chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: Vertigo; Sinus infection and bronchitis; Sinus infection and bronchitis; Sore arm; Discoloration of abdomen; Dizziness; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), SINUSITIS (Sinus infection and bronchitis), BRONCHITIS (Sinus infection and bronchitis), PAIN IN EXTREMITY (Sore arm) and SKIN DISCOLOURATION (Discoloration of abdomen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SKIN DISCOLOURATION (Discoloration of abdomen), DIZZINESS (Dizziness), HEADACHE (Headache) and PYREXIA (Low grade fever). On 04-Mar-2021, the patient experienced SINUSITIS (Sinus infection and bronchitis) and BRONCHITIS (Sinus infection and bronchitis). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, SKIN DISCOLOURATION (Discoloration of abdomen) had resolved. On 16-Feb-2021, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), HEADACHE (Headache) and PYREXIA (Low grade fever) had resolved. At the time of the report, VERTIGO (Vertigo) had not resolved and SINUSITIS (Sinus infection and bronchitis) and BRONCHITIS (Sinus infection and bronchitis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included robutussin, antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Event added and outcome for the events was updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Skin discolouration, Vertigo
Clinical narrative: Vertigo; Sinus infection and bronchitis; Sinus infection and bronchitis; Sore arm; Discoloration of abdomen; Dizziness; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), SINUSITIS (Sinus infection and bronchitis), BRONCHITIS (Sinus infection and bronchitis), PAIN IN EXTREMITY (Sore arm) and SKIN DISCOLOURATION (Discoloration of abdomen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SKIN DISCOLOURATION (Discoloration of abdomen), DIZZINESS (Dizziness), HEADACHE (Headache) and PYREXIA (Low grade fever). On 04-Mar-2021, the patient experienced SINUSITIS (Sinus infection and bronchitis) and BRONCHITIS (Sinus infection and bronchitis). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, SKIN DISCOLOURATION (Discoloration of abdomen) had resolved. On 16-Feb-2021, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), HEADACHE (Headache) and PYREXIA (Low grade fever) had resolved. At the time of the report, VERTIGO (Vertigo) had not resolved and SINUSITIS (Sinus infection and bronchitis) and BRONCHITIS (Sinus infection and bronchitis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included robutussin, antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Event added and outcome for the events was updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Palpitations, Pyrexia
Clinical narrative: Feeling hot; Temperature which reads 98ish; Really tired; Heart has been racing a lot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart has been racing a lot), FEELING HOT (Feeling hot), PYREXIA (Temperature which reads 98ish) and FATIGUE (Really tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included AFib, COPD and Anxiety.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Heart has been racing a lot). On an unknown date, the patient experienced FEELING HOT (Feeling hot), PYREXIA (Temperature which reads 98ish) and FATIGUE (Really tired). At the time of the report, PALPITATIONS (Heart has been racing a lot), FEELING HOT (Feeling hot), PYREXIA (Temperature which reads 98ish) and FATIGUE (Really tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 98 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment medication was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo, Vomiting
Clinical narrative: For 4hs she experienced vertigo and dizziness; For 4hs she experienced vertigo and dizziness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (For 4hs she experienced vertigo and dizziness), DIZZINESS (For 4hs she experienced vertigo and dizziness) and VOMITING (Vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     The patient's past medical history included Vertigo (for shorter periods (1 minute)). Concomitant products included METOPROLOL, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VERTIGO (For 4hs she experienced vertigo and dizziness), DIZZINESS (For 4hs she experienced vertigo and dizziness) and VOMITING (Vomiting). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 25 mg once a day. On 05-Mar-2021, VERTIGO (For 4hs she experienced vertigo and dizziness), DIZZINESS (For 4hs she experienced vertigo and dizziness) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Mild rash; little itchy all over the face; A spontaneous report was received from a consumer (patient) which concerns a  54-year old female patient who experienced immunosuppression, mild rash and itching all over face.  The patient's medical history was not provided. No concomitant product use was reported.  On 10-Mar-2021, the patient received her first dose of two planned doses of mRNA-1273 (Lot number: 044A21A) intramuscularly in left upper arm for prophylaxis of COVID-19 infection.   The patient said the symptoms started a few hours later between 4 to 6 hours after on 10-Mar-2021. A mild rash appeared, and the patient said it was little itchy all over the face. The patient said that she takes immunosuppressors.  No treatment was provided.  Action taken with mRNA-1273 was unknown.  The outcome for all the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site pain, Pain in extremity
Clinical narrative: Sweating; tenderness on the arm where the vaccine was administered; Chills; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (tenderness on the arm where the vaccine was administered), CHILLS (Chills) and INJECTION SITE PAIN (Injection site tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (tenderness on the arm where the vaccine was administered), CHILLS (Chills) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (tenderness on the arm where the vaccine was administered), CHILLS (Chills) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Inappropriate schedule of product administration, Scab, Scar
