chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: not reconstituted with the supplied diluent / possibly reconstituted with sterile water; patient received a dose of Hiberix that was not reconstituted with the supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 4925E, expiry date 24th October 2021) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that an unknown patient received a dose of Hiberix that was not reconstituted with the supplied diluent on unknown date, which led to wrong solution used in drug reconstitution and administration of inappropriate dose of vaccine. The incorrect dose was possibly reconstituted with sterile water. The reporter stated that they have narrowed it down to 4 patients but they were unsure which one patient received the incorrectly reconstituted dose. No further information reported. The reporter consented to follow up. This is 1 of the 4 linked cases, reported by same reporter. Note: All the linked cases were conservatively kept valid as the reporter was unsure which patient received the incorrectly reconstituted dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073596:same reporter US-GLAXOSMITHKLINE-US2021073386:same reporter US-GLAXOSMITHKLINE-US2021AMR073597:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccination / got shingles / about 2years or so afterward /suspected Vaccination failure; shingles on the left side of my face; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In March 2020, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient got the vaccination, but she got shingles on the left side of her face about 2 years or so afterward. That was last March and there was still some reminders once in a while till the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The most painful shots ever, but worth it.; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that it was the most painful shots ever, but it was worth it. No other information was reported. For tolerance of 2nd dose, refer case US2021AMR073669.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073669:same reporter, 2nd dose
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still gets shingles after having the shots/Suspected vaccination failure; still gets shingles after having the shots; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (mother had years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt unlucky that still got shingles after had the shots. However it was not nearly as bad as patient's mom had years ago before they had a vaccine. The patient stated that Get your vaccine or suffer. This case was considered as suspected vaccination failure as details regarding laboratory confirmation and  TTO were unknown at the time of reporting. This case had been linked with case US2021AMR073674, as reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073674:same reporter
Sex: F
Vaccine: UNK
Symptoms: Rash, Urticaria
Clinical narrative: hives on her face; This case was reported by a consumer via call center representative and described the occurrence of hives in a 36-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2018-2019 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Tetra 2018-2019 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, 3 days after receiving FluLaval Tetra 2018-2019 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2018-2019 season and Flulaval Tetra 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 reported as follows: The case was reported by patient herself. The age at vaccination was not reported but patient could be 33 or 34 years old at time of vaccination. The patient reported that she experienced the hives on face, 3 days following the vaccination. The hives came and went for a total of three days and then resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073401:same reporter,2nd dose
Sex: F
Vaccine: MEN
Symptoms: Cardiac arrest, Seizure
Clinical narrative: heart stopped for about 30 seconds and then flatlined in ER; had a seizure within 10 mins; This case was reported by a consumer via  interactive digital media and described the occurrence of asystole in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than an hour after receiving Meningococcal B vaccine, the patient experienced asystole (serious criteria hospitalization and GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the asystole and seizure were recovered/resolved.   It was unknown if the reporter considered the asystole and seizure to be related to Meningococcal B vaccine.  Additional details were reported as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received the Meningococcal vaccine and had a seizure within 10 minutes and then her heart stopped for about 30 seconds and then flatlined in emergency room and off to hospital. The reporter stated that the patient was fine and mentioned that just no more vaccines for the patient. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Injection site pain
Clinical narrative: Lower on energy; soreness in my deltoid (site of injection) / seemed worse than what I had previously experienced with a typical flu shot; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Flu shot (received typical flu shot on an unknown date).   In March 2021, the patient received Influenza vaccine Quadrivalent unspecified season. In March 2021, less than a week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain and energy decreased. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the energy decreased was unknown.   It was unknown if the reporter considered the injection site pain and energy decreased to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details was reported as follows: The age at vaccination was not reported. The patient received vaccine later in the week. The soreness in patient's deltoid (site of injection) lasted for approximately 4 days and seemed worse than what He/She had previously experienced with a typical flu shot.  The reporter stated that nothing that some ibuprofen could not handle. One day over the weekend, Sunday as patient recalled, He/She felt kind a lower on energy, but not specifically ill.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR047449:Shingrix
