chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021 at 4:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Mouth swelling, Pyrexia
Clinical narrative: diarrhea, fever, skin on the inside of lips and mouth felt loose; diarrhea, fever, skin on the inside of lips and mouth felt loose; diarrhea, fever, skin on the inside of lips and mouth felt loose; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (diarrhea, fever, skin on the inside of lips and mouth felt loose), DIARRHOEA (diarrhea, fever, skin on the inside of lips and mouth felt loose) and PYREXIA (diarrhea, fever, skin on the inside of lips and mouth felt loose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced MOUTH SWELLING (diarrhea, fever, skin on the inside of lips and mouth felt loose), DIARRHOEA (diarrhea, fever, skin on the inside of lips and mouth felt loose) and PYREXIA (diarrhea, fever, skin on the inside of lips and mouth felt loose). On 27-Nov-2021, MOUTH SWELLING (diarrhea, fever, skin on the inside of lips and mouth felt loose), DIARRHOEA (diarrhea, fever, skin on the inside of lips and mouth felt loose) and PYREXIA (diarrhea, fever, skin on the inside of lips and mouth felt loose) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Before patient received the booster dose of Moderna COVID-19 vaccine Patient had diarrhea, fever, skin on the inside of the lips and mouth felt loose. 3 days after the booster dose patient felt fine.   This case was linked to MOD-2021-405759 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dysarthria, Nausea
Clinical narrative: Slurred speech; Double vision; little bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA, DIPLOPIA, and NAUSEA 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 06-Dec-2021 at 5:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced DYSARTHRIA, DIPLOPIA, and NAUSEA. At the time of the report, DYSARTHRIA, DIPLOPIA, and NAUSEA outcome was unknown.            It was reported that the patient started exhibiting slurred speech, experiencing double vision and a little bit of nausea around 9:30 on 06 Dec 2021. No concomitant medications were mentioned. No treatment details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a little bit fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a little bit fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (a little bit fever). At the time of the report, PYREXIA (a little bit fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Very itchy hives; She broke out in hives all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy hives) and URTICARIA (She broke out in hives all over body) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced PRURITUS (Very itchy hives) and URTICARIA (She broke out in hives all over body). At the time of the report, PRURITUS (Very itchy hives) and URTICARIA (She broke out in hives all over body) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-405051, MOD-2021-405853 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.) 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 reported.  Both patients administered booster dose on 8.30am and 8.31am 07-Dec-2021. Expiration: 12:08am 07-Dec-2021   This case was linked to MOD-2021-405923 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture) 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 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported Expiration time 12:08am on 07-Dec-2021. Administered time 8.30am and 8.31am on 07-Dec-2021.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-405922 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Feeling rough and not fine; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling rough and not fine) and PYREXIA (Low grade temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced VACCINATION COMPLICATION (Feeling rough and not fine) and PYREXIA (Low grade temperature). At the time of the report, VACCINATION COMPLICATION (Feeling rough and not fine) and PYREXIA (Low grade temperature) had not resolved.            Concomitant information was not provided.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: he was told his vaccine expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (he was told his vaccine expired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (he was told his vaccine expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (he was told his vaccine expired) had resolved. Not Provided          No concomitants medications was reported.  No treatments medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow up contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pain in extremity
Clinical narrative: Feeling sick; No energy; Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-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 MALAISE (Feeling sick), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, MALAISE (Feeling sick), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown.            Treatment medication was not provided.  Concomitant medication was not provided.  Patient experienced events on an unknown date in Dec 2021..   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: individual less than 18 YO receives 0.25mL of Moderna as first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (individual less than 18 YO receives 0.25mL of Moderna as first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (individual less than 18 YO receives 0.25mL of Moderna as first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (individual less than 18 YO receives 0.25mL of Moderna as first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Somnolence, Tendonitis
