chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right arm became a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right arm became a little sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A31A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Right arm became a little sore). At the time of the report, VACCINATION SITE PAIN (Right arm became a little sore) outcome was unknown.            No concomitant medications are provided. No treatment medications are provided   This case was linked to MOD-2021-368757, MOD-2021-368775 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 029A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that it was unknown if the patient experienced any symptoms.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired dose was administered; One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours) 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 EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours) had resolved.        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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Magnetic resonance imaging, Ocular discomfort, Vertigo
Clinical narrative: vertigo; Eyes dizzy; Very unbalance/My body goes to the left; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Eyes dizzy), BALANCE DISORDER (Very unbalance/My body goes to the left) and VERTIGO (vertigo) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-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 August 2021, the patient experienced OCULAR DISCOMFORT (Eyes dizzy) and BALANCE DISORDER (Very unbalance/My body goes to the left). On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, OCULAR DISCOMFORT (Eyes dizzy), BALANCE DISORDER (Very unbalance/My body goes to the left) and VERTIGO (vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) Normal.         No concomitant medications were reported.  No treatment drugs were reported.  The patient does not take any regular medications but, they gave her something for the vertigo for some time. Patient done some tests on her legs, that seems to be fine.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm; Felt very tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and FATIGUE (Felt very tired and fatigued) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Felt very tired and fatigued). At the time of the report, VACCINATION SITE PAIN (Sore arm) and FATIGUE (Felt very tired and fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-368938 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Vaccination site nodule
Clinical narrative: Big node on the injection site; I don't feel very well; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Big node on the injection site), MALAISE (I don't feel very well), CHILLS (Chills) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Big node on the injection site), MALAISE (I don't feel very well), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE NODULE (Big node on the injection site), MALAISE (I don't feel very well), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: I developed a red hard swollen arm after receiving a booster dose; I developed a red hard swollen arm after receiving a booster dose; I developed a red hard swollen arm after receiving a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (I developed a red hard swollen arm after receiving a booster dose), VACCINATION SITE SWELLING (I developed a red hard swollen arm after receiving a booster dose) and VACCINATION SITE INDURATION (I developed a red hard swollen arm after receiving a booster dose) 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 VACCINATION SITE ERYTHEMA (I developed a red hard swollen arm after receiving a booster dose), VACCINATION SITE SWELLING (I developed a red hard swollen arm after receiving a booster dose) and VACCINATION SITE INDURATION (I developed a red hard swollen arm after receiving a booster dose). At the time of the report, VACCINATION SITE ERYTHEMA (I developed a red hard swollen arm after receiving a booster dose), VACCINATION SITE SWELLING (I developed a red hard swollen arm after receiving a booster dose) and VACCINATION SITE INDURATION (I developed a red hard swollen arm after receiving a booster dose) outcome was unknown.            The patient wants to know how to treat the reactions.   Treatment  information was unknown
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  Date the vial was initially stored in the refrigerator 20 Apr 2021  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Added follow up included HCP confirmed number of patients and none of the patients experienced side effects.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 03-Oct-2021, ARTHRALGIA (Sore shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-368944 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail; 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 (patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail) 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 (patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail). At the time of the report, VACCINATION COMPLICATION (patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail) 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: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.) 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 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.). On 30-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No treatment medications were reported.  The reporter had question regarding product re-administration.   Reporter did not allow further contact
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt, tiny bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt, tiny bit sore) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt, tiny bit sore). At the time of the report, PAIN IN EXTREMITY (Arm hurt, tiny bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that On an unknown date, patient had received regular flu shot two weeks ago.  No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-369269 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: third full dose and not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (third full dose and not being immunocompromised) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9399) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Cartia 240 for Atrial fibrillation, SIMVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism, APIXABAN (ELIQUIS) for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (third full dose and not being immunocompromised). On 29-Oct-2021, ACCIDENTAL OVERDOSE (third full dose and not being immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Lot number 9399.. (patient couldn't read the last two numbers) and patient was not immunocompromised and the pharmacist said that she gave a full dose for the third shot, and that this is the recommended dosage for older patients. No treatment medications were reported.    This case was linked to MOD-2021-369334 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have had a reaction for my second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have had a reaction for my second shot) 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 February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (I have had a reaction for my second shot). At the time of the report, VACCINATION COMPLICATION (I have had a reaction for my second shot) outcome was unknown.            no concomitant and treatment medications are provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had a temperature with the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a temperature with the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 PYREXIA (Had a temperature with the second shot). At the time of the report, PYREXIA (Had a temperature with the second shot) had resolved. Not Provided          No concomitant medication information was provided. No treatment medication were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-369437, MOD-2021-369454 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Added no new information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: heat in the injection site arm; swollen injection site arm; Redness that extended 3 to 4 inches down my injection site arm; fever of 98.5 degrees Farenheight; injection site arm itched; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 012MWA and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched). At the time of the report, VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Body temperature: 98.5 (High) 98.5 degrees Fahrenheit.         No concomitant medications were reported .  It was reported that patient had placed icepack on her arm   This case was linked to MOD-2021-371357 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Reporter information updated:  Reporter address, Patient details updated: DOB,age, gender ,weight.Vaccination details updated: dose 1, 2 and 3 information.Newevents added :vaccination site warmth, vaccination site swelling ,vaccination site erythema, pyrexia, vaccination site pruritus .
