chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 15-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 16-FEB-2022, the patient experienced body aches, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient. Patients sister reported that her brother had a stroke after he received the vaccine,  She stated she already reported it and was not going to report that here in her call. No consent was obtained.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected serious adverse event of special interest, Cerebrovascular Accident. The event was medically significant. The event occurred in on an unknown interval after receiving an unspecified dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected serious adverse event of special interest, Cerebrovascular Accident. The event was medically significant. The event occurred in on an unknown interval after receiving an unspecified dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for coronavirus; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for coronavirus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Reporter stated that the patient got over COVID, and had an antibody infusion.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for coronavirus). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for coronavirus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Coronavirus test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         No concomitant medications details were reported.  It was reported home test came back with a positive result as well.  No treatment information details were reported.  Company comment:This case concerns a male patient of an unknown age with a past medical history of Covid-19, who experienced the non serious event of Sars-Cov-test positive. On unknown dates the patient received the first and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, Coronavirus test: positive (Positive) Positive.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of an unknown age with a past medical history of Covid-19, who experienced the non serious event of Sars-Cov-test positive. On unknown dates the patient received the first and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, Coronavirus test: positive (Positive) Positive.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Idiopathic Thrombocytopenic Purpura; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic Thrombocytopenic Purpura) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic Thrombocytopenic Purpura) (seriousness criteria hospitalization and medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic Thrombocytopenic Purpura) had not resolved.            It was reported that vaccine was taken due to job requirement.   No concomitant details were provided. No treatment details were provided.  Company comment: This case concerns a 24-year-old female patient with no medical history provided who experienced serious unexpected event of Immune thrombocytopenia. Very limited information provided precluding comprehensive assessment. No information regarding patient's medical history nor concomitant medications was provided. Detailed information regarding vaccination was also not provided. Furthermore, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event nor hospitalization details was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 24-year-old female patient with no medical history provided who experienced serious unexpected event of Immune thrombocytopenia. Very limited information provided precluding comprehensive assessment. No information regarding patient's medical history nor concomitant medications was provided. Detailed information regarding vaccination was also not provided. Furthermore, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event nor hospitalization details was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cataract operation
Clinical narrative: Scheduled for cataract surgery; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT OPERATION (Scheduled for cataract surgery) 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.   In January 2022, the patient received third 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, 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 CATARACT OPERATION (Scheduled for cataract surgery). At the time of the report, CATARACT OPERATION (Scheduled for cataract surgery) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   It was reported that patient was scheduled to have cataract surgery next week. Caller stated that her husband has had three Moderna shots. The booster shot was in January.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow-up included no new information
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to 10 patients after more than 30 days of storage in the fridge; Dose administered to 10 patients after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30 days of storage in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30 days of storage in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge). At the time of the report, PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30 days of storage in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vials were stored in the fridge since 22Dec2021. Not know if patients are under any concomitant or regular medication.  No treatment medication was reported.   This case was linked to MOD-2022-483999 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow up received  contains Lot number, patient details update
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Cardiac disorder, Chest discomfort, Computerised tomogram, Influenza like illness
Clinical narrative: Seems my heart hurt; every bone in my body hurt; I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was; made me feel like I had a flu; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FISH OIL for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (made me feel like I had a flu). On 17-Jan-2022, the patient experienced CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain scale level is 5 when he is sitting and 10 when getting up in the morning). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) had resolved and INFLUENZA LIKE ILLNESS (made me feel like I had a flu) and PAIN (pain scale level is 5 when he is sitting and 10 when getting up in the morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2022, Computerised tomogram: fine (normal) Fine. On 17-Jan-2022, X-ray: fine (normal) Fine. On an unknown date, Pain assessment: 5 level is 5 when sitting and 10 10 when getting up in the morning.         Patient went to the ER on 17-Jan-2022, X-ray and CT scan results were fine. Then patient was treated for heart inflammation, which got better after two weeks. Now back the same as previous. Treatment: Meloxicam for a month.   This case was linked to MOD-2022-482892 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, X-ray
