chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: SMALL
Symptoms: Blister, Blood test abnormal, Erythema, Generalised vaccinia, Pain
Clinical narrative: Generalized vaccinia several days after wrestling with a friend who had recently received the smallpox vaccine; Generalized vaccinia several days after wrestling with a friend who had recently received the smallpox vaccine; This literature case, derived from a full-text article, was received on 11OCT2022.  Literature citation:   A 20-year-old male patient developed "generalized vaccinia several days after wrestling with a friend who had recently received the ACAM2000 (smallpox vaccine, live)" (PT: Generalised vaccinia and PT: Secondary transmission).  Case report: The case of generalized vaccinia occurred in a 20-year-old man who presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received the smallpox vaccine. Polymerase chain reaction (PCR) of blood and vesicular swabs were both positive for the vaccinia virus. The patient was treated with povidone-iodine ointment and recovered without issue.  Author's comment: Cutaneous findings are a prominent feature of many rare infectious diseases, and recognition of these findings is often essential to diagnosis.  Company comment: A male patient presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received ACAM2000. Patient was treated with povidone-iodine ointment, a broad spectrum antiseptic for topical use. Patient prior medical history or concomitant medications were not noted. The onset of generalized vaccinia and secondary transmission has been reported with ACAM2000 and cannot be ruled out, which is deemed serious and medically significant due to its probable relation.; Sender's Comments: A male patient presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received ACAM2000. Patient was treated with povidone-iodine ointment, a broad spectrum antiseptic for topical use. Patient prior medical history or concomitant medications were not noted. The onset of generalized vaccinia and secondary transmission has been reported with ACAM2000 and cannot be ruled out, which is deemed serious and medically significant due to its probable relation.
Sex: M
Vaccine: SMALL
Symptoms: Papule, Polymerase chain reaction positive, Secondary transmission, Skin plaque, Vaccinia test positive
Clinical narrative: Generalized vaccinia several days after wrestling with a friend who had recently received the smallpox vaccine; Generalized vaccinia several days after wrestling with a friend who had recently received the smallpox vaccine; This literature case, derived from a full-text article, was received on 11OCT2022.  Literature citation:   A 20-year-old male patient developed "generalized vaccinia several days after wrestling with a friend who had recently received the ACAM2000 (smallpox vaccine, live)" (PT: Generalised vaccinia and PT: Secondary transmission).  Case report: The case of generalized vaccinia occurred in a 20-year-old man who presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received the smallpox vaccine. Polymerase chain reaction (PCR) of blood and vesicular swabs were both positive for the vaccinia virus. The patient was treated with povidone-iodine ointment and recovered without issue.  Author's comment: Cutaneous findings are a prominent feature of many rare infectious diseases, and recognition of these findings is often essential to diagnosis.  Company comment: A male patient presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received ACAM2000. Patient was treated with povidone-iodine ointment, a broad spectrum antiseptic for topical use. Patient prior medical history or concomitant medications were not noted. The onset of generalized vaccinia and secondary transmission has been reported with ACAM2000 and cannot be ruled out, which is deemed serious and medically significant due to its probable relation.; Sender's Comments: A male patient presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received ACAM2000. Patient was treated with povidone-iodine ointment, a broad spectrum antiseptic for topical use. Patient prior medical history or concomitant medications were not noted. The onset of generalized vaccinia and secondary transmission has been reported with ACAM2000 and cannot be ruled out, which is deemed serious and medically significant due to its probable relation.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had it for 2 months but I did get the 2 shots/suspected vaccination failure; the side affect was worst pain; had it for 2 months; 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 (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 18-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient get the 2 shots and had them for 2 months also but the side affect was worst pain. The patient ever had to deal with. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: has them after she got the shots/suspected vaccination failure; has them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's sister) had them after she got the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had it, even with the shot/Suspected vaccination failure; Had it four times; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient received shingles shots and still experienced shingles four times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccinated!!! She still got it bad/ suspected vaccination failure; She still got it bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure 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 Shingles vaccine.  Additional details were provided as follows: The patient was reporter's aunt. The age at vaccination was not reported. The patient got vaccinated and she still got it (shingles) bad. The reporter stated that the vaccine was not the answer either. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: told me to get the 2nd one in two weeks so I did; feeling bad/ dont feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On 24th May 2022, unknown after receiving Shingles vaccine and an unknown time after receiving SHINGLES VACCINE, the patient experienced feeling unwell. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the feeling unwell and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: The patient self-reported this case. The patient went to two different pharmacist and the pharmacist told him/her to get the 2nd dose of Shingles vaccine in two weeks and the patient did. On the day of reporting the patient did not feel well and was reading information that one should not get the 2nd dose until 2 to 4 months. Since the patient received the 2nd shingles shot in two weeks which was too quick, the patient wanted to know if he/she was in any physical danger other than feeling bad. Additional Supportive Information: The patient received 2nd dose of Shingles vaccine within 2 weeks after the 1st dose, which led to shortening of vaccination schedule. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: significant muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced significant muscle pain after 2nd dose of second dose of Shingles vaccine. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: M
Vaccine: MENB
Symptoms: Rash
Clinical narrative: generalized confluent rash sparing protected areas; This case was reported by a physician via sales rep and described the occurrence of rash in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 17th October 2022, 14 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be unlikely related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-OCT-2022 Reporters comment:The reporter reported that patient received first dose of bexsero and experienced generalized confluent rash sparing protected areas.
