chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: hives in entire body; very itchy; headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in entire body), PRURITUS (very itchy) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 021C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (hives in entire body) and PRURITUS (very itchy). December 2021, the patient experienced HEADACHE (headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and PARACETAMOL (TYLENOL CHILDRENS) for Adverse event, at a dose of Baby tylenol about 30 hours after the booster. In December 2021, HEADACHE (headache) had resolved. At the time of the report, URTICARIA (hives in entire body) and PRURITUS (very itchy) outcome was unknown.            No relevant concomitant medications were reported. .
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses were given beyond the 12-hour mark; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2022 at 2:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported The vial was initially stored in the refrigerator on 08-Dec-2021. The vial was first punctured on 03-Jan-2022 at 2:45 PM. The vial stored in fridge post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Three times total for drawing up the doses, each time no more than 2-5 minutes. No Treatment medications reported   This case was linked to MOD-2022-444843 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circle at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2021.  Concurrent medical conditions included Allergy, Asthma and Arthritis (Pretty bad). Concomitant products included OXYCODONE, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circle at injection site) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Treatment information was unknown.   This case was linked to MOD-2022-444851 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Pain in extremity, Vaccination site pain
Clinical narrative: Severe pain in hand; Severe pain in the upper right arm; Severe pain in the shoulder joints; Late second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in hand), VACCINATION SITE PAIN (Severe pain in the upper right arm), ARTHRALGIA (Severe pain in the shoulder joints) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late second dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe pain in hand), VACCINATION SITE PAIN (Severe pain in the upper right arm) and ARTHRALGIA (Severe pain in the shoulder joints). On 08-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late second dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Severe pain in hand), VACCINATION SITE PAIN (Severe pain in the upper right arm) and ARTHRALGIA (Severe pain in the shoulder joints) outcome was unknown.            Concomitant medications also included varsakin, infesil and hidrocloroside.  It was also reported that patient did not took any medication to alleviate the symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and HEADACHE (headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and LEVOTHYROXINE 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 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and HEADACHE (headache). On 08-Jan-2021, PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history were provided by the reporter. After receiving the first dose, the patient was tired the next day, had a headache and a sore arm. No treatment information were given.   This case was linked to MOD-2022-444867, MOD-2022-445047 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) had resolved.            No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2022-445032, MOD-2022-445048 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and HEADACHE (headache). On 05-Feb-2021, PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and HEADACHE (headache) had resolved.            Other medications included Vitamins were reported. Treatment information was not provided. No medical history was provided by the reporter.   This case was linked to MOD-2022-444867, MOD-2022-445039 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0078(or B)21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Migraines).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided by the reporter. Treatment information was not provided.  The patient takes some medications but was unable to provide that information. The patient did not remember on which arm the patient was vaccinated.   This case was linked to MOD-2022-445071, MOD-2022-445070 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose of expired moderna vaccine was given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of expired moderna vaccine was given) 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 EXPIRED PRODUCT ADMINISTERED (A dose of expired moderna vaccine was given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of expired moderna vaccine was given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-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 PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.            It was reported that the patient took some unspecified medications. No treatment medications were reported.   This case was linked to MOD-2022-445071, MOD-2022-445052 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Night sweats
