chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: in July she contracted lyme disease; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (in July she contracted lyme disease) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2OA) 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. In July 2021, the patient experienced LYME DISEASE (in July she contracted lyme disease) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, LYME DISEASE (in July she contracted lyme disease) had resolved.            No relevant concomitant medications were reported.  Patient was treated with antibodies for 10 days and recovered from the event.  Lot number for First dose is 01 (2 or Z) L20A, however caller was not sure if it was a 2 or a Z.  Patient stated it was "dexaciclin" or something like that, but was not sure on what the name was.  Company Comment: This case concerns a  71 year-old female patient with no reported medical history, who experienced the unexpected event of Lyme disease. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  71 year-old female patient with no reported medical history, who experienced the unexpected event of Lyme disease. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Kidney infection, Localised infection, Staphylococcal infection
Clinical narrative: developed MERSA infection; affected his kidney; infection in his foot  due to the injury; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (developed MERSA infection) and KIDNEY INFECTION (affected his kidney) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-May-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 STAPHYLOCOCCAL INFECTION (developed MERSA infection) (seriousness criteria hospitalization and medically significant), KIDNEY INFECTION (affected his kidney) (seriousness criteria hospitalization and medically significant) and LOCALISED INFECTION (infection in his foot  due to the injury). At the time of the report, STAPHYLOCOCCAL INFECTION (developed MERSA infection), KIDNEY INFECTION (affected his kidney) and LOCALISED INFECTION (infection in his foot  due to the injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  Treatment medication provided Antibiotics.  Patient stated that During his hospital stay, they flushed his body to get rid of MERSA and antibiotics from his blood.  Company Comment: This case concerns a 59-year-old male patient with no reported medical history who experienced the unexpected events of Infection MRSA and kidney infection. The events occurred on an unspecified date after the first dose of mRNA. The rechallenge was unknown as no details about the second dose was provided. Causality assessment for the event was not provided by the reporter. The benefit-risk relationship of mRNA-1273is not affected by this report. However, the event is of infective origin and thus assessment with product used is determined as unlikely based on biological implausibility.  The benefit-risk relationship of mRNA-1273is not affected by this report.   This case was linked to MOD-2021-325388 (Patient Link).; Sender's Comments: This case concerns a 59-year-old male patient with no reported medical history who experienced the unexpected events of Infection MRSA and kidney infection. The events occurred on an unspecified date after the first dose of mRNA. The rechallenge was unknown as no details about the second dose was provided. Causality assessment for the event was not provided by the reporter. The benefit-risk relationship of mRNA-1273is not affected by this report. However, the event is of infective origin and thus assessment with product used is determined as unlikely based on biological implausibility.  The benefit-risk relationship of mRNA-1273is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only soreness in her arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (only soreness in her arm.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021F) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PAIN IN EXTREMITY (only soreness in her arm.). At the time of the report, PAIN IN EXTREMITY (only soreness in her arm.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-325385 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore (1st dose)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore (1st dose)). At the time of the report, PAIN IN EXTREMITY (Arm was sore (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.   This case was linked to MOD-2021-029199.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chills, Myalgia, Pyrexia, Stress
