chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A sore arm  for a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A sore arm  for a week) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J00A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Skin disorder NOS and Hair disorder NOS. Concomitant products included DOXYCYCLINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (A sore arm  for a week). On 19-Jan-2021, VACCINATION SITE PAIN (A sore arm  for a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included medications for blood pressure and skin and hair condition. Treatment details were not provided.   This case was linked to MOD-2021-304953, MOD-2021-301915 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: greater than 35 days between Moderna Covid-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives/hives; welts/welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/hives) and URTICARIA (welts/welts) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced URTICARIA (hives/hives) and URTICARIA (welts/welts). At the time of the report, URTICARIA (hives/hives) and URTICARIA (welts/welts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient got hives, then welts that went away. No treatment information were provided. Rechallenge was positive on august 2021.   This case was linked to MOD-2021-304977 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in legs and feet on both sides; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in legs and feet on both sides) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PERIPHERAL SWELLING (swelling in legs and feet on both sides). At the time of the report, PERIPHERAL SWELLING (swelling in legs and feet on both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  It was reported that patient not taking any medications and did not receive any treatments
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/Welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/Welts) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported. .  Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced URTICARIA (Hives/Welts). At the time of the report, URTICARIA (Hives/Welts) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-304952 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriovenous fistula site haemorrhage, Back pain, Muscle spasms
Clinical narrative: fistula was bleeding for a couple of weeks; extreme lower back pain; lower back muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks), BACK PAIN (extreme lower back pain) and MUSCLE SPASMS (lower back muscle spasms) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis. Concurrent medical conditions included Immunocompromised and End stage renal disease.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks) (seriousness criterion medically significant), BACK PAIN (extreme lower back pain) (seriousness criterion medically significant) and MUSCLE SPASMS (lower back muscle spasms) (seriousness criterion medically significant). At the time of the report, ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks), BACK PAIN (extreme lower back pain) and MUSCLE SPASMS (lower back muscle spasms) had not resolved.            The patient experienced slight fever after the second dose of Moderna. After the third dose (for/due to being immunocompromised) the patient experienced extreme lower back pain and muscle spasms. Narcotics did nothing, however, muscle relaxers and pain relievers did help but was still very bad. The patient was an end stage renal patient who does his dialysis treatments at home via a fistula. That fistula was bleeding for a couple of weeks and he had to have surgery on it today. The pain was so bad he had difficulty even going to the surgery.  Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset date of the events (likely exacerbation of fistula site bleeding post-vaccination with symptoms of excruciating low back pain and muscle spasms), a causal relationship cannot be excluded.   This case was linked to MOD-2021-304969.   Reporter did not allow further contact; Sender's Comments: Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset date of the events (likely exacerbation of fistula site bleeding post-vaccination with symptoms of excruciating low back pain and muscle spasms), a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: Right arm pain from her shoulder around to her neck; Can hardly sleep; She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.; Muscle pain all over her body all the time; Joint pain all over her body all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Knee pain.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-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 PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-030007 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Swelling
Clinical narrative: swelling under his groin; swelling under the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection). At the time of the report, SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: blood pressure from the 11 patients increased right after the vaccine to dangerous levels; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels) 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 BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Myalgia, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (this is all symptoms of the vaccine booster), DRY MOUTH (mouth started getting dry) and MYALGIA (left arm sore) all the body is sore (chest, shoulder, and back)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E) for COVID-19 vaccination. The patient's past medical history included Breast implant user. On 31-Aug-2021 at 11:00 AM, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced DRY MOUTH (mouth started getting dry) and MYALGIA (left arm sore / all the body is sore (chest, shoulder, and back)). On an unknown date, the patient experienced VACCINATION COMPLICATION (this is all symptoms of the vaccine booster). At the time of the report, VACCINATION COMPLICATION (this is all symptoms of the vaccine booster), DRY MOUTH (mouth started getting dry) and MYALGIA (left arm sore / all the body is sore (chest, shoulder, and back)) was resolving. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-308700. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received included Additional event and events outcome updated. On 03-Sep-2021: Non significant follow up received on 03-Sep-2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided by the reporter.  Treatment information was not reported.  Reporter states that Patient had her second shot on Aug 2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).; positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (positive for COVID-19). On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).). At the time of the report, COVID-19 (positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant medication includes birth control medication.   Treatment information was not provided  On 14-Aug-2021, Patient started with COVID-19 symptoms (water eye, couldn't breath, no sense of smell).  A pharmacist said that she should wait 14 days for 2nd vaccine but other pharmacist (they were evacuees due to a stage 4 hurricane) said that patient had to wait 90 days.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She got the second dose two weeks apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Mobility decreased, Myalgia, Vaccination site pain
