chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Vomiting; Headache; Nausea; Case reference number BN-2021-002406, initially downloaded on 08-Nov-2021, is a spontaneous case received from a consumer/non-health professional via health authority (Safety report ID 1670637-1) and concerns a 22-year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details included Adderall (amfetamine aspartate, amfetamine sulfate, dexamfetaimne saccharate, dexamfetamine sulfate) and birth control (not specified).  On 03-Sep-2021, the patient received first dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch no. ARBA851A) at unknown dose intramuscularly in left arm for unknown indication. On the same date, the patient developed nausea, vomiting x3 events and mild headache.  At the time of this report the outcome for the events of nausea', vomiting' and headache' was unknown.  The reporter assessed events as non serious and the causality assessment was not provided.  No further information was provided.; Reporter's Comments: The 22-year-old female patient received the first dose of Rabipur for unknown indication. As reported, on the same date, the patient developed nausea, vomiting and headache. The events of nausea, vomiting and headache are listed for Rabipur according to the local Datasheet V6. The patient's medical history was not provided. The patient's concomitant medication details included Adderall. The outcome of the events of nausea, vomiting and headache was unknown. The patient's use of concomitant medication could have confounded the causality for the events. However, due to suggestive temporal relationship and known vaccine safety profile, the causality for the events of nausea, vomiting and headache is assessed as related to the suspect vaccine, since contributory role of Rabipur cannot be excluded. This case is considered non-serious.; Sender's Comments: The 22-year-old female patient received the first dose of Rabipur for unknown indication. As reported, on the same date, the patient developed nausea, vomiting and headache. The events of nausea, vomiting and headache are listed for Rabipur according to the local Datasheet V6. The patient's medical history was not provided. The patient's concomitant medication details included Adderall. The outcome of the events of nausea, vomiting and headache was unknown. The patient's use of concomitant medication could have confounded the causality for the events. However, due to suggestive temporal relationship and known vaccine safety profile, the causality for the events of nausea, vomiting and headache is assessed as related to the suspect vaccine, since contributory role of Rabipur cannot be excluded. This case is considered non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient opted not to continue with vaccine series; Case reference number US-BN-2021-002434 is a spontaneous case report initially received from other health professional via regulatory authority (reference ID: USBAV21-0582) on 16-Nov-2021 and concerns a 25-year-old female patient.  The patient's medical history was not provided.  *The patient's concomitant medication included Liletta (levonorgestrel).*  On 08-Nov-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: ARBA911C), at dose of 1 mL, administered intramuscularly, *in the right deltoid*, at unknown route of administration, for pre-exposure prophylaxis.  *As reported, on an unspecified day, the patient opted not to continue with vaccine series (explicitly coded as 'Incomplete course of vaccination').*   *The reporter confirmed that the patient did not experience any adverse event.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).   Follow up information was received from other health professional on 03-Dec-2021: New information included, date of birth and initials for patient, concomitant medication, anatomical location for vaccination, confirmation that the patient did not experience any adverse event.; Reporter's Comments: The 25-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure prophylaxis. As reported, on an unspecified date, the patient opted not to continue with vaccine series, which is considered as inappropriate schedule of product administration and therefore is listed per company convention. No associated adverse events have been reported. The patient's medical history was not provided. The patient's concomitant medication included Liletta (levonorgestrel). Inappropriate schedule of product administration is not related to RabAvert, but to a human action. This case is non-serious.; Sender's Comments: The 25-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure prophylaxis. As reported, on an unspecified date, the patient opted not to continue with vaccine series, which is considered as inappropriate schedule of product administration and therefore is listed per company convention. No associated adverse events have been reported. The patient's medical history was not provided. The patient's concomitant medication included Liletta (levonorgestrel). Inappropriate schedule of product administration is not related to RabAvert, but to a human action. This case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: The patient received first dose in the gluteal region; Case reference number US-BN-2021-002476 is a spontaneous case report initially received from a health care professional via Agency (reference number: USBAV21-0597) on 29-Nov-2021 and concerns an adult male patient.  The patient's medical history was not provided.  The patient's concomitant medication included HRIG (human rabies immunoglobulin)  On 27-Nov-2021 the patient was vaccinated with first dose of Rabavert (inactivated rabies virus vaccine; batch number: not provided) at a dose reported as one vaccine per dose in the gluteal region (explicitly coded as 'Vaccine administered at inappropriate site'), for post exposure immunization due to possible bat bite.   