chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chills, Diarrhoea, Illness, Myalgia
Clinical narrative: can't remember nothing; 12 hours later caller was bad sick; diarrhea ever since starting about two hours after getting the vaccine; shivering; whole body was hurting; running a fever; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (can't remember nothing), ILLNESS (12 hours later caller was bad sick), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering) and MYALGIA (whole body was hurting) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021 and Memory loss (memory loss was from the shot but from having Covid.). Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine in March 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced ILLNESS (12 hours later caller was bad sick), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering), MYALGIA (whole body was hurting) and PYREXIA (running a fever). On an unknown date, the patient experienced AMNESIA (can't remember nothing). In November 2021, ILLNESS (12 hours later caller was bad sick) had resolved. At the time of the report, AMNESIA (can't remember nothing), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering), MYALGIA (whole body was hurting) and PYREXIA (running a fever) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included beta blocker, and antidepressant medication. Patient was sick for 72 hours. No treatment medication were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: can't remember nothing; 12 hours later caller was bad sick; diarrhea ever since starting about two hours after getting the vaccine; shivering; whole body was hurting; running a fever; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (can't remember nothing), ILLNESS (12 hours later caller was bad sick), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering) and MYALGIA (whole body was hurting) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021 and Memory loss (memory loss was from the shot but from having Covid.). Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine in March 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced ILLNESS (12 hours later caller was bad sick), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering), MYALGIA (whole body was hurting) and PYREXIA (running a fever). On an unknown date, the patient experienced AMNESIA (can't remember nothing). In November 2021, ILLNESS (12 hours later caller was bad sick) had resolved. At the time of the report, AMNESIA (can't remember nothing), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering), MYALGIA (whole body was hurting) and PYREXIA (running a fever) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included beta blocker, and antidepressant medication. Patient was sick for 72 hours. No treatment medication were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine greater than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture). On 26-Jan-2022 at 9:30 AM, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter who was a Nurse called to report that 1 vial of Moderna COVID-19 vaccine was taken out of refrigerator on 25-Jan-2021 9:30AM punctured and left at room temperature overnight. The patient received expired booster of Moderna COVID-19 vaccine form the vial on 26-Jan-2021 at 9:30AM. The dose was administered more than 12 hours post puncture.  The date the vial was initially stored in the refrigerator was 21-Jan-2022 and the vial was stored post puncture in the room temperature. It was also reported that the vial didn't undergo any temperature excursions. Reportedly, the total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 24 hours.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experience mild adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experience mild adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Prophylactic vaccination: Janssen covid-19 VACCINE in February 2021 and Janssen covid-19 VACCINE (Patient reported that J AND J vaccine had knocked her out) in February 2021. Past adverse reactions to the above products included Fever with Janssen covid-19 VACCINE; and Teeth chattering with Janssen covid-19 VACCINE.    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 (Experience mild adverse reaction). At the time of the report, VACCINATION COMPLICATION (Experience mild adverse reaction) had resolved.            No Concomitant medications were reported. No treatment medications were reported.  Patient reported that J AND J vaccine had knocked her out. After taking Moderna on an unspecified date patient experienced mild adverse reaction patient also reported that she felt milder and it was like nothing within 48 hours she felt completely normal. Outcome of full blown fever and teeth chattering was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) 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) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose) had resolved.            No Concomitant product use was reported.  The reporter was calling on behalf of their wife who was the patient and stated that their department of health considered the patient's booster vaccine, an invalid dose. The reporter stated that according to the vaccination site, the lot number 022C21A original MFG Expiry Date was Sep-2021 and it was extended to 23-Dec-2021.  It was reported that the patient was given a booster shot on 02-Nov-2021 from a vial that contained the above lot 022C21A.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I seem to still be experiencing symptoms; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (I seem to still be experiencing 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 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (I seem to still be experiencing symptoms). At the time of the report, VACCINATION COMPLICATION (I seem to still be experiencing symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient had the Moderna Booster 13 days ago and the patient seem to still be experiencing symptoms.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination complication
