chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant in the US (UT) reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 10 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 10 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 11 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 11 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 12 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 12 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 13 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 13 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 14 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 14 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 15 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 15 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not able to get the 2nd within the 2-6 month; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The patient asked if he/she go and receives the second dose, would the immune response be equivalent to the response that would have occurred if he/she had been able to get the 2nd dose within the 2 to 6 month protocol. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: suspected vaccination failure; had them a lot; vacinnation every year; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate schedule of vaccine administered 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 for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine every year which led to inappropriate schedule of vaccine administered. After receiving Shingles vaccine, the patient got shingles a lot. The patient suggested to get the Shingles shot before your first outbreak. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: shingles; permanent nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, 1 week after receiving Shingles vaccine, the patient experienced shingles and nerve damage. On an unknown date, the outcome of the shingles and nerve damage were unknown.   It was unknown if the reporter considered the shingles and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received dose of Shingles vaccine and a week later developed bad case of shingles and permanent nerve damage.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: suspected vaccination failure; had them; get the shot every year; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate schedule of vaccine administered 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 for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine every year, which led to inappropriate schedule of vaccine administered. After receiving Shingles vaccine, the patient got shingles. The patient did not want them ever again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed my second shingle shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The patient missed second shingle shot, which led to incomplete course of vaccination. The patient asked could he/she still take it. The follow-up would not possible as no contact details were available.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: rash all over body; This case was reported by a physician via sales rep and described the occurrence of generalized rash in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (1st dose received on 23rd August 2021, for tolerance, refer case US2021AMR225344).   On 25th October 2021, the patient received the 2nd dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. In October 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced generalized rash. The patient was treated with prednisone and allergy medication {nos} (Allergy Medication). On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash all over body, no swelling of tongue.  The patient was prescribed with Prednisone and allergy medications. On the date of reporting (29th October 2021), the patient was going to visit the physician. It was reported that on next day, reported event on website. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR225344:same reporter
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: feverish; pain,/body ache; This case was reported by a physician via sales rep and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The patient experienced feverish pain, body ache and no rash. For tolerance of 2nd dose of Bexsero, refer case US2021AMR225328, reported by same reporter. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR225328:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling at the injection site; pain at the injection site; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of injection site swelling 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 injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient asked that how long might have had pain and swelling at the injection site with the Shingrix vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dysphagia, Fatigue
Clinical narrative: Tiredness; no swallowing of the face or throat; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced tiredness and swallowing difficult. On an unknown date, the outcome of the tiredness and swallowing difficult were unknown.   It was unknown if the reporter considered the tiredness and swallowing difficult to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was unknown. The patient received 2nd shot and was feeling a tiredness and no swallowing of the face or throat. The patient asked if he/she should just rest. The follow-up would not possible as no contact details were available. Note: The event swallowing difficult was coded conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: recalled shingrix lot was given; recalled shingrixlot was given; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Registered pharmacist reported that recalled Shingrix was administered to  patient, which led to recalled drug administered and drug dispensing error. The lot was recalled on 10th February 2021. Health care professional did not have any other details of date of administration. No other information of patient or vaccine available. Reporter did not consented to follow-up. This case was 2 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226054:same reporter US-GLAXOSMITHKLINE-US2021225649:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: recalled shingrix lot was given; recalled shingrixlot was given; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Registered pharmacist reported that recalled Shingrix lot 9lh3y was administered to  patient, which led to recalled drug administered and drug dispensing error. The lot was recalled on 10th February 2021. Health care professional did not have any other details of date of administration. No other information of patient or vaccine available. Reporter did not consented to follow-up. This case was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226053:same reporter US-GLAXOSMITHKLINE-US2021225649:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2-3 years past due for the second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asked that the patient was 2 to 3 years past due for the second dose, should they restart the series. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose two years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose, two years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was self-reported. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient asked if he/she could take the 2nd dose now. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Death, General physical health deterioration
Clinical narrative: health steadily declined; This case was reported by a consumer via interactive digital media and described the occurrence of general physical health deterioration in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced general physical health deterioration (serious criteria death). On an unknown date, the outcome of the general physical health deterioration was fatal. The reported cause of death was general physical health deterioration.   It was unknown if the reporter considered the general physical health deterioration to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient was fighting cancer and her physician felt she should get Shingles vaccine and she got Shingles vaccine.  The patient's health steadily declined after the vaccine and she passed away within 2 months of the vaccine.  The reporter requested not to complicate your body if you were already fighting a life-threatening illness.  The reporter was missing his/her friend. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: health steadily decline
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the 2-6 month return window; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as he/she had missed the return window of 2 to 6 months, as per the vaccination schedule, which led to incomplete course of vaccination. The reporter asked if they could give the 2nd dose outside of the window or did they need to restart the series. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: being vaccinated on 02/04/2021,and the second was not administered yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th February 2021, batch number: H4H34, expiry date: 28th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The pharmacist reported that the patient did not receive second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reported consented to follow up The health care professional gave consent to follow up. The VAERS details were reported for 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: couple patients skipped getting their 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, over a year/ two years ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a couple patients skipped getting their 2nd dose of Shingrix due COVID and its over a year/ two years now. The reporter consented to follow up. The reporter asked for additional details but pharmacist could not provide (seemed in a rush).
