chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration was 7-MAY-2021.  No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-365189 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications are not provided. Treatment medications are not provided. The date of vaccine refrigeration was reported as 19-Aug-2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 319 patients who received the expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-363245 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 07-May-2021.  Treatment information was not provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-365121 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  No treatment information was provided by reporter.  Date of refrigeration was reported as 05-07-2021.   This case was linked to MOD-2021-365137 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. It was stated that the date of refigeration was 19-SEP-2021.   This case was linked to MOD-2021-365135 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was on 7-may-2021 Concomitant medication use was unknown Treatment information was unknown
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-365178, MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021 at 2:08 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021 at 2:08 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 2:08 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not have any adverse events and did not require any medical attention.  No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-366266, MOD-2021-366280 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  The patient did not have any adverse events and did not require any medical attention after receiving the dose.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 2:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021 at 2:40 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Patient did not have any adverse events and did not require any medical attention. no problems reported from patient. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:16 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were Reported. No Treatments were Reported. Patient had No Adverse Events
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 1:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 1:35 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.  The patient did not have any adverse events and did not require any medical attention. No problems reported from the patient.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 3:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 3:17 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications provided. Patient has never tested positive or been diagnosed with COVID-19.  The patient did not have any adverse events and did not require any medical attention after getting the dose. No problems reported from patient.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in anterior aspect of feet upon waking
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Facial paralysis
Clinical narrative: Right eye lids twitching uncontrollably on and off. It lasts for seconds to minutes then dissipates, then returns minutes to hours later. Also, partial paralysis in blinking with the right eye.    It started with the first dose, but went away after 1 week. It started again with the 2nd dose and has not gone away.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Immediate post-injection reaction, Ophthalmological examination, Vision blurred
Clinical narrative: Immediately after injection, there was numbness on the left side of body, most notable in face/head. Observation area nurse flagged for problem and EMT took vitals and decided it was not a stroke. Told numbness is a known side effect and returned to office.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: an improperly stored ROTATEQ vaccine was administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-OCT-2021, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707496, expiration date 29-MAR-2022, experienced the temperature excursion of 51 degrees fahrenheit (F) for 4 hours and 15 minutes. On the same day after the excursion occurred, the patient was vaccinated with an improperly stored dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707496 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported.
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no other AE occurred; Received PROQUAD at an age outside of the recommendation in the Prescribing lnformation; received a dose of PROQUAD, but the patient was supposed to receive a dose of MMRII.; patient received a dose of VARIVAX last week; This spontaneous report was received from a medical assistant and refers to a 27-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, concentration, exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in October 2021 (reported as "last week"), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, concentration, exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). On 21-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dose, lot # t0032150, expiation date reported as 20-MAR-2022 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age) (wrong vaccine administered). No adverse event was reported (no adverse event). Lot Number t0032150 is not valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and does not match any Company product.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot# U015479, expiration date 13-NOV-2022, experienced the temperature excursion of (6 degrees Fahrenheit (F) to 14 F) for 1 hour 3 minutes; (14 F to 46 F) (20.8 F) for 20 hours 32 minutes. On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, once (formulation, concentration, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Inflammation, Myalgia
Clinical narrative: inflammation; muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of inflammation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2021, the patient received Shingrix. On 25th October 2021, less than a day after receiving Shingrix, the patient experienced inflammation and muscle pain. On an unknown date, the outcome of the inflammation and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the inflammation and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she took Shingrix vaccine on the day of reporting (in the morning) and was asking if need to take Motrin for inflammation and Tylenol for muscle aches. No further information was provided.
