chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: Heart Palpitations; Insomnia; Small fiber neuropathy; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8027) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy"; Augmentin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 16Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: ANXIETY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered"; PALPITATIONS (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered", described as "Heart Palpitations"; INSOMNIA (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered"; SMALL FIBRE NEUROPATHY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered", described as "Small fiber neuropathy". The patient was hospitalized for palpitations, insomnia, small fibre neuropathy, anxiety (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results; Lumbar puncture: Small fiber neuropathy. Therapeutic measures were taken as a result of palpitations, insomnia, small fibre neuropathy, anxiety. Clinical course: Other medication in 2weeks: No. Adverse event: Heart Palpitations Insomnia (5 weeks) Small fiber neuropathy (as detected by the lumbar puncture and skin biopsy) Anxiety. AE resulted in: [Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. AE treatment: Gabapentin 600 mg 3/day, Propafenone 225mg 2/day.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: rash, from side to back; week after the dose, developed shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. In April 2022, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced rash. The patient was treated with acyclovir and etodolac. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: The patient reported case for himself. The patient received first dose of Shingrix about a month ago from reporting. The patient stated that a week after the dose of Shingrix, he developed shingles. Less than a month after vaccination, he had a rash that went from the side of his body to his back. His doctor prescribed Acyclovir and Etodolac for the Shingles. He was no longer taking these medications. The patient still had shingles on his back. The reporter did not consent to follow-up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: rash, from side to back; week after the dose, developed shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. In April 2022, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced rash. The patient was treated with acyclovir and etodolac. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: The patient reported case for himself. The patient received first dose of Shingrix about a month ago from reporting. The patient stated that a week after the dose of Shingrix, he developed shingles. Less than a month after vaccination, he had a rash that went from the side of his body to his back. His doctor prescribed Acyclovir and Etodolac for the Shingles. He was no longer taking these medications. The patient still had shingles on his back. The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Irregular heartbeat after receiving the 1st primary dose; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Angioedema and Sinus disorder.    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 experienced HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Company Comment: This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced Non-serious , unexpected, AESI of Heart rate irregular  which occurred on an unknown date post vaccination with the 1st dose of mRNA-1273 vaccine ( date of vaccination also not reported )  This patient reported that he experienced the event  for a minute or two. The details surrounding this event like treatment information , results of laboratories/diagnostic tests if done were not reported. . He states that  he is now better and that he will be visiting his doctor on 01Jun2022.. The age of this patient may be considered as a confounder for the event.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced Non-serious , unexpected, AESI of Heart rate irregular  which occurred on an unknown date post vaccination with the 1st dose of mRNA-1273 vaccine ( date of vaccination also not reported )  This patient reported that he experienced the event  for a minute or two. The details surrounding this event like treatment information , results of laboratories/diagnostic tests if done were not reported. . He states that  he is now better and that he will be visiting his doctor on 01Jun2022.. The age of this patient may be considered as a confounder for the event.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bone pain, Myalgia
Clinical narrative: Irregular heartbeat after receiving the 1st primary dose; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Angioedema and Sinus disorder.    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 experienced HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Company Comment: This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced Non-serious , unexpected, AESI of Heart rate irregular  which occurred on an unknown date post vaccination with the 1st dose of mRNA-1273 vaccine ( date of vaccination also not reported )  This patient reported that he experienced the event  for a minute or two. The details surrounding this event like treatment information , results of laboratories/diagnostic tests if done were not reported. . He states that  he is now better and that he will be visiting his doctor on 01Jun2022.. The age of this patient may be considered as a confounder for the event.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced Non-serious , unexpected, AESI of Heart rate irregular  which occurred on an unknown date post vaccination with the 1st dose of mRNA-1273 vaccine ( date of vaccination also not reported )  This patient reported that he experienced the event  for a minute or two. The details surrounding this event like treatment information , results of laboratories/diagnostic tests if done were not reported. . He states that  he is now better and that he will be visiting his doctor on 01Jun2022.. The age of this patient may be considered as a confounder for the event.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate irregular
