chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: heart palpitations when she restarted taking Lexapro and Adderall; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations when she restarted taking Lexapro and Adderall) and DYSPNOEA (short of breath) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PALPITATIONS (heart palpitations when she restarted taking Lexapro and Adderall) and DYSPNOEA (short of breath). At the time of the report, PALPITATIONS (heart palpitations when she restarted taking Lexapro and Adderall) and DYSPNOEA (short of breath) outcome was unknown.            No treatment medications were reported.   Patient stated that she felt short of breath and heart rate sped up whenever she took stimulants like Adderall. States she adjusted the dosages and tried alternatives. Not ongoing as per patient.  And stated that she was away of the myocarditis and pericarditis reports and stated she has no cardiac history.   Patient stated that she had experienced heart palpitations when she restarted taking Lexapro and Adderall after the 2nd Moderna dose.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Facility administered 2 patients expired doses of the Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Pruritus, Rash erythematous
Clinical narrative: Felt hot in back of his head; Developed a red rash around and behind his head and hairline/Developed a red rash under his arm pit/Developed a red rash in his pelvic area; His hands also itch/He has moments of itchiness throughout his body which comes and goes.; Felt fatigued; Had a strong headache the whole day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot in back of his head), RASH ERYTHEMATOUS (Developed a red rash around and behind his head and hairline/Developed a red rash under his arm pit/Developed a red rash in his pelvic area), PRURITUS (His hands also itch/He has moments of itchiness throughout his body which comes and goes.), FATIGUE (Felt fatigued) and HEADACHE (Had a strong headache the whole day) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Nov-2021, the patient experienced FATIGUE (Felt fatigued) and HEADACHE (Had a strong headache the whole day). On 08-Nov-2021, the patient experienced FEELING HOT (Felt hot in back of his head), RASH ERYTHEMATOUS (Developed a red rash around and behind his head and hairline/Developed a red rash under his arm pit/Developed a red rash in his pelvic area) and PRURITUS (His hands also itch/He has moments of itchiness throughout his body which comes and goes.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Felt hot in back of his head), RASH ERYTHEMATOUS (Developed a red rash around and behind his head and hairline/Developed a red rash under his arm pit/Developed a red rash in his pelvic area), PRURITUS (His hands also itch/He has moments of itchiness throughout his body which comes and goes.), FATIGUE (Felt fatigued) and HEADACHE (Had a strong headache the whole day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were included Antihistamine, Benadryl.  No concomitant medications were provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: It seems like a blister but it's not a blister; at the injection site had pain and tenderness / It was sore/ it hurts when moved hand; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (It seems like a blister but it's not a blister), VACCINATION SITE PAIN (at the injection site had pain and tenderness / It was sore/ it hurts when moved hand) and VACCINATION SITE SWELLING (swelling) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A-B, 002B21A and 023M20A) for COVID-19 vaccination.     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-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (It seems like a blister but it's not a blister), VACCINATION SITE PAIN (at the injection site had pain and tenderness / It was sore/ it hurts when moved hand) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE REACTION (It seems like a blister but it's not a blister), VACCINATION SITE PAIN (at the injection site had pain and tenderness / It was sore/ it hurts when moved hand) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Pressure pills, Cholesterol pills, Bladder pills and Eye drops. No treatment medication was reported.   This case was linked to MOD-2021-224785 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, Headache, Ocular discomfort
Clinical narrative: Sodium Imbalance/LowSodium; Eye problem; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD SODIUM DECREASED (Sodium Imbalance/LowSodium), OCULAR DISCOMFORT (Eye problem) and HEADACHE (Headaches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Two mild heart attacks), Stent insertion NOS (3 times) and Bypass surgery.   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 BLOOD SODIUM DECREASED (Sodium Imbalance/LowSodium), OCULAR DISCOMFORT (Eye problem) and HEADACHE (Headaches). At the time of the report, BLOOD SODIUM DECREASED (Sodium Imbalance/LowSodium), OCULAR DISCOMFORT (Eye problem) and HEADACHE (Headaches) had resolved.            It was reported that patient had a number of heart conditions and patient received her first two Moderna shots in a very nice clinic half mile away from her home.  Patient felt fine now and doctor recommended her to take the booster.  No concomitant medications were reported.  No treatment medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Inappropriate schedule of vaccine administered; a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049c21a and 939676) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection, MULTIVITAMIN [VITAMINS NOS], KERATIN and NALTREXONE for an unknown indication.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE PAIN (a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Nov-2021, VACCINATION SITE PAIN (a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Patient is also taking concomitant medications Ciamin vitamin A  and Liver Medications. No treatment information was provided
