chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Feeling abnormal, Heavy menstrual bleeding, Menstrual disorder, Tenderness
Clinical narrative: menstruation period stared 7 days early for 3 months in a raw; little tenderness; her menstruation is heavy for first 2 days and then bleeding completely stopped; terrible cramping compared to normal; felt like someone punched her in the face; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation period stared 7 days early for 3 months in a raw), TENDERNESS (little tenderness), HEAVY MENSTRUAL BLEEDING (her menstruation is heavy for first 2 days and then bleeding completely stopped), DYSMENORRHOEA (terrible cramping compared to normal) and FEELING ABNORMAL (felt like someone punched her in the face) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and Acne medication  that is diuretic for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (menstruation period stared 7 days early for 3 months in a raw), TENDERNESS (little tenderness), HEAVY MENSTRUAL BLEEDING (her menstruation is heavy for first 2 days and then bleeding completely stopped), DYSMENORRHOEA (terrible cramping compared to normal) and FEELING ABNORMAL (felt like someone punched her in the face). At the time of the report, MENSTRUAL DISORDER (menstruation period stared 7 days early for 3 months in a raw), TENDERNESS (little tenderness), HEAVY MENSTRUAL BLEEDING (her menstruation is heavy for first 2 days and then bleeding completely stopped), DYSMENORRHOEA (terrible cramping compared to normal) and FEELING ABNORMAL (felt like someone punched her in the face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.  Concomitant medications included Adderall, Acne medication  that is diuretic but do not remember the name of it.  The Action Taken for mRNA-1273(Moderna COVID-19 Vaccine) was unknown     This case was linked to US-MODERNATX, INC.-MOD-2021-231618 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-231618:1st Dose spon. case
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site exfoliation
Clinical narrative: Injection site start peeling; Injection site turn red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE EXFOLIATION (Injection site start peeling) and VACCINATION SITE ERYTHEMA (Injection site turn red) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE EXFOLIATION (Injection site start peeling) and VACCINATION SITE ERYTHEMA (Injection site turn red). At the time of the report, VACCINATION SITE EXFOLIATION (Injection site start peeling) and VACCINATION SITE ERYTHEMA (Injection site turn red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccinated with vaccines that were in the fridge for 33 days; Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) and PRODUCT STORAGE ERROR (Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-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 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) and PRODUCT STORAGE ERROR (Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) and PRODUCT STORAGE ERROR (Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The pharmacy received a box of Moderna COVID 19 vaccine on 19-May-2021 and put the expiration date on the box for the 30 days until 18-Jun-2021. It was stored in the refrigerator which was 37-44 degrees Fahrenheit. The staff did not dispose of the vaccine vials and continued to use it on 22-Jun-2021 to vaccinate five patients with vaccines that were in the fridge for 33 days. The patients were vaccinated with their second dose from 10:00 to 11:00 AM on 22-Jun-2021. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: No new medical information was received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Vaccination site pain
Clinical narrative: lump, the size of a marble on neck (left side) right under ear; tenderness in arm where injection was received; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump, the size of a marble on neck (left side) right under ear) and VACCINATION SITE PAIN (tenderness in arm where injection was received) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     The patient's past medical history included Fracture (Fracture in back) and COVID-19 (she had COVID-19 last August 2020.). Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/APAP) for Back pain, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Vitamin B12 deficiency, PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Vomiting, SERTRALINE HYDROCHLORIDE (ZOLOFT), VITAMIN C [ASCORBIC ACID] and BIOTIN for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK MASS (lump, the size of a marble on neck (left side) right under ear) and VACCINATION SITE PAIN (tenderness in arm where injection was received). At the time of the report, NECK MASS (lump, the size of a marble on neck (left side) right under ear) and VACCINATION SITE PAIN (tenderness in arm where injection was received) had resolved.            