chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Greater than 35 days for second dose; Vaccine administered to teenager; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to teenager) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days for second dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to teenager). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days for second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to teenager) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days for second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This spontaneous case was reported by an other health care professional and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) 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 URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) 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 provided.  No treatment medications provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Vaccination site pain
Clinical narrative: mild soreness around injection site for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness around injection site for a day) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 026A21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (mild soreness around injection site for a day). At the time of the report, VACCINATION SITE PAIN (mild soreness around injection site for a day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, C-reactive protein: 0.6 (normal) 0.6mg. On 31-Aug-2021, C-reactive protein: 60.5 (High) 60.5mg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that on 31-Aug-2021, he received a lab test which showed 100-fold increase in his C-reactive protein compared to last year's test. It went from 0.6mg to 60.5mg.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Dizzy; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy), CHILLS (Chills) and PYREXIA (Fever) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included PROPRANOLOL, LOSARTAN and PANTOPRAZOLE for an unknown indication.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy), CHILLS (Chills) and PYREXIA (Fever). On 15-Jul-2021, DIZZINESS (Dizzy), CHILLS (Chills) and PYREXIA (Fever) had resolved. On 18-Jul-2021, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   This case was linked to MOD-2021-317907, MOD-2021-317908 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (side effects from the vaccine a week after the first dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (side effects from the vaccine a week after the first dose). At the time of the report, vaccination complication (side effects from the vaccine a week after the first dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm; Arm pain on site of injected; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm), VACCINATION SITE PAIN (Arm pain on site of injected) and PYREXIA (Fever) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LOSARTAN and PANTOPRAZOLE for an unknown indication.    On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced VACCINATION SITE PAIN (Arm pain on site of injected). On 22-Aug-2021, the patient experienced NEURALGIA (Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm). On an unknown date, the patient experienced PYREXIA (Fever). On 15-Aug-2021, VACCINATION SITE PAIN (Arm pain on site of injected) had resolved. At the time of the report, NEURALGIA (Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm) and PYREXIA (Fever) outcome was unknown.            Treatment information not provided.   This case was linked to MOD-2021-317898, MOD-2021-317908 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Moderate fatigue; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Moderate fatigue), MYALGIA (Body aches) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Moderate fatigue), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, FATIGUE (Moderate fatigue), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.    This case was linked to MOD-2021-317946 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Neuropathic flares; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Neuropathic flares) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neuropathy.    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 NEURALGIA (Neuropathic flares). At the time of the report, NEURALGIA (Neuropathic flares) 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 reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: achy/ sore arm; extremely tired for two weeks; headachy; arm hurts; arm is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), PERIPHERAL SWELLING (arm is still swollen), HEADACHE (headachy), MYALGIA (achy/ sore arm) and FATIGUE (extremely tired for two weeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 1989 and Diabetes since 2010. Concomitant products included ATENOLOL for Blood pressure high, GLIPIZIDE from 2020 to an unknown date for Diabetes, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Pre-diabetes, HYDROCHLOROTHIAZIDE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurts). 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is still swollen). On 05-May-2021, the patient experienced HEADACHE (headachy). On an unknown date, the patient experienced MYALGIA (achy/ sore arm) and FATIGUE (extremely tired for two weeks). At the time of the report, PAIN IN EXTREMITY (arm hurts), HEADACHE (headachy) and FATIGUE (extremely tired for two weeks) had resolved and PERIPHERAL SWELLING (arm is still swollen) and MYALGIA (achy/ sore arm) had not resolved.            No treatment medication were reported. Other concomitant products include HCL for High Blood Pressure since 1989. Dose 2 anatomical location is Mid bicept.Patient height is 68,weight is 205   This case was linked to MOD-2021-317897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received: Added, patient demographics, medical history, concomitant product indication. Updated outcome of event
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Pyrexia
Clinical narrative: sick to the stomach; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to the stomach), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease. Concomitant products included LEVOTHYROXINE, MULTIVITAMINS [VITAMINS NOS], ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to the stomach), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 24-Mar-2021, ABDOMINAL DISCOMFORT (sick to the stomach), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-317960, MOD-2021-317961 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (significantly worse reaction than the second/severe reaction) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (significantly worse reaction than the second/severe reaction). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not reported. This case linked to MOD-2021-317916 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gastric disorder, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: sick to the stomach; Fever; chills; fatigue; Received second dose 22 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (sick to the stomach), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 22 days after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease (immunocompromised). Concomitant products included LEVOTHYROXINE, MULTIVITAMIN [VITAMINS NOS], ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 22 days after first dose). On an unknown date, the patient experienced GASTRIC DISORDER (sick to the stomach), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 22 days after first dose) had resolved. At the time of the report, GASTRIC DISORDER (sick to the stomach), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that the symptoms had lasted for about 12 to 18 hours.   This case was linked to MOD-2021-317925, MOD-2021-317961 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Illness, Product dose omission issue
