chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 18 patients recieved dose from underfilled vials, 9 doses each vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (18 patients recieved dose from underfilled vials, 9 doses each vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (18 patients recieved dose from underfilled vials, 9 doses each vial). At the time of the report, INCORRECT DOSE ADMINISTERED (18 patients recieved dose from underfilled vials, 9 doses each vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The Pharmacist reported that one of their locations had two vials that only contained nine doses each. For both vials the lot number 014M20A and Expiration 12-Aug-2021.  The vials are not available for return and were discarded.  The nine doses in each vial were given to patients.  At that time there are no patient identifiers. Pharmacist stated that it may be possible to get identifiers for all the patient that were given that lot for that day/location but not sure if can single out the 18 patients who specifically got those does out of the two short dosed vials.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Animal bite
Clinical narrative: Squirrel bite; This spontaneous case was reported by a consumer and describes the occurrence of ANIMAL BITE (Squirrel bite) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (She had squirrel bite today and she received Tetanus toxoid vaccine.) since 16-Mar-2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ANIMAL BITE (Squirrel bite). At the time of the report, ANIMAL BITE (Squirrel bite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Diarrhoea, Dysmenorrhoea, Fatigue
Clinical narrative: Stomach upset; Period cramps; Bloating; Gas; Diarrhea (She goes to the bathroom 3-4 times a day); Muscle cramps; Headache; Fatigue; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas) and DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B26A and L031321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas), DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)), MUSCLE SPASMS (Muscle cramps), HEADACHE (Headache), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas), DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)), MUSCLE SPASMS (Muscle cramps), HEADACHE (Headache), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-142570 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Headache, Lymphadenopathy, Muscle spasms
Clinical narrative: Stomach upset; Period cramps; Bloating; Gas; Diarrhea (She goes to the bathroom 3-4 times a day); Muscle cramps; Headache; Fatigue; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas) and DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B26A and L031321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas), DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)), MUSCLE SPASMS (Muscle cramps), HEADACHE (Headache), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas), DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)), MUSCLE SPASMS (Muscle cramps), HEADACHE (Headache), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-142570 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus, Rash, Vaccination site pain
Clinical narrative: Bumps all over my body, some big & some small ones; Minimal itching; Some that are patchy, like a rash; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Bumps all over my body, some big & some small ones), PRURITUS (Minimal itching), RASH (Some that are patchy, like a rash) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 14-May-2021, the patient experienced MASS (Bumps all over my body, some big & some small ones), PRURITUS (Minimal itching) and RASH (Some that are patchy, like a rash). At the time of the report, MASS (Bumps all over my body, some big & some small ones), PRURITUS (Minimal itching), RASH (Some that are patchy, like a rash) and VACCINATION SITE PAIN (Sore arm 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 medications were provided by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermatographia all over body; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographia all over body) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced MECHANICAL URTICARIA (Dermatographia all over body). At the time of the report, MECHANICAL URTICARIA (Dermatographia all over body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. No concomitant medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle soreness all over her body; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness all over her body) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L031321A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (Muscle soreness all over her body) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Muscle soreness all over her body) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.   This case was linked to MOD-2021-142546 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Rash erythematous, Skin reaction, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: hot to the touch near/around injection site; red near/around injection site; itchy  near/around injection site; swollen near/around injection site; large local reaction 8 days after first injection; Red rash; reaction was red and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (large local reaction 8 days after first injection), RASH ERYTHEMATOUS (Red rash), MILIARIA (reaction was red and warm to the touch), VACCINATION SITE WARMTH (hot to the touch near/around injection site) and VACCINATION SITE ERYTHEMA (red near/around injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C2114 and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever. Concurrent medical conditions included Food allergy (mushrooms-Shortness of breath, tight throat) since 2006 and Food allergy (seaweed-Shortness of breath, tight throat) since 2012.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Mar-2021, the patient experienced SKIN REACTION (large local reaction 8 days after first injection), RASH ERYTHEMATOUS (Red rash) and MILIARIA (reaction was red and warm to the touch). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch near/around injection site), VACCINATION SITE ERYTHEMA (red near/around injection site), VACCINATION SITE PRURITUS (itchy  near/around injection site) and VACCINATION SITE SWELLING (swollen near/around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 4 Tab once a day and IBUPROFEN (ADVIL [IBUPROFEN]) from 01-Apr-2021 to 06-Apr-2021 at a dose of 6 Tab once a day. On 06-Apr-2021, SKIN REACTION (large local reaction 8 days after first injection), RASH ERYTHEMATOUS (Red rash) and MILIARIA (reaction was red and warm to the touch) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to the touch near/around injection site) and VACCINATION SITE ERYTHEMA (red near/around injection site) had not resolved and VACCINATION SITE PRURITUS (itchy  near/around injection site) and VACCINATION SITE SWELLING (swollen near/around injection site) outcome was unknown.            No concomitant medications were reported.    This case was linked to MOD-2021-069557.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-Up was received on 08-JUL-2021 and contain Non-Significant information. On 16-Jul-2021: Significant follow up Added :-AE not resolved
