chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasal congestion, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Got Covid; getting sick but test was negative; she is still kind of congested from Covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Got Covid), ILLNESS (getting sick but test was negative) and NASAL CONGESTION (she is still kind of congested from Covid) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L213) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (cephalexin), Allergy to antibiotic (clindamycin) and Sulfonamide allergy (sulfa drugs).    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Got Covid), ILLNESS (getting sick but test was negative) and NASAL CONGESTION (she is still kind of congested from Covid). At the time of the report, SUSPECTED COVID-19 (Got Covid), ILLNESS (getting sick but test was negative) and NASAL CONGESTION (she is still kind of congested from Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller did not test positive for Covid diagnosis but her boyfriend did and she was getting sick but her test was negative last week when she got tested. Caller says she was pretty sure that she got it.   It was reported that patient received a cervical cancer vaccine in junior high12 years ago.  No treatment drug were reported.   No concomitant medication were reported.  Company comment:This spontaneous case concerns an adult female patient, with no relevant medical history, who experienced the non-serious, unexpected AESI event of suspected COVID-19, and non-serious, unexpected events of illness and nasal congestion. Events occurred on unknown date after she received her first dose of mRNA 1273 COVID-19 Vaccine. Patient felt sick and was congested. She suspected she had COVID-19 infection due to exposure to a COVID-19 positive patient however her SARS-COV-2 test was negative. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient, with no relevant medical history, who experienced the non-serious, unexpected AESI event of suspected COVID-19, and non-serious, unexpected events of illness and nasal congestion. Events occurred on unknown date after she received her first dose of mRNA 1273 COVID-19 Vaccine. Patient felt sick and was congested. She suspected she had COVID-19 infection due to exposure to a COVID-19 positive patient however her SARS-COV-2 test was negative. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fibromyalgia, Sleep disorder
Clinical narrative: SHE HAD A LIGHT-MILD FIBROMYLAGIA, LITTLE FLARE; SLEEPING DISORDER WAS light,controable with medicine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FIBROMYALGIA (SHE HAD A LIGHT-MILD FIBROMYALGIA, LITTLE FLARE) and SLEEP DISORDER (SLEEPING DISORDER WAS light,controllable with medicine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 10:15 AM, 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 FIBROMYALGIA (SHE HAD A LIGHT-MILD FIBROMYALGIA, LITTLE FLARE) and SLEEP DISORDER (SLEEPING DISORDER WAS light,controllable with medicine). At the time of the report, FIBROMYALGIA (SHE HAD A LIGHT-MILD FIBROMYALGIA, LITTLE FLARE) and SLEEP DISORDER (SLEEPING DISORDER WAS light,controllable with medicine) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The patient had Heart Arrhythmia after the 2nd dose of Moderna Covid Vaccine. When reporter met patient's family, they informed his health issue to him. Currently, He had made regular consultation/ checkup with his primary doctor and he was doing a healthy diet and workout regularly. No Concomitant medications were reported.  Company comment: This is a spontaneous case concerning a 45-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of fibromyalgia and unexpected non serious event of sleep disorder. The events occurred after the first dose of mRNA1273 vaccine. At the time of this report the outcome for fibromyalgia and sleep disorder was reported as unknown. The patient had Heart Arrhythmia after the 2nd dose of Moderna Covid Vaccine, the event was ongoing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-459811 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a 45-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of fibromyalgia and unexpected non serious event of sleep disorder. The events occurred after the first dose of mRNA-1273 vaccine. At the time of this report the outcome for fibromyalgia and sleep disorder was reported as unknown. The patient had Heart Arrhythmia after the 2nd dose of Moderna Covid Vaccine, the event was ongoing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-459811:Email case : FW: Follow up Request Moderna COVID-19 vaccine: MOD-2022-459811 - Dose 2
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Menopaused and got period; This spontaneous case was reported by an other health care professional and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Menopaused and got period) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Menopause.    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 POSTMENOPAUSAL HAEMORRHAGE (Menopaused and got period). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Menopaused and got period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 7-decade-old female patient, with relevant medical history of Menopause, who experienced the unexpected event of Postmenopausal haemorrhage. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case is downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint.   This case was linked to MOD-2022-485039 (Patient Link).; Sender's Comments: This spontaneous case concerns a 7-decade-old female patient, with relevant medical history of Menopause, who experienced the unexpected event of Postmenopausal haemorrhage. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case is downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: 3rd dose for an immunocompromised patient administered as a booster shot (half of a dose); 3rd dose for an immunocompromised patient administered out of schedule, approximately 4 to 6; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3rd dose for an immunocompromised patient administered as a booster shot (half of a dose)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose for an immunocompromised patient administered out of schedule, approximately 4 to 6) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0000000) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ACCIDENTAL UNDERDOSE (3rd dose for an immunocompromised patient administered as a booster shot (half of a dose)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose for an immunocompromised patient administered out of schedule, approximately 4 to 6). At the time of the report, ACCIDENTAL UNDERDOSE (3rd dose for an immunocompromised patient administered as a booster shot (half of a dose)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose for an immunocompromised patient administered out of schedule, approximately 4 to 6) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M208 and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021) outcome was unknown.            Concomitant medication was not provided. Treatment medication was not provided.   This case was linked to MOD-2022-486653 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired on 12-Feb-2022 and a dose was given on 14-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired on 12-Feb-2022 and a dose was given on 14-Feb-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired on 12-Feb-2022 and a dose was given on 14-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired on 12-Feb-2022 and a dose was given on 14-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. The Moderna had been in the refrigerator for ten days and there had been no temp excursions.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Arthralgia, Dizziness, Inappropriate schedule of product administration, Lethargy
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2021, Asthma (Start Date reported as  very early on in life, exact date unknown.), Allergy (multiple drug and food allergies, tons  of allergies), Allergy to antibiotic (cephalexin), Allergy to antibiotic (Ceclor), Allergy to antibiotic (Keflex), Fruit allergy (watermelon), Vegetable allergy (melons), Fruit allergy (gourds), Vegetable allergy (cucumbers), Fruit allergy (squash), Fruit allergy (pumpkin), Vegetable allergy (cantaloupe), Vegetable allergy (zucchini) and Food allergy (pickles). Concomitant products included LEVOTHYROXINE, ESCITALOPRAM, ALPRAZOLAM, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In January 2022, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 antibody test: positive (Positive) Positive for COVID-19,  exact dates unknown..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Patient reported that the reason why she waited so long between her first and second Moderna dose was because she was diagnosed with COVID-19 infection in January 2022.  No treatment medication was reported.  Company Comment: This is a Spontaneous case concerning a 34-year-old female patient, with no relevant medical history, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred approximately 1 month  after the first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-487069 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 34-year-old female patient, with no relevant medical history, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred approximately 1 month  after the first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Ocular hyperaemia, Periorbital swelling, Pruritus, Skin burning sensation
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2021, Asthma (Start Date reported as  very early on in life, exact date unknown.), Allergy (multiple drug and food allergies, tons  of allergies), Allergy to antibiotic (cephalexin), Allergy to antibiotic (Ceclor), Allergy to antibiotic (Keflex), Fruit allergy (watermelon), Vegetable allergy (melons), Fruit allergy (gourds), Vegetable allergy (cucumbers), Fruit allergy (squash), Fruit allergy (pumpkin), Vegetable allergy (cantaloupe), Vegetable allergy (zucchini) and Food allergy (pickles). Concomitant products included LEVOTHYROXINE, ESCITALOPRAM, ALPRAZOLAM, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In January 2022, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 antibody test: positive (Positive) Positive for COVID-19,  exact dates unknown..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Patient reported that the reason why she waited so long between her first and second Moderna dose was because she was diagnosed with COVID-19 infection in January 2022.  No treatment medication was reported.  Company Comment: This is a Spontaneous case concerning a 34-year-old female patient, with no relevant medical history, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred approximately 1 month  after the first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-487069 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 34-year-old female patient, with no relevant medical history, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred approximately 1 month  after the first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2021, Asthma (Start Date reported as  very early on in life, exact date unknown.), Allergy (multiple drug and food allergies, tons  of allergies), Allergy to antibiotic (cephalexin), Allergy to antibiotic (Ceclor), Allergy to antibiotic (Keflex), Fruit allergy (watermelon), Vegetable allergy (melons), Fruit allergy (gourds), Vegetable allergy (cucumbers), Fruit allergy (squash), Fruit allergy (pumpkin), Vegetable allergy (cantaloupe), Vegetable allergy (zucchini) and Food allergy (pickles). Concomitant products included LEVOTHYROXINE, ESCITALOPRAM, ALPRAZOLAM, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In January 2022, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 antibody test: positive (Positive) Positive for COVID-19,  exact dates unknown..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Patient reported that the reason why she waited so long between her first and second Moderna dose was because she was diagnosed with COVID-19 infection in January 2022.  No treatment medication was reported.  Company Comment: This is a Spontaneous case concerning a 34-year-old female patient, with no relevant medical history, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred approximately 1 month  after the first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-487069 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 34-year-old female patient, with no relevant medical history, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred approximately 1 month  after the first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient did not receive a third full dose of the Moderna Covid-19 vaccine as part of their vaccination schedule; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient did not receive a third full dose of the Moderna Covid-19 vaccine as part of their vaccination schedule) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ACCIDENTAL UNDERDOSE (Patient did not receive a third full dose of the Moderna Covid-19 vaccine as part of their vaccination schedule). At the time of the report, ACCIDENTAL UNDERDOSE (Patient did not receive a third full dose of the Moderna Covid-19 vaccine as part of their vaccination schedule) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No Treatment medications were reported
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Sleep deficit
Clinical narrative: insomnia; rapid heart beat; Sleep deprivation; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (Sleep deprivation), INSOMNIA (insomnia) and HEART RATE INCREASED (rapid heart beat) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced SLEEP DEFICIT (Sleep deprivation) and HEART RATE INCREASED (rapid heart beat). On an unknown date, the patient experienced INSOMNIA (insomnia). In August 2021, HEART RATE INCREASED (rapid heart beat) had resolved. At the time of the report, SLEEP DEFICIT (Sleep deprivation) and INSOMNIA (insomnia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient have done some bloodwork and HCP has not found anything in particular Caller confirmed he did have insomnia prior to getting his Moderna vaccine however it has gotten worse after getting shot. No concomitant medications was reported. Treatment medications was not provided
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: hives/urticaria; dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/urticaria) and MECHANICAL URTICARIA (dermatographia) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B and 025A21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MECHANICAL URTICARIA (dermatographia). On 18-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives/urticaria). At the time of the report, URTICARIA (hives/urticaria) and MECHANICAL URTICARIA (dermatographia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that patient had no previous history of allergies and did not had covid-19 infection in the past. After booster dose, on 18 Jan 2022, patient woke up in hives. Treatment medication included as Antihistamines.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin
Clinical narrative: Dry Skin Patches; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry Skin Patches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, COVID-19 and Foot drop.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (Dry Skin Patches). At the time of the report, DRY SKIN (Dry Skin Patches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's past medical history included Balance and Foot drop. On 28-DEC-2020, patient started therapy with Moderna Covid-19 Vaccine for unknown indication.  No concomitant medication were provided. No treatment details were provided.
Sex: F
Vaccine: FLUX
Symptoms: Neoplasm malignant
Clinical narrative: cancer sprang up on her hands shortly thereafter; Initial information received on 13-Feb-2022 regarding an unsolicited valid  serious case received from a consumer via social media.   This case involves a 97 years old female patient who experienced cancer sprang up on her hands shortly thereafter while receiving vaccine Influenza Vaccine   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Vaccine (formulation, strength, dose, route, batch number and expiry date) in unknown administered site for immunization.  On an unknown date the patient developed a serious cancer sprang up on her hands shortly thereafter (neoplasm malignant) (unknown latency) following the administration of Influenza Vaccine.   Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (cancer sprang up on her hands shortly thereafter).  At time of reporting, the outcome was Unknown for the event cancer sprang up on her hands shortly thereafter.  seriousness- medically significant; Sender's Comments: Sanofi Company Comment dated 16-FEB-2022: This case involves a 97 years old female patient who had cancer sprang up on her hands shortly thereafter, after she was treated with ranitidine hydrochloride [Zantac]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, therapy details, any family history of cancer and any relevant medical history of patient, any concurrent conditions and type of cancer and indication of the drug precludes comprehensive case assessment.
Age: 0.83
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: two patients received MENQUADFI after the temperature excursion occurred; Initial information received on 08-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old male patient who experienced two patients received menquadfi after the temperature excursion occurred while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL).  On 02-Feb-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE  with the dose of 0.5ml with lot U6824AA via intramuscular route in unknown administration site.  On 02-FEB-2022 the patient received menquadfi after the temperature excursion occurred (product temperature excursion issue) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (two patients received MENQUADFI after the temperature excursion occurred).  At time of reporting, the outcome was Unknown for the event two patients received menquadfi after the temperature excursion occurred.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: reconstituted with sterile water with no reported adverse event; Initial information was received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who reported reconstitution of vaccine HIB (PRP/T) Vaccine [ACT-HIB] with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles, mumps and rubella vaccine (live) (MMR vaccine) as prophylactic vaccination.  On 20-Jan-2022, the patient received a dose of suspect HIB (PRP/T) Vaccine (formulation: Powder and solvent for solution for injection, dose: 0.5 ml, 4th dose, lot: UJ589AA, Expiration date: 25Oct2022) (frequency,strength: unknown) via intramuscular route in the right thigh as prophylactic vaccination  On 20-JAN-2022 the patient reported reconstitution with sterile water with no reported adverse event (product preparation error) (latency: same day) of HIB (PRP/T) Vaccine.  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event reconstituted with sterile water with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: I got 2 doses for Pfizer vaccine, then 6 months later, got Moderna as booster.  I had reactions to all the doses. With the second dose, I already was experiencing more severe cramps during my period. Then on  day 1 of my first  period after the booster shot,  (around 11pm) I got urticaria all over my body, focused on palms, neck, inner legs and abdominal. I took antihistamine pill I had, and got better. I thought it was related to what I ate. Then, today, on day 1 of my second period cycle, I am getting the exact reaction. Around 11:30 PM, My palms started itching, then my face, ears, head, neck and body. Rashes showed up. No one told me about this type of side effect, but the Booster shot is the only thing that changed between December. I have never had these hives during my period before. This should be studied.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test negative, Blood test normal, Dermatitis, Rash, Rosacea
Clinical narrative: Shortly after the second dose of the vaccine, a rash appeared on the sunburns of my face. It gradually continued to the checks, nose, forehead, eyebrows, and edges of the ears. I was treated with 2.5% Hydrocortisone cream with no improvement. I am currently treated with 1% ivermectin cream. I saw 4 dermatologists. The prognosis: Dermatitis and Rosacea. I did a total blood test + Allergy test. Today, 10 months later despite using several medications, the rash still covers most of my face and edges of the ears and forehead.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Sunburn
Clinical narrative: Shortly after the second dose of the vaccine, a rash appeared on the sunburns of my face. It gradually continued to the checks, nose, forehead, eyebrows, and edges of the ears. I was treated with 2.5% Hydrocortisone cream with no improvement. I am currently treated with 1% ivermectin cream. I saw 4 dermatologists. The prognosis: Dermatitis and Rosacea. I did a total blood test + Allergy test. Today, 10 months later despite using several medications, the rash still covers most of my face and edges of the ears and forehead.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Very red and swollen area at injection site.  And then significant swelling and pain in lymph node in arm pit area.  Did not have this same reaction with the first two vaccine shots. Only the 3rd booster.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever of 100.4, headache, chills, muscle aches
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt  is only 14 years old and was given booster of Moderna Vaccine which requires 18yrs and above for booster . No sypmtoms,signs of any adverse reaction noted.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Immediate post-injection reaction, Incorrect route of product administration, Injection site pain
Clinical narrative: Shot was incorrectly adminiistered- possibly into shoulder cartilage-immediately extremely painful- patient reported feeling a "crunch", then feeling partial withdrawal of the needle, then rapid injection which caused more pain. As of today Jan 26, patient reports pain in armpit ,downward to ribs, had pain at the back of the shoulder yesterday Jan 25. This was a booster-first two shots did not result in any pain except the usual sore arm a day or so later.This pain is in unusual locations and concerning because of the "crunch" .Patient is planning on a doctor visit/checkup to determine if there is any permanent damage to his shoulder. Also doctor made the excuse like insult on patient. Unreadable signature.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: Shot was incorrectly adminiistered- possibly into shoulder cartilage-immediately extremely painful- patient reported feeling a "crunch", then feeling partial withdrawal of the needle, then rapid injection which caused more pain. As of today Jan 26, patient reports pain in armpit ,downward to ribs, had pain at the back of the shoulder yesterday Jan 25. This was a booster-first two shots did not result in any pain except the usual sore arm a day or so later.This pain is in unusual locations and concerning because of the "crunch" .Patient is planning on a doctor visit/checkup to determine if there is any permanent damage to his shoulder. Also doctor made the excuse like insult on patient. Unreadable signature.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood immunoglobulin G, Blood test, C-reactive protein increased, Headache
Clinical narrative: Acute hip joint pain began on date noted, 3+ weeks after vaccine, gradually appearing in multiple joints, especially shoulders and wrists, accompanied by slight fever, headaches, vertigo. Initially diagnosed as polymyalgia rheumatica with possible giant cell arteritis, but soon mostly ruled out due to limited response to high dose prednisone, which lessened the symptoms  a little.  Extensive testing has since failed to pinpoint the cause. A neighbor in my small, close-knit community developed almost identical symptoms starting the day after he received his 3rd vaccine dose. His doctors have also failed to pinpoint the cause.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Polymyalgia rheumatica, Pyrexia, Red blood cell sedimentation rate increased, Scan
Clinical narrative: Acute hip joint pain began on date noted, 3+ weeks after vaccine, gradually appearing in multiple joints, especially shoulders and wrists, accompanied by slight fever, headaches, vertigo. Initially diagnosed as polymyalgia rheumatica with possible giant cell arteritis, but soon mostly ruled out due to limited response to high dose prednisone, which lessened the symptoms  a little.  Extensive testing has since failed to pinpoint the cause. A neighbor in my small, close-knit community developed almost identical symptoms starting the day after he received his 3rd vaccine dose. His doctors have also failed to pinpoint the cause.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Acute hip joint pain began on date noted, 3+ weeks after vaccine, gradually appearing in multiple joints, especially shoulders and wrists, accompanied by slight fever, headaches, vertigo. Initially diagnosed as polymyalgia rheumatica with possible giant cell arteritis, but soon mostly ruled out due to limited response to high dose prednisone, which lessened the symptoms  a little.  Extensive testing has since failed to pinpoint the cause. A neighbor in my small, close-knit community developed almost identical symptoms starting the day after he received his 3rd vaccine dose. His doctors have also failed to pinpoint the cause.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus
Age: 1.17
Sex: M
Vaccine: ADEN_4_7
Symptoms: Unevaluable event
Clinical narrative: no
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol Inpatient
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after vaccination. Patient was diagnosed with COVID Remdesivir Inpatient
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with COVID Remdesivir Discharged home
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itchy ever since; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced itchy ever since. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose of Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that an expired dose of Twinrix was administered to the patient, which led to expired vaccine used. The reporter was unable to provide date of administration, further reported that the vaccine expired last week. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Haemorrhage, Hot flush, Laziness, Malaise
Clinical narrative: This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non-smoker, and other pre-existing medical conditions included: Patient did not have any known allergies. Patient did not had any drug abuse or illicit drug usage. Patient had no medical history. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total, administered at left arm on 12-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for prophylactic. In the beginning around the first week of AUG-2021, the patient started experiencing side effects such as bleeding/spotting, hot flashes, felt moody, felt lazy, weight gain, and not feeling well (Dose number in series 1). On 24-AUG-2021, gynecologist did some laboratory tests included: Blood test (NR: not provided) not reported, and Diagnostic ultrasound (NR: not provided) not reported. The patient took Tylenol prior to receiving vaccine and continued for 2 days. The patient had no side-effects initially after first dose until the menopause symptoms appeared. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, 1 total, administered at left arm on 22-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with dose of Covid-19 vaccine ad26. cov2.s. (Dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not feeling well, and had not recovered from bleeding/spotting, hot flashes, felt moody, felt lazy, and weight gain. This report was serious (Other Medically Important Condition). It has been determined that this case is a master case 20220240146. This case 20220240216 will be deleted. All relevant information regarding this case will be submitted under 20220240146. Sender's Comments: V0: 20220240146-Covid-19 vaccine ad26.cov2.s-Bleeding/spotting. 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). Therefore, this event(s) is considered unassessable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Mood swings, Ultrasound scan, Weight increased
Clinical narrative: This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non-smoker, and other pre-existing medical conditions included: Patient did not have any known allergies. Patient did not had any drug abuse or illicit drug usage. Patient had no medical history. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total, administered at left arm on 12-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for prophylactic. In the beginning around the first week of AUG-2021, the patient started experiencing side effects such as bleeding/spotting, hot flashes, felt moody, felt lazy, weight gain, and not feeling well (Dose number in series 1). On 24-AUG-2021, gynecologist did some laboratory tests included: Blood test (NR: not provided) not reported, and Diagnostic ultrasound (NR: not provided) not reported. The patient took Tylenol prior to receiving vaccine and continued for 2 days. The patient had no side-effects initially after first dose until the menopause symptoms appeared. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, 1 total, administered at left arm on 22-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with dose of Covid-19 vaccine ad26. cov2.s. (Dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not feeling well, and had not recovered from bleeding/spotting, hot flashes, felt moody, felt lazy, and weight gain. This report was serious (Other Medically Important Condition). It has been determined that this case is a master case 20220240146. This case 20220240216 will be deleted. All relevant information regarding this case will be submitted under 20220240146. Sender's Comments: V0: 20220240146-Covid-19 vaccine ad26.cov2.s-Bleeding/spotting. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: MULTIPLE TEMPERATURE EXCURSIONS; INCORRECTLY STORED VACCINE ADMINISTERED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. 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: 212A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple temperature excursions, incorrectly stored vaccine administered, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion, out of specification product use and incorrectly stored vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220242461.