chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site urticaria, Vaccination site bruising, Vaccination site urticaria
Clinical narrative: Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; This spontaneous report has been received from a company representative referring a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided).  On an unknown date, husband and wife both received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the next day experience hives (vaccination site urticaria) and bruise (vaccination site bruising) at the injection site. At time of reporting, the issues where improving (recovering).   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA002871:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's and no PQC's were reported.; A nurse reported that an expired dose of MMR II was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-OCT-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, quantity 1, lot #T034388, expiration date: 08-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered ). No additional adverse event's and no product quality complaint's were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; A pharmacist stated that an improperly stored GARDASIL 9 was administered to a patient.  No additional AE's and no PQC's were reported.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 09-OCT-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (quantity 1, lot # W006229, expiration date 15-SEP-2024, strength, dose and route were not reported) to prevent human papilloma virus infection (product storage error). No additional adverse event (AE)'s and no product quality complaint (PQC)'s were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Overdose
Clinical narrative: No additional AE details were provided and no additional AE's were reported; administered PROQUAD and VARIVAX on the same day; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient of unknown gender. Information about the patient's current condition, historical condition and concomitant medication was unknown.      On 10-OCT-2022, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, dose number, strength, lot/batch #, expiration date and route were unknown) and dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, dose number, strength, lot/batch #, expiration date and route were unknown) for prophylaxis on the same day (overdose). No additional adverse events were reported. The outcome of the event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site pain
Clinical narrative: injection site sore; 3 inch diameter red spot, like a bruise; like a bruise; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother had it several years ago from the date of reporting).   On 5th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain, localized erythema and contusion. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the localized erythema and contusion were unknown.   It was unknown if the reporter considered the injection site pain, localized erythema and contusion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just got Shingles vaccine on Wednesday morning and his/her arm remained sore at the injection site and a 3 inch diameter red spot kinda like a bruise or something. The patient stated that since his/her mom had it several years ago and it was not something he/she wanted to get. The patient did not get flu shots or any other vaccines but did get this one. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site red; injection site sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine and 4 days after Shingles vaccination the patient experienced injection site red and sore. Additional supportive information: Follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Nervous system disorder
Clinical narrative: progressive nerve issue, caused issues with arm; caused issues with the use of my right arm.; This case was reported by a consumer via call center representative and described the occurrence of neurological disorder nos in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neurological disorder nos and arm discomfort. On an unknown date, the outcome of the neurological disorder nos and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the neurological disorder nos and arm discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's Comments: The reporter reported that patient facing a progressive nerve issue and caused issues with the use of his/her right arm. The reporter wanted to know what could been done to fix it. The patient had seen 5 different physicians regarding the matter and none could identify it. The reporter hoping you had, and could steer me to a cure or corrective action.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle fatigue
Clinical narrative: Severe muscle fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of muscle fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced muscle fatigue. On an unknown date, the outcome of the muscle fatigue was not recovered/not resolved.   It was unknown if the reporter considered the muscle fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine 4 months ago (the day before reporting) and still had severe muscle fatigue. The patient thought he/she would rather had the virus. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient got the Shingles vaccine with no issues other than a sore arm for about a week. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Can it cause rash on back; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked if shingles vaccine could cause rash on back. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Skin odour abnormal
Clinical narrative: odd body odor; This case was reported by a consumer via call center representative and described the occurrence of body odor in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2022, the patient received Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced body odor. On an unknown date, the outcome of the body odor was not recovered/not resolved.   It was unknown if the reporter considered the body odor to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix and since then experienced an odd body odor. The reporter gave medical disclaimer and referred to health care professional. Adverse event filed. The reporter spoke per package insert and content and after call survey offered package insert. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, late 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on March 2019).   On an unknown date, the patient did not received 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: 12-OCT-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received 1st dose of Shingrix vaccine about 3 years ago. The patient want to receive the 2nd dose of the Shingrix vaccine. The patient wanted to know about have to restart the vaccine series over. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 3 years ago, 2nd dose just received; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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: 12-Oct-2022 Reporter's Comments: The HCP (Health care professional) reported that patient just received the 2nd dose.  The date of 2nd dose was not provided.  The HCP (Health care professional) mentioned possible 3rd dose may be given. The HCP declined providing patient identifiers, lot number and expiration date. The reporter did not consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received Shingrix first dose in 2019.).   On an unknown date, the patient received 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: 12-OCT-2022 Reporter's Comments: The reporter stated that a patient who received Shingrix first dose on 2019 and never got second dose. The reporter gave consent to follow up. Additional Supportive Information: The patient never got second dose which leads to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies, HIV test, Laboratory test, Pneumonia viral, Pulmonary fibrosis
