chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness
Clinical narrative: immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021; flu like reactions; weakness; chills; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills), FATIGUE (exhaustion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 021L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Triple vessel bypass graft. Concurrent medical conditions included Immunocompromised.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion). On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills), FATIGUE (exhaustion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021) outcome was unknown.            Concomitant drugs were not reported. It was reported that events usually started later the same day as or the next day after receiving third dose. Treatment information include took Aspirin or Tylenol for their symptoms.   This case was linked to MOD-2022-557622, MOD-2022-557547 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021; flu like reactions; weakness; chills; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills), FATIGUE (exhaustion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 021L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Triple vessel bypass graft. Concurrent medical conditions included Immunocompromised.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion). On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills), FATIGUE (exhaustion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received 3rd dose on 2-Oct-2021 while 2nd dose on 13-Feb-2021) outcome was unknown.            Concomitant drugs were not reported. It was reported that events usually started later the same day as or the next day after receiving third dose. Treatment information include took Aspirin or Tylenol for their symptoms.   This case was linked to MOD-2022-557622, MOD-2022-557547 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: lower dose administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (lower dose administered) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   In February 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In February 2022, the patient experienced ACCIDENTAL UNDERDOSE (lower dose administered). At the time of the report, ACCIDENTAL UNDERDOSE (lower dose administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: elevated anxiety overnight; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (elevated anxiety overnight) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (Patient was diagnosed and was on medication for Anxiety.).    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (elevated anxiety overnight). At the time of the report, ANXIETY (elevated anxiety overnight) outcome was unknown.            Patient was on medication for anxiety. No treatment medications were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Influenza like illness
Clinical narrative: Fell; flu like reactions including chills, exhaustion, and weakness; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell) and INFLUENZA LIKE ILLNESS (flu like reactions including chills, exhaustion, and weakness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and RA (Rheumatoid arthritis).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FALL (Fell) and INFLUENZA LIKE ILLNESS (flu like reactions including chills, exhaustion, and weakness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FALL (Fell) and INFLUENZA LIKE ILLNESS (flu like reactions including chills, exhaustion, and weakness) outcome was unknown.     No relevant concomitant medications were reported. Patient took aspirin or Tylenol for their symptoms.   This case was linked to MOD-2022-557675, MOD-2022-557548 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her booster dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her 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 reported. On 02 May 2022, the vial was initially stored in the refrigerator. The vial did not underwent any temperature excursions. After first dose the patient did not experience any other side effects or adverse reactions.The Nurse was not aware of any side effects after second dose and first booster dose.No other adverse events are reported after second booster.No treatment information was provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Product temperature excursion issue
Clinical narrative: Vial did under went a temperature excursion; Patient received  a Dose administered  greater than 12 hours post puncture; Patient received a second booster  and are not immunocompromised or over 50 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received  a Dose administered  greater than 12 hours post puncture), EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not immunocompromised or over 50 years of age) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vial did under went a temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     The patient had no allergies. The patient never had COVID-19 positive test or diagnosis. The patient had no acute or chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: janssen for primary series and booster (primary series and booster). Past adverse reactions to the above products included No adverse event with janssen for primary series and booster.    On 03-May-2022 at 11:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022 at 11:15 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received  a Dose administered  greater than 12 hours post puncture). 03-May-2022 at 11:15 AM, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not immunocompromised or over 50 years of age). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial did under went a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received  a Dose administered  greater than 12 hours post puncture), EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not immunocompromised or over 50 years of age) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vial did under went a temperature excursion) 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 patient was not immunocompromised. Other vaccines given within 1 month prior to Moderna vaccine reported as no. The adverse event did not cause patient to go for office visit, urgent care, ER and hospital. The vial was initially stored in the refrigerator on 29 Apr 2022 and was first punctured  on 29 Apr 2022 at 8AM. The vial was stored in fridge post puncture and did undergo temperature excursion. The vial was exposed to room temperature range (8 to 25 degree Celsius or  46 to 77 degree F) for 3 hours. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: have a very bad itch sinch the shot.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (have a very bad itch sinch the shot.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (have a very bad itch sinch the shot.). At the time of the report, PRURITUS (have a very bad itch sinch the shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported patient went to doctor and took all the creams made. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Currently has urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Currently has urinary tract infection) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Currently has urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Currently has urinary tract infection) had not resolved.            No concomitant medications were reported. Treatment medication include Antibiotics.   This case was linked to MOD-2021-030725 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on Back, Neck, and Scalp/rash over my back and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on Back, Neck, and Scalp/rash over my back and arms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient was very healthy.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (primary dose 2) and Pfizer COVID-19 vaccine (primary dose 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced RASH (Rash on Back, Neck, and Scalp/rash over my back and arms). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. In March 2022, RASH (Rash on Back, Neck, and Scalp/rash over my back and arms) had resolved.            The patient was not on any maintenance medications.  The patient visited a dermatologist who prescribed topical Cortisone. Dermatologist also prescribed a palliative cream to manage the symptoms. About five months later, the rash subsided.  The patient reported that he did not make the connection that the rash was due to the booster shot.   This case was linked to MOD-2022-557977 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Follow-up information was received on 03-May-2022, treatment medication was added.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on Back, Neck, and Scalp/rash over my back and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on Back, Neck, and Scalp/rash over my back and arms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient was very healthy.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (primary dose 2) and Pfizer COVID-19 vaccine (primary dose 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced RASH (Rash on Back, Neck, and Scalp/rash over my back and arms). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. In March 2022, RASH (Rash on Back, Neck, and Scalp/rash over my back and arms) had resolved.            The patient was not on any maintenance medications.  The patient visited a dermatologist who prescribed topical Cortisone. Dermatologist also prescribed a palliative cream to manage the symptoms. About five months later, the rash subsided.  The patient reported that he did not make the connection that the rash was due to the booster shot.   This case was linked to MOD-2022-557977 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Follow-up information was received on 03-May-2022, treatment medication was added.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again. Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) and INJECTION SITE RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A and 020F21A) for COVID-19 vaccination. Patient was very healthy and was not on any maintenance medications.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (Received 2 primary doses of Pfizer COVID-19 vaccine) and Pfizer COVID-19 vaccine (Received 2 primary doses of Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) and INJECTION SITE RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.). The patient was treated with CORTISONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) and INJECTION SITE RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) had not resolved. No Concomitant product use was reported. The patient called to report that a few days after the 2nd booster, the patient had rash that came back again worst this time than the first time and was all over the body and injection site. The patient visited a dermatologist who prescribed Topical Cortisone. The patient reported that their dermatologist was at a loss and offered a palliative cream to manage the symptoms. This case was linked to MOD-2022-557775 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Significant Follow up was received: Case narrative was updated. Treatment information was added in the narrative.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again. Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) and INJECTION SITE RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A and 020F21A) for COVID-19 vaccination. Patient was very healthy and was not on any maintenance medications.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (Received 2 primary doses of Pfizer COVID-19 vaccine) and Pfizer COVID-19 vaccine (Received 2 primary doses of Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) and INJECTION SITE RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.). The patient was treated with CORTISONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) and INJECTION SITE RASH (Rash came back worst all over body and injection site after the 2nd booster, I took second Moderna Booster shot and the symptoms have erupted again.) had not resolved. No Concomitant product use was reported. The patient called to report that a few days after the 2nd booster, the patient had rash that came back again worst this time than the first time and was all over the body and injection site. The patient visited a dermatologist who prescribed Topical Cortisone. The patient reported that their dermatologist was at a loss and offered a palliative cream to manage the symptoms. This case was linked to MOD-2022-557775 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Significant Follow up was received: Case narrative was updated. Treatment information was added in the narrative.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Pain in extremity, Skin discolouration
