chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shot did not stop mine/ Suspected vaccination failure; Shot did not stop mine; 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) 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 provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and it did not stop the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got 2 part shingles shot and got the shingles/suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the 2 part shingles shot and a few years later got the shingles.  The patient had a mild case because he/she had the vaccination. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the vaccine, I have had 2 bouts of shingles/suspected vaccination failure; had 2 bouts of shingles.; blisters; bad pain; 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, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles, blister and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles vaccine couple of years ago and this past month experienced 2 bouts of shingles, very few blisters and bad pain. The patient stated nothing like what it could have been though, get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/ suspected vaccination failure; shingles; This case was reported by a consumer 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 provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and was told it was a 1 time thing you had to get, later patient got the shingles. The doctor said well if you hadn't got the shot they could have been worse. The patient stated that it seems to her/him someone is making tons of money. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine doesn´t prevent. She had the shots and had them twice/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspect vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient husband. The age at vaccination was not reported. The patient received shingle shot and had them twice. The reporter stated that the shingle shots will not 100 percent prevent shingles. the shots only prevent the severity of shingles. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I still get shingles and have had them 3 times since; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received 1st and 2nd dose last year and still experience Shingles and had 3 times since then. It was a milder case, but he/she was hoping they would be over and done with it. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had the vaccine and still got shingles.; shingles; 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) 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 provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received the Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had the shot but still got Shingles; shingles; 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) 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 provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles and could have a lighter case having it but he/she would not have wanted them any worse either. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as not contact details available.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that,  The reporter stated that, between 16 and 17 patients received Fluarix expired dose season 2020-2021, which led to expired vaccine used. The pharmacist needed time to check patients details involved in this situation. The reporter consented to follow up. This case was liked with case US2021AMR201274, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Inappropriate schedule of product administration
Clinical narrative: a stunned feeling and felt like she couldn't move; waited to get the 2nd shot 3 yrs later; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; woozy; achy; fever; headache; nausea; weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th June 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. the patient received first shingrix vaccine and immediately she had a stunned feeling and felt like she couldn't move. About 2 hours after the first vaccine injection, she exhibited the following symptoms for about 24hours woozy,achy, fever, nausea, headache, and weakness.  The patient also had pain, swelling, and redness at the injection site for about 2 weeks. all of her symptoms have resolved. Due to the reaction to her first shingrix shot, she was hesitant to get the second shot and thus, waited to get the 2nd shot 3 yrs later, which led to drug dose administration interval too long. The patient reported that no symptoms with her second shingrix vaccine. No health care professional details were provided. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Nausea
Clinical narrative: a stunned feeling and felt like she couldn't move; waited to get the 2nd shot 3 yrs later; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; woozy; achy; fever; headache; nausea; weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th June 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. the patient received first shingrix vaccine and immediately she had a stunned feeling and felt like she couldn't move. About 2 hours after the first vaccine injection, she exhibited the following symptoms for about 24hours woozy,achy, fever, nausea, headache, and weakness.  The patient also had pain, swelling, and redness at the injection site for about 2 weeks. all of her symptoms have resolved. Due to the reaction to her first shingrix shot, she was hesitant to get the second shot and thus, waited to get the 2nd shot 3 yrs later, which led to drug dose administration interval too long. The patient reported that no symptoms with her second shingrix vaccine. No health care professional details were provided. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: a stunned feeling and felt like she couldn't move; waited to get the 2nd shot 3 yrs later; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; woozy; achy; fever; headache; nausea; weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th June 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. the patient received first shingrix vaccine and immediately she had a stunned feeling and felt like she couldn't move. About 2 hours after the first vaccine injection, she exhibited the following symptoms for about 24hours woozy,achy, fever, nausea, headache, and weakness.  The patient also had pain, swelling, and redness at the injection site for about 2 weeks. all of her symptoms have resolved. Due to the reaction to her first shingrix shot, she was hesitant to get the second shot and thus, waited to get the 2nd shot 3 yrs later, which led to drug dose administration interval too long. The patient reported that no symptoms with her second shingrix vaccine. No health care professional details were provided. The reporter did not consent to follow up
