chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Don't feel well; Run a fever; 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 MALAISE (Don't feel well) and PYREXIA (Run a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Don't feel well) and PYREXIA (Run a fever). At the time of the report, MALAISE (Don't feel well) and PYREXIA (Run a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Somnolence
Clinical narrative: headache; tiredness; slepiness; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (tiredness), SOMNOLENCE (slepiness) and MYALGIA (myalgia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) 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 07-May-2021, the patient experienced HEADACHE (headache), FATIGUE (tiredness), SOMNOLENCE (slepiness) and MYALGIA (myalgia). At the time of the report, HEADACHE (headache), FATIGUE (tiredness), SOMNOLENCE (slepiness) and MYALGIA (myalgia) outcome was unknown.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error
Clinical narrative: Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Muscle discomfort
Clinical narrative: The muscle In my left leg always bother me as it comes and goes after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (The muscle In my left leg always bother me as it comes and goes after the 2nd dose) 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 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (The muscle In my left leg always bother me as it comes and goes after the 2nd dose). At the time of the report, MUSCLE DISCOMFORT (The muscle In my left leg always bother me as it comes and goes after the 2nd dose) was resolving.            No concomitant medications provided. No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow up received regarding outcome.patient stated "I am much better now"Hence outcome updated as recovering/resolving from unknown
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Impaired driving ability, Vertigo
Clinical narrative: Major vertigo; cannot drive; Can hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Major vertigo), IMPAIRED DRIVING ABILITY (cannot drive) and GAIT DISTURBANCE (Can hardly walk) 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 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 VERTIGO (Major vertigo), IMPAIRED DRIVING ABILITY (cannot drive) and GAIT DISTURBANCE (Can hardly walk). At the time of the report, VERTIGO (Major vertigo), IMPAIRED DRIVING ABILITY (cannot drive) and GAIT DISTURBANCE (Can hardly walk) outcome was unknown.            Concomitant medicines was not reported.  Treatment information was not provided by the reporter.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: No new information.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (7-8 days after getting 2nd dose got hives, since then coming and going, splotchy raised ones, on face, goes around perimeter, eyelid and side of face like eyebrows,  look like mosquito bites, big, not like pimples, never had hives like this before) and HEADACHE (that evening I had really bad headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy (she was allergic to oysters and she gets hives when she eats oysters). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control. On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced HEADACHE (that evening I had really bad headache). On 29-May-2021, the patient experienced URTICARIA (7-8 days after getting 2nd dose got hives, since then coming and going, splotchy raised ones, on face, goes around perimeter, eyelid and side of face like eyebrows,  look like mosquito bites, big, not like pimples, never had hives like this before). The patient was treated with IBUPROFEN 23-May-2021 for Headache, at a dose of 1 dosage form. On 23-May-2021, HEADACHE (that evening I had really bad headache) had resolved. At the time of the report, URTICARIA (7-8 days after getting 2nd dose got hives, since then coming and going, splotchy raised ones, on face, goes around perimeter, eyelid and side of face like eyebrows,  look like mosquito bites, big, not like pimples, never had hives like this before) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient went outside in the heat and hives became bad. Treatment medication include Ibuprofen just 1 tablet OTC on 23MAY2021 and Benadryl on 04JUN2021 at night. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable. This case was linked to MOD-2021-209192.