Clinical narrative: Inappropriate schedule of vaccine administered; Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise; Sores that have scabbed over and are leaving scars; Leaving scars; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise), SCAB (Sores that have scabbed over and are leaving scars), SCAR (Leaving scars) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 2010, Drug allergy, Fluid retention, GERD and Blood pressure high. Concomitant products included OLMESARTAN MEDOXOMIL for Blood pressure management, INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) and METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE for Fluid retention, OMEPRAZOLE for GERD.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CONTUSION (Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise), SCAB (Sores that have scabbed over and are leaving scars) and SCAR (Leaving scars). On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, CONTUSION (Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise), SCAB (Sores that have scabbed over and are leaving scars) and SCAR (Leaving scars) had resolved with sequelae.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Reporter details, patient demographics, medical history, concomitant drugs, product information and event details updated
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Itch; Swelling; Redness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch), SWELLING (Swelling), ERYTHEMA (Redness) and RASH (Rash) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included POTASSIUM, VITAMIN D3 and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN) for an unknown indication.   On 11-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Itch), SWELLING (Swelling), ERYTHEMA (Redness) and RASH (Rash). At the time of the report, PRURITUS (Itch), SWELLING (Swelling), ERYTHEMA (Redness) and RASH (Rash) outcome was unknown.            Concomitant medication also included blood pressure medication. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-JUN-2021 and outcome of event (sick) updated from unknown to resolved and updated event start date. Patient declined  any further follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation, Skin discolouration
Clinical narrative: light area/pale spot on her arm; Burning; Itching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (light area/pale spot on her arm), SKIN BURNING SENSATION (Burning) and PRURITUS (Itching) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (light area/pale spot on her arm), SKIN BURNING SENSATION (Burning) and PRURITUS (Itching). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (light area/pale spot on her arm), SKIN BURNING SENSATION (Burning) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Uncomfortable; injection site is hard; Injection site Itchy; Injection site red; Soreness around injection site; Little swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (Soreness around injection site) and VACCINATION SITE SWELLING (Little swelling around the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included LITHIUM, LAMOTRIGINE (LAMICTAL), QUETIAPINE FUMARATE (SEROQUEL) and OMEPRAZOLE 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 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site) and VACCINATION SITE SWELLING (Little swelling around the injection site). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy) and VACCINATION SITE ERYTHEMA (Injection site red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (Soreness around injection site), VACCINATION SITE SWELLING (Little swelling around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient noticed that the injection area was 4 inches top to bottom and side to side.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Uncomfortable; injection site is hard; Injection site Itchy; Injection site red; Soreness around injection site; Little swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (Soreness around injection site) and VACCINATION SITE SWELLING (Little swelling around the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included LITHIUM, LAMOTRIGINE (LAMICTAL), QUETIAPINE FUMARATE (SEROQUEL) and OMEPRAZOLE 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 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site) and VACCINATION SITE SWELLING (Little swelling around the injection site). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy) and VACCINATION SITE ERYTHEMA (Injection site red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (Soreness around injection site), VACCINATION SITE SWELLING (Little swelling around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient noticed that the injection area was 4 inches top to bottom and side to side.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Achy; Severe chills; Felt very tired; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), CHILLS (Severe chills), FATIGUE (Felt very tired) and NAUSEA (Nauseous) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Achy), CHILLS (Severe chills), FATIGUE (Felt very tired) and NAUSEA (Nauseous). At the time of the report, PAIN (Achy), CHILLS (Severe chills), FATIGUE (Felt very tired) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not given by the reporter.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: feeling really bad; hurts really bad; Swollen arm; he went to the ER room due to the pain in the Left arm; Pain in the left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (feeling really bad), PAIN (hurts really bad), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (he went to the ER room due to the pain in the Left arm) and ARTHRALGIA (Pain in the left shoulder) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE for an unknown indication.    