chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Malaise
Clinical narrative: Fever; Tiredness; Headache; Chills; Nausea; General feeling of being unwell; The patient received the third/booster dose of BNT162b2; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 24-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 01Dec2021 at 10:30 (Lot number: FH8027) at the age of 24 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot Number: EL234, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 19Feb2021, when the patient was 23 years old, for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 29Jan2021, when the patient was 23 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 10:30, outcome "unknown", described as "the patient received the third/booster dose of BNT162b2"; PYREXIA (non-serious) with onset 02Dec2021, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 02Dec2021, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 02Dec2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 02Dec2021, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 02Dec2021, outcome "not recovered", described as "nausea"; MALAISE (non-serious) with onset 02Dec2021, outcome "not recovered", described as "general feeling of being unwell". Therapeutic measures were not taken as a result of pyrexia, fatigue, headache, chills, nausea and malaise. Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Tiredness; Headache; Chills; Nausea; General feeling of being unwell; The patient received the third/booster dose of BNT162b2; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 24-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 01Dec2021 at 10:30 (Lot number: FH8027) at the age of 24 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot Number: EL234, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 19Feb2021, when the patient was 23 years old, for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 29Jan2021, when the patient was 23 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 10:30, outcome "unknown", described as "the patient received the third/booster dose of BNT162b2"; PYREXIA (non-serious) with onset 02Dec2021, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 02Dec2021, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 02Dec2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 02Dec2021, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 02Dec2021, outcome "not recovered", described as "nausea"; MALAISE (non-serious) with onset 02Dec2021, outcome "not recovered", described as "general feeling of being unwell". Therapeutic measures were not taken as a result of pyrexia, fatigue, headache, chills, nausea and malaise. Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation
Clinical narrative: Significant pain in armpit; Dose received 3/ dose number=3; This is a spontaneous report received from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 30Nov2021 at 11:15 (Lot number: 33030BD) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8730, Anatomical site: left arm), administration date: 23Mar2021, when the patient was 41 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot number: EW0162, Anatomical site: left arm), administration date: 13Apr2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 at 11:15, outcome "unknown", described as "Dose received 3/ dose number=3"; AXILLARY PAIN (non-serious) with onset 01Dec2021 at 08:00, outcome "not recovered", described as "Significant pain in armpit". Therapeutic measures were not taken as a result of axillary pain.  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 did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: Two days after the shot had ringing in ears. First, it was both ears but the left ear stopped ringing.  Now the right ear stops and starts ringing. It is a mild noise.; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 18Nov2021 at 13:00 (Lot number: FH8027) at the age of 80 years as dose 3, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6201, Anatomical site: left arm), administration date: 23Feb2021 at 10:15, when the patient was 79 years old and BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8732, Anatomical site: left arm), administration date: 23Mar2021 at 10:00, when the patient was 79 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 at 13:00, outcome "unknown", described as "Dose received 3/ dose number=3"; TINNITUS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Two days after the shot the patient had ringing in her ears. First, it was both ears but the left ear stopped ringing. Then the right ear stopped and started ringing. It was a mild noise". Therapeutic measures were not taken as a result of tinnitus.  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 COVID vaccine. Since the vaccination, the patient had not 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.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Vomiting
Clinical narrative: Vomiting; Diarrhea; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 19Nov2021 at 17:00 (Lot number: FH8027) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing), notes: Blood pressure and "Diabetic" (unspecified if ongoing), notes: Diabetics. The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8737; Anatomical site: left arm; Administration time: 08:45; Route of administration: unspecified), administration date: 02Apr2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0169; Anatomical site: left arm; Administration time: 09:00; Route of administration: unspecified), administration date: 23Apr2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 at 17:00, outcome "unknown", described as "Dose received: 3"; VOMITING (non-serious) with onset 19Nov2021 at 18:00, outcome "recovered" (an unknown date in 2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 19Nov2021 at 18:00, outcome "recovered" (an unknown date in 2021), described as "Diarrhea". Therapeutic measures were not taken as a result of vomiting and diarrhoea.  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 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Immunisation, Lymphadenopathy
