chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The nurse reported that the patient (unknown patient) was administered an expired dose of Bexsero vaccine on the day of reporting. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: possible late 2nd dose, longer than 6 month interval; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The case was received from agency information request via sales representative. The reporter reported that possible late 2nd dose of Shingrix on a longer than 6 months interval . The sales representative did not include any adverse event. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was processed in worst approach, as there is limited information due which incomplete course of vaccination was coded as event and for the vaccination details follow-up clarification request was raised.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Kinrix to an 11 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. In February 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The licensed practical nurse called in to inquired how to proceed or the patient need to be vaccinated with a Boostrix. No additional details were provided. The reporter did not consent to follow-up. The reporter reported that the patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2018 and is late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th September 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: A pharmacist reported that the patient was late for 2nd dose of Shingrix. The reporter did not had the lot/ expiry date. The reporter consented to follow-up via email. Additional supportive information: Till the time reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient has received an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The nurse called to report that on the day of reporting, the patient had received an expired Bexsero vaccine. The expiry date was reported as January 2022 but documented as 31st January 2022 upon search. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient had already received 1 dose as an infant; Administered  Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-Aug-2022 Reporter's ccomment: The certified medical assistant stated that the patient was supposed to get Menveo but was inadvertently administered  Bexsero instead on the day of reporting.  The reporter stated that the patient had already received 1 dose of Bexsero as an infant, and the dose on the day of reporting was a double dose. When asked if the patient received both doses of the Bexsero in the past, and if this was a 3rd dose, she was not able to confirm. The reporter tried to call the health care professional back to confirm the patient received Bexsero as an infant, but unable to reach her.  The reporter consented to follow-up via postal. Additional supportive information: The patient had already received 1 dose of Bexsero at inappropriate age, which led to inappropriate age at vaccine administration. The patient received was supposed to get Menveo but was inadvertently administered  Bexsero instead, which led to wrong vaccine administered.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The reporter reported that on the day of reporting they administered an expired dose of Bexsero to a patient. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-Aug-2022 Reporter comment: The nurse reported that the patient was administered a dose of Bexsero, which had an expiration date of 31st July 2022. This was the patient's second dose in the series.  At the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Ed
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight was 106.59 kilograms, and height was 168 centimeters. The patient's concurrent conditions included: pre-diabetes, sleep apnea, hemorrhage, and hypothyroidism (low thyroid), and other pre-existing medical conditions included: Patient is a nurse. Her blood pressure was fine at the time of this report. The patient was not taking any medicine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-JUL-2022, Laboratory data included: COVID-19 virus test Positive. On 08-JUL-2022, Laboratory data included: COVID-19 virus test Positive. On 09-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 12-JUL-2022, Laboratory data included: COVID-19 virus test Positive. On an unspecified date, the patient experienced confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000244864.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dehydration, Diarrhoea, Drug intolerance, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; INJECTION SITE ITCHING; DEHYDRATION; DRUG INTOLERANCE (BODY WAS REJECTING); TIREDNESS; NUMBNESS LIPS; BODY NUMBNESS (TINGLING ALL OVER BODY); PARAESTHESIA GENERALISED; INJECTION SITE NUMBNESS; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On 25-JUL-2022, the patient experienced diarrhea. On an unspecified date, the patient experienced shortness of breath, injection site itching, dehydration, drug intolerance (body was rejecting), tiredness, numbness lips, body numbness (tingling all over body), paraesthesia generalised, and injection site numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the tiredness, numbness lips, body numbness (tingling all over body), injection site itching, diarrhea, dehydration, shortness of breath, paraesthesia generalised, injection site numbness and drug intolerance (body was rejecting) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site hypoaesthesia, Injection site pruritus, Paraesthesia
