chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got Shingles vaccination and still got the Shingles/Suspected Vaccination Failure; got the Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got Shingles vaccination and still got the Shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient's wife via interactive digital media. The reporter stated that please be careful as her husband got his Shingles vaccination and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: came down with Bells Paulsi; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: came down with Bells Paulsi) (serious criteria GSK medically significant). The outcome of the bell's palsy was not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that he/she had the Shingles shot and came down with Bells Paulsi for the rest of his/her life. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shots but continue to be effected by shingles/Suspected Vaccination Failure; effected by shingles; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots but continue to be effected by shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: effected by shingles) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient had them multiple times and could attest to the pain.  The patient stated that had the shots but he/she was one of those people who continue to be effected by shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Malaise, Ophthalmic herpes zoster, Paraesthesia, Pruritus
Clinical narrative: had both shots came close to going blind from it/suspected vaccination failure; close to going blind from it; ill; sick; itching; tingling on forehead; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots came close to going blind from it/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: close to going blind from it) (serious criteria GSK medically significant), unwell (Verbatim: ill), sickness (Verbatim: sick), pruritus (Verbatim: itching) and tingling (Verbatim: tingling on forehead). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, unwell and sickness were not reported and the outcome of the pruritus and tingling were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, unwell, sickness, pruritus and tingling to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, unwell, sickness, pruritus and tingling to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that he/she came close to going blind from it. The patient was so sick that before he/she could heal enough to fly his/her mother died and he/she could not be there to hold her hand.  The patient stated that three and half years later he/she still get the itching and tingling on forehead. The patient had both shots and the shots made him/her quite ill also. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: had both shots came close to going blind from it/suspected vaccination failure; close to going blind from it; ill; sick; itching; tingling on forehead; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots came close to going blind from it/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: close to going blind from it) (serious criteria GSK medically significant), unwell (Verbatim: ill), sickness (Verbatim: sick), pruritus (Verbatim: itching) and tingling (Verbatim: tingling on forehead). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, unwell and sickness were not reported and the outcome of the pruritus and tingling were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, unwell, sickness, pruritus and tingling to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, unwell, sickness, pruritus and tingling to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that he/she came close to going blind from it. The patient was so sick that before he/she could heal enough to fly his/her mother died and he/she could not be there to hold her hand.  The patient stated that three and half years later he/she still get the itching and tingling on forehead. The patient had both shots and the shots made him/her quite ill also. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have got them after the 2 shots/Suspected Vaccination Failure; have got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: have got them after the 2 shots/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: have got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that sad crying face was not the emoji he/she would use.  The patient stated that it was far far worse than that. The patient had got them even after the 2 shots they gave you for prevention. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shot didn't work, got them now/Suspected Vaccination Failure; got them now; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shot didn't work, got them now/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient stated the shot did not work for him/her and he/she got them now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR059667, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR059667:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurts). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that, thank god he/she got my first vaccine and her/him arm hurts a lot now. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 22-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurts). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got his/her first round and arm hurts but small price to pay he/she think. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Little fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 22-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced fever (Verbatim: Little fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the second one today and experienced little fever sore tomorrow, but so much better than Shingles. The patient sister had them years ago. no shots, had to be admitted to hospital for 2 weeks so painful we thought we would lose her. get the shots. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient got a shingles shot yesterday, sore arm but glad she got the shot. The patient sure the shingles would hurt more than the shot. (Same for her husband). The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information. This case has been linked with case US2023AMR058736 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058736:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient wife via interactive digital media. The patient got a shingles shot and experienced sore arm but glad he got the shot. The patient wife sure the shingles would hurt more than the shot. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information. This case has been linked with case US2023AMR058731 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058731:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient had the shot and had only a sore arm.  The patient had not known anyone that had it, however he/she did not want to write a review about his/her experience if he/she contracted it.  The patient stated that god bless the scientist who discovered it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Sleep disorder
