chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash maculo-papular, Rash papular, Skin warm
Clinical narrative: rash was red, hot to the touch, elevated, and blotchy; rash was red, hot to the touch, elevated, and blotchy; Red rash on the right side of her face; severe arm discomfort at the injection site; Fever; Malaise; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a adult female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date unknown) for prophylaxis.   On 5th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th February 2020, less than a day after receiving Shingrix, the patient experienced injection site discomfort. On 10th February 2020, the patient experienced skin warm, localized maculopapular rash and red rash. In February 2020, the patient experienced fever and malaise. On 15th February 2020, the outcome of the localized maculopapular rash and red rash were recovered/resolved. On an unknown date, the outcome of the injection site discomfort, fever, malaise and skin warm were recovered/resolved.   It was unknown if the reporter considered the injection site discomfort, fever, malaise, skin warm, localized maculopapular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 64 or 65 years old. The patient received Shingrix vaccine in the right deltoid at approximately 12:00 noon. The patient experienced severe arm discomfort at the injection site within four hours of receiving the vaccine. She could not sleep on her right arm due to the discomfort. She experienced fever and general malaise that lasted for 48 hours. On Monday, 10th February 2020, she woke up with a red rash on the right side of her face. The rash was red, hot to the touch, elevated, and blotchy. She said it looked like hives. Tuesday and Wednesday the rash was on both sides of her face and was evident for 2-3 hours in the morning and then gone for the rest of the day. She went to her physician on Thursday, 13th February 2020, but the physician did not know what was causing the rash, she swabbed the area and would be going to run tests. On Saturday, 15th February 2020, she woke up and the rash was gone. No further information was provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: right arm started to hurt/pain at the injection site; pain is felt from the shoulder down to the elbow area; pain is felt from the shoulder down to the elbow area; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received the 2nd dose of Shingrix. On 15th February 2020, 2 days after receiving Shingrix, the patient experienced pain in arm, shoulder pain and pain in elbow. On an unknown date, the outcome of the pain in arm, shoulder pain and pain in elbow were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, shoulder pain and pain in elbow to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and her right arm started to hurt.  The pain was felt from the shoulder down to the elbow area. She described it as very, very sore. Consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Peripheral swelling
Clinical narrative: his hole hand became red and swollen; his hole hand became red/he felt redness around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) for prophylaxis.   On 29th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter reported a patient developed adverse reactions following the dose of Shingrix received on an unknown arm. Whole hand became red and swollen (extensive swelling of vaccinated limb), and also felt redness around the injection site. The reporter provided consent to be contacted for the follow-up of this case.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Skin tightness, Vaccine positive rechallenge
Clinical narrative: fever; sore arm; Face tightening sensation on his left side; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in June 2019, experienced fever and a sore arm, refer case US2020AMR038388).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, pain in arm and skin tightness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and pain in arm were unknown and the outcome of the skin tightness was not recovered/not resolved.   It was unknown if the reporter considered the fever, pain in arm and skin tightness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever and a sore arm which lasted a fewdays after each injection and then resolved. The patient reported that about 2 weeks after dose 2, but not dose 1, the patient experienced face tightening sensation on his left side. The patient seen his dental professional which showed nothing, and his primary care physician, who referred him to his ear nose throat doctor. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Flushing, Pain
Clinical narrative: shivering; achiness; feeling flush; This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd November 2019, 1 days after receiving Shingrix, the patient experienced shivering, pain and flushing. On 5th November 2019, the outcome of the shivering, pain and flushing were recovered/resolved.   It was unknown if the reporter considered the shivering, pain and flushing to be related to Shingrix.  Additional details were provided as follows: The patient reported that he was in his 60's. Limited information was provided by the patient. The patient planned to continue follow-up with his physician and pharmacy. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: received the second dose of Shingrix by subcutaneous route; Redness in the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number L7S74, expiry date 27th March 2022) for prophylaxis.   On 25th February 2020, the patient received Shingrix (subcutaneous). In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema. On 25th February 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix subcutaneous, incorrect route of vaccine administration. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given 0.5 ml instead of 0.25 ml as recommended. Pt tolerated well. No adverse reaction. Mom made aware.
Age: 75.0
Sex: M
Vaccine: TD
Symptoms: Injection site discolouration, Injection site urticaria, Musculoskeletal pain, Pain in extremity
Clinical narrative: Injection was given to right arm.  Two weeks later, my upper arm and shoulder have deep aching.  No noticeable swelling or heat in the upper arm, but there is a small (3mm) purple weal (regular edges)  at the injection site.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Tdap (Boostrix)  vaccine was administered by staff, who was still in training with the immunization program, to an 45 year old male who presented to the clinic with  an injury, requesting a tetanus booster. The vaccine was, in error, pulled from the VFC stock instead of the county purchased stock. The patient did not report any adverse reaction from the vaccine. The simple error being the wrong stock was used in this case.