Clinical narrative: A reaction to PEG; A reaction to PEG; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A reaction to PEG) and ALLERGY TO VACCINE (A reaction to PEG) 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 (A reaction to PEG) and ALLERGY TO VACCINE (A reaction to PEG). At the time of the report, VACCINATION COMPLICATION (A reaction to PEG) and ALLERGY TO VACCINE (A reaction to PEG) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. Patient was prescribed Cetirizine and Benadryl.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.; later I woke up to my entire face and lips swollen and had to go to the ER.; later I woke up to my entire face and lips swollen and had to go to the ER.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.), SWELLING FACE (later I woke up to my entire face and lips swollen and had to go to the ER.) and LIP SWELLING (later I woke up to my entire face and lips swollen and had to go to the ER.) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced URTICARIA (I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.), SWELLING FACE (later I woke up to my entire face and lips swollen and had to go to the ER.) and LIP SWELLING (later I woke up to my entire face and lips swollen and had to go to the ER.). At the time of the report, URTICARIA (I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.), SWELLING FACE (later I woke up to my entire face and lips swollen and had to go to the ER.) and LIP SWELLING (later I woke up to my entire face and lips swollen and had to go to the ER.) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient went to an allergist and they told him that it wasn't caused by the vaccine because it would've happened immediately. Patient took antihistamines and it finally went way.   This case was linked to MOD-2022-461935 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy test, Histamine level increased, Urticaria
Clinical narrative: my second dose and the hives came back immediately; my histamine levels were critically high; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (my second dose and the hives came back immediately) and HISTAMINE LEVEL INCREASED (my histamine levels were critically high) 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 URTICARIA (my second dose and the hives came back immediately) and HISTAMINE LEVEL INCREASED (my histamine levels were critically high). The patient was treated with PREDNISOLONE at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of In the morning and LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at a dose of At night. At the time of the report, URTICARIA (my second dose and the hives came back immediately) and HISTAMINE LEVEL INCREASED (my histamine levels were critically high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: critically high (High) Blood test came back negative for everything on allergies except my histamine levels were critically high..         No concomitant drugs were reported.   This case was linked to MOD-2022-461933 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration, Rash
Clinical narrative: had other side effects including hair loss all with the moderna; had a rash the second day, it started to go away but just woke up and it's spreading/Kinda sore and irritating/It's only on elbow; no rash with first phizer shot and second shot (moderna); This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (had other side effects including hair loss all with the moderna), RASH (had a rash the second day, it started to go away but just woke up and it's spreading/Kinda sore and irritating/It's only on elbow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (no rash with first phizer shot and second shot (moderna)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1). Past adverse reactions to the above products included No adverse reaction with Pfizer.    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 ALOPECIA (had other side effects including hair loss all with the moderna), RASH (had a rash the second day, it started to go away but just woke up and it's spreading/Kinda sore and irritating/It's only on elbow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (no rash with first phizer shot and second shot (moderna)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, ALOPECIA (had other side effects including hair loss all with the moderna) and RASH (had a rash the second day, it started to go away but just woke up and it's spreading/Kinda sore and irritating/It's only on elbow) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (no rash with first phizer shot and second shot (moderna)) had resolved.            No concomitant drug information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I received my second Moderna shot in late January and started have hives in mid February; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I received my second Moderna shot in late January and started have hives in mid February) 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 URTICARIA (I received my second Moderna shot in late January and started have hives in mid February). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (I received my second Moderna shot in late January and started have hives in mid February) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Patient took second Moderna shot in late January and started to have hives in mid February.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.  Patients were administered vaccine after the published expiration date. None of these patients have reported any known symptoms following vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Skin irritation, Urticaria
