chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Illness
Clinical narrative: He got pretty sick; Expired booster dose administered; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (He got pretty sick) and EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced ILLNESS (He got pretty sick) and EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) had resolved. At the time of the report, ILLNESS (He got pretty sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.  A nurse gave an expired booster. Physician would like to now if they should receive a new booster or if it was whether or not good to give another booster shot.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Significant follow up appended ( Patient Demographic updated ,event updated, reporter data updated); Sender's Comments: This is a case of Expired product administered for a patient of an unknown age and gender with no medical history provided. Reportedly, a booster dose of mRNA-1273 vaccine which was administered was actually an expired vaccine. No adverse events were reported. No further information regarding this event was provided at the time of this report. The company causality for the event Expired product administered is not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lip swelling, Swelling face
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of illness (generally sick early afternoon), lip swelling (swollen bottom lip where she previously had fillers) and face swelling (left-side of the face swollen where she previously had fillers) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037521A and 028L20A) for COVID-19 immunization. No medical history reported. On Jan 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient experienced illness  (generally sick early afternoon). On Nov 12, 2021, the patient experienced lip swelling (swollen bottom lip where she previously had fillers) and face swelling (left-side of the face swollen where she previously had fillers). At the time of the report, illness (generally sick early afternoon), lip swelling (swollen bottom lip where she previously had fillers) and face swelling (left-side of the face swollen where she previously had fillers) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-385961 (patient link).
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: horrific headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrific headache) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053621A, 036A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, ATORVASTATIN CALCIUM (LIPITOR), APIXABAN (ELIQUIS) and TRAVOPROST for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (horrific headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at a dose of 625 milligram twice a day. At the time of the report, HEADACHE (horrific headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The headache woke me up on the middle of the night with such intense ache.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Dysstasia, Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of  discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain, arthralgia (gnawing feeling on hip) and chills in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. February 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. March 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. March 2021, patient experienced discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain, arthralgia (gnawing feeling on hip), chills, fatigue (tiredness), nausea and headache. For the adverse events, patient treated with Advil (ibuprofen) at an unspecified dose and frequency; Aleve (naproxen sodium) at an unspecified dose and frequency; and physical therapy for arthralgia. At the time of the report, discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain and arthralgia (gnawing feeling on hip): not resolved; and chills, fatigue (tiredness), nausea and headache: resolved. Most symptoms went away by the following Sunday. Patient visited her doctor in May who ordered X-rays and referred her to a specialist. The specialist ordered 12 sessions of physical therapy, which seemed to help her knees. Patient's hips have continued to feel horrible, and worse on the right-side. Patient has been active the last 14 years without pain, but had pain this year. She has been taking Advil and Aleve for her symptoms.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of  discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain, arthralgia (gnawing feeling on hip) and chills in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. February 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. March 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. March 2021, patient experienced discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain, arthralgia (gnawing feeling on hip), chills, fatigue (tiredness), nausea and headache. For the adverse events, patient treated with Advil (ibuprofen) at an unspecified dose and frequency; Aleve (naproxen sodium) at an unspecified dose and frequency; and physical therapy for arthralgia. At the time of the report, discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain and arthralgia (gnawing feeling on hip): not resolved; and chills, fatigue (tiredness), nausea and headache: resolved. Most symptoms went away by the following Sunday. Patient visited her doctor in May who ordered X-rays and referred her to a specialist. The specialist ordered 12 sessions of physical therapy, which seemed to help her knees. Patient's hips have continued to feel horrible, and worse on the right-side. Patient has been active the last 14 years without pain, but had pain this year. She has been taking Advil and Aleve for her symptoms.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Foot injury (Had an athletic injury on 12-11 years ago (cannot remember whether it was in 2006 or 2007)).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one). In February 2021, INFLUENZA LIKE ILLNESS (After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.  Patient did not had pain at injury site until patient received vaccine. Adverse event lasted for about a week.   This case was linked to MOD-2021-385871, MOD-2021-385889 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Gait disturbance, Headache, Influenza like illness, Limb discomfort