Clinical narrative: 2nd dose put her out, asleep all day; Tendinitis in thumbs, hurt more than usual; Tired; Joint pain; headache; This spontaneous case was reported by a non-health professional and describes the occurrence of SOMNOLENCE (2nd dose put her out, asleep all day), TENDONITIS (Tendinitis in thumbs, hurt more than usual), FATIGUE (Tired), ARTHRALGIA (Joint pain) and HEADACHE (headache) in a 64-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 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 SOMNOLENCE (2nd dose put her out, asleep all day), TENDONITIS (Tendinitis in thumbs, hurt more than usual), FATIGUE (Tired), ARTHRALGIA (Joint pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Sleepiness, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (2nd dose put her out, asleep all day), TENDONITIS (Tendinitis in thumbs, hurt more than usual), FATIGUE (Tired), ARTHRALGIA (Joint pain) and HEADACHE (headache) outcome was unknown.            Patient is on concomitant medication,but does not mentioned which ones.   This case was linked to MOD-2021-405920 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm to touch; little redness/redness where shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH and VACCINATION SITE ERYTHEMA in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation on 03-Mar-2021 and Drug allergy to Accutane. Concomitant products included SERTRALINE for Anxiety, METOPROLOL for Blood pressure, ATORVASTATIN, CHLORTHALIDONE, POTASSIUM CHLORIDE, and FAMOTIDINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE WARMTH and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH and VACCINATION SITE ERYTHEMA had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Allergic conditions which includes drug allergy to Accutane on unknown date. Concomitant medication includes Eliquix 5 mg for indication of blood thinner which is 1 tablet a day and vitamin once a day.  Non prescription medication which includes eye vitamin which is 2 tablets a day and Rogaine 2% topical cream with indication of apply to scalp at 1 time a day.   No treatment information was provided.   This case was linked to MOD-2021-376403, MOD-2021-376348 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Has a lump right below the collar bone on the left side.; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Has a lump right below the collar bone on the left side.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced MASS (Has a lump right below the collar bone on the left side.). At the time of the report, MASS (Has a lump right below the collar bone on the left side.) outcome was unknown.            Concomitant medication use was unknown  Treatment information was unknown
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm hurting for a day or so; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm hurting for a day or so) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A or 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (left arm hurting for a day or so). At the time of the report, VACCINATION SITE PAIN (left arm hurting for a day or so) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that the first shot probably hurt more than the second dose.   This case was linked to MOD-2021-406174 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash 3 weeks after vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash 3 weeks after vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash 3 weeks after vaccine). At the time of the report, RASH (Rash 3 weeks after vaccine) 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.   No concomitant medications were reported. No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: She had normal reactions after the first 2 shots; The first dose her arm hurt a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had normal reactions after the first 2 shots) and PAIN IN EXTREMITY (The first dose her arm hurt a lot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION COMPLICATION (She had normal reactions after the first 2 shots) and PAIN IN EXTREMITY (The first dose her arm hurt a lot). On 07-Apr-2021, VACCINATION COMPLICATION (She had normal reactions after the first 2 shots) and PAIN IN EXTREMITY (The first dose her arm hurt a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. No treatment information was reported.    This case was linked to MOD-2021-406084, MOD-2021-406085 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: mild chill; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (mild chill) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced CHILLS (mild chill). In January 2021, CHILLS (mild chill) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-405969 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Rash
Clinical narrative: She's also been having chest pain; Having a rash from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (She's also been having chest pain) and RASH (Having a rash from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (She's also been having chest pain) and RASH (Having a rash from the vaccine). At the time of the report, CHEST PAIN (She's also been having chest pain) and RASH (Having a rash from the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The reporter stated that they were having a rash from the vaccine and also been having chest pain.  No treatment information was provided.   This case was linked to MOD-2021-404393 (Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Mass, Pain, Pain in extremity, Rash erythematous
