chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Crohn's disease, Pain in extremity, Vaccination site bruising, Vaccination site pain
Clinical narrative: bruising at injection site; sharp pain at the injection site, pain that wake me up from my sleep; Crohn's has acted up; colitis has acted up; Sore Arm; A spontaneous report was received from a consumer who was also an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Crohn's and colitis flare-up, sharp pain and bruising at the vaccine site, and sore arm.  The patient's medical history was Crohn's disease and colitis. No relevant concomitant medications were reported.    On 10 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient's Crohn's and colitis has acted up. She also experienced sharp pain at the injection site that wakes her up at night. On 23 Feb 2021, the patient's arm is still bruised at the injection site. Treatment details included Tylenol with codeine.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events Crohn's and colitis flare-up, sharp pain and bruising at the vaccine site, and sore arm) was unknown. Patient's follow-up consent is not clear.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the vaccine site pain and bruising, a causal relationship cannot be excluded. Patient referred easily bruising which can be a cofounder. Very limited information regarding the Crohn's and colitis aggravation has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: did not feel good; headache, chills, dizzy and weak; headache, chills, dizzy and weak; threw up; headache, chills, dizzy and weak; headache, chills, dizzy and weak; sick all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), FEELING ABNORMAL (did not feel good) and CHILLS (headache, chills, dizzy and weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), CHILLS (headache, chills, dizzy and weak), HEADACHE (headache, chills, dizzy and weak) and VOMITING (threw up). On 14-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel good). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), FEELING ABNORMAL (did not feel good), CHILLS (headache, chills, dizzy and weak), HEADACHE (headache, chills, dizzy and weak) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-Significant follow up appended to AER
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: did not feel good; headache, chills, dizzy and weak; headache, chills, dizzy and weak; threw up; headache, chills, dizzy and weak; headache, chills, dizzy and weak; sick all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), FEELING ABNORMAL (did not feel good) and CHILLS (headache, chills, dizzy and weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), CHILLS (headache, chills, dizzy and weak), HEADACHE (headache, chills, dizzy and weak) and VOMITING (threw up). On 14-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel good). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), FEELING ABNORMAL (did not feel good), CHILLS (headache, chills, dizzy and weak), HEADACHE (headache, chills, dizzy and weak) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-Significant follow up appended to AER
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: SIDE EFFECTS; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (SIDE EFFECTS) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (SIDE EFFECTS). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (SIDE EFFECTS) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up contains report
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: her nose was running; sore throat; high fever; body aches; exhaustion; not appetite; cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion) and DECREASED APPETITE (not appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016320a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion), DECREASED APPETITE (not appetite) and COUGH (cough). On an unknown date, the patient experienced RHINORRHOEA (her nose was running). At the time of the report, OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion), DECREASED APPETITE (not appetite), COUGH (cough) and RHINORRHOEA (her nose was running) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Blood pressure medication, Stomach medication. No treatment details was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: her nose was running; sore throat; high fever; body aches; exhaustion; not appetite; cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion) and DECREASED APPETITE (not appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016320a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion), DECREASED APPETITE (not appetite) and COUGH (cough). On an unknown date, the patient experienced RHINORRHOEA (her nose was running). At the time of the report, OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion), DECREASED APPETITE (not appetite), COUGH (cough) and RHINORRHOEA (her nose was running) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Blood pressure medication, Stomach medication. No treatment details was provided.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, International normalised ratio, Pain
Clinical narrative: Headache; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN (Arm pain) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient is taking blood pressure medications).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PAIN (Arm pain). At the time of the report, HEADACHE (Headache) and PAIN (Arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, International normalised ratio: 1.7 (Inconclusive) Patient's blood work checked and his INR dropped to 1.7.         Concomitant medications taken by the patient included blood thinner, blood pressure medications.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sight soreness in throat; A spontaneous report was received from a consumer concerning an 73-year-old female, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced slight soreness in throat.  The patient's medical history was not reported. No concomitant medications were reported.  On 12 FEB  2021 prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch- lot number 024M20A), intramuscularly in the arm for the prophylaxis of COVID-19 infection.  On 23 FEB 2021, it was reported that the patient experienced slight soreness in her throat (it's not a bad sore throat).     