Treatment information include Phenergan, Hydrocodone apap, hot pack Reporter reported that patient took concomitant medication biotin for hair skin and nails Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-231691 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Felt like someone punched her in the face after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt like someone punched her in the face after the second dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt like someone punched her in the face after the second dose). At the time of the report, VACCINATION COMPLICATION (Felt like someone punched her in the face after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Medical history was not provided. Additional concomitant product includes Acne medication which is diuretic but does not remember the name of it.  Treatment information was not provided.   This case was linked to MOD-2021-231597 (E2B Linked Report).; Sender's Comments:  MOD-2021-231597:1st Dose spon. case
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: My wife mixed/mixing vaccines series; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (My wife mixed/mixing vaccines series) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (My wife mixed/mixing vaccines series). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (My wife mixed/mixing vaccines series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspepsia, Eye pain, Lacrimation increased, Urine analysis
Clinical narrative: watering  eyes; Heartburn; joint pain; soreness in eyes; This case was received via United States FDA (Reference number: 2020SA366865) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (soreness in eyes), LACRIMATION INCREASED (watering  eyes), DYSPEPSIA (Heartburn) and ARTHRALGIA (joint pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included Rash since an unknown date and Nasal disorder since an unknown date. Concomitant products included DUPILUMAB (DUPIXENT) from 17-Dec-2020 to 22-Jun-2021 for Atopic dermatitis.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2020, the patient experienced EYE PAIN (soreness in eyes). On an unknown date, the patient experienced LACRIMATION INCREASED (watering  eyes), DYSPEPSIA (Heartburn) and ARTHRALGIA (joint pain). At the time of the report, EYE PAIN (soreness in eyes), LACRIMATION INCREASED (watering  eyes), DYSPEPSIA (Heartburn) and ARTHRALGIA (joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Urine analysis: positive for bilirubin positive for bilirubin.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by reporter
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Computerised tomogram, Eating disorder, Malaise
Clinical narrative: felt sick; couldn't eat; couldn't hold anything down; irritation on bottom of stomach; joint pain; pain in shoulder; pain in elbow; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ILLNESS (felt sick), EATING DISORDER (couldn't eat), ABDOMINAL DISCOMFORT (couldn't hold anything down), ABDOMINAL DISCOMFORT (irritation on bottom of stomach) and ARTHRALGIA (joint pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WATER, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for an unknown indication.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced ILLNESS (felt sick), EATING DISORDER (couldn't eat), ABDOMINAL DISCOMFORT (couldn't hold anything down), ABDOMINAL DISCOMFORT (irritation on bottom of stomach), ARTHRALGIA (joint pain), ARTHRALGIA (pain in shoulder) and ARTHRALGIA (pain in elbow). At the time of the report, ILLNESS (felt sick), EATING DISORDER (couldn't eat), ABDOMINAL DISCOMFORT (couldn't hold anything down), ABDOMINAL DISCOMFORT (irritation on bottom of stomach), ARTHRALGIA (joint pain), ARTHRALGIA (pain in shoulder) and ARTHRALGIA (pain in elbow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown normal.         Patient reported he has a previous injury on his arm. On 03-APR2-021 symptoms lightened up. Action taken with mRNA 1273 in response to event was not applicable.   This case was linked to MOD-2021-231678 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash
Clinical narrative: inflammatory reaction on face; rashes; This spontaneous case was reported by a nurse and describes the occurrence of INFLAMMATION (inflammatory reaction on face) and RASH (rashes) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory reaction on face) and RASH (rashes). The patient was treated with HYDROCORTISONE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLAMMATION (inflammatory reaction on face) and RASH (rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first dose of Moderna Vaccine 3 weeks ago and scheduled to receive second dose. Patient is thinking on getting Pfizer BioNTech Covid-19 Vaccine instead of Moderna. HCP wanted to know how long patient should wait to restart vaccination series. No concomitants were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Pruritus, Pyrexia
