chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, Incorrect dose administered, No adverse event, Product administration error
Clinical narrative: No additional AEs were reported; patient supposed to receive only PROQUAD and also received VARIVAX on the same day due to human error; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.  On 02-MAY-2022, the patient supposed to receive only measles, mumps, rubella and varicella (oka-merck) virus vaccine (live recombinant human albumin (rHA)) (PROQUAD) (0.5ml/once, lot # was reported as u029323, upon internal validation established as U029323, expiration date: 19-MAR-2023) for prophylaxis (strength, and route of administration were not provided) but also received varicella virus vaccine live (oka/merck) (VARIVAX) (0.5ml/once, lot # was reported as t021825, upon internal validation established as T021825, expiration date: 25-JUN-2022) for prophylaxis (strength, and route of administration were not provided) due to human error (accidental overdose).  No additional adverse events were reported, no further information provided (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; expired vaccine administered; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.   On 04-MAY-2022, the patient vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, and indication were not provided; lot #T013727, expiration date: 21-APR-2022) for prophylaxis (expired product administered).  It was reported that both vaccine and sterile diluent used to reconstitute vaccine had been stored according to prescribing information through date of administration. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additonal AE's; expired dose of VAQTA that was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-MAY-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, lot #U003464, expiration date: 02-MAY-2022 (strength, site and route of administration were not provided) for prophylaxis (Expired product administered). No adverse events were reported (No adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administered subconsciously, should've been given IM; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.       Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: The case was reported by patient. The patient received a Shingrix vaccine last month. It was administered subconsciously. The patient just read that it should have been given intramuscularly. The patient asked if it was problem for him/her.  The patient got more info and he stated he was not sure if he received SHINGRIX subcutaneously or intramuscularly. He would contact the pharmacist. Additional supportive information: The patient received Shingrix subcutaneously which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Four patients received 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 patient who received HBV (Engerix B) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 28th April 2022, the patient received Engerix B. On 28th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: The medical assistant reported that the patient received an expired dose of Engerix-B vaccine. The consent to follow-up was given. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used. This case was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071926:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072337:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072338:Same reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Four patients received 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 patient who received HBV (Engerix B) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 28th April 2022, the patient received Engerix B. On 28th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: The medical assistant reported that the patient received an expired dose of Engerix-B vaccine. The consent to follow-up was given. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used. This case was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR072336:Same reporter. US-GLAXOSMITHKLINE-US2022071926:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072338:Same reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Four patients received 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 patient who received HBV (Engerix B) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 28th April 2022, the patient received Engerix B. On 28th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: The medical assistant reported that the patient received an expired dose of Engerix-B vaccine. The consent to follow-up was given. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used. This case was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR072336:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072337:Same reporter. US-GLAXOSMITHKLINE-US2022071926:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: feel itchiness; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (years before the date of reporting).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient had Shingle years ago but doctor still recommended shingle vaccine. After one week of vaccination, the patient felt itchiness almost same as when had shingles.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity
Clinical narrative: shingles, had first shingles vaccine, second one in June; pain unbearable; covered the left side of body including the left arm; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   The patient's past medical history included shingles (1st episode occured on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, pain and pain in arm. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and pain in arm to be related to Shingles vaccine.     Additional Information:  Receipt Date: 29-Apr-2022 Reporter's comments: This case was received from interactive digital media by the patient. The patient had first shingles vaccine and would get the second one in June. The patient got second case of shingles three weeks after a Covid-19 booster. Not sure if it was connected though the doctor said it was a possibility. The patient had a severe debilitating case that covered the left side of body including the left arm. Antiviral medications did not help at all. Pain was unbearable. The patient still had a great deal of pain months later. No end in sight. The reporter possibley considered the shingles, weakness and pain to be related to COVID-19 BOOSTER.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Loss of consciousness, Mobility decreased, Vomiting
