chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: report a side effect of my booster; As soon as I got the booster, I lost my smell again; I think in 48 hours I wasn't able to smell those things again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FH8027) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy; "Covid-19", start date: 04Aug2021, stop date: 14Aug2021. Concomitant medication(s) included: MONTELUKAST. Vaccination history included: Bnt162b2 (First dose covid-19 vaccine), administration date: Dec2020, for Covid-19 immunization; Bnt162b2 (Second dose covid-19 vaccine), administration date: Jan2021, for Covid-19 immunization; Flu. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "report a side effect of my booster"; ANOSMIA (non-serious), outcome "unknown", described as "As soon as I got the booster, I lost my smell again; I think in 48 hours I wasn't able to smell those things again".  Additional information: On 15Nov2021, time was she thought at like 8:30 pm at night or 8 pm, it was 8 pm. NDC, UPC number of COVID-19 Vaccine. It was on her left arm, like upper (left arm). They didn't give her expiration date. She did not know, not 4 weeks because she got her flu shot like 2 months ago. No investigation assessment. Her birthday was on the 6th and she got COVID on the 4th. So, she was 24 (years) but then she turned 25 (years) in two days, so like I don't know 24 (years) but still she know (Incomplete Sentence). She got COVID on the August 4th and then literally after 14 days her result came negative (Further not clarified hence not captured in tab). This year (2021) August and then she had all the senses, then she also lost smell and taste with after Covid and she was barely getting her smell back and as soon as she got the booster, she lost her smell again. She noticed that the concerned thing was getting her smell back and as soon as she got the COVID, she thought in 48 hours she wasn't able to smell those things again. The booster, she got it at somewhere and the vaccine, she got it somewhere. So the vaccine she got it at withheld and the booster she got it at pharmacy.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Immunisation
Clinical narrative: report a side effect of my booster; As soon as I got the booster, I lost my smell again; I think in 48 hours I wasn't able to smell those things again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FH8027) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy; "Covid-19", start date: 04Aug2021, stop date: 14Aug2021. Concomitant medication(s) included: MONTELUKAST. Vaccination history included: Bnt162b2 (First dose covid-19 vaccine), administration date: Dec2020, for Covid-19 immunization; Bnt162b2 (Second dose covid-19 vaccine), administration date: Jan2021, for Covid-19 immunization; Flu. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "report a side effect of my booster"; ANOSMIA (non-serious), outcome "unknown", described as "As soon as I got the booster, I lost my smell again; I think in 48 hours I wasn't able to smell those things again".  Additional information: On 15Nov2021, time was she thought at like 8:30 pm at night or 8 pm, it was 8 pm. NDC, UPC number of COVID-19 Vaccine. It was on her left arm, like upper (left arm). They didn't give her expiration date. She did not know, not 4 weeks because she got her flu shot like 2 months ago. No investigation assessment. Her birthday was on the 6th and she got COVID on the 4th. So, she was 24 (years) but then she turned 25 (years) in two days, so like I don't know 24 (years) but still she know (Incomplete Sentence). She got COVID on the August 4th and then literally after 14 days her result came negative (Further not clarified hence not captured in tab). This year (2021) August and then she had all the senses, then she also lost smell and taste with after Covid and she was barely getting her smell back and as soon as she got the booster, she lost her smell again. She noticed that the concerned thing was getting her smell back and as soon as she got the COVID, she thought in 48 hours she wasn't able to smell those things again. The booster, she got it at somewhere and the vaccine, she got it somewhere. So the vaccine she got it at withheld and the booster she got it at pharmacy.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Neurological examination
Clinical narrative: About 30 minutes after my vaccine, while on my way home, the left side of my face went numb. It stayed numb, and I kept checking the mirror for signs of a stroke. My numbness lasted about 5 days,; the feeling that the left side of my face was largerthan the right; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 at 11:15 (Lot number: FJ8762) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: Fiber Gummies(unspecified). The following information was reported: HYPOAESTHESIA (non-serious) with onset 29Nov2021 at 11:45, outcome "recovered" (04Dec2021), described as "About 30 minutes after vaccine, while on her way home, the left side of her face went numb. It stayed numb, and she kept checking the mirror for signs of a stroke. Her numbness lasted about 5 days,"; SWELLING FACE (non-serious) with onset 29Nov2021 at 11:45, outcome "recovered" (04Dec2021), described as "the feeling that the left side of her face was larger than the right".   