chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No other AE/no PQC.; VAQTA was given today which expired on 03/28/2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 31-MAR-2022, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) (lot # T034003, expiration date 28-MAR-2022; strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (expired product administered). The vaccine had no history of temperature excursions. No other adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: PPV
Symptoms: Syringe issue, Underdose
Clinical narrative: a patient may have received less than the recommended dose of PNEUMOVAX 23 due to difficullty pushing the prefilled syringe rod; PNEUMOVAX 23 reorted the syringe plunger felt like it was "sticky" as if it were stuck; This spontaneous report as received from a nurse, concerning a female patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medication were not reported.  On 30-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # U018309 has been verified to be valid, expiration date not reported, but upon internal validation established as 08-JAN-2023) (anatomical location not reported) for prophylaxis. Moreover, the nurse explained that the patient may have received less than the recommended dose (incorrect dose administered) of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) due to difficulty pushing the prefilled syringe rod (syringue issue). Caller said, the health care professional (HCP) who administered the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) reported the syringe plunger felt like it was "sticky" as if it were stuck. Caller said the HCP who was administering the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) withdrew the needle and re-stuck the patient to attempt to administer the remaining medication. Caller said upon withdrawal of the needle, there appeared to be some pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) remaining in the syringe. Caller explained since she was not the HCP who administered the medication, she was unable to provide any further clarifying details. Caller declined replacement of the product. Caller was unable to provided photos or return the product because it was already discarded.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; improperly stored vaccines; This spontaneous report was received from a licensed practical nurse referring to patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 25-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, route and anatomical location were not provided), for prophylaxis (product storage error).   The administered vaccine experienced a temperature excursion in 34.3 degrees Fahrenheit for 55 minutes. There was no previous temperature excursion. No additional adverse events (AEs) were reported.   This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001791:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Nausea; arm pain; REDNESS; HEADACHE; MUSCLE ACHE; This case was reported by a consumer and described the occurrence of nausea in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced nausea, pain in arm, erythema, headache and muscle pain. On an unknown date, the outcome of the nausea, pain in arm, erythema, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the nausea, pain in arm, erythema, headache and muscle pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060153, US2022AMR060910   Additional Information: GSK receipt date:06-Apr-2022 Reporter's comment: The patient received a dose of Shingrix in left arm. The patient stated that side effects from the Shingrix vaccine were rough compared to the other vaccines. The events lasted for about 2.5 days. The reporter gave consent to follow-up with health care professional (pharmacy). Additional Supportive Information: For tolerance of 2nd and 3rd dose, refer US2022AMR060910 and US2022AMR060153, respectively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060153:same reporter US-GLAXOSMITHKLINE-US2022AMR060910:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 06-Apr-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got shingles after receiving 2 doses of Shingrix and wanted to know if there was a place to get this information reported. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Administer vaccine, expired two days prior; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Pediarix and Pediarix 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 Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: Nurse administer vaccine and upon documenting, the nurse realized that the vaccine expired two days prior. Additional Supportive Information: The patient received vaccine which was already expired which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 16 month old patient received Pediarix  instead of dtap; This will be dose4; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date 17th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments: Agency reported that patient received Pediarix instead of dtap. This would be dose 4 (1 more than the normal schedule). The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix instead of dtap as a 4th Dose, which led to wrong vaccine and extra dose administered.
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 15 months old received adult dose; 15 months old received adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 15-month-old female patient who received HAV (Havrix adult) (batch number J99R4, expiry date 20th May 2022) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's comments: Nurse Practitioner reported that 3 months old patient received a Havrix adult dose by error. Consent to follow up was reported. Additional Supportive Information: Three month old patient received adult dose of Havrix in error, which led to accidental overdose and adult product administered to child.