Clinical narrative: I passed out; vomited; diarrhea; couldn't get up, lie on bathroom floor; This case was reported by a consumer via call center representative and described the occurrence of passed out in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), vomiting, diarrhea and mobility decreased. On an unknown date, the outcome of the passed out, vomiting, diarrhea and mobility decreased were unknown.   It was unknown if the reporter considered the passed out, vomiting, diarrhea and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporters comment: The patient self-reported the case. After receiving Shingrix, the patient was passed out and experienced vomiting and diarrhea and he/she could only lie on bathroom floor and could not get up. Since the patient had a terrible reaction to 1st dose of Shingles shot, he/she did not get the 2nd shot. The patient needed list of Shingrix ingredients to put on his/her list of things he/she was allergic to. The patient stated that, when he/she told a healthcare person of his/her bad reaction, they asked what ingredients in Shingrix he/she was allergic to.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Bad case of shingles after receiving both doses/Suspected vaccination failure; Bad case of 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: 02-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving both the doses of Shingrix, the patient got a bad case of shingles. Other supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible since contact details were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received both of the Shingrix, then got shingles very bad/Suspected vaccination failure; Then got shingles very bad; 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: 02-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving both the doses of Shingrix, the patient got shingles very bad. Other supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible since contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The patient received only liquid portion of Shingrix, without being reconstituted. The reporter wanted to know if they had to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. The reporter did not have any demographic details from patients since she send them over to the manager. The reporter provided batch number but was not sure if it was for liquid portion or lot number from the box.  The reporter consented to follow up. Additional Supportive Information: The patient first received only liquid portion of Shingrix, without being reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This is 1 of 7 link cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter US-GLAXOSMITHKLINE-US2022AMR073092:Same reporter US-GLAXOSMITHKLINE-US2022AMR073094:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The patient received only liquid portion of Shingrix, without being reconstituted. The reporter wanted to know if they had to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. The reporter did not have any demographic details from patients since she send them over to the manager. The reporter provided batch number but was not sure if it was for liquid portion or lot number from the box.  The reporter consented to follow up. Additional Supportive Information: The patient first received only liquid portion of Shingrix, without being reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This is 1 of 7 link cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022AMR073093:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter US-GLAXOSMITHKLINE-US2022AMR073092:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I missed the time frame for the 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st of Shingrix on 17th September 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: 02-MAY-2022 Reporter's comments: The case was reported via interactive digital media. The patient got the ZOS (herpes zoster recombinant) Shingrix and missed the time frame for the second dose. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Sep2021, didn't get the second dose; 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 (received 1st dose on an unknown date in September 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: 02-MAY-2022 Reporter's comments: The reporter was the patient friend. The patient did not get second dose of Shingrix and the reporter asked what to do in such case. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2 years ago we started administering Shingrix to our employees, Some employees have not; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's Comments: The reporter was a health center manager for on onsite employee wellness center and were opening back up for employees to return to work soon. 2 years before reporting they started administering Shingrix to their employees then the center shut down. Some employees had not received 2nd dose. No additional data was available. Additional Supportive Information: The patients did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second Shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018, intramuscularly).   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: 29-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received her first Shingrix vaccine but never got the second Shingrix vaccine.The patient wished to remain anonymous. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to Incomplete course of vaccination.