On 27-Nov -2021 the patient was vaccinated with second dose of Rabavert (inactivated rabies virus vaccine; batch number: not provided) at a dose reported as one vaccine per dose via in the deltoid region, for post exposure immunization due to possible bat bite.   The reporter assessed 'Vaccine administered at inappropriate site' as not related to Rabavert but as administration error.   The reporter considered 'Vaccine administered at inappropriate site' as serious life threatening (potentially, due to maladministration).  At the time of the report, it was unknown if the patient experienced any adverse event due to Rabevert.   Additional information received from regulatory authority on 30-Nov-2021: Added local RA case id.  No further information was provided.; Reporter's Comments: The 24-year-old male patient was vaccinated with first dose of Rabavert in the gluteal region for post exposure immunization due to possible bat bite, which is considered as product administered at inappropriate site, and with the second dose of Rabavert in the deltoid region. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history was not provided, and concomitant medication included HRIG (human rabies immunoglobulin). The product administered at inappropriate site has been considered as not related to Rabavert, but to a human action. This case is considered as serious due to life-threatening criteria.; Sender's Comments: The 24-year-old male patient was vaccinated with first dose of Rabavert in the gluteal region for post exposure immunization due to possible bat bite, which is considered as product administered at inappropriate site, and with the second dose of Rabavert in the deltoid region. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history was not provided, and concomitant medication included HRIG (human rabies immunoglobulin). The product administered at inappropriate site has been considered as not related to Rabavert, but to a human action. This case is considered as serious due to life- threatening criteria.
Sex: F
Vaccine: RAB
Symptoms: Discomfort, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: kind of flu feeling; Didn't feel well; Feeling like being hit by a car/you are weighted down/you worked out too hard; Case reference number US-BN-2021-002508 is a spontaneous case report initially received from a consumer via Agency (reference number USBAV21-0605) on 07-Dec-2021 and concerns a female patient.  The patient's medical history and concomitant medication details were not provided.   It was reported that the patient was previously vaccinated with RabAvert (unspecified dates).  On 04-Dec-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at a dose reported as one shot via unknown route of administration, for post-exposure immunization.   On an unspecified date, after an unknown time after vaccination, the patient was feeling like being hit by a car. It wasn't like an allergic reaction, but the patient just didn't feel well. It had been on and off like she worked out too hard and was weighted down, kind of a flu feeling, as reported.  There was no treatment given due to the adverse event.  The outcome for the events was not provided.   At the time of this report, it was unknown whether the patient received the second dose of RabAvert.  All the events were assessed as non-serious and as related to Rabipur.  Additional information received from regulatory authority on 03-Dec-2021 included the local RA case ID.  No further information was provided.; Reporter's Comments: A female patient was vaccinated with the first dose of RabAvert at a dose reported as one shot via unknown route of administration, for post-exposure immunization. On an unspecified date, after an unknown time after vaccination, the patient experienced influenza-like symptoms, malaise and abnormal feeling. Influenza-like symptoms are listed for RabAvert per Datasheet, whilst malaise and abnormal feeling are listed as non-specific events per company convention. The patient's medical history and concomitant medication details were not provided. Due to implied temporal relationship, the causality is assessed as related to RabAvert for all three events. The case is non-serious.; Sender's Comments: A female patient was vaccinated with the first dose of RabAvert at a dose reported as one shot via unknown route of administration, for post-exposure immunization. On an unspecified date, after an unknown time after vaccination, the patient experienced influenza-like symptoms, malaise and abnormal feeling. Influenza-like symptoms are listed for RabAvert per Datasheet, whilst malaise and abnormal feeling are listed as non-specific events per company convention. The patient's medical history and concomitant medication details were not provided. Due to implied temporal relationship, the causality is assessed as related to RabAvert for all three events. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Was bitten by a bat; Received all 3 of the pre exposure shots in the gluteal region; Case reference number US-BN-2021-002537 is a spontaneous case report initially received from a physician via regulatory authority (reference number: USBAV21-0626) on 15-Dec-2021 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient was vaccinated with three doses of RabAvert (inactivated rabies virus vaccine; batch number was not provided), all in the gluteal region, at an unknown dose, administered via intragluteal route of administration, for pre-exposure (explicitly coded as 'Vaccine administered at inappropriate site').   On an unspecified date, an unknown amount of time after the vaccination, the patient was bitten by a bat. The physician wanted to know if the patient should be treated as vaccinated or unvaccinated.    At the time of initial report, the outcome for the event animal bite was unknown.  The reporter did not provide seriousness or causality assessment.  Additional information received from Bavarian Nordic on 20-Dec-2021 included the local BN case ID.  