chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus, Vomiting
Clinical narrative: Patient did not get second dose; tinnitus; arm swollen/rock hard; arm was red; it feels as though you're about to have a stroke or anaphylactic reaction; dizziness,felt as if she got thrown on the high way and hit by the truck,; lymph nodes; fever,; vomiting; joint pain; chills,; all the symptoms on the FAQ sheet given to her: nausea; muscle aches,; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red) and FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email:  in response to ADR forms. She is in the middle of filling out. Will send later.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain in extremity, Vaccination site erythema
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness of left arm), back pain (extending to neck, shoulder blade and shoulder), chills and vaccination site erythema (red circle around shot site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 10, 2021, patient experienced pain in extremity (soreness of left arm) and chills. On Apr 18, 2021, patient experienced back pain (extending to neck, shoulder blade and shoulder). On Apr 19, 2021, patient experienced vaccination site erythema (red circle around shot site). At the time of the report, pain in extremity (soreness of left arm), back pain (extending to neck, shoulder blade and shoulder), chills and vaccination site erythema (red circle around shot site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. The patient did not take any treatment to treat the events. The concomitant medications included epilepsy medications. Reporter did not allow further contact.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: blood pressure readings are normal but some shoot up; not feeling so well; medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.; medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.; medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling so well), CARDIAC DISORDER (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.), GASTROOESOPHAGEAL REFLUX DISEASE (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.), DIZZINESS (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.) and BLOOD PRESSURE FLUCTUATION (blood pressure readings are normal but some shoot up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified, Psychogenic visual disorder, Acid reflux (esophageal), LBBB since 26-Feb-2021 and Anemia. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for Acid reflux (oesophageal), ALPRAZOLAM for Imbalance hormonal.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (not feeling so well), CARDIAC DISORDER (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.), GASTROOESOPHAGEAL REFLUX DISEASE (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.) and DIZZINESS (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure readings are normal but some shoot up). At the time of the report, MALAISE (not feeling so well) and BLOOD PRESSURE FLUCTUATION (blood pressure readings are normal but some shoot up) outcome was unknown and CARDIAC DISORDER (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.), GASTROOESOPHAGEAL REFLUX DISEASE (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.) and DIZZINESS (medical conditions started to get worse/heart condition, psychogenic dizziness and acid reflux.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-163870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Significant follow up received on 24-may-2021, Reporter address updated, Patient demographics, ethnicity and race updated, patient medical history updated, concomitant medication updated.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Influenza like illness
Clinical narrative: Congestion in his chest and some tightness too; Flu like symptoms; Feeling really tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Congestion in his chest and some tightness too), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Feeling really tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M201A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced CHEST DISCOMFORT (Congestion in his chest and some tightness too), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Feeling really tired). At the time of the report, CHEST DISCOMFORT (Congestion in his chest and some tightness too), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Feeling really tired) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Increased heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Dementia. Concomitant products included PREDNISONE for Rheumatoid arthritis.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (Increased heart rate). On 20-Mar-2021, HEART RATE INCREASED (Increased heart rate) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.  Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-080368 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 02-Aug-2021: Relevant medical history was updated. On 09-Aug-2021: Follow up received included no new information.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded. MOD-2021-080368:Second dose of vaccine case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: stuffy nose; chills; injection arm pain; thinks she has a fever; body pains; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), CHILLS (chills), INJECTION SITE PAIN (injection arm pain), PYREXIA (thinks she has a fever) and MYALGIA (body pains) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history provided by reporter.     On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced NASAL CONGESTION (stuffy nose), CHILLS (chills), INJECTION SITE PAIN (injection arm pain), PYREXIA (thinks she has a fever) and MYALGIA (body pains). On 20-Apr-2021, NASAL CONGESTION (stuffy nose), CHILLS (chills), INJECTION SITE PAIN (injection arm pain), PYREXIA (thinks she has a fever) and MYALGIA (body pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Nature's Bounty Immu  for Immunity booster.  Treatment information was not provided.   This case was linked to MOD-2021-187259 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-MAY-2021 contains significant information- Patient demographics, concomitant medications, event outcome added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: muscle spasm; Explosive diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhea) and MUSCLE SPASMS (muscle spasm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (Explosive diarrhea). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at a dose of 1 dosage form. On 20-Mar-2021, DIARRHOEA (Explosive diarrhea) had resolved. At the time of the report, MUSCLE SPASMS (muscle spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-080395 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080395:2nd dose event