Clinical narrative: SHORTNESS OF BREATH; INJECTION SITE ITCHING; DEHYDRATION; DRUG INTOLERANCE (BODY WAS REJECTING); TIREDNESS; NUMBNESS LIPS; BODY NUMBNESS (TINGLING ALL OVER BODY); PARAESTHESIA GENERALISED; INJECTION SITE NUMBNESS; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On 25-JUL-2022, the patient experienced diarrhea. On an unspecified date, the patient experienced shortness of breath, injection site itching, dehydration, drug intolerance (body was rejecting), tiredness, numbness lips, body numbness (tingling all over body), paraesthesia generalised, and injection site numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the tiredness, numbness lips, body numbness (tingling all over body), injection site itching, diarrhea, dehydration, shortness of breath, paraesthesia generalised, injection site numbness and drug intolerance (body was rejecting) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Heart rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. Initial information was received along with additional information received on 04-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total administered to right arm on an unspecified date in APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The drug start period was 15 months. The patient received booster dose of non-company suspect Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered to right arm on an unspecified date in NOV-2021 for covid-19 prophylaxis.  The patient received non company suspect unspecified Pfizer drug (form of administration and route of administration were not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 14-JUL-2022 and last dose of administration was 19-JUL-2022 for covid-19 treatment. On 20-JUL-2022, at 12:00 the patient experience fatigue, cough, headache, elevated heart rate (confirmed Covid-19 infection) (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive.  The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported.. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000245099.; Sender's Comments: V0:20220806664-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 65 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: hypertension and an unspecified drug allergy. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 21-FEB-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination was 63 year old. Concomitant medications included lisinopril.  The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered on 10-DEC-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination Moderna covid-19 vaccine (elasomeran, dose number in series 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 31-MAY-2022 for covid-19 prophylaxis.  On 09-JUL-2022, the patient underwent COVID-19 virus test which was positive for COVID-19 (confirmed covid-19 infection) (dose number in series 3), which led to confirmed clinical vaccine failure (dose number in series 1). The patient was treated with Paxlovid (nirmatrelvir, ritonavir) (batch number: GC8123) first dose on 09-JUL-2022 (evening) and last dose on 14-JUL-2022 (AM) for treatment of covid-19 (no missed doses). The patient recovered from COVID and on 15-JUL-2022, the patient underwent COVID-19 virus test which was negative.  On 21-JUL-2022, patient again experienced COVID-19 symptoms. On 22-JUL-2022, the patient underwent COVID-19 virus test which was positive. The patient received OTC (over-the-counter) medications (unspecified) and isolation for the treatment of COVID-19. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0-20220806679-Covid-19 Vaccine ad26.cov2.s -Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient via other company (Pfizer Inc.) concerned a 49 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: underactive thyroid, and drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, 1 total administered on an unspecified date in MAR-2021 to right arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in SEP-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 48 years old. The batch number was not reported and has been requested. Concomitant medications included levothyroxine for underactive thyroid. On 25-JUL-2022, the patient experienced suspected covid-19 infection along with symptoms of altered sense of taste and also experienced trouble swallowing, and diarrhea (Dose number in series 2). The patient was treated with non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 26-JUL-2022 to 27-JUL-2022 for treatment of COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with Paxlovid was withdrawn. The patient recovered from suspected covid-19 infection, trouble swallowing, and diarrhea on 28-JUL-2022. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Laboratory test, Sensory disturbance