Action taken with second dose of mRNA-1273 is unknown.  The outcome of the event, slight soreness in throat was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: episode of gout; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (episode of gout) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 GOUT (episode of gout). At the time of the report, GOUT (episode of gout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Low back pain left side and spreading to right side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Low back pain left side and spreading to right side) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D32L26A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced BACK PAIN (Low back pain left side and spreading to right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Low back pain left side and spreading to right side) outcome was unknown.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received included no new significant information
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: After the second dose, the first site was activated, has itchiness on both arms; irritation on both arms; rash and bumpy of both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (After the second dose, the first site was activated, has itchiness on both arms), SKIN IRRITATION (irritation on both arms) and RASH (rash and bumpy of both arms) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM for Anxiety, RIVAROXABAN (XARELTO), METOPROLOL, DIGOXIN and LEVOTHYROXINE for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, 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 PRURITUS (After the second dose, the first site was activated, has itchiness on both arms), SKIN IRRITATION (irritation on both arms) and RASH (rash and bumpy of both arms). The patient was treated with BETAMETHASONE at a dose of 1 dosage form twice a day. At the time of the report, PRURITUS (After the second dose, the first site was activated, has itchiness on both arms), SKIN IRRITATION (irritation on both arms) and RASH (rash and bumpy of both arms) outcome was unknown.            No laboratory details was given.   This case was linked to MOD-2021-023443.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Other Possible Causes Added.No new information
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: rash around the injection site; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (rash around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site). At the time of the report, VACCINATION SITE PRURITUS (rash around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was not taking any concomitant medications. The treatment reported was topical cream for the rash.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Sweating; Shaking; Chills/ shivering; Head throbs; Did not sleep at all last night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep at all last night), HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concurrent medical conditions included Sleep disorder (normally has trouble sleeping, but gets some sleep).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INSOMNIA (Did not sleep at all last night). On 26-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; Physical therapy (wrapped in blankets and a heating pad) for Hyperhidrosis; Physical therapy (wrapped in blankets and a heating pad) for Tremor; Physical therapy (wrapped in blankets and a heating pad) for Chills and Physical therapy (wrapped in blankets and a heating pad) for Headache. At the time of the report, INSOMNIA (Did not sleep at all last night), HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 97.3 °F (Inconclusive) 97.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sweating; Shaking; Chills/ shivering; Head throbs; Did not sleep at all last night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep at all last night), HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concurrent medical conditions included Sleep disorder (normally has trouble sleeping, but gets some sleep).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INSOMNIA (Did not sleep at all last night). On 26-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; Physical therapy (wrapped in blankets and a heating pad) for Hyperhidrosis; Physical therapy (wrapped in blankets and a heating pad) for Tremor; Physical therapy (wrapped in blankets and a heating pad) for Chills and Physical therapy (wrapped in blankets and a heating pad) for Headache. At the time of the report, INSOMNIA (Did not sleep at all last night), HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 97.3 °F (Inconclusive) 97.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site warmth
Clinical narrative: Arm of the injection turned pink (medium rare) 2nd dose; Arm warm to touch; intense itching; whole arm down to elbow got swollen after 2nd dose; This spontaneous case report was received from a 75 year old female patient who received first dose of Moderna COVID-19 Vaccine (mRNA-1273) on 21-Jan-2021 and experienced swelling and redness on the arm of the injection that lasted 3 or 4 days. She took second dose of the vaccine on 18-Feb-2021 and experienced the arm of the injection turned pink ("medium rare") and her whole arm, down to the elbow, got swollen. Also, it was warm to the touch.  The concomitant medications of the patient included quinapril,omeprazole and levothyroxine. The patient's past medical history was not provided.  On 21-Jan-2021, the patient took first dose of Moderna COVID-19 Vaccine for COVID-19 vaccination intramuscularly into the arm. She experienced swelling and redness on the arm of the injection that lasted 3 or 4 days. The patient got her second dose on 18-Feb-2021 intramuscularly into another arm, and the arm of the injection turned pink ("medium rare") and her whole arm down to the elbow, got swollen. Also, it was warm to the touch. Now, the swelling was going down but there was an intense itching that still persisted.  Topical Benadryl and Ice cubes were used for treatment.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome for events of swelling after second dose was reported as recovering and outcome for the event event of itching was reported as not recovered. The outcome for events of erythema and vaccination site warmth was unknown.  The reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-023613:Same patient, 1st dose