Clinical narrative: could not bend his foot; could barely walk; flu like symptoms; pain on the ball of his left foot; sesamoiditis of the 2 small bones of his left foot/tendonitis; headache; eye strains when looking at the computer; This spontaneous case was reported by a physician and describes the occurrence of METATARSALGIA (pain on the ball of his left foot), TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis), LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and ASTHENOPIA (eye strains when looking at the computer) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Athletic pubalgia (12-11 years ago (2006 or 2007)).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced METATARSALGIA (pain on the ball of his left foot), TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis), LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and INFLUENZA LIKE ILLNESS (flu like symptoms). In November 2021, the patient experienced ASTHENOPIA (eye strains when looking at the computer) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. In November 2021, LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, METATARSALGIA (pain on the ball of his left foot) and TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis) was resolving and ASTHENOPIA (eye strains when looking at the computer) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported   This case was linked to MOD-2021-385888, MOD-2021-385871 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Metatarsalgia, Tendonitis
Clinical narrative: could not bend his foot; could barely walk; flu like symptoms; pain on the ball of his left foot; sesamoiditis of the 2 small bones of his left foot/tendonitis; headache; eye strains when looking at the computer; This spontaneous case was reported by a physician and describes the occurrence of METATARSALGIA (pain on the ball of his left foot), TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis), LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and ASTHENOPIA (eye strains when looking at the computer) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Athletic pubalgia (12-11 years ago (2006 or 2007)).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced METATARSALGIA (pain on the ball of his left foot), TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis), LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and INFLUENZA LIKE ILLNESS (flu like symptoms). In November 2021, the patient experienced ASTHENOPIA (eye strains when looking at the computer) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. In November 2021, LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, METATARSALGIA (pain on the ball of his left foot) and TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis) was resolving and ASTHENOPIA (eye strains when looking at the computer) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported   This case was linked to MOD-2021-385888, MOD-2021-385871 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Interchange of vaccine products, Loss of consciousness
Clinical narrative: passed out twice; extreme hot flashes; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out twice) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: Pfizer on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high (The patient was taking regular medications.). Concomitant products included ATENOLOL and CHLORTALIDONE (CHLORTHALIDONE) for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out twice) (seriousness criterion medically significant), HOT FLUSH (extreme hot flashes) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, LOSS OF CONSCIOUSNESS (passed out twice), HOT FLUSH (extreme hot flashes) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            Treatment information was unknown.  Company comment: This is a case of Interchange of Vaccine Products that concerns a 51-year-old female patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred the same day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-386106 (Patient Link).; Sender's Comments: This is a case of Interchange of Vaccine Products that concerns a 51-year-old female patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred the same day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cataract operation, Tachycardia
Clinical narrative: Atrial fibrillation; Tachycardia; cataract surgery; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-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 ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia) and CATARACT OPERATION (cataract surgery). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), TACHYCARDIA (Tachycardia) and CATARACT OPERATION (cataract surgery) outcome was unknown.            No Concomitant medications were reported.  It was reported that the side effect of the Moderna vaccine were related to her heart. She had atrial fibrillation and tachycardia that she takes medicine for. And due to some cataract surgery she did not realize she was having some effects from the vaccine, but she had.  No treatment medications were reported.  Company Comment: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected event of Atrial Fibrillation. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Followup  received on 15-11-2021 and does not contain any new information.; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected event of Atrial Fibrillation. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient stated it was likely the let down effect
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lip swelling, Swelling face
Clinical narrative: Generally sick early; Also her bottom lip swollen; Also her bottom lip and left side of the face were swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Generally sick early), LIP SWELLING (Also her bottom lip swollen) and SWELLING FACE (Also her bottom lip and left side of the face were swollen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Generally sick early), LIP SWELLING (Also her bottom lip swollen) and SWELLING FACE (Also her bottom lip and left side of the face were swollen). At the time of the report, ILLNESS (Generally sick early), LIP SWELLING (Also her bottom lip swollen) and SWELLING FACE (Also her bottom lip and left side of the face were swollen) outcome was unknown.            No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2021-385757 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site discomfort