Clinical narrative: Irregular heartbeat after receiving the 1st primary dose; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Angioedema and Sinus disorder.    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 experienced HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat after receiving the 1st primary dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Company Comment: This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced Non-serious , unexpected, AESI of Heart rate irregular  which occurred on an unknown date post vaccination with the 1st dose of mRNA-1273 vaccine ( date of vaccination also not reported )  This patient reported that he experienced the event  for a minute or two. The details surrounding this event like treatment information , results of laboratories/diagnostic tests if done were not reported. . He states that  he is now better and that he will be visiting his doctor on 01Jun2022.. The age of this patient may be considered as a confounder for the event.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced Non-serious , unexpected, AESI of Heart rate irregular  which occurred on an unknown date post vaccination with the 1st dose of mRNA-1273 vaccine ( date of vaccination also not reported )  This patient reported that he experienced the event  for a minute or two. The details surrounding this event like treatment information , results of laboratories/diagnostic tests if done were not reported. . He states that  he is now better and that he will be visiting his doctor on 01Jun2022.. The age of this patient may be considered as a confounder for the event.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris
Clinical narrative: she just got Covid; she just got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 15Oct2021 at 08:00 as dose 3 (booster) , single (Lot number: FF2590) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypoglycemic" (unspecified if ongoing), notes: hypoglycemic diagnosed she believes at age 14. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; IBUPROFEN. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 13May2022, outcome "unknown" and all described as "she just got Covid". The event "she just got covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) high, notes: blood pressure was high for her, her normal is low 100's over 60-70. States she was 160/100-110; (unspecified date) low, notes: blood pressure was high for her, her normal is low 100's over 60-70. States she was 160/100-110; Blood test: (unspecified date) Negative; Cardiac stress test: (unspecified date) Unknown results; Computerised tomogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Negative; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (13May2022) Positive.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, COVID-19, Cardiac stress test, Computerised tomogram
Clinical narrative: she just got Covid; she just got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 15Oct2021 at 08:00 as dose 3 (booster) , single (Lot number: FF2590) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypoglycemic" (unspecified if ongoing), notes: hypoglycemic diagnosed she believes at age 14. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; IBUPROFEN. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 13May2022, outcome "unknown" and all described as "she just got Covid". The event "she just got covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) high, notes: blood pressure was high for her, her normal is low 100's over 60-70. States she was 160/100-110; (unspecified date) low, notes: blood pressure was high for her, her normal is low 100's over 60-70. States she was 160/100-110; Blood test: (unspecified date) Negative; Cardiac stress test: (unspecified date) Unknown results; Computerised tomogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Negative; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (13May2022) Positive.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Magnetic resonance imaging, Vaccination failure
Clinical narrative: she just got Covid; she just got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 15Oct2021 at 08:00 as dose 3 (booster) , single (Lot number: FF2590) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypoglycemic" (unspecified if ongoing), notes: hypoglycemic diagnosed she believes at age 14. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; IBUPROFEN. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 13May2022, outcome "unknown" and all described as "she just got Covid". The event "she just got covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) high, notes: blood pressure was high for her, her normal is low 100's over 60-70. States she was 160/100-110; (unspecified date) low, notes: blood pressure was high for her, her normal is low 100's over 60-70. States she was 160/100-110; Blood test: (unspecified date) Negative; Cardiac stress test: (unspecified date) Unknown results; Computerised tomogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Negative; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (13May2022) Positive.