Clinical narrative: a reaction/vaccine symptoms; arm hurt; feeling achy; flu like symptoms; a red rash around neck, arm, back and torso; red bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, and RASH ERYTHEMATOUS in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 022b21a, and 002c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, RASH ERYTHEMATOUS, and MASS. The patient was treated with BENADRYL for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, RASH ERYTHEMATOUS, and MASS had not resolved.            Concomitant medications were not provided.  Treatment included Benadryl which didn't help and medicated shampoo (unspecified).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a reaction/vaccine symptoms; arm hurt; feeling achy; flu like symptoms; a red rash around neck, arm, back and torso; red bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, and RASH ERYTHEMATOUS in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 022b21a, and 002c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, RASH ERYTHEMATOUS, and MASS. The patient was treated with BENADRYL for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, RASH ERYTHEMATOUS, and MASS had not resolved.            Concomitant medications were not provided.  Treatment included Benadryl which didn't help and medicated shampoo (unspecified).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal pain, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: pain on left side of back; pain on left side of buttocks; within 15 minutes she experienced tingling in her left hand and wrist; Later that day she had pain in her arm, pain in her back; This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (pain on left side of back), MUSCULOSKELETAL PAIN (pain on left side of buttocks), VACCINATION SITE PARAESTHESIA (within 15 minutes she experienced tingling in her left hand and wrist) and VACCINATION SITE PAIN (Later that day she had pain in her arm, pain in her back) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced BACK PAIN (pain on left side of back), MUSCULOSKELETAL PAIN (pain on left side of buttocks), VACCINATION SITE PARAESTHESIA (within 15 minutes she experienced tingling in her left hand and wrist) and VACCINATION SITE PAIN (Later that day she had pain in her arm, pain in her back). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, BACK PAIN (pain on left side of back), MUSCULOSKELETAL PAIN (pain on left side of buttocks), VACCINATION SITE PARAESTHESIA (within 15 minutes she experienced tingling in her left hand and wrist) and VACCINATION SITE PAIN (Later that day she had pain in her arm, pain in her back) had not resolved.            Concomitant medication was not reported. Treatment includes Advil and heating pad
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: Vomiting; fatigue and grousy; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and FATIGUE (fatigue and grousy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting) and FATIGUE (fatigue and grousy). At the time of the report, VOMITING (Vomiting) and FATIGUE (fatigue and grousy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-406019 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Severe migraine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine) and HEADACHE (Headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033FZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe migraine) and HEADACHE (Headache). The patient was treated with AMITRIPTYLINE ongoing since an unknown date for Migraine, at a dose of 25 milligram once a day and SUMATRIPTAN ongoing since an unknown date for Migraine, at a dose of 100 milligram. At the time of the report, MIGRAINE (Severe migraine) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient called in to report on the side effects they had after having their first dose of Moderna vaccine. The patient experienced headache and severe migraine and even until now they were still not feeling okay been having migraine attacks from time to time.  The patient was taking Amitriptyline 25mg, every night before bedtime and Sumatriptiline 100mg for severe migraine.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 15 year old patient the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. On 22-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The reporter asked can patient receive the 2nd dose of the Pfizer vaccine or not.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they administered approximately 100 doses of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered approximately 100 doses of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered approximately 100 doses of expired vaccine). In November 2021, EXPIRED PRODUCT ADMINISTERED (they administered approximately 100 doses of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a pharmacist was calling to report that about 100 patients received expired booster Moderna COVID-19 vaccine from 09-Nov-2021 through 21-Nov-2021 with expiry date 11-Oct-2021. Nobody reported side effects. They just discovered the error and reported to VAERS already.  The reporter does not have information on the date the vial was initially stored in the refrigerator and the Date and time vial was first punctured was unknown. The vial was stored in the fridge post puncture and the vial didn't undergo any temperature excursions. Reportedly, the total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F was unknown. The vaccines were stored in the freezer and used as soon as they were thawed.  No Concomitant product use was reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Bad symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031521A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced VACCINATION COMPLICATION (Bad symptoms). At the time of the report, VACCINATION COMPLICATION (Bad symptoms) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered > 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 016B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-406032 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Flatulence, Food craving
