chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt like they could not get enough air; Chest hurt; Every once in a while they feel like they need to take a deep breath; Coughed all night; A little sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (A little sore arm), COUGH (Coughed all night), DYSPNOEA (Felt like they could not get enough air), CHEST PAIN (Chest hurt) and MALAISE (Every once in a while they feel like they need to take a deep breath) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm). On 06-Feb-2021, the patient experienced COUGH (Coughed all night). On 07-Feb-2021, the patient experienced DYSPNOEA (Felt like they could not get enough air), CHEST PAIN (Chest hurt) and MALAISE (Every once in a while they feel like they need to take a deep breath). On 09-Feb-2021, DYSPNOEA (Felt like they could not get enough air) and CHEST PAIN (Chest hurt) had resolved. At the time of the report, PAIN IN EXTREMITY (A little sore arm), COUGH (Coughed all night) and MALAISE (Every once in a while they feel like they need to take a deep breath) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 93 (normal) Then it went up to 95 and 96..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-160014 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Updated patient contact information. Updated Concomitant product use.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-160014:2nd dose case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash of her calf area; fever and chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash of her calf area) and PYREXIA (fever and chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CHOLESTEROL and Blood Pressure for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Rash of her calf area) and PYREXIA (fever and chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. At the time of the report, RASH (Rash of her calf area) was resolving and PYREXIA (fever and chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), RASH (rash), PRURITUS (itchy) and ERYTHEMA (red) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter.  On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (pain), RASH (rash), PRURITUS (itchy) and ERYTHEMA (red). At the time of the report, PAIN (pain), RASH (rash), PRURITUS (itchy) and ERYTHEMA (red) outcome was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Urticaria
Clinical narrative: Bad sore throat; Hives; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Bad sore throat) and URTICARIA (Hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Bad sore throat) and URTICARIA (Hives). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Bad sore throat) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, HEADACHE (Headache) and MYALGIA (Body ache) had not resolved. Not Provided          Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Had chills; Felt tired; headache; Was nauseous; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Had chills), FATIGUE (Felt tired), HEADACHE (headache) and NAUSEA (Was nauseous) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), ATORVASTATIN CALCIUM (LIPITOR), FLUOXETINE HYDROCHLORIDE (PROZAC) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Had chills), FATIGUE (Felt tired), HEADACHE (headache) and NAUSEA (Was nauseous). At the time of the report, CHILLS (Had chills), FATIGUE (Felt tired), HEADACHE (headache) and NAUSEA (Was nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site is very warm; Injection sire is more red; Arm more sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm more sore), VACCINATION SITE WARMTH (Injection site is very warm) and VACCINATION SITE ERYTHEMA (Injection sire is more red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm more sore). On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is very warm) and VACCINATION SITE ERYTHEMA (Injection sire is more red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm more sore), VACCINATION SITE WARMTH (Injection site is very warm) and VACCINATION SITE ERYTHEMA (Injection sire is more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling face, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: large hard knot; Swelling at site of injection; itching in the arm of injection; redness at site of injection; Swelling face; warm at site of injection; Swelling lymph nodes of neck and breast; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast), VACCINATION SITE INDURATION (large hard knot) and VACCINATION SITE SWELLING (Swelling at site of injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (seasame). Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast) and VACCINATION SITE ERYTHEMA (redness at site of injection). On an unknown date, the patient experienced VACCINATION SITE INDURATION (large hard knot), VACCINATION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE PRURITUS (itching in the arm of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling face and Vaccination site swelling, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast), VACCINATION SITE INDURATION (large hard knot), VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE ERYTHEMA (redness at site of injection) and VACCINATION SITE PRURITUS (itching in the arm of injection) 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.   This case was linked to MOD-2021-020217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 and it contains No new information On 07-May-2021: Follow up received on 07-MAY-2021 and added updated patient's demographics. Patient's medical history and concomitant drugs were added. Events were added large hard knot and itching in the arm of injection.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: large hard knot; Swelling at site of injection; itching in the arm of injection; redness at site of injection; Swelling face; warm at site of injection; Swelling lymph nodes of neck and breast; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast), VACCINATION SITE INDURATION (large hard knot) and VACCINATION SITE SWELLING (Swelling at site of injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (seasame). Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast) and VACCINATION SITE ERYTHEMA (redness at site of injection). On an unknown date, the patient experienced VACCINATION SITE INDURATION (large hard knot), VACCINATION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE PRURITUS (itching in the arm of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling face and Vaccination site swelling, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast), VACCINATION SITE INDURATION (large hard knot), VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE ERYTHEMA (redness at site of injection) and VACCINATION SITE PRURITUS (itching in the arm of injection) 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.   This case was linked to MOD-2021-020217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 and it contains No new information On 07-May-2021: Follow up received on 07-MAY-2021 and added updated patient's demographics. Patient's medical history and concomitant drugs were added. Events were added large hard knot and itching in the arm of injection.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 FATIGUE (felt fatigued). At the time of the report, FATIGUE (felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Bedridden, Illness
Clinical narrative: In bed for 3 weeks sicker than a dog; In bed for 3 weeks sicker than a dog; General side effects; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (In bed for 3 weeks sicker than a dog), BEDRIDDEN (In bed for 3 weeks sicker than a dog) and ADVERSE DRUG REACTION (General side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 ILLNESS (In bed for 3 weeks sicker than a dog), BEDRIDDEN (In bed for 3 weeks sicker than a dog) and ADVERSE DRUG REACTION (General side effects). At the time of the report, ILLNESS (In bed for 3 weeks sicker than a dog), BEDRIDDEN (In bed for 3 weeks sicker than a dog) and ADVERSE DRUG REACTION (General side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus
Clinical narrative: Injection site itching; Hard (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE INDURATION (Hard (Injection Site)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE INDURATION (Hard (Injection Site)). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE INDURATION (Hard (Injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Fatigue, Somnolence, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Feel so heavy every time I close my eyes; I'm feeling so sleepy; Itchy at the place where I got the vaccine; Sore at the place where I got vaccine; I'm feeling so tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENOPIA (Feel so heavy every time I close my eyes), SOMNOLENCE (I'm feeling so sleepy), VACCINATION SITE PRURITUS (Itchy at the place where I got the vaccine), VACCINATION SITE PAIN (Sore at the place where I got vaccine) and FATIGUE (I'm feeling so tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and IBUPROFEN for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ASTHENOPIA (Feel so heavy every time I close my eyes), SOMNOLENCE (I'm feeling so sleepy), VACCINATION SITE PRURITUS (Itchy at the place where I got the vaccine), VACCINATION SITE PAIN (Sore at the place where I got vaccine) and FATIGUE (I'm feeling so tired). On 09-Feb-2021, VACCINATION SITE PRURITUS (Itchy at the place where I got the vaccine) and VACCINATION SITE PAIN (Sore at the place where I got vaccine) had resolved. At the time of the report, ASTHENOPIA (Feel so heavy every time I close my eyes), SOMNOLENCE (I'm feeling so sleepy) and FATIGUE (I'm feeling so tired) outcome was unknown.            Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Lost taste; Lost smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste) and ANOSMIA (Lost smell) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-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 08-Feb-2021, the patient experienced AGEUSIA (Lost taste) and ANOSMIA (Lost smell). At the time of the report, AGEUSIA (Lost taste) and ANOSMIA (Lost smell) outcome was unknown. Not Provided          concomitant medicines was not reported by reporter  treatment information was not provided The action taken with mRNA-1273 with the events was considered as not applicable     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site black and blue and warm; Injection site black and blue and warm; Redness extended 6 inches below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Injection site black and blue and warm), VACCINATION SITE WARMTH (Injection site black and blue and warm) and VACCINATION SITE ERYTHEMA (Redness extended 6 inches below injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site black and blue and warm), VACCINATION SITE WARMTH (Injection site black and blue and warm) and VACCINATION SITE ERYTHEMA (Redness extended 6 inches below injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Injection site black and blue and warm), VACCINATION SITE WARMTH (Injection site black and blue and warm) and VACCINATION SITE ERYTHEMA (Redness extended 6 inches below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history and concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received  contains no new significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Metamorphopsia, Somnolence