Clinical narrative: Dose received: 3; Swollen lymph nodes under left arm (soft, size of fist) with mild discomfort x 6 days; With mild discomfort x 6 days; Headache x 4 days; Fatigue x 2d; Sore arm x 4 days; This is a spontaneous report from a non-contactable reporter (consumer). The reporter is the patient.   A 66-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: FF841) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa-rash. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot Number: EN6200; Route of Administration: Unspecified), administration date: 20Feb2021, when the patient was 65 years old, for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE; Lot Number: EL9202; Route of Administration: Unspecified), administration date: 25Jan2021, when the patient was 65 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Oct2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Swollen lymph nodes under left arm (soft, size of fist) with mild discomfort x 6 days"; AXILLARY PAIN (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "With mild discomfort x 6 days"; HEADACHE (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Headache x 4 days"; FATIGUE (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Fatigue x 2d"; PAIN IN EXTREMITY (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Sore arm x 4 days". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, headache, fatigue and pain in extremity.  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. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Dose received: 3; Swollen lymph nodes under left arm (soft, size of fist) with mild discomfort x 6 days; With mild discomfort x 6 days; Headache x 4 days; Fatigue x 2d; Sore arm x 4 days; This is a spontaneous report from a non-contactable reporter (consumer). The reporter is the patient.   A 66-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: FF841) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa-rash. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot Number: EN6200; Route of Administration: Unspecified), administration date: 20Feb2021, when the patient was 65 years old, for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE; Lot Number: EL9202; Route of Administration: Unspecified), administration date: 25Jan2021, when the patient was 65 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Oct2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Swollen lymph nodes under left arm (soft, size of fist) with mild discomfort x 6 days"; AXILLARY PAIN (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "With mild discomfort x 6 days"; HEADACHE (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Headache x 4 days"; FATIGUE (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Fatigue x 2d"; PAIN IN EXTREMITY (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Sore arm x 4 days". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, headache, fatigue and pain in extremity.  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. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors 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.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Immunisation
Clinical narrative: Period Heavier, longer by a day, and more painful; Period Heavier, longer by a day, and more painful; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administration date an unknown date in 2021 (Lot number: UNKNOWN) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was unknown. Concomitant medications included: FLU SHOT. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Intramuscular), for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Intramuscular), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received 3"; HEAVY MENSTRUAL BLEEDING (non-serious )and DYSMENORRHOEA (non-serious) both with onset date on an unknown date in Mar2021, outcome "not recovered", and all described as "period heavier, longer by a day, and more painful". Therapeutic measures were taken as a result of heavy menstrual bleeding and dysmenorrhoea.   Additional Information: It was unknown if the patient had any allergies. The patient received other vaccine within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was reported patient went from needing ADVIL one day to three or 4.It was tough to give quantitative measurements to heavier, but it was definitely longer by a day, and her meds needs were like clockwork, only 1 day but now more. It was instant change and kind of interesting, and a bit surprising. The patient wondered what the relationship was because it was like this is the new normal and had not gone back. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of heavy menstrual bleeding and dysmenorrhoea and included treatment with ibuprofen (ADVIL).  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: soreness at the injection site; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 01Dec2021 09:45 (Lot number: FF8841) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: environmental (dust, mold,mildew, etc)" (unspecified if ongoing); "known allergies: food" (unspecified if ongoing); "known allergies: pets" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; NASACORT; VITAMIN D [COLECALCIFEROL]; FISH OIL. Past drug history included: Robitussin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM, Route of Administration: Intramuscular), administration date: 19Feb2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 10Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 09:45, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 17:00, outcome "recovered" (02Dec2021), described as "soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Soreness had resolved by the next morning. Additional concomitant product included multi-vitamin.  Follow-Up (06Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Condition aggravated, Hypomenorrhoea, Immunisation, Menstruation delayed
Clinical narrative: have a semi normal period but the next month it was delayed and extremely light; have a semi normal period but the next month it was delayed and extremely light; feel more bloated than normal; feel more bloated than normal; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Knwon allergy: Penicillin" (unspecified if ongoing); "bloated" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibp, reaction(s): "Allergy: IBP". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Have to find photo of card), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced card but it's in my home), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose"; MENSTRUATION DELAYED (non-serious), HYPOMENORRHOEA (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "have a semi normal period but the next month it was delayed and extremely light"; ABDOMINAL DISTENSION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "feel more bloated than normal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient took multiple pregnancy tests due to  delay.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test