No medical information was provided by the reporter.  Concomitant products included THYROID for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient received dose of PNEUMOCOCCAL VACCINE (unknown route) unknown. On 07-Mar-2021, the patient experienced FEELING ABNORMAL (feeling really bad), PAIN (hurts really bad), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (he went to the ER room due to the pain in the Left arm) and ARTHRALGIA (Pain in the left shoulder). The patient was treated with KETOROLAC on 07-Mar-2021 at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (feeling really bad), PAIN (hurts really bad), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (he went to the ER room due to the pain in the Left arm) and ARTHRALGIA (Pain in the left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed with meloxicam 7.5mg but he didn't taken them  due to the possible side effects the pill could cause. The patient was told in the emergency room this was due to arthritis or arteriopathy, he could not remember well.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L 20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: really dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (really dry mouth) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DRY MOUTH (really dry mouth). At the time of the report, DRY MOUTH (really dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she did not experience dry mouth before and not for that long time, usually it goes away after brushing teeth. She tried brushing teeth and also spinning water in the mouth and there was no effect. Concomitant medication includes blood pressure and Vertigo medicines. The patient did not receive any treatment medications.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Achy; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy), HEADACHE (Headache) and FATIGUE (Fatigue) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Blood pressure management. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (Achy), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Achy), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            Other concomitant medications included blood pressure and thyroid medicines. The patient did not take any medication for the symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Received vaccine from a vial that was punctured and left at room temperature for 48 hours; Punctured vial left out room temperature was given to 5 people; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Received vaccine from a vial that was punctured and left at room temperature for 48 hours) and POOR QUALITY PRODUCT ADMINISTERED (Punctured vial left out room temperature was given to 5 people) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (Received vaccine from a vial that was punctured and left at room temperature for 48 hours) and POOR QUALITY PRODUCT ADMINISTERED (Punctured vial left out room temperature was given to 5 people). On 10-Mar-2021, PRODUCT STORAGE ERROR (Received vaccine from a vial that was punctured and left at room temperature for 48 hours) and POOR QUALITY PRODUCT ADMINISTERED (Punctured vial left out room temperature was given to 5 people) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Vaccination site erythema, Vaccination site pain
Clinical narrative: diarrhea; upset stomach; redness at injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site). On 08-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (upset stomach). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy arm near site of vaccination; Rash near site of vaccination; three red areas about the size of a nickel each around the site of vaccine shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm near site of vaccination), VACCINATION SITE RASH (Rash near site of vaccination) and VACCINATION SITE ERYTHEMA (three red areas about the size of a nickel each around the site of vaccine shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Allergy to keflex), Allergy to antibiotic (Allergy to Erythromycin), Fruit allergy (Allergy to Strawberries), Blood pressure high and Sleep apnea since 08-Jan-2017. Concomitant products included IRBESARTAN from 01-Jan-2000 to an unknown date for Blood pressure, PROGESTERONE;ESTROGENS from 01-Jan-2003 to an unknown date for Hormonal imbalance, VITAMINS NOS for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm near site of vaccination), VACCINATION SITE RASH (Rash near site of vaccination) and VACCINATION SITE ERYTHEMA (three red areas about the size of a nickel each around the site of vaccine shot). On 04-Mar-2021, VACCINATION SITE PRURITUS (Itchy arm near site of vaccination), VACCINATION SITE RASH (Rash near site of vaccination) and VACCINATION SITE ERYTHEMA (three red areas about the size of a nickel each around the site of vaccine shot) had resolved.            This case was linked to MOD-2021-212844 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2021: Significant follow up received on 04-APR-2021, Patient demographics updated, medical history updated, concomitant medications updated, therapy details of suspect product, event term updated (rash to Rash near site of vaccination), additional events reported (Itchy arm near site of vaccination, three red areas about the size of a nickel each around the site of vaccine shot).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vision blurred
