chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: The case was reported by patient's friend. The patient received a dose of Shingrix and had experienced redness at the injection site. Gave medical disclaimer.  Referred to health care professional.  Spoken as per package insert and content.  Provided medical information phone number for health care professional reference. Did not consent to follow-up. Additional supportive information: The case was linked with case US2022070815, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070815:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix was exposed to 55-64 F for 2 weeks it was administered to more than one patient.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number H4Y3G, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 27-Apr-2022 Reporter's comment: The case was created for unspecified number of patients. Registered nurse stated that Boostrix was exposed to 55 to 64 Fahrenheit for 2 weeks. No prior excursions.  The dates of administration were 18th April 2022, 19th April 2022 and 21st April 2022. No patient demographics available at this time. Consented to follow up via email. Additional Supportive Information: The registered nurse stated that Boostrix was exposed to 55 to 64 Fahrenheit for 2 weeks and administered to more than one patient, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070813:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071808:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071809:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071810:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071811:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071812:Same Reporter
Age: 1.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Accidental overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: instead received Kinrix and Dtap; inadvertently received KINRIX, DOB: 22-OCT-2020; inadvertently received KINRIX; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (DTaP vaccine) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   On 27th April 2022, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and DTaP vaccine. On 27th April 2022, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device and DTaP vaccine, the patient experienced accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered 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: 28-Apr-2022 Reporter's comments: This case was reported by the Office Manager for medical office. The patient inadvertently received Kinrix. The patient was to receive IPV and Dtap, but instead received Kinrix and Dtap. The reporter did not have the doses administered or the site of the vaccine. The reporter gave consent for follow-up.  Additional Supportive Information: The patient was to receive IPV and Dtap, but instead received Kinrix and Dtap, which led to Inappropriate age at vaccine administration, wrong vaccine administered and accidental overdose of DTaP component.
Age: 43.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: engerix B 2 pediatric doses to adult patient; Engerix B 2 pediatric doses to adult patient; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 43-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2022, the patient received the 1st dose of Engerix B pediatric (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device, the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 28th April 2022, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and wrong technique in product usage process. On an unknown date, the outcome of the adult use of a child product and wrong technique in product usage process 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: 28-Apr-2022 Reporter's comments: The patient received a pediatric dose of Engerix-B, in the right arm, on the date of reporting. The patient should have received an adult dose of Energix-B. While the patient was still in the office, a second pediatric dose in the same arm, same lot was given to the patient per the healthcare professional's supervisor on duty. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2 doses of Engerix B pediatric instead of Engerix B adult which led to, which led to adult use of a child product and wrong technique in product usage process
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Patient got Boostrix after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th April 2022, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 28-Apr-2022 Reporter's comments: The patient received Boostrix, later got a call from that facility that the storage was out of temperature range. The reporter did not know if it was frozen, or if it was lower temperature. The reporter asked for advise they did not know the excursion parameters. HCP did not have the lot and expiry at time of interaction but stated that they were in attempts to contacting the other facility to gather that information. The consent to follow up given via postal. Additional Supportive Information: The patient received Boostrix that was stored out of temperature range, which led to incorrect storage of drug.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 2018 received 2nd on 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number k735h, expiry date 13th September 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th April 2018).   On 8th February 2022, the patient received the 2nd dose of Shingrix. On 8th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: The patient was administered delayed 2nd dose of Shingrix. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered delayed 2nd dose of Shingrix, which led to lengthening of vaccination schedule.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: first vaccine NOV2021, second on JAN2022, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix (intramuscular). In November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 5th April 2022, 3 months after receiving Shingrix and between 4 and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex), ambiguous medication nos (Neurontin (Nos)) and steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: The case was reported by the patient. The patient received both doses of Shingrix in left arm. The patient described the shingles on the right side of her body from the mid-front, right arm and mid-back.  Her healthcare professional confirmed that, the case of shingles and started her on Valtrex, Neurontin and a steroid pack (no other details given). The shingles had not resolved.  The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident, Injection site pain, Type 2 diabetes mellitus, Vaccination complication