Clinical narrative: couldn't sleep on that arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleeplessness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sleeplessness (Verbatim: couldn't sleep on that arm). The outcome of the sleeplessness was recovered/resolved (duration 3 days).   It was unknown if the reporter considered the sleeplessness to be related to Shingles vaccine.     It was unknown if the company considered the sleeplessness to be related to Shingles vaccine.   Additional Information: GSK Receipt: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient's physician recently recommended him or her get his or her second vaccination if shingles.  The patient could not sleep on that arm for 3 days. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date:24-MAR-2023 The case was received from the patient via interactive digital media. The patient asked did you got sick with the vaccine. The patient when got his or her second shot he or she thought that was going to have to go to the hospital, better by the next day. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: made me sick). The outcome of the sickness was recovered/resolved (duration 24 hrs).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Mar-2023 The case was received from the patient via interactive digital media. The patient just got his or her shingles booster shot and it made him or her sick for 24 hours. The patient stated better than getting shingles. The follow-up could not be possible as no contact details were available.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Neuropathy peripheral, Pancreatic mass, Pulmonary embolism
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 12/6/2021 PANCREATIC MASS I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 12/28/2021 PANCREATIC MASS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/6/2022 PANCREATIC MASS G62.9 PERIPHERAL NEUROPATHY 12/6/2021 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 12/28/2021 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/6/2022 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Tinnitus, fatigue
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Hypoxia
Clinical narrative: R09.02 HYPOXIA 1/10/2022 HYPERTHYROIDISM
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Fainted about 5 minutes after receiving HPV vaccine. Fell off table and hit head. About 10 minutes later after drinking water and eating crackers, nearly
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Tinnitus, fatigue
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Covid pfizer Bivalent  6months-4 years, vaccine was undiluted at time of admin.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pulmonary embolism, Squamous cell carcinoma of lung
Clinical narrative: Pfizer vaccine was administered outside - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/23/2022 SQUAMOUS CELL CARCINOMA RIGHT LUNG, UNSPECIFIED PART R09.02 HYPOXIA 1/23/2022 SQUAMOUS CELL CARCINOMA RIGHT LUNG, UNSPECIFIED PART I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/23/2022 PULMONARY EMBOLISM, UNSPECIFIED. R09.02 HYPOXIA 1/23/2022 PULMONARY EMBOLISM, UNSPECIFIED.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bedridden, Blood test, Brain fog, Disturbance in attention
Clinical narrative: Aproxomately 8 hours after the innoculation shot... Started to feel super sick.  Muscle aches throughout entire body. Even down through the feet. It hurt to walk. Extreem continuous headache top of forehead, sides of forehead, behind eyes, brow line, down back of head and down neck and back. Intollerance to loud noices, reduced to having to wear noise canceling earbuds around family. Insomnia that would sometimes go up to 3 days. Heat intollerance and body temp irregulation. Eye sight diminished. Sevier brain fog, attention deficite, and constant fatigue.   Almost, and probably should have, gone to the hospitial, but was informed that it was possible to feel this way.  I was basically bed riden for weeks. I was told from all publications that the symptoms from the Covid vaccine will go away after a period of time so I gutted it out, but the symptoms did not subside even causing me to be missing out on the hollidays with my family. Visited Dr. and then finally after a number of months I went in to see Dr. around February 2022  Dr. said that I should go get an MRI done on Feb. 8, 2022 and the results came back that I had fluid around my optic nerves and that it may be an indication that my brain had swollen. I wasn't able to get into a opthamologist for a few weeks due to no openings but, by the time I had gotten in to the the Dr the fluid around the optic nurves had subsited. However, the Headaches, muscle problems, body temperature regulation, insomnia, sevier brain fog, and diminished eyesight continues.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Hyperacusis, Insomnia