Clinical narrative: Seems my heart hurt; every bone in my body hurt; I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was; made me feel like I had a flu; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FISH OIL for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (made me feel like I had a flu). On 17-Jan-2022, the patient experienced CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain scale level is 5 when he is sitting and 10 when getting up in the morning). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) had resolved and INFLUENZA LIKE ILLNESS (made me feel like I had a flu) and PAIN (pain scale level is 5 when he is sitting and 10 when getting up in the morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2022, Computerised tomogram: fine (normal) Fine. On 17-Jan-2022, X-ray: fine (normal) Fine. On an unknown date, Pain assessment: 5 level is 5 when sitting and 10 10 when getting up in the morning.         Patient went to the ER on 17-Jan-2022, X-ray and CT scan results were fine. Then patient was treated for heart inflammation, which got better after two weeks. Now back the same as previous. Treatment: Meloxicam for a month.   This case was linked to MOD-2022-482892 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 6 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after first dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and COPD.   On 28-Feb-2021, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after first dose) outcome was unknown.            No concomitant medications were reported.  Patient received booster dose in August 2021, after he received it, he said he did not think he should had gotten it. He said he thought he got the immunocompromised 3rd dose, but he was not sure which one it was.  No treatment medications were reported.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: We had a patient that accidentally received a 4th dose; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (We had a patient that accidentally received a 4th dose) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A and 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (We had a patient that accidentally received a 4th dose). At the time of the report, EXTRA DOSE ADMINISTERED (We had a patient that accidentally received a 4th dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Patient took booster shot on 08 NOV 2021 and accidentally received a 4th dose as a second booster shot on 16 FEB 2022 at the clinic. No side effects were reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received full dose instead of half dose for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received full dose instead of half dose for booster dose) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson&Johnson COVID-19 vaccine (Primary dose) in May 2021. Past adverse reactions to the above products included No adverse event with Johnson&Johnson COVID-19 vaccine.    On 16-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received full dose instead of half dose for booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Patient received full dose instead of half dose for booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient who received a primary dose of Johnson and Johnson in May-2021 was mistakenly given the full dose of the Moderna COVID 19 vaccine instead of the booster dose. She thought the patient was receiving the COVID-19 vaccine for the 1st time.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Mixed series - 1st dose Pfizer and 2nd Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series - 1st dose Pfizer and 2nd Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 26-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series - 1st dose Pfizer and 2nd Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series - 1st dose Pfizer and 2nd Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported. Pharmacist or reporter wanted to know if it would be right to give another mod shot on feb 2022.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Needle issue
Clinical narrative: patient only received 75% of first dose; Needle twisted off of the syringe while adminstrating; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient only received 75% of first dose) and NEEDLE ISSUE (Needle twisted off of the syringe while adminstrating) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     Concomitant products included CODEINE and AMOXICILLIN for an unknown indication.    On 15-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient only received 75% of first dose) and NEEDLE ISSUE (Needle twisted off of the syringe while adminstrating). At the time of the report, ACCIDENTAL UNDERDOSE (patient only received 75% of first dose) and NEEDLE ISSUE (Needle twisted off of the syringe while adminstrating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that patient got administered with first dose of Moderna COVID-19 vaccine on 15-Feb-2022 where there was only 75 percent of the dose went into the patient due to the needle twisting out of the syringe. Patient was okay.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, Rash
Clinical narrative: hands swollen,finger tips swollen; hands numb,finger tips numb; rash all over his body including his head; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands swollen,finger tips swollen), HYPOAESTHESIA (hands numb,finger tips numb) and RASH (rash all over his body including his head) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEBREX) and GABAPENTIN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (hands swollen,finger tips swollen), HYPOAESTHESIA (hands numb,finger tips numb) and RASH (rash all over his body including his head). At the time of the report, PERIPHERAL SWELLING (hands swollen,finger tips swollen), HYPOAESTHESIA (hands numb,finger tips numb) and RASH (rash all over his body including his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2022-485647, MOD-2022-485571 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Neuralgia