Clinical narrative: experiencing night sweats, she notice it when she wakes up and; Slight headache during all day; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (experiencing night sweats, she notice it when she wakes up and) and HEADACHE (Slight headache during all day) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 046B21A and 0078(or B)21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (experiencing night sweats, she notice it when she wakes up and) and HEADACHE (Slight headache during all day). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Headache, at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (experiencing night sweats, she notice it when she wakes up and) and HEADACHE (Slight headache during all day) had not resolved.      Concomitant medication: patient takes some medications but was unable to provide that information.  It was reported that the symptoms started on 06Jan2022 or 07Jan2022, three or two days after the shot.   This case was linked to MOD-2022-445052, MOD-2022-445070 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Size of orange, red, inflamed and swelling below where the shot was done and above elbow in the left arm; Inflamed and swelling below where the shot was done and above elbow in the left arm; Left arm where she bends her elbow was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm where she bends her elbow was very sore), VACCINATION SITE ERYTHEMA (Size of orange, red, inflamed and swelling below where the shot was done and above elbow in the left arm) and VACCINATION SITE SWELLING (Inflamed and swelling below where the shot was done and above elbow in the left arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 014M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced VACCINATION SITE PAIN (Left arm where she bends her elbow was very sore). On 09-Jan-2022, the patient experienced VACCINATION SITE ERYTHEMA (Size of orange, red, inflamed and swelling below where the shot was done and above elbow in the left arm) and VACCINATION SITE SWELLING (Inflamed and swelling below where the shot was done and above elbow in the left arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Left arm where she bends her elbow was very sore), VACCINATION SITE ERYTHEMA (Size of orange, red, inflamed and swelling below where the shot was done and above elbow in the left arm) and VACCINATION SITE SWELLING (Inflamed and swelling below where the shot was done and above elbow in the left arm) outcome was unknown.            Patient reported that she used some cold packs also as treatment.  No concomitant drug details were reported.   This case was linked to MOD-2022-444926 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Arthralgia, Pyrexia, Swelling, Urticaria
Clinical narrative: Hives all over the body; Swelling; Joint pain; Fever; severe allergic reaction to the booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain), PYREXIA (Fever) and ALLERGY TO VACCINE (severe allergic reaction to the booster) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 004C21A and 031B21A) 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) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction to the booster). On 04-Jan-2022, the patient experienced URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain), PYREXIA (Fever) and ALLERGY TO VACCINE (severe allergic reaction to the booster) had not resolved.            No concomitant drug details were reported.  Treatment medication include antihistamines.  Patient stated that nothing changed in her lifestyle but getting the booster dose. She has seen five doctors including an allergist and an immunologist and they confirmed it is an allergic reaction to the vaccine. Patient stated it is really horrible. Symptoms were still ongoing at the time of reporting. Patient stated she was not obese and she was totally healthy.With the first two shots she had no problems.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Joint swelling, Pyrexia, Urticaria
Clinical narrative: Hives all over the body; Swelling; Joint pain; Fever; severe allergic reaction to the booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain), PYREXIA (Fever) and ALLERGY TO VACCINE (severe allergic reaction to the booster) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 004C21A and 031B21A) 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) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction to the booster). On 04-Jan-2022, the patient experienced URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain), PYREXIA (Fever) and ALLERGY TO VACCINE (severe allergic reaction to the booster) had not resolved.            No concomitant drug details were reported.  Treatment medication include antihistamines.  Patient stated that nothing changed in her lifestyle but getting the booster dose. She has seen five doctors including an allergist and an immunologist and they confirmed it is an allergic reaction to the vaccine. Patient stated it is really horrible. Symptoms were still ongoing at the time of reporting. Patient stated she was not obese and she was totally healthy.With the first two shots she had no problems.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient can smell the vaccine in nostrils; This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION COMPLICATION (Patient can smell the vaccine in nostrils) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient can smell the vaccine in nostrils). At the time of the report, VACCINATION COMPLICATION (Patient can smell the vaccine in nostrils) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered Moderna booster doses from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna booster doses from a vial which has been punctured for more than 12 hours) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna booster doses from a vial which has been punctured for more than 12 hours). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered Moderna booster doses from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.   This case was linked to MOD-2022-445096 (Patient Link).