Clinical narrative: FIBROUS MASSES HAD TO BE SCRAPED FROM LUNGS; COMPLICATED VIRAL PNEUMONIA; This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's past medical history included: covid-19. 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, 1 total for covid-19 prophylaxis.  The batch number was not reported and has been requested.  Concomitant medications included guselkumab (Tremfya). Patient was treated with tremfya for more than 1 year and last injection was on 25-JUN-2022. On an unspecified date in AUG-2022, the patient was hospitalized for 16 days and was diagnosed with complicated viral pneumonia and had Fibrous masses had to be scraped from lungs.  On an unspecified date, patient tested negative for COVID-19, lupus, AIDS, and histoplasmosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the complicated viral pneumonia and fibrous masses had to be scraped from lungs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20221013971.; Sender's Comments: V0: 20221027269-covid-19 vaccine ad26.cov2.s-Fibrous masses had to be scraped from lungs. The case causality is considered NOT RELATED. Rationale: Concurrent event of Viral pneumonia is considered as confounder for lung fibrosis  20221027269-covid-19 vaccine ad26.cov2.s-complicated viral pneumonia. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: FIBROUS MASSES HAD TO BE SCRAPED FROM LUNGS; COMPLICATED VIRAL PNEUMONIA; This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's past medical history included: covid-19. 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, 1 total for covid-19 prophylaxis.  The batch number was not reported and has been requested.  Concomitant medications included guselkumab (Tremfya). Patient was treated with tremfya for more than 1 year and last injection was on 25-JUN-2022. On an unspecified date in AUG-2022, the patient was hospitalized for 16 days and was diagnosed with complicated viral pneumonia and had Fibrous masses had to be scraped from lungs.  On an unspecified date, patient tested negative for COVID-19, lupus, AIDS, and histoplasmosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the complicated viral pneumonia and fibrous masses had to be scraped from lungs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20221013971.; Sender's Comments: V0: 20221027269-covid-19 vaccine ad26.cov2.s-Fibrous masses had to be scraped from lungs. The case causality is considered NOT RELATED. Rationale: Concurrent event of Viral pneumonia is considered as confounder for lung fibrosis  20221027269-covid-19 vaccine ad26.cov2.s-complicated viral pneumonia. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event(s) is considered not related.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; SEVERE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. 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 13-AUG-2021 for covid-19 prophylaxis. Age at time of vaccination 53 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-JUL-2022 23:15, the patient experienced severe allergic reaction. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from severe allergic reaction, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.; 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
Symptoms: Cardiac disorder, Unevaluable event
Clinical narrative: VACCINE ALMOST KILLED ME; WARPED MY HEART; This spontaneous report received from a consumer 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, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine almost killed me, and warped my heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine almost killed me and warped my heart was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Given the same booster they received last year; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given the same booster they received last year) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given the same booster they received last year). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given the same booster they received last year) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. Patient received the same booster that they got exactly one year ago. They want to know how long they should wait before they can get the new bivalent dose. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-658062 (E2B Linked Report).   Reporter did not allow further contact, Sender's Comments:  MODERNATX, INC.-MOD-2022-658062: Wife case
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient arm was swollen; Patient felt very tired; Patient had mild fever; Patient had pain in the injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 031B21A) for COVID-19 vaccination.     No medical history reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Drug allergy (Bentyl).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site). On 14-Mar-2021, PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) had resolved.            Patient was not under any concomitant or regular medication.  Patient also experienced same events on 9-Apr-2021 after 2nd dose. Adverse event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. symptoms were improving.  No treatment medication was provided.   This case was linked to MOD-2022-658151, MOD-2022-658153 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Patient arm was swollen; Patient felt very tired; Patient had mild fever; Patient had pain in the injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 031B21A) for COVID-19 vaccination.     No medical history reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Drug allergy (Bentyl).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site). On 14-Mar-2021, PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) had resolved.            Patient was not under any concomitant or regular medication.  Patient also experienced same events on 9-Apr-2021 after 2nd dose. Adverse event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. symptoms were improving.  No treatment medication was provided.   This case was linked to MOD-2022-658151, MOD-2022-658153 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Patient arm was swollen; Patient felt very tired; Patient had mild fever; Patient had pain in the injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 031B21A) for COVID-19 vaccination.     No medical history reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Drug allergy (Bentyl).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site). On 14-Mar-2021, PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) had resolved.            Patient was not under any concomitant or regular medication.  