chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear infection, Eye pruritus, Fatigue, Fluid retention
Clinical narrative: ear infection; right ear had started to have fluid buildup; little bumps behind my ear; sneezing and watery eyes; left ear was inflamed and had fluid buildup; sinus pressure; pressure in my head; next day I was itchy; with certain foods, I seem to be having an allergic reaction; watery, itchy eyes; headache; little tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction) and EYE PRURITUS (watery, itchy eyes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (chemotherapy and radiation 10 years ago.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache) and FATIGUE (little tired). On 30-Jan-2021, the patient experienced PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes) and HEAD DISCOMFORT (pressure in my head). On 02-Feb-2021, the patient experienced SNEEZING (sneezing and watery eyes). In February 2021, the patient experienced INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup) and PARANASAL SINUS DISCOMFORT (sinus pressure). On 05-Mar-2021, the patient experienced EAR DISCOMFORT (little bumps behind my ear). On an unknown date, the patient experienced EAR INFECTION (ear infection) and FLUID RETENTION (right ear had started to have fluid buildup). At the time of the report, HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes), SNEEZING (sneezing and watery eyes), HEAD DISCOMFORT (pressure in my head), EAR INFECTION (ear infection), INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup), FLUID RETENTION (right ear had started to have fluid buildup), PARANASAL SINUS DISCOMFORT (sinus pressure) and EAR DISCOMFORT (little bumps behind my ear) 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.   treated with Tylenol, Amoxicillin, Colloidal Silver
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypersensitivity, Inner ear inflammation, Paranasal sinus discomfort
Clinical narrative: ear infection; right ear had started to have fluid buildup; little bumps behind my ear; sneezing and watery eyes; left ear was inflamed and had fluid buildup; sinus pressure; pressure in my head; next day I was itchy; with certain foods, I seem to be having an allergic reaction; watery, itchy eyes; headache; little tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction) and EYE PRURITUS (watery, itchy eyes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (chemotherapy and radiation 10 years ago.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache) and FATIGUE (little tired). On 30-Jan-2021, the patient experienced PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes) and HEAD DISCOMFORT (pressure in my head). On 02-Feb-2021, the patient experienced SNEEZING (sneezing and watery eyes). In February 2021, the patient experienced INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup) and PARANASAL SINUS DISCOMFORT (sinus pressure). On 05-Mar-2021, the patient experienced EAR DISCOMFORT (little bumps behind my ear). On an unknown date, the patient experienced EAR INFECTION (ear infection) and FLUID RETENTION (right ear had started to have fluid buildup). At the time of the report, HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes), SNEEZING (sneezing and watery eyes), HEAD DISCOMFORT (pressure in my head), EAR INFECTION (ear infection), INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup), FLUID RETENTION (right ear had started to have fluid buildup), PARANASAL SINUS DISCOMFORT (sinus pressure) and EAR DISCOMFORT (little bumps behind my ear) 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.   treated with Tylenol, Amoxicillin, Colloidal Silver
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sneezing
Clinical narrative: ear infection; right ear had started to have fluid buildup; little bumps behind my ear; sneezing and watery eyes; left ear was inflamed and had fluid buildup; sinus pressure; pressure in my head; next day I was itchy; with certain foods, I seem to be having an allergic reaction; watery, itchy eyes; headache; little tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction) and EYE PRURITUS (watery, itchy eyes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (chemotherapy and radiation 10 years ago.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache) and FATIGUE (little tired). On 30-Jan-2021, the patient experienced PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes) and HEAD DISCOMFORT (pressure in my head). On 02-Feb-2021, the patient experienced SNEEZING (sneezing and watery eyes). In February 2021, the patient experienced INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup) and PARANASAL SINUS DISCOMFORT (sinus pressure). On 05-Mar-2021, the patient experienced EAR DISCOMFORT (little bumps behind my ear). On an unknown date, the patient experienced EAR INFECTION (ear infection) and FLUID RETENTION (right ear had started to have fluid buildup). At the time of the report, HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes), SNEEZING (sneezing and watery eyes), HEAD DISCOMFORT (pressure in my head), EAR INFECTION (ear infection), INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup), FLUID RETENTION (right ear had started to have fluid buildup), PARANASAL SINUS DISCOMFORT (sinus pressure) and EAR DISCOMFORT (little bumps behind my ear) 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.   treated with Tylenol, Amoxicillin, Colloidal Silver
