chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shot , it gave her 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 female 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 reported as follows: The case was reported by the patient's grandparent. The age at vaccination was not reported. The patient took the Shingles shot and it gave her the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: can get the shot and still get 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and still got the shingles, living proof, lessens the effects. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had it 6 times now/ had the shots / suspected vaccination failure; had it 6 times now; painful; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient had it 6 times now. She has had the shots it was not as severely since she had the vaccine but still painful. This case was considered as suspected vaccination failure, as details regarding, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Lots of people got the jab and have gotten shingles / Suspected vaccination failure; Lots of people have gotten shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 case details were reported as follows: The age at vaccination was not applicable for this report.. The reporter knew lots of people who had gotten shingles in the past months. All of them get the jab and reporter did not know one unvaxxed person who had shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and then got 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.   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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shot and then got Shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: nerve pain; was vaccinated and came down with shingles / suspected vaccination failure; came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In May 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient was vaccinated and came down with shingles this past May. The shingles were gone but he was still dealing with the nerve pain months later. The patient stated that this vaccine did not guarantee that you would not get shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shot and now I have 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.   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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shot and now had shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot. She still got 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 female 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 case details were reported as follows: The reporter was patient's family member. The age at vaccination was not reported. The patient got the shot and she still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills while sleeping; Severe headache; Body aches; This case was reported by a consumer and described the occurrence of fever in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 75AX2, expiry date unknown) for prophylaxis.   On 22nd August 2021, the patient received the 1st dose of Shingrix .5 ml. In August 2021, less than a week after receiving Shingrix, the patient experienced fever, chills and general body pain. On 22nd August 2021, the patient experienced headache. On an unknown date, the outcome of the fever, chills, headache and general body pain were recovered/resolved.   The reporter considered the fever, chills, headache and general body pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself. The patient experienced fever, chills at night while sleeping, severe headache (starting approximately 8 hours after dose and lasted for roughly 24 hours) and body aches. The patient was not hospitalized. All symptoms were gone after 48 hours. Reporter consented to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Lyme disease, Vaccination failure
Clinical narrative: Two doses and 8 months later got shingles; Lyme Disease at same time; Shingles Terrible! Still have flair ups; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), lyme disease (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and lyme disease were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, lyme disease and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient reported that, he/she had the two dose of Shingles vaccine and 8 months later got shingles on my face and on his/her scalp was terrible. The patient's doctor said good thing the patient got the vaccines, as it could had been worse. The patient stated that was a year ago and he/she still had flair ups.  The patient stated that he/she also got Lyme disease at the same time, when the patient got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation for shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: didn't work for me either. Within a year ( lifetime shot) I had Shingles; had Shingles. I have had them twice; 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, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, Shingles vaccine did not work for the him/her either, within a year (lifetime Shingles shot) the patient had shingles. The patient said that, he/she had them twice. The internist said that, the patient was not a candidate for vaccines. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. The case had been linked with US2021AMR101908, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101908:IDM response comment
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Redness; Swelling; Soreness; Tenderness; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th August 2021, the patient received the 2nd dose of Shingrix. On 20th August 2021, less than a day after receiving Shingrix, the patient experienced erythema, swelling, pain and tenderness. On an unknown date, the outcome of the erythema, swelling, pain and tenderness were unknown.   It was unknown if the reporter considered the erythema, swelling, pain and tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported the consumer for herself. The patient stated that, she received her second dose of Shingrix and later that day she began experiencing redness, swelling, soreness, and tenderness.  The patient did not know the lot number and expiration date of the dose she received.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Condition aggravated, Oral herpes