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to the touch near/around injection site; red near/around injection site; itchy  near/around injection site; swollen near/around injection site; large local reaction 8 days after first injection; Red rash; reaction was red and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (large local reaction 8 days after first injection), RASH ERYTHEMATOUS (Red rash), MILIARIA (reaction was red and warm to the touch), VACCINATION SITE WARMTH (hot to the touch near/around injection site) and VACCINATION SITE ERYTHEMA (red near/around injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C2114 and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever. Concurrent medical conditions included Food allergy (mushrooms-Shortness of breath, tight throat) since 2006 and Food allergy (seaweed-Shortness of breath, tight throat) since 2012.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Mar-2021, the patient experienced SKIN REACTION (large local reaction 8 days after first injection), RASH ERYTHEMATOUS (Red rash) and MILIARIA (reaction was red and warm to the touch). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch near/around injection site), VACCINATION SITE ERYTHEMA (red near/around injection site), VACCINATION SITE PRURITUS (itchy  near/around injection site) and VACCINATION SITE SWELLING (swollen near/around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 4 Tab once a day and IBUPROFEN (ADVIL [IBUPROFEN]) from 01-Apr-2021 to 06-Apr-2021 at a dose of 6 Tab once a day. On 06-Apr-2021, SKIN REACTION (large local reaction 8 days after first injection), RASH ERYTHEMATOUS (Red rash) and MILIARIA (reaction was red and warm to the touch) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to the touch near/around injection site) and VACCINATION SITE ERYTHEMA (red near/around injection site) had not resolved and VACCINATION SITE PRURITUS (itchy  near/around injection site) and VACCINATION SITE SWELLING (swollen near/around injection site) outcome was unknown.            No concomitant medications were reported.    This case was linked to MOD-2021-069557.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-Up was received on 08-JUL-2021 and contain Non-Significant information. On 16-Jul-2021: Significant follow up Added :-AE not resolved
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Covid arm; delayed hypo allergic reaction; It was red and elevated with 7 or 8cm of diameter at the injection site; It was red and elevated with 7 or 8cm of diameter at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (delayed hypo allergic reaction), VACCINATION SITE SWELLING (It was red and elevated with 7 or 8cm of diameter at the injection site) and VACCINATION SITE ERYTHEMA (It was red and elevated with 7 or 8cm of diameter at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (delayed hypo allergic reaction), VACCINATION SITE SWELLING (It was red and elevated with 7 or 8cm of diameter at the injection site) and VACCINATION SITE ERYTHEMA (It was red and elevated with 7 or 8cm of diameter at the injection site). On 16-May-2021, VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (delayed hypo allergic reaction), VACCINATION SITE SWELLING (It was red and elevated with 7 or 8cm of diameter at the injection site) and VACCINATION SITE ERYTHEMA (It was red and elevated with 7 or 8cm of diameter at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Herpes zoster, Myalgia, Pain
Clinical narrative: needle kind of pain on my torso and back; skin really burnt; Shingles; Rash coming out of my left leg; I had ache and pains; Started feeling kind of rough; I had back pain and it was shooting up down the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt) and HERPES ZOSTER (Shingles) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included AZATHIOPRINE for Ulcerative colitis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt), HERPES ZOSTER (Shingles), RASH (Rash coming out of my left leg) and MYALGIA (I had ache and pains). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) in May 2021 for Shingles, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt), RASH (Rash coming out of my left leg) and MYALGIA (I had ache and pains) outcome was unknown and HERPES ZOSTER (Shingles) was resolving.            The patient contacted gastroenterologist. They wanted him to see a dermatologist who confirmed that patient had shingles. The patient was fully vaccinated for shingles and still got it which was very shocking.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: needle kind of pain on my torso and back; skin really burnt; Shingles; Rash coming out of my left leg; I had ache and pains; Started feeling kind of rough; I had back pain and it was shooting up down the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt) and HERPES ZOSTER (Shingles) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included AZATHIOPRINE for Ulcerative colitis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt), HERPES ZOSTER (Shingles), RASH (Rash coming out of my left leg) and MYALGIA (I had ache and pains). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) in May 2021 for Shingles, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt), RASH (Rash coming out of my left leg) and MYALGIA (I had ache and pains) outcome was unknown and HERPES ZOSTER (Shingles) was resolving.            The patient contacted gastroenterologist. They wanted him to see a dermatologist who confirmed that patient had shingles. The patient was fully vaccinated for shingles and still got it which was very shocking.