Clinical narrative: nerve pain; more than 42 days for administration of second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of NEURALGIA (nerve pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909 and 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). On an unknown date, the patient experienced NEURALGIA (nerve pain). At the time of the report, NEURALGIA (nerve pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was reported that a patient mentioned having side effects after the second Moderna shot. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in Aug2021 and 3 weeks after given the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in Aug2021 and 3 weeks after given 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.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in Aug2021 and 3 weeks after given the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in Aug2021 and 3 weeks after given the 2nd dose) outcome was unknown.            Agent confirmed that they got the Moderna Covid-19 vaccine. Vaccination card was not with the caller during the call.  Caller wants to set an appointment for the booster dose.  No concomitant medication were reported.   No treatment drug were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Antibody test
Clinical narrative: 2 half dose booster doses; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (2 half dose booster doses) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 032L20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer since 2018, Penicillin allergy and Immunocompromised. Concomitant products included VENETOCLAX, DEXAMETHASONE and BORTEZOMIB (VELCADE) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (2 half dose booster doses). At the time of the report, ACCIDENTAL UNDERDOSE (2 half dose booster doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: no antibodies no antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient doctor took him off of his oncology medications to build up his blood members on 04Feb2022. After these three vaccinations patient had no side effects.   This case was linked to MOD-2022-485335 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore to even touch; Terrible pain in her right leg all night long for about a week/ her leg is sore every day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/ her leg is sore every day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 030A21A) for COVID-19 vaccination.     Concomitant products included DEXLANSOPRAZOLE (DEXILANT) for Acid reflux (esophageal), IRON for Anaemia, PIROXICAM (PAXIL [PIROXICAM]) for Anxiety, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, LOSARTAN for Hypertension, TRAZODONE for Sleep disorder.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/ her leg is sore every day). At the time of the report, PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/ her leg is sore every day) had not resolved.            Patient's height was 5'5". Patient did not have any allergies.  Patient did not tested positive for COVID-19 and did not receive any other vaccine 1 month prior to Moderna. At the time of the vaccination, she did not have any acute or chronic illnesses. She never experienced a similar event in the past.  Booster Dose was given on the 17 Dec 2021 every dose in her right deltoid and she doesn't know which dose quantity was applied for those 3 doses. She did not receive a third dose of the Moderna Covid-19 vaccine  The symptoms were ongoing and no treatment had yet been applied.   This case was linked to MOD-2022-485263, MOD-2022-485316 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore to even touch; Terrible pain in her right leg all night long for about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Anxiety, Acid reflux (esophageal), Hypercholesterolaemia, Hypertension, Sleep disorder and Anaemia. Concomitant products included DEXLANSOPRAZOLE (DEXILANT) for Acid reflux (esophageal), IRON for Anaemia, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Anxiety, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, ATORVASTATIN for Hypercholesterolemia, LOSARTAN for Hypertension, TRAZODONE for Sleep disorder.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week). In March 2021, PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week) had resolved. At the time of the report, PAIN (Sore to even touch) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment was yet applied.  Patient does not have any allergies. Patient did not tested positive for COVID-19 and did not received any other vaccine one month prior to Moderna.   This case was linked to MOD-2022-485309, MOD-2022-485316 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Terrible pain in her right leg all night long for about a week/her leg is sore every day; Sore to even touch/The pain does not go away since the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/her leg is sore every day) and PAIN (Sore to even touch/The pain does not go away since the vaccination) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included DEXLANSOPRAZOLE (DEXILANT SOLUTAB) for Acid reflux (esophageal), IRON for Anaemia, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR) for Antidepressant therapy, PIROXICAM (PAXIL [PIROXICAM]) for Anxiety, ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]) for Cholesterol, LOSARTAN for Hypertension, TRAZODONE for Sleep disorder.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/her leg is sore every day) and PAIN (Sore to even touch/The pain does not go away since the vaccination). At the time of the report, PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/her leg is sore every day) and PAIN (Sore to even touch/The pain does not go away since the vaccination) had not resolved.            she does not know which dose quantity was applied for those 3 doses.  she does not have any allergies.she did not have any acute or chronic illnesses.  She did not tested positive for Covid-19 and did not receive any other vaccine 1 month prior to Moderna.  she did not have any acute or chronic illnesses.  She never experienced a similar event on the past.She went to see her Dr at the facility in contact 3 before getting the Booster shot because she did not want to receive Moderna's, but HCP told her that if she got the Moderna primary series she had to receive the Moderna booster as well.  No treatment medication was reported.   This case was linked to MOD-2022-485263, MOD-2022-485309.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Extra dose administered, Headache