Clinical narrative: Blurred Vision; Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred Vision), HEADACHE (Terrible headache) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurred Vision), HEADACHE (Terrible headache) and PYREXIA (Fever). At the time of the report, VISION BLURRED (Blurred Vision), HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Pain
Clinical narrative: pain at the injection site which radiates up to her collar bone,; extreme soreness; a knot that has developed at the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site which radiates up to her collar bone,), PAIN (extreme soreness) and INJECTION SITE MASS (a knot that has developed at the site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site which radiates up to her collar bone,), PAIN (extreme soreness) and INJECTION SITE MASS (a knot that has developed at the site). At the time of the report, INJECTION SITE PAIN (pain at the injection site which radiates up to her collar bone,), PAIN (extreme soreness) and INJECTION SITE MASS (a knot that has developed at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Body temperature, Chills, Cold sweat, Fatigue
Clinical narrative: cold sweats; chills; Pretty intense reaction; achy; arm tingling; headache; nauseous; fatigued, tired; muscles ache; site of injection was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Pretty intense reaction), COLD SWEAT (cold sweats), PAIN (achy), PARAESTHESIA (arm tingling) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds (Allergy to molds and overreact to it). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore). On an unknown date, the patient experienced COLD SWEAT (cold sweats) and CHILLS (chills). At the time of the report, ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore) outcome was unknown and COLD SWEAT (cold sweats) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.9 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took extra dose of Aspirin to help her with the symptoms occurred after 1st dose.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up contain new AE's
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: cold sweats; chills; Pretty intense reaction; achy; arm tingling; headache; nauseous; fatigued, tired; muscles ache; site of injection was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Pretty intense reaction), COLD SWEAT (cold sweats), PAIN (achy), PARAESTHESIA (arm tingling) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds (Allergy to molds and overreact to it). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore). On an unknown date, the patient experienced COLD SWEAT (cold sweats) and CHILLS (chills). At the time of the report, ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore) outcome was unknown and COLD SWEAT (cold sweats) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.9 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took extra dose of Aspirin to help her with the symptoms occurred after 1st dose.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up contain new AE's
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: cold sweats; chills; Pretty intense reaction; achy; arm tingling; headache; nauseous; fatigued, tired; muscles ache; site of injection was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Pretty intense reaction), COLD SWEAT (cold sweats), PAIN (achy), PARAESTHESIA (arm tingling) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds (Allergy to molds and overreact to it). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore). On an unknown date, the patient experienced COLD SWEAT (cold sweats) and CHILLS (chills). At the time of the report, ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore) outcome was unknown and COLD SWEAT (cold sweats) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.9 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took extra dose of Aspirin to help her with the symptoms occurred after 1st dose.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up contain new AE's
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Lethargy, Pain, Swelling
Clinical narrative: lethargic; soreness, Pain; redness; swelling; warm to touch; still having red border at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE WARMTH (warm to touch) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (still having red border at injection site) and HEADACHE (headache). On 11-Mar-2021, the patient experienced LETHARGY (lethargic). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic) and HEADACHE (headache) had not resolved and PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (still having red border at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: lethargic; soreness, Pain; redness; swelling; warm to touch; still having red border at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE WARMTH (warm to touch) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (still having red border at injection site) and HEADACHE (headache). On 11-Mar-2021, the patient experienced LETHARGY (lethargic). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic) and HEADACHE (headache) had not resolved and PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (still having red border at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery from 04-Mar-2021 to March 2021. Concurrent medical conditions included Osteoporosis. Concomitant products included ROMOSOZUMAB (EVENITY [ROMOSOZUMAB]) for Osteoporosis.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11 Mar 2021, the patient  stated  that she was due for second dose of Moderna COVID- 19 vaccine on 04 Mar 2021, but did not received as she was having surgery that day and her health care provider advised her to not take the vaccine due to possible side effects.  Treatment medication was not provided by the reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 ( Lot # 012M20A) with no associated AEs.