Clinical narrative: Hives; totally clears the skin and Irritation skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and SKIN IRRITATION (totally clears the skin and Irritation skin) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and SKIN IRRITATION (totally clears the skin and Irritation skin). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown and SKIN IRRITATION (totally clears the skin and Irritation skin) had resolved. Not Provided      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 use were reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm shoulder deltoid muscle) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (Sore left arm shoulder deltoid muscle) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided. The patient received the vaccine in her left arm shoulder deltoid muscle.    This case was linked to MOD-2022-461986 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Sore injection site arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Low grade fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Low grade fever) outcome was unknown.        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 products and treatment information were reported.   This case was linked to MOD-2022-461997, MOD-2022-462001 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: patient experienced a sore left deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (patient experienced a sore left deltoid muscle) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (patient experienced a sore left deltoid muscle). At the time of the report, VACCINATION SITE PAIN (patient experienced a sore left deltoid muscle) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-461983, MOD-2022-461987 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body aches, muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches, muscle pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 002C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced MYALGIA (Body aches, muscle pain) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches, muscle pain) and HEADACHE (Headache) outcome was unknown.            No Concomitant use were reported No Treatment were reported Patient reported that Patient received the booster dose in her left arm shoulder deltoid muscle. Expiration date is not provided and Physician is not listed as a contact in the case   This case was linked to MOD-2022-461983, MOD-2022-461986 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Arm (injection site) is swollen (size of half an orange); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm (injection site) is swollen (size of half an orange)) 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 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION SITE SWELLING (Arm (injection site) is swollen (size of half an orange)). At the time of the report, VACCINATION SITE SWELLING (Arm (injection site) is swollen (size of half an orange)) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Covid-19 vaccine/ vaccine that was administered 5 days after it's expiration  date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine/ vaccine that was administered 5 days after it's expiration  date.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine/ vaccine that was administered 5 days after it's expiration  date.). On 26-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine/ vaccine that was administered 5 days after it's expiration  date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.  The Moderna COVID-19 vaccine was stored in the refrigerator until 26 JAN 2022 and removed from the refrigerator at 8 AM on 26JAN 2022. The vial was punctured and the dose was withdrawn at 8:15 AM on 26 JAN 2022.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.   The patient's past medical history included Exposure to chemical pollution (exposure to Agent Orange) and Open heart surgery. Concurrent medical conditions included Hypertension.  On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) outcome was unknown.  Concomitant medication of the patient was not reported.  The patient received his second vaccine in his left arm shoulder deltoid muscle.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-461985, MOD-2022-462001 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Nausea, Vomiting
Clinical narrative: nauseated/ nauseated again; threw up a little bit/ she threw up again/ second time I threw up; stomach started bothering me; pain off and on through the night; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach started bothering me), ABDOMINAL PAIN UPPER (pain off and on through the night), NAUSEA (nauseated/ nauseated again) and VOMITING (threw up a little bit/ she threw up again/ second time I threw up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine (She took the flu vaccine around September or October of 2021.) in 2021. Past adverse reactions to the above products included No adverse event with flu vaccine.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced ABDOMINAL DISCOMFORT (stomach started bothering me) and ABDOMINAL PAIN UPPER (pain off and on through the night). On 26-Jan-2022, the patient experienced NAUSEA (nauseated/ nauseated again) and VOMITING (threw up a little bit/ she threw up again/ second time I threw up). At the time of the report, ABDOMINAL DISCOMFORT (stomach started bothering me), ABDOMINAL PAIN UPPER (pain off and on through the night), NAUSEA (nauseated/ nauseated again) and VOMITING (threw up a little bit/ she threw up again/ second time I threw up) 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 medication was reported.  The patient had a reaction to the Moderna vaccine. The patient stated she went to the restroom about 1 o'clock at night on 25-Jan-2022. After she used the bathroom, her stomach started bothering her. She had pain off and on through the night.  In morning on 26-Jan-2022, after she ate, she was nauseated and threw up a little bit. While she was on the phone with physician, she got nauseated again, so then she spoke with a nurse. While she was talking to the nurse, she threw up again, a lot more than she did this morning. That was the second time she threw up. She normally did not have a reaction to vaccines.  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031D21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to chemical pollution and Open heart surgery. Concurrent medical conditions included Hypertension.    On 16-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.            Concomitant medication of the patient was not reported.   The patient received his booster dose in his left arm shoulder deltoid muscle.