chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Poor quality product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. No Adverse event was reported. The Suspect product was exposed at 34 degree Fahrenheit. Expiry date of suspect drug was 02-Jan-2022.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: acute deep vein thrombosis (DVT) in the right upper extremity; This literature-non-study case was reported in a literature article and describes the occurrence of DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report.     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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) to be possibly related.    Patient relevant thrombophilia workup was negative on initial presentation. She was treated with rivaroxaban for 3 months and her symptoms of right upper extremity swelling, and pain improved.  Company Comment: This case concerns a 27-year-old female patient with no relevant medical history, who experienced the unexpected serious event/AESI of Deep venous thrombosis in arm after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the second dose of mRNA- 1273 vaccine. Treatment with Rivaroxaban was given. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report; Sender's Comments: This case concerns a 27-year-old female patient with no relevant medical history, who experienced the unexpected serious event/AESI of Deep venous thrombosis in arm after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the second dose of mRNA- 1273 vaccine. Treatment with Rivaroxaban was given. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Relapsing-remitting multiple sclerosis
Clinical narrative: MS relapse; Based on the current case data, this case has been classified as invalid. This literature-study case was reported in a literature article and describes the occurrence of RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) in subject of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: diagnosed with CIS or RRMS with initial clinical relapse less than 2 weeks after a COVID 19 mRNA vaccine. Mult Scler.     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 experienced RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) (seriousness criterion medically significant). At the time of the report, RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) to be possibly related.    No concomitant information were reported.  Treatment information was not provided.  Company Comment: This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the unexpected serious event/AESI of Relapsing-remitting multiple sclerosis after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred less than two weeks after the first dose of mRNA- 1273 vaccine. Very limited information is available at this moment. The rechallenge is not applicable since only information about the first dose was disclosed.  The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report; Sender's Comments: This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the unexpected serious event/AESI of Relapsing-remitting multiple sclerosis after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred less than two weeks after the first dose of mRNA- 1273 vaccine. Very limited information is available at this moment. The rechallenge is not applicable since only information about the first dose was disclosed.  The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Depressed mood, Fatigue, Headache
Clinical narrative: Slept all day; Weepy/Crying; Sad feeling/Depressed; Anxious; Headache; Little achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), CRYING (Weepy/Crying), DEPRESSED MOOD (Sad feeling/Depressed), ANXIETY (Anxious) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Spice allergy. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid disorder NOS.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept all day), CRYING (Weepy/Crying), DEPRESSED MOOD (Sad feeling/Depressed), ANXIETY (Anxious), HEADACHE (Headache), MYALGIA (Little achy) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Slept all day), CRYING (Weepy/Crying) and ANXIETY (Anxious) outcome was unknown, DEPRESSED MOOD (Sad feeling/Depressed) had not resolved and HEADACHE (Headache), MYALGIA (Little achy) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The other thing that happened the day after the vaccine was trigger finder which was better was all bent when woke up. it went away after a few days. Now seeking therapy and Transcranial magnetic stimulation and breathwork to try to get this under control.  No treatment medications were provided.   This case was linked to MOD-2021-375416, MOD-2021-375495 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: follow-up was received and included  patient demographics,medical history and concomitant medication
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Somnolence
Clinical narrative: Slept all day; Weepy/Crying; Sad feeling/Depressed; Anxious; Headache; Little achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), CRYING (Weepy/Crying), DEPRESSED MOOD (Sad feeling/Depressed), ANXIETY (Anxious) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Spice allergy. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid disorder NOS.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept all day), CRYING (Weepy/Crying), DEPRESSED MOOD (Sad feeling/Depressed), ANXIETY (Anxious), HEADACHE (Headache), MYALGIA (Little achy) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Slept all day), CRYING (Weepy/Crying) and ANXIETY (Anxious) outcome was unknown, DEPRESSED MOOD (Sad feeling/Depressed) had not resolved and HEADACHE (Headache), MYALGIA (Little achy) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The other thing that happened the day after the vaccine was trigger finder which was better was all bent when woke up. it went away after a few days. Now seeking therapy and Transcranial magnetic stimulation and breathwork to try to get this under control.  No treatment medications were provided.   This case was linked to MOD-2021-375416, MOD-2021-375495 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: follow-up was received and included  patient demographics,medical history and concomitant medication
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Painful lump in his groin 3 days after receiving a 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (Painful lump in his groin 3 days after receiving a 3rd dose) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Painful lump in his groin 3 days after receiving a 3rd dose). At the time of the report, LYMPHADENOPATHY (Painful lump in his groin 3 days after receiving a 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Patient had a painful lump in groin three days after receiving a third dose. Reporter enquired if this could be vaccine related.   Reporter did not allow further contact