Clinical narrative: Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood; Pain in their left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood) and ARTHRALGIA (Pain in their left shoulder) in a 52-year-old female patient who received mRNA-1273 (batch nos. 021b21a and 007d21a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood) and ARTHRALGIA (Pain in their left shoulder). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood) and ARTHRALGIA (Pain in their left shoulder) had not resolved.            No concomitant medications were provided by the reporter. It was reported that the patient took the ibuprofen for pain in their left shoulder. It was also mentioned that the patient wanted o do a class action lawsuit and wanted to know what to do with these side effects.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 14 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.  Patient not actively experiencing side effects.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rash, Sinusitis, Swelling face, Vaccination site erythema
Clinical narrative: sinus infection; really bad cold; right side of the face was swollen; rash all over the entire body/pink rash all over me; arm is still red now/It didn't go beyond the red spot on the arm; it's a little bit itchy; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me) and VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 027A21A and 939905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 08-Nov-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 SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me), VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) and VACCINATION SITE PRURITUS (it's a little bit itchy). The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXICILLIN E) for Sinus infection, at a dose of 1 dosage form. At the time of the report, SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me), VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) and VACCINATION SITE PRURITUS (it's a little bit itchy) outcome was unknown.            The patient had been using amoxicillin for a sinus infection but then said that have had a really bad cold, the right side of the face was swollen, the cold was just about done, went to HCP and couldn't realized if it was a sinus infection or something with the teeth. Went to an oral surgeon and was advised to continue with the antibiotics. They couldn't find anything wrong with the teeth.   This case was linked to MOD-2021-386031 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: sinus infection; really bad cold; right side of the face was swollen; rash all over the entire body/pink rash all over me; arm is still red now/It didn't go beyond the red spot on the arm; it's a little bit itchy; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me) and VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 027A21A and 939905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 08-Nov-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 SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me), VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) and VACCINATION SITE PRURITUS (it's a little bit itchy). The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXICILLIN E) for Sinus infection, at a dose of 1 dosage form. At the time of the report, SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me), VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) and VACCINATION SITE PRURITUS (it's a little bit itchy) outcome was unknown.            The patient had been using amoxicillin for a sinus infection but then said that have had a really bad cold, the right side of the face was swollen, the cold was just about done, went to HCP and couldn't realized if it was a sinus infection or something with the teeth. Went to an oral surgeon and was advised to continue with the antibiotics. They couldn't find anything wrong with the teeth.   This case was linked to MOD-2021-386031 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swollen area on my axilla/swollen area the size of a fist; hard to do anything on that side/hard to lay on that side; at the injection site it was swollen/pretty good size; It is a hard lymph spot; it is very tender; injection site less and moved to the axilla; hard to do anything on that side/hard to lay on that side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen area on my axilla/swollen area the size of a fist), VACCINATION SITE DISCOMFORT (hard to do anything on that side/hard to lay on that side), VACCINATION SITE SWELLING (at the injection site it was swollen/pretty good size), LYMPH NODE PAIN (It is a hard lymph spot) and LYMPH NODE PAIN (it is very tender) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN (STATIN [SIMVASTATIN]), ASPIRIN [ACETYLSALICYLIC ACID], LORAZEPAM, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and GLUCOSAMINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-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 VACCINATION SITE LYMPHADENOPATHY (swollen area on my axilla/swollen area the size of a fist), VACCINATION SITE DISCOMFORT (hard to do anything on that side/hard to lay on that side), VACCINATION SITE SWELLING (at the injection site it was swollen/pretty good size), LYMPH NODE PAIN (It is a hard lymph spot), LYMPH NODE PAIN (it is very tender), LYMPHADENITIS (injection site less and moved to the axilla) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to do anything on that side/hard to lay on that side). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 500 mg twice. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen area on my axilla/swollen area the size of a fist), VACCINATION SITE DISCOMFORT (hard to do anything on that side/hard to lay on that side), VACCINATION SITE SWELLING (at the injection site it was swollen/pretty good size), LYMPH NODE PAIN (It is a hard lymph spot), LYMPH NODE PAIN (it is very tender), LYMPHADENITIS (injection site less and moved to the axilla) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to do anything on that side/hard to lay on that side) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-386114 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage; doses administered after temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage) and EXPIRED PRODUCT ADMINISTERED (doses administered after temperature excursions) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage) and EXPIRED PRODUCT ADMINISTERED (doses administered after temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage) and EXPIRED PRODUCT ADMINISTERED (doses administered after temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received added patient demographics.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered after 24 hours of vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after 24 hours of vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after 24 hours of vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered after 24 hours of vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment information mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received on 12-NOV-2021 Not significant follow up contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Pain of skin, Skin reaction
