chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: throbbing pain in the arm; heavy and sleepy arm; pain at the injection site similar to the pain experienced two or three days after receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (throbbing pain in the arm), LIMB DISCOMFORT (heavy and sleepy arm) and VACCINATION SITE PAIN (pain at the injection site similar to the pain experienced two or three days after receiving the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (throbbing pain in the arm), LIMB DISCOMFORT (heavy and sleepy arm) and VACCINATION SITE PAIN (pain at the injection site similar to the pain experienced two or three days after receiving the second dose). At the time of the report, PAIN IN EXTREMITY (throbbing pain in the arm), LIMB DISCOMFORT (heavy and sleepy arm) and VACCINATION SITE PAIN (pain at the injection site similar to the pain experienced two or three days after receiving the second dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     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.    This case was linked to MOD-2021-242280 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose on 4May2021 and did not yet receive second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose on 4May2021 and did not yet receive second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-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 PRODUCT DOSE OMISSION ISSUE (First dose on 4May2021 and did not yet receive second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose on 4May2021 and did not yet receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Irritable bowel syndrome, Proctalgia, Weight decreased
Clinical narrative: may be "some kind" of IBS (Irritable bowel syndrome); "terrible diarrhea"; anything she eats causes an upset stomach; has been losing weight; pain in the rectum; This spontaneous case was reported by a consumer and describes the occurrence of PROCTALGIA (pain in the rectum), DIARRHOEA ("terrible diarrhea"), ABDOMINAL DISCOMFORT (anything she eats causes an upset stomach), WEIGHT DECREASED (has been losing weight) and IRRITABLE BOWEL SYNDROME (may be "some kind" of IBS (Irritable bowel syndrome)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Radiation therapy (Patient stated that she received 15 rounds of radiation treatment and did not received any chemotherapy.) from 20-Feb-2021 to 17-Mar-2021. Concurrent medical conditions included Milk allergy, Hypothyroidism and Breast cancer since November 2020. Concomitant products included LEVOTHYROXINE for Hypothyroidism, ANASTROZOLE from 17-Apr-2021 to an unknown date for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PROCTALGIA (pain in the rectum) and WEIGHT DECREASED (has been losing weight). On 11-Mar-2021, the patient experienced DIARRHOEA ("terrible diarrhea") and ABDOMINAL DISCOMFORT (anything she eats causes an upset stomach). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (may be "some kind" of IBS (Irritable bowel syndrome)). The patient was treated with HYOSCYAMINE for Diarrhea, at an unspecified dose and frequency. At the time of the report, PROCTALGIA (pain in the rectum), DIARRHOEA ("terrible diarrhea"), ABDOMINAL DISCOMFORT (anything she eats causes an upset stomach), WEIGHT DECREASED (has been losing weight) and IRRITABLE BOWEL SYNDROME (may be "some kind" of IBS (Irritable bowel syndrome)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  took Anastrozole (estrogen blocker) one month after the completion of radiation treatment (around 17Apr2021). She stated that she will have to take Anastrozole for 5 years.  The consumer stated that  she had no known drug or food allergies.  No relevant Lab Data was provided.   This case was linked to MOD-2021-242482, MOD-2021-242482 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of blister (blistering/blistering disease), pruritus (itching) and rash (rash/terrible rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. January 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2021, patient experienced blister (blistering/blistering disease), pruritus (itching) and rash (rash/terrible rash). Patient treated with Rituxan (rituximab) ongoing since an unknown date for blistering, at a dose of 1 dosage form. At the time of the report, blister (blistering/blistering disease), pruritus (itching) and rash (rash/terrible rash) outcome: unknown. No  concomitant medications or lab data reported. Most recent follow-up information incorporated: On Jun 30, 2021: Non-significant follow-up appended.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose 4 months ago, no second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 4 months ago, no second dose yet) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 4 months ago, no second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose 4 months ago, no second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Pruritus, Urticaria, Vaccination complication
Clinical narrative: she has not had a reaction like this after any other shot  and doesn't look like a normal reaction; shot site a little raised; only reaction she has experienced has been a headache, specifically a migraine,; Extreme Joint Issues in every joint in her body; where she received the shot is still very red,; Where she received the shot is a little raised; Where she received the shot is extremely itchy; All of her tattoos seem to be welted; All of her tattoos are very itchy; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (only reaction she has experienced has been a headache, specifically a migraine,), ARTHRALGIA (Extreme Joint Issues in every joint in her body), VACCINATION SITE ERYTHEMA (where she received the shot is still very red,), VACCINATION SITE SWELLING (Where she received the shot is a little raised) and VACCINATION SITE PRURITUS (Where she received the shot is extremely itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced MIGRAINE (only reaction she has experienced has been a headache, specifically a migraine,), ARTHRALGIA (Extreme Joint Issues in every joint in her body), VACCINATION SITE ERYTHEMA (where she received the shot is still very