Clinical narrative: still red from shoulder to elbow; now it is pink; hurting in the shoulder; Arm really hurt, aching from shoulder to finger; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (now it is pink), ERYTHEMA (still red from shoulder to elbow), ARTHRALGIA (hurting in the shoulder) and PAIN IN EXTREMITY (Arm really hurt, aching from shoulder to finger) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (third dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, the patient experienced ARTHRALGIA (hurting in the shoulder) and PAIN IN EXTREMITY (Arm really hurt, aching from shoulder to finger). On 02-May-2022, the patient experienced SKIN DISCOLOURATION (now it is pink). On an unknown date, the patient experienced ERYTHEMA (still red from shoulder to elbow). At the time of the report, SKIN DISCOLOURATION (now it is pink), ERYTHEMA (still red from shoulder to elbow) and ARTHRALGIA (hurting in the shoulder) had not resolved and PAIN IN EXTREMITY (Arm really hurt, aching from shoulder to finger) outcome was unknown.            No concomitant medications were reported.  It was reported that after receiving second booster dose, that night patient hurt her arm really, aching from shoulder down to finger. Patient stated that she thinks she received a higher dosage, or an elderly shot from the pharmacist. Patient reported that she did not have these reactions from the first 2 Moderna COVID-19 doses.  No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: given 3rd dose as full dose, non immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (given 3rd dose as full dose, non immunocompromised) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ACCIDENTAL OVERDOSE (given 3rd dose as full dose, non immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (given 3rd dose as full dose, non immunocompromised) outcome was unknown.            No concomitant medication was provided.  Patient received 3rd shot last Oct-2021 which was a full shot. A week later after getting the the full shot, they were told that the booster dose was just supposed to be half a dose.   There was not mention that patient was immunocompromised.   It was reported that, patient was now 7 months away from getting her the 3rd dose (full dose) and patient wants to know what was the best thing for patient to do.   No treatment information was provided.   This case was linked to MOD-2021-009523, MOD-2021-029511 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Had arm pain after moderna (couldn't move it fully); Had arm pain after moderna (couldn't move it fully); This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Had arm pain after moderna (couldn't move it fully)) and PAIN IN EXTREMITY (Had arm pain after moderna (couldn't move it fully)) 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 Drug use for unknown indication: PFIZER  COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER  COVID-19 VACCINE.    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 MOBILITY DECREASED (Had arm pain after moderna (couldn't move it fully)) and PAIN IN EXTREMITY (Had arm pain after moderna (couldn't move it fully)). At the time of the report, MOBILITY DECREASED (Had arm pain after moderna (couldn't move it fully)) and PAIN IN EXTREMITY (Had arm pain after moderna (couldn't move it fully)) had resolved.            No concomitant medication information was provided. Patient received two boosters.  Patient stated that there was no issues after vaccination. Patient thought that his/her body was used to the jabs now and stated that patient would rather had side effects than Covid. Patient also travelled regularly union and 3 jabs were often required. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022; Administered with an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 04-May-2022, one patient was administered expired booster dose of Moderna Covid-19 vaccine.  The vial was initially stored in refrigerator on 03-May-2022 at 11am and the vial did not undergo any temperature excursions.  No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Live follow up received contains Significant information of Updated details about the expired vial received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Immune system disorder, Nasopharyngeal swab, Rash
Clinical narrative: SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak; My immune system has not returned to normal yet; I still have a severe rash; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak), IMMUNE SYSTEM DISORDER (My immune system has not returned to normal yet) and RASH (I still have a severe rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose Number 1, Batch/Lot No EW0150, Location of injection: Left arm, vaccine Administration Time: 03:45 PM) on 01-Apr-2021, Pfizer (On 22-Apr-2021 at 03:45 PM, Second dose, Batch number: EW0164 and Anatomical Location: Left arm.) on 22-Apr-2021. Past adverse reactions to the above products included Allergy with Pfizer; and No adverse event with Pfizer.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak), IMMUNE SYSTEM DISORDER (My immune system has not returned to normal yet) and RASH (I still have a severe rash). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency. At the time of the report, ECZEMA (SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak), IMMUNE SYSTEM DISORDER (My immune system has not returned to normal yet) and RASH (I still have a severe rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, Nasopharyngeal swab: negative (Negative) Negative.         It was reported that the patient received booster dose of Moderna in January of 2022 but that also caused eczema outbreak (patient  was told to expect this). Patient immune system has not returned to normal yet. Patient still have a severe rash.  Concomitant medications details were not reported by the reporter.  Patient received bed ointment as an corrective treatment as prescribed by the doctor.  Device Date was reported as 27-Apr-2022.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Oropharyngeal pain
Clinical narrative: sore throat; anorexia; feel sick again; Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (anorexia), MALAISE (feel sick again), FATIGUE (Fatigue) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Past drug history reaction- Allergy.).    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (anorexia), MALAISE (feel sick again), FATIGUE (Fatigue) and HEADACHE (headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-Apr-2022 to 20-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (anorexia), MALAISE (feel sick again), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.            Concomitant medication was not reported. Patient got sick after full course of Paxlovid. Patient took Paxlovid for five days, got better immediately and seven days after completing course, felt sick again, worse than initial symptoms of COVID.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of covid-19. Adverse event After taking the full course of Paxlovid and testing negative, my symptoms (and positive antigen test results) returned on day +5 after taking the final dose (day 0). Anti viral details Product: COVID 19 Treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Feeling abnormal, Headache, Hypertension