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Tinnitus
Clinical narrative: Worsened tinnitus; Hearing is pertinently impacted; I am unsteady; stepping backwards; Body aches; Flu like symptoms; Fell ill; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Worsened tinnitus), BALANCE DISORDER (stepping backwards), PAIN (Body aches) and MALAISE (Fell ill) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ulcerative colitis (Pandemic Ulcerative colitis) in 1992, Migraine in 2016, Sinusitis in 2016, Tension in 2016, Osteopenia and Hiatal hernia. Concurrent medical conditions included Fibromyalgia (Tinnitus worse), Allergic reaction to drug (Prednisone) and Tinnitus aggravated (Tinnitus worse) since 1992. Concomitant products included CYCLOBENZAPRINE HCL from 2000 to an unknown date for Fibromyalgia, DIAZEPAM from 1980 to an unknown date for Fibromyalgia and Headache, FAMOTIDINE from 2017 to an unknown date for Hiatal hernia, LEVOTHYROXINE SODIUM (L THYROXINE) for Hypothyroidism, AZATHIOPRINE (IMURAN [AZATHIOPRINE]), FOLIC ACID from 2017 to an unknown date and MESALAMINE from 2017 to an unknown date for Ulcerative colitis, BIOTIN, VITAMIN E NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]), ACETYLSALICYLIC ACID (ASPIRIN 81), COD LIVER OIL [COD-LIVER OIL], VITAMIN D3, MAGNESIUM and PROBIOTICS NOS for an unknown indication.   On 21-Jan-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches). On 03-Mar-2021, the patient experienced BALANCE DISORDER (stepping backwards). On an unknown date, the patient experienced TINNITUS (Worsened tinnitus), MALAISE (Fell ill), HYPOACUSIS (Hearing is pertinently impacted) and GAIT DISTURBANCE (I am unsteady). On 22-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches) had resolved. At the time of the report, TINNITUS (Worsened tinnitus) and BALANCE DISORDER (stepping backwards) had not resolved, MALAISE (Fell ill) had resolved and HYPOACUSIS (Hearing is pertinently impacted) and GAIT DISTURBANCE (I am unsteady) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100-101 (High) body temperature 100-101 degrees.         No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Sig followup - Reporter's contact details updated i.e. email address. Patients demographics added, race and ethnicity updated, relevant medical history updated, Concomitant products added, Vaccine facility information updated, New events added, Narrative regenerated.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 6hrs later his arm started to get sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (6hrs later his arm started to get sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Loose bowel (loose bowel movement). Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Loose bowel.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (6hrs later his arm started to get sore). At the time of the report, VACCINATION SITE PAIN (6hrs later his arm started to get sore) 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 product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Myalgia
Clinical narrative: muscle aches; fatigue/ have never been incredibly tired like I have been now; didn't feel well the next day after the second shot; get drained all of a sudden, anemic kind of moment during the day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well the next day after the second shot), ASTHENIA (get drained all of a sudden, anemic kind of moment during the day), MYALGIA (muscle aches) and FATIGUE (fatigue/ have never been incredibly tired like I have been now) in a 66-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MALAISE (didn't feel well the next day after the second shot) and ASTHENIA (get drained all of a sudden, anemic kind of moment during the day). On an unknown date, the patient experienced MYALGIA (muscle aches) and FATIGUE (fatigue/ have never been incredibly tired like I have been now). At the time of the report, MALAISE (didn't feel well the next day after the second shot), ASTHENIA (get drained all of a sudden, anemic kind of moment during the day) and FATIGUE (fatigue/ have never been incredibly tired like I have been now) had not resolved and MYALGIA (muscle aches) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: New events of Malaise and Asthenia along with patient's age was added. Verbatim of fatigue was updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Herpes zoster, Movement disorder, Nausea
Clinical narrative: shingles kept getting worse and she is now having a huge flare up with sores all over the left side of her body; welts feel like they are burning alive all over body; cannot move; pain; nausea; fever; shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), BURNING SENSATION (welts feel like they are burning alive all over body), MOVEMENT DISORDER (cannot move), PAIN (pain) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HERPES ZOSTER (shingles) with CONDITION AGGRAVATED (shingles kept getting worse and she is now having a huge flare up with sores all over the left side of her body), PAIN (pain), NAUSEA (nausea) and PYREXIA (fever). On 23-Feb-2021, the patient experienced BURNING SENSATION (welts feel like they are burning alive all over body) and MOVEMENT DISORDER (cannot move). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles), BURNING SENSATION (welts feel like they are burning alive all over body), MOVEMENT DISORDER (cannot move), PAIN (pain), NAUSEA (nausea) and PYREXIA (fever) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Contact information has been updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: shingles kept getting worse and she is now having a huge flare up with sores all over the left side of her body; welts feel like they are burning alive all over body; cannot move; pain; nausea; fever; shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), BURNING SENSATION (welts feel like they are burning alive all over body), MOVEMENT DISORDER (cannot move), PAIN (pain) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HERPES ZOSTER (shingles) with CONDITION AGGRAVATED (shingles kept getting worse and she is now having a huge flare up with sores all over the left side of her body), PAIN (pain), NAUSEA (nausea) and PYREXIA (fever). On 23-Feb-2021, the patient experienced BURNING SENSATION (welts feel like they are burning alive all over body) and MOVEMENT DISORDER (cannot move). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles), BURNING SENSATION (welts feel like they are burning alive all over body), MOVEMENT DISORDER (cannot move), PAIN (pain), NAUSEA (nausea) and PYREXIA (fever) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Contact information has been updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pyrexia, Vaccination site pain