Additional information: The patient had no known allergies. The patient did not received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: About 30 minutes after my vaccine, while on my way home, the left side of my face went numb. It stayed numb, and I kept checking the mirror for signs of a stroke. My numbness lasted about 5 days,; the feeling that the left side of my face was largerthan the right; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 at 11:15 (Lot number: FJ8762) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: Fiber Gummies(unspecified). The following information was reported: HYPOAESTHESIA (non-serious) with onset 29Nov2021 at 11:45, outcome "recovered" (04Dec2021), described as "About 30 minutes after vaccine, while on her way home, the left side of her face went numb. It stayed numb, and she kept checking the mirror for signs of a stroke. Her numbness lasted about 5 days,"; SWELLING FACE (non-serious) with onset 29Nov2021 at 11:45, outcome "recovered" (04Dec2021), described as "the feeling that the left side of her face was larger than the right".   Additional information: The patient had no known allergies. The patient did not received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Neck pain, Pain
Clinical narrative: bone loss; had covid-pfizer booster 12/2; fever 100.9; chills; neck/shoulder pain; neck/shoulder pain; aching; clenching of teeth/bruxism; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 68 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; palbociclib (IBRANCE), first regimen from 06Dec2019 (Batch/Lot number: unknown) to 01Nov2021 at 125 mg and second regimen since 01Dec2021 (Batch/Lot number: unknown) at 125 mg; denosumab (PROLIA) (Batch/Lot number: unknown) at single (unk, single). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, MANUFACTURER UNKNOWN); Covid-19 vaccine (Dose2, MANUFACTURER UNKNOWN). The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "had covid-pfizer booster 12/2"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovered", described as "fever 100.9"; CHILLS (non-serious) with onset 02Dec2021, outcome "unknown", described as "chills"; NECK PAIN (non-serious) with onset 02Dec2021, outcome "not recovered", ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "not recovered" and all described as "neck/shoulder pain"; PAIN (non-serious) with onset 02Dec2021, outcome "unknown", described as "aching"; BRUXISM (non-serious) with onset 02Dec2021, outcome "not recovered", described as "clenching of teeth/bruxism"; BONE LOSS (non-serious), outcome "unknown", described as "bone loss". The clinical course is as follows: the patient had prolia shot, started palbociclib on 01Dec2021, had covid-Pfizer booster bnt162b2 on 02Dec2021, the patient had fever 100.9, chills, neck/shoulder pain, aching, clenching on 02Dec2021. Fever resolved. Has ongoing clenching of teeth/bruxism, TMS, requiring crowns with bone loss. The action taken for palbociclib was unknown and for denosumab was not applicable. Therapeutic measures were taken as a result of bruxism, bone loss and included TMS and crowns.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: bone loss; had covid-pfizer booster 12/2; fever 100.9; chills; neck/shoulder pain; neck/shoulder pain; aching; clenching of teeth/bruxism; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 68 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; palbociclib (IBRANCE), first regimen from 06Dec2019 (Batch/Lot number: unknown) to 01Nov2021 at 125 mg and second regimen since 01Dec2021 (Batch/Lot number: unknown) at 125 mg; denosumab (PROLIA) (Batch/Lot number: unknown) at single (unk, single). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, MANUFACTURER UNKNOWN); Covid-19 vaccine (Dose2, MANUFACTURER UNKNOWN). The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "had covid-pfizer booster 12/2"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovered", described as "fever 100.9"; CHILLS (non-serious) with onset 02Dec2021, outcome "unknown", described as "chills"; NECK PAIN (non-serious) with onset 02Dec2021, outcome "not recovered", ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "not recovered" and all described as "neck/shoulder pain"; PAIN (non-serious) with onset 02Dec2021, outcome "unknown", described as "aching"; BRUXISM (non-serious) with onset 02Dec2021, outcome "not recovered", described as "clenching of teeth/bruxism"; BONE LOSS (non-serious), outcome "unknown", described as "bone loss". The clinical course is as follows: the patient had prolia shot, started palbociclib on 01Dec2021, had covid-Pfizer booster bnt162b2 on 02Dec2021, the patient had fever 100.9, chills, neck/shoulder pain, aching, clenching on 02Dec2021. Fever resolved. Has ongoing clenching of teeth/bruxism, TMS, requiring crowns with bone loss. The action taken for palbociclib was unknown and for denosumab was not applicable. Therapeutic measures were taken as a result of bruxism, bone loss and included TMS and crowns.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Bone loss, Bruxism, Chills
