chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-513803 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might had been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment information was provided.   This case was linked to MOD-2022-513803 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the digital data loggers and freezers expired before they were re-calibrated. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures.   The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21 A, 064H21A, 024M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially stored in the refrigerator on 21-Apr-2022. The vial didn't undergone any temperature excursion.  No treatment medications was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Eosinophilia, Eye swelling, Swelling, Swelling face
Clinical narrative: Swelling of his eyes 2 months after booster; Swelling of face 2 months after booster; Swelling of neck 2 months after booster; Diagnosed with Hypereosinophilia syndrome 2 months after booster; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling of his eyes 2 months after booster), SWELLING FACE (Swelling of face 2 months after booster), SWELLING (Swelling of neck 2 months after booster) and EOSINOPHILIA (Diagnosed with Hypereosinophilia syndrome 2 months after booster) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 047B21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy ((Nose Congestion), took OTC medications for allergies.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, the patient experienced EYE SWELLING (Swelling of his eyes 2 months after booster), SWELLING FACE (Swelling of face 2 months after booster), SWELLING (Swelling of neck 2 months after booster) and EOSINOPHILIA (Diagnosed with Hypereosinophilia syndrome 2 months after booster). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form. At the time of the report, EYE SWELLING (Swelling of his eyes 2 months after booster), SWELLING FACE (Swelling of face 2 months after booster), SWELLING (Swelling of neck 2 months after booster) and EOSINOPHILIA (Diagnosed with Hypereosinophilia syndrome 2 months after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medication reported.  Patient recently visited physician and they were in the process of diagnosing and finding treatment. Patient took Over the counter Claritin as treatment medication.   This case was linked to MOD-2022-572757 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose: On 05-FEB-2021, 2nd shot: On 20-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose: On 05-FEB-2021, 2nd shot: On 20-APR-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Nose Congestion and from time to time he took OTC medications for allergies.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose: On 05-FEB-2021, 2nd shot: On 20-APR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose: On 05-FEB-2021, 2nd shot: On 20-APR-2021) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-572755 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 at 11:30 as dose 1, single (Lot number: EN6202), in right arm and on 22Mar2021 at 15:00 as dose 2, single (Lot number: Er8727) at the age of 59 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine manufacturer unknown (COVID-19 VACCINE MODERNA), on 13Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 013F21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Prior sarcoidosis" (unspecified if ongoing); "prediabetic" (unspecified if ongoing), notes: prediabetic taking Metformin to control A1C.; "known allergies: shellfish" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, stop date: 29Apr2022; VASCEPA, stop date: 29Apr2022; CRESTOR, stop date: 29Apr2022; ZETIA, stop date: 29Apr2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022, outcome "not recovered" and all described as "04May2022 but PCR positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive; (04May2022) Negative, notes: Rapid antigen test negative but PCR positive; (09May2022) Positive, notes: RAT positive on 09May2022; (17May2022) Positive. Therapeutic measures were taken as a result of Covid-19. The patient was treated with Paxlovid from 29Apr2022 to 04May2022 for Covid -19. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 at 11:30 as dose 1, single (Lot number: EN6202), in right arm and on 22Mar2021 at 15:00 as dose 2, single (Lot number: Er8727) at the age of 59 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine manufacturer unknown (COVID-19 VACCINE MODERNA), on 13Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 013F21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Prior sarcoidosis" (unspecified if ongoing); "prediabetic" (unspecified if ongoing), notes: prediabetic taking Metformin to control A1C.; "known allergies: shellfish" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, stop date: 29Apr2022; VASCEPA, stop date: 29Apr2022; CRESTOR, stop date: 29Apr2022; ZETIA, stop date: 29Apr2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022, outcome "not recovered" and all described as "04May2022 but PCR positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive; (04May2022) Negative, notes: Rapid antigen test negative but PCR positive; (09May2022) Positive, notes: RAT positive on 09May2022; (17May2022) Positive. Therapeutic measures were taken as a result of Covid-19. The patient was treated with Paxlovid from 29Apr2022 to 04May2022 for Covid -19. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022; gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were initially stored in the refrigerator on 22-Apr-2022.  It was states that gave a 2nd booster dose of the Moderna Covid-19 Vaccine that was past the beyond use date. Vial did not undergo any temperature excursion. No treatment medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Inflammation, Pain in extremity