Clinical narrative: headache; high fever/highest registered fever was 102 degrees.; fatigue; Ill for 2 1/2 days; Self treated with ibuprofen and tylenol for fever and sleep; red big blotch about 4 inches tall and 6 iches wide on arm; Itching; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), PYREXIA (high fever/highest registered fever was 102 degrees.), FATIGUE (fatigue), ILLNESS (Ill for 2 1/2 days) and SLEEP DISORDER (Self treated with ibuprofen and tylenol for fever and sleep) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (Always wind up with case of flu after receiving shot.). Concurrent medical conditions included Hay fever. Concomitant products included VITAMIN D2 for Deficiency vitamin, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for GERD, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HCTZ) and LIOTHYRONINE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PYREXIA (high fever/highest registered fever was 102 degrees.), FATIGUE (fatigue), ILLNESS (Ill for 2 1/2 days), SLEEP DISORDER (Self treated with ibuprofen and tylenol for fever and sleep), RASH MACULAR (red big blotch about 4 inches tall and 6 iches wide on arm) and PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at an unspecified dose and frequency; GRAMICIDIN, POLYMYXIN B SULFATE (POLYSPORIN [GRAMICIDIN;POLYMYXIN B SULFATE]) for Swelling, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PYREXIA (high fever/highest registered fever was 102 degrees.), FATIGUE (fatigue), ILLNESS (Ill for 2 1/2 days), SLEEP DISORDER (Self treated with ibuprofen and tylenol for fever and sleep), RASH MACULAR (red big blotch about 4 inches tall and 6 iches wide on arm) and PRURITUS (Itching) outcome was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Sleep disorder
Clinical narrative: headache; high fever/highest registered fever was 102 degrees.; fatigue; Ill for 2 1/2 days; Self treated with ibuprofen and tylenol for fever and sleep; red big blotch about 4 inches tall and 6 iches wide on arm; Itching; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), PYREXIA (high fever/highest registered fever was 102 degrees.), FATIGUE (fatigue), ILLNESS (Ill for 2 1/2 days) and SLEEP DISORDER (Self treated with ibuprofen and tylenol for fever and sleep) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (Always wind up with case of flu after receiving shot.). Concurrent medical conditions included Hay fever. Concomitant products included VITAMIN D2 for Deficiency vitamin, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for GERD, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HCTZ) and LIOTHYRONINE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PYREXIA (high fever/highest registered fever was 102 degrees.), FATIGUE (fatigue), ILLNESS (Ill for 2 1/2 days), SLEEP DISORDER (Self treated with ibuprofen and tylenol for fever and sleep), RASH MACULAR (red big blotch about 4 inches tall and 6 iches wide on arm) and PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at an unspecified dose and frequency; GRAMICIDIN, POLYMYXIN B SULFATE (POLYSPORIN [GRAMICIDIN;POLYMYXIN B SULFATE]) for Swelling, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PYREXIA (high fever/highest registered fever was 102 degrees.), FATIGUE (fatigue), ILLNESS (Ill for 2 1/2 days), SLEEP DISORDER (Self treated with ibuprofen and tylenol for fever and sleep), RASH MACULAR (red big blotch about 4 inches tall and 6 iches wide on arm) and PRURITUS (Itching) outcome was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Malaise
Clinical narrative: Malaise; Fatigue; Swollen lymph node left arm; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node left arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MALAISE (Malaise), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node left arm). On 10-May-2021, MALAISE (Malaise), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node left arm) 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.   concomitant medications were not reported . Treatment information was not provided.    This case was linked to MOD-2021-231719 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Computerised tomogram, Eating disorder, Malaise
Clinical narrative: irritation on bottom of stomach; felt sick; couldn't eat; couldn't hold anything down; joint pain, pain in shoulder, pain in elbow; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down), ARTHRALGIA (joint pain, pain in shoulder, pain in elbow) and ABDOMINAL DISCOMFORT (irritation on bottom of stomach) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down) and ARTHRALGIA (joint pain, pain in shoulder, pain in elbow). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (irritation on bottom of stomach). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) ongoing since an unknown date at a dose of 1 dosage form and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down), ARTHRALGIA (joint pain, pain in shoulder, pain in elbow) and ABDOMINAL DISCOMFORT (irritation on bottom of stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal.         No allergies, current illness was reported by patient.  No concomitant medication was reported by patient. Treatment- Water, Percocet, Pedialyte.  