Age: 9.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Patient got vx on 3Sep2021 and 1Oct2021; patient born 30Apr2012 received Pediarix; patient born 30Apr2012 received Pediarix; This case was reported by a nurse via call center representative and described the occurrence of drug administration duration too short in a 9-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd September 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd September 2021, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 10th October 2021, the patient experienced drug administration duration too short and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug administration duration too short, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's comment: The patient received Pediarix on 3rd September 2021 and 10th October 2021. The reporter did not consent to follow up. Additional Supportive Information: The 9 years old patient received 1st and 2nd dose of Pediarix, which led to inappropriate age at vaccine administration. Also, 2nd dose received too early, which led to shortening of vaccination schedule.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered an 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 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB60AA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st April 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 01-Apr-2022 Reporter's Comments: The reporter stated that the patient was administered an expired dose of Bexsero and want to know what side effects to expect. No additional details were available. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected Vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's Comments: The reporter did not have the lot number or expiration date.  Daughter of patient was reporting that her mother completed her Shingrix vaccine series with her 2nd dose on 17th August 2019 and currently had shingles. Consent was not given to contact health care professional. The reporter did not consent to follow up. Additional Supportive Information: 2nd dose received on left arm. This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: pain at the injections site; fatigue; dizziness; headache; second dose greater than six months since first; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 4th April 2022, the patient received the 2nd dose of Shingrix. On 4th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 5th April 2022, the patient experienced injection site pain, fatigue, dizziness and headache. On an unknown date, the outcome of the injection site pain, fatigue, dizziness and headache were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fatigue, dizziness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comments: The patient received 2nd dose of Shingrix that it had been greater than six months since his first dose, which led to lengthening of the recommended interval between vaccine doses The reporter did not consent to follow-up.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult vaccinated with pediatric dose; adult vaccinated with pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HBV (Engerix B) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st January 2022, the patient received Engerix B .5 ml, Havrix .5 ml and Havrix Pre-Filled Syringe Device. On 21st January 2022, unknown after receiving Engerix B, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: Additional Information: GSK Receipt Date: 05-APR-2022 Reporter comment: The reporter consented to follow-up via email. Other supportive information: An adult patient was vaccinated with a pediatric dose of Havrix and a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 31.0
Sex: U
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult was administered pediatric dose; adult was administered pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 31-year-old patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 3rd March 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product 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: Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comments: The patient received Engerix B in left deltoid. The reporter did not consent to follow-up via email or postal. Other supportive information: An adult patient was administered a pediatric dose of Engerix-B inadvertently, which led to accidental underdose and adult use of a child product.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: accidentally received the adult dose; 16 year old accidentally received the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 16-year-old female patient who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 17th January 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental 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 Information: GSK Receipt Date: 06-APR-2022 Reporter's Comments: This case was reported by practice manager from a medical office. (She was not a nurse or a medical assistant). The provided lot number 39TZ2 corresponds to Engerix B. Other supportive information: 16 years old female patient accidentally received adult dose of Hepatitis B instead of the pediatric dose, which led to accidental overdose and adult product administered to child.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypertension, Vertigo
Clinical narrative: High blood pressure; vertigo; This case was reported by a pharmacist via call center representative and described the occurrence of blood pressure high in a male patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date unknown) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 29th September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than an hour after receiving Shingrix, the patient experienced blood pressure high (serious criteria hospitalization) and vertigo (serious criteria hospitalization). On an unknown date, the outcome of the blood pressure high and vertigo were unknown.   It was unknown if the reporter considered the blood pressure high and vertigo to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comments: Pharmacist reported that the patient received the first dose of Shingrix on 7th July 2021. The patient informed by email to the pharmacist that minutes after receiving the 2nd dose of Shingrix he was hospitalized due to vertigo and high blood pressure. The health care professional requested follow up by phone as soon as possible.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: it has been longer than six months since the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had her first dose in September of 2021.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: The pharmacist reported that the patient had been longer than six months since the first dose of Shingrix. The pharmacist indicated he would be giving the second dose to the patient. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered after it had been exposed to freezing temperatures; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number N3S45, expiry date 27th May 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: The office manager repored a patient was administered Shingrix after it had been exposed to freezing temperatures. The reporter consented to follow up but did not specify phone or postal, address above was office address. Additional Supportive Information: As the patient was administered Shingrix vaccine which was exposed to freezing temperatures, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, wants to get 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: The pharmacist reported that a patient came to the office to get 2nd dose of Shingrix but 1st dose was given 2 years ago. The patient didn't get the 2nd dose at the time of reporting. The pharmacist wanted to know how to proceed. The health care professional didn't provide demographic details from patient neither lot number or expiration date of 1st dose of Shingrix. The patient did not get 2nd dose at the moment of reporting. The follow up was not ask to the HCP. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Very next day after 2nd dose developed shingles; Rash on chest, sides, back and breasts; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in the middle of September 2021).   On 15th March 2022, the patient received the 2nd dose of Shingrix. On 16th March 2022, 1 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comments: This case was reported by husband for his wife.  The patient received 2nd dose of Shingrix and very next day she developed shingles, rash on chest, sides, back and breasts.  The patient went to see her physician who prescribed her Valtrex and Gabapentin and that was helping her with the symptoms of shingles. The consent obtained to contact health care professional (HCP) and consumer for follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose, Needle issue, Syringe issue