Clinical narrative: Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing; Pain isalso getting sooner than later, more often than before, almost everyday; Pain in the middle of her upper arm, in the inside muscle; Second injection wasn't as painful as the first dose, but pain's still there; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing), CONDITION AGGRAVATED (Pain isalso getting sooner than later, more often than before, almost everyday), VACCINATION SITE PAIN (Second injection wasn't as painful as the first dose, but pain's still there) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 206A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (Second injection wasn't as painful as the first dose, but pain's still there). On an unknown date, the patient experienced MOBILITY DECREASED (Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle). an unknown date, the patient experienced CONDITION AGGRAVATED (Pain isalso getting sooner than later, more often than before, almost everyday). At the time of the report, MOBILITY DECREASED (Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing), CONDITION AGGRAVATED (Pain isalso getting sooner than later, more often than before, almost everyday) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle) outcome was unknown and VACCINATION SITE PAIN (Second injection wasn't as painful as the first dose, but pain's still there) had not resolved.            The Patient stated that she has not taken any medication for the pain as it comes in short episodes and last a few seconds.   The patient stated that she consulted her Physician on 31 August 2021.  No concomitant product use was provided by the reporter.   This case was linked to MOD-2021-305083 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Itching badly on upper torso/still itchy; Lips were tingly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching badly on upper torso/still itchy) and PARAESTHESIA ORAL (Lips were tingly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergic reaction to nettle) and Allergy to animal (Allergic reaction to scorpions).    On 31-Aug-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PARAESTHESIA ORAL (Lips were tingly). On 31-Aug-2021 at 4:00 PM, the patient experienced PRURITUS (Itching badly on upper torso/still itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in 2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching badly on upper torso/still itchy) had not resolved and PARAESTHESIA ORAL (Lips were tingly) outcome was unknown.            No concomitant medications were provided.  Patient was taking Benadryl every 3-4 hours and it helped a lot.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Headache
Clinical narrative: had a stroke; got real dizzy; he had headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced DIZZINESS (got real dizzy) and HEADACHE (he had headache). On 17-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency and AMLODIPINE on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke), DIZZINESS (got real dizzy) and HEADACHE (he had headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 17-Jun-2021, patient visited emergency room and got discharged the same night.  Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.; Sender's Comments: Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Tenderness
Clinical narrative: another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet; it feels like a tenderness/like when you work the muscle too much; he had a sore arm from the next day which lasted for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet), TENDERNESS (it feels like a tenderness/like when you work the muscle too much) and MYALGIA (he had a sore arm from the next day which lasted for a couple of days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet), TENDERNESS (it feels like a tenderness/like when you work the muscle too much) and MYALGIA (he had a sore arm from the next day which lasted for a couple of days). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet) had not resolved, TENDERNESS (it feels like a tenderness/like when you work the muscle too much) outcome was unknown and MYALGIA (he had a sore arm from the next day which lasted for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore arm) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown.            Treatment information was unknown Caller received the 1st dose of the Moderna vaccine on 31Mar2021 (no expiration date) on her right arm and had a sore arm. She received the 2nd dose on 28Apr2021 (lot #010M20A, no expiration date) on her left arm and a week later she had a bad headache on the frontal lobe like if she had an aneurism, ringing on her ears, she went to a neurologist, got a MRI done, has had migraines everyday ever since, lost hearing of her right ear, tinnitus, brain fog, vision problems. Caller says she was healthy before the vaccine. She says she's part of a 300,000 people group who has had issues with vaccines  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.     This case was linked to MOD-2021-305146 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Feeling abnormal, Headache, Migraine, Tinnitus
Clinical narrative: lost hearing of her right ear; ringing on her ears / tinnitus; has had migraines everyday ever since; brain fog; vision problems; a bad headache on the frontal lobe like if she had an aneurism; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost hearing of her right ear) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEAFNESS (lost hearing of her right ear) (seriousness criterion medically significant), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism). At the time of the report, DEAFNESS (lost hearing of her right ear), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism) outcome was unknown.            The patient went to MRI and the results were unknown. She went to a neurologist.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.   