chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible; A little headache; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible) and HEADACHE (A little headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible) and HEADACHE (A little headache). At the time of the report, VACCINATION SITE PAIN (For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible) and HEADACHE (A little headache) 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.   Treatment information was not provided.   This case was linked to MOD-2021-294225 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine Exposure during pregnancy) 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine Exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine Exposure during pregnancy) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Rash erythematous
Clinical narrative: red rash on both the breast went across like a bridge; breasts turned fire engine red; symptom she experienced after receiving 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on both the breast went across like a bridge), ERYTHEMA (breasts turned fire engine red) and EXTRA DOSE ADMINISTERED (symptom she experienced after receiving 3rd dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0S2E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (symptom she experienced after receiving 3rd dose). On 21-Aug-2021, the patient experienced RASH ERYTHEMATOUS (red rash on both the breast went across like a bridge) and ERYTHEMA (breasts turned fire engine red). On 20-Aug-2021, EXTRA DOSE ADMINISTERED (symptom she experienced after receiving 3rd dose) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on both the breast went across like a bridge) and ERYTHEMA (breasts turned fire engine red) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient reported that she had an MRI of breasts 3 or 4 months ago.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Vaccination complication
Clinical narrative: sweating; labored breathing, could not catch his breath; chills; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well), HYPERHIDROSIS (sweating), DYSPNOEA (labored breathing, could not catch his breath) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015C21A, 030M21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION COMPLICATION (not feeling well) and CHILLS (chills). On 19-Aug-2021, the patient experienced HYPERHIDROSIS (sweating) and DYSPNOEA (labored breathing, could not catch his breath). At the time of the report, VACCINATION COMPLICATION (not feeling well), HYPERHIDROSIS (sweating), DYSPNOEA (labored breathing, could not catch his breath) and CHILLS (chills) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-294237 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Experienced a lot of swelling; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (Experienced a lot of swelling) 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 provided.  Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.    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 SWELLING (Experienced a lot of swelling). At the time of the report, SWELLING (Experienced a lot of swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  The patient was injected with Restylane Kysse after receiving vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) 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, 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 ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.            Concomitant medication was not provided Treatment information was not reported    Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Middle insomnia, Productive cough, Throat clearing
Clinical narrative: Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back; keeps her up at night and can't even sleep; Little bit of cough; Keeps having to clear her throat; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back), MIDDLE INSOMNIA (keeps her up at night and can't even sleep), COUGH (Little bit of cough) and THROAT CLEARING (Keeps having to clear her throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE for Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back), MIDDLE INSOMNIA (keeps her up at night and can't even sleep), COUGH (Little bit of cough) and THROAT CLEARING (Keeps having to clear her throat). The patient was treated with PREDNISONE at an unspecified dose and frequency; AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) in March 2021 at an unspecified dose and frequency. At the time of the report, PRODUCTIVE COUGH (Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back), MIDDLE INSOMNIA (keeps her up at night and can't even sleep), COUGH (Little bit of cough) and THROAT CLEARING (Keeps having to clear her throat) outcome was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: arm hurt like crazy; patient got the booster vaccine and is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt like crazy) and EXTRA DOSE ADMINISTERED (patient got the booster vaccine and is not immunocompromised) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm hurt like crazy). 15-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient got the booster vaccine and is not immunocompromised). On 15-Aug-2021, EXTRA DOSE ADMINISTERED (patient got the booster vaccine and is not immunocompromised) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt like crazy) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient got the booster vaccine the same day they got the flu shot and less than 8 month after getting the second dose.   This case was linked to MOD-2021-294085 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 18 patients received a dose given greater than 12 hours after puncture; 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 EXPIRED PRODUCT ADMINISTERED (18 patients received a dose given greater than 12 hours after puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) 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 (18 patients received a dose given greater than 12 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (18 patients received a dose given greater than 12 hours after puncture) had resolved.            Concomitant product was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: TCR document received on 25-Aug-2021 included reporter's fax number.; Action taken for Product Details updated to Not Applicable , Medication Error Case.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: A little bit of rash in both injections; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (A little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information  was reported.  Concomitant products included FISH OIL for an unknown indication.    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 SITE RASH (A little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE RASH (A little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included supplements and vitamins.  The treatment information was  not provided.   This case was linked to MOD-2021-294674 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysgeusia, Headache, Illness, Incorrect dose administered