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Nasopharyngitis, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Cold symptoms began 10May evening, tested positive for COVID; Cold symptoms began 10May evening, tested positive for COVID; 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 03:00 as dose 3 (booster) , single (Lot number: FK9893) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Nov2021 at 02:30 as dose 2, single (Lot number: 012F21A), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 at 12:00 as dose 1, single (Lot number: 205A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Treated; "low thyroid function" (unspecified if ongoing), notes: Treated; "overweight" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Dec2017; HYDROCHLOROTHIAZIDE, start date: Dec2017; LEVOTHYROXINE, start date: Dec2017; FLUTICASONE, start date: Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "Cold symptoms began 10May evening, tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) positive, notes: Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning; (20May2022) Negative; (23May2022) positive, notes: Positive rapid test 23May AM (day 13 since initial infection). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID vaccinated and boosted (J&J 09Apr2021; Moderna 05Nov2021, Pfizer 09Apr2022). Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning. Paxlovid taken as prescribed 11May PM through 16May AM. Symptoms improved by 12May AM except for low-grade fever (99.2-99.8 F) which persisted through 23May. Negative rapid test 20May. Cold symptoms (runny nose, cough, fatigue, throat tickle) returned 22May. Positive rapid test 23May AM (day 13 since initial infection).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Cold symptoms began 10May evening, tested positive for COVID; Cold symptoms began 10May evening, tested positive for COVID; 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 03:00 as dose 3 (booster) , single (Lot number: FK9893) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Nov2021 at 02:30 as dose 2, single (Lot number: 012F21A), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 at 12:00 as dose 1, single (Lot number: 205A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Treated; "low thyroid function" (unspecified if ongoing), notes: Treated; "overweight" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Dec2017; HYDROCHLOROTHIAZIDE, start date: Dec2017; LEVOTHYROXINE, start date: Dec2017; FLUTICASONE, start date: Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "Cold symptoms began 10May evening, tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) positive, notes: Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning; (20May2022) Negative; (23May2022) positive, notes: Positive rapid test 23May AM (day 13 since initial infection). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID vaccinated and boosted (J&J 09Apr2021; Moderna 05Nov2021, Pfizer 09Apr2022). Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning. Paxlovid taken as prescribed 11May PM through 16May AM. Symptoms improved by 12May AM except for low-grade fever (99.2-99.8 F) which persisted through 23May. Negative rapid test 20May. Cold symptoms (runny nose, cough, fatigue, throat tickle) returned 22May. Positive rapid test 23May AM (day 13 since initial infection).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: Cold symptoms began 10May evening, tested positive for COVID; Cold symptoms began 10May evening, tested positive for COVID; 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 03:00 as dose 3 (booster) , single (Lot number: FK9893) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Nov2021 at 02:30 as dose 2, single (Lot number: 012F21A), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 at 12:00 as dose 1, single (Lot number: 205A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Treated; "low thyroid function" (unspecified if ongoing), notes: Treated; "overweight" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Dec2017; HYDROCHLOROTHIAZIDE, start date: Dec2017; LEVOTHYROXINE, start date: Dec2017; FLUTICASONE, start date: Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "Cold symptoms began 10May evening, tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) positive, notes: Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning; (20May2022) Negative; (23May2022) positive, notes: Positive rapid test 23May AM (day 13 since initial infection). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID vaccinated and boosted (J&J 09Apr2021; Moderna 05Nov2021, Pfizer 09Apr2022). Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning. Paxlovid taken as prescribed 11May PM through 16May AM. Symptoms improved by 12May AM except for low-grade fever (99.2-99.8 F) which persisted through 23May. Negative rapid test 20May. Cold symptoms (runny nose, cough, fatigue, throat tickle) returned 22May. Positive rapid test 23May AM (day 13 since initial infection).