chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site nodule
Clinical narrative: INJECTION SITE HARD; INJECTION SITE ITCHY; red around the injection site; INJECTION SITE SWOLLEN; swollen arm; Inflammed arm; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammed arm), PRURITUS (itchy arm), VACCINATION SITE NODULE (INJECTION SITE HARD), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE PRURITUS (INJECTION SITE ITCHY) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics (Quinilones) and Drug allergy (sulfa). Concomitant products included ATORVASTATIN for High cholesterol.   On 24-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INFLAMMATION (Inflammed arm). 25-Jan-2021, the patient experienced PRURITUS (itchy arm) and PERIPHERAL SWELLING (swollen arm). On 27-Jan-2021, the patient experienced VACCINATION SITE NODULE (INJECTION SITE HARD), VACCINATION SITE PRURITUS (INJECTION SITE ITCHY), VACCINATION SITE ERYTHEMA (red around the injection site) and VACCINATION SITE SWELLING (INJECTION SITE SWOLLEN). On 02-Mar-2021, INFLAMMATION (Inflammed arm), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE SWELLING (INJECTION SITE SWOLLEN) had resolved. At the time of the report, PRURITUS (itchy arm) had resolved and VACCINATION SITE NODULE (INJECTION SITE HARD), VACCINATION SITE PRURITUS (INJECTION SITE ITCHY) and VACCINATION SITE ERYTHEMA (red around the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-240838 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received 29-jun-2021: Patient demographic information updated.Second dose information updated, reporter demographic information updated, allergies, concomitant medications updated.events recovered and event dates updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: INJECTION SITE HARD; INJECTION SITE ITCHY; red around the injection site; INJECTION SITE SWOLLEN; swollen arm; Inflammed arm; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammed arm), PRURITUS (itchy arm), VACCINATION SITE NODULE (INJECTION SITE HARD), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE PRURITUS (INJECTION SITE ITCHY) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics (Quinilones) and Drug allergy (sulfa). Concomitant products included ATORVASTATIN for High cholesterol.   On 24-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INFLAMMATION (Inflammed arm). 25-Jan-2021, the patient experienced PRURITUS (itchy arm) and PERIPHERAL SWELLING (swollen arm). On 27-Jan-2021, the patient experienced VACCINATION SITE NODULE (INJECTION SITE HARD), VACCINATION SITE PRURITUS (INJECTION SITE ITCHY), VACCINATION SITE ERYTHEMA (red around the injection site) and VACCINATION SITE SWELLING (INJECTION SITE SWOLLEN). On 02-Mar-2021, INFLAMMATION (Inflammed arm), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE SWELLING (INJECTION SITE SWOLLEN) had resolved. At the time of the report, PRURITUS (itchy arm) had resolved and VACCINATION SITE NODULE (INJECTION SITE HARD), VACCINATION SITE PRURITUS (INJECTION SITE ITCHY) and VACCINATION SITE ERYTHEMA (red around the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-240838 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received 29-jun-2021: Patient demographic information updated.Second dose information updated, reporter demographic information updated, allergies, concomitant medications updated.events recovered and event dates updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; A spontaneous report  was received from a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced dizziness. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of event, dizziness, was resolving at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Inward itchy on arms, back and legs without rash; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Inward itchy on arms, back and legs without rash) and PYREXIA (Low grade fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Allergy. Concomitant products included LORATADINE (CLARATYNE) for Allergy, ASCORBIC ACID (VIT C), VITAMIN D NOS and ZINC for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (Inward itchy on arms, back and legs without rash) and PYREXIA (Low grade fever). At the time of the report, PRURITUS (Inward itchy on arms, back and legs without rash) and PYREXIA (Low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient mentioned that she has lot of bad allergy problems to unspecified antibiotics which causes rash, itchy and takes claratyne and other unspecified medicines not for allergy such as supplements. The patient also takes unspecified medicine for heart problems. Treatment medication included was claratyne before going to bed for the event pruritus. The patient has a schedule to receive the second dose of vaccine on 25 Feb 2021 and would like to know if it interferes with Benadryl the day before with the second vaccine. The patient´s doctor was aware that the patient was about to receive the second vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pruritus, Vaccination site reaction
Clinical narrative: Increased heart rate; Itching at injection site; Dots at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate), INJECTION SITE PRURITUS (Itching at injection site) and VACCINATION SITE REACTION (Dots at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Tachycardia (200 beats per minute 3-4 times a year).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEART RATE INCREASED (Increased heart rate), INJECTION SITE PRURITUS (Itching at injection site) and VACCINATION SITE REACTION (Dots at injection site). On 28-Jan-2021, HEART RATE INCREASED (Increased heart rate) outcome was unknown. At the time of the report, INJECTION SITE PRURITUS (Itching at injection site) and VACCINATION SITE REACTION (Dots at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; Reporter'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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Rash, Sneezing
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing like crazy), RASH (Rash on Stomach that is spreading), HEADACHE (Headache) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination. The patient's past medical history included UTI (Had culture and took anti-biotics). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing like crazy), RASH (Rash on Stomach that is spreading), HEADACHE (Headache) and NAUSEA (Nauseous). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing like crazy), RASH (Rash on Stomach that is spreading), HEADACHE (Headache) and NAUSEA (Nauseous) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Event outcome was updated into recovered from unknown.Event listedness recalculated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Inflammation, Pain, Pain in extremity