Clinical narrative: bone loss; had covid-pfizer booster 12/2; fever 100.9; chills; neck/shoulder pain; neck/shoulder pain; aching; clenching of teeth/bruxism; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 68 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; palbociclib (IBRANCE), first regimen from 06Dec2019 (Batch/Lot number: unknown) to 01Nov2021 at 125 mg and second regimen since 01Dec2021 (Batch/Lot number: unknown) at 125 mg; denosumab (PROLIA) (Batch/Lot number: unknown) at single (unk, single). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, MANUFACTURER UNKNOWN); Covid-19 vaccine (Dose2, MANUFACTURER UNKNOWN). The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "had covid-pfizer booster 12/2"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovered", described as "fever 100.9"; CHILLS (non-serious) with onset 02Dec2021, outcome "unknown", described as "chills"; NECK PAIN (non-serious) with onset 02Dec2021, outcome "not recovered", ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "not recovered" and all described as "neck/shoulder pain"; PAIN (non-serious) with onset 02Dec2021, outcome "unknown", described as "aching"; BRUXISM (non-serious) with onset 02Dec2021, outcome "not recovered", described as "clenching of teeth/bruxism"; BONE LOSS (non-serious), outcome "unknown", described as "bone loss". The clinical course is as follows: the patient had prolia shot, started palbociclib on 01Dec2021, had covid-Pfizer booster bnt162b2 on 02Dec2021, the patient had fever 100.9, chills, neck/shoulder pain, aching, clenching on 02Dec2021. Fever resolved. Has ongoing clenching of teeth/bruxism, TMS, requiring crowns with bone loss. The action taken for palbociclib was unknown and for denosumab was not applicable. Therapeutic measures were taken as a result of bruxism, bone loss and included TMS and crowns.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Neck pain, Pain, Pyrexia
Clinical narrative: bone loss; had covid-pfizer booster 12/2; fever 100.9; chills; neck/shoulder pain; neck/shoulder pain; aching; clenching of teeth/bruxism; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 68 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; palbociclib (IBRANCE), first regimen from 06Dec2019 (Batch/Lot number: unknown) to 01Nov2021 at 125 mg and second regimen since 01Dec2021 (Batch/Lot number: unknown) at 125 mg; denosumab (PROLIA) (Batch/Lot number: unknown) at single (unk, single). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, MANUFACTURER UNKNOWN); Covid-19 vaccine (Dose2, MANUFACTURER UNKNOWN). The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "had covid-pfizer booster 12/2"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovered", described as "fever 100.9"; CHILLS (non-serious) with onset 02Dec2021, outcome "unknown", described as "chills"; NECK PAIN (non-serious) with onset 02Dec2021, outcome "not recovered", ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "not recovered" and all described as "neck/shoulder pain"; PAIN (non-serious) with onset 02Dec2021, outcome "unknown", described as "aching"; BRUXISM (non-serious) with onset 02Dec2021, outcome "not recovered", described as "clenching of teeth/bruxism"; BONE LOSS (non-serious), outcome "unknown", described as "bone loss". The clinical course is as follows: the patient had prolia shot, started palbociclib on 01Dec2021, had covid-Pfizer booster bnt162b2 on 02Dec2021, the patient had fever 100.9, chills, neck/shoulder pain, aching, clenching on 02Dec2021. Fever resolved. Has ongoing clenching of teeth/bruxism, TMS, requiring crowns with bone loss. The action taken for palbociclib was unknown and for denosumab was not applicable. Therapeutic measures were taken as a result of bruxism, bone loss and included TMS and crowns.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Affect lability, Aggression, Fatigue, Lethargy, Myalgia
Clinical narrative: Combative behavior; Labile emotions; Fever (greater than 102); Myalgias; Lethargy; Fatigue; This is a spontaneous report received from a contactable reporter (pharmacist). The reporter is the parent.  A 8-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Dec2021 at 16:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "ADHD (attention deficit hyperactive disorder)" (unspecified if ongoing). Concomitant medications included: GUANFACINE and COTEMPLA XR ODT. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5618, Route of administration: intramuscular, Administration time: 15:45, Anatomical location: left arm), administration date: 11Nov2021, when the patient was 8 years old, for COVID-19 immunisation.  The following information was reported: AGGRESSION (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Combative behavior"; AFFECT LABILITY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Labile emotions"; PYREXIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fever (greater than 102)"; MYALGIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Myalgias"; LETHARGY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Lethargy"; FATIGUE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, myalgia and fatigue.