Clinical narrative: patient received 3rd dose on 19-Aug-2021; She has been "so sick"; a horrible metallic taste in her mouth; she "felt like she had the flu"; red rash; very hot rash; itchiness/itching; it "has been a nightmare."; fever up to 103; headache; muscle pains/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu") and RASH ERYTHEMATOUS (red rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893, 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunocompromised (compromised immune system with leukemia). Concurrent medical conditions included Leukemia.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), PRURITUS (itchiness/itching), NIGHTMARE (it "has been a nightmare."), PYREXIA (fever up to 103), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness). On 19-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. In August 2021, PRURITUS (itchiness/itching) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), NIGHTMARE (it "has been a nightmare."), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness) outcome was unknown and PYREXIA (fever up to 103) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: bring it down for 4 hours (Low) which would bring it down for 4 hours before raising again. In August 2021, Body temperature: up to 103 (High) up to 103.         No concomitant products was provided by the reporter. The patient had been using ice on her arm as a self-treatment method and her itching symptom went away.   This case was linked to MOD-2021-294276 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nightmare, Pruritus, Pyrexia
Clinical narrative: patient received 3rd dose on 19-Aug-2021; She has been "so sick"; a horrible metallic taste in her mouth; she "felt like she had the flu"; red rash; very hot rash; itchiness/itching; it "has been a nightmare."; fever up to 103; headache; muscle pains/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu") and RASH ERYTHEMATOUS (red rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893, 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunocompromised (compromised immune system with leukemia). Concurrent medical conditions included Leukemia.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), PRURITUS (itchiness/itching), NIGHTMARE (it "has been a nightmare."), PYREXIA (fever up to 103), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness). On 19-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. In August 2021, PRURITUS (itchiness/itching) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), NIGHTMARE (it "has been a nightmare."), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness) outcome was unknown and PYREXIA (fever up to 103) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: bring it down for 4 hours (Low) which would bring it down for 4 hours before raising again. In August 2021, Body temperature: up to 103 (High) up to 103.         No concomitant products was provided by the reporter. The patient had been using ice on her arm as a self-treatment method and her itching symptom went away.   This case was linked to MOD-2021-294276 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin warm
Clinical narrative: patient received 3rd dose on 19-Aug-2021; She has been "so sick"; a horrible metallic taste in her mouth; she "felt like she had the flu"; red rash; very hot rash; itchiness/itching; it "has been a nightmare."; fever up to 103; headache; muscle pains/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu") and RASH ERYTHEMATOUS (red rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893, 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunocompromised (compromised immune system with leukemia). Concurrent medical conditions included Leukemia.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), PRURITUS (itchiness/itching), NIGHTMARE (it "has been a nightmare."), PYREXIA (fever up to 103), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness). On 19-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. In August 2021, PRURITUS (itchiness/itching) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been "so sick"), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she "felt like she had the flu"), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), NIGHTMARE (it "has been a nightmare."), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness) outcome was unknown and PYREXIA (fever up to 103) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: bring it down for 4 hours (Low) which would bring it down for 4 hours before raising again. In August 2021, Body temperature: up to 103 (High) up to 103.         No concomitant products was provided by the reporter. The patient had been using ice on her arm as a self-treatment method and her itching symptom went away.   This case was linked to MOD-2021-294276 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pruritus
Clinical narrative: Arm went to itching; Redness /has a pretty good size red; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm went to itching), ERYTHEMA (Redness /has a pretty good size red) and MYALGIA (Arm was sore) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRURITUS (Arm went to itching) and ERYTHEMA (Redness /has a pretty good size red). In August 2021, the patient experienced MYALGIA (Arm was sore). In August 2021, MYALGIA (Arm was sore) had resolved. At the time of the report, PRURITUS (Arm went to itching) and ERYTHEMA (Redness /has a pretty good size red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that her arm was sore for 3 days and on the 11th day, it went to itching, red and has a pretty good size red. She only put alcohol on it, she did not take any medications. She was due to receive the second dose of the vaccine on 01-Sep-2021 and wanted to know if she should receive it.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Intentional dose omission, Limb discomfort, Vision blurred
