chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Vaccination complication
Clinical narrative: neighbor could not walk/she was hospitalized; my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (neighbor could not walk/she was hospitalized) and VACCINATION COMPLICATION (my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (neighbor could not walk/she was hospitalized) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized) (seriousness criterion hospitalization). At the time of the report, GAIT DISTURBANCE (neighbor could not walk/she was hospitalized) and VACCINATION COMPLICATION (my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information was provided.   Case crosslinked with #MOD21-175641.  Limited AE: Reporter did not have information on patient, since it is their neighbor. Reporter said that patient had the same side effects as patient from case #MOD21-175641 (reporter's spouse). Patient is or was hospitalized after receiving Moderna COVID-19 Vaccine. Company comment: This Spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected, serious(hospitalization) events of gait disturbance and vaccination complication. The events occurred after receiving an unknown dose number of mRNA-1273 vaccine on an unknown date. Rechallenge was not applicable, as vaccination date, dose number and events dates are not available. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-175641.; Sender's Comments: This Spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected, serious(hospitalization) events of gait disturbance and vaccination complication. The events occurred after receiving an unknown dose number of mRNA-1273 vaccine on an unknown date. Rechallenge was not applicable, as vaccination date, dose number and events dates are not available. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: feeling a little weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling a little weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21A, A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-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 ASTHENIA (feeling a little weak). At the time of the report, ASTHENIA (feeling a little weak) outcome was unknown.            On 29-Dec-2021, the patient had a swab test done because there were a lot of people in her job who were getting sick. On 31-Dec-2021, the result came, and it was positive.   Other than she was feeling a little weak and she did not have other signs and symptoms.  Concomitant product use was not provided by the reporter.   No treatment information provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A relative infected with COVID -19 after vaccination with Moderna; Breakthrough COVID-19 infection on 15Dec2021; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (A relative infected with COVID -19 after vaccination with Moderna) and COVID-19 (Breakthrough COVID-19 infection on 15Dec2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced DRUG INEFFECTIVE (A relative infected with COVID -19 after vaccination with Moderna) and COVID-19 (Breakthrough COVID-19 infection on 15Dec2021). At the time of the report, DRUG INEFFECTIVE (A relative infected with COVID -19 after vaccination with Moderna) outcome was unknown and COVID-19 (Breakthrough COVID-19 infection on 15Dec2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a 49-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective. The events occurred almost 2 months after administration of the second dose of the Moderna mRNA-1273 vaccine. No further details about the events were provided. Treatment information was also not provided. However, the event COVID-19 had resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 49-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective. The events occurred almost 2 months after administration of the second dose of the Moderna mRNA-1273 vaccine. No further details about the events were provided. Treatment information was also not provided. However, the event COVID-19 had resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Magnetic resonance imaging, Malaise
Clinical narrative: Booster administered less than 6months after primary series; towards the evening started not to feel well/ not feeling very well; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6months after primary series) and MALAISE (towards the evening started not to feel well/ not feeling very well) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, lot no-ER8733; thinks it was in the left arm) on 24-Oct-2021, Pfizer (2nd dose and lot no-ER8733; thinks it was in the left arm) on 15-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Type 2 diabetes mellitus (On medication), Headache (On medication) and Neuropathy (On medication).    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (towards the evening started not to feel well/ not feeling very well). On 30-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6months after primary series). On 30-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6months after primary series) had resolved. At the time of the report, MALAISE (towards the evening started not to feel well/ not feeling very well) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Magnetic resonance imaging: results not provided MRI with contrast: results not provided, performed to scan all his body but focusing in the skull area.         It was reported that the patient did not have any side effect after the first and second doses from Pfizer.  The patient was suffering from Migraines since the early 70's right after he returned from.  He also stated that he takes a lot of medications for neuropathy, headaches, Type 2 diabetes and others.  Treatment information was not reported
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Illness, Obstruction, Stenosis, Vertigo CNS origin