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: heat in the injection site arm; swollen injection site arm; Redness that extended 3 to 4 inches down my injection site arm; fever of 98.5 degrees Farenheight; injection site arm itched; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 012MWA and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched). At the time of the report, VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Body temperature: 98.5 (High) 98.5 degrees Fahrenheit.         No concomitant medications were reported .  It was reported that patient had placed icepack on her arm   This case was linked to MOD-2021-371357 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Reporter information updated:  Reporter address, Patient details updated: DOB,age, gender ,weight.Vaccination details updated: dose 1, 2 and 3 information.Newevents added :vaccination site warmth, vaccination site swelling ,vaccination site erythema, pyrexia, vaccination site pruritus .
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Body temperature, Diarrhoea, Heart rate, Pyrexia
Clinical narrative: Diarrhea; fever of 101.1 deg F; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (fever of 101.1 deg F) and VOMITING (Vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Concurrent medical conditions included AFib and Type 2 diabetes mellitus. Concomitant products included INSULIN, LIRAGLUTIDE (VICTOZA) and METFORMIN for an unknown indication.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (fever of 101.1 deg F) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved and PYREXIA (fever of 101.1 deg F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Blood glucose: 177 (High) blood sugar lever went up to 177 units from its usual 120 units.. On 30-Oct-2021, Body temperature: 101.1 (High) 101.1 degree F. On 30-Oct-2021, Heart rate: 101-103 breaths per minute (High) it only ranges from 70-90BPM prior to vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; fever of 101.1 deg F; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (fever of 101.1 deg F) and VOMITING (Vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Concurrent medical conditions included AFib and Type 2 diabetes mellitus. Concomitant products included INSULIN, LIRAGLUTIDE (VICTOZA) and METFORMIN for an unknown indication.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (fever of 101.1 deg F) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved and PYREXIA (fever of 101.1 deg F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Blood glucose: 177 (High) blood sugar lever went up to 177 units from its usual 120 units.. On 30-Oct-2021, Body temperature: 101.1 (High) 101.1 degree F. On 30-Oct-2021, Heart rate: 101-103 breaths per minute (High) it only ranges from 70-90BPM prior to vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: received our COVID booster, and had a sore arm and generally felt fatigued the day after.; received our COVID booster, and had a sore arm and generally felt fatigued the day after.; This spontaneous case was reported by a dentist and describes the occurrence of VACCINATION SITE PAIN (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) and FATIGUE (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) and FATIGUE (received our COVID booster, and had a sore arm and generally felt fatigued the day after.). At the time of the report, VACCINATION SITE PAIN (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) and FATIGUE (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Arm is tight where they got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm is tight where they got the shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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 INDURATION (Arm is tight where they got the shot). At the time of the report, VACCINATION SITE INDURATION (Arm is tight where they got the shot) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-369479, MOD-2021-369499 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Palpitations, Tachycardia
Clinical narrative: heart racing; tachycardia; random bouts of flushing; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (random bouts of flushing), PALPITATIONS (heart racing) and TACHYCARDIA (tachycardia) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination. Concurrent medical conditions included Chemical sensitivity. On 25-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. In April 2021, the patient experienced FLUSHING (random bouts of flushing). On 23-Apr-2021, the patient experienced PALPITATIONS (heart racing) and TACHYCARDIA (tachycardia). At the time of the report, FLUSHING (random bouts of flushing) had not resolved and PALPITATIONS (heart racing) and TACHYCARDIA (tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Heart rate: irregular (abnormal) irregular and fast heart rate. Patients reports not taking any medication as treatment and not being on any concomitant medications. Patient is experiencing the dehydration but only having to consume twice as much instead of 5 times as much. No treatment details was reported. This case concerns a 52-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HEART RATE IRREGULAR. The event occurred one day after receiving the second dose of Spikevax. Rechallenge is not applicable since the event has not resolved. The benefit-risk relation of Spikevax is not affected by this report. This case was linked to MOD-2021-369045 (Patient Link). Sender's Comments: This case concerns a 52-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HEART RATE IRREGULAR. The event occurred one day after receiving the second dose of Spikevax. Rechallenge is not applicable since the event has not resolved. The benefit-risk relation of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Hypertension