Clinical narrative: tip of their fingers presented concentric ring-shaped marking; Very tender to the touch; This spontaneous case was reported by a patient and describes the occurrence of SKIN REACTION (tip of their fingers presented concentric ring-shaped marking) and PAIN OF SKIN (Very tender to the touch) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SKIN REACTION (tip of their fingers presented concentric ring-shaped marking) and PAIN OF SKIN (Very tender to the touch). At the time of the report, SKIN REACTION (tip of their fingers presented concentric ring-shaped marking) and PAIN OF SKIN (Very tender to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided.  The patient had to be treated in the hospital. After 11 months of first vaccination, the patient was interested for second dose.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling
Clinical narrative: Her right eye had puffed and swollen shut.; Her right eye had puffed and swollen shut.; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Her right eye had puffed and swollen shut.) and PERIORBITAL SWELLING (Her right eye had puffed and swollen shut.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced EYE SWELLING (Her right eye had puffed and swollen shut.) and PERIORBITAL SWELLING (Her right eye had puffed and swollen shut.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Her right eye had puffed and swollen shut.) and PERIORBITAL SWELLING (Her right eye had puffed and swollen shut.) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: little swelling at the injection site on the axilla; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (little swelling at the injection site on the axilla) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE SWELLING (little swelling at the injection site on the axilla). At the time of the report, VACCINATION SITE SWELLING (little swelling at the injection site on the axilla) outcome was unknown.      No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-386035 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: full dose instead of booster; feel a little bit out of it; have sore arm; fever; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (full dose instead of booster), FEELING ABNORMAL (feel a little bit out of it), MYALGIA (have sore arm) and PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma and COPD. Concurrent medical conditions included Overweight.    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, the patient experienced ACCIDENTAL OVERDOSE (full dose instead of booster), FEELING ABNORMAL (feel a little bit out of it), MYALGIA (have sore arm) and PYREXIA (fever). At the time of the report, ACCIDENTAL OVERDOSE (full dose instead of booster) had resolved and FEELING ABNORMAL (feel a little bit out of it), MYALGIA (have sore arm) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No lab data was provided. has a history of asthma/ copd as well as pots   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Significant follow-up appended medical history   added asthma,COPD.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: couldn't sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep) and HEADACHE (headache) 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 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 INSOMNIA (couldn't sleep) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, INSOMNIA (couldn't sleep) and HEADACHE (headache) outcome was unknown.            No Concomitant medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The dose administered past the expiry date was their booster dose, administered on 12Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose administered past the expiry date was their booster dose, administered on 12Nov2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025A21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose administered past the expiry date was their booster dose, administered on 12Nov2021). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The dose administered past the expiry date was their booster dose, administered on 12Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported No treatment medication was reported
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Full blood count, Full blood count abnormal, Haemoglobin, Red blood cell count
Clinical narrative: his blood work, cbc,  is  way out of wack, red blood cells, content  of blood cells, is completely like it hast never been in five years; This spontaneous case was reported by a consumer and describes the occurrence of FULL BLOOD COUNT ABNORMAL (his blood work, cbc,  is  way out of wack, red blood cells, content  of blood cells, is completely like it hast never been in five years) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016m20a and 029a21a) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Thyroid disorder (Tyrod problems). Concomitant products included BENPROPERINE PHOSPHATE (NORCOL), LEVOTHYROXINE SODIUM (TIROSINT) and RAMIPRIL for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced FULL BLOOD COUNT ABNORMAL (his blood work, cbc,  is  way out of wack,, red blood cells, content  of blood cells, is completely like it hast never been in five years). At the time of the report, FULL BLOOD COUNT ABNORMAL (his blood work, cbc,  is  way out of wack,, red blood cells, content  of blood cells, is completely like it hast never been in five years) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: abnormal (abnormal) abnormal. In November 2021, Full blood count: abnormal (abnormal) abnormal and abnormal (abnormal) abnormal. In November 2021, Haemoglobin: abnormal (abnormal) abnormal. In November 2021, Red blood cell count: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients reported that his blood work, cbc, is way out of wack, hemoglobin, red blood cells, content of blood cells, is completely like it hast never been in five years.   Reporter stated that  they get their blood work every November.  Concomitant medication including blood pressure medication and  pain medication  was reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash both times; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash both times) 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 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 RASH (Rash both times). At the time of the report, RASH (Rash both times) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.    This case was linked to MOD-2021-386112 (Patient Link).