Clinical narrative: Came down sick with occlusion; Stenosis; Vertigo of central origin; Dizziness; Came down sick; This spontaneous case was reported by a consumer and describes the occurrence of OBSTRUCTION (Came down sick with occlusion), STENOSIS (Stenosis), VERTIGO CNS ORIGIN (Vertigo of central origin), DIZZINESS (Dizziness) and ILLNESS (Came down sick) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 031m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBSTRUCTION (Came down sick with occlusion) (seriousness criterion hospitalization), STENOSIS (Stenosis) (seriousness criterion hospitalization), VERTIGO CNS ORIGIN (Vertigo of central origin) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and ILLNESS (Came down sick) (seriousness criterion hospitalization). At the time of the report, OBSTRUCTION (Came down sick with occlusion), STENOSIS (Stenosis), VERTIGO CNS ORIGIN (Vertigo of central origin), DIZZINESS (Dizziness) and ILLNESS (Came down sick) had not resolved.            No Concomitant medications were reported.  Patient was in the hospital for his symptoms and he was treated. Patient started to experience events on late November-early December.  No Treatment information was reported.  Company Comment: This case concerns a 93-year-old-male subject, with no relevant medical history reported in this case, who experienced serious unexpected adverse events of Obstruction, Stenosis, Vertigo CNS origin, Dizziness and Illness. The events occurred in an unknown date after the administration of the second dose of a proper schedule of product administration of mRNA-1273 vaccine. The rechallenge is not applicable since the events occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2021: Follow Up received include no new information.; Sender's Comments: This case concerns a 93-year-old-male subject, with no relevant medical history reported in this case, who experienced serious unexpected adverse events of Obstruction, Stenosis, Vertigo CNS origin, Dizziness and Illness. The events occurred in an unknown date after the administration of the second dose of a proper schedule of product administration of mRNA-1273 vaccine. The rechallenge is not applicable since the events occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Lack of drug effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C2A and 025B21A) 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 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced COVID-19 (Tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant and treatment product use was provided. The patient tested COVID-19 positive. The patient was done with the 5 day isolation period and had no symptoms now wanted to get the booster dose.  This is a spontaneous case concerning a 33-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19, and drug ineffective. The event occurred approximately 8 months after the second dose of the mRNA  1273 vaccine. At the time of report outcome of events was still unknown. The reporter's assessment was not provided. The rechallenge is not applicable since there's no information provided about the first dose. The benefit-risk relationship of the vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 33-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19, and drug ineffective. The event occurred approximately 8 months after the second dose of the mRNA  1273 vaccine. At the time of report outcome of events was still unknown. The reporter's assessment was not provided. The rechallenge is not applicable since there's no information provided about the first dose. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge
Clinical narrative: right eye began leaking and progresses; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISCHARGE in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced EYE DISCHARGE. At the time of the report, EYE DISCHARGE had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. Patient stated his right eye began leaking and as the week progressed, it was still leaking profusely. No treatment drug details was reported.   This case was linked to MOD-2021-436262, MOD-2021-436731 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain, Vaccination site swelling
Clinical narrative: mostly like discomfort, different to the other, It took about two weeks for it to go away,I do not feel anything there now; swollen underneath her right arm 5 days after dose 2; It was not really swollen, but sore; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCOMFORT (mostly like discomfort, different to the other, It took about two weeks for it to go away,I do not feel anything there now), VACCINATION SITE SWELLING (swollen underneath her right arm 5 days after dose 2) and VACCINATION SITE PAIN (It was not really swollen, but sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004/2B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Lactose intolerant. Concurrent medical conditions included Thyroid disorder (taking thyroid medicine for 40 years.), Blood pressure high (taking medicine for high blood pressure for 15 years.  ), Spice allergy, Penicillin allergy, Sucrose intolerance (sucrose which gives her stomach problems) and Drug allergy (even as a child. mentions that if she takes a Tylenol she can be up all night). Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ATORVASTATIN CALCIUM (LIPITOR), VITAMIN C [ASCORBIC ACID] and PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE DISCOMFORT (mostly like discomfort, different to the other, It took about two weeks for it to go away,I do not feel anything there now) and VACCINATION SITE PAIN (It was not really swollen, but sore). March 2021, the patient experienced VACCINATION SITE SWELLING (swollen underneath her right arm 5 days after dose 2). In April 2021, VACCINATION SITE DISCOMFORT (mostly like discomfort, different to the other, It took about two weeks for it to go away,I do not feel anything there now), VACCINATION SITE SWELLING (swollen underneath her right arm 5 days after dose 2) and VACCINATION SITE PAIN (It was not really swollen, but sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug included Centrum 1/day (for 50 years). Treatment medications were not provided.  It was reported that patient did not have any adverse reaction after the first shot. It was reported that patient had the events after 5 days of vaccination and recovered after 2 weeks.   This case was linked to MOD-2021-436279 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) 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 concomitant medications were reported. No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Eye all red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eye all red) 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 November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (Eye all red). At the time of the report, OCULAR HYPERAEMIA (Eye all red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: feel really bad; Fever of 100-101 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel really bad) and PYREXIA (Fever of 100-101 F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced FEELING ABNORMAL (feel really bad) and PYREXIA (Fever of 100-101 F). At the time of the report, FEELING ABNORMAL (feel really bad) and PYREXIA (Fever of 100-101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Body temperature: 100-101 (High) 100-101 F.         