No additional information provided.; Reporter's Comments: The female patient of unknown age was vaccinated with three doses of RabAvert, all in the gluteal region for pre-exposure, which is considered as product administered at inappropriate site. Reportedly, an unknown amount of time after the vaccination, the patient was bitten by a bat. The product administered at inappropriate site is considered as listed per convention, whilst animal bite is not listed for RabAvert according to the PI and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was unknown. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. The animal bite has been considered as not related to RabAvert, but to life circumstances. This case is considered as non-serious.; Sender's Comments: The female patient of unknown age was vaccinated with three doses of RabAvert, all in the gluteal region for pre-exposure, which is considered as product administered at inappropriate site. Reportedly, an unknown amount of time after the vaccination, the patient was bitten by a bat. The product administered at inappropriate site is considered as listed per convention, whilst animal bite is not listed for RabAvert according to the PI and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was unknown. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. The animal bite has been considered as not related to RabAvert, but to life circumstances. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Medication error, No adverse event, Product administered at inappropriate site
Clinical narrative: Rabavert administered in the gluteal muscle; Case reference number US-BN-2021-002544 is a spontaneous case report initially received from a health care professional via regulatory authority (reference ID: USBAV21-0636) on 17-Dec-2021 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient found a bat in her bedroom, however, no bite wound was found.  On an unspecified date, the patient was vaccinated with RabAvert (inactivated rabies virus vaccine; batch number: not reported) at an unknown dose, in the gluteal muscle via intragluteal route of administration, for post-exposure prophylaxis (explicitly coded as ' Vaccine administered at inappropriate site')  At the time of this report, it was not known whether the patient experienced any adverse event.  Additional information received on 20-Dec-2021: included local BN case ID.  No further information was provided.; Reporter's Comments: The female patient of unspecified age was vaccinated with RabAvert in the gluteal muscle, for post-exposure prophylaxis, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: The female patient of unspecified age was vaccinated with RabAvert in the gluteal muscle, for post-exposure prophylaxis, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received the third dose on day 14 instead of day 21; Case reference number US-BN-2021-002550 is a spontaneous case report initially received on 20-Dec-2021 from a pharmacist via Agency (reference number: USBAV21-0641) and concerns an adult female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first two doses of RabAvert (inactivated rabies virus vaccine; batch number: unknown), at an unknown dose, intramuscularly, for pre-exposure immunization.   On an unspecified date, 14 days after the first dose, the patient was vaccinated with the third dose of RabAvert (inactivated rabies virus vaccine; batch number: unknown), at an unknown dose, intramuscularly, for pre-exposure immunization (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown whether the patient experienced any adverse event due to RabAvert vaccine.  Additional information received on 21-Dec-2021 via Agency included reporter, patient and vaccine details.  Additional information received on 21-Dec-2021 included local RA case ID.  No further information was provided.; Reporter's Comments: The 25-year-old female patient was vaccinated with the first two doses of RabAvert for pre-exposure immunization. Reportedly, on the day 14, the patient was vaccinated with the third dose of RabAvert, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. The inappropriate schedule of product administration is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: The 25-year-old female patient was vaccinated with the first two doses of RabAvert for pre-exposure immunization. Reportedly, on the day 14, the patient was vaccinated with the third dose of RabAvert, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. The inappropriate schedule of product administration is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Second dose of RabAvert delayed several days after day 7; Case reference number US-BN-2022-000216 is a spontaneous case report initially received from a health care professional via regulatory authority (reference number USBAV22-0079) on 01-Mar-2022 and concerns a 29-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 19-Feb-2022, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at an unknown dose, route or site of administration, for pre-exposure prophylaxis (PrEP).  As reported, the RabAvert was unavailable to obtain through the vendor and the patient could not receive the second dose on day 7 (explicitly coded as 'Incomplete course of vaccination'). The reporter asked if the second dose could be delayed for several days and if the RabAvert could be interchanged with Imovax, which was available.  At the time of this report, it was unknown whether the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: A 29-year-old female patient could not receive the second dose of RabAvert for pre-exposure prophylaxis (PrEP) on day 7, because the RabAvert was unavailable to obtain through the vendor, as reported, which is considered as incomplete course of vaccination. No associated adverse events have been reported with the reported medication error. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: A 29-year-old female patient could not receive the second dose of RabAvert for pre-exposure prophylaxis (PrEP) on day 7, because the RabAvert was unavailable to obtain through the vendor, as reported, which is considered as incomplete course of vaccination. No associated adverse events have been reported with the reported medication error. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product container issue, Product dose omission issue