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Cold symptoms began 10May evening, tested positive for COVID; Cold symptoms began 10May evening, tested positive for COVID; 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 03:00 as dose 3 (booster) , single (Lot number: FK9893) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Nov2021 at 02:30 as dose 2, single (Lot number: 012F21A), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 at 12:00 as dose 1, single (Lot number: 205A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Treated; "low thyroid function" (unspecified if ongoing), notes: Treated; "overweight" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Dec2017; HYDROCHLOROTHIAZIDE, start date: Dec2017; LEVOTHYROXINE, start date: Dec2017; FLUTICASONE, start date: Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "Cold symptoms began 10May evening, tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) positive, notes: Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning; (20May2022) Negative; (23May2022) positive, notes: Positive rapid test 23May AM (day 13 since initial infection). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID vaccinated and boosted (J&J 09Apr2021; Moderna 05Nov2021, Pfizer 09Apr2022). Cold symptoms began 10May evening, tested positive for COVID by rapid test 11May morning. Paxlovid taken as prescribed 11May PM through 16May AM. Symptoms improved by 12May AM except for low-grade fever (99.2-99.8 F) which persisted through 23May. Negative rapid test 20May. Cold symptoms (runny nose, cough, fatigue, throat tickle) returned 22May. Positive rapid test 23May AM (day 13 since initial infection).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Head discomfort, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 13:00 as dose number unknown, single (Lot number: FJ4989) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (12May2022) positive; (21May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine within 4 weeks and no other medication was taken within 2 weeks. She tested COVID positive on 12May2022 and started treatment with Paxlovid on that evening on 12May2022 and finished it on 18May2022. She tested negative for COVID on 18May2022 and symptoms started again on 20May2022. She tested COVID positive on 21May2022 morning.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 13:00 as dose number unknown, single (Lot number: FJ4989) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (12May2022) positive; (21May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine within 4 weeks and no other medication was taken within 2 weeks. She tested COVID positive on 12May2022 and started treatment with Paxlovid on that evening on 12May2022 and finished it on 18May2022. She tested negative for COVID on 18May2022 and symptoms started again on 20May2022. She tested COVID positive on 21May2022 morning.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 13:00 as dose number unknown, single (Lot number: FJ4989) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (12May2022) positive; (21May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine within 4 weeks and no other medication was taken within 2 weeks. She tested COVID positive on 12May2022 and started treatment with Paxlovid on that evening on 12May2022 and finished it on 18May2022. She tested negative for COVID on 18May2022 and symptoms started again on 20May2022. She tested COVID positive on 21May2022 morning.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022; Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 2:03 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 2:03 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022  The vial did not undergo any temperature excursion.   The reporter confirmed no side effects were reported.  Treatment information was not reported
Age: 38.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022; Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 2:03 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 2:03 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Apr-2022 which had got expired vaccine on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022  The vial did not undergo any temperature excursion.   The reporter confirmed no side effects were reported.  Treatment information was not reported
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid on Saturday night; got covid on Saturday night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid on Saturday night".  Clinical course: Pfizer last booster. Patient got covid on sat night, so she cancelled my last booster shot and when should she schedule her booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid on Saturday night; got covid on Saturday night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid on Saturday night".  Clinical course: Pfizer last booster. Patient got covid on sat night, so she cancelled my last booster shot and when should she schedule her booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Fatigue, Myalgia, Nasal congestion
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 007M20A, 032F21A and 056M21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Hashimoto's thyroiditis.   On 12-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021 at 3:00 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Device date was provided as 21-MAY-2022 No concomitant product was provided. No treatment information were reported. Patient took Paxlovid as a treatment for COVID-19 on from 08-May-2022 to 10-May-2022.   This case was linked to MOD-2022-574022 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 007M20A, 032F21A and 056M21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Hashimoto's thyroiditis.   On 12-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021 at 3:00 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Device date was provided as 21-MAY-2022 No concomitant product was provided. No treatment information were reported. Patient took Paxlovid as a treatment for COVID-19 on from 08-May-2022 to 10-May-2022.   This case was linked to MOD-2022-574022 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Ear pain, Electrocardiogram normal, Eye pain