Clinical narrative: STROKE; TYPE 2 DIABETES MELLITUS; VACCINATION ADVERSE REACTION/BAD REACTION TO THE VACCINE; PAIN DURING INJECTION/HURTS WHEN TOOK HUMIRA SHOT; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number not reported and expiry: unknown) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   The patient received non-company suspect drug adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis and moderate to severe ulcerative colitis. Age at time of vaccination 48 years old. No concomitant medications were reported. On an unspecified date, patient had a bad reaction to the covid-19 vaccine ad26.cov2.s vaccine (vaccination adverse reaction). The patient also had a stroke. As of 22-APR-2022, patient had type II diabetes mellitus (onset date not specified, reported as 2022). The patient felt hurt when he took adalimumab shot (pain during injection). It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from pain during injection/hurts when took Humira shot, and the outcome of stroke, type 2 diabetes mellitus and vaccination adverse reaction/bad reaction to the vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220458195-covid-19 vaccine ad26.cov2.s -Stroke and Type 2 Diabetes Mellitus . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphonia, Ear infection fungal, Fatigue, Fungal pharyngitis
Clinical narrative: COVID-19 INFECTION; FATIGUE; YEAST INFECTION TO THROAT (FOOD TASTES BAD, THROAT DRY); YEAST INFECTION TO INNER EAR; 40LB WEIGHT LOSS SINCE VACCINATION; VERTIGO; ULCERS ON THE BACK OF TONGUE; LOSING VOICE; This spontaneous report received from a patient via a company representative concerned an 8 decade old female. Initial information was processed along with the additional information received on 03-MAY-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 in total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter could not recollect exactly when the patient's symptoms began, but stated that, the patient recollected that, the symptoms began in the week following receiving the JNJ Covid-19 vaccine. The reporter mentioned that, it was unknown to what extent the reported symptoms had resolved, if at all. On MAR-2021, the patient experienced yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb (18.14 kilograms) weight loss since vaccination, vertigo, ulcers on the back of tongue, losing voice, and fatigue. Laboratory data included: Weight (NR: not provided) lost weight 40lb. On OCT-2021, the patient experienced covid-19 infection. The reporter stated that she was told the patient's family physician was aware of the patient's complaints, and the patient sought physician office visit for the reported events of yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb weight loss since vaccination, vertigo, ulcers on the back of tongue and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb weight loss since vaccination, vertigo, ulcers on the back of tongue, losing voice, fatigue and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229232.; Sender's Comments: V0: 20220458906- covid-19 vaccine ad26.cov2.s- yeast infection to throat. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Tongue ulceration, Vertigo, Weight, Weight decreased
Clinical narrative: COVID-19 INFECTION; FATIGUE; YEAST INFECTION TO THROAT (FOOD TASTES BAD, THROAT DRY); YEAST INFECTION TO INNER EAR; 40LB WEIGHT LOSS SINCE VACCINATION; VERTIGO; ULCERS ON THE BACK OF TONGUE; LOSING VOICE; This spontaneous report received from a patient via a company representative concerned an 8 decade old female. Initial information was processed along with the additional information received on 03-MAY-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 in total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter could not recollect exactly when the patient's symptoms began, but stated that, the patient recollected that, the symptoms began in the week following receiving the JNJ Covid-19 vaccine. The reporter mentioned that, it was unknown to what extent the reported symptoms had resolved, if at all. On MAR-2021, the patient experienced yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb (18.14 kilograms) weight loss since vaccination, vertigo, ulcers on the back of tongue, losing voice, and fatigue. Laboratory data included: Weight (NR: not provided) lost weight 40lb. On OCT-2021, the patient experienced covid-19 infection. The reporter stated that she was told the patient's family physician was aware of the patient's complaints, and the patient sought physician office visit for the reported events of yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb weight loss since vaccination, vertigo, ulcers on the back of tongue and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb weight loss since vaccination, vertigo, ulcers on the back of tongue, losing voice, fatigue and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229232.; Sender's Comments: V0: 20220458906- covid-19 vaccine ad26.cov2.s- yeast infection to throat. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2022 for prophylactic vaccination. Age at time of vaccination 29 years old. No concomitant medications were reported. On 28-MAR-2022, the patient experienced vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505162, 20220505824, 20220505593, 20220505044, 20220505192 and 20220505373.