chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: pain in arm/pain in left arm; I can hardly lift; left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm/pain in left arm), MYALGIA (I can hardly lift) and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back) 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 26-Feb-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 (pain in arm/pain in left arm), MYALGIA (I can hardly lift) and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back). At the time of the report, PAIN IN EXTREMITY (pain in arm/pain in left arm) and MYALGIA (I can hardly lift) had not resolved and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided. The patient gone to urgent care, still had not got the events resolved.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: New event Muscular weakness added, outcome of an event pain in arm and narrative updated. On 28-Jul-2021: Follow up was received does not contains any new information
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of lymphadenopathy (lymph node swelling) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced lymphadenopathy (lymph node swelling). At the time of the report, lymphadenopathy (lymph node swelling) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Incorrect route of administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration) 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.   No concomitant or treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed their second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed their second dose) 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 (missed their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed their second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) 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 OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.      No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: experienced a blood clot behind my left eye; 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 OCULAR HYPERAEMIA (experienced a blood clot behind my left eye) in a patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced OCULAR HYPERAEMIA (experienced a blood clot behind my left eye). At the time of the report, OCULAR HYPERAEMIA (experienced a blood clot behind my left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Crosslinked with case MOD21-116551. AE submitted via social media. Consent for follow up declined. I experienced a blood clot behind my left eye after my first shot in February...since then I have found 4 more people with same thing....any correlation?   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Product dose omission issue
Clinical narrative: Missed her second dose/More than 35 days have passed; tested positive for COVID; was sick; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (was sick), PRODUCT DOSE OMISSION ISSUE (Missed her second dose/More than 35 days have passed) and COVID-19 (tested positive for COVID) 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 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ILLNESS (was sick) and COVID-19 (tested positive for COVID). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second dose/More than 35 days have passed). At the time of the report, ILLNESS (was sick) and COVID-19 (tested positive for COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed her second dose/More than 35 days have passed) 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.   No concomitant medications reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Rash, Skin reaction
Clinical narrative: becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate; any new supplement or drug she tries he has a reaction dermatologically; arms burn like sunburn; rash under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol), Drug allergy and Food allergy (Sensitive to food that contained salicylate).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin). At the time of the report, HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-239094 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Worried about the second vaccine side effects; Chills; Fever 100.3 F; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 100.3 F), MYALGIA (Body Aches) and ANXIETY (Worried about the second vaccine side effects) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Medical history was not provided.     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 CHILLS (Chills), PYREXIA (Fever 100.3 F) and MYALGIA (Body Aches). On 28-Jun-2021, the patient experienced ANXIETY (Worried about the second vaccine side effects). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 23-Jun-2021, CHILLS (Chills), PYREXIA (Fever 100.3 F) and MYALGIA (Body Aches) had resolved. At the time of the report, ANXIETY (Worried about the second vaccine side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3f (High) Increased 100.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose 37 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose) had resolved.            No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site bruising (bruise at the injection site) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site bruising (bruise at the injection site). At the time of the report, vaccination site bruising (bruise at the injection site) outcome: unknown. Action taken with mRNA-1273 in response to the event: not applicable. No concomitant medications or treatment details reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-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 DYSPNOEA (difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded). At the time of the report, DYSPNOEA (difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medications were reported.  Action taken with mRNA-1273 vaccine due to the event was not applicable.   This case was linked to MOD-2021-239099 (Patient Link).