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Tendonitis; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (Relapsing remitting).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced TENDONITIS (Tendonitis). At the time of the report, TENDONITIS (Tendonitis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in an 18-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). On 27-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported No treatment information was provided; Sender's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 004C21A) with no associated AEs reported in an 18 year old Female. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: strange tingling in my left arm; numbness in my left arm; 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 VACCINATION SITE PARAESTHESIA (strange tingling in my left arm) and VACCINATION SITE ANAESTHESIA (numbness in my left arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PARAESTHESIA (strange tingling in my left arm) and VACCINATION SITE ANAESTHESIA (numbness in my left arm). At the time of the report, VACCINATION SITE PARAESTHESIA (strange tingling in my left arm) and VACCINATION SITE ANAESTHESIA (numbness in my left arm) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: side effects were pretty intense,lasting for the most part of 3 weeks/massive hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (side effects were pretty intense,lasting for the most part of 3 weeks/massive hair loss) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (side effects were pretty intense,lasting for the most part of 3 weeks/massive hair loss). The patient was treated with MULTIVITAMIN & MINERAL at a dose of UNK dosage form; B-COMPLEX 2000 at a dose of 1 UNK; CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) at a dose of UNK dosage form and COLLAGEN at a dose of UNK dosage form. At the time of the report, ALOPECIA (side effects were pretty intense,lasting for the most part of 3 weeks/massive hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Patient stated that events started from beginning of Feb-2021.Patient stated that she had lost at least 1/3 of her volume and had massive  breakage throughout. She stated that she had  very long and healthy hair before vaccine. Patient stated that she had no genetic conditions or predisposition to alopecia or hair loss.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second Moderna Dose Delayed >35 Days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second Moderna Dose Delayed >35 Days) 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 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second Moderna Dose Delayed >35 Days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second Moderna Dose Delayed >35 Days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: started having a red  at injection; started having  bumped arm at injection; Pain at injection; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (started having a red  at injection), VACCINATION SITE SWELLING (started having  bumped arm at injection), VACCINATION SITE PAIN (Pain at injection), PYREXIA (Fever) and NAUSEA (Nausea) 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 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE SWELLING (started having  bumped arm at injection), VACCINATION SITE PAIN (Pain at injection), PYREXIA (Fever) and NAUSEA (Nausea). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (started having a red  at injection). At the time of the report, VACCINATION SITE ERYTHEMA (started having a red  at injection), VACCINATION SITE SWELLING (started having  bumped arm at injection), VACCINATION SITE PAIN (Pain at injection), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment drugs included no concomitant drugs included
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-209011.   See case MOD-2021-209011 for details regarding the related case.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Serious vertigo; Dizziness and light headed; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Serious vertigo), DIZZINESS (Dizziness and light headed) and NAUSEA (Nausea) 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 VERTIGO (Serious vertigo), DIZZINESS (Dizziness and light headed) and NAUSEA (Nausea). At the time of the report, VERTIGO (Serious vertigo) outcome was unknown and DIZZINESS (Dizziness and light headed) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated on Day 5 serious vertigo subsided.  No concomitant products were reported.  No treatment medication information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01-JUL-2021 contains significant information. New event nausea was added. Changed the outcome of the event dizziness from unknown to not recovered/not resolved. On 21-Jul-2021: Follow-up contains NNI
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose, Vaccination site haemorrhage
Clinical narrative: A little blood came out of my arm/ mnimal amount of blood; Vaccine was running over my arm; Vaccine was running over arm; Vaccine was running over arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (A little blood came out of my arm/ mnimal amount of blood), UNDERDOSE (Vaccine was running over my arm), DEVICE CONNECTION ISSUE (Vaccine was running over arm) and EXPOSURE VIA SKIN CONTACT (Vaccine was running over arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 004C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM from 01-Jan-2020 to an unknown date for Cholesterol.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (A little blood came out of my arm/ mnimal amount of blood), UNDERDOSE (Vaccine was running over my arm), DEVICE CONNECTION ISSUE (Vaccine was running over arm) and EXPOSURE VIA SKIN CONTACT (Vaccine was running over arm). On 05-Jun-2021, UNDERDOSE (Vaccine was running over my arm) and DEVICE CONNECTION ISSUE (Vaccine was running over arm) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (A little blood came out of my arm/ mnimal amount of blood) and EXPOSURE VIA SKIN CONTACT (Vaccine was running over arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication were provided. No treatment was provided. Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information included- Concomitant medication with details was added and event outcome was updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at injection site, Arm is still pink; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site, Arm is still pink) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site, Arm is still pink). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site, Arm is still pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE for Anxiety, TAMSULOSIN for BPH, BENAZEPRIL and AMLODIPINE for Blood pressure, ATORVASTATIN CALCIUM (ATORVASTAN) for Cholesterol, ESCITALOPRAM OXALATE (ESCITALOPRAM +PHARMA) for Depression.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Malaise, SARS-CoV-2 test