Age: 29.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse events reported Gave MMRV and recipient over 13 years of age
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: 4 inch red swelling Rigors, chills and fever. (patient said she knew she had a fever but never took her temp)
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rash on left arm and right forearm and a few dots on left knee. Itching of whole body beginning around 7:30 p.m. the day she received the vaccine. She treated with PO benadryl and I gave her some benadryl cream to help with the itching.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reports that since 3/4/2020 he has had severe pain in his left upper arm, "where the shot was given."  He currently rates pain "8" out of 10.  He describes it as a "prodding, hammer" pain.  It is constant.  It is not exacerbated by movement.  He is currently taking ibuprofen, which does not help much.  Ice also does not help much.  Paint denies redness or swelling in the arm.  He denies any history of blisters, sores, or any lesions.  He denies any history of pain or problems with that arm prior to 3/2/2020.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Headache, Herpes zoster, Injection site pain
Clinical narrative: While I did experience chills, pain at site, malaise, and general aches the evening of the injection, several days later I also noticed a constant headache with continued malaise.  When I felt my head/skull where it hurt the most, I noticed lumps/bumps which ran upward from my upper neck along the route of my occipital nerve on the right side of my skull.   I also noted an enlarged lymph node behind my right ear. These were tender to touch and made it hard to sleep laying on my right side.  I did not have fever, chills, sore throat or other issues.  But after two weeks of  the tender bumps and headache, I became suspicious that I was actually experiencing a case of Shingles.  When I awoke on 3/24/20 with a new small vesicle on my eyelid, I became more concerned.  So I made an appt. to see my MD where she did confirm that she felt I had a case of shingles and started me on a course of cortisone and Valacyclovir.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Lymph node pain, Lymphadenopathy, Malaise, Pain
Clinical narrative: While I did experience chills, pain at site, malaise, and general aches the evening of the injection, several days later I also noticed a constant headache with continued malaise.  When I felt my head/skull where it hurt the most, I noticed lumps/bumps which ran upward from my upper neck along the route of my occipital nerve on the right side of my skull.   I also noted an enlarged lymph node behind my right ear. These were tender to touch and made it hard to sleep laying on my right side.  I did not have fever, chills, sore throat or other issues.  But after two weeks of  the tender bumps and headache, I became suspicious that I was actually experiencing a case of Shingles.  When I awoke on 3/24/20 with a new small vesicle on my eyelid, I became more concerned.  So I made an appt. to see my MD where she did confirm that she felt I had a case of shingles and started me on a course of cortisone and Valacyclovir.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: While I did experience chills, pain at site, malaise, and general aches the evening of the injection, several days later I also noticed a constant headache with continued malaise.  When I felt my head/skull where it hurt the most, I noticed lumps/bumps which ran upward from my upper neck along the route of my occipital nerve on the right side of my skull.   I also noted an enlarged lymph node behind my right ear. These were tender to touch and made it hard to sleep laying on my right side.  I did not have fever, chills, sore throat or other issues.  But after two weeks of  the tender bumps and headache, I became suspicious that I was actually experiencing a case of Shingles.  When I awoke on 3/24/20 with a new small vesicle on my eyelid, I became more concerned.  So I made an appt. to see my MD where she did confirm that she felt I had a case of shingles and started me on a course of cortisone and Valacyclovir.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient began noticing swelling of her left arm and redness on Thursday, March 19, 2020. Applied cool rags off and on and took ibuprofen. Left arm continued to swell and spread so she came to the health department on March 24, 2020. Left arm was swollen, warm to touch, and looked pink. Right arm measured 14 1/2 inches, left arm 15 1/2 inches. Called her primary doctor. I sent pictures to her and the arm measurements per her request and with permission from the patient. Dr send an order of Bactrim twice a day for 5 days and Diflucan 150mg (2 pills...take one on 1st day of Bactrim and 2nd one on last day of Bactrim) to patients pharmacy Dr will see the patient in her office on Thursday, March 25, 2020. Patient is to begin antibiotics today.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 70-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 04-SEP-2012, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), In November 2012, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 61-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 23-DEC-2010, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), In 2010, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia
Clinical narrative: Between 3/6 and 3/7 Patient experienced mild numbness, more pronounced in the hands. Patient called me yesterday on 3/24 to report numbness is still present. Seems to "come and go" throughout the day. Gave him referral numbers of providers in town helping patients without insurance. Suggested calling providers to set up apt or make arrangements re: numbness.