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: My dad had the same thing; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (My dad had the same thing) in an 80-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 CARDIAC DISORDER (My dad had the same thing). At the time of the report, CARDIAC DISORDER (My dad had the same thing) outcome was unknown.            Concomitant medications was not reported. No treatment information was provided.  Company comment This case concerns a 80-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event of Cardiac disorder after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Very limited information was provided at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 80-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event of Cardiac disorder after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Very limited information was provided at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills after 2nd dose). At the time of the report, CHILLS (Chills after 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-384017 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: It's tender /really painful; really painful; in my left armpit, there's complete swelling of lymph nodes; soreness at the injection site; I felt extremely tired, I could barely keep my eyes open; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (It's tender /really painful), LYMPH NODE PAIN (really painful), LYMPHADENOPATHY (in my left armpit, there's complete swelling of lymph nodes), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (I felt extremely tired, I could barely keep my eyes open) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 045A21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). 10-Nov-2021, the patient experienced FATIGUE (I felt extremely tired, I could barely keep my eyes open). On 11-Nov-2021, the patient experienced LYMPH NODE PAIN (It's tender /really painful), LYMPH NODE PAIN (really painful) and LYMPHADENOPATHY (in my left armpit, there's complete swelling of lymph nodes). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPH NODE PAIN (It's tender /really painful), LYMPH NODE PAIN (really painful), LYMPHADENOPATHY (in my left armpit, there's complete swelling of lymph nodes), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (I felt extremely tired, I could barely keep my eyes open) outcome was unknown.            No concomitant medications reported.   This case was linked to MOD-2021-384391, MOD-2021-384392 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Thrombosis, Ultrasound scan
Clinical narrative: fever; headache; blood clot on right calf; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot on right calf) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthroscopy (right knee) on 19-Oct-2021.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced THROMBOSIS (blood clot on right calf) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with RIVAROXABAN (XARELTO) at a dose of 15mg twice a day for 21 day then 20mg d. At the time of the report, THROMBOSIS (blood clot on right calf), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Ultrasound scan: blood clot (abnormal) blood clot..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has under gone 5 surgeries before.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported.  Company comment This case concerns a 40-year-old male patient, with medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), who experienced the serious unexpected event of THROMBOSIS. The events occurred approximately 6 months after the administration if the second dose of mRNA-1273 vaccine. Re-challenge was not applicable. Patient´s medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 40-year-old male patient, with medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), who experienced the serious unexpected event of THROMBOSIS. The events occurred approximately 6 months after the administration if the second dose of mRNA-1273 vaccine. Re-challenge was not applicable. Patient´s medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Malaise, Vaccination site pain
Clinical narrative: Didn't feel good; little bit of diarrhea; arm was very, very sore from injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), DIARRHOEA (little bit of diarrhea) and VACCINATION SITE PAIN (arm was very, very sore from injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to beef ) and Food allergy (Allergic to pork).    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced MALAISE (Didn't feel good), DIARRHOEA (little bit of diarrhea) and VACCINATION SITE PAIN (arm was very, very sore from injection). At the time of the report, MALAISE (Didn't feel good), DIARRHOEA (little bit of diarrhea) and VACCINATION SITE PAIN (arm was very, very sore from injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: low (Low) low-grade temperature.         No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-384221 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Infection, SARS-CoV-2 test