red,), VACCINATION SITE SWELLING (Where she received the shot is a little raised), VACCINATION SITE PRURITUS (Where she received the shot is extremely itchy), URTICARIA (All of her tattoos seem to be welted) and PRURITUS (All of her tattoos are very itchy). On an unknown date, the patient experienced VACCINATION COMPLICATION (she has not had a reaction like this after any other shot  and doesn't look like a normal reaction) and VACCINATION SITE RASH (shot site a little raised). At the time of the report, MIGRAINE (only reaction she has experienced has been a headache, specifically a migraine,), ARTHRALGIA (Extreme Joint Issues in every joint in her body), VACCINATION SITE ERYTHEMA (where she received the shot is still very red,), VACCINATION SITE SWELLING (Where she received the shot is a little raised), VACCINATION SITE PRURITUS (Where she received the shot is extremely itchy), URTICARIA (All of her tattoos seem to be welted), PRURITUS (All of her tattoos are very itchy), VACCINATION COMPLICATION (she has not had a reaction like this after any other shot  and doesn't look like a normal reaction) and VACCINATION SITE RASH (shot site a little raised) outcome was unknown.        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 was not provided.  Treatment medications were not given.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: She has a ball in her left arm at injected site/It never dissipated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (She has a ball in her left arm at injected site/It never dissipated) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (She has a ball in her left arm at injected site/It never dissipated). At the time of the report, VACCINATION SITE SWELLING (She has a ball in her left arm at injected site/It never dissipated) outcome was unknown.            No concomitant medication was reported.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: muscular soreness on the upper arms; her symptoms got worse; exhausted; slept most of the time; symptoms of Covid-19; soreness on the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the injection site (right arm)), MYALGIA (muscular soreness on the upper arms), FATIGUE (exhausted), SOMNOLENCE (slept most of the time) and COVID-19 (symptoms of Covid-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) milliliter. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness on the injection site (right arm)). On 21-Jun-2021, the patient experienced FATIGUE (exhausted), SOMNOLENCE (slept most of the time) and COVID-19 (symptoms of Covid-19). On an unknown date, the patient experienced MYALGIA (muscular soreness on the upper arms) and CONDITION AGGRAVATED (her symptoms got worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness on the injection site (right arm)), MYALGIA (muscular soreness on the upper arms), FATIGUE (exhausted), SOMNOLENCE (slept most of the time), COVID-19 (symptoms of Covid-19) and CONDITION AGGRAVATED (her symptoms got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, SARS-CoV-2 test: Positive.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: muscular soreness on the upper arms; her symptoms got worse; exhausted; slept most of the time; symptoms of Covid-19; soreness on the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the injection site (right arm)), MYALGIA (muscular soreness on the upper arms), FATIGUE (exhausted), SOMNOLENCE (slept most of the time) and COVID-19 (symptoms of Covid-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) milliliter. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness on the injection site (right arm)). On 21-Jun-2021, the patient experienced FATIGUE (exhausted), SOMNOLENCE (slept most of the time) and COVID-19 (symptoms of Covid-19). On an unknown date, the patient experienced MYALGIA (muscular soreness on the upper arms) and CONDITION AGGRAVATED (her symptoms got worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness on the injection site (right arm)), MYALGIA (muscular soreness on the upper arms), FATIGUE (exhausted), SOMNOLENCE (slept most of the time), COVID-19 (symptoms of Covid-19) and CONDITION AGGRAVATED (her symptoms got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, SARS-CoV-2 test: Positive.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Now I feel numb in my fingers and feet, The numbness is mainly in the heel of my feet, and mainly on my left foot, The tingling is mainly in my fingers; After the 2nd dose, I felt tingling in my feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After the 2nd dose, I felt tingling in my feet) and HYPOAESTHESIA (Now I feel numb in my fingers and feet, The numbness is mainly in the heel of my feet, and mainly on my left foot, The tingling is mainly in my fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included LOSARTAN for Blood pressure management, LOVASTATIN for Cholesterol.    On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PARAESTHESIA (After the 2nd dose, I felt tingling in my feet). On an unknown date, the patient experienced HYPOAESTHESIA (Now I feel numb in my fingers and feet, The numbness is mainly in the heel of my feet, and mainly on my left foot, The tingling is mainly in my fingers). At the time of the report, PARAESTHESIA (After the 2nd dose, I felt tingling in my feet) and HYPOAESTHESIA (Now I feel numb in my fingers and feet, The numbness is mainly in the heel of my feet, and mainly on my left foot, The tingling is mainly in my fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information, if any, was not provided  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-242346 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received on 30-Jun-2021 and does not contain any new information.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Serious menstrual cramps; Heavy menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Serious menstrual cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced DYSMENORRHOEA (Serious menstrual cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding). At the time of the report, DYSMENORRHOEA (Serious menstrual cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug details were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Proctalgia
