chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Temperature intolerance, Urticaria
Clinical narrative: Severe itch/itchy; Little bumps; Heat; Red dots on my back; Hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat), ERYTHEMA (Red dots on my back) and URTICARIA (Hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat), ERYTHEMA (Red dots on my back) and URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Adverse event, at a dose of 5 milligram. At the time of the report, PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat) and ERYTHEMA (Red dots on my back) outcome was unknown and URTICARIA (Hives) had resolved.            Concomitant drug included Low dose of blood pressure pill. Treatment medication included ice pack, 2 creams and 2 pills for allergy and the itch. It was reported as patient had no allergies.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Slight pain on the shoulder after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Slight pain on the shoulder after the first dose) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]), ALLOPURINOL, GABAPENTIN, TESTOSTERONE, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 26-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 ARTHRALGIA (Slight pain on the shoulder after the first dose). At the time of the report, ARTHRALGIA (Slight pain on the shoulder after the first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products included prostate medication for an unknown indication. No treatment medications were reported.  Patient he did not feel anything after the second dose.    This case was linked to MOD-2021-322736 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Hypoacusis, Inappropriate schedule of product administration, Vertigo
Clinical narrative: Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear; I have a little vertigo; But I already have a little imbalance thing already; second dose received on 16-Sep-2021, more than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear), VERTIGO (I have a little vertigo), BALANCE DISORDER (But I already have a little imbalance thing already) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose). On 17-Sep-2021, the patient experienced HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear) and VERTIGO (I have a little vertigo). 17-Sep-2021, the patient experienced BALANCE DISORDER (But I already have a little imbalance thing already). At the time of the report, HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear), VERTIGO (I have a little vertigo), BALANCE DISORDER (But I already have a little imbalance thing already) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose) outcome was unknown.            No concomitant medications and treatment information reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Headache, Hyperhidrosis, Pyrexia, Urticaria
Clinical narrative: sweating; woke up with a severe headache; developed a fever; Acidic vomiting; Double vision; broke out in hives; bump on my right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump on my right arm injection site), URTICARIA (broke out in hives), HYPERHIDROSIS (sweating), DIPLOPIA (Double vision) and HEADACHE (woke up with a severe headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PROPRANOLOL, PREDNISONE from 12-Aug-2021 to an unknown date and PYRIDOSTIGMINE BROMIDE (MESTINON) from 17-Sep-2021 to an unknown date for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (bump on my right arm injection site). On 22-Jan-2021, the patient experienced URTICARIA (broke out in hives). On 30-Jan-2021, the patient experienced DIPLOPIA (Double vision). On 31-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), HEADACHE (woke up with a severe headache), PYREXIA (developed a fever) and VOMITING (Acidic vomiting). On 21-Jan-2021, VACCINATION SITE MASS (bump on my right arm injection site) had resolved. At the time of the report, URTICARIA (broke out in hives), HYPERHIDROSIS (sweating), DIPLOPIA (Double vision), HEADACHE (woke up with a severe headache), PYREXIA (developed a fever) and VOMITING (Acidic vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Information were provided by the reporter   This case was linked to MOD-2021-323941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Followup received contains contact information like Address Updated
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vomiting
Clinical narrative: sweating; woke up with a severe headache; developed a fever; Acidic vomiting; Double vision; broke out in hives; bump on my right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump on my right arm injection site), URTICARIA (broke out in hives), HYPERHIDROSIS (sweating), DIPLOPIA (Double vision) and HEADACHE (woke up with a severe headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PROPRANOLOL, PREDNISONE from 12-Aug-2021 to an unknown date and PYRIDOSTIGMINE BROMIDE (MESTINON) from 17-Sep-2021 to an unknown date for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (bump on my right arm injection site). On 22-Jan-2021, the patient experienced URTICARIA (broke out in hives). On 30-Jan-2021, the patient experienced DIPLOPIA (Double vision). On 31-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), HEADACHE (woke up with a severe headache), PYREXIA (developed a fever) and VOMITING (Acidic vomiting). On 21-Jan-2021, VACCINATION SITE MASS (bump on my right arm injection site) had resolved. At the time of the report, URTICARIA (broke out in hives), HYPERHIDROSIS (sweating), DIPLOPIA (Double vision), HEADACHE (woke up with a severe headache), PYREXIA (developed a fever) and VOMITING (Acidic vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Information were provided by the reporter   This case was linked to MOD-2021-323941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Followup received contains contact information like Address Updated