Sex: U
Vaccine: VARZOS
Symptoms: Joint range of motion decreased
Clinical narrative: limited use of shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of joint range of motion decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was not recovered/not resolved.   It was unknown if the reporter considered the joint range of motion decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine over 2 years ago (the day before reporting) and still had limited use of shoulder. The patient asked so weigh your opinions. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Mistakenly took 3rd shot; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Patient reported that he/she mistakenly took third shot of Shingrix. Patient wanted to know what side effect he/she might have. Additional supportive information: As patient received extra dose of Shingrix mistakenly which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose given; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comment: The patient received third dose of Shingrix vaccine. The reporter consented to follow-up. Additional Supportive Information: The patient received third dose of Shingrix vaccine, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient seen his/her ex mother-in-law suffer bad with shingles.  The patient went and got a shingles shot, it made his/her arm sore for a week, so patient did not get any more shots. Additional supportive information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comments:  The pharmacist mentioned that one of their employees developed a rash after having been vaccinated with Shingrix.  She did not state whether this was after 1st or 2nd dose. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Lingering redness side effect.; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-OCT-2022 Reporters comment: This case was reported via interactive digital media. The patient had lingering redness as side effect. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 1st dose in11-24-2018, no record of receiving 2nd; This case was reported by a consumer 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 (1st dose received on 24 November 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The reporter reported that the patient received first dose of Shingrix vaccine and not had record of receiving the 2nd dose. The reporter wanted to know whether should start over the series. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter requested to consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain; redness; swelling; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to Shingles vaccine.     Additional Information: GSK receipt date : 18-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received shingles vaccine and experienced pain redness and swelling.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Ear pain, Gait disturbance, Herpes zoster, Hypoaesthesia
Clinical narrative: Shingles; itchy throat; poor balance; scalp pain/painful skin on neck and ear; numbness; bumps; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Thyroid cancer (Patient had radioactive iodine therapy). Concomitant products included clopidogrel bisulfate (Plavix).   In July 2022, the patient received the 1st dose of Shingrix (intramuscular). In July 2022, 2 weeks after receiving Shingrix, the patient experienced shingles, itchy throat, balance difficulty, scalp pain, numbness in leg and papular rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, scalp pain and papular rash were not recovered/not resolved and the outcome of the itchy throat, balance difficulty and numbness in leg were recovered/resolved.   It was unknown if the reporter considered the shingles, itchy throat, balance difficulty, scalp pain, numbness in leg and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comments: This case was reported by the patient. He received Shingrix dose about 2 weeks ago. While the patient was walking 3 mile walk his leg and feet became numb and he had poor balance. His wife had to assist his walking. The numbness and poor balance lasted a few minutes. At that time he also noticed that he had scalp pain and painful skin on his neck and ear. Even the wind blowing through his hair was painful. After he had returned from his walk, he noticed about 20 bumps on his ear and side of his neck. The patient thought that the bumps were mosquito bites or hives.  The patient saw the doctor on the day before reporting and was diagnosed with shingles. The patient was treated with Valacyclovir 1 gram tid for 7 days. The reporter consented to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain of skin, Rash papular, Throat irritation
Clinical narrative: Shingles; itchy throat; poor balance; scalp pain/painful skin on neck and ear; numbness; bumps; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Thyroid cancer (Patient had radioactive iodine therapy). Concomitant products included clopidogrel bisulfate (Plavix).   In July 2022, the patient received the 1st dose of Shingrix (intramuscular). In July 2022, 2 weeks after receiving Shingrix, the patient experienced shingles, itchy throat, balance difficulty, scalp pain, numbness in leg and papular rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, scalp pain and papular rash were not recovered/not resolved and the outcome of the itchy throat, balance difficulty and numbness in leg were recovered/resolved.   It was unknown if the reporter considered the shingles, itchy throat, balance difficulty, scalp pain, numbness in leg and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comments: This case was reported by the patient. He received Shingrix dose about 2 weeks ago. While the patient was walking 3 mile walk his leg and feet became numb and he had poor balance. His wife had to assist his walking. The numbness and poor balance lasted a few minutes. At that time he also noticed that he had scalp pain and painful skin on his neck and ear. Even the wind blowing through his hair was painful. After he had returned from his walk, he noticed about 20 bumps on his ear and side of his neck. The patient thought that the bumps were mosquito bites or hives.  The patient saw the doctor on the day before reporting and was diagnosed with shingles. The patient was treated with Valacyclovir 1 gram tid for 7 days. The reporter consented to follow-up.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain
Clinical narrative: Shingles; Redness; Pain; Blister; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine (received 10 to 15 years ago from reporting).   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced shingles, erythema, pain and blister. On an unknown date, the outcome of the shingles, erythema and pain were not recovered/not resolved and the outcome of the blister was unknown.   It was unknown if the reporter considered the shingles, erythema, pain and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine about 1 week ago from reporting. The patient reports that she now had shingles.  She had redness, pain, and she was starting to get blisters. The patient stated that this current case of shingles was in the same area as before. Patient gave consent to follow up with healthcare professional (pharmacy). The reporter consented to follow up.