No concomitant medication details was reported. No treatment medication details was reported. Patient said even if it was half dose, she is sick as the first time.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; Her son started having hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (Her son started having hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 024M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-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 PRURITUS (itching) and URTICARIA (Her son started having hives). At the time of the report, PRURITUS (itching) and URTICARIA (Her son started having hives) had not resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-437822, MOD-2022-437824, MOD-2022-437864 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm [after first dose]; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm [after first dose]) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm [after first dose]). At the time of the report, PAIN IN EXTREMITY (sore arm [after first dose]) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2022-437834 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she had fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to Tetracycline.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA. At the time of the report, PYREXIA had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-438766, MOD-2022-438771 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Not much side effects after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not much side effects after receiving the first dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Prescription medications (Unknown)) and Asthma. Concomitant products included ROSUVASTATIN, HCTZ, SPIRONOLACTONE, VITAMIN D3 and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION COMPLICATION (Not much side effects after receiving the first dose). At the time of the report, VACCINATION COMPLICATION (Not much side effects after receiving the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.   This case was linked to MOD-2022-438683, MOD-2022-438684 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Patient further stated about 30 minutes after she received the booster she had blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Patient further stated about 30 minutes after she received the booster she had blurred vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030621A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VISION BLURRED (Patient further stated about 30 minutes after she received the booster she had blurred vision). At the time of the report, VISION BLURRED (Patient further stated about 30 minutes after she received the booster she had blurred vision) outcome was unknown.            No Concomitant product use was reported.  The patient reported that they received the Moderna booster on 04-Jan-2022. The patient further stated about 30 minutes after they received the booster, they had blurred vision.  No treatment information was provided.   This case was linked to MOD-2021-032391, MOD-2021-032445 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm/ injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm/ injection site arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left arm/ injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left arm/ injection site arm) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-438831 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction from my Moderna vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction from my Moderna vaccination). At the time of the report, VACCINATION COMPLICATION (reaction from my Moderna vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Sneezing, Throat irritation
Clinical narrative: The flue gripa /Flu - hasn't had one for over 5 years; Throat itches; Sneezing frequently; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (The flue gripa /Flu - hasn't had one for over 5 years), THROAT IRRITATION (Throat itches) and SNEEZING (Sneezing frequently) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INFLUENZA (The flue gripa /Flu - hasn't had one for over 5 years), THROAT IRRITATION (Throat itches) and SNEEZING (Sneezing frequently). At the time of the report, INFLUENZA (The flue gripa /Flu - hasn't had one for over 5 years), THROAT IRRITATION (Throat itches) and SNEEZING (Sneezing frequently) outcome was unknown.            No concomitant medications reported. Treatment included Natural remedies.  It was reported that patient had vaccination two days before Surgery related to sight and it was a requirement for her to be vaccinated. She stated that she hadn't had flu for over 5 years but blamed it on travelling and weather changes.   This case was linked to MOD-2022-440630 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Influenza like illness, Pain, Pyrexia, Vaccination complication
Clinical narrative: Expected reaction; felt like she got the cold; felt like she got the flu; Achy for 24 hrs; Little bit fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Expected reaction), FEELING COLD (felt like she got the cold), INFLUENZA LIKE ILLNESS (felt like she got the flu), PAIN (Achy for 24 hrs) and PYREXIA (Little bit fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-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 COMPLICATION (Expected reaction), FEELING COLD (felt like she got the cold), INFLUENZA LIKE ILLNESS (felt like she got the flu), PAIN (Achy for 24 hrs) and PYREXIA (Little bit fever). At the time of the report, VACCINATION COMPLICATION (Expected reaction), FEELING COLD (felt like she got the cold) and INFLUENZA LIKE ILLNESS (felt like she got the flu) outcome was unknown and PAIN (Achy for 24 hrs) and PYREXIA (Little bit fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2022-439044, MOD-2022-439068 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick from the first 2 doses of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick from the first 2 doses of the Moderna COVID-19 vaccine.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick from the first 2 doses of the Moderna COVID-19 vaccine.). At the time of the report, ILLNESS (very sick from the first 2 doses of the Moderna COVID-19 vaccine.) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.  Patient was so sick that she though she was going to die.  Reportedly, patient weight was 104 .   This case was linked to MOD-2021-416241 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Hypersensitivity, Pruritus