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Gastrointestinal inflammation, Oesophagitis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of severe chest pain (like a heart attack), gastrointestinal inflammation (inflammation of his gastrointestinal region noted) and esophagitis (inflammation of his esophageal region noted) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 022M20A and 042L20A) for COVID-19 immunization. Concurrent medical conditions included seasonal allergy, pollen allergy and allergy to animals (cat). On Jan 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 23, 2021, patient experienced severe chest pain (like a heart attack) and gastrointestinal inflammation (inflammation of his gastrointestinal region noted). Feb 23, 2021, patient experienced esophagitis (inflammation of his esophageal region noted). At the time of the report, severe chest pain (like a heart attack), gastrointestinal inflammation (inflammation of his gastrointestinal region noted) and esophagitis (inflammation of his esophageal region noted) outcome: unknown. No concomitant medications provided. Treatment: Patient prescribed acupuncture, antacids and gabapentin but he is not taking.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st and 2nd dose: sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (1st and 2nd dose: sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Underlying Asthma which is usually in control) and Autoimmune disorder. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and GABAPENTIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (1st and 2nd dose: sore arm). The patient was treated with LEVALBUTEROL [LEVOSALBUTAMOL] (LEVALBUTEROL [LEVOSALBUTAMOL] NEBULISER) for Adverse event, at an unspecified dose and frequency; ITRACONAZOLE for Adverse event, at an unspecified dose and frequency; AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency and ANTIHISTAMINES for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (1st and 2nd dose: sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient used a box of Kleenex each day. The patient felt nauseated and vertigo after administration of gabapentin.   This case was linked to MOD-2021-323634, MOD-2021-323635 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Temp 102; Tiredness; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102), FATIGUE (Tiredness) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (Taken on 8/11/21 Intramuscular at Right Arm). Concurrent medical conditions included Allergy to antibiotic (Allergy to Vancomycin.), Asthma and Bronchiectasis.    On 11-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 3:00 PM, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102), FATIGUE (Tiredness) and HEADACHE (Headache). On 13-Feb-2021, PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Tiredness) was resolving. Not Provided          No concomitant medications were reported. No treatments were reported.   This case was linked to MOD-2021-323610, MOD-2021-310473 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Interchange of vaccine products, Mobility decreased, Vaccination complication
Clinical narrative: Had a severe reaction; could not get up; an irregular heart beat; Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up), HEART RATE IRREGULAR (an irregular heart beat) and INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine). On 15-Sep-2021, the patient experienced VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up) and HEART RATE IRREGULAR (an irregular heart beat). At the time of the report, VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up) and HEART RATE IRREGULAR (an irregular heart beat) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) irregular heart beat.         No concomitant medication were reported. No treatment information was provided by the reporter.  Patient received first 2 doses of Pfizer vaccine the last one was around 4 months ago.patient does not take any medication regularly and that not aware of the patient having a previous diagnose of myocarditis or pericarditis and state the patient did not get covid-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: bad watery diarrhea and 6 loose stools per day; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad watery diarrhea and 6 loose stools per day) and VACCINATION SITE PAIN (sore right injection site arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced DIARRHOEA (bad watery diarrhea and 6 loose stools per day) and VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, DIARRHOEA (bad watery diarrhea and 6 loose stools per day) and VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.    This case was linked to MOD-2021-323763 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: red lump; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Patient states being allergic to some food and medications but never experienced a reaction), Allergy to allopathic drugs (Patient states being allergic to some food and medications but never experienced a reaction), Blood pressure high, Osteoporosis and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis, MULTIVITAMINS [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-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 ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for No adverse event, at a dose of 1 dosage form once a day. At the time of the report, ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm) had resolved.            This case was linked to MOD-2021-323808 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Rash