Clinical narrative: Bells Palsy affecting left side of face as per doctor  due to stress; stress; chills; body aches; 102.2 fever; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy affecting left side of face as per doctor  due to stress) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells Palsy affecting left side of face as per doctor  due to stress) (seriousness criterion medically significant), STRESS (stress), CHILLS (chills), MYALGIA (body aches) and PYREXIA (102.2 fever). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy affecting left side of face as per doctor  due to stress), STRESS (stress), CHILLS (chills), MYALGIA (body aches) and PYREXIA (102.2 fever) outcome was unknown.            Patient states she woke up last woke up last Wednesday with drooping left face "I thought I had a stroke". Went to doctor was diagnosed with Bells Palsy and as per doctor it is "due to stress". Says it is affecting left side of face and caller states  she was injected in left arm also, same side of body.  1st dose 5Aug2021 Lot # 088D21A Expiration not on vaccine card. Left arm  2nd dose 2Sep2021 Lot # 020F21A Expiration not on vaccine card. Left arm  Reports after 1st dose she had fever, chills, headache and left sore arm.  Reports after 2nd dose she had body aches, 102.2 fever, and chills. Treatment: Was prescribed Prednisone, antiviral valacyclovir 3x a day  Concomitant : blood pressure medication  Company Comment : This case concerns a 36 year old female who experience serious expected event of Bell's palsy on unknown date. Second dose was given on 02Sep2021. No relevant medical history.The benefit-risk relationship is not affected by this report for Moderna Covid 19 vaccine.   This case was linked to MOD-2021-325463 (Patient Link).; Sender's Comments: This case concerns a 36 year old female who experience serious expected event of Bell's palsy on unknown date. Second dose was given on 02Sep2021. No relevant medical history.The benefit-risk relationship is not affected by this report for Moderna Covid 19 vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the vaccine past expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) 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 concomitant medications are provided. No treatment medications are provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Chronic fatigue syndrome, Cognitive disorder, Headache
Clinical narrative: Cognitive word findings (disconnection between brain and hand; Chronic fatigue syndrome every single day with various intensity; short term memory loss; Insomnia; Persistent sore throat every single day.; Feeling not physically active anymore.; Chronic muscle pain; Sometimes waking up with headache.; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (Cognitive word findings (disconnection between brain and hand), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome every single day with various intensity), AMNESIA (short term memory loss), INSOMNIA (Insomnia) and OROPHARYNGEAL PAIN (Persistent sore throat every single day.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MELATONIN for Sleep disorder, MULTIVITAMINS [VITAMINS NOS], PROBIOTICS NOS, FISH OIL and CURCUMIN for Supplementation therapy.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced COGNITIVE DISORDER (Cognitive word findings (disconnection between brain and hand), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome every single day with various intensity), AMNESIA (short term memory loss), INSOMNIA (Insomnia), OROPHARYNGEAL PAIN (Persistent sore throat every single day.), ASTHENIA (Feeling not physically active anymore.), MYALGIA (Chronic muscle pain) and HEADACHE (Sometimes waking up with headache.). At the time of the report, COGNITIVE DISORDER (Cognitive word findings (disconnection between brain and hand), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome every single day with various intensity), AMNESIA (short term memory loss), INSOMNIA (Insomnia), OROPHARYNGEAL PAIN (Persistent sore throat every single day.), ASTHENIA (Feeling not physically active anymore.), MYALGIA (Chronic muscle pain) and HEADACHE (Sometimes waking up with headache.) had not resolved.            No treatment medications were reported.  Elevated body temperature (intermittent); noted as degree or a half higher that normal body temp.; Sender's Comments: This case concerns a 45 year old female with no reported history who experienced the non-serious unlisted events of Cognitive disorder, Chronic fatigue syndrome and Amnesia along with others and non-serious listed event of Myalgia one day after the second dose of Moderna COVID-19 vaccine. Re-challenge is not applicable as this was the second dose and unknown for the first dose as no information except for date is reported. Benefit-risk relationship for Moderna COVID-19 vaccine is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Oropharyngeal pain
Clinical narrative: Cognitive word findings (disconnection between brain and hand; Chronic fatigue syndrome every single day with various intensity; short term memory loss; Insomnia; Persistent sore throat every single day.; Feeling not physically active anymore.; Chronic muscle pain; Sometimes waking up with headache.; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (Cognitive word findings (disconnection between brain and hand), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome every single day with various intensity), AMNESIA (short term memory loss), INSOMNIA (Insomnia) and OROPHARYNGEAL PAIN (Persistent sore throat every single day.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MELATONIN for Sleep disorder, MULTIVITAMINS [VITAMINS NOS], PROBIOTICS NOS, FISH OIL and CURCUMIN for Supplementation therapy.