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: got some product in his eye; got some product in his eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 44-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2022, the patient received Shingrix. On 27th April 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Linked case(s) involving the same patient:  US2022AMR072582   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comment: The patient self-reported this case. The patient stated that as he was withdrawing Shngrix, he inadvertently got some product in his eye.  He also stated that he flushed his eyes and started Valtrex prophylactically. The reporter consented to follow-up. Additional supportive information: As the patient was withdrawing Shngrix, he inadvertently got some product in his eye, which led to occupational exposure while preparing product for administration and exposure via eye contact.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR072582:Same Reporter/Same Patient
Age: 0.33
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 4 months old patient received Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received HAV (Havrix pediatric) (batch number 4ZY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: A health care professional reported that the patient was administered with a havrix dose. The reporter consented to follow up. Additional supportive information: The 4 months old patient received havrix which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: Drawing up reconstituted vx accidentally splashed into eye; Vx accidentally splashed into her eye; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2022, the patient received Shingrix. On 27th April 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.       Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: The reporter was an HCP (pharmacist). The HCP reported that a nurse was drawing up reconstituted Shingrix and it accidentally splashed into her eye. She rinsed her eye immediately with water and was asymptomatic. She has nothing else to report. The reporter consented to follow up. The reporter had limited information. Patient initials and DOB unknown. Additional supportive information: Reconstituted Shingrix was accidentally splashed into pharmacist's eye, which led to occupational exposure while preparing product and exposure via eye contact.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose until 6 months later; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included TWINRIX (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: The pharmacist reported that the patient received her first dose of Twinrix and did not come back for a 2nd dose until 6 months later. The reporter consented to follow up via email, he had no details at time of reporting due to being at home and not at work. The details provided for 1st dose. Additional supportive information: It was unknown if the patient received 2nd dose till the time of reporting which led to incomplete course of vaccination.
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received the administration of only the diluent; Received the administration of only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a infant female patient who received Rota (Rotarix lyophilized formulation) (batch number H395H, expiry date 9th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   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: 29-APR-2022 Reporter's Comment: The reporter was medical assistant. The patient received the administration of only the diluent of Rotarix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received only the diluent of Rotarix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case had been linked to US2022071939,reported by the same reporter, for a twin patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071939:Same Reporter
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received the administration of only the diluent of vaccine; Received the administration of only the diluent of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Rota (Rotarix lyophilized formulation) (batch number H395H, expiry date 9th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   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: 29-APR-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, the patient received the administration of only the diluent of Rotarix vaccine. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, the patient received the administration of only the diluent of Rotarix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case had been linked to US2022071938, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071938:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently received four doses; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a infant patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included hepatitis B (received a dose of hepatitis B (unknown brand) at birth) and Engerix B (received 3 doses on an unknown date).   On 29th April 2022, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 29th April 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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: 29-APR-2022 Reporter's comments: Nurse practitioner reported that a patient inadvertently received four doses of Engerix-B due to a transmission error with the patient's vaccination record. On the day of reporting, the patient received 4th dose of Engerix B. The patient was reportedly not experiencing any adverse reactions at the time of the call. Additional information was not known during the call due to the caller being out of the office. The consent to follow-up was given. Additional Supportive Information: The patient received 4th dose Engerix B which led to extra dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Peripheral swelling, Pruritus, Rash
Clinical narrative: Very swollen red itchy arm for four days so far.  Headache and rash on my bottom.  Runny nose and congestion.  Took the free Covid test that I received and it was negative.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Very swollen red itchy arm for four days so far.  Headache and rash on my bottom.  Runny nose and congestion.  Took the free Covid test that I received and it was negative.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-Apr-2022 Reporter's comment: Medical assistant reported that on the day of reporting 16 years old patient received Infanrix instead of Boostrix. Consented to follow-up. Additional Supportive Information: The patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration. This case is linked with case US2022071957 reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071957:Same reporter
