chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA581A, expiry date 31st August 2022) for prophylaxis.   On 14th September 2022, the patient received Menveo. On 14th September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: The vaccine coordinator reported that a patient received an expired dose of Menveo. The vaccine was expired on 31st August 2022. The reporter consented to follow-up via email. Additional Supportive Information: The patient received a dose of Menveo which was already expired, which led to expired vaccine used.
Age: 0.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 3 month old received the Kinrix; Received the Kinrix as their 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of 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: 26-SEP-2022 Reporter's Comment: The reporter reported that the 3 months 19 days old patient received the Kinrix vaccine. The reporter stated that the patient received Kinrix vaccine as their 2nd dose in the Dtap and IPV series. No reactions was reported. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that the patient received Kinrix as a 2nd dose in the Dtap and IPV series which led to which led to inappropriate schedule of vaccine administered.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Tooth extraction, Tooth infection
Clinical narrative: Tooth Infection; Tooth Extraction; This case was reported by a pharmacist via call center representative and described the occurrence of tooth infection in a 66-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced tooth infection and tooth extraction. On an unknown date, the outcome of the tooth infection and tooth extraction were not recovered/not resolved.   It was unknown if the reporter considered the tooth infection and tooth extraction to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   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-Sept-2022 Reporter's comment: The patient was 67 years old. The pharmacist reported that the patient had received first dose of Twinrix series and was not going to be able to come in for the second dose until 30th September 2022 or 1st October 2022. The reporter stated that the dose was delayed because the patient had tooth infection and had to have tooth extraction. The reporter gave permission for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Few people didn't get 2nd dose due to covid; This case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date series in late 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The reporter reported that few people that were late getting their second shingrix vaccine due to covid. The reporter was asked as long was too long in between doses to consider the series complete. There were a few people that started the series in late 2020. The reporter's follow-up permission was unknown. The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administered the Liquid component only; administered the Liquid component only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA756A, expiry date 30th April 2024) for prophylaxis.   On 28th September 2022, the patient received Menveo. On 28th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The licensed practical nurse called to inquired that any adverse effects to look for. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered the Menveo liquid component only without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.83
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: gave a 4th dose; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 10-month-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B  (received 3 doses on an unknown date).   On 29th September 2022, the patient received the 4th dose of Engerix B. On 29th September 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received 4th dose of Engerix-B on the day of reporting, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 29-SEP-2022 Reporter's comment: The reporter reported that the patient received Shingrix vaccine. The pharmacist stated that the Shingrix vaccine was exposed down to 28 Fahrenheit for 8 hours, the reporter stated that there was no prior excursions. The reporter reported that the 8 patients were administered temperature exposed Shingrix vaccines. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide patient details. The reporter did not consent to follow up. Additional supportive information: The Shingrix vaccine temperature was exposed upto 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140236:Same reporter US-GSK-US2022140234:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 29-SEP-2022 Reporter's comment: The reporter reported that the patient received Shingrix vaccine. The pharmacist stated that the Shingrix vaccine was exposed down to 28 Fahrenheit for 8 hours, the reporter stated that there was no prior excursions. The reporter reported that the 8 patients were administered temperature exposed Shingrix vaccines. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide patient details. The reporter did not consent to follow up. Additional supportive information: The Shingrix vaccine temperature was exposed upto 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022140241:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140236:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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 suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20221003775 and 20221005834. This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be voided, this record states the patient was vaccinated and had covid-19. There is no product quality issue described in the information reported as there is no timeline for date of vaccination to contracting covid-19 and no confirmatory test reported, based on the evaluation/investigation performed.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSE OF JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned an 80 year old female. 