Clinical narrative: The doctor was not able to administer the vaccine; There were two scratches in the vial; Case reference number US-BN-2022-000848 is a spontaneous case report initially received from a pharmacist via regulatory authority (reference number: USBAV22-0105) on 24-Mar-2022 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, there were two scratches on the RabAvert (Inactivated, Strain Flury LEP), batch number YRBA821A) vial and the doctor was not able to administer the vaccine to the patient (explicitly coded as 'product dose omission issue' and 'product container issue') for post exposure immunisation.  At the time of this report, it was unknown if another vaccine was administered to the patient nor if which dose this was supposed to be.  Additional information was received from Bavarian Nordic on 28-Mar-2022 included BN PQC reference and local BN case ID.; Reporter's Comments: The reporter stated that there were two scratches on the RabAvert vial (product container issue) and the doctor was not able to administer the vaccine to the patient (product dose omission issue). Product container issue and product dose omission issue are listed by convention. No information regarding medical history and concomitant medications was provided. No associated adverse events have been reported. Product container issue and product dose omission issue are not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: The reporter stated that there were two scratches on the RabAvert vial (product container issue) and the doctor was not able to administer the vaccine to the patient (product dose omission issue). Product container issue and product dose omission issue are listed by convention. No information regarding medical history and concomitant medications was provided. No associated adverse events have been reported. Product container issue and product dose omission issue are not related to the suspect product but to a human action. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Lip swelling, Pruritus
Clinical narrative: Pruritus; Lip swelling; Case reference number BN-2022-000854, initially downloaded on 28-Mar-2022, is a spontaneous case received from a health professional via Health authority (ID: 2173543-1) and concerns a 35-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 18-Feb-2022, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine; batch number: yrba821a), at an unknown dose, intramuscularly, in the left arm, for unknown indication.  On 20-Feb-2022, two days after the RabAvert, the patient began experiencing itchiness on the arms and extremities followed by swelling of the lips and the patient took diphenhydramine (Benadryl) on Sunday.  At the time of this report, the patient's symptoms lip swelling and pruritus resolved on Sunday, as reported.  The reporter assessed all the events as non-serious. Causality for the events was not provided.  No further information was provided.; Reporter's Comments: A 35-year-old female patient experienced non-serious events of pruritus and lip swelling on the day 2 after the vaccination with the 2nd dose of RabAvert for unknown indication. The events of pruritus and lip swelling are listed according to the Datasheet v6. Time-to-onset was plausible. The patient's medical history and concomitant medication details were not provided. Reportedly, the patient recovered from the events. Considering plausible temporal relationship, known product safety profile and since the contributory role of the suspect vaccine cannot be excluded with certainty, pruritus and lip swelling have been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A 35-year-old female patient experienced non-serious events of pruritus and lip swelling on the day 2 after the vaccination with the 2nd dose of RabAvert for unknown indication. The events of pruritus and lip swelling are listed according to the Datasheet v6. Time-to-onset was plausible. The patient's medical history and concomitant medication details were not provided. Reportedly, the patient recovered from the events. Considering plausible temporal relationship, known product safety profile and since the contributory role of the suspect vaccine cannot be excluded with certainty, pruritus and lip swelling have been considered as related to RabAvert. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: Vaccinated wrong patient; Case reference number BN-2022-000855, initially downloaded on 28-Mar-2022, is a spontaneous case received from a health professional via Health authority (ID: 2178214-1) and concerns a 43-year old female patient.  The patient had no medical history.  On 14-Mar-2022, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: BNYRBA821A), at an unknown dose, intramuscularly, in the right arm, for unknown indication.  The reporter stated that the wrong patient was vaccinated, the client answered to wrong name and the client tolerated vaccine well (explicitly coded as 'Wrong patient').  At the time od this report it was unknown if the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: A 43-year old female patient was vaccinated with the first dose of RabAvert, but reporter stated that the wrong patient was vaccinated. Reportedly the client answered to wrong name and the client tolerated vaccine well. No associated adverse events were reported. Wrong patient is listed per company convention. The patient had no medical history. Giving vaccine to a wrong patient is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 43-year old female patient was vaccinated with the first dose of RabAvert, but reporter stated that the wrong patient was vaccinated. Reportedly the client answered to wrong name and the client tolerated vaccine well. No associated adverse events were reported. Wrong patient is listed per company convention. The patient had no medical history. Giving vaccine to a wrong patient is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: RAB, UNK