Patient reported that he received first vaccine on 1-Apr-2021 and had no symptoms after first dose. patient received second dose on 29-4-2021, he was sick for 3 days after vaccine and symptoms lightened up on 3-May-2021. Patient had a previous injury on his arm, patient visited HCP he was suggested CT scan that came normal. Patient also reported small irritation found on bottom of stomach, HCP confirmed that is common irritation and was not related to vaccine.  Clarification requested from Safety regarding date of the following sentence 3-Apr-2021 symptoms lightened up. Agent spoke to original agent and he clarified that he meant 3-May-2021.   This case was linked to MOD-2021-231643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-June-2021 and it contains No new information.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: irritation on bottom of stomach; felt sick; couldn't eat; couldn't hold anything down; joint pain, pain in shoulder, pain in elbow; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down), ARTHRALGIA (joint pain, pain in shoulder, pain in elbow) and ABDOMINAL DISCOMFORT (irritation on bottom of stomach) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down) and ARTHRALGIA (joint pain, pain in shoulder, pain in elbow). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (irritation on bottom of stomach). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) ongoing since an unknown date at a dose of 1 dosage form and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down), ARTHRALGIA (joint pain, pain in shoulder, pain in elbow) and ABDOMINAL DISCOMFORT (irritation on bottom of stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal.         No allergies, current illness was reported by patient.  No concomitant medication was reported by patient. Treatment- Water, Percocet, Pedialyte.  Patient reported that he received first vaccine on 1-Apr-2021 and had no symptoms after first dose. patient received second dose on 29-4-2021, he was sick for 3 days after vaccine and symptoms lightened up on 3-May-2021. Patient had a previous injury on his arm, patient visited HCP he was suggested CT scan that came normal. Patient also reported small irritation found on bottom of stomach, HCP confirmed that is common irritation and was not related to vaccine.  Clarification requested from Safety regarding date of the following sentence 3-Apr-2021 symptoms lightened up. Agent spoke to original agent and he clarified that he meant 3-May-2021.   This case was linked to MOD-2021-231643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-June-2021 and it contains No new information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Pruritus, Urticaria
Clinical narrative: Getting dizzy when he turns his head; Developed red bumps like hives all over his body; Itching all over; Tiredness; Brain fog\ Cloudy brain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog\ Cloudy brain), DIZZINESS (Getting dizzy when he turns his head), URTICARIA (Developed red bumps like hives all over his body), PRURITUS (Itching all over) and FATIGUE (Tiredness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced FEELING ABNORMAL (Brain fog\ Cloudy brain) and FATIGUE (Tiredness). On an unknown date, the patient experienced DIZZINESS (Getting dizzy when he turns his head), URTICARIA (Developed red bumps like hives all over his body) and PRURITUS (Itching all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain fog\ Cloudy brain), DIZZINESS (Getting dizzy when he turns his head), URTICARIA (Developed red bumps like hives all over his body), PRURITUS (Itching all over) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication was provided by the reporter.   This case was linked to MOD-2021-231649 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non significant follow up received on 19-JUL-2021. Reporter is asking to call on her number.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain in extremity, Wrong technique in device usage process
Clinical narrative: Sore arm; Left boob was very tender; 1st dose wasn't given properly/not clear of how much I got; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BREAST PAIN (Left boob was very tender) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (1st dose wasn't given properly/not clear of how much I got) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (1st dose wasn't given properly/not clear of how much I got). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and BREAST PAIN (Left boob was very tender). On 30-Jan-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (1st dose wasn't given properly/not clear of how much I got) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and BREAST PAIN (Left boob was very tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . Concomitant and treatment medication were not provided.   This case was linked to MOD-2021-039293 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nasopharyngitis, Tremor