Clinical narrative: Cold sores decreased after schedule; Covid 19; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (cold sores were very usual for patient). Previously administered products included Shingrix (1st dose received 2 to 3 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cold sores and covid-19. On an unknown date, the outcome of the cold sores and covid-19 were unknown.   It was unknown if the reporter considered the cold sores and covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the patient had continued to develop cold sore after completing a dosing schedule of Shingrix over two or three years ago.  The cold sores were very usual for patient but decreased after Shingrix.  The patient contracted Covid-19 and started to develop more cold sores again.  Due to the reporter's nature and limited interactions with agent, no further probing was done to obtain more adverse event report details. The pharmacist did agree to follow-up but refused to provide any personal information, so no way for contact could be done.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Mass, Muscular weakness, Myalgia
Clinical narrative: weakness in the muscle; Joint pain; lumps under the skin / Little lumps on left hand side; Fatigue; painful if you touch it them / in contact with water hurts like needles; Muscle pain; Tngling; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9R2, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling. On an unknown date, the outcome of the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling were not recovered/not resolved.  It was unknown if the reporter considered the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient got the dose of Shingrix vaccine in the right arm and developed little lumps on left hand side every 2 ,3 inches, they go to the back, painful if you touch it them, in contact with water hurts like needles, muscle pain, fatigue, tingling, joint pain all mostly on the left hand side  The reporter consented to follow up. For tolerance to the 2nd dose refer case US2021178461; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178461:Same reporter
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nodule, Pain, Paraesthesia, Skin mass
Clinical narrative: weakness in the muscle; Joint pain; lumps under the skin / Little lumps on left hand side; Fatigue; painful if you touch it them / in contact with water hurts like needles; Muscle pain; Tngling; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9R2, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling. On an unknown date, the outcome of the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling were not recovered/not resolved.  It was unknown if the reporter considered the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient got the dose of Shingrix vaccine in the right arm and developed little lumps on left hand side every 2 ,3 inches, they go to the back, painful if you touch it them, in contact with water hurts like needles, muscle pain, fatigue, tingling, joint pain all mostly on the left hand side  The reporter consented to follow up. For tolerance to the 2nd dose refer case US2021178461; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178461:Same reporter
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Muscular weakness, Swelling
Clinical narrative: weakness in the muscle; Joint pain; lumps under the skin / Little lumps on left hand side; Fatigue; painful if you touch it them / in contact with water hurts like needles; Muscle pain; Tngling; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9R2, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling. On an unknown date, the outcome of the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling were not recovered/not resolved.  It was unknown if the reporter considered the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient got the dose of Shingrix vaccine in the right arm and developed little lumps on left hand side every 2 ,3 inches, they go to the back, painful if you touch it them, in contact with water hurts like needles, muscle pain, fatigue, tingling, joint pain all mostly on the left hand side  The reporter consented to follow up. For tolerance to the 2nd dose refer case US2021178461; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178461:Same reporter
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Condition aggravated, Fatigue, Mass, Muscular weakness
Clinical narrative: weakness in the muscle; Joint pain; lumps under the skin / Little lumps on left hand side; Fatigue; painful if you touch it them / in contact with water hurts like needles; Muscle pain; Tngling; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9R2, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling. On an unknown date, the outcome of the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling were not recovered/not resolved.  It was unknown if the reporter considered the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient got the dose of Shingrix vaccine in the right arm and developed little lumps on left hand side every 2 ,3 inches, they go to the back, painful if you touch it them, in contact with water hurts like needles, muscle pain, fatigue, tingling, joint pain all mostly on the left hand side  The reporter consented to follow up. For tolerance to the 2nd dose refer case US2021178461; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178461:Same reporter
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Nodule, Pain, Paraesthesia