Clinical narrative: PROBLEM WITH FEET AND IT WENT UP INTO LEGS; BLOOD PRESSURE PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2022, the patient experienced problem with feet and it went up into legs, and blood pressure problems. Laboratory data included: Laboratory test only have blood pressure problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problem with feet and it went up into legs and blood pressure problems was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via agency (Pfizer) concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (unspecified). The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: unknown) dose was not reported, 1 total administered on 03-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 45 years old. Concomitant medications included hydrochlorothiazide/olmesartan medoxomil, levothyroxine/liothyronine, and montelukast. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1).  The patient received two doses of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran), (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 017E21A expiry: unknown) dose was not reported, administered on 20-SEP-2021 to left arm and (form of admin, route of admin were not reported, batch number: 040C21A expiry: unknown) dose was not reported, administered on 22-SEP-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received booster with non-company suspect vaccine Moderna covid-19 vaccine (elasomeran), (Dose number in series 3) (batch number: 026L21B expiry: unknown, form of admin, route of admin were not reported) dose was not reported, administered on 25-MAR-2022 to left arm for covid-19 prophylaxis. On an unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series 3) The patient received non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: GA8778, expiry: unknown) dose was not reported, administered from 13-JUL-2022 to 17-JUL-2022 for treatment of COVID-19. On 22-JUL-2022, the patient experienced rebound post Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Dose number in series 2), elasomeran (Dose number in series 3) was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Illness, Pain in extremity
Clinical narrative: it made me very ill; they had me dizzy and weak; a fast heartbeat; Problem with breathing; Face was swollen; they had me dizzy; My arm sore; Broke my face out/Broke my arm out; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing) and SWELLING FACE (Face was swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing), SWELLING FACE (Face was swollen), DIZZINESS (they had me dizzy), PAIN IN EXTREMITY (My arm sore) and RASH (Broke my face out/Broke my arm out). At the time of the report, ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing), SWELLING FACE (Face was swollen), DIZZINESS (they had me dizzy), PAIN IN EXTREMITY (My arm sore) and RASH (Broke my face out/Broke my arm out) outcome was unknown.     No concomitant medications reported. Treatment included pain medications given at the hospital.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Swelling face, Tachycardia
Clinical narrative: it made me very ill; they had me dizzy and weak; a fast heartbeat; Problem with breathing; Face was swollen; they had me dizzy; My arm sore; Broke my face out/Broke my arm out; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing) and SWELLING FACE (Face was swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing), SWELLING FACE (Face was swollen), DIZZINESS (they had me dizzy), PAIN IN EXTREMITY (My arm sore) and RASH (Broke my face out/Broke my arm out). At the time of the report, ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing), SWELLING FACE (Face was swollen), DIZZINESS (they had me dizzy), PAIN IN EXTREMITY (My arm sore) and RASH (Broke my face out/Broke my arm out) outcome was unknown.     No concomitant medications reported. Treatment included pain medications given at the hospital.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Got some plaques and when they would heal/new ones would come out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. No Medical History information was reported. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced PSORIASIS (Got some plaques and when they would heal/new ones would come out.). At the time of the report, PSORIASIS (Got some plaques and when they would heal/new ones would come out.) had not resolved. No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Influenza like illness, Psoriasis, Sinusitis, Urinary tract infection
Clinical narrative: Occasional Urinary tract infection; Hair thinning; Plaque Psoriasis flare-up /flare up of Rare break out on shins/ankles and scaring on legs; Occasional Sinus infection; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Occasional Urinary tract infection), ALOPECIA (Hair thinning), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PSORIASIS (Plaque Psoriasis flare-up /flare up of Rare break out on shins/ankles and scaring on legs) and SINUSITIS (Occasional Sinus infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Psoriasis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On 20-Jan-2022, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) at an unspecified dose. On 01-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On an unknown date, the patient experienced URINARY TRACT INFECTION (Occasional Urinary tract infection), ALOPECIA (Hair thinning), PSORIASIS (Plaque Psoriasis flare-up /flare up of Rare break out on shins/ankles and scaring on legs) and SINUSITIS (Occasional Sinus infection). At the time of the report, URINARY TRACT INFECTION (Occasional Urinary tract infection), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and SINUSITIS (Occasional Sinus infection) outcome was unknown and ALOPECIA (Hair thinning) and PSORIASIS (Plaque Psoriasis flare-up /flare up of Rare break out on shins/ankles and scaring on legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for all event(s) with Skyrizi was no reasonable possibility. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (a little upset stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Cigarette smoker (for 25 years but has stopped 6 months ago which at the time, he also received the Moderna Covid 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (a little upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (a little upset stomach) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle discomfort, Muscular weakness, Myalgia, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MUSCLE DISCOMFORT (Muscle discomfort in her arm, legs, and abdominal area), PAIN (with each vaccination she would feel achy), MUSCULAR WEAKNESS (Muscles would be sore and weak) and MYALGIA (Muscles would be sore and weak) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Spinal stenosis, Thyroid disorder, Blood pressure high (Started in patient's late 40s-50s), Hypothyroidism (Started in patient's mid 30s), Sneezing (Seasonal allergy), Drug allergy (Lisinopril, cannot have any prils), Cane user, Walker user (Rollator walker depending on the day started either in 2017 or 2018), Persistent cough since 2000, Foot drop (Left), Heat intolerance (heat affect her nerves and muscles, utilizes shade and a cooling rag), Arthritis multiple joint (especially hands and knuckles, comes on gradually, does not have joint pain, began 2-3 years ago, weather affects it), Tiredness (Increases at the end of the day), Urinary frequency and Seasonal allergy. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN, LEVOTHYROXINE, DULOXETINE, ASPIRIN [ACETYLSALICYLIC ACID] and OCRELIZUMAB (OCREVUS) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ASTHENIA (Weakness), MUSCLE DISCOMFORT (Muscle discomfort in her arm, legs, and abdominal area), PAIN (with each vaccination she would feel achy), MUSCULAR WEAKNESS (Muscles would be sore and weak) and MYALGIA (Muscles would be sore and weak). At the time of the report, ASTHENIA (Weakness), MUSCLE DISCOMFORT (Muscle discomfort in her arm, legs, and abdominal area), PAIN (with each vaccination she would feel achy), MUSCULAR WEAKNESS (Muscles would be sore and weak) and MYALGIA (Muscles would be sore and weak) outcome was unknown. The patient started with Moderna vaccine therapy on 06-Apr-2021 and experienced adverse events with COVID vaccines and boosters. Patient was taking blood pressure medication and thyroid medication. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2022: Live follow-up with non-significant information was received.
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: COVID-19; Dose 2 30-APR-2021,  booster dose 01-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 30-APR-2021,  booster dose 01-AUG-2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 30-APR-2021,  booster dose 01-AUG-2021). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 30-APR-2021,  booster dose 01-AUG-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.  The third dose received on 01-Aug-2021 was reported as booster dose.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a 30-year-old female patient with no relevant medical reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred on an unknown date after the third dose of mRNA-1273 in covid-19 vaccination series. Inappropriate schedule of product administration is also noted in this case. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event COVID-19 was reported as resolving. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 30-year-old female patient with no relevant medical reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred on an unknown date after the third dose of mRNA-1273 in covid-19 vaccination series. Inappropriate schedule of product administration is also noted in this case. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event COVID-19 was reported as resolving. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Ear discomfort, Head discomfort
Clinical narrative: his head feels clogged up; lack of energy; ear feels plugged; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (his head feels clogged up), ASTHENIA (lack of energy) and EAR DISCOMFORT (ear feels plugged) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced HEAD DISCOMFORT (his head feels clogged up), ASTHENIA (lack of energy) and EAR DISCOMFORT (ear feels plugged). At the time of the report, HEAD DISCOMFORT (his head feels clogged up), ASTHENIA (lack of energy) and EAR DISCOMFORT (ear feels plugged) outcome was unknown.            No concomitant medications were reported.  It was reported that patient was on unspecified research trial drug.  Patient was waiting to get Covid test done.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) and RASH (Generalized rash) 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 Hypothyroidism ((years ago)) and Rheumatoid arthritis. Concomitant products included Levothyroxine; Methotrexate for an unknown indication. On 11-Apr-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) and RASH (Generalized rash). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and RASH (Generalized rash) had not resolved. It was unknown whether patient was enrolled in a COVID-19 vaccine trial. No treatment medication was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: SORE ARM FROM COVID VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINATION) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINATION). At the time of the report, VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINATION) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in COVID-19 vaccine trial. Concomitant medications were not reported. Treatment medications were not reported.