Clinical narrative: Blurry vision; Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves; Brain fog; She was not going to get the next dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Did not receive the monoclonal antibody drip treatment) in March 2021.  On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose). At the time of the report, VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient had some underlying conditions.  No concomitant medications were provided. Treatment information was not provided.   This case was linked to MOD-2021-294440 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in their hands; 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 PAIN IN EXTREMITY (Pain in their hands) 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 PAIN IN EXTREMITY (Pain in their hands). At the time of the report, PAIN IN EXTREMITY (Pain in their hands) 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 reported
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.) in a 46-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 TINNITUS (patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.). At the time of the report, TINNITUS (patient received his second Moderna Covid-19 vaccination and he told me that he experienced tinnitus in his ears.) outcome was unknown.            No concomitant medication was reported.                   No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Facial pain, Insomnia, Pruritus, Rash
Clinical narrative: Severe itching in her face; Severe burning rash in her face; Pain in the face; Couldn't sleep the entire night; Severe burning rash in her face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching in her face), BURNING SENSATION (Severe burning rash in her face), FACIAL PAIN (Pain in the face), INSOMNIA (Couldn't sleep the entire night) and RASH (Severe burning rash in her face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRURITUS (Severe itching in her face), BURNING SENSATION (Severe burning rash in her face), FACIAL PAIN (Pain in the face) and INSOMNIA (Couldn't sleep the entire night). March 2021, the patient experienced RASH (Severe burning rash in her face). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Severe itching in her face), BURNING SENSATION (Severe burning rash in her face), FACIAL PAIN (Pain in the face), INSOMNIA (Couldn't sleep the entire night) and RASH (Severe burning rash in her face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Staphylococcus test: negative (Negative) Culture done because they thought it was staph, but the result came back as not bacterial infected.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication list was not provided.   This case was linked to MOD-2021-294462 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Staphylococcus test
Clinical narrative: Severe itching in her face; Severe burning rash in her face; Pain in the face; Couldn't sleep the entire night; Severe burning rash in her face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching in her face), BURNING SENSATION (Severe burning rash in her face), FACIAL PAIN (Pain in the face), INSOMNIA (Couldn't sleep the entire night) and RASH (Severe burning rash in her face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRURITUS (Severe itching in her face), BURNING SENSATION (Severe burning rash in her face), FACIAL PAIN (Pain in the face) and INSOMNIA (Couldn't sleep the entire night). March 2021, the patient experienced RASH (Severe burning rash in her face). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Severe itching in her face), BURNING SENSATION (Severe burning rash in her face), FACIAL PAIN (Pain in the face), INSOMNIA (Couldn't sleep the entire night) and RASH (Severe burning rash in her face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Staphylococcus test: negative (Negative) Culture done because they thought it was staph, but the result came back as not bacterial infected.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication list was not provided.   This case was linked to MOD-2021-294462 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Headache, Hyperhidrosis
Clinical narrative: he had sweating; he cannot smell; he had headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (he had sweating), ANOSMIA (he cannot smell) and HEADACHE (he had headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 HYPERHIDROSIS (he had sweating), ANOSMIA (he cannot smell) and HEADACHE (he had headache). At the time of the report, HYPERHIDROSIS (he had sweating), ANOSMIA (he cannot smell) and HEADACHE (he had headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: They have not received a second dose at this time; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They have not received a second dose at this time) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-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 (They have not received a second dose at this time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They have not received a second dose at this time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not  provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Urticaria, Vaccination site swelling
Clinical narrative: redness of the injection site for a few days; Swelling of the injection site; developed hives on her legs and under her arms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling of the injection site), URTICARIA (developed hives on her legs and under her arms) and INJECTION SITE ERYTHEMA (redness of the injection site for a few days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis. Concurrent medical conditions included Egg allergy.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced URTICARIA (developed hives on her legs and under her arms). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling of the injection site) and INJECTION SITE ERYTHEMA (redness of the injection site for a few days). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling of the injection site), URTICARIA (developed hives on her legs and under her arms) and INJECTION SITE ERYTHEMA (redness of the injection site for a few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Patient stated that, on 18/19th August  she developed hives on her legs and under arms. When she took Benadryl  it went away and returned when the Benadryl wears off . She states that she had lot of allergies and did not take flu shots as she ended up in the hospital with bad bronchitis.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nerve injury, Vaccination complication