Sex: U
Vaccine: VARZOS
Symptoms: Epilepsy, Pain, Product use in unapproved indication
Clinical narrative: Epilepsy; given the shingles shot while I had shingles; Pain; This case was reported by a consumer and described the occurrence of epilepsy in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced epilepsy (serious criteria GSK medically significant), pain and drug use for unapproved indication. On an unknown date, the outcome of the epilepsy and drug use for unapproved indication were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the epilepsy and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was given the shingles shot while the patient had shingles which led to drug use for unapproved indication.  It was useless. The patient ended up 7 weeks later with a different doctor who prescribed meds for epilepsy. Event epilepsy was coded as per conservative approach due to limited information. The pain was gone within 24 hours.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a pediatric female patient received an expired dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-month-old female patient who received HBV (Engerix B) (batch number 5327R, expiry date 15th March 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th March 2021, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 16th March 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired Engerix B, which led to expired vaccine used. The reporter consented to follow up.  Follow up received from an other health professional on 31st March 2021: Patient suffered no ill effects after received a one day expired vaccine.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unknown amount of 19 year old patients may have received adult doses; Unknown amount of 19 year old patients may have received adult doses; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in an unspecified number of patients who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose 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 was provided as follows: The number of patients of 19 year of age received adult doses of Engerix-B, which led to adult product administered to child and overdose. The health care professional was not in the office at the time of repot and did not have any patient information. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: A dose of Menveo / administered / 30 hours after reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA432A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reported reported that the dose of Menveo was adminstered to the pateint 30 hours after the reconstitution, which led to wrong technique in drug usage process. The information regarding consent to follow up was not reported.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old patient who received a dose of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number G5BE3, expiry date 25th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th March 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 19th March 2021, unknown after receiving Infanrix and Infanrix 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 reported as follows: The patient was 11 years old and received the dose of Infanrix, which led to inappropriate age at vaccine administration. No adverse reaction reported. The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Incomplete course of vaccination, Nausea, Palpitations, Pyrexia
Clinical narrative: Fever; Dizziness; Nausea; Heart Palpitations; incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of pyrexia (received 1st dose about 5 to 6 years ago from the day of reporting (2015 or 2016) and experienced dizziness, nausea and heart palpitations, refer case- US2021AMR073266).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, several days after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced fever, dizziness, nausea, palpitation and incomplete course of vaccination. Rechallenge with Hepatitis B vaccine was positive. On an unknown date, the outcome of the fever, dizziness, nausea and palpitation were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, dizziness, nausea and palpitation to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After 1st shot, the patient received 2nd dose of Hepatitis B vaccine as scheduled and started feeling dizzy, fever, nausea and heart palpitations, a few days after. The patient did not receive the 3rd dose of Hepatitis B vaccine as per the vaccination schedule, which led to incomplete course of vaccination. The patient went to the emergency room for a doctor visit, a few days after the 2nd dose and was not admitted. The patient did not take the 3rd dose as scheduled due to the previous complications and precaution.  The patient do not remember the location of the shots and had no details about the vaccine lot number, expiration date or dosage. The patient was recovered from the events. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073266:Same reporter
Sex: F
Vaccine: HEP, HEP
Symptoms: Vaccine positive rechallenge
Clinical narrative: Fever; Dizziness; Nausea; Heart Palpitations; incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of pyrexia (received 1st dose about 5 to 6 years ago from the day of reporting (2015 or 2016) and experienced dizziness, nausea and heart palpitations, refer case- US2021AMR073266).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, several days after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced fever, dizziness, nausea, palpitation and incomplete course of vaccination. Rechallenge with Hepatitis B vaccine was positive. On an unknown date, the outcome of the fever, dizziness, nausea and palpitation were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, dizziness, nausea and palpitation to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After 1st shot, the patient received 2nd dose of Hepatitis B vaccine as scheduled and started feeling dizzy, fever, nausea and heart palpitations, a few days after. The patient did not receive the 3rd dose of Hepatitis B vaccine as per the vaccination schedule, which led to incomplete course of vaccination. The patient went to the emergency room for a doctor visit, a few days after the 2nd dose and was not admitted. The patient did not take the 3rd dose as scheduled due to the previous complications and precaution.  