Clinical narrative: Didn't receive 2nd dose/more than 35 days since caller got the first dose and does not have the second yet; got really sick/seriously ill; really really weak; no appetite; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (got really sick/seriously ill), ASTHENIA (really really weak), DECREASED APPETITE (no appetite) and PRODUCT DOSE OMISSION ISSUE (Didn't receive 2nd dose/more than 35 days since caller got the first dose and does not have the second yet) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid function abnormal. Concomitant products included LEVOTHYROXINE for Thyroid function abnormal, METFORMIN, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ILLNESS (got really sick/seriously ill), ASTHENIA (really really weak) and DECREASED APPETITE (no appetite). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive 2nd dose/more than 35 days since caller got the first dose and does not have the second yet). At the time of the report, ILLNESS (got really sick/seriously ill), ASTHENIA (really really weak) and DECREASED APPETITE (no appetite) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Didn't receive 2nd dose/more than 35 days since caller got the first dose and does not have the second yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (abnormal) The temperature fluctuated between 99.4 and 101.8 F, and stayed like that for 4 days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included vitamins, immune Booster, elderberry, flax seeds.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: An event was added.
Sex: M
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: The condition he was diagnosed with pemphigus vulgaris is also happening to other people; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGUS (The condition he was diagnosed with pemphigus vulgaris is also happening to other people) 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 PEMPHIGUS (The condition he was diagnosed with pemphigus vulgaris is also happening to other people). At the time of the report, PEMPHIGUS (The condition he was diagnosed with pemphigus vulgaris is also happening to other people) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated he was diagnosed with pemphigus vulgaris was also happening to other people which received the vaccine.  Concomitant product use was not provided by reporter.  Treatment information was not provided.; Sender's Comments: This case concerns a male subject with no relevant medical history, who experienced the unexpected event of Pemphigus. Time to onset from vaccination was not reported. The rechallenge was unknown as vaccination dates are not reported. The benefit-risk relationship of drug Spikevax is not affected by this report. Despite the event Pemphigus is on IME list this event was assessed as non serious according with regulatory authority assessment and narrative.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Receiving lower than full dose of the vaccine because of leaking; Content leaked out on her arm  and the pharmacist stated that it happened because of the needle; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Receiving lower than full dose of the vaccine because of leaking) and DEVICE CONNECTION ISSUE (Content leaked out on her arm  and the pharmacist stated that it happened because of the needle) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced UNDERDOSE (Receiving lower than full dose of the vaccine because of leaking) and DEVICE CONNECTION ISSUE (Content leaked out on her arm  and the pharmacist stated that it happened because of the needle). At the time of the report, UNDERDOSE (Receiving lower than full dose of the vaccine because of leaking) and DEVICE CONNECTION ISSUE (Content leaked out on her arm  and the pharmacist stated that it happened because of the needle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received 4 vaccines, Not immunocompromised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 4 vaccines, Not immunocompromised) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received 4 vaccines, Not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (received 4 vaccines, Not immunocompromised) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt for a day and a half) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt for a day and a half). At the time of the report, VACCINATION SITE PAIN (Arm hurt for a day and a half) outcome was unknown.            No Concomitant medication reported. Patient was vaccinated in left arm for first dose and vaccinated in right are for second dose. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination complication
Clinical narrative: Some reaction from each one of the shots; Contracted covid after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted covid after the shot) and VACCINATION COMPLICATION (Some reaction from each one of the shots) 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. In August 2021, the patient experienced COVID-19 (Contracted covid after the shot). On an unknown date, the patient experienced VACCINATION COMPLICATION (Some reaction from each one of the shots). At the time of the report, COVID-19 (Contracted covid after the shot) and VACCINATION COMPLICATION (Some reaction from each one of the shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 on August 28th; congestion; cough; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 on August 28th), NASAL CONGESTION (congestion), COUGH (cough) and PYREXIA (fever   ) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced NASAL CONGESTION (congestion), COUGH (cough) and PYREXIA (fever   ). On 28-Aug-2021, the patient experienced COVID-19 (tested positive for COVID-19 on August 28th). At the time of the report, COVID-19 (tested positive for COVID-19 on August 28th), NASAL CONGESTION (congestion), COUGH (cough) and PYREXIA (fever   ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported No treatment medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Slight headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Slight headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Slight headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment drugs were not reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Hot flush