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). The patient was treated with CEFDINIR at a dose of 300 mg and CIPROFLOXACIN at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not reported.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Erythema, Fatigue, Headache
Clinical narrative: Cough; Redness; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Rash; Mild headache; Muscle pain; Injection site pain, which went down to her wrist; Fatigue; Joint pain around the hips; Felt as if she had to breath in deeper, but had no fast heart beat; Itching on the opposite arm and face; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face) and RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain around the hips). On an unknown date, the patient experienced COUGH (Cough), ERYTHEMA (Redness), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), ARTHRALGIA (Joint pain around the hips) and MYALGIA (Muscle pain) outcome was unknown and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow-up information received on 01-Apr-2021 to be processed with the initial report. Event were updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Injection site pain, Myalgia, Nasal discharge discolouration, Pruritus
Clinical narrative: Cough; Redness; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Rash; Mild headache; Muscle pain; Injection site pain, which went down to her wrist; Fatigue; Joint pain around the hips; Felt as if she had to breath in deeper, but had no fast heart beat; Itching on the opposite arm and face; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face) and RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain around the hips). On an unknown date, the patient experienced COUGH (Cough), ERYTHEMA (Redness), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), ARTHRALGIA (Joint pain around the hips) and MYALGIA (Muscle pain) outcome was unknown and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow-up information received on 01-Apr-2021 to be processed with the initial report. Event were updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Cough; Redness; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Rash; Mild headache; Muscle pain; Injection site pain, which went down to her wrist; Fatigue; Joint pain around the hips; Felt as if she had to breath in deeper, but had no fast heart beat; Itching on the opposite arm and face; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face) and RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain around the hips). On an unknown date, the patient experienced COUGH (Cough), ERYTHEMA (Redness), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), ARTHRALGIA (Joint pain around the hips) and MYALGIA (Muscle pain) outcome was unknown and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow-up information received on 01-Apr-2021 to be processed with the initial report. Event were updated.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported  No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: TCR was received stating consent denied for follow up contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy) 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 27-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 PRURITUS (very itchy). At the time of the report, PRURITUS (very itchy) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itched; red; puffy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy). At the time of the report, VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatments details were not provided.   This case was linked to MOD21-046699 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: NNI; Sender's Comments:  MOD21-046699:Crosslinked
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Annoying ringing in bilateral ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Annoying ringing in bilateral ears) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced TINNITUS (Annoying ringing in bilateral ears). At the time of the report, TINNITUS (Annoying ringing in bilateral ears) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: Heart beating faster; Blood pressure elevated; A spontaneous report was received from a consumer concerning a 75 years old, female patient who experienced elevated blood pressure/blood pressure high and faster heart beating/heart rate high.   The patient's medical history included elevated blood pressure. Concomitant product use was not provided by the reporter; however it was reported that the patient was on other medication.  On 22 Feb 2021, prior to the onset of the events, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, after vaccination the patient experienced elevated blood pressure. On an unknown date, after vaccination, the patient's heart beat increased (reported as heart beating faster).  The patient was treated with ibuprofen for the events.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events elevated blood pressure/blood pressure high and faster heart beating/heart rate high was unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with hypertension confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Body temperature, Illness, Myalgia, Pain
