chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Gait disturbance, Gait inability, Hypotonia, Injection site induration
Clinical narrative: area around injection site firmer; Tired, wanted to be held; legs limp and flaccid/Flaccid leg muscles; legs limp and flaccid/Flaccid leg muscles; would not stand up or walk; 23 month old, received 4th dose; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 23-month-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTP IPV HIB (received other pentacle vaccine).   On 22nd February 2022 10:15, the patient received the 4th dose of Infanrix (intramuscular). On 22nd February 2022, the patient started Infanrix Pre-Filled Syringe Device. On 22nd February 2022, less than a day after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced injection site induration, tiredness, flaccidity muscle, limping, gait inability and inappropriate age at vaccine administration. On 23rd February 2022, the outcome of the flaccidity muscle, limping and gait inability were recovered/resolved. On an unknown date, the outcome of the injection site induration, tiredness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site induration, tiredness, flaccidity muscle, limping and gait inability to be related to Infanrix and Infanrix 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 reporter was a medical doctor.   The patient received 3 other pentacle vaccine prior to receiving Infanrix. The patient received Infanrix in left anterior leg.  He had no other vaccines on this day.   The doctor stated that, the patient was tired after he got home after his vaccination, and he wanted to be held, so his mother held him for a long time.  When his mother put him down, she noticed that, there was no spontaneous movement in either of his legs, they were limp and flaccid.   The patient would not stand up or walk.   There was no swelling at the injection site, but the area around the injection site was firmer.   EMS was called around 5 pm.   After much effort, the EMS team was able to get the child to bear weight on his legs, but he would not walk. The next evening, the doctor had a video conference with his mother, and the symptoms had resolved. The patient was able to lift his legs and walk. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: area around injection site firmer; Tired, wanted to be held; legs limp and flaccid/Flaccid leg muscles; legs limp and flaccid/Flaccid leg muscles; would not stand up or walk; 23 month old, received 4th dose; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 23-month-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTP IPV HIB (received other pentacle vaccine).   On 22nd February 2022 10:15, the patient received the 4th dose of Infanrix (intramuscular). On 22nd February 2022, the patient started Infanrix Pre-Filled Syringe Device. On 22nd February 2022, less than a day after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced injection site induration, tiredness, flaccidity muscle, limping, gait inability and inappropriate age at vaccine administration. On 23rd February 2022, the outcome of the flaccidity muscle, limping and gait inability were recovered/resolved. On an unknown date, the outcome of the injection site induration, tiredness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site induration, tiredness, flaccidity muscle, limping and gait inability to be related to Infanrix and Infanrix 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 reporter was a medical doctor.   The patient received 3 other pentacle vaccine prior to receiving Infanrix. The patient received Infanrix in left anterior leg.  He had no other vaccines on this day.   The doctor stated that, the patient was tired after he got home after his vaccination, and he wanted to be held, so his mother held him for a long time.  When his mother put him down, she noticed that, there was no spontaneous movement in either of his legs, they were limp and flaccid.   The patient would not stand up or walk.   There was no swelling at the injection site, but the area around the injection site was firmer.   EMS was called around 5 pm.   After much effort, the EMS team was able to get the child to bear weight on his legs, but he would not walk. The next evening, the doctor had a video conference with his mother, and the symptoms had resolved. The patient was able to lift his legs and walk. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the first dose two years ago and did not get a second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) 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.   Previously administered products included Twinrix (1st dose received two years before the date of reporting).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not want to answer any safety questions. No more information was available. The reporter consented to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: pain/ burning; Body aches; Chills; Headaches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 08th December 2021, for tolerance to 1st dose, refer case US2022AMR040148).   On 25th February 2022, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, general body pain, chills and headache. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the general body pain, chills and headache were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, chills and headache to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR040148  Additional details were provided as follows: The patient self-reported this case. The patient received her second dose of Shingrix into the muscle of her left arm, she took Tylenol and iced her arm after the injection. The patient still experienced the pain and burning with the injection. The patient also developed body aches and chills with the second dose. The reporter did not consent to follow-up. The reporter did not give consent to contact her health care professional.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR040148:Same patient, 1st dose
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only liquid portion was administered; only liquid portion was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported. The reporter reported that only liquid portion of Menveo was administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The case had been linked to US2022039263, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039263:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only liquid portion administered; only liquid portion administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that only liquid portion of Menveo was administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2022039261, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039261:Same reporter
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child female patient who received Flu Seasonal QIV  (FluLaval Tetra 2021-2022 season) (batch number XF9HG, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported a patient received the flulaval vaccine in left deltoid after a temperature excursion.  The reporter consented to follow up.  This is 1 of 6 cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039274:same reporter US-GLAXOSMITHKLINE-US2022039275:same reporter US-GLAXOSMITHKLINE-US2022039277:same reporter US-GLAXOSMITHKLINE-US2022039278:same reporter