Clinical narrative: Pain in her rectum; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PROCTALGIA (Pain in her rectum) and DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since November 2020, Milk allergy (milk intolerance) and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, ANASTROZOLE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PROCTALGIA (Pain in her rectum) and DIARRHOEA (Diarrhea). At the time of the report, PROCTALGIA (Pain in her rectum) and DIARRHOEA (Diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Lab Data was provided. No treatment medication information was provided Patient taking radiation to treat breast cancer on 25Feb2021 and ended the radiation treatment on 17Mar2021. Patient stated received 15 rounds of radiation treatment. Patient taking Anastrozole for 5 years.   This case was linked to MOD-2021-242430 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Discomfort at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort at the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (Allergy to Pollen), Food allergy (Allergy to Pine tart) and Allergy to animal (Allergy to Cat).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort at the site). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort at the site) outcome was unknown.        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 products included Allergy injection as patient reported its intake twice a month for past 20-30 years. Concomitant medication included vitamins. Treatment information were not provided.   This case was linked to MOD-2021-242526 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not get second dose within the one month time frame; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get second dose within the one month time frame) 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.    In January 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 PRODUCT DOSE OMISSION ISSUE (Did not get second dose within the one month time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get second dose within the one month time frame) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Limb discomfort, Lip swelling
Clinical narrative: leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight; gets dizzy but does not  if it is related to the shot; pain in right hip/pain right hip to right knee to left knee all over the leg comes up quickly and goes away quickly; sore throat; swelling of lips; headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LIMB DISCOMFORT (leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight), DIZZINESS (gets dizzy but does not  if it is related to the shot), LIP SWELLING (swelling of lips) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic to cats and Allergic reaction (Allergic to pollen and pine tart). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), LIP SWELLING (swelling of lips), HEADACHE (headache) and PYREXIA (low grade fever). On an unknown date, the patient experienced LIMB DISCOMFORT (leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight), DIZZINESS (gets dizzy but does not  if it is related to the shot) and ARTHRALGIA (pain in right hip/pain right hip to right knee to left knee all over the leg comes up quickly and goes away quickly). The patient was treated with DIETHYLAMINE SALICYLATE, METHYL NICOTINATE (ASPERCREME [DIETHYLAMINE SALICYLATE;METHYL NICOTINATE]) ongoing since an unknown date at an unspecified dose and frequency. On 15-Apr-2021, OROPHARYNGEAL PAIN (sore throat), LIP SWELLING (swelling of lips), HEADACHE (headache) and PYREXIA (low grade fever) had resolved. At the time of the report, LIMB DISCOMFORT (leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight), DIZZINESS (gets dizzy but does not  if it is related to the shot) and ARTHRALGIA (pain in right hip/pain right hip to right knee to left knee all over the leg comes up quickly and goes away quickly) outcome was unknown.        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 products includes allergic injection.  No treatment medication provided.   This case was linked to MOD-2021-242504 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight; gets dizzy but does not  if it is related to the shot; pain in right hip/pain right hip to right knee to left knee all over the leg comes up quickly and goes away quickly; sore throat; swelling of lips; headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LIMB DISCOMFORT (leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight), DIZZINESS (gets dizzy but does not  if it is related to the shot), LIP SWELLING (swelling of lips) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic to cats and Allergic reaction (Allergic to pollen and pine tart). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), LIP SWELLING (swelling of lips), HEADACHE (headache) and PYREXIA (low grade fever). On an unknown date, the patient experienced LIMB DISCOMFORT (leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight), DIZZINESS (gets dizzy but does not  if it is related to the shot) and ARTHRALGIA (pain in right hip/pain right hip to right knee to left knee all over the leg comes up quickly and goes away quickly). The patient was treated with DIETHYLAMINE SALICYLATE, METHYL NICOTINATE (ASPERCREME [DIETHYLAMINE SALICYLATE;METHYL NICOTINATE]) ongoing since an unknown date at an unspecified dose and frequency. On 15-Apr-2021, OROPHARYNGEAL PAIN (sore throat), LIP SWELLING (swelling of lips), HEADACHE (headache) and PYREXIA (low grade fever) had resolved. At the time of the report, LIMB DISCOMFORT (leg feel tight/when moving her legs and she hears crack/she bends her leg it feels tight), DIZZINESS (gets dizzy but does not  if it is related to the shot) and ARTHRALGIA (pain in right hip/pain right hip to right knee to left knee all over the leg comes up quickly and goes away quickly) outcome was unknown.        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 products includes allergic injection.  No treatment medication provided.   This case was linked to MOD-2021-242504 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Migraine, Pain in extremity
Clinical narrative: sore arm; migraine; received her second dose of the Moderna Covid-19 vaccine on 26Jun2021 ( 7 weeks after the first dose); This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second dose of the Moderna Covid-19 vaccine on 26Jun2021 ( 7 weeks after the first dose)) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN ASPART (NOVOLOG) and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 26-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second dose of the Moderna Covid-19 vaccine on 26Jun2021 ( 7 weeks after the first dose)). On 30-Jun-2021, the patient experienced MIGRAINE (migraine). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second dose of the Moderna Covid-19 vaccine on 26Jun2021 ( 7 weeks after the first dose)) had resolved. At the time of the report, MIGRAINE (migraine) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-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 PRODUCT DOSE OMISSION ISSUE (caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported by the reporter.  Treatment medication for these events were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I am pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (I am pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: puking; worst headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (puking) and HEADACHE (worst headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced VOMITING (puking) and HEADACHE (worst headache). At the time of the report, VOMITING (puking) and HEADACHE (worst headache) 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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: if he even touches his head, it hurts; feeling very achy/feels body was crushed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (if he even touches his head, it hurts) and MYALGIA (feeling very achy/feels body was crushed) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included Back surgery.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced HEADACHE (if he even touches his head, it hurts) and MYALGIA (feeling very achy/feels body was crushed). At the time of the report, HEADACHE (if he even touches his head, it hurts) and MYALGIA (feeling very achy/feels body was crushed) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Treatment information included Eurafina.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: fatigued; joint pain; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigued) and ARTHRALGIA (joint pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued) and ARTHRALGIA (joint pain). At the time of the report, FATIGUE (fatigued) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Movement disorder
Clinical narrative: dizzy/had crystals out of place in her right inner ear; could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy/had crystals out of place in her right inner ear) and MOVEMENT DISORDER (could not get out of bed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 010A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (A month prior to the Moderna shot she did receive a flu shot) in February 2021. Concurrent medical conditions included Blood pressure high. Concomitant products included CLONIDINE, LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], HYDRALAZINE, TORSEMIDE, LABETALOL, ALLOPURINOL, ATORVASTATIN, NIFEDIPINE, VITAMIN D [VITAMIN D NOS] and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (dizzy/had crystals out of place in her right inner ear) and MOVEMENT DISORDER (could not get out of bed). On 05-Apr-2021, MOVEMENT DISORDER (could not get out of bed) outcome was unknown. In April 2021, DIZZINESS (dizzy/had crystals out of place in her right inner ear) outcome was unknown.            It was reported that the patient went to therapy once and wore a brace for 24 hours and was taught how to manipulate the head to help alleviate the symptoms if they should return.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbeness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbeness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbeness). At the time of the report, HYPOAESTHESIA (Numbeness) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: very sick; Sore throat; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (very sick), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (very sick), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, MALAISE (very sick), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had not resolved.            No concomitant medications were provided by the reporter. Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tenderness
Clinical narrative: Some pain in right arm; Some tenderness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Some pain in right arm) and TENDERNESS (Some tenderness in right arm) 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 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced MYALGIA (Some pain in right arm) and TENDERNESS (Some tenderness in right arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, MYALGIA (Some pain in right arm) and TENDERNESS (Some tenderness in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.
Sex: U
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Severe cramps; Heavy menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Severe cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (Severe cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding). At the time of the report, DYSMENORRHOEA (Severe cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after allowed expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) 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) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow Up received on 01-JUL-2021 contains No New Information
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tired/tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (tired/tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (tired/tired). On 19-Feb-2021, FATIGUE (tired/tired) had resolved. On 23-Jun-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-243019 (Patient Link).