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose administered 10/2019.Second dose not yet administered; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The nurse reported that the second dose of Shingrix was not received till the time of reporting, which led to incomplete course of vaccination. Nurse reporting second dose of Shingrix greater than 6 months. Lot number and expiration date unavailable per health care professional. Day of month not available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Mild rash at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th October 2021, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   The reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of  Shingrix vaccine and experienced mild rash at her injection site.  The reporter stated that the rash started the day following her injection and had resolved. The patient didn't wish to give her birthday or any more information in regards to her Shingrix vaccine. No health care professional details were provided. The patient did not consent to follow-up. This case has been linked with case US2021224256, reported by the same reporter (husband's case).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224256:Husband's case
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: numbness that started at the injection site; numbness from  the shoulder area to the fingers.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site numbness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2021, the patient received the 2nd dose of Shingrix. On 14th October 2021, 2 days after receiving Shingrix, the patient experienced injection site numbness and numbness. On an unknown date, the outcome of the injection site numbness and numbness were not recovered/not resolved.   It was unknown if the reporter considered the injection site numbness and numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the immunocompetent patient presented 2 days after the 2nd dose of Shingrix vaccine, numbness that started at the injection site and goes now from the shoulder area to the fingers. The patient got in contact with a neurologist and suggested to report the adverse event. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GM34, expiry date 10th February 2023) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On 29th October 2021, the patient received the 3rd dose of Shingrix. On 29th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient accidentally received third dose of Shingrix, which led to an extra dose administered. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the suspension portion; received only the suspension portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number b4z44, expiry date 27th January 2023) and (batch number de9LR, expiry date 27th January 2023) for prophylaxis.   On 28th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 28th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown  Additional details were reported as follows:  The nurse stated that the patient received only the suspension portion of Shingrix, not the antigen which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Some patients were given Moderna after the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some patients were given Moderna after the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some patients were given Moderna after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some patients were given Moderna after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH CASE AS WELL; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough case as well, and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough case as well and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority:90000200150. This case, from the same reporter is linked to 20211103834.; Sender's Comments: V0: 20211102956 -covid-19 vaccine ad26.cov2.s- breakthrough case as well This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211102956-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in OCT-2021, the patient died from unknown cause of death. The patient took a lot of risks after getting the vaccine too. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211103115-covid-19 vaccine ad26.cov2.s- Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Carotid artery thrombosis, Cerebrovascular accident, Cough, Hypersomnia, Suspected COVID-19
Clinical narrative: BLOOD CLOT IN CAROTID ARTERY; SUSPECTED CLINICAL VACCINATION FAILURE; SLEEPING ALL DAY; CHRONIC COUGH; SUSPECTED COVID-19 INFECTION; SMALL STROKE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: acid reflux, and allergic to some antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included omeprazole for acid reflux. Patient received Janssen covid-19 vaccine around late May or early June (patient could not find vaccine card). On 18-OCT-2021, she was recently diagnosed with covid-19 (suspected covid-19 infection) and also experienced suspected clinical vaccination failure. On an unspecified date, she was feeling very sick, like 'the grip' from the 50s. she was throwing up, felt feverish at night time, very fatigued and was sleeping all day long. She currently was feeling better, but post nasal drip was causing a chronic cough. On JUL-2021, patient suffered a small stroke (at the end of July, approximately 2 months after getting the Janssen vaccine). Blood clot was discovered in her carotid artery. Surgery has been scheduled to repair some damage done while looking for the blood clot. Patient was put on blood thinners for 10 days post stroke but was not taking any at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small stroke, was recovering from suspected covid-19 infection, blood clot in carotid artery, and suspected clinical vaccination failure, had not recovered from chronic cough, and the outcome of sleeping all day was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0 20211103276- COVID-19 VACCINE AD26.COV2.S-Blood clot in carotid artery, small stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20211103276- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: BLOOD CLOT IN CAROTID ARTERY; SUSPECTED CLINICAL VACCINATION FAILURE; SLEEPING ALL DAY; CHRONIC COUGH; SUSPECTED COVID-19 INFECTION; SMALL STROKE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: acid reflux, and allergic to some antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included omeprazole for acid reflux. Patient received Janssen covid-19 vaccine around late May or early June (patient could not find vaccine card). On 18-OCT-2021, she was recently diagnosed with covid-19 (suspected covid-19 infection) and also experienced suspected clinical vaccination failure. On an unspecified date, she was feeling very sick, like 'the grip' from the 50s. she was throwing up, felt feverish at night time, very fatigued and was sleeping all day long. She currently was feeling better, but post nasal drip was causing a chronic cough. On JUL-2021, patient suffered a small stroke (at the end of July, approximately 2 months after getting the Janssen vaccine). Blood clot was discovered in her carotid artery. Surgery has been scheduled to repair some damage done while looking for the blood clot. Patient was put on blood thinners for 10 days post stroke but was not taking any at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small stroke, was recovering from suspected covid-19 infection, blood clot in carotid artery, and suspected clinical vaccination failure, had not recovered from chronic cough, and the outcome of sleeping all day was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0 20211103276- COVID-19 VACCINE AD26.COV2.S-Blood clot in carotid artery, small stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20211103276- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: SPONTANEOUS ABORTION; DRUG EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report was received from literature: Spontaneous Abortion Following COVID-19 Vaccination During Pregnancy. JAMA. 2021 Sep 08; 326/161629-1631. This report concerned multiple patients. The objective of this study was case-control surveillance of COVID-19 vaccination during pregnancy and spontaneous abortion. The patients' height, and weight were not reported. No past medical histories and concurrent conditions were reported. It was not reported whether the patients had been pregnant before. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The patients were pregnant at the time of vaccination (drug exposure during pregnancy). The batch numbers were not reported and have been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced drug exposure during pregnancy. The date of the patients' last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a spontaneous abortion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug exposure during pregnancy and spontaneous abortion was not reported. The authors concluded that among women with spontaneous abortions, the odds of COVID-19 vaccine exposure were not increased in the prior 28 days compared with women with ongoing pregnancies. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211103304 -covid-19 vaccine ad26.cov2.s- spontaneous abortions, This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211103304 -COVID-19 VACCINE AD26.COV2.S- drug exposure during pregnancy.This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.