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Flu Seasonal QIV  (FluLaval Tetra 2021-2022 season) (batch number XF9HG, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported a patient received the flulaval vaccine after a temperature excursion.  The reporter consented to follow up.  This is 1 of 6 cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:same reporter US-GLAXOSMITHKLINE-US2022039274:same reporter US-GLAXOSMITHKLINE-US2022039275:same reporter US-GLAXOSMITHKLINE-US2022039277:same reporter
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: patients who may have been vaccinated with imporoperlu stored vaccines; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  The reporter stated that at his/her office recently discovered that fridge temperature were out of range. The reporter asked what excursions were permitted. The reporter wanted to know if the vaccines still effective. The Lowest temperature was 26F. It was first known excursion, Might had been up to 3 months. The fridge temps were pocketed. Some spots were 26 F, Some were 40F.  The reporter wanted to know if there was recommendations for patients who might have been vaccinated with improperly stored vaccines. The number of patients who received the vaccines and the demographics and lot and expiry dates, HCP stated it was unknown at the time of reporting. The reporter consented to follow up via email.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix maladministration due to expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAB (Twinrix) (batch number 93K5F5, expiry date 20th February 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.   On 3rd March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd March 2022, unknown after receiving Twinrix and Twinrix 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 health care professional reported a Twinrix maladministration due to expired dose. The patient received Twinrix which was already expired in 20th February 2022, which led to expired vaccine used. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Malaise
Clinical narrative: Malaise; Headache; insomnia; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2022, the patient received the 1st dose of Shingrix. On 2nd March 2022, 5 days after receiving Shingrix, the patient experienced malaise, headache and insomnia. On an unknown date, the outcome of the malaise, headache and insomnia were not recovered/not resolved.   It was unknown if the reporter considered the malaise, headache and insomnia to be related to Shingrix.  Additional details were provided as follows: On 2nd March 2022, in the evening, she began to feel malaise, headache and insomnia. The patient stated that the symptoms were not resolved. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: excessive swelling at injection site (softball size); This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult 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 extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that she received Shingrix vaccine (was not sure what dose or injection site), further stated that the vaccine was given over a year ago from reporting date (unknown date). The patient reported had excessive swelling at injection site (softball size).
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received an adult dose; pediatric patient received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2022, the patient received the 2nd dose of Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 1st March 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 reporter was a pharmacy intern. The reporter stated that the pediatric patient received an adult dose (1 ml) of Havrix, which led to overdose and adult product administered to child. No symptoms were reported. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: boostrix underwent above temp excur and was administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   On 28th February 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The vaccine administration facility was the same as primary reporter. The reporter stated that the Boostrix underwent above temperature excursion with high temperature of 67 degree F for 14 days and was administered to the patient, which let to incorrect storage of drug. The reporter consented to follow up. The case was linked with case US2022040246, US2022040251, US2022040252, US2022040253 and US2022040254, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040246:same reporter US-GLAXOSMITHKLINE-US2022040253:Same reporter
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Flulaval administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 334RL, expiry date 30th June 2022) 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 23rd February 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter reported that Flulaval underwent above temperature excursion with high 67 degree F for 14 days and was administered to a patient, which let to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case is one of 6 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter
Age: 30.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccines administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 30-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 334RL, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   On 1st March 2022, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Boostrix. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter reported that Flulaval and Boostrix underwent above temperature excursion with high 67 Fahrenheit for 14 days and was administered to a patient, which let to Incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number N254C, expiry date 23rd November 2023) for prophylaxis.   On 2nd March 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The reporter reported that Boostrix underwent above temperature excursion with high 67 Fahrenheit for 14 days and was administered to a patient, which let to Incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Flulaval administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2021-2022 season) (batch number 334RL, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter reported that flulaval underwent above temperature excursion with high 67 Fahrenheit for 14 days and was administered to a patient, which let to Incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid CWY component; administered only the liquid CWY component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA604A, expiry date 30th September 2022) for prophylaxis.   On 2nd March 2022, the patient received Menveo. On 2nd March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse stated that only the liquid CWY component of the Menveo vaccine was administered to the patient in the left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix more than 6 months ago from reporting date).   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 reported as follows: The reporter was patient's sister. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not provide any additional information. The reporter did not consent to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2022, the patient received the 2nd dose of Shingrix. On 25th February 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient reported this case for himself. He had pain at the injection site in the left arm. The reporter reported that this did go away after about 24 hours. However, on 3rd March 2022, the pain at the site had started again and stated it was worse. The reporter consented to follow-up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only diluent portion; received only diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 21st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only diluent portion of Menveo, without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked with case US2022040278, reported by same reporter for different patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; COVID-19 PNEUMONIA; COVID-19; This spontaneous report received from a Health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System concerned a 49 year old female 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, intramuscular, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 23-JUN-2021 on left arm (LA) for an unspecified indication. Drug start period was 235 days. No concomitant medications were reported. Patient had second bout of covid infection after 5 week of hospitalization for covid pneumonia with pulmonary embolism (PE), deep vein thrombosis (DVTs) on 12-NOV-2021. On 13-FEB-2022, the patient experienced covid-19, covid-19 pneumonia and deep vein thrombosis. On an unspecified date, the patient was hospitalized for unspecified number of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, covid-19 pneumonia and deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000219430. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the RA evaluation/investigation performed.   Additional information received from Central Complaint Vigilance department on 04-MAR-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation results.; Sender's Comments: V2: Follow up information updates about product quality complaint investigation results. This does not alter the previous causality assessment. 20220258546-covid-19 vaccine ad26.cov2.s-Covid-19, Covid-19 pneumonia, Deep vein thrombosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Paralysis, Rash
Clinical narrative: MILD HEADACHES; PARALYZED; SKIN FELT LIKE IT WAS ON FIRE; DIZZY; TROUBLE WITH VISION; DIFFICULTY WALKING; RASH ON BACK; This spontaneous report received from a patient concerned a 95 year old African American and non Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201821A and expiry: unknown) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. No adverse events reported following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total administered on 19-NOV-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 19-NOV-2021, about an hour or hour and a half later, the patient experienced difficulty walking, skin felt like it was on fire, dizzy, felt like to was paralyzed (paralysis), trouble with vision, and rash on back (Dose number in series 2). On an unspecified date, the patient experienced mild headaches (Dose number in series 2). The patient had tried cold water for these side effects and would use aspirin, and rubbing alcohol if the patient needed a pain killer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralyzed, skin felt like it was on fire, dizzy, trouble with vision, difficulty walking, and rash on back, and had not recovered from mild headaches. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220302627-covid-19 vaccine ad26. cov2. s-Paralyzed. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Visual impairment
Clinical narrative: MILD HEADACHES; PARALYZED; SKIN FELT LIKE IT WAS ON FIRE; DIZZY; TROUBLE WITH VISION; DIFFICULTY WALKING; RASH ON BACK; This spontaneous report received from a patient concerned a 95 year old African American and non Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201821A and expiry: unknown) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. No adverse events reported following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total administered on 19-NOV-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 19-NOV-2021, about an hour or hour and a half later, the patient experienced difficulty walking, skin felt like it was on fire, dizzy, felt like to was paralyzed (paralysis), trouble with vision, and rash on back (Dose number in series 2). On an unspecified date, the patient experienced mild headaches (Dose number in series 2). The patient had tried cold water for these side effects and would use aspirin, and rubbing alcohol if the patient needed a pain killer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralyzed, skin felt like it was on fire, dizzy, trouble with vision, difficulty walking, and rash on back, and had not recovered from mild headaches. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220302627-covid-19 vaccine ad26. cov2. s-Paralyzed. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bronchitis, Localised infection
Clinical narrative: INFECTED TOE; BRONCHITIS; This spontaneous report received from a patient concerned an adult female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe hidradenitis suppurativa. The patient received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number and expiry was not reported) 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drugs adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. No concomitant medications were reported.  On an unspecified date, the patient experienced infected toe, and bronchitis (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab non-company was withdrawn. The patient was recovering from infected toe, and bronchitis. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Musculoskeletal stiffness, Pain
Clinical narrative: STIFFNESS; PAIN; FEELING UNWELL; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included: stiff, and hurting, and concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced stiffness, pain, and feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab was not reported. The patient recovered from stiffness, pain, and feeling unwell. This report was non-serious. This case, involving the same patient is linked to 20220307647.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECT LIKE IF PATIENT HAD COVID-19; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced side effect like if patient had covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect like if patient had covid-19 was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Headache
Clinical narrative: HEADACHE; FELT A LITTLE STRANGE; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: patient was not taking any concomitant medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On JUL-2021, the patient experienced felt a little strange. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from felt a little strange on JUL-2021, and headache. This report was non-serious.