Clinical narrative: I have a strange feeling that I am going to suffer a cardiac arrest; I never have felt so unwell; I have trouble to breathe; I feel that I have blood pressure high; hyperventilation; I have headache every night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 , MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I have a strange feeling that I am going to suffer a cardiac arrest"; MALAISE (non-serious), outcome "unknown", described as "I never have felt so unwell"; DYSPNOEA (non-serious), outcome "unknown", described as "I have trouble to breathe"; HYPERTENSION (non-serious), outcome "unknown", described as "I feel that I have blood pressure high"; HYPERVENTILATION (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "I have headache every night". Relevant laboratory tests and procedures are available in the appropriate section. The third dose, patient never have felt so unwell. This was the 18th day after vaccine, had trouble to breathe, felt that had blood pressure high. Sometimes, had a strange feeling that he was going to suffer a cardiac arrest, a really weird thing like some sort of hyperventilation. patient want to know if it was normal things happened or was vaccinated with a poor dose or your vaccines do not work, had headache every night. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hyperventilation, Malaise
Clinical narrative: I have a strange feeling that I am going to suffer a cardiac arrest; I never have felt so unwell; I have trouble to breathe; I feel that I have blood pressure high; hyperventilation; I have headache every night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 , MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I have a strange feeling that I am going to suffer a cardiac arrest"; MALAISE (non-serious), outcome "unknown", described as "I never have felt so unwell"; DYSPNOEA (non-serious), outcome "unknown", described as "I have trouble to breathe"; HYPERTENSION (non-serious), outcome "unknown", described as "I feel that I have blood pressure high"; HYPERVENTILATION (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "I have headache every night". Relevant laboratory tests and procedures are available in the appropriate section. The third dose, patient never have felt so unwell. This was the 18th day after vaccine, had trouble to breathe, felt that had blood pressure high. Sometimes, had a strange feeling that he was going to suffer a cardiac arrest, a really weird thing like some sort of hyperventilation. patient want to know if it was normal things happened or was vaccinated with a poor dose or your vaccines do not work, had headache every night. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Retinal detachment
Clinical narrative: got his retina detached; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization), for COVID-19 immunization. The following information was reported: RETINAL DETACHMENT (medically significant), outcome "not recovered", described as "got his retina detached". Therapeutic measures were taken as a result of retinal detachment. Additional information: The reporter states that the reporter has a friend who got a dose of the Pfizer Covid 19 vaccine and got his retina detached, she further shares that they had to fly to (State name withheld) to get it reattached. The reporter asking for information regarding retinal dettachment and/or retinal problems being reported as adverse events when taking the vaccine. Reporter also states that reporter himself has not experienced any problems with the vaccine. Is report related to a study or programme: No. The reporter states a patient reporter knows got a detached retina in patient eye when patient got the booster. Reporter states that reporter doesn't know if the guy was joking or not since people make covid jokes all the time, but he said that was a side effects of the booster shot. The guy was on vacation and had to be flown home and have emergency surgery on patient eye, they fixed it but then 2 weeks later it detached again. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Diabetic ketoacidosis, Pancreatitis, Renal failure
Clinical narrative: Pancreatitis; kidney failure; Diabetes Ketoacidosis; legal blindness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Birth control" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Product: COVID 19, Brand: Pfizer,, Lot unknown reason: Unable to locate or read the details, Administration date: Oct2021, Vaccine location: Left arm), administration date: Oct2021, for COVID-19 immunization. The following information was reported: DIABETIC KETOACIDOSIS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "Diabetes Ketoacidosis"; PANCREATITIS (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae"; RENAL FAILURE (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "kidney failure"; BLINDNESS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "legal blindness". The patient was hospitalized for pancreatitis (hospitalization duration: 16 day(s)); for renal failure, diabetic ketoacidosis, blindness (hospitalization duration: 16 day(s)). The events "pancreatitis", "kidney failure", "diabetes ketoacidosis" and "legal blindness" required emergency room visit. Therapeutic measures were taken as a result of pancreatitis, renal failure, diabetic ketoacidosis, blindness.  Clinical course: There was no other vaccine in four weeks. Other medications in two weeks for birth control. Patient was hospitalized with resulting dialysis, vision changes resulting in legal blindness. Patient was hospitalized for 16 days. The patient was recovered with lasting effects. There was treatment for AE included hospitalization, dialysis, insulin therapy. There was no COVID prior vaccination. There was no COVID tested post vaccination. There was no known allergies. There was no other medical history prior to adverse reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.