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 22-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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No relevant concomitant medications were reported.   No treatment information was provided.  All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine with the majority occurring within 3 days (range 1-13 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived.  Myocarditis was a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose was not known at this time.  This literature case concerns a 22-year-old male patient with no details on relevant medical history, who experienced the expected serious event/AESI of Myocarditis after mRNA- 1273 Moderna vaccine. The event occurred within 2 weeks after the second dose of mRNA- 1273 vaccine. The case was mild. Very limited information is avaliable at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-380819, MOD-2021-380877, MOD-2021-380878 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This literature case concerns a 22-year-old male patient with no details on relevant medical history, who experienced the expected serious event/AESI of Myocarditis after mRNA- 1273 Moderna vaccine. The event occurred within 2 weeks after the second dose of mRNA- 1273 vaccine. The case was mild. Very limited information is avaliable at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following COVID-19 mRNA Vaccine: A case series and incidence rate determination.     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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant information were reported. Treatment information was not provided.  All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine with the majority occurring within 3 days (range 1-13 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived.  Myocarditis was a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose was not known at this time.  Company Comment: This is a literature study case concerning a 44-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant and AESI) event of Myocarditis. The event occurred approximately with unknown latency after a dose of Moderna COVID 19 vaccine.  The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-380819, MOD-2021-380876, MOD-2021-380878 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a literature study case concerning a 44-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant and AESI) event of Myocarditis. The event occurred approximately with unknown latency after a dose of Moderna COVID 19 vaccine.  The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: IgA nephropathy, Protein urine
Clinical narrative: IgAN with moderate interstitial nephritis; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgAN with moderate interstitial nephritis) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (privacy)     The patient's past medical history included SARS-CoV-2 infection.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IGA NEPHROPATHY (IgAN with moderate interstitial nephritis) (seriousness criterion medically significant). The patient was treated with PREDNISONE for IgA nephropathy, at an unspecified dose and frequency and RAMIPRIL for IgA nephropathy, at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (IgAN with moderate interstitial nephritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: positive (Positive) positive. On an unknown date, Blood creatinine: 1.2 mg/dl 1.2 mg/dl, 2.5 mg/dl 2.5 mg/dl and 2.7 mg/dl 2.7 mg/dl. On an unknown date, Protein urine: 14.4 g/d 14.4 g/d. On an unknown date, Urine analysis: 21-30 rbc/hpf 21-30 RBC/hpf.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgAN with moderate interstitial nephritis) to be possibly related.    No concomitant information were reported.  Company Comment: This is a literature case concerning a 43 years old, male patient with no clinical history who experienced the unexpected event of IGA NEPHROPATHY  The event occurred unknown days after the first dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.   This case was linked to MOD-2021-380949 (Patient Link).; Sender's Comments: This is a literature case concerning a 43 years old, male patient with no clinical history who experienced the unexpected event of IGA NEPHROPATHY  The event occurred unknown days after the first dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Unknown cause of death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 948548) 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. Death occurred on 01-Nov-2021 The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          No treatment drug information provided. No concomitant drug information provided.  Company comment: This case concerns a patient with unknown age  and gender, with no reported medical history , who experienced Serious , unexpected event of Death, which occurred on Nov , 1, 2021 with an unknown dose number of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine). The cause of death is unknown and it is also unknown if an autopsy was done . The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine (moderna Covid 19 vaccine ) is not affected by this report.; Sender's Comments: This case concerns a patient with unknown age  and gender, with no reported medical history , who experienced Serious , unexpected event of Death, which occurred on Nov , 1, 2021 with an unknown dose number of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine). The cause of death is unknown and it is also unknown if an autopsy was done . The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine (moderna Covid 19 vaccine ) is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Pain in extremity