Clinical narrative: Breakthrough Infection on al older woman after her two shots of Moderna; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (Breakthrough Infection on al older woman after her two shots of Moderna) and COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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 INFECTION (Breakthrough Infection on al older woman after her two shots of Moderna) and COVID-19 (COVID-19). At the time of the report, INFECTION (Breakthrough Infection on al older woman after her two shots of Moderna) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP did not know her exact age, guessed patient was between 70 and 80 years old. Patient had two COVID vaccines more than 6 months ago but recently tested positive for COVID.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.  This is a spontaneous case concerning an elderly female patient with  concurrent medical condition of Immunocompromised, who experienced non serious, AESI, unexpected event of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 vaccine. It was reported that patient had two COVID vaccines more than 6 months ago but recently tested positive for COVID. Re-challenge is not applicable. Concurrent medical condition of Immunocompromised remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Follow-up received on 13-Nov-2021.  Email Id was added and Address updated.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with  concurrent medical condition of Immunocompromised, who experienced non serious, AESI, unexpected event of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 vaccine. It was reported that patient had two COVID vaccines more than 6 months ago but recently tested positive for COVID. Rechallenge is not applicable. Concurrent medical condition of Immunocompromised remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discomfort
Clinical narrative: Itchy skin; Patchy skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) and SKIN DISCOMFORT (Patchy skin) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, Anxiety, Depression and Bladder discomfort.    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 PRURITUS (Itchy skin) and SKIN DISCOMFORT (Patchy skin). At the time of the report, PRURITUS (Itchy skin) and SKIN DISCOMFORT (Patchy skin) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concurrent condition also included bladder control issues.  No concomitant and treatment medication details were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 015M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: No new information appended.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Ding ding ding noise in the head; Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ding ding ding noise in the head) and HEADACHE (Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TINNITUS (Ding ding ding noise in the head) and HEADACHE (Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull). At the time of the report, TINNITUS (Ding ding ding noise in the head) and HEADACHE (Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 015M20A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up information received on 12-NOV-2021 contain No New Information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site swelling
Clinical narrative: hand feel numb; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen). At the time of the report, HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.    This case was linked to MOD-2021-384207 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site pain
Clinical narrative: It presented as little blisters that itch; Breaking out in different places after receiving the 1st dose; Arm soreness on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (It presented as little blisters that itch), RASH (Breaking out in different places after receiving the 1st dose) and VACCINATION SITE PAIN (Arm soreness on her left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     Patient has no medical history.  Concurrent medical conditions included Depression. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RASH (Breaking out in different places after receiving the 1st dose) and VACCINATION SITE PAIN (Arm soreness on her left arm). On an unknown date, the patient experienced URTICARIA (It presented as little blisters that itch). The patient was treated with MOMETASONE FUROATE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (It presented as little blisters that itch) and RASH (Breaking out in different places after receiving the 1st dose) had not resolved and VACCINATION SITE PAIN (Arm soreness on her left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient went to the dermatologist and he mentioned the reaction was due to the vaccine.She was given Mometasone Furoate cream by the dermatologist but it did not work for her. She mentioned that she did not change any soaps or detergents recently.   This case was linked to MOD-2021-384243, MOD-2021-384247 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen). At the time of the report, HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown.            No concomitant medication was provided.            No treatment information was provided.  Patient also had the booster dose of the Moderna COVID19 vaccine   This case was linked to MOD-2021-384165 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a sore arm at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Lot of food allergies including beef and pork.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (had a sore arm at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitants and treatment drugs are provided. The patient had a sore arm at the injection site.   This case was linked to MOD-2021-384105 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: Received doses from a vial after been punctured 20 times; Received doses from a vial after been punctured 20 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received doses from a vial after been punctured 20 times) and PRODUCT ADMINISTRATION ERROR (Received doses from a vial after been punctured 20 times) 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 POOR QUALITY PRODUCT ADMINISTERED (Received doses from a vial after been punctured 20 times) and PRODUCT ADMINISTRATION ERROR (Received doses from a vial after been punctured 20 times). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received doses from a vial after been punctured 20 times) and PRODUCT ADMINISTRATION ERROR (Received doses from a vial after been punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Reporter stated that 24 patients received doses from a vial after been punctured 20 times.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received contains No New Information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Inappropriate schedule of product administration, Myalgia, Pruritus, Rash
Clinical narrative: First Dose on 26 March and second on 2 April... less than dosing window; Unresolved Itch; Unresolved Small blisters; Breaking out since 1st dose; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 26 March and second on 2 April... less than dosing window), PRURITUS (Unresolved Itch), BLISTER (Unresolved Small blisters), RASH (Breaking out since 1st dose) and MYALGIA (Arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017b21a and 017b21a) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (Unresolved Itch), BLISTER (Unresolved Small blisters) and RASH (Breaking out since 1st dose). 26-Mar-2021, the patient experienced MYALGIA (Arm soreness). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 26 March and second on 2 April... less than dosing window). The patient was treated with MOMETASONE FUROATE (MOMENTASONE) at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 26 March and second on 2 April.. less than dosing window) had resolved and PRURITUS (Unresolved Itch), BLISTER (Unresolved Small blisters), RASH (Breaking out since 1st dose) and MYALGIA (Arm soreness) outcome was unknown.            This case was linked to MOD-2021-384200, MOD-2021-384247 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Arm soreness for a couple of days with the first 2 doses; Fatigue for a day with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (Arm soreness for a couple of days with the first 2 doses) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.  On 02-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 FATIGUE (Fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (Arm soreness for a couple of days with the first 2 doses). At the time of the report, FATIGUE (Fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (Arm soreness for a couple of days with the first 2 doses) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No treatment information was reported.  The patient had no comorbidities, no regular chronic medications.   Patient received second dose of Moderna vaccine on 02-Mar-2021; batch number 011A21A and Expiry Date: 16-Aug-2021.  Patient received third dose of Moderna vaccine on 08-Nov-2021; Batch number: 039F21A.   This case was linked to MOD-2021-384343, MOD-2021-384344 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, SARS-CoV-2 test, Vertigo
Clinical narrative: felt he lost some equilibrium; sometimes felt like he was spinning; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (felt he lost some equilibrium) and VERTIGO (sometimes felt like he was spinning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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 and 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 BALANCE DISORDER (felt he lost some equilibrium) and VERTIGO (sometimes felt like he was spinning). At the time of the report, BALANCE DISORDER (felt he lost some equilibrium) and VERTIGO (sometimes felt like he was spinning) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported.  No treatment information was provided.  Onset of event was about 2 days after the mRNA-1273 booster dose. Symptoms had persisted for 10 days and are ongoing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Arm was sore at the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore at the injection site) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 045A21A and 051F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at a dose of 2 dosage form. At the time of the report, VACCINATION SITE PAIN (Arm was sore at the injection site) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   This case was linked to MOD-2021-384391, MOD-2021-384074 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Pain in extremity, Underdose
Clinical narrative: 15-20%less than full dose administered; When the syringe was removed from his arm, his arm was all wet; his arm hurts less than usual; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his arm hurts less than usual), UNDERDOSE (15-20%less than full dose administered) and DEVICE CONNECTION ISSUE (When the syringe was removed from his arm, his arm was all wet) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced UNDERDOSE (15-20%less than full dose administered) and DEVICE CONNECTION ISSUE (When the syringe was removed from his arm, his arm was all wet). In November 2021, the patient experienced PAIN IN EXTREMITY (his arm hurts less than usual). On 11-Nov-2021, UNDERDOSE (15-20%less than full dose administered) and DEVICE CONNECTION ISSUE (When the syringe was removed from his arm, his arm was all wet) had resolved. At the time of the report, PAIN IN EXTREMITY (his arm hurts less than usual) outcome was unknown.            No Concomitant and Treatment medication were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder. Concomitant products included LISINOPRIL for Blood pressure high, DILTIAZEM HYDROCHLORIDE (CARTIA [DILTIAZEM HYDROCHLORIDE]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021) had resolved.            Concomitant medications also included Thyroid medications.  No treatment information was provided.    This case was linked to MOD-2021-384436 (Patient Link).