Clinical narrative: can't stop itching; is having an allergic reaction to it; has an allergy or something to whatever is in it; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (can't stop itching), HYPERSENSITIVITY (is having an allergic reaction to it) and ALLERGY TO VACCINE (has an allergy or something to whatever is in it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (can't stop itching), HYPERSENSITIVITY (is having an allergic reaction to it) and ALLERGY TO VACCINE (has an allergy or something to whatever is in it). At the time of the report, PRURITUS (can't stop itching) had not resolved and HYPERSENSITIVITY (is having an allergic reaction to it) and ALLERGY TO VACCINE (has an allergy or something to whatever is in it) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder, Disorganised speech, General physical health deterioration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (deteriorating), BONE DISORDER (has a bone sticking out) and DISORGANISED SPEECH (hard to try to organized her speech) in an elderly 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 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 GENERAL PHYSICAL HEALTH DETERIORATION (deteriorating), BONE DISORDER (has a bone sticking out) and DISORGANISED SPEECH (hard to try to organized her speech). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (deteriorating), BONE DISORDER (has a bone sticking out) and DISORGANISED SPEECH (hard to try to organized her speech) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Elderly and confused patient called to inform according to her doctor was ignoring her and doctor was not doing anything. No concomitant medications was reported. No treatment drug details was reported. This case was linked to MOD-2021-238873, MOD-2021-253505 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: got their  butt kick pretty good, first couple of days,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got their  butt kick pretty good, first couple of days,) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-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 VACCINATION COMPLICATION (got their  butt kick pretty good, first couple of days,). At the time of the report, VACCINATION COMPLICATION (got their  butt kick pretty good, first couple of days,) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that reporter could report side effects.   This case was linked to MOD-2022-437114 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm is hard to the touch; Arm is red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is hard to the touch) and ERYTHEMA (Arm is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is hard to the touch) and ERYTHEMA (Arm is red). At the time of the report, PAIN IN EXTREMITY (Arm is hard to the touch) and ERYTHEMA (Arm is red) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were reported.  The patient queried upon follow up about what were the side effects of the 50 mcg booster dose, and whether they were the same as experienced after receiving the primary series or different than that.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jan-2022: Follow-up information received contains non significant information
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: daughter who lives in another state had the same r/ (hive reaction with a rash); I still have the rash; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (daughter who lives in another state had the same r/ (hive reaction with a rash)) and RASH (I still have the rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (daughter who lives in another state had the same r/ (hive reaction with a rash)) and RASH (I still have the rash). At the time of the report, URTICARIA (daughter who lives in another state had the same r/ (hive reaction with a rash)) outcome was unknown and RASH (I still have the rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2022-437363 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: intermitted side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (intermitted side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (intermitted side effects). At the time of the report, VACCINATION COMPLICATION (intermitted side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hive reaction with a rash 10 days after my booster.; still have the rash; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hive reaction with a rash 10 days after my booster.) and RASH (still have the rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hive reaction with a rash 10 days after my booster.) and RASH (still have the rash). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hive reaction with a rash 10 days after my booster.) outcome was unknown and RASH (still have the rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  Patient developed a hive reaction with a rash 10 days after the booster.   This case was linked to MOD-2022-437361 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in her face; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (Numbness in her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in her face). At the time of the report, HYPOAESTHESIA (Numbness in her face) 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 relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination complication
Clinical narrative: my reaction to my second dose; I ran 105.4 temp for about 30 allergies; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (my reaction to my second dose) and PYREXIA (I ran 105.4 temp for about 30 allergies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy, Food allergy and Drug allergy.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (my reaction to my second dose) and PYREXIA (I ran 105.4 temp for about 30 allergies). At the time of the report, VACCINATION COMPLICATION (my reaction to my second dose) and PYREXIA (I ran 105.4 temp for about 30 allergies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105.4 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.; rash and itching.on different body areas; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.) and RASH PRURITIC (rash and itching.on different body areas) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 030A12A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced RASH ERYTHEMATOUS (Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.) and RASH PRURITIC (rash and itching.on different body areas). At the time of the report, RASH ERYTHEMATOUS (Rash as flat red and it starts from hand to neck and after halfand hour it goes to stomach and other parts of body.) and RASH PRURITIC (rash and itching.on different body areas) had not resolved.            No concomitant medications was reported.  No treatment drug details was reported.  Patient had no prior allergy and pre existing conditions.