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received HBV (Engerix B) (batch number 3727z, expiry date 16th October 2020) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   On 23rd September 2021, the patient received Engerix B and hepatitis B vaccine pre-filled syringe device. On 23rd September 2021, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that, the patient received an expired dose of Engerix-B, which led to expired vaccine used. No further events or details were reported. The health care professional agreed to be contacted through their email address for follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received an early second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 22nd September 2021, the patient received the 2nd dose of Havrix and hepatitis A vaccine pre-filled syringe device. On 22nd September 2021, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device and an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 age at vaccination was not reported. The reporter stated that, the patient inadvertently received an early second dose of Havrix, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 1 month apart instead of 6 months apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On an unknown date, the patient received the 2nd dose of Havrix and hepatitis A vaccine pre-filled syringe device. On an unknown date, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device and an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 age at vaccination was not reported. The reporter stated that, the patient received 2nd dose of Havrix 1 month apart instead of 6 months apart, which led to shortening of vaccination schedule. The reporter stated that, call dropped before could collect any demographic details from patient or any other information regarding the administered vaccine such as lot number o expiration date. The reporter did not consent to follow up.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received the HAVRIX that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HAV (Havrix) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   On 24th September 2021, the patient received Havrix and hepatitis A vaccine pre-filled syringe device. On 24th September 2021, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional stated that, the patient received expired dose of Havrix, which led to expired vaccine used. No reactions reported. The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: No adverse event, Overdose
Clinical narrative: Pediarix and Kinrix at the same time; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 5CK5K, expiry date 17th January 2022) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 was administered with Pediarix and Kinrix at the same time, which led to overdose. No adverse event were reported at the time of call and no further details were provided. The reporter consented to follow up via mail.
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to 16 month old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Kinrix dose was given to the patient at 16 months of age, which led to inappropriate age at vaccine administration. No other details of the vaccine was provided. The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: 19 YO male received the first dose of the Engerix-B adult vaccine inadvertently; 19 YO male received the first dose of the Engerix-B adult; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 19-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   In September 2021, the patient received the 1st dose of Engerix B adult. In September 2021, unknown after receiving Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The 19 years old patient received dose of Engerix-B adult inadvertently about two and a half (2.5) weeks ago of the date of reporting, which led to accidental overdose and adult product administered to child. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain in extremity
Clinical narrative: sore arm; Flu-like symptoms; felt crappy; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 28th September 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms and feeling abnormal. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the pain in arm, influenza-like symptoms and feeling abnormal were not recovered/not resolved.   The reporter considered the pain in arm, influenza-like symptoms and feeling abnormal 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 Shingrix yesterday and felt bad. She stated that she had flu-like symptoms and a sore arm that started this morning.  The patient reported that she was self treating the symptoms with pain medication. Patient was unable to provide Shingrix lot, expiration date, or dosage. The reporter gave consent to follow up with her health care professional. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product administration error
Clinical narrative: 27 months old was scheduled to receive a dose of Bexsero; This case was reported by a consumer via call center representative and described the occurrence of intercepted product administration error in a 27-month-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 an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted product administration error. On an unknown date, the outcome of the intercepted product administration error 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: This case was reported by the patient's mother. The age at vaccination was not applicable for this report. The patient's demographics were not provided.  The family was moving to location and the mother wanted to get her daughter vaccinated based on the vaccine recommendations. The patient was scheduled to receive a dose of Bexsero tomorrow from the date of reporting. The mother read in the online PI that Bexsero was only indicated for patients aged 10 to 25 years old. At the time of reporting, the mother stated that she would not give the Bexsero to her daughter at this time, which led to intercepted drug administration error. Mother was given medical disclaimer and was referred to her health care professional. Consent to contact the doctor was not obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, about 1 year ago of reporting 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. The patient missed to receive the second dose of Shingrix at appropriate time and had not received it till the time of reporting, which led to incomplete course of vaccination. No vaccine data was provided. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The age at vaccination was not reported. The patient stated that after receiving the shingrix 10 days ago of the reporting date,  he developed shingles on his arm. The patient wanted to know how frequent was this and what to do for this consented to follow-up. No other information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Administration of 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On 29th September 2021, the patient received the 3rd dose of Shingrix. On 29th September 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 age at vaccination was not reported. The pharmacist reported that the patient received 3rd dose of Shingrix vaccine, which led to extra dose administered. No patient details or date of administration was reported. The reporter consented to follow up.