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included Ibuprofen for pyrexia, myalgia and fatigue. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures which included: SARS-CoV-2 test (BINAX NOW) by test type nasal swab on 06Dec2021 and the result was negative.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Combative behavior; Labile emotions; Fever (greater than 102); Myalgias; Lethargy; Fatigue; This is a spontaneous report received from a contactable reporter (pharmacist). The reporter is the parent.  A 8-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Dec2021 at 16:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "ADHD (attention deficit hyperactive disorder)" (unspecified if ongoing). Concomitant medications included: GUANFACINE and COTEMPLA XR ODT. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5618, Route of administration: intramuscular, Administration time: 15:45, Anatomical location: left arm), administration date: 11Nov2021, when the patient was 8 years old, for COVID-19 immunisation.  The following information was reported: AGGRESSION (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Combative behavior"; AFFECT LABILITY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Labile emotions"; PYREXIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fever (greater than 102)"; MYALGIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Myalgias"; LETHARGY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Lethargy"; FATIGUE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, myalgia and fatigue.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included Ibuprofen for pyrexia, myalgia and fatigue. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures which included: SARS-CoV-2 test (BINAX NOW) by test type nasal swab on 06Dec2021 and the result was negative.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Affect lability, Aggression, Body temperature, Fatigue, Lethargy
Clinical narrative: Combative behavior; Labile emotions; Fever (greater than 102); Myalgias; Lethargy; Fatigue; This is a spontaneous report received from a contactable reporter (pharmacist). The reporter is the parent.  A 8-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Dec2021 at 16:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "ADHD (attention deficit hyperactive disorder)" (unspecified if ongoing). Concomitant medications included: GUANFACINE and COTEMPLA XR ODT. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5618, Route of administration: intramuscular, Administration time: 15:45, Anatomical location: left arm), administration date: 11Nov2021, when the patient was 8 years old, for COVID-19 immunisation.  The following information was reported: AGGRESSION (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Combative behavior"; AFFECT LABILITY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Labile emotions"; PYREXIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fever (greater than 102)"; MYALGIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Myalgias"; LETHARGY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Lethargy"; FATIGUE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, myalgia and fatigue.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included Ibuprofen for pyrexia, myalgia and fatigue. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures which included: SARS-CoV-2 test (BINAX NOW) by test type nasal swab on 06Dec2021 and the result was negative.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Combative behavior; Labile emotions; Fever (greater than 102); Myalgias; Lethargy; Fatigue; This is a spontaneous report received from a contactable reporter (pharmacist). The reporter is the parent.  A 8-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Dec2021 at 16:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "ADHD (attention deficit hyperactive disorder)" (unspecified if ongoing). Concomitant medications included: GUANFACINE and COTEMPLA XR ODT. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5618, Route of administration: intramuscular, Administration time: 15:45, Anatomical location: left arm), administration date: 11Nov2021, when the patient was 8 years old, for COVID-19 immunisation.  The following information was reported: AGGRESSION (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Combative behavior"; AFFECT LABILITY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Labile emotions"; PYREXIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fever (greater than 102)"; MYALGIA (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Myalgias"; LETHARGY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Lethargy"; FATIGUE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovering", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, myalgia and fatigue.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included Ibuprofen for pyrexia, myalgia and fatigue. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures which included: SARS-CoV-2 test (BINAX NOW) by test type nasal swab on 06Dec2021 and the result was negative.