Clinical narrative: Aproxomately 8 hours after the innoculation shot... Started to feel super sick.  Muscle aches throughout entire body. Even down through the feet. It hurt to walk. Extreem continuous headache top of forehead, sides of forehead, behind eyes, brow line, down back of head and down neck and back. Intollerance to loud noices, reduced to having to wear noise canceling earbuds around family. Insomnia that would sometimes go up to 3 days. Heat intollerance and body temp irregulation. Eye sight diminished. Sevier brain fog, attention deficite, and constant fatigue.   Almost, and probably should have, gone to the hospitial, but was informed that it was possible to feel this way.  I was basically bed riden for weeks. I was told from all publications that the symptoms from the Covid vaccine will go away after a period of time so I gutted it out, but the symptoms did not subside even causing me to be missing out on the hollidays with my family. Visited Dr. and then finally after a number of months I went in to see Dr. around February 2022  Dr. said that I should go get an MRI done on Feb. 8, 2022 and the results came back that I had fluid around my optic nerves and that it may be an indication that my brain had swollen. I wasn't able to get into a opthamologist for a few weeks due to no openings but, by the time I had gotten in to the the Dr the fluid around the optic nurves had subsited. However, the Headaches, muscle problems, body temperature regulation, insomnia, sevier brain fog, and diminished eyesight continues.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Malaise, Myalgia, Neck pain, Pain
Clinical narrative: Aproxomately 8 hours after the innoculation shot... Started to feel super sick.  Muscle aches throughout entire body. Even down through the feet. It hurt to walk. Extreem continuous headache top of forehead, sides of forehead, behind eyes, brow line, down back of head and down neck and back. Intollerance to loud noices, reduced to having to wear noise canceling earbuds around family. Insomnia that would sometimes go up to 3 days. Heat intollerance and body temp irregulation. Eye sight diminished. Sevier brain fog, attention deficite, and constant fatigue.   Almost, and probably should have, gone to the hospitial, but was informed that it was possible to feel this way.  I was basically bed riden for weeks. I was told from all publications that the symptoms from the Covid vaccine will go away after a period of time so I gutted it out, but the symptoms did not subside even causing me to be missing out on the hollidays with my family. Visited Dr. and then finally after a number of months I went in to see Dr. around February 2022  Dr. said that I should go get an MRI done on Feb. 8, 2022 and the results came back that I had fluid around my optic nerves and that it may be an indication that my brain had swollen. I wasn't able to get into a opthamologist for a few weeks due to no openings but, by the time I had gotten in to the the Dr the fluid around the optic nurves had subsited. However, the Headaches, muscle problems, body temperature regulation, insomnia, sevier brain fog, and diminished eyesight continues.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Papilloedema, Temperature intolerance, Temperature regulation disorder, Visual impairment
Clinical narrative: Aproxomately 8 hours after the innoculation shot... Started to feel super sick.  Muscle aches throughout entire body. Even down through the feet. It hurt to walk. Extreem continuous headache top of forehead, sides of forehead, behind eyes, brow line, down back of head and down neck and back. Intollerance to loud noices, reduced to having to wear noise canceling earbuds around family. Insomnia that would sometimes go up to 3 days. Heat intollerance and body temp irregulation. Eye sight diminished. Sevier brain fog, attention deficite, and constant fatigue.   Almost, and probably should have, gone to the hospitial, but was informed that it was possible to feel this way.  I was basically bed riden for weeks. I was told from all publications that the symptoms from the Covid vaccine will go away after a period of time so I gutted it out, but the symptoms did not subside even causing me to be missing out on the hollidays with my family. Visited Dr. and then finally after a number of months I went in to see Dr. around February 2022  Dr. said that I should go get an MRI done on Feb. 8, 2022 and the results came back that I had fluid around my optic nerves and that it may be an indication that my brain had swollen. I wasn't able to get into a opthamologist for a few weeks due to no openings but, by the time I had gotten in to the the Dr the fluid around the optic nurves had subsited. However, the Headaches, muscle problems, body temperature regulation, insomnia, sevier brain fog, and diminished eyesight continues.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Hypertension
Clinical narrative: High blood pressure
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms child was over the age of 8 months and one day
Age: 3.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse effect, wrong covid vaccine given
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix dose was given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HAV (Havrix 720) (batch number YG7YJ, expiry date 03-FEB-2023) for prophylaxis.   On 14-APR-2023, the patient received the 2nd dose of Havrix 720 (intramuscular). On 14-APR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix dose was given). 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 Information: GSK Receipt Date: 17-APR-2023 The healthcare professional called to report that an expired Havrix dose was given. The reporter requested guidance on how to proceed with patient.  The reporter was provided with medical information telephone number and transferred to medical Information department for help.  The reporter consented to follow up. The patient received an expired Havrix dose, which led to expired vaccine used.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity
Clinical narrative: Injection site arm red/left arm is still (4 days later) red; Left arm is still sore/Tenderness and pain at the injection site; This non-serious case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (one episode of shingles 10 years ago).   On 14-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In APR-2023, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Injection site arm red/left arm is still (4 days later) red) and pain in arm (Verbatim: Left arm is still sore/Tenderness and pain at the injection site). The outcome of the erythema of extremities and pain in arm were not resolved.   The reporter considered the erythema of extremities and pain in arm to be related to Shingrix.     The company considered the erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2023 The reporter (patient) was a retired nurse. The patient did not had the lot number. The patient reports that her left arm was still (4 days later) sore and red and also said she was experiencing tenderness and pain at the injection site.  The patient had not (yet) reported this to her physician. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inappropriate Reconstitution Technique; Reconstituted the Menveo Lyophilized component with a non-GSK diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA859A, expiry date 31-JAN-2024) for prophylaxis.   On 14-APR-2023, the patient received Menveo. On 14-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique) and incorrect dose administered (Verbatim: Reconstituted the Menveo Lyophilized component with a non-GSK diluent). The outcome of the wrong solution used in drug reconstitution and incorrect dose administered were unknown.   Additional Information: GSK Receipt Date: 17-APR-2023 The nurse manager called to inquire that how to proceed?  The reporter reported that they reconstituted the Menveo lyophilized component with a non-GlaxoSmithKline diluent and inadvertently administered to a patient.  The reporter confirmed dose was administered at their facility.  The reporter did not consent to follow-up. The patient received Menveo lyophilized component reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and incorrect dose administered.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 3 year old received Kinrix; Kinrix as 2nd dose of DTaP and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included Pediarix (1st dose received on an unknown date).   On 29-MAR-2023, the patient received Kinrix. On 29-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 year old received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as 2nd dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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 Information: GSK Receipt Date: 17-APR-2023 The nurse reported that a patient received a dose of Kinrix. The reporter clarified regarding the Kinrix that was administered was the patient's 2nd dose of DTaP and 2nd dose of IPV.  The reporter consented to follow-up via email. The patient received 2nd dose of DTaP and IPV as Kinrix at inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after the recommended schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th May 2019, batch number 23JK5 and expiry date 13th April 2020).   On 30-JAN-2023, the patient received the 2nd dose of Shingrix. On 30-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose after the recommended schedule). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter called and reported that a patient received their second dose of Shingrix after the recommended schedule and wished to know if the vaccine needed to be reapplied.  The reporter gave information about vaccine and patient.  The reporter consented to follow up. The reporter declined written information. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule (Drug dose administration interval too long).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED BENEFIT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: suspected covid-19 (residual cough and lost her sense of smell). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unexpected benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Because of COVID vaccine something horrible is happening in his body; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Because of COVID vaccine something horrible is happening in his body) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Because of COVID vaccine something horrible is happening in his body). At the time of the report, IMMUNISATION REACTION (Because of COVID vaccine something horrible is happening in his body) outcome was unknown.            No concomitant medications were reported.  It was reported that patient was not a participant of a Moderna clinical trial.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022; No adverse event; Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022).    No concomitant information was reported. It was reported that monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-JUL-2022 and beyond use date was 05-AUG-2022. The unknown vial did not underwent any temperature excursions.   No treatment medications were reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Pain
Clinical narrative: Mild discomforted; Achy; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Mild discomforted) and PAIN (Achy) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 prophylaxis.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Hypothyroidism, Hypertension, Allergy to intravenous contrast media (IV Dye Allergy) and Iodine allergy. Concomitant products included NAPROXEN from 11-Apr-2023 to 12-Apr-2023 for an unknown indication.    On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced DISCOMFORT (Mild discomforted) and PAIN (Achy). On 17-Sep-2022, DISCOMFORT (Mild discomforted) and PAIN (Achy) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient had previous doses of Moderna covid-19 vaccine on 25 Mar 2021, 27 Apr 2021, 01 Nov 2021 and 04 Apr 2022. Patient had Paxlovid on 10-APR-2023 till 15 Apr 2013 for COVID-19 treatment. The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. Device date was reported as 22 Apr 2023. No treatment information was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Moderna 1st dose on 1-Jun-2021 Moderna 2nd dose on 10-Jul-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 1-Jun-2021 Moderna 2nd dose on 10-Jul-2021) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 1-Jun-2021 Moderna 2nd dose on 10-Jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 1-Jun-2021 Moderna 2nd dose on 10-Jul-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 1-Jun-2021 Moderna 2nd dose on 10-Jul-2021).    No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2023-720804 (Patient Link).