Clinical narrative: diarrhea; sore arm; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 24266443) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Feb-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) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 contains TCR document and No New Information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal discomfort
Clinical narrative: Area of muscle around his neck where he had the surgery was bothering him; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Area of muscle around his neck where he had the surgery was bothering him) and HEADACHE (Mild headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (stent placed in his right carotid).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Area of muscle around his neck where he had the surgery was bothering him) and HEADACHE (Mild headache). On 26-Jan-2021, MUSCULOSKELETAL DISCOMFORT (Area of muscle around his neck where he had the surgery was bothering him) and HEADACHE (Mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-023672 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The patient informed that he was doing fine and declined further follow up.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Chills, Fatigue
Clinical narrative: Tested COVID positive; Sore throat like burning in his throat up to his jaw area; Weakness; Fever; Headaches; Muscle aches; Chills; Fatigue; Nausea without vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Headaches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting). On 13-Feb-2021, the patient experienced COVID-19 (Tested COVID positive). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PHENOL (CHLORASEPTIC) at a dose of Sprays and Lozenges; PSEUDOEPHEDRINE at an unspecified dose and frequency and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of Augementin Antibiotic. At the time of the report, COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive. On 13-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive to the covid-19 virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medications also included nasal sprays.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Tested COVID positive; Sore throat like burning in his throat up to his jaw area; Weakness; Fever; Headaches; Muscle aches; Chills; Fatigue; Nausea without vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Headaches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting). On 13-Feb-2021, the patient experienced COVID-19 (Tested COVID positive). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PHENOL (CHLORASEPTIC) at a dose of Sprays and Lozenges; PSEUDOEPHEDRINE at an unspecified dose and frequency and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of Augementin Antibiotic. At the time of the report, COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive. On 13-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive to the covid-19 virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medications also included nasal sprays.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested COVID positive; Sore throat like burning in his throat up to his jaw area; Weakness; Fever; Headaches; Muscle aches; Chills; Fatigue; Nausea without vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Headaches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting). On 13-Feb-2021, the patient experienced COVID-19 (Tested COVID positive). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PHENOL (CHLORASEPTIC) at a dose of Sprays and Lozenges; PSEUDOEPHEDRINE at an unspecified dose and frequency and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of Augementin Antibiotic. At the time of the report, COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive. On 13-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive to the covid-19 virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medications also included nasal sprays.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 30-Mar-2021. On 22-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 22-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included, Prenatal vitamins was reported.   Treatment information was not provided. The patient's date of positivity pregnancy test is on JUL 2020 and estimated date of conception is on JUN 2020. This is a case of product exposure during pregnancy with no associated adverse events for this 37-year-old female. Patient will continue to be contacted for further monitoring of the AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 37-year-old female. Patient will continue to be contacted for further monitoring of the AEs during the pregnancy.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Tenderness, Vaccination site pain
Clinical narrative: Pain was hot and tender; Pain all the way past her elbow; Pain was hot; Pain in the arm; Red arm; Pain where the injection-site occurred; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Pain was hot and tender), PAIN (Pain all the way past her elbow), FEELING HOT (Pain was hot), PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (Red arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039KRDA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced TENDERNESS (Pain was hot and tender), PAIN (Pain all the way past her elbow), FEELING HOT (Pain was hot), PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Pain where the injection-site occurred). At the time of the report, TENDERNESS (Pain was hot and tender), PAIN (Pain all the way past her elbow), FEELING HOT (Pain was hot), PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Pain where the injection-site occurred) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Regulatory Authority was received Patient's family member stated everything is fine now