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: difficulty breathing; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and PYREXIA (low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergies were ongoing and have been really bad for the last two weeks. Allergies were not worse since receiving the vaccine.).    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (difficulty breathing) and PYREXIA (low grade fever). At the time of the report, DYSPNOEA (difficulty breathing) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant FU: Outcome of events reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient did not receive full second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient did not receive full second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient did not receive full second dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient did not receive full second dose) had resolved. 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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: diarrhea; vomited; low grade fever (around 100 degrees F); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (low grade fever (around 100 degrees F)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 in Dec/2020 and was hospitalized until February. She had some blood clots during the COVID-19 hospitalization. She still had a cough and used oxygen.) in December 2020. Concurrent medical conditions included Cough.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Apr-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (low grade fever (around 100 degrees F)). On 18-Apr-2021, DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (low grade fever (around 100 degrees F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 100 degrees f (High) 100 degrees F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. The patient drank water and juice.   This case was linked to MOD-2021-142683 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site discolouration
Clinical narrative: Upper arm turned light pink / pink area on the arm came back after it went away; Two small pink blotches developed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Upper arm turned light pink / pink area on the arm came back after it went away) and RASH MACULAR (Two small pink blotches developed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Cancer surgery (done 22 years ago). Concurrent medical conditions included Lymphedema (Lymphedema in right arm from a breast cancer surgery from 22 years ago), Rosacea (takes a facial ointment for Rosacea), Oral herpes (last time  outbreak was 8 years ago and then got an outbreak one week before the first vaccine) and Sensitive skin (skin is so sensitive. Can't wear a bandage). Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Oral herpes, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Upper arm turned light pink / pink area on the arm came back after it went away) and RASH MACULAR (Two small pink blotches developed). At the time of the report, VACCINATION SITE DISCOLOURATION (Upper arm turned light pink / pink area on the arm came back after it went away) outcome was unknown and RASH MACULAR (Two small pink blotches developed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She went grocery shopping right after vaccine and had no other reaction. The next day, she called the dermatologist and by the time they called her back she was able to get to a public computer and saw there was something called Covid arm, so she was not very concerned. About 5 days later, the pink came back again, no blotchy, no other reaction at all. She went back to the library to use the public computer, and it seems like the second time the pinkish area came back is the most normal. Concomitant medication also included a facial treatment for Rosacea. The patient did not receive any treatment medications.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: patient needed to be vaccinated again because of the wrong temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient needed to be vaccinated again because of the wrong temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient needed to be vaccinated again because of the wrong temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient needed to be vaccinated again because of the wrong temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: wasn't up to par; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (wasn't up to par), CHILLS (chills) and HEADACHE (bad headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She was hospitalized until February.She had some blood clots during the COVID-19 hospitalization. She still had a cough and used oxygen.) in December 2020. Concurrent medical conditions included Cough.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced CHILLS (chills) and HEADACHE (bad headache). On 17-May-2021, the patient experienced MALAISE (wasn't up to par). The patient was treated with PARACETAMOL (TYLENOL) on 16-May-2021 for Chills and Headache, at a dose of UNK, one time dose. On 17-May-2021, CHILLS (chills) and HEADACHE (bad headache) had resolved. At the time of the report, MALAISE (wasn't up to par) was resolving.            On 18-May-2021, the patient felt better. She made her breakfast by herself. Concomitant medications were not provided.   This case was linked to MOD-2021-142645 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Motion sickness, Nausea, Sleep disorder
Clinical narrative: nausea; motion sickness; I wake up in the middle of the night (1-3x week); This spontaneous case was reported by a patient and describes the occurrence of MOTION SICKNESS (motion sickness), SLEEP DISORDER (I wake up in the middle of the night (1-3x week)) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOTION SICKNESS (motion sickness), SLEEP DISORDER (I wake up in the middle of the night (1-3x week)) and NAUSEA (nausea). At the time of the report, MOTION SICKNESS (motion sickness), SLEEP DISORDER (I wake up in the middle of the night (1-3x week)) and NAUSEA (nausea) outcome was unknown.            No treatment and concomitant medication were not included.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Somnolence