Clinical narrative: weakness in the muscle; Joint pain; lumps under the skin / Little lumps on left hand side; Fatigue; painful if you touch it them / in contact with water hurts like needles; Muscle pain; Tngling; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9R2, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling. On an unknown date, the outcome of the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling were not recovered/not resolved.  It was unknown if the reporter considered the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient got the dose of Shingrix vaccine in the right arm and developed little lumps on left hand side every 2 ,3 inches, they go to the back, painful if you touch it them, in contact with water hurts like needles, muscle pain, fatigue, tingling, joint pain all mostly on the left hand side  The reporter consented to follow up. For tolerance to the 2nd dose refer case US2021178461; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178461:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of social problem in an elderly female patient who received Herpes zoster SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose on 4th February 2020).  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 patient reported that due Covid situation she missed SHINGRIX second dose. The patient stated that her physician will call Information Department in order to discuss for further instructions. The reporter consented to follow up by e-mail.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has now been over 6 months; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date over a 6 months ago).   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 reporter was an acquaintance (friend/employer) of the patient. The age at vaccination was not applicable. The reporter did not know the patient's exact date of birth.  The patient did not know the exact date (or even the month any year) of Shingrix shot 1. The patient got shot number 1 of Shingrix but did not go back for shot 2 (due to the high copay) and it was now been over 6 months, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.  It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The reporter reported the case for her sister. The reporter requested to be anonymous. The age at vaccination was not reported. The reporter reported for the patient that the patient received shingrix vaccine in arm and had malaise for few days then recovered. The reporter did not consented to follow up. This case is linked with US2021179659, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179659:same report
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received an adult dose; pediatric patient received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HBV (Engerix B adult) (batch number J2J9R, expiry date 14th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th August 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. The action taken with Engerix B Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the overdose and adult product administered to child 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 pediatric patient received an adult dose of Engerix-b instead of a pediatric dose, which led to adult product administered to child and overdose. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administrated indivertibly with bexsero instead of Boostrix; 65 years old/ was administrated indivertibly with bexsero; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 65-year-old female patient who received Men B NVS (Bexsero) (batch number abxa87az, expiry date 31st January 2022) 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 Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 nurse reported that, the 65 years old patient was administrated indivertibly with Bexsero vaccine instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event was reported .  The reporter consented to follow up.  The vaccination date was not provided.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult patient received a dose of Infanrix; 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 47-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 26th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. 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 reported as follows: Medical assistant reported that, an adult patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 26-FEB-2021. The second dose was administered today on 26-AUG-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 female patient who received HAB (Twinrix) (batch number 9RT94, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th February 2021).   On 26th August 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. The action taken with Twinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as the age at vaccination was not reported. A patient received 2nd dose of Twinrix, which was later than recommended schedule which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.  Note included in structured field batch number was reported as 9RT94 but in description of source document batch number reported as 95T9R.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 14 years old received adult dose; 14 years old received adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 14-year-old male patient who received HAV (Havrix adult) (batch number ek59b, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. In January 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 registered pharmacist reported that, the patient of 14 years old received adult dose of Havrix in January 2021 as first dose & realized once the patient arrived to the facility to receive the 2nd dose of Havrix, which led to overdose and adult product administered to child.  The reporter consented to follow up. The health care professional did not mentioned if the 2nd dose of Havrix was given.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: Patient most likely experience vasovagal syncope
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: Patient most likely experience vasovagal syncope
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had not eaten all day. She began to feel much better after drinking some apple juice approximately 10 minutes after the vaccine. EMT came to evaluate her, but she chose not to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Malaise