Age: 64.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Expired product administered
Clinical narrative: received first dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HBV (Engerix B) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received the 1st dose of Engerix B (intramuscular) 1 ml and Engerix B Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the patient received 1st dose of Engerix B which was expired on 12th November 2021. The nurse wanted to know if patient needs to be re-vaccinated. The nurse reported that the patient did not experience any side effects.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: Rash developed to the trunk and  bilateral upper extremities involving palms and and few sites  to bilateral lower extremities
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash developed to the trunk and  bilateral upper extremities involving palms and and few sites  to bilateral lower extremities
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 yo attended workplace clinic with parents. Clerk recorded 15 as eligible for "booster". RN administering vaccine did not note child's age. 15 yo received third dose of Pfizer adult vaccine .3 ml. Parents and pediatrician notified. No adverse events reported following vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 yo attended workplace clinic with parents. Clerk recorded 15 as eligible for "booster". RN administering vaccine did not note child's age. 15 yo received third dose of Pfizer adult vaccine .3 ml. Parents and pediatrician notified. No adverse events reported following vaccine.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pfizer adult dose .3 ml given to 13 yo accompanied by parents for Pfizer "booster" shot > 6 months after initial 2 doses.    Paperwork indicated "booster" shot.  Admin did not check age of patient.  Family contacted on 12/10/21 and reported no adverse effects.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: Pfizer adult dose .3 ml given to 13 yo accompanied by parents for Pfizer "booster" shot > 6 months after initial 2 doses.    Paperwork indicated "booster" shot.  Admin did not check age of patient.  Family contacted on 12/10/21 and reported no adverse effects.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: chest pain; diagnosed with myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and MYOCARDITIS (diagnosed with myocarditis) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization) and MYOCARDITIS (diagnosed with myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to CHEST PAIN and MYOCARDITIS. At the time of the report, CHEST PAIN (chest pain) and MYOCARDITIS (diagnosed with myocarditis) outcome was unknown.            No concomitant medication details was reported.  No treatment medication details was reported.  For mRNA-1273 (COVID 19 Vaccine) (unknown route), the reporter did not provide any causality assessments.   On an unknown date the patient was diagnosed with myocarditis 3-4 days after getting the second dose of the Moderna vaccine and was hospitalized for 2 days.  Company comment:  This case concerns a 31-year-old male patient with no previous medical history, who experienced the unexpected serious event of Chest pain and the serious expected event of Myocarditis (AESI). The events reportedly, occurred 3-4 days after the patient received the second dose of the mRNA-1273 vaccine. The exact dates of vaccination and the start dates of the events were not provided. The patient was hospitalized. The outcome of the reported events remained unknown at the time of this report and no further information regarding the clinical course of the events was provided. The reported event of Chest pain could have been occurred in the setting of Myocarditis. The re-challenge is not applicable having in mind that the events developed after the second dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 31-year-old male patient with no previous medical history, who experienced the unexpected serious event of Chest pain and the serious expected event of Myocarditis (AESI). The events reportedly, occurred 3-4 days after the patient received the second dose of the mRNA-1273 vaccine. The exact dates of vaccination and the start dates of the events were not provided. The patient was hospitalized. The outcome of the reported events remained unknown at the time of this report and no further information regarding the clinical course of the events was provided. The reported event of Chest pain could have been occurred in the setting of Myocarditis. The re-challenge is not applicable having in mind that the events developed after the second dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: My GI doctor had mild heart failure after getting the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (My GI doctor had mild heart failure after getting the vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (My GI doctor had mild heart failure after getting the vaccine.) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE (My GI doctor had mild heart failure after getting the vaccine.) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine) (unknown route), the reporter did not provide any causality assessments.  No concomitant medication details was reported. No treatment medication details was reported. The patient did not expand on the type of side effects and did not give any further information on this adverse event.  