Clinical narrative: inflamed; Pain in the arm; Redness; Swelling; severe pain; my arm felt like a rock; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Redness), SWELLING (Swelling), PAIN (severe pain) and INDURATION (my arm felt like a rock) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (sulfa drugs), Latex allergy, Drug allergy (formaldehyde), Hiatal hernia and Anxiety. Concomitant products included SERTRALINE for Anxiety, OMEPRAZOLE for Hiatal hernia, VITAMINS NOS for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Redness), SWELLING (Swelling), PAIN (severe pain) and INDURATION (my arm felt like a rock). On an unknown date, the patient experienced INFLAMMATION (inflamed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and PAIN (severe pain) had not resolved and ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (my arm felt like a rock) and INFLAMMATION (inflamed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had been to the physician's office. Treatment details included applying ice pad. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-084745 (E2B Linked Report). This case was linked to MOD-2021-084638, MOD-2021-084638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up information received and patient demographics updated, medical history, dosage information, reporter details and events updated.; 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. Further information has been requested. MOD-2021-084745:crosslinked, Husband
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: inflamed; Pain in the arm; Redness; Swelling; severe pain; my arm felt like a rock; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Redness), SWELLING (Swelling), PAIN (severe pain) and INDURATION (my arm felt like a rock) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (sulfa drugs), Latex allergy, Drug allergy (formaldehyde), Hiatal hernia and Anxiety. Concomitant products included SERTRALINE for Anxiety, OMEPRAZOLE for Hiatal hernia, VITAMINS NOS for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Redness), SWELLING (Swelling), PAIN (severe pain) and INDURATION (my arm felt like a rock). On an unknown date, the patient experienced INFLAMMATION (inflamed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and PAIN (severe pain) had not resolved and ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (my arm felt like a rock) and INFLAMMATION (inflamed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had been to the physician's office. Treatment details included applying ice pad. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-084745 (E2B Linked Report). This case was linked to MOD-2021-084638, MOD-2021-084638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up information received and patient demographics updated, medical history, dosage information, reporter details and events updated.; 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. Further information has been requested. MOD-2021-084745:crosslinked, Husband
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Oral pruritus, Pruritus
Clinical narrative: itchy mouth; Itchy swollen lips; red swollen face; whole body is itchy; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PRURITUS (itchy mouth), LIP SWELLING (Itchy swollen lips), ERYTHEMA (red swollen face) and PRURITUS (whole body is itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol.    On 23-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 ORAL PRURITUS (itchy mouth), LIP SWELLING (Itchy swollen lips), ERYTHEMA (red swollen face) and PRURITUS (whole body is itchy). At the time of the report, ORAL PRURITUS (itchy mouth), LIP SWELLING (Itchy swollen lips), ERYTHEMA (red swollen face) and PRURITUS (whole body is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Vision blurred
Clinical narrative: sick to her stomache; dizzy; blurry vision, didn't last very long, laid down, and then she was fine; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomache), DIZZINESS (dizzy) and VISION BLURRED (blurry vision, didn't last very long, laid down, and then she was fine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included TRAZODONE for an unknown indication.    On 28-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 ABDOMINAL DISCOMFORT (sick to her stomache), DIZZINESS (dizzy) and VISION BLURRED (blurry vision, didn't last very long, laid down, and then she was fine). At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomache), DIZZINESS (dizzy) and VISION BLURRED (blurry vision, didn't last very long, laid down, and then she was fine) was resolving.        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 event, a causal relationship cannot be excluded
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gastrooesophageal reflux disease, Nausea, Vomiting
Clinical narrative: felt to the floor once, he was conscious all the time; felt dizzy; Acid reflux; throwing up , most of the day; had nausea all the time; A spontaneous report  was received from a Consumer concerning a 80-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, throwing up , most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room, was told he had acid reflux.  The patient's medical history was not provided. Concomitant medications reported were simvastatin for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the events, throwing up. most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room, was told he had acid reflux. Event felt to the floor once, he was conscious all the time was considered medically significant.  Treatment details included unspecified nausea pills, as needed, from the emergency room on 31Jan2021.  Action taken with mRNA-1273 in response to the events, throwing up , most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room, was told he had acid reflux was not reported.   The outcome of events include, throwing up , most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room was told he had acid reflux was not reported.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Erythema, Neuralgia, Swelling
Clinical narrative: nerve pain; like electrical shocks; redness at injection site, intensified and bigger; swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE BITARTRATE (ASTHMAHALER) and GABAPENTIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Around the third or fourth day the redness at the injection site intensified. It started to go away on day 5 but it came back on 28-JAN-2021. It is much more red, swollen, and bigger this time. She was very concerned and wanted to know whether nerve pain was commonly reported and when she should expect the delayed reaction to get better. Treatment information included acetaminophen and ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (injection site was hard/little knot), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site/pink at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE MASS (injection site was hard/little knot), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site/pink at injection site). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) ongoing since an unknown date at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form; CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE (PEPCID COMPLETE) ongoing since an unknown date at a dose of 1 dosage form and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) ongoing since an unknown date at a dose of 1 dosage form. In January 2021, VACCINATION SITE PRURITUS (itchiness at injection site) outcome was unknown. At the time of the report, VACCINATION SITE MASS (injection site was hard/little knot), VACCINATION SITE WARMTH (injection site was hot) and VACCINATION SITE ERYTHEMA (redness at injection site/pink at injection site) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Patient contact detail(email) was updated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Vaccination site rash, Vaccination site swelling
Clinical narrative: high blood pressure; rash at the injection site; a little bit of swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit of swelling at the injection site) in an 82-year-old male 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 HYPERTENSION (high blood pressure), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit of swelling at the injection site). At the time of the report, HYPERTENSION (high blood pressure), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit of swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint noise, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: scarlet fever from neck to toes; diagnosis of strep throat; finger and wrist stiffness; snapping joints; fever; lymphadenopathy; fatigue; myalgia in both hips; arthralgia; This spontaneous case was reported by a physician and describes the occurrence of SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints) and ARTHRALGIA (arthralgia) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ARTHRALGIA (arthralgia), FATIGUE (fatigue) and MYALGIA (myalgia in both hips). On an unknown date, the patient experienced SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints), PYREXIA (fever) and LYMPHADENOPATHY (lymphadenopathy). At the time of the report, SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints), ARTHRALGIA (arthralgia), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (myalgia in both hips) and LYMPHADENOPATHY (lymphadenopathy) 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.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pharyngitis streptococcal, Pyrexia, Scarlet fever
Clinical narrative: scarlet fever from neck to toes; diagnosis of strep throat; finger and wrist stiffness; snapping joints; fever; lymphadenopathy; fatigue; myalgia in both hips; arthralgia; This spontaneous case was reported by a physician and describes the occurrence of SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints) and ARTHRALGIA (arthralgia) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ARTHRALGIA (arthralgia), FATIGUE (fatigue) and MYALGIA (myalgia in both hips). On an unknown date, the patient experienced SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints), PYREXIA (fever) and LYMPHADENOPATHY (lymphadenopathy). At the time of the report, SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints), ARTHRALGIA (arthralgia), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (myalgia in both hips) and LYMPHADENOPATHY (lymphadenopathy) 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.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm became itchy around the injection; Round red blotch around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm became itchy around the injection) and VACCINATION SITE ERYTHEMA (Round red blotch around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm became itchy around the injection) and VACCINATION SITE ERYTHEMA (Round red blotch around the injection site). On 01-Feb-2021, VACCINATION SITE ERYTHEMA (Round red blotch around the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm became itchy around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not use any treatment medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness around where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around where the shot was given) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around where the shot was given). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around where the shot was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 29-Jan-202, redness looked more like a pentagon. It went up 5 inches and the square part was about 4 inches. It was getting bigger in an unusual way. It was no hotter than the rest of her body. It did not itch. It was not a rash. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: spectacular edematous rash about 15 x 7cm around injection site; local pain at injection site; local redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (local pain at injection site), VACCINATION SITE ERYTHEMA (local redness at injection site) and VACCINATION SITE RASH (spectacular edematous rash about 15 x 7cm around injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Food allergy.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (local pain at injection site) and VACCINATION SITE ERYTHEMA (local redness at injection site). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (spectacular edematous rash about 15 x 7cm around injection site). At the time of the report, VACCINATION SITE PAIN (local pain at injection site), VACCINATION SITE ERYTHEMA (local redness at injection site) and VACCINATION SITE RASH (spectacular edematous rash about 15 x 7cm around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included antihypertensives. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Oropharyngeal pain