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 not reported, batch number: 1822811 expiry: 17-AUG-2022) dose was not reported, administered on 03-OCT-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 80 years old. No concomitant medications were reported. On 03-OCT-2022, the patient experienced expired dose of janssen covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of janssen covid-19 vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20221006123.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total, first dose, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm after initial dose for which he took 2 doses of Tylenol (paracetamol) and the pain was resolved (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total, booster dose, dose and start therapy date were not reported for covid-19 prophylaxis. The patient took Tylenol before the vaccination to which he had no pain or sore arm following covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSE OF JANSEN COVID 19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 23 year old male. 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 not reported, batch number: 1822811 expiry: 17-AUG-2022) dose was not reported, administered on 03-OCT-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 23 years old. No concomitant medications were reported. On 03-OCT-2022, the patient experienced expired dose of jansen covid 19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of jansen covid 19 vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20221006059.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (arm pain) in a 93-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Oct-2022, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE PAIN (arm pain) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vccine was stored in the refrigerator for more than 30 days; No adverse event; Dose was given one day after 30 days beyound use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date), PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No allergies to medication, food and other products.     On 15-Sep-2022 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Sep-2022 at 1:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date), PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date) and PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days).    The site of vaccination was left deltoid arm. No concomitant medication were reported.  It was reported that the date they removed the vial from the freezer on 16-Aug-2022. They administered the vaccine to 2 kids on day 31 of its storage in refrigerator. It was reported that the reporter had slight confusion as the day the reporter reported the incident the reporter was informed by 2 people that the vaccine was not considered expired based on date it was received and placed in refrigerator. Per their calculation expiry would be 15-Sep-2022 but reporter wanted to know if it was now considered the vaccine was expired on 14-Sep-2022.  Patient had no adverse events, patient was fine. The event had not caused patient to seek medical care. The patient had not experienced a similar event in the past.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654885 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Follow up received contains no new information. On 04-Oct-2022: Significant follow-up information was received: Patient demographics updated, suspect product details updated, onset time of event was added, reporter details added and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654885:Case for C-D(second pt)
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Slight Temperature; Site pain; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Slight Temperature) and VACCINATION SITE PAIN (Site pain) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight Temperature) and VACCINATION SITE PAIN (Site pain). At the time of the report, PYREXIA (Slight Temperature) outcome was unknown and VACCINATION SITE PAIN (Site pain) had resolved.            No concomitant medication was reported. It was reported that patient had no side effects other than the site pain for just 2 days, and a slight temperature just like the Moderna jabs. No treatment medication was reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness on the skin near the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on the skin near the injection site) in a 24-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027B221A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE ERYTHEMA (redness on the skin near the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness on the skin near the injection site) had not resolved.            Concomitant product use was not provided by the reporter.  On 05-Apr-2021, the patient received first dose of intramuscular Moderna COVID-19 vaccine (lot number 026B21A).  On 03-May-2021, received second dose of intramuscular Moderna COVID-19 vaccine (lot number 030B21A).  On 19-Nov-2021, received third dose of intramuscular Moderna COVID-19 vaccine (lot number 013F21A).  The redness has not changed in any way since patient first noticed it.  Patient has not taken any medications or treatments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat; Pain in the back of her legs; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in the back of her legs) and COVID-19 (Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003H21A, 008C21A and 008C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat). In September 2022, the patient experienced PAIN IN EXTREMITY (Pain in the back of her legs). At the time of the report, PAIN IN EXTREMITY (Pain in the back of her legs) and COVID-19 (Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2022, SARS-CoV-2 test: (Positive) Positive.   No concomitant medications were provided. The patient went to the emergency room where they recommended paxlovid, however patient did not take that injection. Instead, patient drank orange juice. No treatment medications were taken by the patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Illness, Malaise, Nausea