Clinical narrative: High pressure 140/73; Pounding in the head; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High pressure 140/73) and HEADACHE (Pounding in the head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     Concurrent medical conditions included Angioma. Concomitant products included DEXAMETHASONE for Angioma.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced HYPERTENSION (High pressure 140/73) and HEADACHE (Pounding in the head). At the time of the report, HYPERTENSION (High pressure 140/73) and HEADACHE (Pounding in the head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: 140/73 (High) High pressure 140/73. In October 2021, Heart rate: abnormal (abnormal) Uncomfortable heartbeat.         No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Granuloma annulare, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Diagnose with a granuloma annular; "Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"; Swollen on my foot/ "on the top of my foot, don't know how deep it goes"; "I have had an issue with a gross rash in my foot and leg"; "Much pain"; "Mainly I was in bed"; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (Diagnose with a granuloma annular), PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed"). On an unknown date, the patient experienced GRANULOMA ANNULARE (Diagnose with a granuloma annular), PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes") and RASH ("I have had an issue with a gross rash in my foot and leg"). At the time of the report, GRANULOMA ANNULARE (Diagnose with a granuloma annular) and RASH ("I have had an issue with a gross rash in my foot and leg") had not resolved and PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed") outcome was unknown.            Concomitant medication included unspecified Thyroid medication. Treatment medications included unspecified 2 different ointment creams.  Doctor gave her 2 different ointment creams but, it has not help yet and granuloma takes it time and maybe don't even go away   This case was linked to MOD-2021-370406 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Diagnose with a granuloma annular; "Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"; Swollen on my foot/ "on the top of my foot, don't know how deep it goes"; "I have had an issue with a gross rash in my foot and leg"; "Much pain"; "Mainly I was in bed"; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (Diagnose with a granuloma annular), PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed"). On an unknown date, the patient experienced GRANULOMA ANNULARE (Diagnose with a granuloma annular), PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes") and RASH ("I have had an issue with a gross rash in my foot and leg"). At the time of the report, GRANULOMA ANNULARE (Diagnose with a granuloma annular) and RASH ("I have had an issue with a gross rash in my foot and leg") had not resolved and PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed") outcome was unknown.            Concomitant medication included unspecified Thyroid medication. Treatment medications included unspecified 2 different ointment creams.  Doctor gave her 2 different ointment creams but, it has not help yet and granuloma takes it time and maybe don't even go away   This case was linked to MOD-2021-370406 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Second dose I had aches, fatigue nausea headache; Second dose I had aches, fatigue nausea headache; Second dose I had aches, fatigue nausea headache; Second dose I had aches, fatigue nausea headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Second dose I had aches, fatigue nausea headache), FATIGUE (Second dose I had aches, fatigue nausea headache), NAUSEA (Second dose I had aches, fatigue nausea headache   ) and HEADACHE (Second dose I had aches, fatigue nausea headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 012M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 PAIN (Second dose I had aches, fatigue nausea headache), FATIGUE (Second dose I had aches, fatigue nausea headache), NAUSEA (Second dose I had aches, fatigue nausea headache) and HEADACHE (Second dose I had aches, fatigue nausea headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (Second dose I had aches, fatigue nausea headache) outcome was unknown and FATIGUE (Second dose I had aches, fatigue nausea headache), NAUSEA (Second dose I had aches, fatigue nausea headache) and HEADACHE (Second dose I had aches, fatigue nausea headache) had resolved.            The patient reports experiencing headache, nausea, fatigue. Symptoms have resolved    This case was linked to MOD-2021-370969, MOD-2021-371024 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 (lot number: EL3247), dose 1, single and on 18Feb2021 (lot number: EL3247), dose 2, single; both via an unspecified route of administration at the age of 29-year-old for COVID-19 immunisation. The patient's medical history was not reported and there were no concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22Oct2021, the patient got COVID. The patient underwent lab tests and procedures which included (nasal swab) test: positive on 23Oct2021. No treatment was received for the event. The event was reported as serious (medically significant). The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: tested positive for flu; Initial information received on 27-Oct-2021 regarding an unsolicited valid serious case from consumer/non-health care professional via social media.  This case involves a patient (unknown age and gender) who had tested positive for flu (influenza), after receiving INFLUENZA VACCINE .  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had tested positive for flu (influenza), (serious) [unknown latency] following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were other relevant laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  Information on the batch number was requested.; Sender's Comments: This case involves a patient who had influenza after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Furthermore information regarding other relevant conditions and previous vaccinations of the patient will be needed to fully assess the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: sick with the flu; sick with the flu; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media. This case involves an unknown age male patient who experienced sick with the flu (influenza and illness) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick with the flu (influenza and illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported "My husband used to get the flu shot every year and every year he'd get sick with the flu. Two years ago, he stopped getting the flu shot and hasn't gotten sick with flu since. To each his own I guess."  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: many people get sick after getting it; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional via Social Media.  This case involves patients (unknown demographics) who got sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patients had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patients received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patients got sick (illness, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "No thanks seen too many people get sick after getting it and has baby Parts in it I looked it up a long time ago and it did"  It was unknown if the patients experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patients received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.