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; VACCINE WAS INJECTED DIRECTLY FROM THE FREEZER INTO THE PATIENT WITHOUT THE VACCINE BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2022 for prophylactic vaccination. Age at time of vaccination 25 years old. No concomitant medications were reported.  On 01-APR-2022, the patient experienced vaccine was injected directly from the freezer without the vaccine being stored at recommended storage conditions of 2 to 8 degree celsius.  On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was injected directly from the freezer into the patient without the vaccine being stored at recommended storage conditions of 2 to 8 degree celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505162, 20220505373, 20220505593, 20220504995 and 20220505044.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; VACCINE WAS ADMINISTERED TO PATIENT DIRECTLY FROM THE FREEZER WITHOUT BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2022 for prophylactic vaccination. Age at time of vaccination 41 years old. No concomitant medications were reported.  On 28-MAR-2022, the patient experienced vaccine was administered to patient directly from the freezer without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient directly from the freezer without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220504995, 20220505044, 20220505162, 20220505192, 20220505373, 20220505593 and 20220505824.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; VACCINE WAS INJECTED DIRECTLY FROM THE FREEZER WITHOUT BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 DEGREE CELSIUS; This spontaneous report received from a health care professional concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2022 for prophylactic vaccination. Age at time of vaccination 32 years old. No concomitant medications were reported. On 01-APR-2022, the patient experienced vaccine was injected directly from the freezer without being stored at recommended storage conditions of 2 to 8 degree celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was injected directly from the freezer without being stored at recommended storage conditions of 2 to 8 degree celsius and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505162, 20220505340, 20220505192, 20220504995, 20220505593, 20220505824 and 20220505044.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 05-FEB-2022 for prophylactic vaccination. Age at time of vaccination 37 years old. No concomitant medications were reported.  On 05-FEB-2022, the patient experienced vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220504995, 20220505593, 20220505044, 20220505162, 20220505192, 20220505340 and 20220505373.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was stored  greater than 12 hours post-puncture; 3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (vial was stored  greater than 12 hours post-puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022 at 1:44 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022 at 1:44 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored  greater than 12 hours post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (vial was stored  greater than 12 hours post-puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient received first Booster dose. Number of doses/vials: 3 booster doses / 1 vial (15.5 ml) Red Cap Date the vial was initially stored in the refrigerator: 22 APRIL 2022 Date and time vial was first punctured: 22 APRIL 2022 at 9:55AM vial was stored in the Refrigerator post puncture. No temperature excursions Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 22APR2022 for 2 hours; 25APR2022 1 hour and 26APR2022 1.5 hours at room temperature.  The rest of the time the vial was in the refrigerator Treatment details was not reported by the reporter.   This case was linked to MOD-2022-551984, MOD-2022-551989 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live Significant follow up-Added vaccine and event related information. On 28-Apr-2022: Live follow up-added secondary phone number of reporter
Sex: F
Vaccine: COVID19
Symptoms: Accident, Hip fracture
Clinical narrative: Broken hip; Had an accident; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken hip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (Broken hip) (seriousness criterion medically significant) and ACCIDENT (Had an accident). At the time of the report, HIP FRACTURE (Broken hip) and ACCIDENT (Had an accident) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.  Patient had an accident and because of these accident, patient broke hip and was not able to receive the booster dose of the Moderna COVID 19 Vaccine. Patient wanted to know if after all this time she can still receive the first booster dose of the Moderna COVID 19 vaccine.  Company comment: This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, serious (medically significant) event of Hip fracture, unspecified days after receiving a dose of mRNA-1273 vaccine. The patient had an accident which caused a broken hip. The patient reported missing her first booster dose of mRNA-1273 vaccine due to the event. Clinical course and treatment details are not available in this report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, serious (medically significant) event of Hip fracture, unspecified days after receiving a dose of mRNA-1273 vaccine. The patient had an accident which caused a broken hip. The patient reported missing her first booster dose of mRNA-1273 vaccine due to the event. Clinical course and treatment details are not available in this report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had localized pain on the injection site after receiving the 4 doses.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no known allergies and no chronic illness at the time of vaccination.  Concomitant products included CANNABIDIOL (CBD OIL), SIMVASTATIN and FAMOTIDINE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses.). At the time of the report, VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses.) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2022-554212, MOD-2022-554220, MOD-2022-554223 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: all the side effects except a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (all the side effects except a fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Multiple allergies, Drug allergy (Compazine - almost had a stroke) and Drug allergy (allergy to a blood pressure medication where she went into Atrial Fibrillation). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Multiple allergies, PROPRANOLOL and SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (all the side effects except a fever). At the time of the report, VACCINATION COMPLICATION (all the side effects except a fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant included: Daily inhaler that was discontinued No treatment information was provided.   This case was linked to MOD-2022-554312 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Blood pressure measurement, COVID-19, Drug ineffective, Hypertension
Clinical narrative: all the side effects except a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (all the side effects except a fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Multiple allergies, Drug allergy (Compazine - almost had a stroke) and Drug allergy (allergy to a blood pressure medication where she went into Atrial Fibrillation). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Multiple allergies, PROPRANOLOL and SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (all the side effects except a fever). At the time of the report, VACCINATION COMPLICATION (all the side effects except a fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant included: Daily inhaler that was discontinued No treatment information was provided.   This case was linked to MOD-2022-554312 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypokinesia
Clinical narrative: all the side effects except a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (all the side effects except a fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Multiple allergies, Drug allergy (Compazine - almost had a stroke) and Drug allergy (allergy to a blood pressure medication where she went into Atrial Fibrillation). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Multiple allergies, PROPRANOLOL and SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (all the side effects except a fever). At the time of the report, VACCINATION COMPLICATION (all the side effects except a fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant included: Daily inhaler that was discontinued No treatment information was provided.   This case was linked to MOD-2022-554312 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Immunisation reaction, Nausea, Vomiting
Clinical narrative: I had some pretty severe side effects for my second Moderna booster shot.; diarrhea; nausea; vomiting; horrible chills that lasted all night long; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I had some pretty severe side effects for my second Moderna booster shot.), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (horrible chills that lasted all night long) 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. On an unknown date, the patient experienced IMMUNISATION REACTION (I had some pretty severe side effects for my second Moderna booster shot.), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (horrible chills that lasted all night long). At the time of the report, IMMUNISATION REACTION (I had some pretty severe side effects for my second Moderna booster shot.) was resolving and DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (horrible chills that lasted all night long) had resolved.            No concomitant medications were reported.  After the vomiting, the patient was finally able to get a little bit of sleep. Patient blamed this on some bug that was going through the neighborhood, but the patient went immediately on the day of report to doctor. The patient did not had fever, but it was a bad night and patient felt little bit better on the day of report.  No treatment medications were reported.   This case was linked to MOD-2022-554613 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 patients 16-17 years of age were administered from the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No adverse events were reported.  No treatment medications were provided.   This case was linked to MOD-2022-554700, MOD-2022-554702, MOD-2022-554701 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received included no new information.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: doses were given to patient aged 16-17 years; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (doses were given to patient aged 16-17 years) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (doses were given to patient aged 16-17 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (doses were given to patient aged 16-17 years) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had no adverse events (AEs).  No treatment information was reported.   This case was linked to MOD-2022-554595, MOD-2022-554702, MOD-2022-554701 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 patients 16-17 years of age were administered from the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported as 4 doses were given to 4 patients (ages 16-17 years).  No AEs were reported by patient.  No treatment medications were reported   This case was linked to MOD-2022-554595, MOD-2022-554700, MOD-2022-554702 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received contains no new information.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 patients 16-17 years of age were administered from the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported as 4 doses were given to 4 patients (ages 16-17 years).  No treatment medications were reported.   This case was linked to MOD-2022-554595, MOD-2022-554700 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information.