chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Immunisation, Inappropriate schedule of product administration
Clinical narrative: started the series of doses at age 10-11 and never received the 3rd booster. She eventually had to restart the series of doses; This spontaneous report was received from the patient's mother and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with a first dose quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, he received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) 2 weeks early before the 6 months frame (inappropriate schedule of vaccine administered). All vaccines were administered for prophylaxis.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA007004:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Product storage error, Wrong technique in product usage process
Clinical narrative: This non-serious spontaneous report (USASP2021068522) was reported to Amgen on 03/MAY/2021 by a consumer and involves an approximately 57 year old female patient who had swollen lymph node for reported 'node on the right side under the chin/jaw is hurting and swollen [PT: lymph node pain], never knew to leave her sureclick out at room temperature before injecting has not been doing it previously patient states optumrx told her enbrel could be frozen for four days [PT: wrong technique in product usage process], she had been storing in the freezer instead of in the fridge [PT: product storage error] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in the past that happened when she took something she had allergy. On 20/MAR/2021, the patient had COVID-19 vaccine and on an unknown date in 2021 the patient's lymph node on the right side under the chin/jaw was hurting and swollen. The patient wanted to know was her system building antibodies from the vaccine or could this happen from being off Enbrel because the patient had been off it a couple weeks. On 23/APR/2021, a few days ago, Friday or Saturday (30/APR/2021 or 01/MAY/2021) the patient stated that her son put her Enbrel in the freezer instead of in the fridge, which she just noticed after having attempted three doses. She stated they malfunctioned when she pulled the cap straight off and it looked like more came off than normal. When the patient pressed down the patient was not sure the needle was even going in. It stuck down but the color didn't change. Also the patient stated that she never knew to leave her Sureclick out at room temperature before injecting and had not been doing it previously. No treatment information was received. The outcome of the events lymph node pain, wrong technique in product usage process, product storage error was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event lymph node pain. The causal relationship between the events lymph node pain, wrong technique in product usage process, product storage error and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient got pre-exposure shot on 01Dec2020. She didn't understand to get another one 7 days later; Case reference number US-BN-2020-019902 is a spontaneous case report initially received from a pharmacist via Agency (reference number  USBAV20-0245) on 28-Dec-2020, and concerns a *20-year-old* female patient.  The patient's medical history and concomitant medication details were not provided.  On 01-Dec-2020, the patient received RabAvert (Inactivated Rabies Virus Vaccine, Batch no. *ARBA7318*) at unknown dose for pre-exposure prophylaxis.  On 28-Dec-2020, the patient went back for the second shot as she did not understand that she needed to get another the second dose 7 days after the first dose (inappropriate schedule of vaccine administered).   *At the time of this report it was reported that the patient did not experienced any adverse events due to RabAvert.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).   Follow up information was received from a pharmacist on 30-Jan-2021: Information included patient details, batch number, and confirmation that the patient did not experienced any adverse event due to RabaVert.; Reporter's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was actually scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.; Sender's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was actually scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.
Sex: F
Vaccine: RAB
Symptoms: Economic problem, No adverse event, Product dose omission issue
Clinical narrative: She had her Day 0 and Day 7 dose in October, but she had to delay her third dose due to cost; Case reference number US-BN-2021-000020 is a spontaneous case report initially received from pharmacist via Agency (reference number USBAV21-0021) on 15-JAN-2021, and concerns a 27-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date in Oct-2020, on day 0, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for pre-exposure vaccinations.   On an unspecified date in Oct-2020, on day 7, the patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for pre-exposure vaccinations.   It was stated that the patient had to delay her third dose due to cost (product dose omission issue).  At the time of this report it was not known whether the patient developed any adverse event.  Additional information received from Agency on 18-Jan-2021 included LRD.; Reporter's Comments: Product dose omission is listed by convention. Reportedly, the patient had to delay the third dose due to cost which is considered to be missed dose (product dose omission issue). No adverse events were reported. Product dose omission issue is not related to RabaVert, but to human action.; Sender's Comments: Product dose omission is listed by convention. Reportedly, the patient had to delay the third dose due to cost which is considered to be missed dose (product dose omission issue). No adverse events were reported. Product dose omission issue is not related to RabaVert, but to human action.