Sex: F
Vaccine: MENB
Symptoms: Migraine
Clinical narrative: migraine; This case was reported by a nurse via sales rep and described the occurrence of migraine in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced migraine. On an unknown date, the outcome of the migraine was unknown.   It was unknown if the reporter considered the migraine to be related to Bexsero and Bexsero 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 details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient experienced a migraine the day after first Bexsero injection. No further information reported. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second Shingrix shot too soon; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   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 short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received second Shingrix shot too soon, only about a month later, which led to drug dose administration interval too short. The patient asked that was he/she covered, or did he/she need to do the process again. The patient stated that he/she had side effects with the second shot and would prefer not to go back. The patient also stated that his/her pharmacist hasn't been able to give him/her an answer. The follow-up would not possible as no contact details were available.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: infant patient received a dose of kinrix; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 13th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The infant patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.  The event was reported to VAERS, according to the reporter. Lot number was from the Salesforce GlaxoSmithKline database.  The reporter consented to follow up. Follow up via email was okay.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Septic shock
Clinical narrative: ACUTE KIDNEY INJURY; SEPTIC SHOCK; This spontaneous report was received from literature: This report concerned a 64 year old male. The objective of this study was to describe fatal and non-fatal possible AEs after COVID-19 vaccine administration. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, type 2 diabetes mellitus, lymphoma, and obstructive sleep apnea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced acute kidney injury, and septic shock. On an unspecified date, the patient died from septic shock, and acute kidney injury. It was unspecified if an autopsy was performed. The action taken with COVID-19 vaccine AD26.CoV2. was not applicable. The authors concluded that Although reported AEs are not necessarily caused by the vaccination, this study provides further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. This study also supports prior data that serious AEs post vaccination are much lower than primary COVID-19 infections. Further studies are needed to investigate causalities between vaccines and reported AEs across all age groups. This report was serious (Death). This case, from Same Literature article is linked to 20211045466 and 20211048130.; Sender's Comments: V0- 20211060043 covid-19 vaccine ad26.cov2.s- Acute kidney injury, Septic shock. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SEPTIC SHOCK; ACUTE KIDNEY INJURY
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Influenza like illness, Malaise
Clinical narrative: STROKE; FLU LIKE SYMPTOMS (FEVER FOR 4 HOURS AND ACHINESS); FELT A LITTLE OFF (NOT FEELING GOOD); This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known dug or food allergies and no any history drug abuse / illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: Unknown) dose was not reported, 1 total, administered on 23-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAY-2021, the day of the vaccine the patient was fine and he went out to dinner and around 9 pm he started not feeling good and felt like he had the flu (flu like symptoms). He had a fever for about four hours and took some Tylenol (paracetamol) for it along with this he had achiness like someone had pounded his back with a hammer. The day after the vaccine he still felt a little off so he took the day off from work and was fine after that until he had the stroke was reported. On 01-JUN-2021 (eight days later), the patient developed stroke, and was hospitalized for around 30 hours and on 02-JUN-2021 he was discharged from hospital was also reported. The treatment medications included: Aspirin 81 mg (acetylsalicylic acid) and Lipitor (atorvastatin calcium) were reported The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke, and was recovering from felt a little off (not feeling good), and flu like symptoms (fever for 4 hours and achiness). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211061443-covid-19 vaccine ad26.cov2.s-stroke.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Death, Headache, Hyperhidrosis
Clinical narrative: BACK WAS HURTING ON THE RIGHT SIDE; DEATH; CHEST PAIN; SWEATING; ARM TIGHTNESS (LEFT SIDE); HEADACHE; THROWING UP; This spontaneous report received from a consumer concerned a 53 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, expiry: Unknown, batch number: Unknown) dose was not reported, 1 total, administered at left arm on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-OCT-2021, the patient experienced headache, chest pain, arm tightness (left side), sweating, throwing up. Patients back was hurting on the right side. On 21-OCT-2021, the patient died from unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache, chest pain, arm tightness (left side), sweating, throwing up and back was hurting on the right side was not reported. This report was serious (Death).; Sender's Comments: V0- 20211061610-covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Vomiting
Clinical narrative: BACK WAS HURTING ON THE RIGHT SIDE; DEATH; CHEST PAIN; SWEATING; ARM TIGHTNESS (LEFT SIDE); HEADACHE; THROWING UP; This spontaneous report received from a consumer concerned a 53 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, expiry: Unknown, batch number: Unknown) dose was not reported, 1 total, administered at left arm on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-OCT-2021, the patient experienced headache, chest pain, arm tightness (left side), sweating, throwing up. Patients back was hurting on the right side. On 21-OCT-2021, the patient died from unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache, chest pain, arm tightness (left side), sweating, throwing up and back was hurting on the right side was not reported. This report was serious (Death).; Sender's Comments: V0- 20211061610-covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Diarrhoea, Fatigue, Muscular weakness