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose; accidentally received a full dose of Moderna as second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received a full dose of Moderna as second dose) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (received the first Pfizer dose) on 27-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 08-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received a full dose of Moderna as second dose). On 08-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received a full dose of Moderna as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Discomfort
Clinical narrative: weak; discomfort in my midsection as though I'm going to throw up; chills; This spontaneous case was reported by another health care professional and describes the occurrence of ASTHENIA (weak), DISCOMFORT (discomfort in my midsection as though I'm going to throw up) and CHILLS (chills) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 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 ASTHENIA (weak), DISCOMFORT (discomfort in my midsection as though I'm going to throw up) and CHILLS (chills). At the time of the report, ASTHENIA (weak), DISCOMFORT (discomfort in my midsection as though I'm going to throw up) and CHILLS (chills) had not resolved.        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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received series from the Pfizer COVID-19 vaccine and received booster less than 90 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received series from the Pfizer COVID-19 vaccine and received booster less than 90 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Received monoclonal antibody treatment while he had COVID for 2 months.). Past adverse reactions to the above products included COVID-19 with Pfizer COVID-19 vaccine.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received series from the Pfizer COVID-19 vaccine and received booster less than 90 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received series from the Pfizer COVID-19 vaccine and received booster less than 90 days) had resolved.            Concomitant medications were not reported.  Patient received monoclonal antibody treatment while he had COVID. 2 months following treatment with monoclonal antibodies, he received the Moderna COVID-19 booster dose. He then found out that he was supposed to wait 3 months until he received the booster, and the booster may not work if he receives it in less time period. He was concerned if he received the booster before 90 days, it can interfere with the way the booster was supposed to work.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vial was punctured and used beyond the 12 hour; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was punctured and used beyond the 12 hour) 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 EXPIRED PRODUCT ADMINISTERED (Vial was punctured and used beyond the 12 hour). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was punctured and used beyond the 12 hour) 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.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: left arm is sore to the touch; left arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm is sore to the touch) and VACCINATION SITE ERYTHEMA (left arm is red) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 023M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (left arm is sore to the touch) and VACCINATION SITE ERYTHEMA (left arm is red). At the time of the report, VACCINATION SITE PAIN (left arm is sore to the touch) and VACCINATION SITE ERYTHEMA (left arm is red) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Malaise, Myalgia, Pain in extremity
Clinical narrative: was so dick.; in bed for two full dayz; arm is so sore; hurting everywhere; fever; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (was so dick.), MALAISE (in bed for two full dayz), PAIN IN EXTREMITY (arm is so sore), MYALGIA (hurting everywhere) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ILLNESS (was so dick.), MALAISE (in bed for two full dayz), PAIN IN EXTREMITY (arm is so sore), MYALGIA (hurting everywhere), PYREXIA (fever) and CHILLS (chills). At the time of the report, ILLNESS (was so dick.), MALAISE (in bed for two full dayz), PAIN IN EXTREMITY (arm is so sore), MYALGIA (hurting everywhere), PYREXIA (fever) and CHILLS (chills) 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 drug details were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: was so dick.; in bed for two full dayz; arm is so sore; hurting everywhere; fever; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (was so dick.), MALAISE (in bed for two full dayz), PAIN IN EXTREMITY (arm is so sore), MYALGIA (hurting everywhere) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ILLNESS (was so dick.), MALAISE (in bed for two full dayz), PAIN IN EXTREMITY (arm is so sore), MYALGIA (hurting everywhere), PYREXIA (fever) and CHILLS (chills). At the time of the report, ILLNESS (was so dick.), MALAISE (in bed for two full dayz), PAIN IN EXTREMITY (arm is so sore), MYALGIA (hurting everywhere), PYREXIA (fever) and CHILLS (chills) 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 drug details were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Musculoskeletal pain, Vaccination site mass