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-461997, MOD-2022-461985 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Severe chronic fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Severe chronic fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-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 FATIGUE (Severe chronic fatigue). At the time of the report, FATIGUE (Severe chronic fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment included antibiotic injection.  After the second vaccination which was in June, the patient had severe chronic fatigue. After treating with antibiotic injection, she got better.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 6 Days after i got my second moderna shot i developed hives exactly as you described; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (6 Days after i got my second moderna shot i developed hives exactly as you described) 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 URTICARIA (6 Days after i got my second moderna shot i developed hives exactly as you described). At the time of the report, URTICARIA (6 Days after i got my second moderna shot i developed hives exactly as you described) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck) and HEADACHE (Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 020B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, the patient experienced MYALGIA (Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 11:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022 at 11:40 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jan-2022 at 11:40 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. Reporter stated that the patient did not experience any adverse reaction after receiving the vaccine. Did the vial undergo any temperature excursions: No temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Rash, Vaccination site reaction
Clinical narrative: Covid arm; it was like a kick in the gutt; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), DEPRESSED MOOD (it was like a kick in the gutt) and RASH (rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), DEPRESSED MOOD (it was like a kick in the gutt) and RASH (rash). At the time of the report, VACCINATION SITE REACTION (Covid arm), DEPRESSED MOOD (it was like a kick in the gutt) and RASH (rash) outcome was unknown.            No Concomitant product use was reported.  The patient got Moderna as a booster, it was fine and then got a Covid arm and a rash. The patient felt like a kick in the gut.  No treatment information was provided.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Booster dose given to a 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 14 year old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (Batch number EW0185,Dose 1) on 17-Jun-2021, pfizer (Batch Number FA6780 andDose 2) on 08-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer and pfizer.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 14 year old). On 26-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Maternal exposure during pregnancy, Pyrexia
Clinical narrative: Chills; Headache; Fever; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient (gravida 5, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 immunisation.    The patient's past medical history included COVID-19 on 25-Mar-2020, Miscarriage and Elective abortion (one past pregnancy, 1 abortion). Concurrent medical conditions included Multigravida. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 06-Apr-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 20-Feb-2021 and the estimated date of delivery was 27-Nov-2021. On 06-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) beginning at sixth week of the pregnancy.  On 06-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 08-Apr-2021, CHILLS (Chills) had resolved. On 09-Apr-2021, PYREXIA (Fever) had resolved. On 13-Apr-2021, HEADACHE (Headache) had resolved.            No treatment medication was reported. EDD was given as Nov-2021.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now) 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 31-May-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 10-Jun-2021, the patient experienced URTICARIA (Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) ongoing since an unknown date for Adverse event, at a dose of 10 milligram once a day. At the time of the report, URTICARIA (Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was just at the start now with the hives.  No concomitant medication reported.   This case was linked to MOD-2022-462072 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria, Vaccination complication
Clinical narrative: Rashes all over my body was getting extremely itchy; I hope our hives eventually go away; Same side effects; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes all over my body was getting extremely itchy), URTICARIA (I hope our hives eventually go away) and VACCINATION COMPLICATION (Same side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rashes all over my body was getting extremely itchy), URTICARIA (I hope our hives eventually go away) and VACCINATION COMPLICATION (Same side effects). At the time of the report, RASH PRURITIC (Rashes all over my body was getting extremely itchy), URTICARIA (I hope our hives eventually go away) and VACCINATION COMPLICATION (Same side effects) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had second dose of Moderna in mid June. Patient's doctor prescribed steroid pills and cream which was yet to be taken by the patient.  No concomitant medications were reported. No other treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Hypertension
Clinical narrative: Stabbing heart pain; Huge blood pressure increase; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Stabbing heart pain) and HYPERTENSION (Huge blood pressure increase) 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 CHEST PAIN (Stabbing heart pain) and HYPERTENSION (Huge blood pressure increase). At the time of the report, CHEST PAIN (Stabbing heart pain) and HYPERTENSION (Huge blood pressure increase) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) huge blood pressure increase.         Patient had stated that he was an one of the young men who have experienced events and his specialist had told him that he should never had gotten it.  No concomitant information was reported. No treatment information was reported.