Clinical narrative: I feel weak until now; Low temp fever; Chill; Super tired; Sore of my arms; After 1week i start palpiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore of my arms), PALPITATIONS (After 1week i start palpiting), ASTHENIA (I feel weak until now), PYREXIA (Low temp fever) and CHILLS (Chill) in a  patient of an unknown age and gender 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 27-Sep-2021, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PALPITATIONS (After 1week i start palpiting). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore of my arms), ASTHENIA (I feel weak until now), PYREXIA (Low temp fever), CHILLS (Chill) and FATIGUE (Super tired). At the time of the report, PAIN IN EXTREMITY (Sore of my arms), PALPITATIONS (After 1week i start palpiting), PYREXIA (Low temp fever), CHILLS (Chill) and FATIGUE (Super tired) outcome was unknown and ASTHENIA (I feel weak until now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low temperature fever (High) low temperature fever.         Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: I feel weak until now; Low temp fever; Chill; Super tired; Sore of my arms; After 1week i start palpiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore of my arms), PALPITATIONS (After 1week i start palpiting), ASTHENIA (I feel weak until now), PYREXIA (Low temp fever) and CHILLS (Chill) in a  patient of an unknown age and gender 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 27-Sep-2021, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PALPITATIONS (After 1week i start palpiting). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore of my arms), ASTHENIA (I feel weak until now), PYREXIA (Low temp fever), CHILLS (Chill) and FATIGUE (Super tired). At the time of the report, PAIN IN EXTREMITY (Sore of my arms), PALPITATIONS (After 1week i start palpiting), PYREXIA (Low temp fever), CHILLS (Chill) and FATIGUE (Super tired) outcome was unknown and ASTHENIA (I feel weak until now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low temperature fever (High) low temperature fever.         Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: patient came down with a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (patient came down with a cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot in October 2021. Past adverse reactions to the above products included No adverse event with flu shot.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 NASOPHARYNGITIS (patient came down with a cold). At the time of the report, NASOPHARYNGITIS (patient came down with a cold) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  The patient had waited till Nov2021 to get booster shot.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: The day after her covid vaccine, Patient got her menstrual period for the first time. She is on the younger side for this to happen. I don?t necessarily know if this is linked but did want to report it in case many other children report the same issue.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Discomfort, Headache, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Pain and swelling at injection site, but also in the armpit of that arm. Very uncomfortable. Headache.
Age: 52.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: rashes on arm, trunk and neck; swelling on arm; redness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 34ys7, expiry date 23rd January 2023) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for prophylaxis.   Concurrent medical conditions included cancer and lymph node cancer metastatic (has a lymph node due to cancer). Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)) and INFLUENZA VACCINE.   On 1st October 2021, the patient received the 1st dose of Shingrix and COVID 19 VACCINE PFIZER. On 1st October 2021, less than a day after receiving Shingrix, the patient experienced rash, swelling arm and localized erythema. On an unknown date, the outcome of the rash, swelling arm and localized erythema were recovered/resolved.   It was unknown if the reporter considered the rash, swelling arm and localized erythema to be related to Shingrix.  Additional details were provided are as follows: The registered pharmacist reported that the patient received a dose of Shingrix in unknown arm along with Covid shot (Pfizer) and that afternoon patient developed rashes on the arm, redness and swelling. 1day after vaccination, the patient developed rash on the trunk and neck. The patient requested both shot to be injected on the same arm as patient had has a lymph node due to cancer  on one of the arm (did not knew which one).  The reporter reported another batch number as 344s7. The patient received 1st dose of covid and flu shot on 10th September 2021. On an unknown date, the rashes went after couple of days. The reporter consented to follow-up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Injection site erythema, Injection site papule, Nodule
Clinical narrative: This spontaneous report received from a patient concerned an adult female of an unspecified age (at time of event), race and ethnic origin (age at time of vaccination: 51 years). The patient's height, and weight were not reported. The patient's concurrent condition included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 20-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drug included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis flare up (one/two days before Humira shot), purple bumps on bottom of feet/patches on hands, osteoporosis in hands, chronic cough, red bumps at injection site on stomach, peeling of fingers, wearing off effect, knots on fingers, redness, swelling, and painful finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from osteoporosis in hands, psoriatic arthritis flare up, chronic cough, and wearing off effect, and the outcome of purple bumps on bottom of feet/patches on hands, bumps at injection site on stomach, fingers peeling, knots on fingers, redness, finger tips painful, red bumps at injection site on stomach and swelling was not reported. This report was serious (Other Medically Important Condition). This report is associated with a product quality complaint.; Sender's Comments: V0: 20211120809- Covid-19 vaccine ad26.cov2.s- Psoriatic arthritis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211120809-Covid-19 vaccine ad26.cov2.s- Wearing off effect. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoporosis, Pain in extremity, Psoriatic arthropathy, Skin disorder, Skin exfoliation
