chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Urticaria, Vaccination site lymphadenopathy, Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching) and PAIN OF SKIN (felt like she was stung by a wasp) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Allergy to penicillin) and Allergy to insect sting. Concomitant products included ALPRAZOLAM (XANAX) and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for an unknown indication. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced VOMITING (she woke up and started to throw up/threw up clear film). On 23-Aug-2021, the patient experienced HORDEOLUM (Stye) and EYE SWELLING (eye was swelling). On 24-Aug-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen). On 25-Aug-2021, the patient experienced URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), PAIN (still sore to the touch) and DYSPNOEA (short or breath as she is talking). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for Itching and Swelling, at an unspecified dose and frequency. At the time of the report, HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), DYSPNOEA (short or breath as she is talking) and VOMITING (she woke up and started to throw up/threw up clear film) outcome was unknown and PAIN (still sore to the touch), VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching) and PAIN OF SKIN (felt like she was stung by a wasp) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Allergy to penicillin) and Allergy to insect sting. Concomitant products included ALPRAZOLAM (XANAX) and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for an unknown indication. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced VOMITING (she woke up and started to throw up/threw up clear film). On 23-Aug-2021, the patient experienced HORDEOLUM (Stye) and EYE SWELLING (eye was swelling). On 24-Aug-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen). On 25-Aug-2021, the patient experienced URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), PAIN (still sore to the touch) and DYSPNOEA (short or breath as she is talking). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for Itching and Swelling, at an unspecified dose and frequency. At the time of the report, HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), DYSPNOEA (short or breath as she is talking) and VOMITING (she woke up and started to throw up/threw up clear film) outcome was unknown and PAIN (still sore to the touch), VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: painful and hurts a lot; got a 102.6 Fahrenheit degrees fever after receiving their first dose of the Moderna covid19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (painful and hurts a lot) and PYREXIA (got a 102.6 Fahrenheit degrees fever after receiving their first dose of the Moderna covid19 vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017ez1a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PYREXIA (got a 102.6 Fahrenheit degrees fever after receiving their first dose of the Moderna covid19 vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (painful and hurts a lot). At the time of the report, VACCINATION SITE PAIN (painful and hurts a lot) and PYREXIA (got a 102.6 Fahrenheit degrees fever after receiving their first dose of the Moderna covid19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Body temperature: 102.6 (High) 102.6 Fahrenheit degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Head ache for 7 days.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache for 7 days.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Head ache for 7 days.). At the time of the report, HEADACHE (Head ache for 7 days.) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Myalgia, Pruritus, Rash
Clinical narrative: Whole area on the arm is very itchy; Rash; Arm has been sore for the past couple of days; hives; it was very itchy at the injection site; allergic reaction; very red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site). On 28-Aug-2021, the patient experienced PRURITUS (Whole area on the arm is very itchy), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days). At the time of the report, HYPERSENSITIVITY (allergic reaction) had not resolved and ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives), VACCINATION SITE PRURITUS (it was very itchy at the injection site), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information was provided. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up report contains additional events were added. On 03-Sep-2021: Follow-up document received on 03-SEP-2021. It contains no new information.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pruritus
Clinical narrative: Whole area on the arm is very itchy; Rash; Arm has been sore for the past couple of days; hives; it was very itchy at the injection site; allergic reaction; very red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site). On 28-Aug-2021, the patient experienced PRURITUS (Whole area on the arm is very itchy), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days). At the time of the report, HYPERSENSITIVITY (allergic reaction) had not resolved and ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives), VACCINATION SITE PRURITUS (it was very itchy at the injection site), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information was provided. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up report contains additional events were added. On 03-Sep-2021: Follow-up document received on 03-SEP-2021. It contains no new information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms (second dose); Sore arm (second dose); Tired (second dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms (second dose)), MYALGIA (Sore arm (second dose)) and FATIGUE (Tired (second dose)) in a 74-year-old male 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms (second dose)), MYALGIA (Sore arm (second dose)) and FATIGUE (Tired (second dose)). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms (second dose)), MYALGIA (Sore arm (second dose)) and FATIGUE (Tired (second dose)) outcome was unknown.      The patient has a half lung.  Concomitant medications included blood thinners, kidney medications and heart medications.  Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Product dose omission issue, Vaccination complication
Clinical narrative: Slight symptoms from first dose of vaccine; Headache; Body aches; Greater than 36 days since first dose of vaccine/still has not received their second dose as of 27 Aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight symptoms from first dose of vaccine), HEADACHE (Headache), MYALGIA (Body aches) and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days since first dose of vaccine/still has not received their second dose as of 27 Aug 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-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 VACCINATION COMPLICATION (Slight symptoms from first dose of vaccine), HEADACHE (Headache), MYALGIA (Body aches) and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days since first dose of vaccine/still has not received their second dose as of 27 Aug 2021). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Slight symptoms from first dose of vaccine), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days since first dose of vaccine/still has not received their second dose as of 27 Aug 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received and reporter contact information, patient demographics, suspect product start date, treatment medication and new events were updated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: Light Sweat; Pain; Low grade fever; sore arm; rear of neck/rear of shoulder; rear of neck/rear of shoulder; eyes were painful; muscle pain; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Light Sweat), PAIN (Pain), PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder) and ARTHRALGIA (rear of neck/rear of shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myocardial infarction on 16-Dec-2016. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Torodol) and Back pain (L5-S1OR 1985; L4-S1 Fusions 1999 & 1999 twice) since 1972. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Clot blood, LAMOTRIGINE, TIZANIDINE and AMITRIPTYLINE for Nerve pain, ALFUZOSIN for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder), ARTHRALGIA (rear of neck/rear of shoulder), EYE PAIN (eyes were painful), MYALGIA (muscle pain) and INJECTION SITE PAIN (injection site soreness). On an unknown date, the patient experienced HYPERHIDROSIS (Light Sweat), PAIN (Pain) and PYREXIA (Low grade fever). The patient was treated with RANOLAZINE (RANEXA) (oral) at a dose of 500 mg twice a day; ROSUVASTATIN at a dose of 20 mg once a day; CARVEDILOL at a dose of 3.125 mg twice a day and LOSARTAN POTASSIUM (LOSARTAN POTASSSIUM) at a dose of 25 mg once a day. At the time of the report, HYPERHIDROSIS (Light Sweat), PAIN (Pain), INJECTION SITE PAIN (injection site soreness) and PYREXIA (Low grade fever) outcome was unknown and PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder), ARTHRALGIA (rear of neck/rear of shoulder), EYE PAIN (eyes were painful) and MYALGIA (muscle pain) had resolved.            This case was linked to MOD-2021-300126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: FU received on 30 Aug 2021,Contains no new information
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Light Sweat; Pain; Low grade fever; sore arm; rear of neck/rear of shoulder; rear of neck/rear of shoulder; eyes were painful; muscle pain; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Light Sweat), PAIN (Pain), PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder) and ARTHRALGIA (rear of neck/rear of shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myocardial infarction on 16-Dec-2016. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Torodol) and Back pain (L5-S1OR 1985; L4-S1 Fusions 1999 & 1999 twice) since 1972. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Clot blood, LAMOTRIGINE, TIZANIDINE and AMITRIPTYLINE for Nerve pain, ALFUZOSIN for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder), ARTHRALGIA (rear of neck/rear of shoulder), EYE PAIN (eyes were painful), MYALGIA (muscle pain) and INJECTION SITE PAIN (injection site soreness). On an unknown date, the patient experienced HYPERHIDROSIS (Light Sweat), PAIN (Pain) and PYREXIA (Low grade fever). The patient was treated with RANOLAZINE (RANEXA) (oral) at a dose of 500 mg twice a day; ROSUVASTATIN at a dose of 20 mg once a day; CARVEDILOL at a dose of 3.125 mg twice a day and LOSARTAN POTASSIUM (LOSARTAN POTASSSIUM) at a dose of 25 mg once a day. At the time of the report, HYPERHIDROSIS (Light Sweat), PAIN (Pain), INJECTION SITE PAIN (injection site soreness) and PYREXIA (Low grade fever) outcome was unknown and PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder), ARTHRALGIA (rear of neck/rear of shoulder), EYE PAIN (eyes were painful) and MYALGIA (muscle pain) had resolved.            This case was linked to MOD-2021-300126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: FU received on 30 Aug 2021,Contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: Tingling on the arm on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling on the arm on the injection site) 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 VACCINATION SITE PARAESTHESIA (Tingling on the arm on the injection site). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling on the arm on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Patient asked was  tingling on the arm on the injection site a common side effect and how long does it last
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: seems like patient is having the flu; swelling in the hole upper arm; fever of 99.9; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (seems like patient is having the flu), PERIPHERAL SWELLING (swelling in the hole upper arm) and PYREXIA (fever of 99.9) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (patient has a heart disease and went under many surgical procedures.). Concurrent medical conditions included Heart disease, unspecified.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (seems like patient is having the flu). 27-Aug-2021, the patient experienced PERIPHERAL SWELLING (swelling in the hole upper arm) and PYREXIA (fever of 99.9). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (seems like patient is having the flu), PERIPHERAL SWELLING (swelling in the hole upper arm) and PYREXIA (fever of 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Body temperature: 99.9 (High) High fever of 99.9.         concomitant medications include medication for heart disease.  Treatment information not provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive second dose yet (5 months past); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose yet (5 months past)) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose yet (5 months past)). On 26-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose yet (5 months past)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported by reporter.  Treatment information was not provided by reporter
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received expired vaccine beyond 12 hour expiration limit of the punctured vial/the vial first punctured on Aug 19, 2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026C21A) for COVID-19 immunization. No medical history reported. On Aug 26, 2021, patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 26, 2021, patient experienced administered expired product (received expired vaccine beyond 12 hour expiration limit of the punctured vial/the vial first punctured on Aug 19, 2021). At the time of the report, administered expired product (received expired vaccine beyond 12 hour expiration limit of the punctured vial/the vial first punctured on Aug 19, 2021) outcome: unknown. Lot number: "026C21A" Number of doses/vials: "1 dose /1 vial." Date the vial was initially stored in the refrigerator: "Unknown." Date of administration of vaccine: "Aug 26, 2021." Did the vial undergo any previous temperature excursions? "No." Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77° F): "Unknown." The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessment, concomitant medication or treatment information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some site tenderness in left deltoid; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (some site tenderness in left deltoid) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Urticaria. Concurrent medical conditions included Asthma and Autoimmune disorder (was diagnosed in her 20s). Concomitant products included MONTELUKAST and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Asthma, SIMVASTATIN for Cholesterol, AZITHROMYCIN for Flu, MELATONIN for Sleep disorder NOS, MULTIVITAMIN [VITAMINS NOS], CALCIUM, GLUCOSAMINE & CHONDORITIN, ASPIRIN [ACETYLSALICYLIC ACID], ALBUTEROL [SALBUTAMOL], OXYMETAZOLINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (some site tenderness in left deltoid). At the time of the report, VACCINATION SITE PAIN (some site tenderness in left deltoid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-300242 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and INJECTION SITE PAIN (sore injection site arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and INJECTION SITE PAIN (sore injection site arm). At the time of the report, PYREXIA (Fever) and INJECTION SITE PAIN (sore injection site arm) outcome was unknown.            