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced COGNITIVE DISORDER (Cognitive word findings (disconnection between brain and hand), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome every single day with various intensity), AMNESIA (short term memory loss), INSOMNIA (Insomnia), OROPHARYNGEAL PAIN (Persistent sore throat every single day.), ASTHENIA (Feeling not physically active anymore.), MYALGIA (Chronic muscle pain) and HEADACHE (Sometimes waking up with headache.). At the time of the report, COGNITIVE DISORDER (Cognitive word findings (disconnection between brain and hand), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome every single day with various intensity), AMNESIA (short term memory loss), INSOMNIA (Insomnia), OROPHARYNGEAL PAIN (Persistent sore throat every single day.), ASTHENIA (Feeling not physically active anymore.), MYALGIA (Chronic muscle pain) and HEADACHE (Sometimes waking up with headache.) had not resolved.            No treatment medications were reported.  Elevated body temperature (intermittent); noted as degree or a half higher that normal body temp.; Sender's Comments: This case concerns a 45 year old female with no reported history who experienced the non-serious unlisted events of Cognitive disorder, Chronic fatigue syndrome and Amnesia along with others and non-serious listed event of Myalgia one day after the second dose of Moderna COVID-19 vaccine. Re-challenge is not applicable as this was the second dose and unknown for the first dose as no information except for date is reported. Benefit-risk relationship for Moderna COVID-19 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Arm was hurting and hot; Itching; Redness that got bigger and started to spread on her arm; Arm was hurting and hot; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was hurting and hot), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness that got bigger and started to spread on her arm), FEELING HOT (Arm was hurting and hot) and VACCINATION SITE REACTION (COVID arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included ALIROCUMAB (PRALUENT) for Blood cholesterol abnormal, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was hurting and hot), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness that got bigger and started to spread on her arm), FEELING HOT (Arm was hurting and hot) and VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE PAIN (Arm was hurting and hot), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness that got bigger and started to spread on her arm), FEELING HOT (Arm was hurting and hot) and VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included decongestive pills.   This case was linked to MOD-2021-325448 (Patient Link).
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Micturition urgency, Pyrexia, Vaccination site discharge, Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: has to go use bathroom, constantly; Fever; my arm swelled up/left arm swelled up; it's leaking pus/started leaking fluid; barely can lift her arm up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (it's leaking pus/started leaking fluid), VACCINATION SITE MOVEMENT IMPAIRMENT (barely can lift her arm up), MICTURITION URGENCY (has to go use bathroom, constantly), PYREXIA (Fever) and VACCINATION SITE SWELLING (my arm swelled up/left arm swelled up) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced VACCINATION SITE DISCHARGE (it's leaking pus/started leaking fluid), VACCINATION SITE MOVEMENT IMPAIRMENT (barely can lift her arm up) and VACCINATION SITE SWELLING (my arm swelled up/left arm swelled up). On an unknown date, the patient experienced MICTURITION URGENCY (has to go use bathroom, constantly) and PYREXIA (Fever). At the time of the report, VACCINATION SITE DISCHARGE (it's leaking pus/started leaking fluid), VACCINATION SITE MOVEMENT IMPAIRMENT (barely can lift her arm up), MICTURITION URGENCY (has to go use bathroom, constantly), PYREXIA (Fever) and VACCINATION SITE SWELLING (my arm swelled up/left arm swelled up) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant and treatment medication was not provided.   On 19-Sep-2021, the patient left arm swelled up and started leaking fluid ever since, and patient could barely lift her arm up due to which she could not go to her work.   It was reported that, patient still had the same conditions.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Upon follow-up receipt: Updated Reporters details, dose 1 details, event start dates. On 22-Sep-2021: follow up received on 22-Sep-2021, outcome of the events updated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Exposure to SARS-CoV-2, Hyperhidrosis, Suspected COVID-19