Clinical narrative: Weigt increased; Dizziness; Tired; Chills; Having to frequently urinate at night it is like clockwork every 2 hours; Increased craving for sugar; sick; slightly sore arms; Urinating more than usual; I didn't sleep well last night; Lot of gas when i bend over; This spontaneous case was reported by a non-health professional and describes the occurrence of NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms) and POLLAKIURIA (Urinating more than usual) in a 77-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.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera.    Concurrent medical conditions included Polycythemia vera. Concomitant products included VITAMINS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In February 2021, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), FATIGUE (Tired) and CHILLS (Chills). On an unknown date, the patient experienced WEIGHT INCREASED (Weigt increased) and DIZZINESS (Dizziness). At the time of the report, NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours) had not resolved and FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), WEIGHT INCREASED (Weigt increased), DIZZINESS (Dizziness), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 5 lbs (High) Month before last patient gained weight 5 lbs and 4 lbs (High) Weight gained 4 lbs .Patient went from 125 lbs to 135 lbs.         No Treatment details were reported. Patient received third, 100 percentage Modena dose.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nocturia, Pain in extremity, Pollakiuria, Sleep disorder
Clinical narrative: Weigt increased; Dizziness; Tired; Chills; Having to frequently urinate at night it is like clockwork every 2 hours; Increased craving for sugar; sick; slightly sore arms; Urinating more than usual; I didn't sleep well last night; Lot of gas when i bend over; This spontaneous case was reported by a non-health professional and describes the occurrence of NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms) and POLLAKIURIA (Urinating more than usual) in a 77-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.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera.    Concurrent medical conditions included Polycythemia vera. Concomitant products included VITAMINS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In February 2021, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), FATIGUE (Tired) and CHILLS (Chills). On an unknown date, the patient experienced WEIGHT INCREASED (Weigt increased) and DIZZINESS (Dizziness). At the time of the report, NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours) had not resolved and FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), WEIGHT INCREASED (Weigt increased), DIZZINESS (Dizziness), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 5 lbs (High) Month before last patient gained weight 5 lbs and 4 lbs (High) Weight gained 4 lbs .Patient went from 125 lbs to 135 lbs.         No Treatment details were reported. Patient received third, 100 percentage Modena dose.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: Weigt increased; Dizziness; Tired; Chills; Having to frequently urinate at night it is like clockwork every 2 hours; Increased craving for sugar; sick; slightly sore arms; Urinating more than usual; I didn't sleep well last night; Lot of gas when i bend over; This spontaneous case was reported by a non-health professional and describes the occurrence of NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms) and POLLAKIURIA (Urinating more than usual) in a 77-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.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera.    Concurrent medical conditions included Polycythemia vera. Concomitant products included VITAMINS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In February 2021, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), FATIGUE (Tired) and CHILLS (Chills). On an unknown date, the patient experienced WEIGHT INCREASED (Weigt increased) and DIZZINESS (Dizziness). At the time of the report, NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours) had not resolved and FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), WEIGHT INCREASED (Weigt increased), DIZZINESS (Dizziness), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 5 lbs (High) Month before last patient gained weight 5 lbs and 4 lbs (High) Weight gained 4 lbs .Patient went from 125 lbs to 135 lbs.         No Treatment details were reported. Patient received third, 100 percentage Modena dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered > 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 039A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator was on 15th September 2021 and the date vial was first punctured was  on 23rd November 2021 at approximately 15:20.  No concomitant medications was provided. No treatment information was provided.   This case was linked to MOD-2021-406023 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 53 expired doses of booster dose given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (53 expired doses of booster dose given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FH8027) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (53 expired doses of booster dose given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (53 expired doses of booster dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  Number of doses,vials 2 vials from the same lot provided. Doses were administered  out on 2 different dates: 30Nov2021 and 3Dec2021. Date the vial was initially stored in the refrigerator 29Oct2021
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (body aches) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 039A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B COMPLEX, BIOTIN and ASCORBIC ACID (VIT C) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-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 CHILLS (chills) and MYALGIA (body aches). At the time of the report, CHILLS (chills) and MYALGIA (body aches) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406000, MOD-2021-406041 (Patient Link).