Clinical narrative: Rash on the chest that spread all the way to the back and neck; Sore; Joint hurt; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the chest that spread all the way to the back and neck), MYALGIA (Sore) and ARTHRALGIA (Joint hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 026L20A and 30M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to some food and medications) and Drug allergy (Allergic to some food and medications). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced MYALGIA (Sore) and ARTHRALGIA (Joint hurt). On 19-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on the chest that spread all the way to the back and neck). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK UNK, qd. In September 2021, MYALGIA (Sore) and ARTHRALGIA (Joint hurt) had resolved. At the time of the report, RASH (Rash on the chest that spread all the way to the back and neck) outcome was unknown.            The patient was also taking high blood pressure medication (unspecified) concomitantly.  The patient was allergic to some food and medications but never experienced a reaction like this, the patient related rash to a possible reaction after taken third dose of the vaccine. The patient consulted to the physician for treatment medication.   This case was linked to MOD-2021-323796 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Very sick for 3 days; she had a flu-like symptoms; fever temperature 99; nauseated / couldn't eat all day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 3 days), INFLUENZA LIKE ILLNESS (she had a flu-like symptoms), PYREXIA (fever temperature 99) and NAUSEA (nauseated / couldn't eat all day) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 08-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick for 3 days), INFLUENZA LIKE ILLNESS (she had a flu-like symptoms), PYREXIA (fever temperature 99) and NAUSEA (nauseated / couldn't eat all day). At the time of the report, ILLNESS (Very sick for 3 days), INFLUENZA LIKE ILLNESS (she had a flu-like symptoms), PYREXIA (fever temperature 99) and NAUSEA (nauseated / couldn't eat all day) outcome was unknown.            concomitant medications were not reported. treatment medications were not reported.   This case was linked to MOD-2021-026932 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Non Significant followup received
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: felt kinda achy; 4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt kinda achy) and ARTHRALGIA (4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Latex allergy. Concomitant products included MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced MYALGIA (felt kinda achy) and ARTHRALGIA (4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800mg. At the time of the report, MYALGIA (felt kinda achy) outcome was unknown and ARTHRALGIA (4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Cholesterol medications and multivitamins for  an unknown indications.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain, Chills, Erythema, Fatigue
Clinical narrative: red area near the areola; tingling in the back of my head; lethargic; moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; overall yucky; lump arise in my right breast, which caused a soreness and red area near the areola; Lump in breast; Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; fever; fatigue; nausea; severe headache; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola) and FEELING ABNORMAL (overall yucky) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 1996, Cystitis interstitial since 2018 and Barrett's esophagus since 2017. Concomitant products included VITAMINS NOS for an unknown indication.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), LETHARGY (lethargic), FEELING ABNORMAL (overall yucky), BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola), BREAST MASS (Lump in breast), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting). On an unknown date, the patient experienced PARAESTHESIA (tingling in the back of my head) and ERYTHEMA (red area near the areola). In September 2021, BREAST MASS (Lump in breast) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting) had not resolved and PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola), FEELING ABNORMAL (overall yucky) and BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola) outcome was unknown.            No treatment information was provided   This case was linked to MOD-2021-269309 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Joint range of motion decreased, Lethargy, Nausea