Clinical narrative: hurts to walk; inflammation in the body; pain in knees,pain in ankles,it is unusual for left knee to hurt; right arm pain,pain in bottom of feet and ankles; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles), GAIT DISTURBANCE (hurts to walk), INFLAMMATION (inflammation in the body), ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). On 17-Apr-2022, the patient experienced PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles) and ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt). On an unknown date, the patient experienced GAIT DISTURBANCE (hurts to walk) and INFLAMMATION (inflammation in the body). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles), GAIT DISTURBANCE (hurts to walk), INFLAMMATION (inflammation in the body), ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt), CHILLS (chills) and PYREXIA (fever) had not resolved.            No concomitant medications reported. Treatment also included 15 minutes of exercise a day to help the pain and staying hydrated. Patient called the doctor who said that the vaccine attacks inflammatory system.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: hurts to walk; inflammation in the body; pain in knees,pain in ankles,it is unusual for left knee to hurt; right arm pain,pain in bottom of feet and ankles; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles), GAIT DISTURBANCE (hurts to walk), INFLAMMATION (inflammation in the body), ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). On 17-Apr-2022, the patient experienced PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles) and ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt). On an unknown date, the patient experienced GAIT DISTURBANCE (hurts to walk) and INFLAMMATION (inflammation in the body). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles), GAIT DISTURBANCE (hurts to walk), INFLAMMATION (inflammation in the body), ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt), CHILLS (chills) and PYREXIA (fever) had not resolved.            No concomitant medications reported. Treatment also included 15 minutes of exercise a day to help the pain and staying hydrated. Patient called the doctor who said that the vaccine attacks inflammatory system.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nasal congestion, Nausea
Clinical narrative: Cough; Nasal congestion; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 017E21A, 012M20A and 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Urticaria aquagenic. Concurrent medical conditions included Anxiety and Postural orthostatic tachycardia syndrome. Concomitant products included CYCLOSPORINE, AMITRIPTYLINE, TOPIRAMATE and CLONAZEPAM for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient experienced COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) had not resolved.            It was reported as patient had no allergy.  The co suspect drug was reported as unknown (manufacturer Pfizer), Batch/lot number: GA6765, Start date: 13-MAY-2022, stop date: 17-MAY-2022, Indication: Treatment of COVID-19.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Inappropriate schedule of product administration, Vaccination site pain, Vaccination site rash
Clinical narrative: tightness of her chest; sore arm at the site of injection; swollen arm at the site of injection; red rash in the site of injection; headache; Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (tightness of her chest), VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection), VACCINATION SITE RASH (red rash in the site of injection) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 044A21A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Cancer. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), MECOBALAMIN (ELGIN), CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced CHEST DISCOMFORT (tightness of her chest), VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection), VACCINATION SITE RASH (red rash in the site of injection), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.). On 30-Nov-2021, HEADACHE (headache) had resolved. On 06-Dec-2021, VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection) and VACCINATION SITE RASH (red rash in the site of injection) had resolved. On 13-Dec-2021, CHEST DISCOMFORT (tightness of her chest) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.) outcome was unknown.            It was reported that with 1st and 2nd dose patient did not experienced any symptoms. After 3rd dose patient experienced sore and swollen arm with a red rash in the site of injection for 1 week, headache for a couple of days, and tightness in her chest intermittently 1or 2 weeks. It was unknown if AE cause patient to seek medical care. Treatment information were unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: tightness of her chest; sore arm at the site of injection; swollen arm at the site of injection; red rash in the site of injection; headache; Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (tightness of her chest), VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection), VACCINATION SITE RASH (red rash in the site of injection) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 044A21A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Cancer. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), MECOBALAMIN (ELGIN), CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced CHEST DISCOMFORT (tightness of her chest), VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection), VACCINATION SITE RASH (red rash in the site of injection), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.). On 30-Nov-2021, HEADACHE (headache) had resolved. On 06-Dec-2021, VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection) and VACCINATION SITE RASH (red rash in the site of injection) had resolved. On 13-Dec-2021, CHEST DISCOMFORT (tightness of her chest) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.) outcome was unknown.            