Clinical narrative: Body sweats; Shaking; Really cold; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERHIDROSIS (Body sweats), TREMOR (Shaking) and NASOPHARYNGITIS (Really cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced HYPERHIDROSIS (Body sweats), TREMOR (Shaking) and NASOPHARYNGITIS (Really cold). At the time of the report, HYPERHIDROSIS (Body sweats), TREMOR (Shaking) and NASOPHARYNGITIS (Really cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: doses administered after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion). On 13-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   30 Patients were reported as patient identifiers in this case.  No concomitant medications were reported.  No treatment medications were reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age for vaccine administration; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for vaccine administration) 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 medication information was provided by the reporter.  No treatment information was provided by the reporter.  Upon internal review on 11-AUG-2021, the patient age was corrected to 16 years.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Incorrect route of product administration, Injection site haemorrhage
Clinical narrative: I had some scant bleeding; I did have a small bruise; Needle didn't make it to the muscle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (I had some scant bleeding), CONTUSION (I did have a small bruise) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle didn't make it to the muscle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle didn't make it to the muscle). On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (I had some scant bleeding) and CONTUSION (I did have a small bruise). On 20-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle didn't make it to the muscle) had resolved. At the time of the report, INJECTION SITE HAEMORRHAGE (I had some scant bleeding) and CONTUSION (I did have a small bruise) outcome was unknown.            Concomitant product details was not provided by the reporter.  Treatment information was not provided.  For mRNA-1273 (COVID-19 Vaccine Moderna), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-231790 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated Patient demographics , Ethnic group and Race .Added new events Injection site haemorrhage and Contusion
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node in my underarm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node in my underarm) 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 LYMPHADENOPATHY (swollen lymph node in my underarm). At the time of the report, LYMPHADENOPATHY (swollen lymph node in my underarm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: facial paralysis
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dysstasia, Fatigue, Headache, Heavy menstrual bleeding
Clinical narrative: Biontech Manufacturing SARS-CoV-2 mRNA vaccine 1st dose 19/January/2021:  had a sore arm for 1 a coupe of days and felt a bit tired, not much else to report.   Biontech Manufacturing SARS-CoV-2 mRNA vaccine 2nd dose 17/March/2021:  a bit of a sore arm on the day but about a week later I had severe headaches and couldn't stand up form bed as I was feeling nauseous. Vomiting the next 24 hours a few times and after 3 days of headaches and vomiting I was feeling very weak but it then stopped.  I am 49 years old and into peri-menopause, in other words, I had my period very irregularly and somethings nothing for months, until the second dose vaccine. Now I'm back to having very heavy periods (bright red) for 2 weeks every month AND incredible migraines that don't go away, not even when I sleep the whole day.  I would like to report this as it could be a coincidence but this only started happening after the 2nd vaccine. I'm writing this report with a very sore head and having my period (today is the 13th day on a row). Thank you.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Migraine, Nausea, Oligomenorrhoea, Pain in extremity
Clinical narrative: Biontech Manufacturing SARS-CoV-2 mRNA vaccine 1st dose 19/January/2021:  had a sore arm for 1 a coupe of days and felt a bit tired, not much else to report.   Biontech Manufacturing SARS-CoV-2 mRNA vaccine 2nd dose 17/March/2021:  a bit of a sore arm on the day but about a week later I had severe headaches and couldn't stand up form bed as I was feeling nauseous. Vomiting the next 24 hours a few times and after 3 days of headaches and vomiting I was feeling very weak but it then stopped.  I am 49 years old and into peri-menopause, in other words, I had my period very irregularly and somethings nothing for months, until the second dose vaccine. Now I'm back to having very heavy periods (bright red) for 2 weeks every month AND incredible migraines that don't go away, not even when I sleep the whole day.  I would like to report this as it could be a coincidence but this only started happening after the 2nd vaccine. I'm writing this report with a very sore head and having my period (today is the 13th day on a row). Thank you.