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 year old received the first dose of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine) 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.   No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: still have numbness on two fingers; still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now; uncomfortable feeling; soreness of the arm after both shots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (still have numbness on two fingers), PARAESTHESIA (still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now), FEELING ABNORMAL (uncomfortable feeling) and PAIN IN EXTREMITY (soreness of the arm after both shots) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 HYPOAESTHESIA (still have numbness on two fingers), PARAESTHESIA (still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now), FEELING ABNORMAL (uncomfortable feeling) and PAIN IN EXTREMITY (soreness of the arm after both shots). The patient was treated with VITAMIN B12 [VITAMIN B12 NOS] at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (still have numbness on two fingers), PARAESTHESIA (still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now) and FEELING ABNORMAL (uncomfortable feeling) had not resolved and PAIN IN EXTREMITY (soreness of the arm after both shots) outcome was unknown.            No Concomitant medications were reported. HCP recommended to ice the area.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram, Intentional product use issue
Clinical narrative: She was afraid to take her second injection Will not take second dose; heaviness in chest; burning in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (heaviness in chest), CHEST PAIN (burning in chest) and INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST DISCOMFORT (heaviness in chest) and CHEST PAIN (burning in chest). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose). At the time of the report, CHEST DISCOMFORT (heaviness in chest), CHEST PAIN (burning in chest) and INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Electrocardiogram: normal Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Clostridium test, Diarrhoea, Tenderness, Vaccination complication
Clinical narrative: Diarrhea; Vaccination adverse reaction; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness). At the time of the report, DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Clostridium test: negative (Negative) Negative.         This case was linked to MOD-2021-239141 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, General symptom, Hypokinesia, Pain in extremity
Clinical narrative: chills; could not bend  her right leg /could not bend her leg; pain in left hip/ after couple of days started in her left knee and left hip; Patient got severe pain behind her left  leg and  could not  bend  her leg; left knee very painful/could only bend her left knee a little bit; some general side effects; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HYPOKINESIA (could not bend  her right leg /could not bend her leg), ARTHRALGIA (pain in left hip/ after couple of days started in her left knee and left hip), PAIN IN EXTREMITY (Patient got severe pain behind her left  leg and  could not  bend  her leg) and ARTHRALGIA (left knee very painful/could only bend her left knee a little bit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 8077Z27399) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HYPOKINESIA (could not bend  her right leg /could not bend her leg), ARTHRALGIA (pain in left hip/ after couple of days started in her left knee and left hip), PAIN IN EXTREMITY (Patient got severe pain behind her left  leg and  could not  bend  her leg), ARTHRALGIA (left knee very painful/could only bend her left knee a little bit) and GENERAL SYMPTOM (some general side effects). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Chills, Knee pain and Pain in hip, at a dose of 1 dosage form. At the time of the report, CHILLS (chills), HYPOKINESIA (could not bend  her right leg /could not bend her leg), ARTHRALGIA (pain in left hip/ after couple of days started in her left knee and left hip), PAIN IN EXTREMITY (Patient got severe pain behind her left  leg and  could not  bend  her leg), ARTHRALGIA (left knee very painful/could only bend her left knee a little bit) and GENERAL SYMPTOM (some general side effects) outcome was unknown.            Patient stated that she was not on any concomitant medications. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tenderness, Vaccination complication
Clinical narrative: very little local reactions; Tenderness; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021. The most recent information was received on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Trigeminal neuralgia since 18-Mar-2020, Penicillin allergy, Fruit allergy, Latex allergy, Hay fever and Cholesterol. Concomitant products included CALCIUM for Calcium supplementation, PRAVASTATIN for Cholesterol, CYANOCOBALAMIN (VIT B12) for Elderly, ASCORBIC ACID (VITAMINS C) for Immunization, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation.    On 27-Jan-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-239138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow-up received. Updated reporter name, patient current condition/allergy, and concomitant drugs.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: punctured 18 hours before vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured 18 hours before vaccination) 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 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured 18 hours before vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (punctured 18 hours before vaccination) 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 Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingle sensation in the index finger all up to the middle finger; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger). At the time of the report, PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger) 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.    