Clinical narrative: Total loss of appetite/ I couldn't eat or drink anything; Loss of taste; I was felling very sick; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Total loss of appetite/ I couldn't eat or drink anything), AGEUSIA (Loss of taste) and MALAISE (I was felling very sick) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (Total loss of appetite/ I couldn't eat or drink anything), AGEUSIA (Loss of taste) and MALAISE (I was felling very sick). On 01-Jun-2021, DECREASED APPETITE (Total loss of appetite/ I couldn't eat or drink anything), AGEUSIA (Loss of taste) and MALAISE (I was felling very sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant product use was reported No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Women family members had reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Women family members had reactions) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Women family members had reactions). At the time of the report, ADVERSE REACTION (Women family members had reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       61-year-old female patient is calling to ask a question and reported her side effects.  Case #MOD21-107498 Cross-Linked. (Reporter's Case) She inadvertently reported, "All women in my family had reactions to the vaccine vs. men were fine after vaccination."  No relevant concomitant medications were reported. No treatment information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Throat tightness, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Throat closing sensation; Dizziness; Itchy rash injection site; Fist-sized swollen injection site; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat closing sensation), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (Itchy rash injection site), VACCINATION SITE SWELLING (Fist-sized swollen injection site) and FATIGUE (Tiredness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug (Allergy to Paracetamol) and Allergic reaction to antibiotics (Allergy to Zithromax/Azithromycin).    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced THROAT TIGHTNESS (Throat closing sensation), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (Itchy rash injection site), VACCINATION SITE SWELLING (Fist-sized swollen injection site) and FATIGUE (Tiredness). At the time of the report, THROAT TIGHTNESS (Throat closing sensation), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (Itchy rash injection site), VACCINATION SITE SWELLING (Fist-sized swollen injection site) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient has a history of negative reactions to vaccines.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: autoimmune inflammation response; 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 INFLAMMATION (autoimmune inflammation response) 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 INFLAMMATION (autoimmune inflammation response). At the time of the report, INFLAMMATION (autoimmune inflammation response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported. Patient experienced an autoimmune inflammation response.   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vomiting
Clinical narrative: slept off and on for the next 24 hours; threw up / slept for 2 hours and threw up again; was very tired after throwing up; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept off and on for the next 24 hours), VOMITING (threw up / slept for 2 hours and threw up again) and FATIGUE (was very tired after throwing up) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 025C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Eloquis and Omeprazole 40mg for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced SOMNOLENCE (slept off and on for the next 24 hours), VOMITING (threw up / slept for 2 hours and threw up again) and FATIGUE (was very tired after throwing up). At the time of the report, SOMNOLENCE (slept off and on for the next 24 hours), VOMITING (threw up / slept for 2 hours and threw up again) and FATIGUE (was very tired after throwing up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Extreme fatigue; Head aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue) and HEADACHE (Head aches) 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 FATIGUE (Extreme fatigue) and HEADACHE (Head aches). At the time of the report, FATIGUE (Extreme fatigue) and HEADACHE (Head aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: my mother who also had Moderna this year is now suffering the same ill fate; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (my mother who also had Moderna this year is now suffering the same ill fate) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], ASCORBIC ACID (VITAMIN C ACID), B COMPLEX [BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE], COLLAGEN and COLECALCIFEROL (D) for an unknown indication.   On 31-Dec-2020, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (my mother who also had Moderna this year is now suffering the same ill fate). At the time of the report, ALOPECIA (my mother who also had Moderna this year is now suffering the same ill fate) outcome was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include Inhaler and Hypertensive medicines. No treatment information was provided.   This case was linked to MOD-2021-209053 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Flashback, Nausea
Clinical narrative: Some sort of dream flash back/as no real events; Some sort of dream flash back; Nauseous be at the same time of event; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Some sort of dream flash back/as no real events, flashbacks), NAUSEA (Nauseous be at the same time of event) and FLASHBACK (Some sort of dream flash back/as no real events, flashbacks) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced ABNORMAL DREAMS (Some sort of dream flash back/as no real events, flashbacks), NAUSEA (Nauseous be at the same time of event) and FLASHBACK (Some sort of dream flash back/as no real events, flashbacks). On 03-Jun-2021, ABNORMAL DREAMS (Some sort of dream flash back/as no real events, flashbacks), NAUSEA (Nauseous be at the same time of event) and FLASHBACK (Some sort of dream flash back/as no real events, flashbacks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: allergic reaction; itching; rush all over their body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PRURITUS (itching) and RASH (rush all over their body) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), PRURITUS (itching) and RASH (rush all over their body). At the time of the report, HYPERSENSITIVITY (allergic reaction), PRURITUS (itching) and RASH (rush all over their body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Loose tooth, Somnolence
Clinical narrative: Loose teeth; waking up and my hands are numb / asleep; Waking up and my hands are numb / asleep; Tired; 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 LOOSE TOOTH (Loose teeth), HYPOAESTHESIA (waking up and my hands are numb / asleep), SOMNOLENCE (Waking up and my hands are numb / asleep) and FATIGUE (Tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOOSE TOOTH (Loose teeth), HYPOAESTHESIA (waking up and my hands are numb / asleep), SOMNOLENCE (Waking up and my hands are numb / asleep) and FATIGUE (Tired). At the time of the report, LOOSE TOOTH (Loose teeth), HYPOAESTHESIA (waking up and my hands are numb / asleep), SOMNOLENCE (Waking up and my hands are numb / asleep) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration
Clinical narrative: I received my 1st dose 12/31/20 and my second dose twenty something days later.; massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose 12/31/20 and my second dose twenty something days later.) and ALOPECIA (massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose 12/31/20 and my second dose twenty something days later.) and ALOPECIA (massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout). The patient was treated with MULTIVITAMINS [VITAMINS NOS] for Hair loss, at an unspecified dose and frequency; VITAMIN B COMPLEX for Hair loss, at an unspecified dose and frequency; COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Hair loss, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Hair loss, at an unspecified dose and frequency and COLLAGEN at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose 12/31/20 and my second dose twenty something days later.) had resolved and ALOPECIA (massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout) outcome was unknown.            No concomitant medication reported. Patient stated that events started from beginning of Feb-2021.Patient stated that she had lost at least 1/3 of her volume and had massive  breakage throughout. She stated that she had  very long and healthy hair before vaccine. Patient stated that she had no genetic conditions or predisposition to alopecia or hair loss.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: stuffy nose; 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 NASAL CONGESTION (stuffy nose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (stuffy nose). At the time of the report, NASAL CONGESTION (stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALOPECIA (Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss). At the time of the report, ALOPECIA (Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Non-Significant follow-up appended to AER
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness, Immunisation reaction
Clinical narrative: I have been as sick as I was with covid; I have been as sick as I was with covid; I am having adverse effects after my first dose; 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 ILLNESS (I have been as sick as I was with covid), COVID-19 (I have been as sick as I was with covid) and IMMUNISATION REACTION (I am having adverse effects after my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 ILLNESS (I have been as sick as I was with covid), COVID-19 (I have been as sick as I was with covid) and IMMUNISATION REACTION (I am having adverse effects after my first dose). At the time of the report, ILLNESS (I have been as sick as I was with covid), COVID-19 (I have been as sick as I was with covid) and IMMUNISATION REACTION (I am having adverse effects after my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE SWELLING (Swelling at the injection site 10 days after) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE SWELLING (Swelling at the injection site 10 days after). At the time of the report, HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE SWELLING (Swelling at the injection site 10 days after) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant product use was reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: His discomfort started about 10 days after 2nd vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (His discomfort started about 10 days after 2nd vaccine) 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 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced DISCOMFORT (His discomfort started about 10 days after 2nd vaccine). At the time of the report, DISCOMFORT (His discomfort started about 10 days after 2nd vaccine) outcome was unknown.      No treatment information was provided. No relevant concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Product dose omission issue
Clinical narrative: Left ear ache; Got first dose on 09Apr2021, did not get second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Left ear ache) and PRODUCT DOSE OMISSION ISSUE (Got first dose on 09Apr2021, did not get second dose yet) 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 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got first dose on 09Apr2021, did not get second dose yet). On an unknown date, the patient experienced EAR PAIN (Left ear ache). On 04-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Got first dose on 09Apr2021, did not get second dose yet) had resolved. At the time of the report, EAR PAIN (Left ear ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.