Patient also experienced same events on 9-Apr-2021 after 2nd dose. Adverse event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. symptoms were improving.  No treatment medication was provided.   This case was linked to MOD-2022-658151, MOD-2022-658153 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient got COVID-19; patient felt very tired; mild fever; pain in the injection site; his arm was swollen; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19), FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 031B21A and 022M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (Bentyl).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen). On 08-Jul-2022, the patient experienced COVID-19 (Patient got COVID-19). At the time of the report, COVID-19 (Patient got COVID-19), FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. AE did not caused patient to seek medical care. Patient had not experienced a similar event in the past. It was reported that the symptoms were improving. No treatment details were reported.   This case was linked to MOD-2022-658087, MOD-2022-658153 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Patient got COVID-19; patient felt very tired; mild fever; pain in the injection site; his arm was swollen; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19), FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 031B21A and 022M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (Bentyl).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen). On 08-Jul-2022, the patient experienced COVID-19 (Patient got COVID-19). At the time of the report, COVID-19 (Patient got COVID-19), FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. AE did not caused patient to seek medical care. Patient had not experienced a similar event in the past. It was reported that the symptoms were improving. No treatment details were reported.   This case was linked to MOD-2022-658087, MOD-2022-658153 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Patient got COVID-19; patient felt very tired; mild fever; pain in the injection site; his arm was swollen; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19), FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 031B21A and 022M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (Bentyl).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen). On 08-Jul-2022, the patient experienced COVID-19 (Patient got COVID-19). At the time of the report, COVID-19 (Patient got COVID-19), FATIGUE (patient felt very tired), PYREXIA (mild fever), VACCINATION SITE PAIN (pain in the injection site) and VACCINATION SITE SWELLING (his arm was swollen) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. AE did not caused patient to seek medical care. Patient had not experienced a similar event in the past. It was reported that the symptoms were improving. No treatment details were reported.   This case was linked to MOD-2022-658087, MOD-2022-658153 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medications was reported. No treatment drug details was reported. The reporter reported that they called the CDC and were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day.  This case contains information for the 7th adult patient out of 15 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-658139, MODERNATX, INC.-MOD-2022-658159, MODERNATX, INC.-MOD-2022-658149, MODERNATX, INC.-MOD-2022-658161, MODERNATX, INC.-MOD-2022-658162, MODERNATX, INC.-MOD-2022-658154, MODERNATX, INC.-MOD-2022-658160 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-658139:Adult patient 1 MODERNATX, INC.-MOD-2022-658149:Adult patient 2 MODERNATX, INC.-MOD-2022-658159:Adult patient 10 MODERNATX, INC.-MOD-2022-658154:Adult patient 5 MODERNATX, INC.-MOD-2022-658161:Adult patient 12 MODERNATX, INC.-MOD-2022-658160:Adult patient 11 MODERNATX, INC.-MOD-2022-658162:Adult patient 13
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medication was reported.    Patient received vaccine at an off site clinic.Pharmacist stated that they called the CDC and they were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day. No treatment information was reported.  This case contains information for the 12th adult patient out of 15 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-658139, MODERNATX, INC.-MOD-2022-658149, MODERNATX, INC.-MOD-2022-658150, MODERNATX, INC.-MOD-2022-658154, MODERNATX, INC.-MOD-2022-658155, MODERNATX, INC.-MOD-2022-658156, MODERNATX, INC.-MOD-2022-658157, MODERNATX, INC.-MOD-2022-658159, MODERNATX, INC.-MOD-2022-658162, MODERNATX, INC.-MOD-2022-658168, MODERNATX, INC.-MOD-2022-658173, US-MODERNATX, INC.-MOD-2022-658160 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1 US-MODERNATX, INC.-MOD-2022-658149:Adult patient 2 US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5 US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6 US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7 US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10 US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13 US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14 US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15 US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; first COVID19 vaccination was bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster).    Concomitant drugs were not reported. It was reported that patient received 0.5 mL of a Moderna bivalent booster however, reported that patient did not receive any previous dose of vaccine hence might have been the first dose.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-658652 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658652:same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered dose to adult patient from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered dose to adult patient from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (administered dose to adult patient from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered dose to adult patient from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered dose to adult patient from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster).    No concomitant drug was reported. Reporter stated that on 8-Oct-2022, 9-Oct-2022 and 10-Oct-2022 they administered 26 doses to adult patients. Reporter was not aware of any AEs after the vaccines were given. Lot number and expiration date was unknown for suspect drug. No treatment drug was reported. This case contains information for the 17th of 26 adult patients described by the reporter.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: inadvertently given expired product with no reported adverse event; inadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA418835(CLUSTER), 2022SA419132(CLUSTER) and 2022SA418873(CLUSTER).  This case involves a 13 years old female patient who was inadvertently given expired product with no reported adverse event ,after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7378MA and expiration date: 30-Jun-2024) at a dose of 0.5ml once via intramuscular route in the left deltoid for immunization.  On 07-Oct-2022(latency: same day), the patient was inadvertently given expired product with no reported adverse event (expired product administered) (accidental exposure to product) following the administration.  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.