The patient do not remember the location of the shots and had no details about the vaccine lot number, expiration date or dosage. The patient was recovered from the events. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073266:Same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: Patient moved her arm and half of the liquid came out; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number L55HS, expiry date 10th October 2022) for prophylaxis.   On 31st March 2021, the patient received the 2nd dose of Shingrix. On 31st March 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The patient while receiveing  shingrix  moved her arm and half liquid came out, which led to accidental underdose. No adverse event was reported. The reporter consented to follow up.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage patient accidentally given shingrix / patient is 47 years old; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female 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 inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional details were provided as follows: The reporter stated that, an underage patient accidentally given Shingrix, which led to inappropriate age at vaccine administration. The patient wanted to continue with Shingrix series so the reporter asked if that was acceptable. No further information available. The patient consented to follow up
Sex: F
Vaccine: HIBV
Symptoms: Intercepted product prescribing error
Clinical narrative: Ordered Hiberix / Patient that will be having  pancreatic surgery; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter called and wants to double check if Hiberix was ok to use in adults because she ordered Hiberix for a female patient that would be having pancreatic surgery. She noticed this past time, when she got the prescription, the age indication on the box. The Hiberix not yet administered to patient, which led to intercepted drug prescribing error. No additional details provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 04Aug2020 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th August 2020) and Zostavax (received in 2015).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The Healthcare professional did not have the lot number and expiration date. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Late for the third dose / First dose on January 30 2020 / Second dose on March 11 2020; Late for the third dose /First dose on January 30 2020 / Second dose on March 11 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 30th January 2020).   On 11th March 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 11th March 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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 details were provided as follows: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting patient was late for 3rd dose of Twinrix which led to incomplete course of vaccination. No adverse event was reported. The reporter did not consent to follow up.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Boostrix was administrated; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2774D, expiry date 9th March 2021) for prophylaxis.   On 1st April 2021, the patient received Boostrix. On 1st April 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The reporter was a manager. The reporter stated that the patient was administrated with a dose of Boostrix expired on 9th March 2021, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow-up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of menveo was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 31st March 2021) for prophylaxis.   On 1st April 2021, the patient received Menveo. On 1st April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The reporter stated that the patient was administrated with a dose of Menveo expired on 31th March 2021, which led to expired vaccine used. The healthcare professional asked how to move forward. The reporter consented to follow-up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Insomnia
Clinical narrative: BODY ACHES MOSTLY IN THE JOINTS AND ESPECIALLY THE ANKLES; COULD NOT SLEEP- WOKE EVERY 15 MIN; CHILLS-FREEZING; JOINT PAINS  WRISTS, SHOULDERS, HIPS, KNEES AND ANKLES; FEVER; SEVERE POUNDING HEADACHE; This spontaneous report received from a patient concerned a 47 year old. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included percocet allergy, seasonal allergy, gluten allergy, alcohol use, nonsmoker, bile salt malabsorption -gi condition, anxiety, and vitamin d deficiency, and other pre-existing medical conditions included the patient reported no other relevant medical history. the patient had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included loratadine for allergies, sertraline hydrochloride for anxiety, colestipol for bile salt malabsorption, colecalciferol for vitamin d deficiency, and vitamins nos for vitamin d deficiency. On 06-MAR-2021, the subject experienced body aches mostly in the joints and especially the ankles. On 06-MAR-2021, the subject experienced could not sleep- woke every 15 min. On 06-MAR-2021, the subject experienced chills-freezing. On 06-MAR-2021, the subject experienced joint pains wrists, shoulders, hips, knees and ankles. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe pounding headache. Laboratory data included: Body temperature (NR: not provided) 103 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep- woke every 15 min, joint pains wrists, shoulders, hips, knees and ankles, and severe pounding headache on 08-MAR-2021, and chills-freezing on 06-MAR-2021, and had not recovered from body aches mostly in the joints and especially the ankles, and fever. This report was non-serious.  