Clinical narrative: She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before; When she stretches it it's like very tight; Like it's a nerve damage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before), MUSCLE TIGHTNESS (when she stretches it it's like very tight) and NERVE INJURY (like it's a nerve damage) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before), MUSCLE TIGHTNESS (when she stretches it it's like very tight) and NERVE INJURY (like it's a nerve damage). At the time of the report, VACCINATION COMPLICATION (She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before), MUSCLE TIGHTNESS (when she stretches it it's like very tight) and NERVE INJURY (like it's a nerve damage) outcome was unknown.            Concomitant product was not provided by the reporter  Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: Achy legs; Felt weak and tired; Little short of breath; Lightheaded; Headache and Head hurt; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded) and HEADACHE (Headache and Head hurt) in a male patient of an unknown age 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 27-Jul-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 PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded), HEADACHE (Headache and Head hurt) and MYALGIA (Sore arm). At the time of the report, PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded), HEADACHE (Headache and Head hurt) and MYALGIA (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.  No treatment information was provided.  The patient is scheduled to get the second dose on 27Aug2021.  Patient mentioned that the J&J vaccine is known for causing blood clots. After the first dose patient  experienced achy legs, headache, sore arm, felt weak and tired. Their head hurt and immediately after the shot felt a little short of breath and  lightheaded. Patient  provides consent for Safety to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Achy legs; Felt weak and tired; Little short of breath; Lightheaded; Headache and Head hurt; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded) and HEADACHE (Headache and Head hurt) in a male patient of an unknown age 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 27-Jul-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 PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded), HEADACHE (Headache and Head hurt) and MYALGIA (Sore arm). At the time of the report, PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded), HEADACHE (Headache and Head hurt) and MYALGIA (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.  No treatment information was provided.  The patient is scheduled to get the second dose on 27Aug2021.  Patient mentioned that the J&J vaccine is known for causing blood clots. After the first dose patient  experienced achy legs, headache, sore arm, felt weak and tired. Their head hurt and immediately after the shot felt a little short of breath and  lightheaded. Patient  provides consent for Safety to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 017B21A) 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 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (insomnia). At the time of the report, INSOMNIA (insomnia) outcome was unknown.            No concomitant medication information was provided by the reporter.  The patient took several medications for insomnia but nothing seems to work.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling hot, Illness, Insomnia
Clinical narrative: tingles down the arm up until their fingers; pain is awful; it keeps them up at night; chills for 2 weeks; pretty sick; right arm still hurts, all day, but it is worse at night; right arm is hot; right shoulder hurts too; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick), PAIN IN EXTREMITY (right arm still hurts, all day, but it is worse at night), FEELING HOT (right arm is hot), PARAESTHESIA (tingles down the arm up until their fingers) and PAIN (pain is awful) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal fusion. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, VITAMINS NOS and OXYCODONE for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm still hurts, all day, but it is worse at night), FEELING HOT (right arm is hot) and ARTHRALGIA (right shoulder hurts too). On an unknown date, the patient experienced ILLNESS (pretty sick), PARAESTHESIA (tingles down the arm up until their fingers), PAIN (pain is awful), INSOMNIA (it keeps them up at night) and CHILLS (chills for 2 weeks). At the time of the report, ILLNESS (pretty sick), PAIN IN EXTREMITY (right arm still hurts, all day, but it is worse at night), FEELING HOT (right arm is hot), PARAESTHESIA (tingles down the arm up until their fingers), PAIN (pain is awful), INSOMNIA (it keeps them up at night), CHILLS (chills for 2 weeks) and ARTHRALGIA (right shoulder hurts too) outcome was unknown.            No Treatment Medications were provided.   This case was linked to MOD-2021-294361 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: tingles down the arm up until their fingers; pain is awful; it keeps them up at night; chills for 2 weeks; pretty sick; right arm still hurts, all day, but it is worse at night; right arm is hot; right shoulder hurts too; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick), PAIN IN EXTREMITY (right arm still hurts, all day, but it is worse at night), FEELING HOT (right arm is hot), PARAESTHESIA (tingles down the arm up until their fingers) and PAIN (pain is awful) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal fusion. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, VITAMINS NOS and OXYCODONE for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm still hurts, all day, but it is worse at night), FEELING HOT (right arm is hot) and ARTHRALGIA (right shoulder hurts too). On an unknown date, the patient experienced ILLNESS (pretty sick), PARAESTHESIA (tingles down the arm up until their fingers), PAIN (pain is awful), INSOMNIA (it keeps them up at night) and CHILLS (chills for 2 weeks). At the time of the report, ILLNESS (pretty sick), PAIN IN EXTREMITY (right arm still hurts, all day, but it is worse at night), FEELING HOT (right arm is hot), PARAESTHESIA (tingles down the arm up until their fingers), PAIN (pain is awful), INSOMNIA (it keeps them up at night), CHILLS (chills for 2 weeks) and ARTHRALGIA (right shoulder hurts too) outcome was unknown.            No Treatment Medications were provided.   This case was linked to MOD-2021-294361 (Patient Link).