Clinical narrative: exposed to a potential Covid-19 case in the post office; mild symptoms of Covid-19/exposed to a potential Covid-19 case in the post office; Sweaty; Clammy; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (mild symptoms of Covid-19, exposed to a potential Covid-19 case in the post office), HYPERHIDROSIS, COLD SWEAT, CLAMMY, and EXPOSURE TO SARS-COV-2 (exposed to a potential Covid-19 case in the post office) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0208L20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020, Situs inversus, and Surgery (for his peritonitis) in 1987.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 16-Sep-2021, the patient experienced SUSPECTED COVID-19 (mild symptoms of Covid-19, exposed to a potential Covid-19 case in the post office), HYPERHIDROSIS, COLD SWEAT, and CLAMMY. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to a potential Covid-19 case in the post office). At the time of the report, SUSPECTED COVID-19 (mild symptoms of Covid-19, exposed to a potential Covid-19 case in the post office), HYPERHIDROSIS, COLD SWEAT and CLAMMY outcome was unknown and EXPOSURE TO SARS-COV-2 (exposed to a potential Covid-19 case in the post office) had resolved.            No treatment medication was reported. No concomitant medication was reported. Patient medical history includes, he states that he that his organs are inverted. He thinks he is immunocompromised. This case concerns 68-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of suspected COVID-19. The event occurred approximately 6 months after the second dose of Spikevax. The re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Swelling, Vaccination site pain, Vaccination site pruritus
Clinical narrative: skin is very scabby; it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh; bad hives; swelling; little itchy/super duper itchy/scratched my arm to the point of bleeding; the day of injection my arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), DRY SKIN (skin is very scabby), PRURITUS (it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh), VACCINATION SITE PRURITUS (little itchy/super duper itchy/scratched my arm to the point of bleeding) and VACCINATION SITE PAIN (the day of injection my arm was really sore) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced SWELLING (swelling), VACCINATION SITE PRURITUS (little itchy/super duper itchy/scratched my arm to the point of bleeding) and VACCINATION SITE PAIN (the day of injection my arm was really sore). On 28-Aug-2021, the patient experienced DRY SKIN (skin is very scabby), PRURITUS (it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh) and VACCINATION SITE URTICARIA (bad hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Aug-2021, VACCINATION SITE PAIN (the day of injection my arm was really sore) had resolved. At the time of the report, SWELLING (swelling) was resolving, DRY SKIN (skin is very scabby), PRURITUS (it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh) and VACCINATION SITE URTICARIA (bad hives) outcome was unknown and VACCINATION SITE PRURITUS (little itchy/super duper itchy/scratched my arm to the point of bleeding) had not 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 drug details were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: skin is very scabby; it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh; bad hives; swelling; little itchy/super duper itchy/scratched my arm to the point of bleeding; the day of injection my arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), DRY SKIN (skin is very scabby), PRURITUS (it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh), VACCINATION SITE PRURITUS (little itchy/super duper itchy/scratched my arm to the point of bleeding) and VACCINATION SITE PAIN (the day of injection my arm was really sore) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced SWELLING (swelling), VACCINATION SITE PRURITUS (little itchy/super duper itchy/scratched my arm to the point of bleeding) and VACCINATION SITE PAIN (the day of injection my arm was really sore). On 28-Aug-2021, the patient experienced DRY SKIN (skin is very scabby), PRURITUS (it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh) and VACCINATION SITE URTICARIA (bad hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Aug-2021, VACCINATION SITE PAIN (the day of injection my arm was really sore) had resolved. At the time of the report, SWELLING (swelling) was resolving, DRY SKIN (skin is very scabby), PRURITUS (it's spreading on entire left side of the body/leg is itching/back is itching/itching is on the inside of flesh) and VACCINATION SITE URTICARIA (bad hives) outcome was unknown and VACCINATION SITE PRURITUS (little itchy/super duper itchy/scratched my arm to the point of bleeding) had not 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 drug details were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pain of skin, Pruritus, Rash