Sex: U
Vaccine: RAB
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: lump that was tender consistent with a supraclavicular node; Case reference number US-BN-2021-000035 is a spontaneous case report initially received from a consumer via GSK on 20-JAN-2021, 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 received RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) in left arm at unknown dose and route of administration for unknown indication.   On an unspecified date, on next day, it was reported as last night and this day the patient noticed a lump that was tender consistent with a supraclavicular node.  At the time of this report the outcome of the event was not provided.  The reporter did not provide the seriousness and causality assessment.  Additional information received from Agency on 25-Jan-2021 included the confirmation that the case should be process as a case; Reporter's Comments: Lymphadenopathy is listed for RabaVert as per prescriber information  and as per Agency. The patient received RabaVert and on the next day experienced a lump that was tender consistent with a supraclavicular node. No information was provided regarding the patient's medical history and concomitant medications. However, due to plausible temporal relationship and as the contributory role of RabaVert cannot be excluded, the causality is assessed as possibly related.; Sender's Comments: Lymphadenopathy is listed for RabaVert as per  prescriber information  and as per Agency. The patient received RabaVert and on the next day experienced a lump that was tender consistent with a supraclavicular node. No information was provided regarding the patient's medical history and concomitant medications. However, due to plausible temporal relationship and as the contributory role of RabaVert cannot be excluded, the causality is assessed as possibly related.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: The patient received first Rabavert pre-exposure vaccine on 27Jan2021. The patient missed Dose 2.; Case reference number US-BN-2021-000067 is a spontaneous case report initially received from a pharmacist via Agency (reference number USBAV21-0057) on 17-Feb-2021 and concerns a 20-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 27-Jan-2021, the patient received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731B, expiration date Sep-2023) at a dose of 1 mL, administrated intramuscularly for pre-exposure prophylaxis.   It was stated by the reporter that the patient forgot to come for the second dose of vaccine (product dose omission issue).   It was not reported if the patient experienced any adverse events due to RabAvert.  The reporter assessed the event as non-serious.  No further information was provided.  Company comment:  Product dose omission issue is listed by convention. Reportedly, the patient did not come for the second dose of RabAvert vaccine which is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product, but to human action.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient did not come for the second dose of RabAvert vaccine which is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product, but to human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient did not come for the second dose of RabAvert vaccine which is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product, but to human action.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product storage error
Clinical narrative: The vial was administered after a temperature excursion; Case reference number US-BN-2021-000163 is a spontaneous case report initially received from other health professional on 03-MAR-2021 and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On unknown date, the patient started therapy with RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for unknown indication. The vial was affected by temperature excursion. Duration of excursion was 12 h, and max temperature reached 8.3 C. The vial was administered to a patient.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  Company comment: Product temperature excursion issue is listed by convention. Reportedly, a vial of RabAvert was stored about 12h on temperature that reached 8.3C, which is considered to be product temperature excursion issue. The product was administered to the patient and no adverse events were reported. Product temperature excursion issue is not related to RabAvert, but to human action.; Reporter's Comments: Product temperature excursion issue is listed by convention. Reportedly, a vial of RabAvert was stored about 12h on temperature that reached 8.3C, which is considered to be product temperature excursion issue. The product was administered to the patient and no adverse events were reported. Product temperature excursion issue is not related to RabAvert, but to human action.; Sender's Comments: Product temperature excursion issue is listed by convention. Reportedly, a vial of RabAvert was stored about 12h on temperature reached 8.3C, which is considered to be product temperature excursion issue. The product was administered to the patient and no adverse events were reported. Product temperature excursion issue is not related to RabAvert, but to human action
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: First dose was administered into gluteal region; Case reference number US-BN-2021-000281 is a spontaneous case report initially received from consumer on 22-Mar-2021, and concerns a female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 17--Mar-2021, the patient started therapy with RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered into gluteal region (Product administered at inappropriate site).  On 20--Mar-2021, patient received second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered in deltoid region.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  This case is linked with cases US-BN-2021-000280 and US-BN-2021-000282 (same reporter).; Reporter's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.; Sender's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient received two doses of RabaVert and for the other two didn't show; Case reference number US-BN-2021-000708 is a spontaneous case report initially received from a pharmacist on 05-Apr-2021, and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medications included Immunoglobulin (immunoglobulin human normal).  On an unspecified date, the patient received the initial dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. not provided) at an unknown dosage regimen for post-exposure prophylaxis.  On an unspecified date, the patient received the second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. not provided) at an unknown dosage regimen for post-exposure prophylaxis.  On an unspecified date, the patient was supposed to receive the other two doses according to the vaccination schedule, but the patient was out of the town and did not show up on time for the other two doses (product dose omission issue).   At the time of this report it was not known whether the patient developed any adverse event.  Further information was not provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert for post-exposure prophylaxis instead of four. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert for post-exposure prophylaxis instead of four. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.