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: DTaP injection given on 4/5/22. Redness and pain to injection site noted in AM on 4/6/22. Redness gradually dissipated, encircling injection site for several days until no longer noted by 4/12/22. Injection site was mildly swollen during this time and pain to touch also persisted. By 4/12/22, a faint bruise was noted at the site and a small lump was palpable under the skin. Lump is approximately pea or blueberry-sized. At this time, 5/10/22, the lump - or nodule - is still palpable, has not decreased in size, and is still painful to touch. No bruising, redness, or edema noted at injection site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Fever of 102+, excruciating body pain that nothing helped including percocet, tylenol,  motrin, was unable to life my head 2 inches off my pillow, needed help to get to bathroom, and was unable to get out of bed due to all of the above for 3 days. 3 days before fever reduced.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate increased
Clinical narrative: My smart watch alerted me that I started going into A-fib, so I took half of my dose (pill) of Metoprolol (25mg) and was advised to go to the ER. My heart rate was over 150 when I got there, then it started getting back down to a normal range as the Metoprolol took effect.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: I don?t know if this is explicitly related to the vaccine, but I have been diagnosed with DVT in a femoral vein in my right leg as of 4/22/2022, when a doctor at an Urgent Care called Urgent Care found a blood clot in my femoral vein in my right leg. This is unusual because I am only 21, don?t have a history of blood clots, don?t smoke, haven?t flown on a plane in years, and am very active. I just wanted to put this in to notify that a young person that has gotten this vaccine is experiencing this.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Excessive bruising on arms, legs and trunk
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired Havrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 29th April 2022, the patient received Havrix. On 29th April 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: 2-May-2022 Reporter's comments: An expired Havrix was administered to the patient.  The consent to follow up was given via email. the vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Pt got a dose of Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received Shingrix subcutaneously. No symptoms reported. The consent to follow up was given by mail. The healthcare professional did not have the patient's date of birth or any vaccination details at time of report. Additional Supportive Information: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Age: 29.0
Sex: M
Vaccine: HEPA
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 29-year-old male patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   On 2nd May 2022, the patient received Havrix. On 2nd May 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: 2-May-2022 Reporter's comments: The patient received an expired dose of Havrix.  The consent to follow up was given via mail. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: inadvertently administered expired Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAV (Havrix adult) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 30th April 2022, unknown after receiving Havrix adult 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: 2-May-2022 Reporter's comments: The pharmacy technician called in to inquire about the efficacy and safety after expiration date. The patient was inadvertently administered an expired Havrix adult. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Havrix adult, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received 1st dose with the adjuvant portion only; Patient received 1st dose with the adjuvant portion only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th April 2022, the patient received the 1st dose of Shingrix. On 5th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Pharmacist called to report that, a patient received a Shingrix first dose with the adjuvant portion only.  There was not data available about gender date of birth and lot number at the moment of the call. Did not consent to follow-up. Additional Supportive Information: The patient received Shingrix vaccine with the adjuvant portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer metastatic, Lung cancer metastatic, Lymphadenopathy, Lymphoma
Clinical narrative: This spontaneous report was received from literature: Axillary Adenopathy after COVID-19 Vaccine: No Reason to Delay Screening Mammogram. This report concerned multiple patients. The objective of the study was to determine the outcomes of axillary lymphadenopathy after COVID-19 vaccination on breast imaging examinations. The patients height, and weight were not reported. The patients concurrent conditions included: lung cancer (one patient). The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total administered on an unspecified date 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 an unspecified date, the patients experienced axillary lymphadenopathy, lymphoma and metastatic lung cancer, metastatic to axillary lymph node and four patients was diagnosed with metastatic breast cancer. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) had benign results and malignant results. Four patients were diagnosed with metastatic breast cancer, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size (follow-up examinations within 12 weeks, 25% were given Breast Imaging Reporting and Data System or BI-RADS, category 3 recommendations. No patients in the follow-up group were diagnosed with a subsequent malignancy), No malignancy, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size (15.7 weeks after the initial examinations, decreased lymph node size and were assessed as benign), No malignancy, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size, and Sonogram (NR: not provided) lymphadenopathy (identified lymphadenopathy and the average node measured as 1.8 cm (range, 0.54.2 cm). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the axillary lymphadenopathy, metastatic breast cancer, lymphoma, lung cancer metastatic and metastatic to axillary lymph node was not reported. The authors emphasized on there should be no delay in screening mammograms due to recent vaccination and there is variable time to resolution of reactive lymphadenopathy. Lymphadenopathy should be interpreted in the context of patient risk factors with vigilance in patients with concurrent suspicious mammographic findings in the ipsilateral breast. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220458141-COVID-19 VACCINE AD26.COV2.S-lung cancer metastatic, metastatic to axillary lymph node. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Confounding factor as pre-existing medical history) 20220458141-COVID-19 VACCINE AD26.COV2.S-metastatic breast cancer, lymphoma. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.