Clinical narrative: mild cough; little sore throat; feel under the weather; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (mild cough), OROPHARYNGEAL PAIN (little sore throat) and ILLNESS (feel under the weather) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, ATORVASTATIN CALCIUM (LIPITOR), APREMILAST (OTEZLA) and VITAMIN D NOS for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced COUGH (mild cough), OROPHARYNGEAL PAIN (little sore throat) and ILLNESS (feel under the weather). At the time of the report, COUGH (mild cough), OROPHARYNGEAL PAIN (little sore throat) and ILLNESS (feel under the weather) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen, daytime cold and flu medicine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot; Hard; Itching; Swollen; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3 (stage 3). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LOSARTAN, FENOFIBRATE, FUROSEMIDE (LASIX [FUROSEMIDE]), MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (VITAMIN D 3) and ZINC for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.  On 31 Jan 2021, the patient experienced the events itching, redness, swollen, hot, and hard. On 1 Feb 2021, the patient experienced increase to the size of an orange.; 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: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot injection site; Itching injection site; Target shaped red reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE ERYTHEMA (Target shaped red reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM, TROSPIUM, ENALAPRIL, PANTOPRAZOLE, METFORMIN, AMLODIPINE BESYLATE, ATORVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE ERYTHEMA (Target shaped red reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) on 01-Feb-2021 for Itching, at an unspecified dose and frequency and BACITRACIN ZINC, POLYMYXIN B SULFATE (ANTIBIOTIC OINTMENT) on 01-Feb-2021 for Infection, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE ERYTHEMA (Target shaped red reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl to stop the itching and antibiotic cream (unspecified) because it looked like an infection.  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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Tenderness
Clinical narrative: a small red spot; it was tender; it got itchy and larger; a very small amount of redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (a small red spot), TENDERNESS (it was tender), PRURITUS (it got itchy and larger) and ERYTHEMA (a very small amount of redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041(6 or L)20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, OMEPRAZOLE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 16-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 RASH MACULAR (a small red spot), TENDERNESS (it was tender), PRURITUS (it got itchy and larger) and ERYTHEMA (a very small amount of redness). At the time of the report, RASH MACULAR (a small red spot), TENDERNESS (it was tender), PRURITUS (it got itchy and larger) and ERYTHEMA (a very small amount of redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar levels spiked, are extremely high and the insulin is not helping) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol. Concomitant products included INSULIN and METFORMIN for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar levels spiked, are extremely high and the insulin is not helping). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar levels spiked, are extremely high and the insulin is not helping) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment medication included Insulin.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site bruising, Vaccination site pain
Clinical narrative: injection left a bruise; injection was painful, stung; pain and itching in upper upper glands under their arms; pain and itching in upper upper glands under their arms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (injection left a bruise), VACCINATION SITE PAIN (injection was painful, stung), PAIN (pain and itching in upper upper glands under their arms) and PRURITUS (pain and itching in upper upper glands under their arms) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE BRUISING (injection left a bruise), VACCINATION SITE PAIN (injection was painful, stung), PAIN (pain and itching in upper upper glands under their arms) and PRURITUS (pain and itching in upper upper glands under their arms). At the time of the report, VACCINATION SITE BRUISING (injection left a bruise) and VACCINATION SITE PAIN (injection was painful, stung) had not resolved and PAIN (pain and itching in upper upper glands under their arms) and PRURITUS (pain and itching in upper upper glands under their arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she used hot compresses to treat the painful area.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site). On 21-Jan-2021, INJECTION SITE PAIN (Soreness at the injection site) 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 treatment and concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat Closed "tightness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat Closed "tightness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (penicillin and sulfa).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced THROAT TIGHTNESS (Throat Closed "tightness). On 09-Jan-2021, THROAT TIGHTNESS (Throat Closed "tightness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included diphenhydramine twice daily.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash that appeared approximately 9-10 days after she had the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash that appeared approximately 9-10 days after she had the 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 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 RASH (rash that appeared approximately 9-10 days after she had the vaccination). At the time of the report, RASH (rash that appeared approximately 9-10 days after she had the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.