Clinical narrative: He got a 4th Moderna COVID-19 booster vaccine (half dose); mild joint pain/increases during the day/quite painful as the day progresses; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (mild joint pain/increases during the day/quite painful as the day progresses), HEADACHE (mild headache) and EXTRA DOSE ADMINISTERED (He got a 4th Moderna COVID-19 booster vaccine (half dose)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 031M20A and 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin), Cancer since 2018 and Immunocompromised. Concomitant products included VENETOCLAX, DEXAMETHASONE and BORTEZOMIB (VELCADE) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (He got a 4th Moderna COVID-19 booster vaccine (half dose)). In February 2022, the patient experienced ARTHRALGIA (mild joint pain/increases during the day/quite painful as the day progresses) and HEADACHE (mild headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (mild joint pain/increases during the day/quite painful as the day progresses) and HEADACHE (mild headache) had not resolved and EXTRA DOSE ADMINISTERED (He got a 4th Moderna COVID-19 booster vaccine (half dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It had been 7 days and patient still had the joint pain and mild headache. His doctor took him off of his oncology medications to build up his "blood members" on 04Feb2022.   This case was linked to MOD-2022-485302 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After receiving the first dose, she experienced just a sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving the first dose, she experienced just a sore arm for a couple of days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergies to Cedar tree). Concomitant products included CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (After receiving the first dose, she experienced just a sore arm for a couple of days). On 07-Apr-2021, PAIN IN EXTREMITY (After receiving the first dose, she experienced just a sore arm for a couple of days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment drug information was provided.   This case was linked to MOD-2022-485374 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Food poisoning, Maternal exposure during pregnancy
Clinical narrative: Food poisoning; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of FOOD POISONING (Food poisoning) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced FOOD POISONING (Food poisoning) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, FOOD POISONING (Food poisoning) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.         Patient was hospitalized due to severe health problems during pregnancy. The were no severe health event due to complication of patient pregnancy.  Company Comment - This case concerns an adult female patient with no relevant medical history, who experienced the serious unexpected event of food poisoning and maternal exposure during pregancy. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  Relevant concomitant medications were not reported.  Treatment information was not provided.; Sender's Comments: This case concerns an adult female patient with no relevant medical history, who experienced the serious unexpected event of food poisoning and maternal exposure during pregancy. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis, Maternal exposure during pregnancy
Clinical narrative: Gastroenteritis; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of GASTROENTERITIS (Gastroenteritis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced GASTROENTERITIS (Gastroenteritis) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, GASTROENTERITIS (Gastroenteritis) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Subject ID for the patient was 100008.  Patient was hospitalized due to severe health problems during pregnancy. The were no severe health event due to complication of patient pregnancy  Relevant concomitant medications were not reported.  Company Comment - This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and gatroenteritis. The events occurred on an unknown date after a dose of the mRNA-1273 vaccine. Patient was hospitalized during pregnancy due to health problems during pregnancy. The benefit-risk relationship of the MRNA-1273 vaccine is not affected by this report.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2022: Live follow up received on 09-Jan-2022, contains no new information; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and gatroenteritis. The events occurred on an unknown date after a dose of the mRNA-1273 vaccine. Patient was hospitalized during pregnancy due to health problems during pregnancy. The benefit-risk relationship of the MRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Neck pain, Oral pain, Pain in jaw
Clinical narrative: Pain in her neck/ Pain has grown substantially/ It is more acute in her neck; Pain has grown substantially/ It is more acute in her jaw; Pain has grown substantially/ It is more acute around her chest; Pain in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in her neck/ Pain has grown substantially/ It is more acute in her neck), PAIN IN JAW (Pain has grown substantially/ It is more acute in her jaw), CHEST PAIN (Pain has grown substantially/ It is more acute around her chest) and ORAL PAIN (Pain in her mouth) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Pain in her neck/ Pain has grown substantially/ It is more acute in her neck), PAIN IN JAW (Pain has grown substantially/ It is more acute in her jaw), CHEST PAIN (Pain has grown substantially/ It is more acute around her chest) and ORAL PAIN (Pain in her mouth). At the time of the report, NECK PAIN (Pain in her neck/ Pain has grown substantially/ It is more acute in her neck), PAIN IN JAW (Pain has grown substantially/ It is more acute in her jaw) and CHEST PAIN (Pain has grown substantially/ It is more acute around her chest) had not resolved and ORAL PAIN (Pain in her mouth) outcome was unknown.            No concomitant medication were provided. No treatment information was provided.  Reporter stated that patient got the first two Moderna shots around February 2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vaccination complication, Vertigo
Clinical narrative: vertigo; had to hold on to the walls & has had to crawl at times; vaccine has caused biologic changes to his body; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), BALANCE DISORDER (had to hold on to the walls & has had to crawl at times), VACCINATION COMPLICATION (vaccine has caused biologic changes to his body) and DIZZINESS (dizziness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-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 VERTIGO (vertigo), BALANCE DISORDER (had to hold on to the walls & has had to crawl at times), VACCINATION COMPLICATION (vaccine has caused biologic changes to his body) and DIZZINESS (dizziness). At the time of the report, VERTIGO (vertigo) and DIZZINESS (dizziness) had not resolved and BALANCE DISORDER (had to hold on to the walls & has had to crawl at times) and VACCINATION COMPLICATION (vaccine has caused biologic changes to his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported.  Patient had not taken second dose of vaccine.