Clinical narrative: Very ill/very sick; Unable to speak; Pain; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Very ill/very sick; Unable to speak; Pain; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Root canal infection, Swelling face
Clinical narrative: root canal that caused an infection; facial swelling; This spontaneous case was reported by a non-health professional and describes the occurrence of ROOT CANAL INFECTION ( root canal that caused an infection) and SWELLING FACE (facial swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 1. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Mar-2021, the patient experienced ROOT CANAL INFECTION ( root canal that caused an infection) and SWELLING FACE (facial swelling). At the time of the report, ROOT CANAL INFECTION ( root canal that caused an infection) and SWELLING FACE (facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was treated with prednisone and antibiotics.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, C-reactive protein increased, Chills, Ear discomfort, Ear pain
Clinical narrative: Dropped weight; Sore neck; Swollen lymph nodes; Chills; Right side from ear down to shoulder was tight, sore and very uncomfortable; Right side from ear down to shoulder was tight, sore and very uncomfortable; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), EAR PAIN (Right side from ear down to shoulder was tight, sore and very uncomfortable), EAR DISCOMFORT (Right side from ear down to shoulder was tight, sore and very uncomfortable), ABNORMAL LOSS OF WEIGHT (Dropped weight) and NECK PAIN (Sore neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Feb-2021, the patient experienced EAR PAIN (Right side from ear down to shoulder was tight, sore and very uncomfortable), EAR DISCOMFORT (Right side from ear down to shoulder was tight, sore and very uncomfortable) and CHILLS (Chills). On 23-Feb-2021, the patient experienced ABNORMAL LOSS OF WEIGHT (Dropped weight), NECK PAIN (Sore neck) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 daily. At the time of the report, PAIN IN EXTREMITY (Sore arm), EAR PAIN (Right side from ear down to shoulder was tight, sore and very uncomfortable), EAR DISCOMFORT (Right side from ear down to shoulder was tight, sore and very uncomfortable), ABNORMAL LOSS OF WEIGHT (Dropped weight), NECK PAIN (Sore neck), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein increased: high (High) CRP were high.. On an unknown date, Red blood cell sedimentation rate increased: high (High) ESR were high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medication was reported.   This case was linked to MOD-2021-036697.; Sender's Comments:  MOD-2021-036697:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Dropped weight; Sore neck; Swollen lymph nodes; Chills; Right side from ear down to shoulder was tight, sore and very uncomfortable; Right side from ear down to shoulder was tight, sore and very uncomfortable; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), EAR PAIN (Right side from ear down to shoulder was tight, sore and very uncomfortable), EAR DISCOMFORT (Right side from ear down to shoulder was tight, sore and very uncomfortable), ABNORMAL LOSS OF WEIGHT (Dropped weight) and NECK PAIN (Sore neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Feb-2021, the patient experienced EAR PAIN (Right side from ear down to shoulder was tight, sore and very uncomfortable), EAR DISCOMFORT (Right side from ear down to shoulder was tight, sore and very uncomfortable) and CHILLS (Chills). On 23-Feb-2021, the patient experienced ABNORMAL LOSS OF WEIGHT (Dropped weight), NECK PAIN (Sore neck) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 daily. At the time of the report, PAIN IN EXTREMITY (Sore arm), EAR PAIN (Right side from ear down to shoulder was tight, sore and very uncomfortable), EAR DISCOMFORT (Right side from ear down to shoulder was tight, sore and very uncomfortable), ABNORMAL LOSS OF WEIGHT (Dropped weight), NECK PAIN (Sore neck), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein increased: high (High) CRP were high.. On an unknown date, Red blood cell sedimentation rate increased: high (High) ESR were high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medication was reported.   This case was linked to MOD-2021-036697.; Sender's Comments:  MOD-2021-036697:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Feeling abnormal, Influenza like illness
Clinical narrative: Very terrible symptoms; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Very terrible symptoms) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (Very terrible symptoms) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, FEELING ABNORMAL (Very terrible symptoms) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) showed she had antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided   Reporter did not allow further contact