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Biontech Manufacturing SARS-CoV-2 mRNA vaccine 1st dose 19/January/2021:  had a sore arm for 1 a coupe of days and felt a bit tired, not much else to report.   Biontech Manufacturing SARS-CoV-2 mRNA vaccine 2nd dose 17/March/2021:  a bit of a sore arm on the day but about a week later I had severe headaches and couldn't stand up form bed as I was feeling nauseous. Vomiting the next 24 hours a few times and after 3 days of headaches and vomiting I was feeling very weak but it then stopped.  I am 49 years old and into peri-menopause, in other words, I had my period very irregularly and somethings nothing for months, until the second dose vaccine. Now I'm back to having very heavy periods (bright red) for 2 weeks every month AND incredible migraines that don't go away, not even when I sleep the whole day.  I would like to report this as it could be a coincidence but this only started happening after the 2nd vaccine. I'm writing this report with a very sore head and having my period (today is the 13th day on a row). Thank you.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy, Facial paralysis
Clinical narrative: Systemic: Bell's Palsy-Mild, Additional Details: Husband reported consultation with neurologist yesterday. After patient explained loss of taste that had just recently resolved, and some drooping of the face that had resolved earlier, doctor concluded that patient had Bell's Palsy after receiving Janssen vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Flushing, Hyperhidrosis, Hypertension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: PT FELL FROM CHAIR- POSITIONED PT TO LIE FLAT DOWN UNTIL PT WAS ABLE TO GET UP.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: Many floaters in left eye
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient's mother said he always passes out after getting any vaccine..he passed out for few seconds. he fell on his head. I called 911. he was responsive and doing okay by the time they arrived.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Soreness at injection site,  extreme fatigue 3 days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING AND WARMTH WITH INCREASE SIZE OF INJECTION SITE ONE WEEK AFTER VACCINE
Sex: M
Vaccine: MMR
Symptoms: Angiogram, Angiogram cerebral normal, Antibody test positive, Arteriogram carotid normal, Blood immunoglobulin G increased
Clinical narrative: aseptic meningitis; varicella-zoster virus (VZV); .  This report has been received from the authors in a published article, tittle as stated above concerning a 31-year-old male patient. The patient's medical history included two dermatomal varicella-zoster virus (chickenpox) infection episodes in the past, first during childhood and second at 29 years. There were no other complications, and the recovery was uneventful. The patient has been healthy and took no medications.   On an unknown date in 2020 (reported as the prior week), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, as part of his workplace requirement.  On an unknown date in 2020, the patient presented to the emergency room (ER) with an acute headache for 5 days in the summer of 2020. The headache was localized frontally. The pain was described as sharp and non-pulsating in nature and 10/10 in intensity. It worsened gradually and was associated with nausea and one episode of nonbilious, non-bloody vomiting. He took over-the-counter Nonsteroidal anti-inflammatory drugs (NSAIDs) for the headaches with no improvement. The patient was admitted to a hospital. On physical examination, he appeared uncomfortable and complained of a persistent frontal headache. Vitals were within normal limits, and physical examination was unremarkable without any dermatomal rash. Signs of meningeal irritation were negative. COVID-19 PCR and COVID-19 antibody testing were negative. CT head and CT angiogram head and neck were unremarkable. Lumbar puncture was performed, which showed elevated proteins (86 mg/dL) and mononuclear cells with a lymphocytic predominance (96%) on initial studies suggestive of viral meningitis. The patient received acyclovir and ceftriaxone. The patient reported an improvement of his symptoms on hospital day 2 with an appropriate pain control regimen. The patient was tested for human immunodeficiency virus (HIV), with results of negative. Cerebrospinal fluid (CSF) PCR studies were positive for varicella zoster virus (VZV) PCR (6800 copies/mL) and negative for Herpes Simplex Virus 1 and 2. Diagnosis of aseptic meningitis secondary to VZV was made. VZV IgG came back positive. Intravenous acyclovir with appropriate hydration was continued. The patient's headache resolved gradually, and he was discharged home (hospital day 4) on oral acyclovir for 10 days. The patient was followed up after discharge and was doing well with complete resolution of symptoms on an unknown date.  The reporter considered the event of aseptic meningitis secondary to VZV to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  Upon internal review, the event of meningitis aseptic was considered to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.