Clinical narrative: 5/25/22 - 5/26/22:  Headache, fever, and chills, treated on 5/26/22 with acetaminophen 1000 mg at 2:45am and 10:50am, fever resolved later in day. Headache remained intermittent through 5/26/22. 5/25/22:  Right shoulder pain. Treated on 5/26/22 with lidoderm patch. Improved. 5/25/22 - 5/26/22:  Right eye and right side facial pain. Resolved 5/27/22 5/26/22 - Current:  Right ear pain and frontal aspect of right ear. Unresolved 5/26/22:  Chest tightness. EKG result was sinus rhythm via Fitness Watch. Resolved on 5/27/22 5/26/22:  Right scapula pain. Resolved on 5/27/22 5/25/22 - current:  Sore right upper arm. Treated with warm water. Unresolved. 5/26/22 - current:  Swollen lower, right axilla (between right, lower axilla and upper right side of right breast). Swollen and spongy feel when touched. Unresolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Injection site pain, Musculoskeletal pain, Pyrexia
Clinical narrative: 5/25/22 - 5/26/22:  Headache, fever, and chills, treated on 5/26/22 with acetaminophen 1000 mg at 2:45am and 10:50am, fever resolved later in day. Headache remained intermittent through 5/26/22. 5/25/22:  Right shoulder pain. Treated on 5/26/22 with lidoderm patch. Improved. 5/25/22 - 5/26/22:  Right eye and right side facial pain. Resolved 5/27/22 5/26/22 - Current:  Right ear pain and frontal aspect of right ear. Unresolved 5/26/22:  Chest tightness. EKG result was sinus rhythm via Fitness Watch. Resolved on 5/27/22 5/26/22:  Right scapula pain. Resolved on 5/27/22 5/25/22 - current:  Sore right upper arm. Treated with warm water. Unresolved. 5/26/22 - current:  Swollen lower, right axilla (between right, lower axilla and upper right side of right breast). Swollen and spongy feel when touched. Unresolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: 5/25/22 - 5/26/22:  Headache, fever, and chills, treated on 5/26/22 with acetaminophen 1000 mg at 2:45am and 10:50am, fever resolved later in day. Headache remained intermittent through 5/26/22. 5/25/22:  Right shoulder pain. Treated on 5/26/22 with lidoderm patch. Improved. 5/25/22 - 5/26/22:  Right eye and right side facial pain. Resolved 5/27/22 5/26/22 - Current:  Right ear pain and frontal aspect of right ear. Unresolved 5/26/22:  Chest tightness. EKG result was sinus rhythm via Fitness Watch. Resolved on 5/27/22 5/26/22:  Right scapula pain. Resolved on 5/27/22 5/25/22 - current:  Sore right upper arm. Treated with warm water. Unresolved. 5/26/22 - current:  Swollen lower, right axilla (between right, lower axilla and upper right side of right breast). Swollen and spongy feel when touched. Unresolved.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood test abnormal, Chronic spontaneous urticaria, Gene mutation identification test, Herpes zoster
Clinical narrative: Hives started 1/1/2022> Broke out in massive hives 1/15/2022 with left sides shingles.  Now chronic idiopathic uticaria.  Angioedema with lips swelling  every few weeks.  Pressure hives with pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Tryptase, Urine analysis, Urticaria
Clinical narrative: Hives started 1/1/2022> Broke out in massive hives 1/15/2022 with left sides shingles.  Now chronic idiopathic uticaria.  Angioedema with lips swelling  every few weeks.  Pressure hives with pain.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Laboratory test, Seizure
Clinical narrative: My son had a seizure the next day after receiving this vaccine 4/6/2022. He had another seizure on May 14, 2022. He has no prior history of seizure.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Heart rate irregular, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: My hair is thinning and falling out, my heart is beating differently, I?m more tired, my periods are longer and they keep changing start dates. My hair was healthy and grew with no problems until I got vaccinated. I also experience head aches and migraines daily
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, New daily persistent headache
Clinical narrative: My hair is thinning and falling out, my heart is beating differently, I?m more tired, my periods are longer and they keep changing start dates. My hair was healthy and grew with no problems until I got vaccinated. I also experience head aches and migraines daily
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Paraesthesia, Visual impairment
Clinical narrative: After my second dose, I felt tingling in my fingers and numbness, along with headaches and vision issues. My booster was the third shot and the tingling was worse. Headaches got worse and vision remained the same (w/issues).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Patient may have received the vaccine at a site lower than deltoid (ie biceps).  Patient had no other symptoms or adverse reactions
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: I did not know at the time they were related but now I am having what is called a delayed allergic reaction to the dermal filler Juvederm Volbella, injected into my tear troughs by Dr. at Facility. I got the fillers less than one week following my second booster of the Moderna vaccine