Clinical narrative: Patient received less than half of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 3527M, expiry date 3rd June 2023) for prophylaxis.   On 6th April 2022, the patient received the 2nd dose of Shingrix. On 6th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.       Additional Information: GSK Receipt Date: 6th April 2022 Reporter's Comments: The pharmacist reported that patient came for second dose of Shingrix series.  During administration, some of the product leaked out of a gap between needle and syringe.  The pharmacist estimated patient received less than half of the vaccine.  At the time of reporting, patient had not been redosed. The reporter consented to follow up. Additional Supportive Information: The patient received less than half dose of shingrix which led to accidental underdose.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered Bexsero instead of Menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: A Medical Assistant reported they inadvertently administered Bexsero instead of Menactra to the patient. A Medical Assistant wanted to know if it would it be safe to administer Menactra after Bexsero. If so, how long to wait. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received Bexsero instead of Menactra, which led to wrong vaccine administered. This case has been linked with the case US2022061050 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061050:same reporter
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered Bexsero instead of Menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: A Medical Assistant reported they inadvertently administered Bexsero instead of Menactra to the patient. A Medical Assistant wanted to know if it would it be safe to administer Menactra after Bexsero. If so, how long to wait. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received Bexsero instead of Menactra, which led to wrong vaccine administered. This case has been linked with the case US2022061048 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061048:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 skin been crazy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin been crazy. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included: had Covid-19 before vaccination, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2022, the patient experienced confirmed Covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 04-APR-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed Covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20220406167. This report was associated with product quality complaint: 90000224615. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Headache, Pain, Visual field defect
Clinical narrative: This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and was not pregnant at the time of reporting. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855791, expiry: 11-APR-2022) dose was not reported, administered on 01-APR-2022 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2022, the patient experienced mental fogginess, body aches/achiness, sharp pain behind both eyes, blurry peripheral vision on both eyes/more predominant on the left eye, and headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mental fogginess on 03-APR-2022, and was recovering from headache, body aches/achiness, sharp pain behind both eyes, and blurry peripheral vision on both eyes/more predominant on the left eye. This report was non-serious. Sender's Comments: V0:  Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient (Health care professional) concerned an adult female of unknown race and ethnicity. The patient's height, and weight were not reported. Patient was health care professional. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total administered on left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine Pfizer BioNTech Covid-19 vaccine (Tozinameran) (dose number in series 2) (form of admin not reported, route of admin, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on 28-OCT-2021 for prophylactic vaccination. On an unspecified date, the patient experienced back ache (dose number in series 2). On 03-APR-2022, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) negative. The action taken with tozinameran was not applicable. The outcome of back ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: ANGIOEDEMA; This spontaneous report received from a consumer via other manufacturer (Pfizer Inc.) concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: mild asthma (Patient had an inhaler and the asthma was diagnosed probably in 2015), and cholesterol abnormal (Patient was taking unspecified medication for cholesterol but once patient's weight went down she discontinued that medication). The patient was not taking any other prescription medications. The patient previously received influenza vaccine for prophylactic vaccination. The patient was taking flu shot every year. She got the flu shot before the covid vaccine, she separated them out. She did not receive them on the same day The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Albuterol (salbutamol) once a day inhalation by mouth for asthma.  On 08-MAR-2021, the patient experienced urticaria/hives, swelling, and angioedema (dose number in series 1). The swelling and hives lasted three or four months. The patient's primary care physician referred patient to an immunologist. The patient went to the immunologist. The immunologist started patient with antihistamines cetirizine (generic for Zyrtec), and montelukast (generic for Singulair) as a treatment (date unspecified) for angioedema. The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, administered on unspecified date for prophylactic vaccination. No adverse events reported 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. The outcome of angioedema was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220409138-COVID-19 VACCINE AD26.COV2.S-Angioedema. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous report received from a health care professional concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced down for 6 hours with exhaustion. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down for 6 hours with exhaustion was not reported. This report was non-serious. This case, involving the same patient is linked to 20220413004.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Off label use
Clinical narrative: This spontaneous report received from a patient via other manufacturer (RA) concerned a 3 decade old adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received two doses of Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) doses were not reported, 1 total, first dose administered on 04-APR-2021 and second dose administered on an unspecified date in 2021 which was off label use as inappropriate schedule of vaccine administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. 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 ulcerative colitis. On an unspecified date, the patient experienced allergic reaction (Dose number in series 1). The patient received third dose (booster dose) of Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 30-NOV-2021 for prophylactic vaccination. No adverse events reported post booster vaccination (Dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of allergic reaction, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Influenza like illness, Peripheral vascular disorder
Clinical narrative: This spontaneous report received from a consumer concerned a male 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 was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JUL-2021, the patient experienced flu-like symptoms, problems with circulation in both legs, difficulty walking, and numbness in both legs. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, problems with circulation in both legs, numbness in both legs, and difficulty walking. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a patient concerned a male 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced adverse events nos (not specified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events nos (not specified) was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous report received from a health care professional concerned a 71 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1) suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose was not reported, start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patient was down for six hours with exhaustion after receiving Janssen Covid-19 vaccine with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). On an unspecified date, patient was recovered from down for six hours with exhaustion. The patient additionally received Covid-19 vaccine ad26.cov2.s  (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was down for six hours with exhaustion after receiving Janssen Covid-19 booster vaccine (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, patient was recovered from down for six hours with exhaustion. This report was non-serious. This case, involving the same patient is linked to 20220410217.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced can't even sleep in bed because if I roll over on it I wake up because of the pain, and arm still sore like whole upper arm hurts. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still sore like whole upper arm hurts, and can't even sleep in bed because if I roll over on it I wake up because of the pain. This report was non-serious.