Clinical narrative: eye was kind of distorted, wavy, weird looking; she was kind of sleeping whole day; headache; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (eye was kind of distorted, wavy, weird looking), SOMNOLENCE (she was kind of sleeping whole day) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney ablation (Partial Kidney removal). Concurrent medical conditions included Arthritis.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced METAMORPHOPSIA (eye was kind of distorted, wavy, weird looking), SOMNOLENCE (she was kind of sleeping whole day) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, METAMORPHOPSIA (eye was kind of distorted, wavy, weird looking), SOMNOLENCE (she was kind of sleeping whole day) and HEADACHE (headache) 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Vaccination site swelling; Vaccination site erythema; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), CHILLS (Chills) and HEADACHE (headache) in a 74-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 RAMIPRIL, METOPROLOL, ISOSORBIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, OXYBUTYNIN, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) and CLINDAMYCIN for an unknown indication.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), CHILLS (Chills) and HEADACHE (headache). On 04-Feb-2021, CHILLS (Chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            No treatment details were reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash all over their body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed rash all over their body) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Developed rash all over their body). At the time of the report, RASH (Developed rash all over their body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included steroid injection and an steroid pack.    This case was linked to US-MODERNATX, INC.-MOD-2021-012597 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-012597:Cross link (patient 1)
Sex: F
Vaccine: COVID19
Symptoms: Chills, Movement disorder, Muscle spasms, Pyrexia
Clinical narrative: muscle cramps on both legs; having hard time getting up; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (Fever), MUSCLE SPASMS (muscle cramps on both legs) and MOVEMENT DISORDER (having hard time getting up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 10-Feb-2021, the patient experienced MUSCLE SPASMS (muscle cramps on both legs) and MOVEMENT DISORDER (having hard time getting up). At the time of the report, CHILLS (chills), PYREXIA (Fever), MUSCLE SPASMS (muscle cramps on both legs) and MOVEMENT DISORDER (having hard time getting up) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Rash, Serum sickness-like reaction, Swelling
Clinical narrative: a serum sickness-like reaction; swelling; a faint rash; joint pain; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SERUM SICKNESS-LIKE REACTION (a serum sickness-like reaction), SWELLING (swelling), RASH (a faint rash), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SERUM SICKNESS-LIKE REACTION (a serum sickness-like reaction), SWELLING (swelling), RASH (a faint rash), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, SERUM SICKNESS-LIKE REACTION (a serum sickness-like reaction), SWELLING (swelling), RASH (a faint rash), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chills, Coronavirus test, Cough, Headache
Clinical narrative: tested positive for covid; Cough; Congested nose; sinus pressure; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), COUGH (Cough), NASAL CONGESTION (Congested nose), PARANASAL SINUS DISCOMFORT (sinus pressure) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced COUGH (Cough), NASAL CONGESTION (Congested nose), PARANASAL SINUS DISCOMFORT (sinus pressure), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On 08-Feb-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid), COUGH (Cough), NASAL CONGESTION (Congested nose), PARANASAL SINUS DISCOMFORT (sinus pressure), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Coronavirus test: (Positive) tested Covid positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Paranasal sinus discomfort, Pyrexia
Clinical narrative: tested positive for covid; Cough; Congested nose; sinus pressure; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), COUGH (Cough), NASAL CONGESTION (Congested nose), PARANASAL SINUS DISCOMFORT (sinus pressure) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced COUGH (Cough), NASAL CONGESTION (Congested nose), PARANASAL SINUS DISCOMFORT (sinus pressure), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On 08-Feb-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid), COUGH (Cough), NASAL CONGESTION (Congested nose), PARANASAL SINUS DISCOMFORT (sinus pressure), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Coronavirus test: (Positive) tested Covid positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Rash, Swelling
Clinical narrative: Shortness of Breath; Swelling; Rash; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of Breath), SWELLING (Swelling), RASH (Rash) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 01-Feb-2021, the patient experienced DYSPNOEA (Shortness of Breath), SWELLING (Swelling), RASH (Rash) and FATIGUE (Fatigue). The patient was treated with FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K) at a dose of UNK dosage form. At the time of the report, DYSPNOEA (Shortness of Breath), SWELLING (Swelling), RASH (Rash) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Pt didn't want to provide contact info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Rhinorrhoea
Clinical narrative: Tested for Covid which came back positive; Cough; Runny nose; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested for Covid which came back positive), COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced COVID-19 (Tested for Covid which came back positive). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested for Covid which came back positive), COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant FU : AE outcome provided