Age: 44.0
Sex: F
Vaccine: HEPAB
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 44-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 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 17th October 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 17th October 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 Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The medical assistant called to inquired that how to proceed, the expiration date was firm. The reporter did not consent to follow-up. Additional supportive information: The patient inadvertently administered an expired dose of Twinrix in their facility, which led to expired vaccine used.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number H4922, expiry date 9th October 2022) for prophylaxis.   On 17th October 2022, the patient received Shingrix. On 17th October 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired FluLaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a specified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number ZD3NZ, 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 an unknown date, 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 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: 17-Oct-2022 Reporter's comment: The nurse reported that upto 5 patients might had received an expired dose of Flulaval from the 2021-2022 season. The vaccine administration facility was the same as primary reporter. The reporter said follow-up was ok via email above in reporter's details, she was not sure she could give out any patient information and she was still not sure about what patients might had gotten expired doses. The reporter consented to follow-up. Additional supportive information: The patients received an expired of Flulaval, which led to expired vaccine used.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HBV (Engerix B pediatric) (batch number 2h575, expiry date 12th September 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 17th October 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Engerix B pediatric formulation, which led to expired vaccine used. Suspect was coded as per narrative information.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient was still not vaccinated with the 2nd dose at the moment of the conversation; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately one year ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's comment: The pharmacist requested to administer the second dose or to revaccinate the patient.  That means that patient was still not vaccinated with the 2nd dose at the moment of the conversation.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.83
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 04Oct2022, 2nd 17Oct2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 10-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 737X2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 17th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   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: 17-OCT-2022 Reporters comment: The reporter was a medical assistant. The patient's first Flulaval dose was on 4th October 2022. The reporter reported that they inadvertently administered an early dose of Flulaval vaccine to a patient in their facility. The reporter did not consent to follow-up. Additional Supportive information: The patient received second dose of Flulaval vaccine early than recommended interval, which led to shortening of vaccinations schedule.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving Havrix and Havrix 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: 18-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.  Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-Oct-2022 Reporter's comment: The reporter consented to follow-up with health care professional. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The vaers details were reported for the first dose of Shingrix.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 6th October 2022, the patient received Havrix. On 6th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comment: Medical assistance reported that the patient was administered expired doses of Havrix. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used. This case was one of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149857:Same reporter US-GSK-US2022149859:Same reporter US-GSK-US2022149860:Same reporter
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 17th October 2022, the patient received Havrix. On 17th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comment: Medical assistance reported that a patient was administered expired dose of Havrix on different dates. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used. This case was one of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149858:Same reporter US-GSK-US2022149859:Same reporter US-GSK-US2022149857:Same reporter
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th 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 20th July 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 20th July 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 Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments: The pharmacist called and wanted to know does expiration date move, how to proceed and would patient need to be revaccinated. The RPH stated that they realized their Twinrix was expired and a few patients were administered. The RPH reported that they inadvertently administered expired Twinrix doses to three separate patients.  All administered at their facility. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used. This was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022150646:Same reporter US-GSK-US2022150645:Same reporter
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 month patient received Kinrix; Kinrix administered instead of infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by nurse. Nurse reported that 15 month patient received Kinrix. Nurse was not sure if patient received 3 doses of Pediarix before or just 2.  Nurse thought the correct vaccine that should had being administered instead of Kinrix was Infanrix.  Reporter did not consent to follow up. Additional supportive information: As patient received vaccine at inappropriate age and received Kinrix instead of Pediarix which led to inappropriate age at vaccination and wrong vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Pericardial effusion, Pericardial mass
Clinical narrative: PERICARDIAL EFFUSION/SHORTNESS OF BREATH/CHEST TIGHTNESS; PERICARDIAL/MEDIASTINAL MASS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 28-SEP-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination, the patient subsequently developed a pericardial effusion, tachycardia along with a pericardial/mediastinal mass that caused heart attack symptoms and was removed on 03-AUG-2022. The patient had also issues with shortness of breath and chest tightness (symptoms subsumed under pericardial effusion), and as of yet patient's cardiologist and pulmonologist had not been able to find the cause of this. The patient still had on going breathing issues at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pericardial/mediastinal mass on 03-AUG-2022, and had not recovered from pericardial effusion/shortness of breath/chest tightness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20221038771-covid-19 vaccine ad26.cov2.s - Pericardial effusion/shortness of breath/chest tightness, Pericardial/Mediastinal mass. The event(s) has an unknown/unclear 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
Symptoms: COVID-19
Clinical narrative: GOT OMICRON; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether the adverse event reported following to first dose of 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, and batch number were not reported) dose was not reported, 01 total, administered on JAN-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2022, the patient experienced got omicron (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got omicron was not reported. This report was non-serious. This case was associated with product quality complaint: