chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory
Clinical narrative: sensorineural hearing loss left ear; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inner ear disorder (Prior oto history was stable).    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 DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) to be possibly related.    No concomitant medication was reported. Treatment information was not reported.  This study includes 18 patients with post-vaccination otologic symptoms.  Most of our patients are still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. Our pre-treatment audiograms, with the PTA and WRS recorded, have given us a good baseline with which to document any treatment effect, as well as review outcome versus specific treatment given, to be reported in the future. The extent of hearing recovery and/or symptom resolution was currently unknown.  Company Comment: A 77-year-old female, with concurrent inner ear disorder, presented with a serious unexpected event of sensorineural hearing loss. Event latency 30 days after second dose. Event outcome not reported. Rechallenge not applicable. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with current knowledge of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: A 77-year-old female, with concurrent inner ear disorder, presented with a serious unexpected event of sensorineural hearing loss. Event latency 30 days after second dose. Event outcome not reported. Rechallenge not applicable. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with current knowledge of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness, Tinnitus
Clinical narrative: Hearing loss in left ear; Dizziness; Tinnitus; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in left ear) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Otologic manifestations after COVID-19 vaccination: ear clinic experience. 2021;42(9):e1213-8     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Hearing loss in left ear) (seriousness criterion medically significant), DIZZINESS (Dizziness) and TINNITUS (Tinnitus). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in left ear), DIZZINESS (Dizziness) and TINNITUS (Tinnitus) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in left ear), DIZZINESS (Dizziness) and TINNITUS (Tinnitus) to be possibly related.    No concomitant information were reported. This study includes identifying 30 patients with post-vaccination otologic symptoms. In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in left ear. The days to onset of symptoms was set as between 7 days. Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear. Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown.  Company Comment: This case concerns a 67 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown after the second dose of the Moderna Covid 19 vaccine on unknown date.  Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns a 67 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown after the second dose of the Moderna Covid 19 vaccine on unknown date.  Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness, Vertigo
Clinical narrative: Hearing loss in righ ear; Vertigo; Dizziness; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in righ ear) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Hearing loss in righ ear) (seriousness criterion medically significant), VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in righ ear), VERTIGO (Vertigo) and DIZZINESS (Dizziness) 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 considered DEAFNESS UNILATERAL (Hearing loss in righ ear), VERTIGO (Vertigo) and DIZZINESS (Dizziness) to be possibly related.    Concomitant medications were not provided.   This study includes identifying 18 patients with post-vaccination otologic symptoms. In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in right ear.  Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear.  Company Comment: This case concerns a 59 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown date after receiving the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns a 59 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown date after receiving the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss in right ear; This literature-study case describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in right ear) in a 51-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Hearing loss in right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in right ear) 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 DEAFNESS UNILATERAL (Hearing loss in right ear) to be possibly related.    No concomitant information were reported.  In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in right ear. The days to onset of symptoms was set as between 21 days. Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear. Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown.  Company Comment: This case concerns a 51 year old female with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown  date after the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns a 51 year old female with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown  date after the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired second dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired second dose of the Moderna vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired second dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired second dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F). On 23-Sep-2021, PRODUCT STORAGE ERROR (Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Reporter called to check on a temperature excursion. Refrigerator was cooling a little bit more than normal. Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F. Minimum temperature was 34.7°F. There were 145 incidents in total and each one lasted less than 15 minutes: 142 times fridge temperatures were between 35°F and 36°F; while 3 times temperatures were under 35°F, reaching 34.7°F (minimum).    Patient had experienced a temperature excursion.  No Treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  A part-time Pharmacist called 30SEP2021 to report that expired doses of the Moderna vaccine was administered to 25 patients. The vials were in refrigerator for over 30 days.  Number of doses/vials - 27SEP2021 1 vials of 14 doses, 29SEP2021, 1 vial, 11 doses Date the vial was initially stored in the refrigerator: 24AUG2021 Date(s) of administration of vaccine, 27SEP2021 and 29SEP2021   This case was linked to MOD-2021-338604 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Palpitations, Thermal burn
Clinical narrative: rapid heart beat; headache; left shoulder burned; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heart beat), HEADACHE (headache) and THERMAL BURN (left shoulder burned) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (rapid heart beat), HEADACHE (headache) and THERMAL BURN (left shoulder burned). At the time of the report, PALPITATIONS (rapid heart beat), HEADACHE (headache) and THERMAL BURN (left shoulder burned) outcome was unknown.            Patient received first dose of the vaccine on 12Feb2021. After first dose patient had a headache and left shoulder burned. Patient received second dose on 12Mar2021. Patient had same side effects after the second dose. Patient received booster dose on 23Aug2021. Patient experienced same side effects on third dose and rapid heart beat   This case was linked to MOD-2021-338406, MOD-2021-338314 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: felt a bit tired the next day; she had a little bit of soreness at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had a little bit of soreness at the area of the injection) and FATIGUE (felt a bit tired the next day) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M201A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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. In March 2021, the patient experienced VACCINATION SITE PAIN (she had a little bit of soreness at the area of the injection). On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt a bit tired the next day). At the time of the report, VACCINATION SITE PAIN (she had a little bit of soreness at the area of the injection) and FATIGUE (felt a bit tired the next day) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .     This case was linked to MOD-2021-338431 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Johnson and Johnson vaccine then I got the moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine then I got the moderna vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included HIV positive (takes antivirals).    In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine then I got the moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine then I got the moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received Johnson and Johnson vaccine in March 2021. He was supposed to return for a second dose of the Moderna vaccine on 21 Sep 2021, but was declined that dose by the pharmacist.  Concomitant medications included antivirals for HIV.   No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema
Clinical narrative: red arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C71A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (high blood pressure) and High cholesterol (high cholesterol). Concomitant products included ATORVASTATIN and AMLODIPINE for an unknown indication.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm) and CHILLS (chills). At the time of the report, VACCINATION SITE ERYTHEMA (red arm) outcome was unknown and CHILLS (chills) had resolved.            No treatment medication was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Back pain; Pain got worst to the rest of the arm; (Pain) to the rest of the body/Mild localized pain/at night got horrible pain/got spots of pain during the night that woke the patient up; Fever- 99F; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain got worst to the rest of the arm), MYALGIA ((Pain) to the rest of the body/Mild localized pain/at night got horrible pain/got spots of pain during the night that woke the patient up) and PYREXIA (Fever- 99F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 016M20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis (Degenerative spinal stenosis). Concomitant products included LORAZEPAM for Insomnia, ROSUVASTATIN and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain got worst to the rest of the arm), MYALGIA ((Pain) to the rest of the body/Mild localized pain/at night got horrible pain/got spots of pain during the night that woke the patient up) and PYREXIA (Fever- 99F). At the time of the report, BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain got worst to the rest of the arm) and MYALGIA ((Pain) to the rest of the body/Mild localized pain/at night got horrible pain/got spots of pain during the night that woke the patient up) was resolving and PYREXIA (Fever- 99F) outcome was unknown.            No Treatment medications were reported.   This case was linked to MOD-2021-338672 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Anxiety, Autism spectrum disorder, Dizziness
Clinical narrative: Autism; Dizzy spells at night; A bit anxious; This spontaneous case was reported by a consumer and describes the occurrence of AUTISM SPECTRUM DISORDER (Autism) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TREPROSTINIL tablet, extended release for Primary pulmonary hypertension and TREPROSTINIL DIOLAMIN (ORENITRAM) tablet, extended release for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included AMBRISENTAN for an unknown indication.   On 19-Nov-2014, the patient started TREPROSTINIL (Oral) UNK mg. In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 5 mg. In 2021, the patient experienced AUTISM SPECTRUM DISORDER (Autism) (seriousness criterion medically significant), DIZZINESS (Dizzy spells at night) and ANXIETY (A bit anxious). At the time of the report, AUTISM SPECTRUM DISORDER (Autism), DIZZINESS (Dizzy spells at night) and ANXIETY (A bit anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication has been reported.  Company Comment: This case concerns a 28-year-old male patient with medical history of pulmonary arterial hypertension. And on concomitant treatment Ambrisentan and Treprostinil who experienced an unexpected event of Autism. The event occurred after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) administration. The rechallenge was unknown as details about the specific dose administered was not provided. Causality for the reported evens were not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Event is assessed as medically significant per Regulatory Authority reporting. Autism spectrum disorder is an important medical event.   Reporter did not allow further contact; Sender's Comments: This case concerns a 28-year-old male patient with medical history of pulmonary arterial hypertension. And on concomitant treatment Ambrisentan and Treprostinil who experienced an unexpected event of Autism. The event occurred after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) administration. The rechallenge was unknown as details about the specific dose administered was not provided. Causality for the reported evens were not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Event is assessed as medically significant per Regulatory Authority reporting. Autism spectrum disorder is an important medical event.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer and then the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer and then the Moderna) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043D21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 Vaccine (She receive the Pfizer vaccine on 26APR2021 (lot number EX0438)) on 26-Apr-2021.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer and then the Moderna). On 30-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer and then the Moderna) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that patient received the Pfizer vaccine on 26APR2021 (lot number EX0438) and then the Moderna vaccine on 23JUN2021 (lot number 043D21A). They received these vaccines from a health authority, but recently moved. They wanted to travel, and do not want to be "grounded" due to their vaccination status. She has not experienced any symptoms or received any treatments since receiving the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: swelling underneath arm; Could not lift arm; Fever; Chills; Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Shortness of breath in march2021 due to covid also tightness of chest and trouble breathing).   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.) and HEADACHE (Headache) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported. Treatment information was not provided.   This case was linked to MOD-2021-338784 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant follow up (Additional event)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: swelling underneath arm; Could not lift arm; Fever; Chills; Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Shortness of breath in march2021 due to covid also tightness of chest and trouble breathing).   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.) and HEADACHE (Headache) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported. Treatment information was not provided.   This case was linked to MOD-2021-338784 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant follow up (Additional event)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine that had experienced a temperature excursion was given as 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine that had experienced a temperature excursion was given as 2nd dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine that had experienced a temperature excursion was given as 2nd dose). On 23-Sep-2021, PRODUCT STORAGE ERROR (Vaccine that had experienced a temperature excursion was given as 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Influenza, Vaccination site pain
Clinical narrative: a little pain in his left arm where he got both shots; flu; sick on his stomach; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), ABDOMINAL DISCOMFORT (sick on his stomach) and VACCINATION SITE PAIN (a little pain in his left arm where he got both shots) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery in January 2020.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA (flu) and ABDOMINAL DISCOMFORT (sick on his stomach). On an unknown date, the patient experienced VACCINATION SITE PAIN (a little pain in his left arm where he got both shots). At the time of the report, INFLUENZA (flu), ABDOMINAL DISCOMFORT (sick on his stomach) and VACCINATION SITE PAIN (a little pain in his left arm where he got both shots) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to moderna (Over 35 days from 1st dose); This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Reaction to moderna (Over 35 days from 1st dose)) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (Reaction to moderna (Over 35 days from 1st dose)). At the time of the report, VACCINATION COMPLICATION (Reaction to moderna (Over 35 days from 1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication is reported No treatement of maedication is reported The caller's 20 year old son received his 1st shot  in Feb 2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Approximately 10 patients received the expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Approximately 10 patients received the expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Approximately 10 patients received the expired vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Approximately 10 patients received the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported stated that 1 vial that was frozen was received from another provider.   The vaccine had a written expiration date of 28-Sep-2021. The vaccine expiration date was later confirmed as 14-Sep-2021.   No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Peripheral swelling
Clinical narrative: I can't move my hand; it swelled a lot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I can't move my hand) and PERIPHERAL SWELLING (it swelled a lot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (I can't move my hand) and PERIPHERAL SWELLING (it swelled a lot). At the time of the report, HYPOKINESIA (I can't move my hand) and PERIPHERAL SWELLING (it swelled a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: Chest pain; Left arm pain; Tingling and sore in the injection site; sore in the injection site; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Left arm pain), PARAESTHESIA (Tingling and sore in the injection site), VACCINATION SITE PAIN (sore in the injection site) and MYALGIA (Muscle pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Left arm pain), PARAESTHESIA (Tingling and sore in the injection site), VACCINATION SITE PAIN (sore in the injection site) and MYALGIA (Muscle pain). At the time of the report, CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Left arm pain), PARAESTHESIA (Tingling and sore in the injection site), VACCINATION SITE PAIN (sore in the injection site) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided. No treatment information was provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Crying, Dysgeusia, Pain
Clinical narrative: crying and scare; sharp body pains in her body; that food is tasting like ashes / has a  nasty taste in her mouth; chills; symptoms are getting worst with time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sharp body pains in her body), DYSGEUSIA (that food is tasting like ashes / has a  nasty taste in her mouth), CHILLS (chills), CONDITION AGGRAVATED (symptoms are getting worst with time) and CRYING (crying and scare) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039d21a and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN (sharp body pains in her body), DYSGEUSIA (that food is tasting like ashes / has a  nasty taste in her mouth), CHILLS (chills) and CONDITION AGGRAVATED (symptoms are getting worst with time). On an unknown date, the patient experienced CRYING (crying and scare). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (sharp body pains in her body), DYSGEUSIA (that food is tasting like ashes / has a  nasty taste in her mouth), CHILLS (chills), CONDITION AGGRAVATED (symptoms are getting worst with time) and CRYING (crying and scare) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   This case was linked to MOD-2021-339129 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Ovarian mass, Paraesthesia, Stress
Clinical narrative: Tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body; Numbness in her feet/tingling and numbness in her that rotates around her body; Tingling and numbness in her hands; Removal of benign ovarian mass; Stress worsens symptoms of numbness and tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (Numbness in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (Tingling and numbness in her hands), OVARIAN MASS (Removal of benign ovarian mass) and STRESS (Stress worsens symptoms of numbness and tingling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Ovarian mass (Patient had emergency surgery for an ovarian mass that was removed). Concurrent medical conditions included Chronic kidney disease stage 3 and Congestive heart failure (Pericardial episode).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 PARAESTHESIA (Tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (Numbness in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (Tingling and numbness in her hands), OVARIAN MASS (Removal of benign ovarian mass) and STRESS (Stress worsens symptoms of numbness and tingling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and Surgery for Ovarian mass. At the time of the report, PARAESTHESIA (Tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (Numbness in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (Tingling and numbness in her hands), OVARIAN MASS (Removal of benign ovarian mass) and STRESS (Stress worsens symptoms of numbness and tingling) outcome was unknown.            Concomitant medication was not provided.  Treatment information include patient plains to see a neurologist, ER, emergency surgery.   This case was linked to MOD-2021-339149 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pfizer COVID-19 shot administered for the second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID-19 shot administered for the second dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID-19 shot administered for the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID-19 shot administered for the second dose) 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.