Company comment:  This case concerns a patient of an unknown age and gender with no medical history provided, who experienced a serious unexpected event of Cardiac failure (AES) after the vaccination with mRNA-1273 vaccine. The exact temporal relationship cannot be determined as the start date of the event and date of vaccination was not provided. At the time of the report, the outcome of the event remained unknown and no further information regarding the clinical course of the event was provided. The rechallenge is not applicable as it remained whether adverse event occurred after the first or the second dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-400097, MOD-2021-400130 (Patient Link).; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced a serious unexpected event of Cardiac failure (AES) after the vaccination with mRNA-1273 vaccine. The exact temporal relationship cannot be determined as the start date of the event and date of vaccination was not provided. At the time of the report, the outcome of the event remained unknown and no further information regarding the clinical course of the event was provided. The rechallenge is not applicable as it remained whether adverse event occurred after the first or the second dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Wheelchair user
Clinical narrative: In the Wheel chair for the rest of her life  after vaccination; Pain all over her body after Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WHEELCHAIR USER (In the Wheel chair for the rest of her life  after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced WHEELCHAIR USER (In the Wheel chair for the rest of her life  after vaccination) (seriousness criterion disability) and PAIN (Pain all over her body after Moderna COVID-19 vaccine). At the time of the report, WHEELCHAIR USER (In the Wheel chair for the rest of her life  after vaccination) and PAIN (Pain all over her body after Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter states that her friend had pain all over her body after Moderna COVID-19 vaccine and she ended up in the Wheel chair for the rest of her life. Consent received for safety to follow up. Company comment: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected event of wheelchair user. The event occurred after an unknown time interval after the dose of the mRNA-1273 vaccine. The rechallenge is not applicable since there is no information that states vaccination dose number, the dose date and there is only one dose reported. The event implies disability, although there is not enough information. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected event of wheelchair user. The event occurred after an unknown time interval after the dose of the mRNA-1273 vaccine. The rechallenge is not applicable since there is no information that states vaccination dose number, the dose date and there is only one dose reported. The event implies disability, although there is not enough information. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       CC: This is a regulatory case concerning a 56-year-old female patient with no reported medical history, who experienced the  non serious event Sore arm,  after receiving the first dose of mRNA-1273.  Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-403769 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 56-year-old female patient with no reported medical history, who experienced the non serious event Sore arm,  after receiving the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain
Clinical narrative: Weird feeling in her heart; Heart hurt; Later that night the patient felt a lot of anxiety; This spontaneous case was reported by a non-health professional and describes the occurrence of CHEST DISCOMFORT (Weird feeling in her heart), CHEST PAIN (Heart hurt) and ANXIETY (Later that night the patient felt a lot of anxiety) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0441321A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included Sickness (Patient may have had COVID-19.Not diagnosed as COVID-19.) in February 2020.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHEST DISCOMFORT (Weird feeling in her heart), CHEST PAIN (Heart hurt) and ANXIETY (Later that night the patient felt a lot of anxiety). At the time of the report, CHEST DISCOMFORT (Weird feeling in her heart), CHEST PAIN (Heart hurt) and ANXIETY (Later that night the patient felt a lot of anxiety) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.Treatment information was not provided.   This case was linked to MOD-2021-406202, MOD-2021-406203, MOD-2021-406090 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Maternal exposure during breast feeding
Clinical narrative: Breastfeeding at time of her second Moderna dose.; Maternal exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On 02-Feb-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved.            No concomitant medications were provided No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic, Vaccination complication
Clinical narrative: Moderna Arm; red blotches; itchy blotches; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Moderna Arm), RASH MACULAR (red blotches) and RASH PRURITIC (itchy blotches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna Arm), RASH MACULAR (red blotches) and RASH PRURITIC (itchy blotches). At the time of the report, VACCINATION COMPLICATION (Moderna Arm), RASH MACULAR (red blotches) and RASH PRURITIC (itchy blotches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: It was reported that the patient stated the events experienced by 16 patients after taking Moderna COVID-19 vaccine, out of which 13 were women, onset of event was 2-12 days post vaccination and median duration was 5 days till 21 days.  No concomitant medications were reported No treatment medications were reported