Clinical narrative: Felt a bit dizzy; Slept a lot that same day of the vaccine; Felt a bit tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a bit dizzy), SOMNOLENCE (Slept a lot that same day of the vaccine) and FATIGUE (Felt a bit tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Felt a bit dizzy), SOMNOLENCE (Slept a lot that same day of the vaccine) and FATIGUE (Felt a bit tired). At the time of the report, DIZZINESS (Felt a bit dizzy), SOMNOLENCE (Slept a lot that same day of the vaccine) and FATIGUE (Felt a bit tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-142902 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Just a little pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little pain in the injection site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included COVID-19 (discharged on 25-Mar-2021) on 12-Mar-2021. Concurrent medical conditions included Diabetes.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Just a little pain in the injection site). On 12-Apr-2021, VACCINATION SITE PAIN (Just a little pain in the injection site) had resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.    Concomitant medications included unspecified medicines for diabetes. The patient did not receive any treatment medications.  This case was linked to MOD-2021-143359, MOD-2021-143384 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: NNI.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed). On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: few people on the same pharmacy had the ear infections too; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (few people on the same pharmacy had the ear infections too) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (few people on the same pharmacy had the ear infections too). At the time of the report, EAR INFECTION (few people on the same pharmacy had the ear infections too) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight head ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight head ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Bipolar disorder and Vitamin D deficiency. Concomitant products included CLONAZEPAM (KLONOPIN), PROPRANOLOL HYDROCHLORIDE (INDERAL) and FLUOXETINE HYDROCHLORIDE (PROZAC DURAPAC) for Anxiety, CARBAMAZEPINE (TEGRETOL CR) for Bipolar disorder, VITAMIN D NOS for Vitamin D deficiency.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEADACHE (Slight head ache). The patient was treated with IBUPROFEN on 12-Jan-2021 for Headache, at an unspecified dose and frequency. On 13-Jan-2021, HEADACHE (Slight head ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-142851 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pigmentation disorder
Clinical narrative: Small brown outline on left forearm, not the injection site; It's very tender and hasn't gone away; This spontaneous case was reported by a patient and describes the occurrence of PIGMENTATION DISORDER (Small brown outline on left forearm, not the injection site) and PAIN OF SKIN (It's very tender and hasn't gone away) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PIGMENTATION DISORDER (Small brown outline on left forearm, not the injection site) and PAIN OF SKIN (It's very tender and hasn't gone away). At the time of the report, PIGMENTATION DISORDER (Small brown outline on left forearm, not the injection site) and PAIN OF SKIN (It's very tender and hasn't gone away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non-Significant follow up appended to MOD-2021-142752
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose to be taken 60 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose to be taken 60 days after the first dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose to be taken 60 days after the first dose). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose to be taken 60 days after the first dose) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient; Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient) and DEVICE CONNECTION ISSUE (Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient) and DEVICE CONNECTION ISSUE (Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off). At the time of the report, UNDERDOSE (Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient) and DEVICE CONNECTION ISSUE (Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off) had resolved.        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.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021)) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 PRODUCT DOSE OMISSION ISSUE (more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021)) had resolved.            Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Headache, Hyperhidrosis, Migraine
Clinical narrative: diagnosed her with Migraines; Vomiting; sensation of extreme nausea; Severe headache, pain in the back of head; sweating all my body; like my eyes were going to pop out of my head with pain; pain in the back of neck; Diagnosed her with vertigo; Dizziness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo) and DIZZINESS (Dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Bipolar disorder and Vitamin D deficiency. Concomitant products included CLONAZEPAM (KLONOPIN), PROPRANOLOL HYDROCHLORIDE (INDERAL) and FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, CARBAMAZEPINE (TEGRETOL) for Bipolar disorder, VITAMIN D [VITAMIN D NOS] for Vitamin D deficiency.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo), DIZZINESS (Dizziness) and NAUSEA (sensation of extreme nausea). 03-Apr-2021, the patient experienced HEADACHE (Severe headache, pain in the back of head). On 18-May-2021, the patient experienced MIGRAINE (diagnosed her with Migraines) and VOMITING (Vomiting). The patient was treated with ONDANSETRON for Nausea, at a dose of 4 mg as required; MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg as required; BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Migraine, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 18-May-2021, VOMITING (Vomiting) had resolved. At the time of the report, HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo), DIZZINESS (Dizziness), MIGRAINE (diagnosed her with Migraines), NAUSEA (sensation of extreme nausea) and HEADACHE (Severe headache, pain in the back of head) outcome was unknown.            The patient had three episodes of severe head ache and a sensation of extreme nausea, sweating all my body, pain in back of neck and head, like my eyes were going to pop out of my head with pain. The last episode happened on 18-May-2021. The patient could not remember the other two dates of these episodes. The patient went to emergency room on 18-May-2021 and vomited before entering the emergency room. The patient felt that episodes were becoming more frequent.    This case was linked to MOD-2021-142747 (Patient Link).