Age: 38.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: missing 3rd dose of Engerix-B; 1 dose: 01/12/2021 - 2 dose: 02/23/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 38-year-old male patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 23rd February 2021, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B. On 23rd February 2021, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for 3rd dose. On 12th January 2021, the patient received 1st dose of Engerix B. The patient received 2nd dose of Engerix B later than recommended interval, which led to lengthening of vaccine schedule. The health care practitioner did contact the patient to receive the 3 dose but did not come in, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 2 doses of Shingrix on same clinical day; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date 28th February 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 28th September 2021, the patient received the 2nd dose of Shingrix. On 28th September 2021, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: The pharmacist reported that a patient was administered with 2 doses of Shingrix on same clinical day, which led to overdose. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered Hiberix after it was reconstituted with sterile water; administered Hiberix after it was reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacy student reported that a patient was inadvertently administered Hiberix after it was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not had additional information at the time of reporting. The reporter did not consent to follow-up. The reporter declined follow-up from safety.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer concerned multiple patients. 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) 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 number. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chest discomfort, Feeling abnormal
Clinical narrative: CHEST HAS BEEN VERY TIGHT; WORKED UP; STROKE; This spontaneous report received from a consumer via social media concerned a 25 year old of unspecified sex, race and ethnicity (local case ID# 003264333). 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-SEP-2021, the patient experienced stroke. On an unspecified date, the patient experienced chest has been very tight, and worked up about it and the patient thought that something was wrong. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest has been very tight, worked up and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210956447-covid-19 vaccine ad26.cov2.s- 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).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Pyrexia, Tachycardia
Clinical narrative: 180 RESTING HEART RATE; RIGORS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced 180 resting heart rate, rigors, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 (unit not reported), and Heart rate (NR: not provided) 180 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 180 resting heart rate, rigors and fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Prenatal screening test, Ultrasound antenatal screen
Clinical narrative: Milk soy protein intolerance; Gastrooesophageal reflux disease; Foetal exposure during pregnancy; This solicited pregnancy report received from a consumer concerned a female neonate. The patient was enrolled in a non-company sponsored study: COVID 19 Vaccines International Pregnancy Exposure Registry number: C02188) of unknown race and ethnicity. The patient's height was reported as 55.88 cm and weight was 4.904 kilogram. The patient's pre-existing medical conditions included: the mother did not use drugs for recreational use, tobacco or alcohol during pregnancy. The female foetus mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin trans-placental, batch number: 1802072 expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid, calcium carbonate/magnesium hydroxide, docusate sodium, doxylamine succinate/pyridoxine hydrochloride, ferrous sulfate, folic acid, omeprazole, prenatal vitamins and ondansetron.  On 10-MAR-2021 (at gestational age 17 weeks and four days), the foetal exposure during pregnancy was occurred. On 30-JUL-2021 (at gestational age of 37 weeks), female foetus, was delivered by caesarean method of delivery (C-section). Primary reason for the C-section was reported to be breech presentation of baby. On 09-AUG-2021, the female neonate was diagnosed with milk soy protein intolerance (MSPI) and gastrooesophageal reflux disease and received treatment consisting of omeprazole, malox, lactulose and vitamin D. Baby has not been diagnosed with any genetic or inherited disorder. On unspecified date in 2021, Laboratory data included: Acoustic stimulation tests for which baby passed the hearing test. On unspecified date Laboratory data included: alphafetoprotein, foetal nuchal translucency, prenatal cell-free DNA screening and prenatal screening and results did not show any problem or concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the milk soy protein intolerance, gastrooesophageal reflux disease and foetal exposure during pregnancy was not reported.  The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and milk soy protein intolerance, and gastrooesophageal reflux disease was related, and between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958843. This parent/child case is linked to 20210763712.; Sender's Comments: V0: 20210958552-Covid-19 vaccine ad26.cov2.s-milk soy protein intolerance, Gastrooesophageal reflux disease. This event(s) is considered related. 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).