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: The second dose for rabies immunization was administered on day six; Imovax given as a second dose for rabies immunization after RabAvert which was given as a first dose; Case reference number BN-2022-000953, initially downloaded on 02-May-2022, is a spontaneous case received from a health care proffesional via health authority (Worldwide Unique Identifier: 2237998-1; Project number: USSA2022SA121275) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert ((Chicken Embryo Cell) (rabies virus (Inactivated, Strain Flury LEP) (PCEC) batch number was not provided)), at an unknown dose or route of administration, for pre-exposure immunization.  On an unspecified date, six days after the first dose, the patient was vaccinated with IMOVAX as the second dose of rabies immunization(Rabies vaccine; batch number was not provided), at an unknown dose or route of administration, since RabAvert could not be ordered, as reported (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Interchange of vaccine products').  It was also reported that the patient did not experience any adverse reaction.  No further information was provided.; Reporter's Comments: A patient of unknown demographics was vaccinated with IMOVAX as the second dose of rabies immunization on the day 6 after the first dose of RabAvert for pre-exposure immunization, which is considered as inappropriate schedule of product administration and interchange of vaccine products. No associated adverse events have been reported with the reported medication error. Inappropriate schedule of product administration and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and interchange of vaccine products have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with IMOVAX as the second dose of rabies immunization on the day 6 after the first dose of RabAvert for pre-exposure immunization, which is considered as inappropriate schedule of product administration and interchange of vaccine products. No associated adverse events have been reported with the reported medication error. Inappropriate schedule of product administration and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and interchange of vaccine products have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site indentation, Injection site pain, Injection site pruritus
Clinical narrative: Injecton site warm; Injection site hard; redness in arm she got her shot; swell in arm she got her shot/swelling in bump form; hives; itchy; arm redness; Arm swelling; pain and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2022, the patient received Shingrix (intramuscular). On 23rd June 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 28th June 2022, the patient experienced injection site swelling, hives, pruritus, erythema of extremities and swelling arm. On 29th June 2022, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site induration, hives, erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the injection site swelling and injection site pain were unknown and the outcome of the pruritus was recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site warmth, injection site induration, hives, pruritus, erythema of extremities and swelling arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: The reporter reported on behalf of his wife. AE (adverse event) filed.  The reporter was wondering if it was normal to have a reaction to the Shingrix vaccine 5 days after receiving it. The reporter's wife had redness and swell in the arm where she got her shot. The patient received a dose of Shingrix vaccine into unknown arm and less than a day patient experienced pain and soreness at the injection site.  The reporter reported that patient experienced swelling in bump form and redness that looked like hives and was itchy.  The reporter reported that the itching had going down but on the day of reporting the injection site was red, warm and hard.  The reporter inquired if there was any information about delayed reactions.  The reporter spoke from content and PI (package insert) and referred to HCP (health care professional).  The reporter consented to follow up. The case US2022099909 was identified as duplicate of this case. The case US2022099909 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Peripheral swelling, Urticaria
Clinical narrative: Injecton site warm; Injection site hard; redness in arm she got her shot; swell in arm she got her shot/swelling in bump form; hives; itchy; arm redness; Arm swelling; pain and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2022, the patient received Shingrix (intramuscular). On 23rd June 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 28th June 2022, the patient experienced injection site swelling, hives, pruritus, erythema of extremities and swelling arm. On 29th June 2022, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site induration, hives, erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the injection site swelling and injection site pain were unknown and the outcome of the pruritus was recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site warmth, injection site induration, hives, pruritus, erythema of extremities and swelling arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: The reporter reported on behalf of his wife. AE (adverse event) filed.  The reporter was wondering if it was normal to have a reaction to the Shingrix vaccine 5 days after receiving it. The reporter's wife had redness and swell in the arm where she got her shot. The patient received a dose of Shingrix vaccine into unknown arm and less than a day patient experienced pain and soreness at the injection site.  The reporter reported that patient experienced swelling in bump form and redness that looked like hives and was itchy.  The reporter reported that the itching had going down but on the day of reporting the injection site was red, warm and hard.  The reporter inquired if there was any information about delayed reactions.  The reporter spoke from content and PI (package insert) and referred to HCP (health care professional).  The reporter consented to follow up. The case US2022099909 was identified as duplicate of this case. The case US2022099909 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Crying, Myalgia, Pain in extremity