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 18-Apr-2021, NAUSEA (Nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Concussion, Heart attack and Brain operation NOS. Concomitant products included TERIPARATIDE (FORTEO) and GABAPENTIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 25-Mar-2021, PAIN IN EXTREMITY (Pain in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included heart medications and medications for recent brain surgery.   It was reported that the patient is scheduled for her second dose on 20-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-AUG-2021,contains new information. Patient information, medical history, concomitant medicine and treatment medicine was updated and an event was added. On 02-Aug-2021: Non significant FU_Contact information updated and caller doesn't want safety to follow up with her on AE.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chapped lips, Lip disorder, Lip swelling, Oral discomfort
Clinical narrative: both top and bottom lips have small tiny bumps; lips were swollen; lips look burnt; fever blister; burning; cracked; bump on lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (bump on lips), ORAL HERPES (fever blister), BURNING SENSATION (burning), CHAPPED LIPS (cracked) and LIP SWELLING (lips were swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, CLONAZEPAM (KLONOPIN), ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) and OMEPRAZOLE.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced LIP DISORDER (bump on lips). On 03-Apr-2021, the patient experienced ORAL HERPES (fever blister), BURNING SENSATION (burning) and CHAPPED LIPS (cracked). On 06-Apr-2021, the patient experienced LIP SWELLING (lips were swollen) and ORAL DISCOMFORT (lips look burnt). On 19-Apr-2021, the patient experienced LIP DISORDER (both top and bottom lips have small tiny bumps). At the time of the report, LIP DISORDER (bump on lips), ORAL HERPES (fever blister), BURNING SENSATION (burning), CHAPPED LIPS (cracked), LIP SWELLING (lips were swollen), ORAL DISCOMFORT (lips look burnt) and LIP DISORDER (both top and bottom lips have small tiny bumps) 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: both top and bottom lips have small tiny bumps; lips were swollen; lips look burnt; fever blister; burning; cracked; bump on lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (bump on lips), ORAL HERPES (fever blister), BURNING SENSATION (burning), CHAPPED LIPS (cracked) and LIP SWELLING (lips were swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, CLONAZEPAM (KLONOPIN), ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) and OMEPRAZOLE.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced LIP DISORDER (bump on lips). On 03-Apr-2021, the patient experienced ORAL HERPES (fever blister), BURNING SENSATION (burning) and CHAPPED LIPS (cracked). On 06-Apr-2021, the patient experienced LIP SWELLING (lips were swollen) and ORAL DISCOMFORT (lips look burnt). On 19-Apr-2021, the patient experienced LIP DISORDER (both top and bottom lips have small tiny bumps). At the time of the report, LIP DISORDER (bump on lips), ORAL HERPES (fever blister), BURNING SENSATION (burning), CHAPPED LIPS (cracked), LIP SWELLING (lips were swollen), ORAL DISCOMFORT (lips look burnt) and LIP DISORDER (both top and bottom lips have small tiny bumps) 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: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate for about an hour after the second dose), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 008B21-2A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis and Dementia. Concomitant products included PREDNISONE for Rheumatoid arthritis. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (increased heart rate for about an hour after the second dose). On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 17-Apr-2021, HEART RATE INCREASED (increased heart rate for about an hour after the second dose) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Heart rate: increased (High) Increased heart rate and normal (normal) Heart beat became normal. Treatment information was not provided. This case was linked to MOD-2021-080357 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR added to case-denied further FU; On 09-Aug-2021: Significant Follow-up : Patient current condition (Dementia) was added.; Sender's Comments: MOD-2021-080357:First dose of vaccine case.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Tinnitus, Tongue discomfort
Clinical narrative: Head was burning; Ringing in her ear; her tongue was burning; This spontaneous case was reported by a health care professional and describes the occurrence of BURNING SENSATION (Head was burning), TINNITUS (Ringing in her ear) and TONGUE DISCOMFORT (her tongue was burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Head was burning), TINNITUS (Ringing in her ear) and TONGUE DISCOMFORT (her tongue was burning). At the time of the report, BURNING SENSATION (Head was burning), TINNITUS (Ringing in her ear) and TONGUE DISCOMFORT (her tongue was burning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment was given.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Slight exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slight exhaustion) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Slight exhaustion). At the time of the report, FATIGUE (Slight exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Myalgia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of anosmia (loss of smell and taste), nasal congestion (congested), ageusia (loss of taste and smell) and myalgia  (soreness of the arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 vaccination. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient had myalgia (soreness of the arm). On Apr 6, 2021, patient experienced anosmia (loss of smell and taste), nasal congestion (congested) and ageusia (loss of taste and smell). At the time of the report, anosmia (loss of smell and taste), nasal congestion (congested), ageusia (loss of taste and smell) and myalgia (soreness of the arm) outcome: unknown. Diagnostic results: On Apr 6, 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Fatigue, Feeling abnormal, Herpes zoster, Product dose omission issue