Clinical narrative: Sweating a lot; She does not feel well,Vaccine is knocking her down; Sick as a dog; wanted to throw up; Nauseous; Headache; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up) and NAUSEA (Nauseous) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027A22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Penicillin allergy.    On 01-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Oct-2022, the patient experienced HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up), NAUSEA (Nauseous) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up), NAUSEA (Nauseous) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided by the reporter. On 26-Feb-2021, the patient received first dose of Moderna COVID-19 Vaccine (Lot number-WT012AZ1A). The patient received the bivalent booster of the Moderna Covid 9 vaccine in the morning and at 3 or 4 o'clock she started to have the events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sweating a lot; She does not feel well,Vaccine is knocking her down; Sick as a dog; wanted to throw up; Nauseous; Headache; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up) and NAUSEA (Nauseous) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027A22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Penicillin allergy.    On 01-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Oct-2022, the patient experienced HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up), NAUSEA (Nauseous) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up), NAUSEA (Nauseous) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided by the reporter. On 26-Feb-2021, the patient received first dose of Moderna COVID-19 Vaccine (Lot number-WT012AZ1A). The patient received the bivalent booster of the Moderna Covid 9 vaccine in the morning and at 3 or 4 o'clock she started to have the events.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: did not feel well; something was going on in his body that was not normal; tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that was not normal) and FATIGUE (tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-CA) for COVID-19 prophylaxis.     The patient's past medical history included Bypass surgery (heart). Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Arthritis and Heart disease, unspecified.    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2022, the patient experienced MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that was not normal) and FATIGUE (tired). At the time of the report, MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that was not normal) and FATIGUE (tired) outcome was unknown.            No concomitant information reported. Patient not taken any medications or treatments for his symptoms.    This case was linked to US-MODERNATX, INC.-MOD-2022-654638 (E2B Linked Report). This case was linked to MOD-2022-654640 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654638:Husband Case (Influenza, Cough, Pyrexia, Fatigue, Headache)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Wrong product administered
Clinical narrative: Received a monovalent vaccine instead of bivalent; did not feel well; something was going on in his body that wasn't normal; tired; also had a headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that wasn't normal), FATIGUE (tired), HEADACHE (also had a headache) and WRONG PRODUCT ADMINISTERED (Received a monovalent vaccine instead of bivalent) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR4504B and 033K21-CA) for COVID-19 prophylaxis.     The patient's past medical history included Bypass surgery (Heart). Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Arthritis and Heart disease, unspecified.   On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that wasn't normal), FATIGUE (tired) and HEADACHE (also had a headache). On 28-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Received a monovalent vaccine instead of bivalent). At the time of the report, MALAISE (did not feel well), FEELING ABNORMAL (something was going on in his body that wasn't normal), FATIGUE (tired), HEADACHE (also had a headache) and WRONG PRODUCT ADMINISTERED (Received a monovalent vaccine instead of bivalent) outcome was unknown.            Concomitant medication was not reported. Patient had not taken any medications or treatments for his symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2022-654632, US-MODERNATX, INC.-MOD-2022-654638 (E2B Linked Report). This case was linked to MOD-2022-654637 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654632:Wife's case US-MODERNATX, INC.-MOD-2022-654638:Wife's case
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Biopsy, Lymphadenopathy, Pseudolymphoma
Clinical narrative: Non-cancerous lymphoma; Back pain; Swollen abdomen; Swollen lymph nodes in her stomach; This spontaneous case was reported by a patient and describes the occurrence of PSEUDOLYMPHOMA (Non-cancerous lymphoma), BACK PAIN (Back pain), ABDOMINAL DISTENSION (Swollen abdomen) and LYMPHADENOPATHY (Swollen lymph nodes in her stomach) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 004M20A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In June 2022, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in her stomach). On an unknown date, the patient experienced PSEUDOLYMPHOMA (Non-cancerous lymphoma), BACK PAIN (Back pain) and ABDOMINAL DISTENSION (Swollen abdomen). At the time of the report, PSEUDOLYMPHOMA (Non-cancerous lymphoma) had not resolved and BACK PAIN (Back pain), ABDOMINAL DISTENSION (Swollen abdomen) and LYMPHADENOPATHY (Swollen lymph nodes in her stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Biopsy: non-cancerous lymphoma.         No concomitant medications were reported. Before, 04-Jul-2022, patient went to the hospital and a biopsy was performed. Patient stated that her physician told her that the antibody for the Covid-19 vaccine may reverse the lymph nodes (resolve). She was also told during her yearly mammogram that the vaccine can produce swollen lymph nodes in her breasts. No treatment details were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Heart rate, Heart rate increased, Hyperacusis