Clinical narrative: Hot Scalp after first dose; Itching constantly scalp  after first dose; Constant pain on scalp  after first dose; Rash on the scalp  after first dose; Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot Scalp after first dose), PRURITUS (Itching constantly scalp  after first dose), PAIN OF SKIN (Constant pain on scalp  after first dose), PAIN IN EXTREMITY (Sore arm after first dose) and RASH (Rash on the scalp  after first dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after first dose). On 12-Aug-2021, the patient experienced FEELING HOT (Hot Scalp after first dose), PRURITUS (Itching constantly scalp  after first dose), PAIN OF SKIN (Constant pain on scalp  after first dose) and RASH (Rash on the scalp  after first dose). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency; TEA TREE OIL for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Aug-2021, PAIN IN EXTREMITY (Sore arm after first dose) had resolved. At the time of the report, FEELING HOT (Hot Scalp after first dose), PRURITUS (Itching constantly scalp  after first dose), PAIN OF SKIN (Constant pain on scalp  after first dose) and RASH (Rash on the scalp  after first dose) outcome was unknown.            No concomitant medication provided.  On 12-Aug-2021, 24 hours after vaccination, the patient had rash on the scalp which was hot to touch, itching constantly with constant pain.   Treatment medication like Hydrocortisone OTC cream on scalp, Tea tree oil on scalp, Tylenol for discomfort were provided.   This case was linked to MOD-2021-326242.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose) and FATIGUE (Tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose) and FATIGUE (Tired). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose) had resolved and FATIGUE (Tired) outcome was unknown.            Concomitant medication was not provided. Treatment medication  was not provided .
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: A patient (40 year old Male) was given Moderna for their first dose and incorrectly given Pfizer as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (A patient (40 year old Male) was given Moderna for their first dose and incorrectly given Pfizer as a second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) 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 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) .3 ml. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (A patient (40 year old Male) was given Moderna for their first dose and incorrectly given Pfizer as a second dose). On 20-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (A patient (40 year old Male) was given Moderna for their first dose and incorrectly given Pfizer as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Additional information received contains patient demographics and contact details were updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Diarrhoea, Headache, Illness
Clinical narrative: Magnet stuck to her arm on injection site; still has a bruise on her arm; Just plumb sick/sick as a dog; Diarrhea for 2 days; Two hours after the shot, she was on the couch with chills; Two hours after the shot, she was on the couch with fever; Two hours after the shot, she was on the couch with headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (still has a bruise on her arm), ILLNESS (Just plumb sick/sick as a dog), VACCINATION SITE REACTION (Magnet stuck to her arm on injection site), DIARRHOEA (Diarrhea for 2 days) and CHILLS (Two hours after the shot, she was on the couch with chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced ILLNESS (Just plumb sick/sick as a dog), DIARRHOEA (Diarrhea for 2 days), CHILLS (Two hours after the shot, she was on the couch with chills), PYREXIA (Two hours after the shot, she was on the couch with fever) and HEADACHE (Two hours after the shot, she was on the couch with headache). On 21-Sep-2021, the patient experienced CONTUSION (still has a bruise on her arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (Magnet stuck to her arm on injection site). On 18-Sep-2021, DIARRHOEA (Diarrhea for 2 days) had resolved. At the time of the report, CONTUSION (still has a bruise on her arm) had not resolved and ILLNESS (Just plumb sick/sick as a dog), VACCINATION SITE REACTION (Magnet stuck to her arm on injection site), CHILLS (Two hours after the shot, she was on the couch with chills), PYREXIA (Two hours after the shot, she was on the couch with fever) and HEADACHE (Two hours after the shot, she was on the couch with headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  the patient saw a doctor who put her on antibiotics and ruled out Covid and the flu   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up include no new information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site reaction