It was reported that with 1st and 2nd dose patient did not experienced any symptoms. After 3rd dose patient experienced sore and swollen arm with a red rash in the site of injection for 1 week, headache for a couple of days, and tightness in her chest intermittently 1or 2 weeks. It was unknown if AE cause patient to seek medical care. Treatment information were unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: experienced non stop numb lips since his first vaccine; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (experienced non stop numb lips since his first vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (experienced non stop numb lips since his first vaccine). At the time of the report, HYPOAESTHESIA ORAL (experienced non stop numb lips since his first vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Patient did not report any other adverse reactions or side effects and also not having a Physician. No treatment information was provided by the reporter.   This case was linked to MOD-2022-573240 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Inappropriate schedule of product administration, Muscle tightness, Vaccination site movement impairment
Clinical narrative: Patient says lips are still numb.; Extremely tight tense muscles in his left arm; Could not lift his arm above his left shoulder; First Moderna Covid-19 vaccine on 05-Feb-2021 and second Moderna Covid-19 vaccine on 08-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (Patient says lips are still numb.), MUSCLE TIGHTNESS (Extremely tight tense muscles in his left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift his arm above his left shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 05-Feb-2021 and second Moderna Covid-19 vaccine on 08-Mar-2022) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 032M24A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2022, the patient experienced HYPOAESTHESIA ORAL (Patient says lips are still numb.), MUSCLE TIGHTNESS (Extremely tight tense muscles in his left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift his arm above his left shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 05-Feb-2021 and second Moderna Covid-19 vaccine on 08-Mar-2022). At the time of the report, HYPOAESTHESIA ORAL (Patient says lips are still numb.) had not resolved and MUSCLE TIGHTNESS (Extremely tight tense muscles in his left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift his arm above his left shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 05-Feb-2021 and second Moderna Covid-19 vaccine on 08-Mar-2022) outcome was unknown.            Concomitant medication details were not provided. It was reported that the patient had extremely tight tense muscles in the left arm, could not lift the arm above left shoulder. Patient said lips were still numb. The patient did not receive Moderna COVID-19 vaccine booster dose and the patient did not have a physician. Treatment information was not provided.   This case was linked to MOD-2022-573137 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Neck pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Neck pain), CHILLS (Chills) and ARTHRALGIA (Shoulder pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE). In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NECK PAIN (Neck pain), CHILLS (Chills) and ARTHRALGIA (Shoulder pain). At the time of the report, NECK PAIN (Neck pain), CHILLS (Chills) and ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Unknown Date in 2022 patient received booster vaccine. Action taken with Humira was unknown, dechallenge was not applicable for events Neck pain, Chills and Shoulder pain. The reporter's causality for co-suspect Humira for the events Neck pain, Chills and Shoulder pain was not provided. No treatment information was provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Feeling cold, Gait inability
Clinical narrative: could not walk/could not move; was shaking; felt cold; felt terrible; had chills/ teeth were chattering; had a temperature; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible) and CHILLS (had chills/ teeth were chattering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis and had no history relating to mentioned AE and both Acute and chronic illnesses at the time of vaccination.  Previously administered products included for Pneumonia: PNEUMOCOCCAL VACCINE in October 2021; for Flu: FLU [INFLUENZA VACCINE] in October 2021. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE] and PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) 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. In 2021, the patient experienced GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible), CHILLS (had chills/ teeth were chattering) and PYREXIA (had a temperature). In 2021, GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible), CHILLS (had chills/ teeth were chattering) and PYREXIA (had a temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: had a temperature had a temperature.   mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Reporter stated that she had the adverse events after getting the 1st dose of the Moderna Covid-19 vaccine. These went on for 3 days and they resolved. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 010M2AA). On 21-Aug-2021, received 1st booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 053E21A). On 09-May-2022, received 2nd booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 056M21A). Treatment medications were not provided.   