This case was linked to MOD-2021-305139 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: lost hearing of her right ear; ringing on her ears / tinnitus; has had migraines everyday ever since; brain fog; vision problems; a bad headache on the frontal lobe like if she had an aneurism; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost hearing of her right ear) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEAFNESS (lost hearing of her right ear) (seriousness criterion medically significant), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism). At the time of the report, DEAFNESS (lost hearing of her right ear), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism) outcome was unknown.            The patient went to MRI and the results were unknown. She went to a neurologist.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.   This case was linked to MOD-2021-305139 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose past 26 hours punctured today; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose past 26 hours punctured today) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose past 26 hours punctured today). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose past 26 hours punctured today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Product dose omission issue, Vomiting
Clinical narrative: it's been over 4 months since receiving the 1st dose; It was 2nd worst migraine I've ever had; severe vomiting; started to get migraine-like symptoms headache/severe pain in the head; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting), HEADACHE (started to get migraine-like symptoms headache/severe pain in the head) and PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (preservatives) and Migraine (pretty bad).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting) and HEADACHE (started to get migraine-like symptoms headache/severe pain in the head). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose). At the time of the report, MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting) and HEADACHE (started to get migraine-like symptoms headache/severe pain in the head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 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 VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. The treatment information were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal discomfort
Clinical narrative: is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough; throat is also, like the inside of her throat is a; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a) 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 30-Aug-2021 at 9:04 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a). At the time of the report, COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated something regarding the inside of the throat which is unclear. Concomitant medications were not provided. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Grip strength decreased, Headache, Tinnitus
Clinical narrative: She drops things; Kind of a headache; Felt tired for the first couple of days; Got tinnitus, can only hear whistles and noise; Shaking, hands are shaking / hand shaking; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Shaking, hands are shaking / hand shaking). On 27-Aug-2021, the patient experienced TINNITUS (Got tinnitus, can only hear whistles and noise). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days). At the time of the report, TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Blood pressure measurement: increased (High) Blood pressure increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any medication for the adverse events and does not take any concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2021: Patient medical history and lab data were added. Event verbatim was changed and hand shaking event date was added.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: She drops things; Kind of a headache; Felt tired for the first couple of days; Got tinnitus, can only hear whistles and noise; Shaking, hands are shaking / hand shaking; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Shaking, hands are shaking / hand shaking). On 27-Aug-2021, the patient experienced TINNITUS (Got tinnitus, can only hear whistles and noise). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days). At the time of the report, TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Blood pressure measurement: increased (High) Blood pressure increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any medication for the adverse events and does not take any concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2021: Patient medical history and lab data were added. Event verbatim was changed and hand shaking event date was added.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient confirmed that the tingling stared after the first dose and was able to do things; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Tingling, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-305223.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: I spent 3 days in bed, I slept 14 hours at a time; pain in my right injection site arm; feverish; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish). At the time of the report, SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Dyspepsia, Flatulence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea came back and never went away), FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013M20A) for COVID-19 vaccination. Concomitant products included PRIMIDONE, MELATONIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), COLECALCIFEROL (VITAMIN D3), ACETYLSALICYLIC ACID (BABY ASPIRIN), DICLOFENAC SODIUM, LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), SERTRALINE, QUETIAPINE FUMARATE (SEROQUEL) and UBIDECARENONE (COQ10 [UBIDECARENONE]) 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 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DIARRHEA (Diarrhea came back and never went away). On an unknown date, the patient experienced FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn). The patient was treated with ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Heartburn, at an unspecified dose and frequency and DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea came back and never went away) had not resolved and FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn) 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-2021-305229.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: cut his finger; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (cut his finger) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20a and 015m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced SKIN LACERATION (cut his finger). The patient was treated with DOXYCYCLINE for Laceration of finger, at an unspecified dose and frequency. At the time of the report, SKIN LACERATION (cut his finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes blood pressure medicines as concomitant drug.  Patient had to receive a tetanus shot as a week ago he cut his finger.