still feel the pain from the injection in my left arm occasionally". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Nausea, Pain in extremity
Clinical narrative: Fever of 101 F; Arm pain; Fatigue; Nausea; Dose received: 3/ Dose number =3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 18-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 20Dec2021 at 14:30 (Lot number: 33130BA) at the age of 18 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Constipation chronic" (unspecified if ongoing), notes: Chronic Constipation and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TRULANCE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Anatomical site: Left arm), administration date: 18Mar2021, when the patient was 17 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955, Anatomical site: Left arm), administration date: 08Apr2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3/ Dose number =3"; PYREXIA (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Fever of 101 F"; PAIN IN EXTREMITY (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Arm pain"; FATIGUE (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Fatigue"; NAUSEA (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue and nausea.  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. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101 F; Arm pain; Fatigue; Nausea; Dose received: 3/ Dose number =3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 18-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 20Dec2021 at 14:30 (Lot number: 33130BA) at the age of 18 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Constipation chronic" (unspecified if ongoing), notes: Chronic Constipation and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TRULANCE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Anatomical site: Left arm), administration date: 18Mar2021, when the patient was 17 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955, Anatomical site: Left arm), administration date: 08Apr2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3/ Dose number =3"; PYREXIA (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Fever of 101 F"; PAIN IN EXTREMITY (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Arm pain"; FATIGUE (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Fatigue"; NAUSEA (non-serious) with onset 21Dec2021 at 06:30, outcome "recovered" (an unknown date in Dec2021), described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue and nausea.  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. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Dose received: 3/ Dose number= 3; Fever; Chills; Body Aches; Lymph Node Swelling in Arm Pit; COVID arm; 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), administration date 19Dec2021 (Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy NOS" (unspecified if ongoing), notes: Known allergies: Yes. 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) with onset 19Dec2021, outcome "unknown", described as "Dose received: 3/ Dose number= 3"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Body Aches"; LYMPHADENOPATHY (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Lymph Node Swelling in Arm Pit"; VACCINATION SITE RASH (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "COVID arm". Therapeutic measures were not taken as a result of pyrexia, chills, pain, lymphadenopathy and vaccination site rash.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Dose received: 3/ Dose number= 3; Fever; Chills; Body Aches; Lymph Node Swelling in Arm Pit; COVID arm; 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), administration date 19Dec2021 (Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy NOS" (unspecified if ongoing), notes: Known allergies: Yes. 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) with onset 19Dec2021, outcome "unknown", described as "Dose received: 3/ Dose number= 3"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Body Aches"; LYMPHADENOPATHY (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Lymph Node Swelling in Arm Pit"; VACCINATION SITE RASH (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "COVID arm". Therapeutic measures were not taken as a result of pyrexia, chills, pain, lymphadenopathy and vaccination site rash.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Influenza like illness
Clinical narrative: Dose number=3; Flu-like symptoms; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 56-year-old male patient received bnt162b2 (BNT162B2), administration date an unknown date in Dec2021 (Lot number: unknown) at the age of 56 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, Route of Administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of Administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Dose number=3"; INFLUENZA LIKE ILLNESS (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Flu-like symptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: It was unknown if the patient received any other vaccines within four weeks the 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.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Paraesthesia, Peripheral swelling
Clinical narrative: Extreme tingling on right side of body; Swelling in hand and foot; Dose number: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 (Lot number: unknown) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medications included unspecified BIRTH CONTROL medications. Past drug history included: Medrol, reaction: "Drug allergy", notes: known allergies: Medrol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown, Anatomical site: left arm), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown, Anatomical site: left arm), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "dose number: 3"; PARESTHESIA (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Extreme tingling on right side of body"; PERIPHERAL SWELLING (non-serious) with onset 06Dec2021, outcome "not recovered", described as "swelling in hand and foot". The events "Extreme tingling on right side of body" and "swelling in hand and foot" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of paresthesia and peripheral swelling.   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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest discomfort, Cough, Drug ineffective