Clinical narrative: Shingles; Swelling outside of her ear and behind ear; Noticed spots on neck; Feeling unhappy; Patient did not take the second dose of vaccine; Big and painful rash characterized by patches and spots on her neck; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy) and PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O43L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy), PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine), RASH (Big and painful rash characterized by patches and spots on her neck) and FATIGUE (Tired). At the time of the report, HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy), RASH (Big and painful rash characterized by patches and spots on her neck) and FATIGUE (Tired) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant Text: The patient post receiving their first dose of vaccine experienced big and painful rash characterized by patches on their neck and swelling behind and outside of their ear. Patient visited their primary care physician. The doctor said it might be shingles and prescribed Valacyclovir for the event.  The patient also reported that the shingles and the vaccination administered site were on the same side (Left side). The patient's second dose is due on 05 May 2021 which has already passed the 42-day mark.  No Concomitant product use was reported.  Treatment medication prescribed for the event shingles included Valaciclovir.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Shingles; Swelling outside of her ear and behind ear; Noticed spots on neck; Feeling unhappy; Patient did not take the second dose of vaccine; Big and painful rash characterized by patches and spots on her neck; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy) and PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O43L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy), PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine), RASH (Big and painful rash characterized by patches and spots on her neck) and FATIGUE (Tired). At the time of the report, HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy), RASH (Big and painful rash characterized by patches and spots on her neck) and FATIGUE (Tired) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant Text: The patient post receiving their first dose of vaccine experienced big and painful rash characterized by patches on their neck and swelling behind and outside of their ear. Patient visited their primary care physician. The doctor said it might be shingles and prescribed Valacyclovir for the event.  The patient also reported that the shingles and the vaccination administered site were on the same side (Left side). The patient's second dose is due on 05 May 2021 which has already passed the 42-day mark.  No Concomitant product use was reported.  Treatment medication prescribed for the event shingles included Valaciclovir.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Nurse administered second dose 19 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (Nurse administered second dose 19 days after first dose) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced OFF LABEL USE (Nurse administered second dose 19 days after first dose). On 18-Apr-2021, OFF LABEL USE (Nurse administered second dose 19 days after first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 18-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 PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) 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-2021-080348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No new information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash pruritic, Vaccination site rash
Clinical narrative: sore arm; Rash is itchy; Large red rash at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH PRURITIC (Rash is itchy), VACCINATION SITE RASH (Large red rash at the injection site) and HEADACHE (headache) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), RASH PRURITIC (Rash is itchy), VACCINATION SITE RASH (Large red rash at the injection site) and HEADACHE (headache). In April 2021, PAIN IN EXTREMITY (sore arm), RASH PRURITIC (Rash is itchy) and HEADACHE (headache) outcome was unknown. At the time of the report, VACCINATION SITE RASH (Large red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed her appointment second dose on 9 Apr 2021 because she is wheel-chair bound and did not have someone to transport her to the appointment; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her appointment second dose on 9 Apr 2021 because she is wheel-chair bound and did not have someone to transport her to the appointment) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for Arthritis, ATENOLOL and AMLODIPINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her appointment second dose on 9 Apr 2021 because she is wheel-chair bound and did not have someone to transport her to the appointment). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her appointment second dose on 9 Apr 2021 because she is wheel-chair bound and did not have someone to transport her to the appointment) 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: does not feel that good; low grade fever; Fever; arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is hurting), FEELING ABNORMAL (does not feel that good), PYREXIA (Fever) and PYREXIA (low grade fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is hurting). On 18-Apr-2021, the patient experienced PYREXIA (Fever). On 19-Apr-2021, the patient experienced FEELING ABNORMAL (does not feel that good) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (arm is hurting), FEELING ABNORMAL (does not feel that good), PYREXIA (Fever) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was provided. Action taken with mRNA-1273 in response to the event was unknown