Clinical narrative: hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week); hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 004L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-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 HOT FLUSH (hot flashes). In August 2021, the patient experienced HALLUCINATION (hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week)) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week)) outcome was unknown and HOT FLUSH (hot flashes) had resolved.            No treatment drug information provided. No concomitant drug information provided.  Company comment- This case concerns a 58-year-old, male patient with no previous relevant medical history, who experienced the unexpected event of hallucination. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was negative. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-317611 (E2B Linked Report). This case was linked to MOD-2021-317637 (Patient Link).; Sender's Comments: This case concerns a 58-year-old, male patient with no previous relevant medical history, who experienced the unexpected event of hallucination. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was negative. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2021-317611:Same reporter and Patient but different patient
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unspecific AE; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific AE) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unspecific AE). At the time of the report, VACCINATION COMPLICATION (Unspecific AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: sore throat; congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) 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 OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knee pain when bending knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA. At the time of the report, ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: feeling sick; feel like I got the flu; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick) and INFLUENZA LIKE ILLNESS (feel like I got the flu) 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 MALAISE (feeling sick) and INFLUENZA LIKE ILLNESS (feel like I got the flu). At the time of the report, MALAISE (feeling sick) and INFLUENZA LIKE ILLNESS (feel like I got the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild symptoms). At the time of the report, VACCINATION COMPLICATION (Mild symptoms) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Red rash around the injection site; Red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash around the injection site) and VACCINATION SITE ERYTHEMA (Red rash around the injection site) 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 10-Sep-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 RASH (Red rash around the injection site) and VACCINATION SITE ERYTHEMA (Red rash around the injection site). At the time of the report, VACCINATION SITE RASH (Red rash around the injection site) and VACCINATION SITE ERYTHEMA (Red rash around the injection site) outcome was unknown.            Concomitant medications were not reported. Treatment details were not received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really ill) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really ill). At the time of the report, ILLNESS (really ill) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain, Pruritus, Rash
Clinical narrative: Not so itchy/in the arms it was where it itched the most (the blisters)/most itchy in the palms/most itchy beneath her feet; In the arms it was where it itched the most (the blisters)/it was like blisters/blisters got pain-tender/it was like blisters; Blisters got pain-tender/it was like blisters; rash in arms/rash in thighs/rash in front trunk (the worst)/rash in back/rash in scalp/rash in back of the neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH, PRURITUS, BLISTER, and PAIN in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced RASH. On an unknown date, the patient experienced PRURITUS, BLISTER, PAIN, and RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue, Tooth infection
Clinical narrative: felt sick; tooth infection; Product dose omission issue; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (felt sick), TOOTH INFECTION (tooth infection) and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick), TOOTH INFECTION (tooth infection) and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) ongoing since an unknown date for Tooth infection, at a dose of 1 dosage form. At the time of the report, MALAISE (felt sick) and TOOTH INFECTION (tooth infection) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information were reported by the reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pruritus, Rash, Skin swelling
Clinical narrative: They are puffy/They swell like welts; She has bruised her body from scratching,she can't help it; They start as red dots; Extremely itchy/ they itch so bad; They swell like welts; A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad) and URTICARIA (They swell like welts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad), URTICARIA (They swell like welts) and RASH (A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad), URTICARIA (They swell like welts) and RASH (A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she is on some medications.  It was reported that patient experienced adverse events 7 days post her first dose and  thought the adverse events occurred was due to poison ivy.The patient is unsure about getting her second dose. She had an appointment with her rheumatologist on 14-Sep-2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: They are puffy/They swell like welts; She has bruised her body from scratching,she can't help it; They start as red dots; Extremely itchy/ they itch so bad; They swell like welts; A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad) and URTICARIA (They swell like welts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad), URTICARIA (They swell like welts) and RASH (A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad), URTICARIA (They swell like welts) and RASH (A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she is on some medications.  It was reported that patient experienced adverse events 7 days post her first dose and  thought the adverse events occurred was due to poison ivy.The patient is unsure about getting her second dose. She had an appointment with her rheumatologist on 14-Sep-2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Herpes zoster, Pruritus, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm) and ERYTHEMA (redness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness) and HEADACHE (very bad headache). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness) and HEADACHE (very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was reported.   This case was linked to MOD-2021-315988 (Patient Link).