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested for Covid which came back positive; Cough; Runny nose; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested for Covid which came back positive), COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced COVID-19 (Tested for Covid which came back positive). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested for Covid which came back positive), COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant FU : AE outcome provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nocturia
Clinical narrative: Urinated throughout the night; This spontaneous case was reported by a consumer and describes the occurrence of NOCTURIA (Urinated throughout the night) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced NOCTURIA (Urinated throughout the night). At the time of the report, NOCTURIA (Urinated throughout the night) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided. Patient stated that she had taken  some Ibuprofen couple of hours before the shot. Now, she is worried that action might affect the efficacy of the vaccine.   This case was linked to MOD-2021-254015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Added Reporter email id and updated Patient initials and Added anatomical route
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness on the area were she got the injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness on the area were she got the injection.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LETROZOLE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tenderness on the area were she got the injection.). At the time of the report, VACCINATION SITE PAIN (Tenderness on the area were she got the injection.) outcome was unknown. Not Provided      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.   Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever; fFtigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (fFtigue) and HEADACHE (Headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Fever), FATIGUE (fFtigue) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), FATIGUE (fFtigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Reporter did not allow further contact; Sender's Comments:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site is itching; Injection site is burning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site is itching) and VACCINATION SITE PAIN (Injection site is burning) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itching) and VACCINATION SITE PAIN (Injection site is burning). At the time of the report, VACCINATION SITE PRURITUS (Injection site is itching) and VACCINATION SITE PAIN (Injection site is burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Lotion.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Mobility decreased; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Mobility decreased) and VACCINATION SITE PAIN (Vaccination site pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010W20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced MOBILITY DECREASED (Mobility decreased) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MOBILITY DECREASED (Mobility decreased) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-084794 (E2B Linked Report). This case was linked to MOD-2021-027614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: IRD date updated, contact information, email, name, address was updated.; Sender's Comments:  MOD21-084794:follow up - contact information updated - name , email , address
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Lip swelling, Pain in jaw
Clinical narrative: jaw was hurting; ear was closed; lips were swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw was hurting), EAR DISCOMFORT (ear was closed) and LIP SWELLING (lips were swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN JAW (jaw was hurting), EAR DISCOMFORT (ear was closed) and LIP SWELLING (lips were swollen). At the time of the report, PAIN IN JAW (jaw was hurting), EAR DISCOMFORT (ear was closed) and LIP SWELLING (lips were swollen) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2021: Telephone contact, email address provided.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: splitting migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (splitting migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 7:00 AM, the patient experienced MIGRAINE (splitting migraine). The patient was treated with NAPROXEN SODIUM at an unspecified dose and frequency. At the time of the report, MIGRAINE (splitting migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Malaise, Pyrexia
Clinical narrative: Dont feel good; Joints ache; Headache; Fever of 100.5F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Dont feel good), PYREXIA (Fever of 100.5F), ARTHRALGIA (Joints ache) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Jan-2021.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever of 100.5F). On an unknown date, the patient experienced MALAISE (Dont feel good), ARTHRALGIA (Joints ache) and HEADACHE (Headache). At the time of the report, MALAISE (Dont feel good), PYREXIA (Fever of 100.5F), ARTHRALGIA (Joints ache) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.5 °F (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Right side of her upper lip swollen/ then the upper lip; Right cheek was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), TIMOLOL, LATANOPROST, AMLODIPINE BESILATE (NORVASC) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen). At the time of the report, LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.