This case was linked to MOD-2022-573190 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: could not walk/could not move; was shaking; felt cold; felt terrible; had chills/ teeth were chattering; had a temperature; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible) and CHILLS (had chills/ teeth were chattering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis and had no history relating to mentioned AE and both Acute and chronic illnesses at the time of vaccination.  Previously administered products included for Pneumonia: PNEUMOCOCCAL VACCINE in October 2021; for Flu: FLU [INFLUENZA VACCINE] in October 2021. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE] and PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) 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. In 2021, the patient experienced GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible), CHILLS (had chills/ teeth were chattering) and PYREXIA (had a temperature). In 2021, GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible), CHILLS (had chills/ teeth were chattering) and PYREXIA (had a temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: had a temperature had a temperature.   mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Reporter stated that she had the adverse events after getting the 1st dose of the Moderna Covid-19 vaccine. These went on for 3 days and they resolved. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 010M2AA). On 21-Aug-2021, received 1st booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 053E21A). On 09-May-2022, received 2nd booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 056M21A). Treatment medications were not provided.   This case was linked to MOD-2022-573190 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired Moderna COVID Vaccine as a second booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired Moderna COVID Vaccine as a second booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient's past medical history included Iron deficiency. Concurrent medical conditions included Chronic kidney disease stage 3 (Stage 3B Chronic Kidney Disease) since 2021.   On 21-May-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milligram. On 21-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired Moderna COVID Vaccine as a second booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired Moderna COVID Vaccine as a second booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. It was reported that the expired Moderna COVID Vaccine that was administered to two patient as a second booster dose on 21 May 2021 about 30 minutes ago. Possible Stage 3B Chronic Kidney Disease after a Moderna COVID-19 vaccine No treatment information was provided by the reporter.   This case was linked to MOD-2022-572850.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Finger pain; COVID vaccine issue Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (COVID vaccine issue Low grade temperature) and PAIN IN EXTREMITY (Finger pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2021, the patient experienced PYREXIA (COVID vaccine issue Low grade temperature). On an unknown date, the patient experienced PAIN IN EXTREMITY (Finger pain). At the time of the report, PYREXIA (COVID vaccine issue Low grade temperature) and PAIN IN EXTREMITY (Finger pain) outcome was unknown.            Concomitant products were not provided. Treatment medications were not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Miliaria, Rash, Rash pruritic
Clinical narrative: allergic contact dermatitis; Got a second rash; it didn't itch until 2 or 3 days later and lasted for; got a rash, like overheated/broke out on chest| left arm| collarbone| a little bit on shoulder| base of neck| started to hit the right arm/second rash; got a rash like overheat; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MILIARIA (got a rash like overheat), DERMATITIS CONTACT (allergic contact dermatitis), RASH (got a rash, like overheated/broke out on chest| left arm| collarbone| a little bit on shoulder| base of neck| started to hit the right arm/second rash), RASH (Got a second rash) and RASH PRURITIC (it didn't itch until 2 or 3 days later and lasted for) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 038B21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Rash all over (Patent have a history of rashes on her full body.), Heat rash and Rash on leg.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MILIARIA (got a rash like overheat), RASH (got a rash, like overheated/broke out on chest| left arm| collarbone| a little bit on shoulder| base of neck| started to hit the right arm/second rash) and RASH PRURITIC (it didn't itch until 2 or 3 days later and lasted for). In April 2022, the patient experienced RASH (Got a second rash). On an unknown date, the patient experienced DERMATITIS CONTACT (allergic contact dermatitis). The patient was treated with TRIAMCINOLONE for Rash, at an unspecified dose and frequency; HYDROXYZINE HCL in April 2022 for Antihistamine therapy, at a dose of 25 milligram and DESOXIMETASONE in April 2022 for Antihistamine therapy, at an unspecified dose and frequency. At the time of the report, MILIARIA (got a rash like overheat), DERMATITIS CONTACT (allergic contact dermatitis) and RASH (Got a second rash) outcome was unknown and RASH (got a rash, like overheated/broke out on chest| left arm| collarbone| a little bit on shoulder| base of neck| started to hit the right arm/second rash) and RASH PRURITIC (it didn't itch until 2 or 3 days later and lasted for) had resolved.            Concomitant medication included Triamcinolone cream 0.1 %. It was reported that rash did not itch until 2 or 3 days later and lasted for about a month  Dermatologist prescribed hydroxyzine hcl 25mg tablet, antihistamine and desoximetasone 0.25% cream an diagnosed with allergic contact dermatitis.