Clinical narrative: sensitive to noise; not feeling good; Rapid heartbeat; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (sensitive to noise), FEELING ABNORMAL (not feeling good), HEART RATE INCREASED (Rapid heartbeat) and DIZZINESS (lightheadedness) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERACUSIS (sensitive to noise), FEELING ABNORMAL (not feeling good), HEART RATE INCREASED (Rapid heartbeat) and DIZZINESS (lightheadedness). At the time of the report, HYPERACUSIS (sensitive to noise), FEELING ABNORMAL (not feeling good), HEART RATE INCREASED (Rapid heartbeat) and DIZZINESS (lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Rapid heartbeat. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I felt just a little something when they gave the injection.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I felt just a little something when they gave the injection.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I felt just a little something when they gave the injection.). At the time of the report, IMMUNISATION REACTION (I felt just a little something when they gave the injection.) outcome was unknown.            The concomitant and treatment medication was not reported. On 01-Jan of an unknown year, the patient felt a little something after injection was administered.   Out of 4 shots, fourth shot was the 1st one after which the patient had no pain. The patient di dnot know what else he was given for which he had no pain, unable to read the writing of the reporter and LOT no was not known.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) currently has COVID-19.         No concomitant medications were reported.  On an unknown date, the patient had received the 1st booster dose of COVID-19 vaccine. On an unknown date, the patient had received the 2nd booster dose of Moderna COVID-19 vaccine, Bivalent.  No treatment medications were reported.   Reporter did not allow further contact
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19/had symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19/had symptoms) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022T21A) for COVID-19 prophylaxis.     No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: J and J (1st Dose-J and J but did not like the " whole clotting"). Past adverse reactions to the above products included Clot blood with J and J. Concurrent medical conditions included Penicillin allergy and Blood pressure high (Blood pressure spikes up when was stressed. So a low dose Lisinopril 10mg once a day was given). Concomitant products included LISINOPRIL for Blood pressure high.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2022, the patient experienced COVID-19 (tested positive for Covid-19/had symptoms). At the time of the report, COVID-19 (tested positive for Covid-19/had symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2022, SARS-CoV-1 test: (Positive) Positive. On 06-Sep-2022, SARS-CoV-1 test: (Negative) Negative.         The patient tested positive for COVID-19 on 27-AUG-2022, a week after he was due to 2nd Moderna booster dose. The patient had symptoms then and again tested negative on 06-Sep or 07-Sep-2022. The patient's height was not asked. The treatment medication was not reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator for more than 30 days; No adverse event; Dose was given one day after 30 days beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No allergies to medication, food and other products. It was unknown whether patient had ever diagnosed or tested positive for COVID-19.     On 15-Sep-2022 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) to be not related.    No concomitant medications were provided by the reporter.  Patient's site of application was right leg.  It was reported that the date they removed the vial from the freezer on 16-Aug-2022. They administered the vaccine to 2 kids on day 31 of its storage in refrigerator. It was reported that the reporter had slight confusion as the day the reporter reported the incident the reporter was informed by 2 people that the vaccine was not considered expired based on date it was received and placed in refrigerator. Per their calculation expiry would be 15-Sep-2022 but reporter wanted to know if it was now considered the vaccine was expired on 14-Sep-2022.  Patient had no adverse events, patient was fine. The event had not caused patient to seek medical care. The patient had not experienced a similar event in the past.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647008 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647008:Case for C-D(second pt)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022; No Adverse Event; Received 2nd primary dose 2 days after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022) and NO ADVERSE EVENT (No Adverse Event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 053B22A and 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022).    No concomitant medication were reported.  Patient received Monovalent product. Individual vials from broken carton with vial size of 5.5 ml. The vial was initially stored in the refrigerator on 26-AUG-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-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 29-Sep-2022, the patient experienced UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) 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 UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    Concomitant drugs were not reported. It was reported that patients did not report any AEs. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654905, US-MODERNATX, INC.-MOD-2022-654906, US-MODERNATX, INC.-MOD-2022-654910 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654905:Patient 2 US-MODERNATX, INC.-MOD-2022-654906:Patient 3 US-MODERNATX, INC.-MOD-2022-654910:Patient 4