Clinical narrative: TREMORS; 8 WEEKS OF UPSET STOMACH; SORE ARM; MUSCLE WEAKNESS; FATIGUE; 8 WEEKS OF DIARRHEA; FEVER; This spontaneous report received from a patient via a company representative concerned an 8 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: pennicillium allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient was in relatively good health and do not take medication for any long term or chronic conditions. The patient has a natural redhead and had a fair skin and has reaction to anesthesia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tremors, 8 weeks of upset stomach, sore arm, muscle weakness, fatigue, 8 weeks of diarrhea, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) nothing was wrong, Sigmoidoscopy (NR: not provided) nothing was wrong, and Stool analysis (NR: not provided) nothing was wrong. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 8 weeks of diarrhea, and the outcome of sore arm, fatigue, muscle weakness, tremors, fever and 8 weeks of upset stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sigmoidoscopy, Stool analysis, Tremor
Clinical narrative: TREMORS; 8 WEEKS OF UPSET STOMACH; SORE ARM; MUSCLE WEAKNESS; FATIGUE; 8 WEEKS OF DIARRHEA; FEVER; This spontaneous report received from a patient via a company representative concerned an 8 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: pennicillium allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient was in relatively good health and do not take medication for any long term or chronic conditions. The patient has a natural redhead and had a fair skin and has reaction to anesthesia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tremors, 8 weeks of upset stomach, sore arm, muscle weakness, fatigue, 8 weeks of diarrhea, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) nothing was wrong, Sigmoidoscopy (NR: not provided) nothing was wrong, and Stool analysis (NR: not provided) nothing was wrong. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 8 weeks of diarrhea, and the outcome of sore arm, fatigue, muscle weakness, tremors, fever and 8 weeks of upset stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 31-OCT-2021, the patient experienced body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and body aches. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccination site reaction
Clinical narrative: Covid arm. Red, tender, swollen to the size of a softball arm where the vaccine was received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypertension, Ocular hypertension, Ophthalmological examination abnormal, Palpitations
Clinical narrative: My right eye started to have shooting lights and floaters.  The flashing lights were repeated over and over.  The floaters were off to the right of the eye where the flashers were.  I have gone to an ophthalmologist and have a follow up appointment next week.  The pressure in the effected eye is a bit higher that the other eye.  The vision is blurred now. It was not at blurred at first.  I also have been very very tired since the vaccine.   My heart feels racy  as if it is going way too fast.  My Blood pressure is very high which is NOT normal.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Vision blurred, Vitreous floaters
Clinical narrative: My right eye started to have shooting lights and floaters.  The flashing lights were repeated over and over.  The floaters were off to the right of the eye where the flashers were.  I have gone to an ophthalmologist and have a follow up appointment next week.  The pressure in the effected eye is a bit higher that the other eye.  The vision is blurred now. It was not at blurred at first.  I also have been very very tired since the vaccine.   My heart feels racy  as if it is going way too fast.  My Blood pressure is very high which is NOT normal.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo, mostly when laying down but also sometimes on standing
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Incorrect dose administered, Injected limb mobility decreased, Lethargy, Nausea
Clinical narrative: Feeling lousy today; She can't think and feels lethargic; Right arm is hurting; Can't move her right arm good; Dizziness; Nausea; Given full dose instead of half dose (booster); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling lousy today), LETHARGY (She can't think and feels lethargic), PAIN IN EXTREMITY (Right arm is hurting), INJECTED LIMB MOBILITY DECREASED (Can't move her right arm good) and DIZZINESS (Dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 027170A and 013M2ZA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure high and Allergy to antibiotic. Concomitant products included INSULIN, PARACETAMOL (TYLENOL) and GABAPENTIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Given full dose instead of half dose (booster)). On 21-Oct-2021, the patient experienced VACCINATION COMPLICATION (Feeling lousy today), LETHARGY (She can't think and feels lethargic), PAIN IN EXTREMITY (Right arm is hurting), INJECTED LIMB MOBILITY DECREASED (Can't move her right arm good), DIZZINESS (Dizziness) and NAUSEA (Nausea). On 20-Oct-2021, INCORRECT DOSE ADMINISTERED (Given full dose instead of half dose (booster)) had resolved. At the time of the report, VACCINATION COMPLICATION (Feeling lousy today), LETHARGY (She can't think and feels lethargic), PAIN IN EXTREMITY (Right arm is hurting), INJECTED LIMB MOBILITY DECREASED (Can't move her right arm good), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.      Concomitant medications also included blood pressure medication.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Feeling lousy today; She can't think and feels lethargic; Right arm is hurting; Can't move her right arm good; Dizziness; Nausea; Given full dose instead of half dose (booster); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling lousy today), LETHARGY (She can't think and feels lethargic), PAIN IN EXTREMITY (Right arm is hurting), INJECTED LIMB MOBILITY DECREASED (Can't move her right arm good) and DIZZINESS (Dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 027170A and 013M2ZA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure high and Allergy to antibiotic. Concomitant products included INSULIN, PARACETAMOL (TYLENOL) and GABAPENTIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Given full dose instead of half dose (booster)). On 21-Oct-2021, the patient experienced VACCINATION COMPLICATION (Feeling lousy today), LETHARGY (She can't think and feels lethargic), PAIN IN EXTREMITY (Right arm is hurting), INJECTED LIMB MOBILITY DECREASED (Can't move her right arm good), DIZZINESS (Dizziness) and NAUSEA (Nausea). On 20-Oct-2021, INCORRECT DOSE ADMINISTERED (Given full dose instead of half dose (booster)) had resolved. At the time of the report, VACCINATION COMPLICATION (Feeling lousy today), LETHARGY (She can't think and feels lethargic), PAIN IN EXTREMITY (Right arm is hurting), INJECTED LIMB MOBILITY DECREASED (Can't move her right arm good), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.      Concomitant medications also included blood pressure medication.  No treatment information was provided.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal, Extrasystoles
Clinical narrative: Chest pain and "heart skipping a beat" No fever. No other symptoms.  Pain is reproducible with pressure over sternum. Symptoms resolved completely after ibuprofen was given.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza virus test negative, Pain, Pain in extremity
Clinical narrative: Fever 102.3, Terrible headache, head congestion, sore arm, Body aches, FATIGUE
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Fever 102.3, Terrible headache, head congestion, sore arm, Body aches, FATIGUE