chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: also had a melanoma develop on his back; Patient had a warm feeling at the injection site; Patient had some swelling at the injection site; Patient had some tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of MALIGNANT MELANOMA (also had a melanoma develop on his back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007H20A and 011L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALIGNANT MELANOMA (also had a melanoma develop on his back) (seriousness criterion medically significant), VACCINATION SITE WARMTH (Patient had a warm feeling at the injection site), VACCINATION SITE SWELLING (Patient had some swelling at the injection site) and VACCINATION SITE PAIN (Patient had some tenderness at the injection site). At the time of the report, MALIGNANT MELANOMA (also had a melanoma develop on his back), VACCINATION SITE WARMTH (Patient had a warm feeling at the injection site), VACCINATION SITE SWELLING (Patient had some swelling at the injection site) and VACCINATION SITE PAIN (Patient had some tenderness at the injection site) outcome was unknown.            Concomitant medications details were not reported by the reporter.  The patient also had a melanoma develop on back. The patient says the melanoma was related to sun damage. The melanoma was removed.  Treatment details were not reported by the reporter.  Company comment: This spontaneous case reported by a patient, concerns a 78-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Malignant melanoma. The event occurred on the same day of receiving second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Reporter stated that the melanoma was reported to the sun damage, and it was removed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-676537, MOD-2022-676549, MOD-2022-676551 (Patient Link).; Sender's Comments: This spontaneous case reported by a patient, concerns a 78-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Malignant melanoma. The event occurred on the same day of receiving second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Reporter stated that the melanoma was reported to the sun damage, and it was removed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: Caller reported VARIVAX and PROQUAD were administered to a 12 month old at the same visit.  No other information provided.  No Additional AEs or PQC reported.; Caller reported VARIVAX and PROQUAD were administered to a 12 month old at the same visit.  No other information provided.  No Additional AEs or PQC reported.; This spontaneous report was received from a nurse prescriber and refers to a 12-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 04-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) 0.5 milliliter (ml), lot # U031561, expiration date: 06-APR-2023, administered subcutaneously (SQ) for prophylaxis (strength was not provided), and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # U015681, expiration date: 18-MAY-2023, administered subcutaneously for prophylaxis (strength was not provided) (Overdose) at the same visit. No other adverse event occurred (No adverse event).
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Cardiac index normal, Cardiac output, Incomplete course of vaccination, Laboratory test, Vascular resistance pulmonary
Clinical narrative: Flu immunization and shingles vaccine were due; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included flu vaccine (received dose on and unknown date) and Shingrix (received dose on and unknown date). Concurrent medical conditions included rheumatoid arthritis and pulmonary arterial hypertension. Concomitant products included sildenafil, ambrisentan (Letairis), treprostinil sodium (Remodulin) and ibuprofen (Advil).   On an unknown date, the patient did not receive Flu vaccine and Shingles vaccine. On an unknown date, unknown after receiving Flu vaccine and Shingles vaccine, 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: 16-NOV-2022 Reporter's Comments:  The patient was due for flu immunization and shingles vaccines. The patient was informed. Additional Supportive Information: Till the time of reporting, the patient did not receive dose of flu vaccine and shingles vaccine, which led to incomplete course of vaccination. Incomplete course of vaccination event captured conservatively since it was unknown that how many doses of flu and shingles vaccine were received.; Sender's Comments:  USCH2022AMR044838: ID
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Product administered at inappropriate site, Skin discolouration
Clinical narrative: Grey dots on legs; Vaccine administered at inappropriate site; This case was reported by a pharmacist and described the occurrence of skin discoloration in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number BD27G, expiry date unknown) for prophylaxis and pneumococcal vaccine (Prevenar) for prophylaxis.   On 10th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, the patient started Prevenar at an unknown dose and frequency. On 10th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171028   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots on skin after receiving Pediarix and Hiberix. The reporter was consented to follow up. Additional supportive information: For tolerance to the 2nd dose refer case US2022AMR171028. This was 1 of 19 linked cases, reported by same reporter It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Skin discolouration
Clinical narrative: gray dots that have been noted on patient's legs on right thigh  after receiving Pediarix, Hiberix and/or Prevnar.; This case was reported by a pharmacist and described the occurrence of skin discoloration in a 4-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number BD27G, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR) for prophylaxis.   Previously administered products included Pediarix (On 8th Jun 2022 1st dose received of Pediarix and Hiberix For tolerance to the 1st dose refer case US2022AMR171034) and Hiberix.   On 11th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, the patient received PREVENAR. On an unknown date, less than 3 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171034, US2022AMR171042   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Pediarix and Hiberix. The reporter consented to follow up. Additional supportive information: For tolerance to the 3rd dose refer case US2022AMR171042. This was 1 of 19 linked cases, reported by same reporter It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, less than 6 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171048, US2022AMR171050, US2022AMR171052   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on left thigh that have been noted on patient's legs after receiving Pediarix and Hiberix. The reporter consented to follow up. Additional supportive information: For tolerance to the 2nd, 3rd dose refer case US2022AMR171048, US2022AMR171050 and US2022AMR171052. This was 1 of 19 linked cases, reported by same reporter It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration
Clinical narrative: Gray dot on right thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number BD27G, expiry date unknown) for prophylaxis.   On 27th June 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. On an unknown date, less than 5 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171083   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Pediarix and Hiberix and Prevenar The reporter consented to follow up. Additional supportive information: For tolerance to the2nd dose refer case US2022AMR171083. This was 1 of 19 linked cases, reported by same reporter As per narrative after receiving Pediarix, Hiberix and/or Prevnar,suspect Prevenar conservatively coded; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter
Age: 0.42
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (On 14th Jun 2022 1st dose received .) and hiberix (On 14th Jun 2022 1st dose received .).   On 14th September 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix 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.   Linked case(s) involving the same patient:  US2022AMR171044, US2022AMR171050, US2022AMR171052   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Pediarix and Hiberix and Prevenar. The reporter consented to follow up. Additional supportive information:This case has been link to the case US2022AMR171050 reported by same reporter for hiberix suspect. This was 1 of 19 linked cases, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received Hib (Hiberix) for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX).   On 17th August 2022, the patient received the 2nd dose of Hiberix. On an unknown date, less than 3 months after receiving Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Hiberix.     Linked case(s) involving the same patient:  US2022AMR171044, US2022AMR171048, US2022AMR171052   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Hiberix. The reporter consented to follow up. Additional supportive information: This case has been linked to the case US2022AMR171048. This was 1 of 19 linked cases, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received Hib (Hiberix) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (received 1st dose on 14th June 2022, refer link case US2022AMR171044), Pediarix with an associated reaction of skin discolouration (received 2nd dose on 14th September 2022, refer link case US2022AMR171048), Hiberix (received 1st dose on 14th June 2022, refer link case US2022AMR171044) and Hiberix with an associated reaction of skin discolouration (received 2nd dose on 17th August 2022, refer link case US2022AMR171050).   On 17th October 2022, the patient received the 3rd dose of Hiberix. On an unknown date, less than a month after receiving Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Hiberix.     Linked case(s) involving the same patient:  US2022AMR171044, US2022AMR171048, US2022AMR171050   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on left thigh that have been noted on patient's legs after receiving Hiberix. The reporter consented to follow up. Additional supportive information: This case linked with US2022AMR171048, US2022AMR171050 and US2022AMR171044. This was 1 of 19 linked cases, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix 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.   Linked case(s) involving the same patient:  US2022AMR171062   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: The reporter reported that the patient experienced gray dots on the left thigh after received Pediarix vaccine. The gray mark noted on 25th October 2022 visit prior to receiving additional vaccine doses. The reporter did consent to follow up. Additional supportive information: This case had been linked with US2022AMR171062 by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (received 1st dose on 27th June 2022, refer link case US2022AMR171056).   On 7th September 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171056   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (left thigh) after receiving 2nd dose of Pediarix, 1st dose of Hiberix. The reporter was consented to follow up. Additional supportive information: This case linked with US2022AMR171056 as same patient. This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration, Vaccine positive rechallenge
Clinical narrative: Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (received 1st dose on 27th June 2022, refer link case US2022AMR171047) and Hiberix with an associated reaction of skin discolouration (received 1st dose on 27th June 2022, refer link case US2022AMR171047).   On 29th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. Rechallenge with Hiberix was positive. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171047   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving 2nd dose of Pediarix, 2nd dose of Hiberix. The reporter was consented to follow up. Additional supportive information: This case linked with US2022AMR171047 as same patient. This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR149561: US-GSK-US2022AMR148961: US-GSK-US2022AMR149560:
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration
Clinical narrative: Gray dot on right thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number FY4E9, expiry date unknown) for prophylaxis.   On 5th July 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, less than 4 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171095   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: The reporter reported that the patient experienced gray dots on right leg after received Pediarix and Hiberix vaccine. The reporter stated that the mark was observed on 28th October 2022 visit prior to receiving the additional vaccines. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 2nd dose, refer linked case US2022AMR171095, reported by same reporter. Note: As per the case was created for first doses of Pediarix and Hiberix the event onset date was not captured.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149561:
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities
Clinical narrative: been out of work; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In September 2022, unknown after receiving Shingles vaccine, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was not recovered/not resolved.   It was unknown if the reporter considered the activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had been out of work since Sep 2022. The patient was out of work because of the poison that were injecting in people. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration
Clinical narrative: Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number B4277, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number BA975, expiry date unknown) for prophylaxis.   On 20th June 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, less than 4 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171174   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving 1st dose of Pediarix, 1st dose of Hiberix. The reporter was consented to follow up. Additional supportive information: This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR149560: US-GSK-US2022AMR149561: US-GSK-US2022AMR148961:
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Skin discolouration
Clinical narrative: Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, less than 4 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix 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.   Linked case(s) involving the same patient:  US2022AMR171230, US2022AMR171264   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (left thigh) after receiving 1st dose of Pediarix, 2nd dose of Pediarix and Hiberix. The reporter was consented to follow up. Additional supportive information: This case linked with US2022AMR171230, US2022AMR171264 as same patient. This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR149560: US-GSK-US2022AMR149561: US-GSK-US2022AMR148961:
Sex: U
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age, Skin discolouration
Clinical narrative: Gray dot on thigh; 1st dose: 18-JAN-2022; This case was reported by a nurse and described the occurrence of skin discoloration in a patient who received Hib (Hiberix) (batch number 25N39, expiry date unknown) for prophylaxis.   On 18th January 2022, the patient received the 1st dose of Hiberix. On 18th January 2022, unknown after receiving Hiberix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the skin discoloration to be related to Hiberix.     Linked case(s) involving the same patient:  US2022AMR171197, US2022AMR171230   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: he reporter reported that the patient after received Hiberix and experienced gray dot on the legs. The patient received Hiberix vaccine on the day of birth. Additional supportive information: The patient received Hiberix who was younger than the indicated age which led to inappropriate age at vaccine administration. This case had been linked with US2022AMR171197 and US2022AMR171230  by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149561: US-GSK-US2022AMR149560:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 or 3 years ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date, 2 or 3 years before date of reporting).   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: 16-NOV-2022 Reporter's comments:  Pharmacist reported on 16th November 2022 that, female patient received the first dose of Shingrix 2 or 3 years ago (not exact date provided) and the second dose had not been administered yet.  The reporter asked whether they should restart the series. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. 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: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect product storage in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number P7K5P, expiry date 10th March 2023) for prophylaxis.   On 14th November 2022, the patient received Shingrix (intramuscular). On 14th November 2022, unknown after receiving Shingrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Linked case(s) involving the same patient:  US2022170353   Additional Information: GSK Receipt Date: 16-Nov-2022 Reporter's Comments:  The reporter was pharmacist (HCP). The patient was administered Shingrix vaccine, on 14th November 2022, after it was stored at room temperature for two weeks. The employee pharmacy within a medical center dispensed vaccine to patient or employee who was then directed to go to Human Resources (HR) for administration.  The patient or employee mistakenly took the vaccine home, stored it unrefrigerated for two weeks, then returned with it to HR for administration. Nothing else was reported.  The reporter consented to follow up at employee pharmacy or via email.  No other details were available at the moment of the call. Additional Supportive Information: the patient received dose of vaccine, which was stored at room temperature for 2 weeks, which led to incorrect storage of Vaccine.; Sender's Comments:  US-GSK-US2022170353:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: injection site was red/ it's still a little red, but ok otherwise.; injection site was itchy; injection site was warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site itching and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to Shingrix.     Additional Information: GSK receipt date: 16-NOV-2022 Reporter's comment: The patient had her first Shingrix vaccine about 2 weeks ago. She stated that about 24 hours after the vaccine, the injection site was itchy, red, and warm to the touch. At the time of reporting, it was still a little red, but okay otherwise. The patient did not want to provide anymore demographics and did not have any further info about the vaccine itself. The reporter did not consent to follow up.