No treatment information was provided by the reporter. No concomitant medication  information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: glands in throat to swell/It feels like i have a golf ball in my throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (glands in throat to swell/It feels like i have a golf ball in my throat) 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 LYMPHADENOPATHY (glands in throat to swell/It feels like i have a golf ball in my throat). At the time of the report, LYMPHADENOPATHY (glands in throat to swell/It feels like i have a golf ball in my throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PROGESTERONE and ESTRADIOL for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site pain). At the time of the report, VACCINATION SITE PAIN (Sore injection site pain) 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 treatment medication provided by reporter.   This case was linked to MOD-2021-239156.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.). On 21-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 07-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 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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Product dose omission issue
Clinical narrative: I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in; have not taken shot since 4/22/2021; and they said I had the Flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu) 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 22-Apr-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 FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu). At the time of the report, FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Pollakiuria
Clinical narrative: stomach ache; excessive urination; Body Chills; Debilitating Headache/headache was sensitive to light; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21 and 038C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PROGESTERONE and ESTRADIOL for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light). On 27-Jun-2021, ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light) had resolved.            No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-239147 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vertigo CNS origin, Vomiting
Clinical narrative: "Horrendous case of vertigo",; Cerebellar vertigo; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-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 an unknown date, the patient experienced VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting). The patient was treated with SALINE [SODIUM CHLORIDE] for Vomiting, at a dose of UNK dosage form and MECLIZINE HCL for Vomiting, at a dose of UNK dosage form. At the time of the report, VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse 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 EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) 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.   no concomitant medications were reported. no treatment drugs were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN, PARACETAMOL (ACETAMINOPHEN) and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, 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.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-239201 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat) 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 03-May-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat). At the time of the report, HEART RATE INCREASED (rapid heartbeat) outcome was unknown.            the patient received the first dose of vaccination on January 2021 and the second dose was received on February 2021. No concomitant medications and treatment information were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Nausea, Vaccination complication, Vaccination site reaction, Vomiting
Clinical narrative: throwing up twice the next day; Nausea; after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Sickness), VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN GLARGINE (LANTUS XR), METFORMIN, ATORVASTATIN, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) and VITAMIN D3 for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sickness). On an unknown date, the patient experienced VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything). On 30-Mar-2021, VACCINATION COMPLICATION (Sickness) had resolved. At the time of the report, VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood glucose increased: increased (High) increased..     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.   N0 treatment medication provided by reporter.   This case was linked to MOD-2021-239097 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up appended
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Loss of personal independence in daily activities, Mobility decreased, Nausea, Pain
Clinical narrative: Could not drive; Immobilized for 3 days in bed; Fever; Nausea; Arm was tender; Lethargy; Generalized burning pain; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive) and MOBILITY DECREASED (Immobilized for 3 days in bed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy in 1994. Concurrent medical conditions included Drug allergy (Allergy to Narcotics), Allergy to edible fungus (Allergy to Yeast), Allergy to nuts (Allergy to Peanuts), Allergy to vaccine (Tetanus), Fibromyalgia since 2009, Hypoglycemia since 1980, Hypothyroidism since 2015 and Irritable bowel syndrome since 1980. Concomitant products included LEVOTHYROXINE and ESTRADIOL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), MOBILITY DECREASED (Immobilized for 3 days in bed), PYREXIA (Fever) and NAUSEA (Nausea). On 19-Apr-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive). The patient was treated with PARACETAMOL (TYLENOL) for Pain, Fever, Nausea and Lethargy, at a dose of UNK dosage form; IBUPROFEN ongoing since an unknown date for Fever, Pain, Nausea and Lethargy, at a dose of UNK dosage form; GABAPENTIN ongoing since an unknown date for Pain, Fever, Nausea and Lethargy, at a dose of UNK dosage form and MELOXICAM ongoing since an unknown date for Fever, Nausea, Pain and Lethargy, at a dose of UNK dosage form. On 23-Apr-2021, TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive), MOBILITY DECREASED (Immobilized for 3 days in bed), PYREXIA (Fever) and NAUSEA (Nausea) had resolved.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to MOD-2021-073340 (Patient Link).