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. On 07-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Paraesthesia, Wrong technique in product usage process
Clinical narrative: Injection hit nerve; Pain in arm; Stinging; Tingling in shoulder blade and neck; A spontaneous report was received from a consumer concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain, injection hit nerve (wrong injection technique), stinging, and tingling in shoulder blade and neck.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, after the vaccination, the patient experienced arm pain, injection hit nerve, stinging, and tingling in shoulder blade and neck. The patient was concerned that the shot was not administered properly. Treatment information included tylenol.  Action taken with mRNA-1273 in response to the events was unknown.    The outcome of the event, injection hit nerve (wrong injection technique) was considered as recovered on 03 Feb 2021. The outcome of the events, arm pain, stinging, and tingling in shoulder blade and neck, was considered as unknown at the time of this report.; Reporter's Comments: This case concerns a 71-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot # 004M20A), reporting that wrong technique in product usage process with injection that hit a nerve with associated adverse events of unexpected pain, paresthesia and expected injection site pain. The events occurred the same day as first dose mRNA-1273. Treated with Tylenol. Adverse event outcomes unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Diverticulum
Clinical narrative: Diverticula; Severe Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe Diarrhea) and DIVERTICULUM (Diverticula) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030m20A) for COVID-19 vaccination.     Concomitant products included TRIAMTERENE and LEVOTHYROXINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Severe Diarrhea). On an unknown date, the patient experienced DIVERTICULUM (Diverticula). On 07-Mar-2021, DIARRHOEA (Severe Diarrhea) had resolved. At the time of the report, DIVERTICULUM (Diverticula) outcome was unknown.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant Follow-up received on 07-JUL-2021 ADR form attached :  reporter information ,contact details, patient information, concomitant medications, newevent and event outcome were updated.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Body shakes; Arm Pain,Hand Pain; Head pain; Body aches; Vomiting; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body shakes), PAIN IN EXTREMITY (Arm Pain,Hand Pain), HEADACHE (Head pain), MYALGIA (Body aches) and VOMITING (Vomiting) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TREMOR (Body shakes), PAIN IN EXTREMITY (Arm Pain,Hand Pain), HEADACHE (Head pain), MYALGIA (Body aches), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, TREMOR (Body shakes), PAIN IN EXTREMITY (Arm Pain,Hand Pain), HEADACHE (Head pain), MYALGIA (Body aches), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Body shakes; Arm Pain,Hand Pain; Head pain; Body aches; Vomiting; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body shakes), PAIN IN EXTREMITY (Arm Pain,Hand Pain), HEADACHE (Head pain), MYALGIA (Body aches) and VOMITING (Vomiting) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TREMOR (Body shakes), PAIN IN EXTREMITY (Arm Pain,Hand Pain), HEADACHE (Head pain), MYALGIA (Body aches), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, TREMOR (Body shakes), PAIN IN EXTREMITY (Arm Pain,Hand Pain), HEADACHE (Head pain), MYALGIA (Body aches), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 101 (High) high. On 06-Mar-2021, Body temperature: 104 (High) high.         Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-239231 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Red mark around Injection site; hand pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE ERYTHEMA (Red mark around Injection site) and PAIN IN EXTREMITY (hand pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red mark around Injection site) and PAIN IN EXTREMITY (hand pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE ERYTHEMA (Red mark around Injection site) and PAIN IN EXTREMITY (hand pain) outcome was unknown.            No concomitant medications reported.   This case was linked to MOD-2021-036745, MOD-2021-036745 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Myalgia, Pyrexia
Clinical narrative: temperature of 101; achiness; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 101), MYALGIA (achiness) and LETHARGY (lethargy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ROSUVASTATIN, LEVOTHYROXINE, Ziopan, LOSARTAN, ZINC, FISH OIL, TESTOSTERONE, POLYCARBOPHIL CALCIUM (FIBER), Relieve eye drops, COLECALCIFEROL (VIT D [COLECALCIFEROL]), UBIDECARENONE (Q10) and ASCORBIC ACID (VIT C) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (temperature of 101), MYALGIA (achiness) and LETHARGY (lethargy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In March 2021, PYREXIA (temperature of 101) had resolved. At the time of the report, MYALGIA (achiness) and LETHARGY (lethargy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 (High) 101F.     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.