Clinical narrative: red area near the areola; tingling in the back of my head; lethargic; moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; overall yucky; lump arise in my right breast, which caused a soreness and red area near the areola; Lump in breast; Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; fever; fatigue; nausea; severe headache; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola) and FEELING ABNORMAL (overall yucky) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 1996, Cystitis interstitial since 2018 and Barrett's esophagus since 2017. Concomitant products included VITAMINS NOS for an unknown indication.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), LETHARGY (lethargic), FEELING ABNORMAL (overall yucky), BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola), BREAST MASS (Lump in breast), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting). On an unknown date, the patient experienced PARAESTHESIA (tingling in the back of my head) and ERYTHEMA (red area near the areola). In September 2021, BREAST MASS (Lump in breast) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting) had not resolved and PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola), FEELING ABNORMAL (overall yucky) and BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola) outcome was unknown.            No treatment information was provided   This case was linked to MOD-2021-269309 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: red area near the areola; tingling in the back of my head; lethargic; moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; overall yucky; lump arise in my right breast, which caused a soreness and red area near the areola; Lump in breast; Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; fever; fatigue; nausea; severe headache; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola) and FEELING ABNORMAL (overall yucky) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 1996, Cystitis interstitial since 2018 and Barrett's esophagus since 2017. Concomitant products included VITAMINS NOS for an unknown indication.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), LETHARGY (lethargic), FEELING ABNORMAL (overall yucky), BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola), BREAST MASS (Lump in breast), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting). On an unknown date, the patient experienced PARAESTHESIA (tingling in the back of my head) and ERYTHEMA (red area near the areola). In September 2021, BREAST MASS (Lump in breast) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting) had not resolved and PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola), FEELING ABNORMAL (overall yucky) and BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola) outcome was unknown.            No treatment information was provided   This case was linked to MOD-2021-269309 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adolescent received Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever up to 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever up to 102) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PYREXIA (Fever up to 102). At the time of the report, PYREXIA (Fever up to 102) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Body temperature: 102 (High) Fever upto 102.         No concomitant medication reported. No treatment medication reported.  Reporter stated that patient was given booster dose and patient still had the event, fever even the next day morning.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago). On 19-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medication was not provided by the reporter.  On 06-Sep-2021, the vial was initially stored in the refrigerator.  Technician immunizer gave a second shot of a previous-date vial. The vial was punctured and exposed at room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F), for more than 24 hours (between 24 and 26 hours), as it was first punctured on 18-Sep-2021 morning. The vial did not undergo any temperature excursions.  There was no records of patient taking any regular medication. The pharmacist would like to know if the patient needs to get revaccinated or not. Or if there were any steps they need to take.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inflammation (head felt inflamed in different places), headache (painful, bad headache) and myalgia (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included neurological disorder (NOS) and blood clot. Patient had neurological and blood clot concerns. In 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In 2021, patient experienced inflammation (head felt inflamed in different places), headache (painful, bad headache) and myalgia (body aches). At the time of the report, inflammation (head felt inflamed in different places), headache (painful, bad headache) and myalgia (body aches) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin plaque
Clinical narrative: two arm plaques; This spontaneous case was reported by a physician and describes the occurrence of SKIN PLAQUE (two arm plaques) in a 73-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN PLAQUE (two arm plaques). At the time of the report, SKIN PLAQUE (two arm plaques) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.   This case was linked to MOD-2021-327033 (Patient Link).   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Skin plaque
Clinical narrative: two arm plaques; This spontaneous case was reported by a physician and describes the occurrence of SKIN PLAQUE (two arm plaques) in a 26-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN PLAQUE (two arm plaques). At the time of the report, SKIN PLAQUE (two arm plaques) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-327027, MOD-2021-327034 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over my body starting at my arms now all over my stomach and legs. Seems to be getting worse everyday. Taking benadryl and zytrc to help with it.  I am very worried please help someone check this for me. I do not have insurance and really want to get this checked and cured. I never had any issues like this before thr vaccine. Please help me I am really worried about this.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Joint effusion, Joint swelling, Synovial fluid white blood cells positive
Clinical narrative: bilateral knee pain and swelling
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Approximately 1 hr after receiving the J&J COVID 19 vaccine SEVERE pruritus began over my entire body. It lasted for 1 1/2 days.  I took 75mg of diphenhydramine every 4 hrs during that time.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Nausea, Panic attack, Syncope, Tinnitus
Clinical narrative: The night of second Covid vaccine I fainted after urinating, fell on my face and tried to stand up 2 times but couldn't, my ears where ringing and I felt like vomiting right before.  About 2 days after the vaccine I'm having panic attacks and bad anxiety that isn't going away and I'm continuing to have done then. I started taking Lexapro and Xanax to help but the anxiety still persist and not getting any relief.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Bell's palsy, Swelling, Swelling face
Clinical narrative: Morning flu vaccination given at vaccination site: Covid-19 Vaccinator for 2021 Flu Vaccine (without Covid-19 shot) on Saturday, Sep 25, 2021 at 10:00 AM.   By evening facial swelling, the next day more extreme swelling, and evening urgent care appointment for Bells Palsy. A recurrence from four years prior, also potentially linked to flu vaccine (around the same time of year).  Steroids (prednisone) prescribed at urgent care Sunday night at 8 pm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Fibrin D dimer, Pericarditis
Clinical narrative: Pericarditis, no myocardial involvement, no effusion, treated with NSAIDs and colchicine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Pericarditis, no myocardial involvement, no effusion, treated with NSAIDs and colchicine
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Imaging procedure, Laboratory test, Paraesthesia
Clinical narrative: chronic dyspnea now, atrial fibrillation, paresthesias
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Arthralgia, Blood test, Computerised tomogram
Clinical narrative: Constant severe nausea, severe abdominal burning and cramping, vomiting, loss of appetite, weight loss, severe lymph node pain in arm, neck, shoulder leading to nerve pain in arm.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Endoscopy, Lymph node pain, Nausea, Neck pain
Clinical narrative: Constant severe nausea, severe abdominal burning and cramping, vomiting, loss of appetite, weight loss, severe lymph node pain in arm, neck, shoulder leading to nerve pain in arm.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Urine analysis, Vomiting, Weight decreased
Clinical narrative: Constant severe nausea, severe abdominal burning and cramping, vomiting, loss of appetite, weight loss, severe lymph node pain in arm, neck, shoulder leading to nerve pain in arm.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Mild headache, nausea
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: Accidental exposure to product, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; a 4 month old child was inadvertently administered a dose of PNEUMOVAX23; a 4 month old child was inadvertently administered a dose of PNEUMOVAX23; This spontaneous report was received from a medical assistant concerning a 4-month-old patient. No concurrent condition, medical history, or concomitant therapy was reported.  On 16-SEP-2021, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 mL (strength and route were unknown; lot # T040202 has been verified to be a valid lot number, expiration date reported as 20-SEP-2022 but upon internal validation was established as 11-SEP-2022) for prophylaxis (Inadvertent exposure to vaccine and Inappropriate age at vaccine administration). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T040202; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: herpes zoster related injuries; herpes zoster related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or about 2016, the patient was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) by unspecified healthcare provider at the physician's office, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a physician, for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): herpes zoster related injuries. The outcome of herpes zoster related injuries was not reported. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: No additional adverse events reported; Agent informed Pharmacist of dosage information as listed in prescribing information, that dosage is listed as 0.5 mL and 1.0 mL and clarify if patient received "5 mcg" and Pharmacist confirms dose.; adult patient was administered pediatric dose; This spontaneous report was received from a pharmacist concerning an adult female patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.    On 20-JUL-2021, the patient was prescribed and vaccinated with pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength and route were unknown; lot # T024551 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 03-NOV-2022; thimerosal free), 5 Micrograms for prophylaxis (incorrect dose administered). It was her first dose.   The pharmacist was informed of dosage information as listed in prescribing information, that dosage was listed as 0.5 mL and 1.0 mL (product prescribing issue) and clarified if the patient received "5 mcg". The pharmacist confirmed dose. No additional adverse events were reported.