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: received the first dose around 10:00 AM and after his arm hurt for a couple days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (received the first dose around 10:00 AM and after his arm hurt for a couple days.) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021321A, 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (received the first dose around 10:00 AM and after his arm hurt for a couple days.). On 19-Mar-2021, VACCINATION SITE PAIN (received the first dose around 10:00 AM and after his arm hurt for a couple days.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   This case was linked to MOD-2021-080394 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Added reporter details and outcome of the event arm hurt is recovered. On 23-Jul-2021: follow-up received on 22-jul-2021 contains no new information On 10-Aug-2021: follow-up received on 10-Aug-2021: Event stop date updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Liver function test, Pyrexia
Clinical narrative: Chills; Fever; Felt tired; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Felt tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ROSUVASTATIN, OLANZAPINE, MULTIVITAMINS [VITAMINS NOS], VITAMIN B12 [VITAMIN B12 NOS], FISH OIL and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Felt tired). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Felt tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Liver function test: abnormal abnormal (High) Alanine aminotransferase level was elevated.         No treatment medications were reported.  The action taken with mRNA 1273 with the events were considered as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Lymphadenopathy, Myalgia
Clinical narrative: extreme dizziness - severity of dizziness is very annoying; extreme pain in right arm; headache; swelling of lymph node; chills; a little bit body ache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness - severity of dizziness is very annoying), PAIN IN EXTREMITY (extreme pain in right arm), HEADACHE (headache), LYMPHADENOPATHY (swelling of lymph node) and CHILLS (chills) in a female patient of an unknown age 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 COVID-19 in June 2020 and Colostomy in August 2020.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DIZZINESS (extreme dizziness - severity of dizziness is very annoying), PAIN IN EXTREMITY (extreme pain in right arm), HEADACHE (headache), LYMPHADENOPATHY (swelling of lymph node), CHILLS (chills) and MYALGIA (a little bit body ache). At the time of the report, DIZZINESS (extreme dizziness - severity of dizziness is very annoying), HEADACHE (headache) and MYALGIA (a little bit body ache) had not resolved and PAIN IN EXTREMITY (extreme pain in right arm), LYMPHADENOPATHY (swelling of lymph node) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Ibuprofen, Fexofenadine, Cetirizine and ice. Concomitant medication not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: extreme dizziness - severity of dizziness is very annoying; extreme pain in right arm; headache; swelling of lymph node; chills; a little bit body ache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness - severity of dizziness is very annoying), PAIN IN EXTREMITY (extreme pain in right arm), HEADACHE (headache), LYMPHADENOPATHY (swelling of lymph node) and CHILLS (chills) in a female patient of an unknown age 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 COVID-19 in June 2020 and Colostomy in August 2020.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DIZZINESS (extreme dizziness - severity of dizziness is very annoying), PAIN IN EXTREMITY (extreme pain in right arm), HEADACHE (headache), LYMPHADENOPATHY (swelling of lymph node), CHILLS (chills) and MYALGIA (a little bit body ache). At the time of the report, DIZZINESS (extreme dizziness - severity of dizziness is very annoying), HEADACHE (headache) and MYALGIA (a little bit body ache) had not resolved and PAIN IN EXTREMITY (extreme pain in right arm), LYMPHADENOPATHY (swelling of lymph node) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Ibuprofen, Fexofenadine, Cetirizine and ice. Concomitant medication not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Appetite pretty much zero; Lost 8-10 pounds in three weeks; skin senstivity; achey body; Super tired; Feet hurt; Abdomen tightness; Diarrhea / loose stool; Tingling sensation; Numbness; Felt like tired muscles all over the body; Joint pains; Swollen lymph node under armpit; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), MUSCULAR WEAKNESS (Felt like tired muscles all over the body), PAIN IN EXTREMITY (Feet hurt) and ABDOMINAL DISCOMFORT (Abdomen tightness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under armpit). On 27-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), MUSCULAR WEAKNESS (Felt like tired muscles all over the body), DIARRHOEA (Diarrhea / loose stool) and ARTHRALGIA (Joint pains). On 05-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Abdomen tightness). On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Feet hurt) and FATIGUE (Super tired). On 01-May-2021, the patient experienced SENSITIVE SKIN (skin senstivity) and MYALGIA (achey body). On an unknown date, the patient experienced DECREASED APPETITE (Appetite pretty much zero) and WEIGHT DECREASED (Lost 8-10 pounds in three weeks). On 08-Apr-2021, ARTHRALGIA (Joint pains) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), MUSCULAR WEAKNESS (Felt like tired muscles all over the body), PAIN IN EXTREMITY (Feet hurt), DECREASED APPETITE (Appetite pretty much zero), WEIGHT DECREASED (Lost 8-10 pounds in three weeks), LYMPHADENOPATHY (Swollen lymph node under armpit) and FATIGUE (Super tired) was resolving and ABDOMINAL DISCOMFORT (Abdomen tightness) and DIARRHOEA (Diarrhea / loose stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment details was not provided. The patient reports that she felt fine for a week post vaccination except swollen lymph nodes and for two weeks the symptoms were bad then started to get better in third week but still had abdomen tightness and loose stool. She also felt sensation in her body kept changing.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Initial Addition Info Received on 27-Apr-2021 and it contains reporter address  AE start date, additional AE, medication taken and consumer saying that : I feel much better now and able to live a normal life but I'm not 100% back to baseline.