Additional information was received on 30-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter email, Patient demographic details( age, height, weight), age at time of vaccination, Patient history (seasonal, gluten allergy, alcohol use, nonsmoker, anxiety, vitamin d deficiency), events(could not sleep, joint pain, headache) Product batch no, therapy start date and end date, Concomitant medications.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES MOSTLY IN THE JOINTS AND ESPECIALLY THE ANKLES; COULD NOT SLEEP- WOKE EVERY 15 MIN; CHILLS-FREEZING; JOINT PAINS  WRISTS, SHOULDERS, HIPS, KNEES AND ANKLES; FEVER; SEVERE POUNDING HEADACHE; This spontaneous report received from a patient concerned a 47 year old. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included percocet allergy, seasonal allergy, gluten allergy, alcohol use, nonsmoker, bile salt malabsorption -gi condition, anxiety, and vitamin d deficiency, and other pre-existing medical conditions included the patient reported no other relevant medical history. the patient had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included loratadine for allergies, sertraline hydrochloride for anxiety, colestipol for bile salt malabsorption, colecalciferol for vitamin d deficiency, and vitamins nos for vitamin d deficiency. On 06-MAR-2021, the subject experienced body aches mostly in the joints and especially the ankles. On 06-MAR-2021, the subject experienced could not sleep- woke every 15 min. On 06-MAR-2021, the subject experienced chills-freezing. On 06-MAR-2021, the subject experienced joint pains wrists, shoulders, hips, knees and ankles. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe pounding headache. Laboratory data included: Body temperature (NR: not provided) 103 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep- woke every 15 min, joint pains wrists, shoulders, hips, knees and ankles, and severe pounding headache on 08-MAR-2021, and chills-freezing on 06-MAR-2021, and had not recovered from body aches mostly in the joints and especially the ankles, and fever. This report was non-serious.  Additional information was received on 30-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter email, Patient demographic details( age, height, weight), age at time of vaccination, Patient history (seasonal, gluten allergy, alcohol use, nonsmoker, anxiety, vitamin d deficiency), events(could not sleep, joint pain, headache) Product batch no, therapy start date and end date, Concomitant medications.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Dizziness, Headache
Clinical narrative: BODY ACHE; DIZZY; CHILLS; HEADACHE; TEMPERATURE GOT AS HIGH AS 101.8; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight was not reported and height was 170.18 centimeters. The patient's concurrent conditions included alcohol user, non-smoker, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies to vaccine, drug and food. the patient had no history of drug abuse, no illness at the time of vaccination, no past history of similar events, no adverse event after any previous vaccination, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days and no family history of any disease (relevant to vaccination) or allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered to the right arm, on 08-MAR-2021 06:07 for prophylactic vaccination. Concomitant medications included empagliflozin for type 2 diabetes mellitus, and metformin for type 2 diabetes mellitus. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced temperature got as high as 101.8. Laboratory data included: Body temperature (NR: not provided) 101.8 deg. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, headache, and temperature got as high as 101.8 on 09-MAR-2021, and had not recovered from dizzy. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHE; DIZZY; CHILLS; HEADACHE; TEMPERATURE GOT AS HIGH AS 101.8; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight was not reported and height was 170.18 centimeters. The patient's concurrent conditions included alcohol user, non-smoker, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies to vaccine, drug and food. the patient had no history of drug abuse, no illness at the time of vaccination, no past history of similar events, no adverse event after any previous vaccination, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days and no family history of any disease (relevant to vaccination) or allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered to the right arm, on 08-MAR-2021 06:07 for prophylactic vaccination. Concomitant medications included empagliflozin for type 2 diabetes mellitus, and metformin for type 2 diabetes mellitus. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced temperature got as high as 101.8. Laboratory data included: Body temperature (NR: not provided) 101.8 deg. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, headache, and temperature got as high as 101.8 on 09-MAR-2021, and had not recovered from dizzy. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Listless, Pain
Clinical narrative: LISTLESSNESS; BODY ACHES AND PAINS; CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned an 83 year old female. The patient's weight and height was not reported. The patient's concurrent conditions included abstains from alcohol, non smoker, and low thyroid, The patient experienced drug allergy when treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:00 to Left Deltoid for prophylactic vaccination. Concomitant medications included rosuvastatin calcium for cholesterol, and levothyroxine for hypothyroid. On 08-MAR-2021, the subject experienced listlessness. On 08-MAR-2021, the subject experienced body aches and pains. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, body aches and pains, listlessness, and tiredness. This report was non-serious.   Version created to amend previously reported information on 08-MAR-2021. Upon review the following information was amended: Labeling of event (chills) updated to unlabeled from labeled in USPI. Labeling of event (body aches) updated to unlabeled from labeled in USPI and Core. Event ranking has been changed as per labeling corrections.  