Clinical narrative: have a semi normal period but the next month it was delayed and extremely light; have a semi normal period but the next month it was delayed and extremely light; feel more bloated than normal; feel more bloated than normal; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Knwon allergy: Penicillin" (unspecified if ongoing); "bloated" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibp, reaction(s): "Allergy: IBP". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Have to find photo of card), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced card but it's in my home), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose"; MENSTRUATION DELAYED (non-serious), HYPOMENORRHOEA (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "have a semi normal period but the next month it was delayed and extremely light"; ABDOMINAL DISTENSION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "feel more bloated than normal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient took multiple pregnancy tests due to  delay.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Lip swelling, Myalgia
Clinical narrative: Swelling of lips; Swelling of tongue; Swelling of cheeks; Sore throat; Chills; Fatigue; Muscle pain; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 at 16:00 (Lot number: EW0176) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot Number: EN6199; Anatomical site: Left arm; Administration time: 09:00; Route of Administration: Unspecified), administration date: 05Mar2021, when the patient was 48 years old, for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE; Lot number: EN6201; Anatomical site: Right arm; Administration time: 09:00; Route of Administration: Unspecified), administration date: 11Feb2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 at 16:00, outcome "unknown", described as "Dose received: 3"; LIP SWELLING (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of lips"; SWOLLEN TONGUE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of tongue"; SWELLING FACE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of cheeks"; OROPHARYNGEAL PAIN (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Sore throat"; CHILLS (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; FATIGUE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Fatigue"; MYALGIA (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lip swelling, swollen tongue, swelling face, oropharyngeal pain, chills, fatigue and myalgia.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Swelling face, Swollen tongue
Clinical narrative: Swelling of lips; Swelling of tongue; Swelling of cheeks; Sore throat; Chills; Fatigue; Muscle pain; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 at 16:00 (Lot number: EW0176) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot Number: EN6199; Anatomical site: Left arm; Administration time: 09:00; Route of Administration: Unspecified), administration date: 05Mar2021, when the patient was 48 years old, for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE; Lot number: EN6201; Anatomical site: Right arm; Administration time: 09:00; Route of Administration: Unspecified), administration date: 11Feb2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 at 16:00, outcome "unknown", described as "Dose received: 3"; LIP SWELLING (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of lips"; SWOLLEN TONGUE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of tongue"; SWELLING FACE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of cheeks"; OROPHARYNGEAL PAIN (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Sore throat"; CHILLS (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; FATIGUE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Fatigue"; MYALGIA (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lip swelling, swollen tongue, swelling face, oropharyngeal pain, chills, fatigue and myalgia.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Covid -19 Positive; Tested Covid -19 Positive on 02Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Sep2021 14:15 (Lot number: EW0196) at the age of 54 years as dose 2, single and intramuscular, administered in arm left, administration date 17Aug2021 14:00 (Lot number: EW0196) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Dairy" (unspecified if ongoing), notes: known allergies: Dairy. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 30Nov2021 07:00, outcome "recovering", described as "Tested Covid -19 Positive"; COVID-19 (medically significant) with onset 30Nov2021 07:00, outcome "recovering", described as "Tested Covid -19 Positive on 02Dec2021". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (30Nov2021) positive, notes: Nasal Swab; sars-cov-2 test: (26Nov2021) positive, notes: Tested Covid -19; (02Dec2021) positive, notes: Tested Covid -19. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: After about 15 minutes a VERY strong metallic taste in back of throat...lasted approx. 3-4 days after 1st dose...happened again after 2nd dose but much fainter and only for a day or 2; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 57-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 26Mar2021 (Lot number: ER8730) at the age of 57 years as dose 1, single and COVID-19 VACCINE (MANUFACTURER UNKNOWN), administered in left arm, administration date 23Apr2021 (Lot number: ER8731) at the age of 57 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: VITAMINS, CALCIUM CITRATE and OMEPRAZOLE. The following information was reported: DYSGEUSIA (non-serious) with onset an unknown date in Mar2021, outcome "recovered" (an unknown date in Apr2021), described as "After about 15 minutes a VERY strong metallic taste in back of throat...lasted approx. 3-4 days after 1st dose...happened again after 2nd dose but much fainter and only for a day or 2". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Immunisation, Splenomegaly
Clinical narrative: Enlarged and painful spleen; Enlarged and painful spleen; 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 55 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 10:30 (Lot number: unknown) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Anatomical location: right arm; Administration time: 11:00), administration date: 04Apr2021, when the patient was 54 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical location: right arm; Administration time: 11:00), administration date: 05May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported IMMUNISATION (non-serious) with onset 29Nov2021 at 10:30, outcome "unknown", described as "Dose received 3/ dose number=3"; SPLENOMEGALY (non-serious), ABDOMINAL PAIN (non-serious); both with onset 01Dec2021 at 04:00, outcome "recovering", and both described as "Enlarged and painful spleen". Therapeutic measures were not taken as a result of splenomegaly and abdominal 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, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Nasal congestion, Rhinorrhoea