Clinical narrative: pain in my arm; pain on the bicep and shoulder; So painful that I cry; bicep pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   In February 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine, the patient experienced pain in arm, shoulder pain, crying and muscle pain. On an unknown date, the outcome of the pain in arm, shoulder pain, crying and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, crying and muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case reported by patient via interactive digital media. The patient received second shingles shot and had pain in arm ever since.  It was so painful sometimes that he/she cry.  It was on the bicep and often times it felt like it was in his/her shoulder too.  The patient could lift his/her shirt over head. Additional supportive information: Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: doctor has me getting two more; doctor has me getting two more; This case was reported by a consumer via interactive digital media and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received two Shingrix shots in 2018).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and extra dose administered were unknown.  Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case was reported via interactive digital media. The patient reported that he/she had two Shingrix shots in 2018 and the doctor had him/her getting two more this year. The reporter enquired of the doctor's action was right. Additional Supportive Information: The patient had received two doses of shingrix and the doctor had him/her getting two more therefore, if received, could led to potential error, extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pretty high fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment: The patient self-reported the case via interactive digital media. The patient had a pretty high fever the day after second vaccine. The patient wanted to know if it was normal. The reporter consented for follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had two doses, still get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received two doses of Shingrix vaccine and still got shingles, fairly often. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Limb discomfort
Clinical narrative: redness looks rashy; discomfort in arm; large area of arm was red; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 97-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2022, the patient received the 1st dose of Shingrix. In June 2022, 2 days after receiving Shingrix, the patient experienced injection site erythema and arm discomfort. On 28th June 2022, the patient experienced injection site rash. On an unknown date, the outcome of the injection site erythema, injection site rash and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash and arm discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient stated that approximately 2 days after receiving her 1st shot of Shingrix on right arm, she noticed a large area of her right arm was red. The redness was 6 to 7 inches in diameter and 7 days after vaccination, the redness looked rashy. The patient also stated since receiving Shingrix, less than a week after vaccination, she had discomfort in her arm. The patient provided limited information. The reporter consented to follow up with herself and healthcare professional.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix powder vials unmatched adjuvant diluents; Patients may have received the diluent 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 an unknown date, the patient received Shingrix. On an unknown date, 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: 28-JUN-2022 Reporter's comment: Pharmacist reported that they found in their stock three Shingrix powder vials unmatched with adjuvant diluents.  Three patients might have received the diluent only. The consent to follow up was given. Additional Supportive Information: The patient received Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR099690:Same Reporter, Patient 2 US-GLAXOSMITHKLINE-US2022AMR099689:Same Reporter, Patient 3
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received Shingrix. In June 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: 28-JUN-2022 Reporter's Comments: The GlaxoSmithKline sales representative called response center on the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix.  The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was somewhere in beginning of June, they were administered to 5 patients.  No further information was gathered by sales representative such as lot number, patients initials, patients genders, or route of administration.  The Vaccine Administration Facility was the same as Primary Reporter. HCP reported somewhere in beginning of June, 5 patients were administered only adjuvant.  The consented to follow up was given. Additional Supportive Information: The patient received Shingrix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022AMR100447:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter US-GLAXOSMITHKLINE-US2022101093:duplicate/deleted case