Clinical narrative: Magnet stuck to her arm on injection site; still has a bruise on her arm; Just plumb sick/sick as a dog; Diarrhea for 2 days; Two hours after the shot, she was on the couch with chills; Two hours after the shot, she was on the couch with fever; Two hours after the shot, she was on the couch with headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (still has a bruise on her arm), ILLNESS (Just plumb sick/sick as a dog), VACCINATION SITE REACTION (Magnet stuck to her arm on injection site), DIARRHOEA (Diarrhea for 2 days) and CHILLS (Two hours after the shot, she was on the couch with chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced ILLNESS (Just plumb sick/sick as a dog), DIARRHOEA (Diarrhea for 2 days), CHILLS (Two hours after the shot, she was on the couch with chills), PYREXIA (Two hours after the shot, she was on the couch with fever) and HEADACHE (Two hours after the shot, she was on the couch with headache). On 21-Sep-2021, the patient experienced CONTUSION (still has a bruise on her arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (Magnet stuck to her arm on injection site). On 18-Sep-2021, DIARRHOEA (Diarrhea for 2 days) had resolved. At the time of the report, CONTUSION (still has a bruise on her arm) had not resolved and ILLNESS (Just plumb sick/sick as a dog), VACCINATION SITE REACTION (Magnet stuck to her arm on injection site), CHILLS (Two hours after the shot, she was on the couch with chills), PYREXIA (Two hours after the shot, she was on the couch with fever) and HEADACHE (Two hours after the shot, she was on the couch with headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  the patient saw a doctor who put her on antibiotics and ruled out Covid and the flu   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up include no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chest discomfort, Chills, Cough
Clinical narrative: Lost appetite; Tightness in her chest, but could have been anxiety; Lost taste; Lost smell; Coughing; Pain behind her eyes; Chills; Terrible terrible headache; Pain at injection site; Muscle aches beyond description; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell) and COUGH (Coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Coughing), EYE PAIN (Pain behind her eyes), CHILLS (Chills), HEADACHE (Terrible terrible headache), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Muscle aches beyond description), PYREXIA (Fever) and VOMITING (Throwing up). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Eye pain, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Coughing), EYE PAIN (Pain behind her eyes), CHILLS (Chills), HEADACHE (Terrible terrible headache), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Muscle aches beyond description), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document received contains NNI.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Eye pain, Headache, Injection site pain, Myalgia
Clinical narrative: Lost appetite; Tightness in her chest, but could have been anxiety; Lost taste; Lost smell; Coughing; Pain behind her eyes; Chills; Terrible terrible headache; Pain at injection site; Muscle aches beyond description; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell) and COUGH (Coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Coughing), EYE PAIN (Pain behind her eyes), CHILLS (Chills), HEADACHE (Terrible terrible headache), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Muscle aches beyond description), PYREXIA (Fever) and VOMITING (Throwing up). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Eye pain, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Coughing), EYE PAIN (Pain behind her eyes), CHILLS (Chills), HEADACHE (Terrible terrible headache), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Muscle aches beyond description), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document received contains NNI.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Lost appetite; Tightness in her chest, but could have been anxiety; Lost taste; Lost smell; Coughing; Pain behind her eyes; Chills; Terrible terrible headache; Pain at injection site; Muscle aches beyond description; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell) and COUGH (Coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Coughing), EYE PAIN (Pain behind her eyes), CHILLS (Chills), HEADACHE (Terrible terrible headache), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Muscle aches beyond description), PYREXIA (Fever) and VOMITING (Throwing up). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Eye pain, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Lost appetite), CHEST DISCOMFORT (Tightness in her chest, but could have been anxiety), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Coughing), EYE PAIN (Pain behind her eyes), CHILLS (Chills), HEADACHE (Terrible terrible headache), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Muscle aches beyond description), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document received contains NNI.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip started to hurt again last night/hip soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip started to hurt again last night/hip soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced ARTHRALGIA (hip started to hurt again last night/hip soreness). At the time of the report, ARTHRALGIA (hip started to hurt again last night/hip soreness) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided. The patient would like to take Advil Dual Action to relieve the hip soreness. The patient reported that the hip soreness was totally unassociated with getting the vaccine and the patient had no symptoms following the first dose of the vaccine. The patient moved a few months ago and overused the hip with bending and lifting.