Clinical narrative: Running nose; congestion; chills; fatigue; Dose Number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 15:15 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetics" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, lot number, expiry date were not reported, arm right), for Covid-19 Immunisation; Bnt162b2 (Dose 1, single, lot number, expiry date were not reported, arm right,15:15), for Covid-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 15:15, outcome "unknown", described as "Dose Number 3"; RHINORRHOEA (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "Running nose"; NASAL CONGESTION (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "congestion"; CHILLS (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of rhinorrhoea, nasal congestion, chills, fatigue.  Additional information: The patient didn't receive any other vaccines within 4 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 lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (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: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain".  Additional information: The vaccine was received on Thursday (as reported). The reporter wanted to know when the pain would subside and how long the event would last  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain my right shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number and expiry date not reported), administration date: Mar2021, for Covid-19 Immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain my right shoulder".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Headache, Immunisation, Lymphadenopathy
Clinical narrative: Headache; Joint pain; Pain in armpit of left arm; Lymphadenopathy left; Mild nausea; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 54-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 01Dec2021 (Lot number: PH8030) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation Relevant medical history included: "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient received unspecified concomitant medications. Past drug history included: Thimerosal, reaction(s): "Drug allergy", notes: Known allergy: Thimerasol; Minocycline, reaction(s): "Drug allergy", notes: Known allergy: minocycline and Calamine lotion, reaction(s): "Drug allergy", notes: Known allergy: calamine lotion. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, Anatomical site: Left arm), administration date: 05Apr2021, when the patient was 53 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot number: EW0171, Anatomical site: Left arm), administration date: 27Apr2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 02Dec2021, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Joint pain"; AXILLARY PAIN (non-serious) with onset 02Dec2021, outcome "recovering", described as "Pain in armpit of left arm"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021, outcome "recovering", described as "Lymphadenopathy left"; NAUSEA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Mild nausea". Therapeutic measures were taken as a result of headache, arthralgia, axillary pain, lymphadenopathy and nausea.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, arthralgia, axillary pain, lymphadenopathy and nausea and included treatment with ACETAMINOPHEN.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Headache; Joint pain; Pain in armpit of left arm; Lymphadenopathy left; Mild nausea; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 54-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 01Dec2021 (Lot number: PH8030) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation Relevant medical history included: "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient received unspecified concomitant medications. Past drug history included: Thimerosal, reaction(s): "Drug allergy", notes: Known allergy: Thimerasol; Minocycline, reaction(s): "Drug allergy", notes: Known allergy: minocycline and Calamine lotion, reaction(s): "Drug allergy", notes: Known allergy: calamine lotion. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, Anatomical site: Left arm), administration date: 05Apr2021, when the patient was 53 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot number: EW0171, Anatomical site: Left arm), administration date: 27Apr2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 02Dec2021, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Joint pain"; AXILLARY PAIN (non-serious) with onset 02Dec2021, outcome "recovering", described as "Pain in armpit of left arm"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021, outcome "recovering", described as "Lymphadenopathy left"; NAUSEA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Mild nausea". Therapeutic measures were taken as a result of headache, arthralgia, axillary pain, lymphadenopathy and nausea.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, arthralgia, axillary pain, lymphadenopathy and nausea and included treatment with ACETAMINOPHEN.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Muscle disorder, Pain in extremity
Clinical narrative: lower back pain; abdomen pain; leg pain; big muscle on the left side of her back, that won't loosen up/ knots; This is a spontaneous report received from a contactable consumer from medical information team.  An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 07Feb2021 (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: BACK PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "lower back pain"; ABDOMINAL PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "abdomen pain"; PAIN IN EXTREMITY (non-serious) with onset 28Feb2021, outcome "unknown", described as "leg pain"; MUSCLE DISORDER (non-serious) with onset 28Feb2021, outcome "unknown", described as "big muscle on the left side of her back, that won't loosen up/ knots".  Additional information: The reporter stated that her mother (patient) has been bed ridden since 28Feb2021. The patient has been experiencing lower back pain, abdomen pain, and leg pain and it's been hard to get out of bed for the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.