Clinical narrative: fever; cough; chest congestion; nasal congestion; sickness; COVID-19; COVID-19; sinus infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "COVID-19"; PYREXIA (non-serious), outcome "unknown", described as "fever"; COUGH (non-serious), outcome "unknown", described as "cough"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest congestion"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nasal congestion"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; SINUSITIS (non-serious) with onset 17Dec2021, outcome "unknown", described as "sinus infection". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) fever; sars-cov-2 test: (20Dec2021) positive, notes: confirmed rapid test result; (19Dec2021) positive, notes: rapid test.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :S-PFIZER INC-202101835469 Same reporter/drug, different patient;-PFIZER INC-202101836976 Same reporter/drug, different patient;-PFIZER INC-202101836868 Same reporter/drug, different patient
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nasal congestion, Pyrexia, SARS-CoV-2 test, Sinusitis
Clinical narrative: fever; cough; chest congestion; nasal congestion; sickness; COVID-19; COVID-19; sinus infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "COVID-19"; PYREXIA (non-serious), outcome "unknown", described as "fever"; COUGH (non-serious), outcome "unknown", described as "cough"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest congestion"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nasal congestion"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; SINUSITIS (non-serious) with onset 17Dec2021, outcome "unknown", described as "sinus infection". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) fever; sars-cov-2 test: (20Dec2021) positive, notes: confirmed rapid test result; (19Dec2021) positive, notes: rapid test.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :S-PFIZER INC-202101835469 Same reporter/drug, different patient;-PFIZER INC-202101836976 Same reporter/drug, different patient;-PFIZER INC-202101836868 Same reporter/drug, different patient
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Muscle fatigue, Muscle twitching, Tremor
Clinical narrative: Muscle twitching calfs, arms, neck etc (both sides of body),; Internal tremor; some muscle fatigue in calfs and forearms; Dose 1: J&J COVID-19 vaccine and Dose 2: Pfizer COVID-19 vaccine; Dose 1: J&J COVID-19 vaccine and Dose 2: Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 09Nov2021 at 13:00 (Lot number: FH8028) at the age of 51 years as dose 2 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin. There were no concomitant medications. Vaccination history included: Jnj 78436735 (DOSE 1, SINGLE, Lot Number: 1808980, Anatomical site: Left Arm), administration date: 31Mar2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) both with onset 09Nov2021 at 13:00 , outcome "unknown", and both described as "Dose 1: J&J COVID-19 vaccine and Dose 2: Pfizer COVID-19 vaccine"; MUSCLE TWITCHING (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Muscle twitching calfs, arms, neck etc (both sides of body),"; TREMOR (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Internal tremor"; MUSCLE FATIGUE (non-serious) with onset 15Nov2021, outcome "not recovered", described as "some muscle fatigue in calfs and forearms". The events "Muscle twitching calfs, arms, neck etc (both sides of body),", "Internal tremor" and "some muscle fatigue in calfs and forearms" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscle twitching, tremor and muscle fatigue.  Additional Information: Other medical history was reported as None, healthy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. It was reported that symptoms were still there 6 weeks after second shot and he did not have these symptoms after the first shot and its very concerning and it was reported that will those ever dissipate. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Dose number 3; Pain at injection site; Swelling at injection site; Muscle aches; Joint aches; This is a spontaneous report from a contactable reporter (consumer or other non-hcp).   An adult female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 at 09:30 (Lot number: FH8027) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: intramuscular), administration date: 16Mar2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: intramuscular), administration date: 06Apr2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 09:30, outcome "unknown", described as "Dose number 3"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Pain at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Swelling at injection site"; MYALGIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Muscle aches"; ARTHRALGIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Joint aches". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, 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. 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: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pyrexia, Syncope
Clinical narrative: booster; fainted; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 17 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), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; SYNCOPE (medically significant), outcome "unknown", described as "fainted"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". The events "booster", "fainted", "fever" and "chills" were evaluated at the emergency room visit. Clinical course: The reporter (Pharmacist) stated that her son got Pfizer Biontech COVID-19 Booster dose and had fever and chills but subsequently he fainted. The patient was then taken to ER. The reporter said, had read all the information regarding myocarditis in the PI and asks if information from the trials regarding within how many days after the vaccine dose did myocarditis happened. The reporter asked if encountered this problem with a particular lot of Pfizer Biontech COVID-19 vaccines.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events immunization and syncope 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.