The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-169099 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Memory loss. Concurrent medical conditions included Idiopathic pulmonary fibrosis. Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite). At the time of the report, DECREASED APPETITE (Loss of appetite) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) 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 VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered to patient after improper storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  The treatment information was  not provided.  It was reported that patient  was given vaccine that was  thawed, frozen and thawed.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional information received and added patient details (race information, height/ weight),  suspect product details and additional information in I - narrative.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications were reported. No treatment medications were reported.  It was reported that Its been 48 hours and patient getting a fever.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination complication
Clinical narrative: Tested positive for COVID-19; She was sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She was sick) and COVID-19 (Tested positive for COVID-19) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION COMPLICATION (She was sick). On 10-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, VACCINATION COMPLICATION (She was sick) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   This case was linked to MOD-2021-300317 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No second dose after more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose after more than 36 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose after more than 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose after more than 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash (around her abdomen), pyrexia (fever) and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. August 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. August 2021, patient experienced rash (around her abdomen), pyrexia (fever) and fatigue. At the time of the report, rash (around her abdomen), pyrexia (fever) and fatigue outcome: unknown. Patient given antihistamines. No concomitant medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lost hair or have thinner hair after getting the Moderna covid19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (lost hair or have thinner hair after getting the Moderna covid19 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 ALOPECIA (lost hair or have thinner hair after getting the Moderna covid19 vaccine). At the time of the report, ALOPECIA (lost hair or have thinner hair after getting the Moderna covid19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site rash
Clinical narrative: Chest pain; Big rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) and VACCINATION SITE RASH (Big rash around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-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 CHEST PAIN (Chest pain) and VACCINATION SITE RASH (Big rash around the injection site). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain) and VACCINATION SITE RASH (Big rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administering potentially spoiled vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administering potentially spoiled 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 EXPIRED PRODUCT ADMINISTERED (Administering potentially spoiled vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administering potentially spoiled vaccine) 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 medication was not provided Treatment information was not reported
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dyspnoea, Palpitations
Clinical narrative: heart palpitations, heart palpitations change randomly; shortness of breath; low blood pressure 99/60; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations, heart palpitations change randomly), DYSPNOEA (shortness of breath) and BLOOD PRESSURE DECREASED (low blood pressure 99/60) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-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 PALPITATIONS (heart palpitations, heart palpitations change randomly), DYSPNOEA (shortness of breath) and BLOOD PRESSURE DECREASED (low blood pressure 99/60). At the time of the report, PALPITATIONS (heart palpitations, heart palpitations change randomly), DYSPNOEA (shortness of breath) and BLOOD PRESSURE DECREASED (low blood pressure 99/60) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 99/60 (Low) 99/60.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 101.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot); This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot)) in a 101-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot)). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot)) 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 concomitant medications were reported  No treatment information was provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z0F21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). At the time of the report, PAIN IN EXTREMITY (Arm Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment drugs were not provided   Reporter did not allow further contact
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Papule, Peripheral swelling
Clinical narrative: a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder; sore arm; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling), PAPULE (a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder) and MYALGIA (sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced PERIPHERAL SWELLING (swelling) and MYALGIA (sore arm). On 17-Aug-2021, the patient experienced PAPULE (a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder). At the time of the report, PERIPHERAL SWELLING (swelling), PAPULE (a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had a strong reaction to the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a strong reaction to the first shot) 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a strong reaction to the first shot). At the time of the report, VACCINATION COMPLICATION (I had a strong reaction to the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lift nodes on their collar bone, on their left side, got swollen) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037c21a) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced LYMPHADENOPATHY (Lift nodes on their collar bone, on their left side, got swollen). At the time of the report, LYMPHADENOPATHY (Lift nodes on their collar bone, on their left side, got swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information was reported by reporter. This case was linked to MOD-2021-300750.