Additional information received from patient on 30-MAR-2021.The following information was updated and incorporated into the case: Reporter tab: primary reporter address added, Patient tab: date of birth, Age at the time of the event, age group, sex, height pregnancy and age at the time of vaccination added. Disease sub tab : abstain from alcohol, non smoker, low thyroid was added. Event tab: listlessness, tiredness, body ache and pains was added along with onset date and outcome as 08-MAR-2021 and recovering/ resolving. event onset date and outcome for events chills, headache, body ache and pains was changed to 08-MAR-2021 and recovering /resolving. Product tab: Concomitant drugs :Levothyroxine for hypothyroid and Crestor for cholesterol and the expiry date for suspect product was added as 25-MAY-2021. Causality was added as possible for the events listlessness, tiredness, body ache and pains. Ranking of events was changed. Seriousness criteria was changed to recovering and resolving.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Headache, Injection site erythema
Clinical narrative: NAUSEA; TIREDNESS; HEADACHE; TEMPERATURE 99 DEGREES; BODY ACHES; INJECTION SITE REDNESS; SORE ARM; This spontaneous report received from a vaccine facility concerned a 68 year old female. The patient's weight was 195 pounds, and height was 173.73 centimeters. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no history of drug abuse. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:30 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, venlafaxine hydrochloride for hot flashes, colecalciferol for immune health, ascorbic acid/rosa canina/sodium ascorbate for immune support, and ascorbic acid/biotin/calcium pantothenate/choline bitartrate/colecalciferol/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/inositol/inulin/magnesium citrate/nicotinamide/pyridoxine hydrochloride/retinol palmitate/zinc citrate for overall health. On MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced injection site redness. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg. On 08-MAR-2021 11:30, the subject experienced body aches. On 08-MAR-2021 11:30, the subject experienced nausea. On 08-MAR-2021 11:30, the subject experienced tiredness. On 08-MAR-2021 11:30, the subject experienced headache. On 08-MAR-2021 11:30, the subject experienced temperature 99 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, injection site redness, nausea, tiredness, headache, and temperature 99 degrees on MAR-2021. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: NAUSEA; TIREDNESS; HEADACHE; TEMPERATURE 99 DEGREES; BODY ACHES; INJECTION SITE REDNESS; SORE ARM; This spontaneous report received from a vaccine facility concerned a 68 year old female. The patient's weight was 195 pounds, and height was 173.73 centimeters. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no history of drug abuse. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:30 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, venlafaxine hydrochloride for hot flashes, colecalciferol for immune health, ascorbic acid/rosa canina/sodium ascorbate for immune support, and ascorbic acid/biotin/calcium pantothenate/choline bitartrate/colecalciferol/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/inositol/inulin/magnesium citrate/nicotinamide/pyridoxine hydrochloride/retinol palmitate/zinc citrate for overall health. On MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced injection site redness. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg. On 08-MAR-2021 11:30, the subject experienced body aches. On 08-MAR-2021 11:30, the subject experienced nausea. On 08-MAR-2021 11:30, the subject experienced tiredness. On 08-MAR-2021 11:30, the subject experienced headache. On 08-MAR-2021 11:30, the subject experienced temperature 99 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, injection site redness, nausea, tiredness, headache, and temperature 99 degrees on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES; This spontaneous report received from a patient via a company representative concerned a male 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 not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: LOOSE STOOL/LITTLE DIARRHEA; CHILLS; FELT TIRED FOR 5 TO 6 HOURS; This spontaneous report received from a patient concerned a 70 year old. The patient's weight was 184 pounds, and height was 163.83 centimeters. The patient's concurrent conditions included high blood pressure, autism, mild glaucoma, cholesterol, non smoker, non alcohol user, extreme anxiety, and stress, and other pre-existing medical conditions included the patient had no illness at time of vaccination, no past history of similar event, no adverse event after any previous vaccination, the patient had no known drug allergies and no any drug abuse / illicit drug use, no history of allergy to vaccine, drug or food. the patient had no pre-existing acute illness, history of hospitalization in last 30 days, family history of any disease or (relevant to vaccination) or allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination on left deltoid muscle. Concomitant medications included amlodipine besilate/benazepril hydrochloride for blood pressure, simvastatin for cholesterol, and timolol maleate for glaucoma. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced felt tired for 5 to 6 hours. On 11-MAR-2021, the subject experienced loose stool/little diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loose stool/little diarrhea, and felt tired for 5 to 6 hours on 11-MAR-2021, and chills on 10-MAR-2021. This report was non-serious.  Additional information recieved from patient on 30-MAR-2021 The following information was updated and incorporated into the case narrative: Reporter details (middle name of the reporter and new reporter), patient details (date of birth, age group, hight, weight and gender), patient medication history, concurrent condition (high blood pressure, autism, mild glaucoma, cholesterol, non smoker, non alcohol user, extreme anxiety, and stress) and concomitant medication (amlodipine besilate/benazepril hydrochloride, simvastatin and timolol maleate), RRT of the event updated to loose stool/little diarrhea and reporter causality updated.