Clinical narrative: I started experiencing side effects from my vaccine 24 hours ( at 2pm) after my second shot, 8/31/2021. I started with aches, injection site pain, and an overall feeling of not being well . Shortly after that started ( at 2:45pm), the lymph nodes under my left arm  began to swell to the size of a tennis ball. I applied heat and took OTC pain medication. The pain continued to worsen through the night to the point that I was unable to use that arm. I did notice that the lymph nodes on the left side of my neck had started to swell. Today, 9/1/2021, the swelling in my arm pit has not gone down and has spread into the left side of my breast. The lymph node in my neck has reduced in size but now I have noticed that the lymph nodes located in my inner thighs have started to swell. I am still rotating ibuprofen and Tylenol to try to minimize the pain and get the swelling to go down.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I started experiencing side effects from my vaccine 24 hours ( at 2pm) after my second shot, 8/31/2021. I started with aches, injection site pain, and an overall feeling of not being well . Shortly after that started ( at 2:45pm), the lymph nodes under my left arm  began to swell to the size of a tennis ball. I applied heat and took OTC pain medication. The pain continued to worsen through the night to the point that I was unable to use that arm. I did notice that the lymph nodes on the left side of my neck had started to swell. Today, 9/1/2021, the swelling in my arm pit has not gone down and has spread into the left side of my breast. The lymph node in my neck has reduced in size but now I have noticed that the lymph nodes located in my inner thighs have started to swell. I am still rotating ibuprofen and Tylenol to try to minimize the pain and get the swelling to go down.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient recieved Pfizer vaccine on 8.27.2021 and reported seeing welts on 8.28.2021. Rash appears right bicep towards axilla, left wrist, back, and right leg with extreme itchiness. Patient started on steroids and diphenhydramine but itchiness still persists.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient was feeling dizzy and was shivering. Called EMT but everything was normal vitals were normal no confusion patient was repsonsive and normal.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Flushing, Hyperhidrosis, Hypertension
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient passed out 5 mins after giving vaccination.  He was unresponsive for 5 mins and paremadics came and monitored him.  Blood pressure was high.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient passed out 5 mins after giving vaccination.  He was unresponsive for 5 mins and paremadics came and monitored him.  Blood pressure was high.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Fatigue, Lethargy
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient complains of chest tightness and requests to vitals checked, nurse and lpn from minute clinic checks her and read: 144/80 bp, oxygen levels 100, and heart rate 74. nurse comes back to recheck her in 5 minutes and believes she may just feel nervous due to the second shot, patient suggests she go outside for fresh air, and end up going home, we call to check up on her, and symptoms are the same, will let us know how she feels and will call dr if symptoms dont go away
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient complains of chest tightness and requests to vitals checked, nurse and lpn from minute clinic checks her and read: 144/80 bp, oxygen levels 100, and heart rate 74. nurse comes back to recheck her in 5 minutes and believes she may just feel nervous due to the second shot, patient suggests she go outside for fresh air, and end up going home, we call to check up on her, and symptoms are the same, will let us know how she feels and will call dr if symptoms dont go away
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cyanosis, Vaccination site pain, Vascular pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient complains of chest tightness and requests to vitals checked, nurse and lpn from minute clinic checks her and read: 144/80 bp, oxygen levels 100, and heart rate 74. nurse comes back to recheck her in 5 minutes and believes she may just feel nervous due to the second shot, patient suggests she go outside for fresh air, and end up going home, we call to check up on her, and symptoms are the same, will let us know how she feels and will call dr if symptoms dont go away
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Fatigue, Lethargy
Clinical narrative: No reaction to first vaccine but are pain. Day of second vaccine two mins  after receiving vaccine had right upper chest pain and both palms of  hands turned bluish color tingling  pain in veins of lower legs and  arms.  Bp was checked 140/100 pulse 82.  15 min later bp 144/82. No history of HTN. My bp range is normal -120/80
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: No reaction to first vaccine but are pain. Day of second vaccine two mins  after receiving vaccine had right upper chest pain and both palms of  hands turned bluish color tingling  pain in veins of lower legs and  arms.  Bp was checked 140/100 pulse 82.  15 min later bp 144/82. No history of HTN. My bp range is normal -120/80
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cyanosis, Vaccination site pain, Vascular pain
Clinical narrative: No reaction to first vaccine but are pain. Day of second vaccine two mins  after receiving vaccine had right upper chest pain and both palms of  hands turned bluish color tingling  pain in veins of lower legs and  arms.  Bp was checked 140/100 pulse 82.  15 min later bp 144/82. No history of HTN. My bp range is normal -120/80
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site swelling, Pain, Pruritus
Clinical narrative: swelling 4 days later spreading beyond injection site,, itchiness, redness, soreness, headache, blurry vision
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vision blurred
Clinical narrative: swelling 4 days later spreading beyond injection site,, itchiness, redness, soreness, headache, blurry vision
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Crying, Dizziness, Dyspnoea
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER ADMINSTING THE VACCINE, IN FEW MINUTES PT STARTED CRYING, SHE HAS SHORT OF BREATH, Dizziness / Lightheadness, MILD RASH ON CHEST TRIED GIVING HER BENADRYL OR EPIPEN, PT REFUSED, SHE SAID SHE WAS FINE. CALL 911, PARAMEDICAS CAME CHECKED VITALS SHE WAS OK, SHE REFUSED TO GO TO ER. PATIENT LEFT PHARMACY AFTER 1/2 HOUR WALKING. PT WAS STABLE.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypersensitivity, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER ADMINSTING THE VACCINE, IN FEW MINUTES PT STARTED CRYING, SHE HAS SHORT OF BREATH, Dizziness / Lightheadness, MILD RASH ON CHEST TRIED GIVING HER BENADRYL OR EPIPEN, PT REFUSED, SHE SAID SHE WAS FINE. CALL 911, PARAMEDICAS CAME CHECKED VITALS SHE WAS OK, SHE REFUSED TO GO TO ER. PATIENT LEFT PHARMACY AFTER 1/2 HOUR WALKING. PT WAS STABLE.