Sex: F
Vaccine: RAB
Symptoms: COVID-19, Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient not going to be able to come in for her 2nd vaccine on day 7; Case reference number US-BN-2021-001649  is a spontaneous case report initially received from nurse on 26-Apr-2021, and concerns a 22 years-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 21-Apr-2021, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. ARBA8018) at unknown dosage regimen for pre exposure vaccination. After the patient was administered with first dose of RabaVert, she experienced COVID-19 infection (reported as not related to vaccination), and she was not able to come for her second vaccine on day 7. The vaccination on day 14 was questioned, because that would have been when her 10 days would be up. (Inappropriate schedule of vaccine administered)  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was scheduled due to COVID-19 infection, which is considered to be inappropriate schedule of product administration. No adverse events were reported. Inappropriate schedule of product administration is not related to the vaccine itself, but to human action.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was scheduled due to COVID-19 infection, which is considered to be inappropriate schedule of product administration. No adverse events were reported. Inappropriate schedule of product administration is not related to the vaccine itself, but to human action.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Rabavert has not been given at this time; Case reference number US-BN-2021-001681 is a spontaneous case report initially received on 10-May-2021 from a pharmacist via Agency (reference number: USBAV21-0206) and concerned a male patient of unspecified age.   The patient's medical history was not reported.  The patient's concomitant medication included HRIG (immunoglobulin human anti-rabies) for post-exposure.  On unspecified date, the patient was supposed to receive Rabavert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: not reported) at unknown dose for post-exposure, but the vaccine was not given (explicitly coded as 'Product dose omission issue').  The reporter did not give consent for further follow-up.  This case is linked to the case US-BN-2021-001682 (the same reporter).   No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received only HRIG for post-exposure and RabAvert was not administered. That is considered to be missed dose. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received only HRIG for post-exposure and RabAvert was not administered. That is considered to be missed dose. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site streaking, Lymphadenopathy, Lymphangitis
Clinical narrative: ipsilateral axillary lymphadenopathy; Lymphangitis; Injection site cellulitis; Injection site streaking; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LYMPHANGITIS (Lymphangitis) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphadenopathy axillary (from the first moderna vaccine on 1/8/21) since 08-Jan-2021.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced LYMPHANGITIS (Lymphangitis) (seriousness criterion medically significant), INJECTION SITE CELLULITIS (Injection site cellulitis) and INJECTION SITE STREAKING (Injection site streaking). On an unknown date, the patient experienced LYMPHADENOPATHY (ipsilateral axillary lymphadenopathy). At the time of the report, LYMPHANGITIS (Lymphangitis), INJECTION SITE CELLULITIS (Injection site cellulitis) and INJECTION SITE STREAKING (Injection site streaking) had resolved and LYMPHADENOPATHY (ipsilateral axillary lymphadenopathy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for an unknown indication.     Concomitant products included SILDENAFIL CITRATE (VIAGRA) for an unknown indication.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: We had all 4 of the shots and the immunoglobulin for post exposure; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a 27-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RabAvert (1st dose received with immunoglobulins on 22nd November 2016), RabAvert (2nd dose received on 25th November 2016), RabAvert (3rd dose received on 29th November 2016) and RabAvert (4th dose received on 6th December 2016).   On an unknown date, the patient received the 5th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient's mother reported that they had bat in the house and the patient received 4 shots with immunoglobulins. All 4 doses received in 2016 and the patient had not received 5th dose which led to incomplete course of vaccination. This was medication error without harm. The reporter consented for follow up. This is 1 of 3 cases reported.   Following internal review it was determined that initial reciept date was 12th August 2020, which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163493: US-GLAXOSMITHKLINE-US2020AMR163473:
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration
Clinical narrative: gave it in her glute and then I saw that the information states to give it in the deltoid / One of the doses was given in the gluteus; This case was reported by a nurse via licensee and described the occurrence of intramuscular formulation administered by other route in a 85-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA731A, expiry date unknown) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle (batch number ARBA731A, expiry date unknown) for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe (batch number ARBA731A, expiry date unknown) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 5th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 5th November 2020, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient recently exposed to a bat received the rabies vaccine series. The patient was in clinic to get her day 3, 2nd dose post-exposure Rabies vaccine.  The nurse given it in the patient's glute which led to intramuscular formulation administered by other route.  Then the nurse saw it was to be given in the deltoid. The nurse asked what need to do to make the patient was protected from rabies because she had an exposure.   Follow-up information received from nurse on 5th November 2020:
Sex: F
Vaccine: RAB
Symptoms: Immunisation, Inappropriate schedule of product administration
Clinical narrative: had day 0 dose / missed day / 3 dose / came today for day 7 / This is for post exposure; This case was reported by a other health professional via licensee and described the occurrence of drug dose administration interval too long in a 35-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA651A, expiry date unknown) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On an unknown date, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The pharmacy student verified that patient had day 0 dose and missed day number 3 dose and went for day 7.  The vaccination was for post exposure.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Tinnitus
Clinical narrative: causes chronic ringing in the ears; other side effects/was awful but living with aftereffects; This case was reported by a consumer via media and described the occurrence of ringing in ears in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced ringing in ears and adverse reaction. Shingles vaccine was discontinued. On an unknown date, the outcome of the ringing in ears and adverse reaction were unknown.   The reporter considered the ringing in ears and adverse reaction to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that Shingrix caused chronic ringing in the ears and other side effects. The patient had one shot and he/she would not get another one after what it did to him/her. The patient had shingles and stated that, it was awful but living with after effects of the shot were awful too. The patient suggested to read all the information.
Age: 48.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 48 yr old patient received shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021, the patient received Shingrix. On 24th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The director of quality reported the 48 year old patient received Shingrix before recommended age, which led to inappropriate age at vaccine administration. The reporter wanted to know if there was any adverse outcome and if it was recommended to complete the vaccine series. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: had a rash that was itchy and painful on his abdomen; had a rash that was itchy and painful on his abdomen; had a rash that was itchy and painful on his abdomen; This case was reported by a physician via sales rep and described the occurrence of itchy rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced itchy rash, painful rash and pain. On an unknown date, the outcome of the itchy rash, painful rash and pain were unknown.   The reporter considered the itchy rash, painful rash and pain to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a rash that was itchy and painful on his abdomen. The reporter said that, the rash did not look like shingles and did not think it was vaccine related but was requesting additional safety information for Shingrix. No further information was available.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity, Pain of skin, Skin irritation
Clinical narrative: painful skin irritation; radiating pain in his left shoulder and down his left leg; radiating pain in his left shoulder and down his left leg; radiating pain in his left shoulder and down his left leg; This case was reported by a other health professional via sales rep and described the occurrence of skin irritation in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced skin irritation, radiating pain, shoulder pain and leg pain. On an unknown date, the outcome of the skin irritation, radiating pain, shoulder pain and leg pain were unknown.   It was unknown if the reporter considered the skin irritation, radiating pain, shoulder pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had radiating pain in left shoulder and down his left leg.  The patient told doctor he thought he had shingles, but doctor saw the patient and diagnosed him with painful skin irritation and confirmed that it was not shingles.  The patient had refused the second dose of Shingrix vaccine at the time of reporting. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Pain in extremity
Clinical narrative: pain in my arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included denosumab (Prolia) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Prolia at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and adverse drug reaction. On an unknown date, the outcome of the pain in arm and adverse drug reaction were unknown.   It was unknown if the reporter considered the pain in arm and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The patient received 1st dose of shingrix vaccine had minor side effects and experienced pain in arm. The patient wanted to know if GlaxoSmithKline have a list of the most common side effects reported after receiving the first dose of the vaccine The person who was beside the patient during the call, asked if Prolia had some interaction with Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccine my friend now is suffering with Shingles/Suspected Vaccination failure; Had vaccine my friend now is suffering with Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and at the time of reporting, he was suffering with shingles. The reporter stated that he/she understand that you had to get follow up, but why did not they tell them about that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: I got both Shingles vaccines and about 5 months later had an large and painful outbreak in the same place that reoccurs/suspected Vaccination failure; had an large and painful outbreak in the same place that reoccurs; painful outbreak; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both dose of Shingles vaccine and about 5 months later had a large and painful outbreak in the same place that reoccurs. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure / After vaccine, got shingles a year later / I got the vaccine and a year later got shingles again; After vaccine, got shingles a year later / I got the vaccine and a year later got shingles again; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (2 times before the vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself.  The age at vaccination was not reported. The patient got shingles a year later after vaccination and it did not work for him/her. The reporter mentioned that, it was worse then the 2 previous times, he/she had it before the vaccine. The reporter just pray that he/she did not get them again and asked what was shingle gel. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: arm was quite sore; arm was/ red; arm / had swelling; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included glaucoma and blood cholesterol increased. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in November 2018, and experienced arm redness and had swelling, refer case US2021AMR116501).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and swelling arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not reported, however could be 69 or 70 years. The reported medical history as taking statin, a blood pressure medication for high cholesterol and eye drops for glaucoma. The patient did not provide any product names. In 2018, the patient received the Shingrix vaccine. After Shingrix vaccination, the patient experienced that her arm was quite sore, red, and had swelling. The patient stated that there was little more redness and swelling than the Covid vaccine. The reporter consented to follow up. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116501:same reporter same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Have had shingles twice since then; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and experienced shingles twice since then. This case was considered as suspected vaccination failure since the details regarding time to onset, completion of primary vaccination  schedule and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know a person that got the shot then got the shingles!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the shingles shot then got the shingles. This case was considered as suspected vaccination failure since the details regarding time to onset, completion of primary vaccination  schedule and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Diabetic retinopathy, Optic ischaemic neuropathy, Optic neuropathy, Visual field defect
Clinical narrative: Proliferative diabetic retinopathy; Peripheral visual field defect of both eyes; Optic neuropathy; ischemic Optic neuropathy; This case was reported by a lawyer and described the occurrence of ischemic optic neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.  The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). Plaintiff current condition includes Tobacco use disorder. As per the medical records plaintiff had received Shingrix on 14 August 2018 for Prophylaxis. Patient was diagnosed with Optic neuropathy and Ischemic Optic neuropathy on 21 March 2019, Peripheral visual field defect of both eyes on 02 April 2019 and Proliferative diabetic retinopathy on 06 May 2019
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatica; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 1st October 2018, the patient received the 1st dose of Shingrix (intramuscular). On 1st February 2019, the dose was an unknown dose. On 20th October 2018, 19 days after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to Shingrix.  The initial information was received on 27 May 2021 via medical record (case is medically confirmed). The patient received Shingrix on 01 October 2018 and 01 February 2019. The patient experienced Polymyalgia Rheumatica on 20 October 2018.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatomyositis, Eyelid rash, Muscular weakness, Rash, Rash erythematous
Clinical narrative: Dermatomyositis; muscle weakness/ muscle weakness in the arms and leg; a red skin rash around the eyelids and red bumps around the joints; This case was reported by a lawyer and described the occurrence of dermatomyositis in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than a month after receiving Shingrix, the patient experienced dermatomyositis (serious criteria GSK medically significant), muscle weakness and rash. The action taken with Shingrix was unknown. On an unknown date, the outcome of the dermatomyositis, muscle weakness and rash were unknown.   It was unknown if the reporter considered the dermatomyositis, muscle weakness and rash to be related to Shingrix.  Additional details: The patient received Shingrix first dose unknown and second dose was approx. December 2019. On approx. January 2020 patient experienced Dermatomyositis was an autoimmune condition that causes skin changes and muscle weakness. Symptoms can include a red skin rash around the eyelids, red bumps around the joints, and muscle weakness in the arms and legs.