Clinical narrative: pain near the scapula; Less than several hours of getting the booster, a person has three lumps near the site of injection; Two near shoulder and one on armpit; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL PAIN (pain near the scapula), VACCINATION SITE MASS (Less than several hours of getting the booster, a person has three lumps near the site of injection) and AXILLARY MASS (Two near shoulder and one on armpit) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (pain near the scapula), VACCINATION SITE MASS (Less than several hours of getting the booster, a person has three lumps near the site of injection) and AXILLARY MASS (Two near shoulder and one on armpit). At the time of the report, MUSCULOSKELETAL PAIN (pain near the scapula), VACCINATION SITE MASS (Less than several hours of getting the booster, a person has three lumps near the site of injection) and AXILLARY MASS (Two near shoulder and one on armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication.   Reporter stated that a patient experienced 3 lumps near the site of injection of which one was on patient's armpit and two being near the patient's shoulder after less than several hours of receiving the booster dose. Reporter also stated that the patient experienced pain near the scapula and queries whether it was normal as the reporter have also experienced similar reactions and lump near the armpit.  treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) 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 medications were reported.  No adverse reactions were experienced by the patient.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: A lower dose (half dose) was administered by mistake; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (A lower dose (half dose) was administered by mistake) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (A lower dose (half dose) was administered by mistake). On 06-Jan-2022, ACCIDENTAL UNDERDOSE (A lower dose (half dose) was administered by mistake) 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 medication was reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal and vaccination complication (experienced unusual and concerning symptoms) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. No medical history reported. On Jan 4, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal and vaccination complication (experienced unusual and concerning symptoms). At the time of the report, feeling abnormal and vaccination complication (experienced unusual and concerning symptoms): resolving. Healthy male, no underlying health issues. Symptoms eased. No concomitant medication or treatment information reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: provided 6 patients with Moderna vaccines from a vial that expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (provided 6 patients with Moderna vaccines from a vial that expired two days prior) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (provided 6 patients with Moderna vaccines from a vial that expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (provided 6 patients with Moderna vaccines from a vial that expired two days prior) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. No adverse event was reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Vaccinated with two days prior expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with two days prior expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Dose 2) and Pfizer Biontech Covid-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with two days prior expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vaccinated with two days prior expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   30 days expiry date was on 3-Jan-2022.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Patient had no other adverse reaction.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired two days prior) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired two days prior) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feeling yucky all over; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (feeling yucky all over) 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 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling yucky all over). At the time of the report, FEELING ABNORMAL (feeling yucky all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: felt crummy; Got chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt crummy) and CHILLS (Got chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS, XANTOFYL (KIRKLAND SIGNATURE ADULT MULTIVITAMIN) from 01-Jan-2020 to an unknown date for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 FEELING ABNORMAL (felt crummy) and CHILLS (Got chills). At the time of the report, FEELING ABNORMAL (felt crummy) and CHILLS (Got chills) outcome was unknown.            On 10-Jan-2021, patient received concomitant drug Garden of Life Probiotics dose Garden 218 mg, (route-Ingest) 1 capsule per day. On 01-Jan-2021, NeoraFit Block plus Balance Pre and Probiotic dose .07 oz., route: powder, 1 per day before big meal. All reported concomitants were still ongoing.   No treatment drug were reported.  patient was not diagnosed with/ tested positive for COVID-19   This case was linked to MOD-2022-439130, MOD-2022-439598 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a patient that received an expired dose of the Moderna booster (3rd dose) vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient that received an expired dose of the Moderna booster (3rd dose) 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 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient that received an expired dose of the Moderna booster (3rd dose) vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (a patient that received an expired dose of the Moderna booster (3rd dose) vaccine) had resolved.      No concomitant medications were reported.  No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Pyrexia
Clinical narrative: spent the day in bed after 2nd dose; high fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (spent the day in bed after 2nd dose) and PYREXIA (high fever after 2nd dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Intrauterine contraception since an unknown date. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced BEDRIDDEN (spent the day in bed after 2nd dose) and PYREXIA (high fever after 2nd dose). At the time of the report, BEDRIDDEN (spent the day in bed after 2nd dose) and PYREXIA (high fever after 2nd dose) outcome was unknown.     No concomitant medications were reported. No treatment medications were reported for second dose events.   This case was linked to MOD-2022-445417 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2022-445539 (Patient Link).