Clinical narrative: This spontaneous report received from a patient concerned an adult female of an unspecified age (at time of event), race and ethnic origin (age at time of vaccination: 51 years). The patient's height, and weight were not reported. The patient's concurrent condition included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 20-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drug included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis flare up (one/two days before Humira shot), purple bumps on bottom of feet/patches on hands, osteoporosis in hands, chronic cough, red bumps at injection site on stomach, peeling of fingers, wearing off effect, knots on fingers, redness, swelling, and painful finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from osteoporosis in hands, psoriatic arthritis flare up, chronic cough, and wearing off effect, and the outcome of purple bumps on bottom of feet/patches on hands, bumps at injection site on stomach, fingers peeling, knots on fingers, redness, finger tips painful, red bumps at injection site on stomach and swelling was not reported. This report was serious (Other Medically Important Condition). This report is associated with a product quality complaint.; Sender's Comments: V0: 20211120809- Covid-19 vaccine ad26.cov2.s- Psoriatic arthritis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211120809-Covid-19 vaccine ad26.cov2.s- Wearing off effect. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Therapeutic response shortened
Clinical narrative: This spontaneous report received from a patient concerned an adult female of an unspecified age (at time of event), race and ethnic origin (age at time of vaccination: 51 years). The patient's height, and weight were not reported. The patient's concurrent condition included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 20-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drug included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis flare up (one/two days before Humira shot), purple bumps on bottom of feet/patches on hands, osteoporosis in hands, chronic cough, red bumps at injection site on stomach, peeling of fingers, wearing off effect, knots on fingers, redness, swelling, and painful finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from osteoporosis in hands, psoriatic arthritis flare up, chronic cough, and wearing off effect, and the outcome of purple bumps on bottom of feet/patches on hands, bumps at injection site on stomach, fingers peeling, knots on fingers, redness, finger tips painful, red bumps at injection site on stomach and swelling was not reported. This report was serious (Other Medically Important Condition). This report is associated with a product quality complaint.; Sender's Comments: V0: 20211120809- Covid-19 vaccine ad26.cov2.s- Psoriatic arthritis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211120809-Covid-19 vaccine ad26.cov2.s- Wearing off effect. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 40 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine  was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132362, 20211132383 and 20211132415.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-NOV-2021, the patient was tested positive for COVID-19 antigen test at home (suspected covid 19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and the reference number has been requested.; Sender's Comments: V0: 20211128784 -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-NOV-2021, the patient became ill first (covid-19 infection). On 11-NOV-2021, the patient tested positive for Covid (confirmed clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient experienced side effects for several weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection, confirmed clinical vaccination failure and side effects for several weeks was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority number: 90000202098.; Sender's Comments: V0; 20211130145-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SEVERE COVID-19 POST VACCINATION; SIDE EFFECTS AFTER RECEIVING THE VACCINE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1803982 expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient had experienced several side effects after receiving the vaccine. On 27-OCT-2021, the patient experienced severe covid-19 post vaccination and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, severe covid-19 post vaccination and side effects after receiving the vaccine was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint: 90000202088.; Sender's Comments: V0- 20211130147-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Immobile
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned an adult female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was had all the mobility before getting the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, frequency 1 total, start therapy date were not reported administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, It was reported that the patient after being vaccinated lost all of her mobility that put her in the ICU unit (intensive care unit)(Hospitalized) (dates unspecified) for unspecified days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss all mobility was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211130149-covid-19 vaccine ad26.cov2.s- loss all mobility. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy
Clinical narrative: LINGERING HIP PROBLEM; LINGERING HIP PAIN; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced lingering hip problem, and lingering hip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lingering hip pain, and lingering hip problem. This report was non-serious.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 39 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132362, 20211132383 and 20211121650.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Fatigue, Headache, Nasal dryness, Oropharyngeal pain
Clinical narrative: DRY THROAT; DRY NASAL PASSAGES; SORE THROAT; SEVERE HEADACHE ALL OVER HEAD; SEVERE SINUS CONGESTION; BODY ACHEYNESS; ARM FELT LIKE GOT HIT WITH BASEBALL BAT/MUSCLE SORENESS; FATIGUE FOR 1 DAY/FATIGUE; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 252 pounds, and height was 73 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies/had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820096 expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced fatigue for 1 day/fatigue. On 16-JUL-2021, the patient experienced arm felt like got hit with baseball bat/muscle soreness. On 14-NOV-2021, the patient experienced severe sinus congestion. On 14-NOV-2021, the patient experienced body acheyness. On 14-NOV-2021, the patient experienced severe headache all over head. On 15-NOV-2021, the patient experienced dry throat. On 15-NOV-2021, the patient experienced dry nasal passages. On 15-NOV-2021, the patient experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt like got hit with baseball bat/muscle soreness on 18-JUL-2021, had not recovered from severe sinus congestion, severe headache all over head, body acheyness, dry throat, dry nasal passages, and sore throat, and the outcome of fatigue for 1 day/fatigue was not reported. This report was non-serious.