Sex: U
Vaccine: VARZOS
Symptoms: Oral infection, Pharyngitis
Clinical narrative: developed a sore throat / have a reaction in his mouth and throat; mouth infection; This case was reported by a consumer via call center representative and described the occurrence of throat infection in a 78-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced throat infection and oral infection. On an unknown date, the outcome of the throat infection and oral infection were unknown.   It was unknown if the reporter considered the throat infection and oral infection to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had experienced throat infection after vaccination. The patient asked could a person have a reaction in his mouth and throat from the shingles shot.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; sore arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with 1st dose of shingrix, experienced  fever and a sore arm  which lasted a few days and then resolved. For the tolarence of 2nd dose refere case US2020037860, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Burning sensation, Fatigue, Pain, Pain in extremity
Clinical narrative: skin sensation / it burn; red bumps between waist to knees; itchy; Scratch; extremely tired; arm was terrible sore; had fever; aches /I scratched were very painful!; napped throughout the day; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles few years ago).   On 14th February 2020, the patient received the 2nd dose of Shingrix. On 15th February 2020, 1 days after receiving Shingrix, the patient experienced fatigue, pain in arm, fever, general body pain and bedridden. On 29th February 2020, the patient experienced burning sensation, red rash, pruritus and scratch. On an unknown date, the outcome of the fatigue, pain in arm, general body pain, bedridden, burning sensation, red rash, pruritus and scratch were recovering/resolving and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fatigue, pain in arm, fever, general body pain, bedridden, burning sensation, red rash, pruritus and scratch to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. After vaccination, the next day had terrible sore arm, fever, aches and was extremely tired, napped throught day and was better on sunday. Just over 2 weeks after vaccination,on the evening of Saturday before the date of reporting, the patient felt skin sensation, scratched a bit, did it burn and very painful. The patient reported that, when changing for bed I found small red bumps between waist to knees and itchy. The last evening before the date of reporting,  found couple more and in the morning of day of reporting experienced 2 more. At the time of reporting, did not have fever and aches. The patient reported that, had shingles few years ago and could not get the shots due to out of stock at pharmacy being administering it to older seniors.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash erythematous, Scratch
Clinical narrative: skin sensation / it burn; red bumps between waist to knees; itchy; Scratch; extremely tired; arm was terrible sore; had fever; aches /I scratched were very painful!; napped throughout the day; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles few years ago).   On 14th February 2020, the patient received the 2nd dose of Shingrix. On 15th February 2020, 1 days after receiving Shingrix, the patient experienced fatigue, pain in arm, fever, general body pain and bedridden. On 29th February 2020, the patient experienced burning sensation, red rash, pruritus and scratch. On an unknown date, the outcome of the fatigue, pain in arm, general body pain, bedridden, burning sensation, red rash, pruritus and scratch were recovering/resolving and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fatigue, pain in arm, fever, general body pain, bedridden, burning sensation, red rash, pruritus and scratch to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. After vaccination, the next day had terrible sore arm, fever, aches and was extremely tired, napped throught day and was better on sunday. Just over 2 weeks after vaccination,on the evening of Saturday before the date of reporting, the patient felt skin sensation, scratched a bit, did it burn and very painful. The patient reported that, when changing for bed I found small red bumps between waist to knees and itchy. The last evening before the date of reporting,  found couple more and in the morning of day of reporting experienced 2 more. At the time of reporting, did not have fever and aches. The patient reported that, had shingles few years ago and could not get the shots due to out of stock at pharmacy being administering it to older seniors.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient experienced every side effect listed on website. No further details were provided.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient experienced every side effect listed on website. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: reported "feeling awful all over"; This case was reported by a physician via sales rep and described the occurrence of feels awful in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient felt awful all over after receiving first dose of shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feeling very unwell for a short period of time; This case was reported by a other health professional via call center representative and described the occurrence of malaise in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date, refer case US2020AMR037675).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. Rechallenge with Shingrix was positive. 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 information was received as follows: The age at vaccination was not reported. The patient received 2nd dose Shingrix and experienced feeling very unwell for a short period of time. As per the reporter, she normally did not experienced any untoward event following receipt of vaccines. The reporter declined consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Rash, Rash erythematous
Clinical narrative: Anaphylactic reaction; Erythematous rash on her LEFT arm that extended to her finger tips; Erythematous rash / which was mildly painful; This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), red rash and painful rash. On an unknown date, the outcome of the anaphylactic reaction, red rash and painful rash were unknown.   It was unknown if the reporter considered the anaphylactic reaction, red rash and painful rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced a erythematous rash on her left arm that extended to her finger tips which was mildly painful. This occurred 3 days after receiving Shingrix in her right arm. She did not receive any other vaccines. It was unknown if she had other symptoms consistent with an anaphylactic reaction.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Rash
Clinical narrative: rash just below injection site; chest tightness; This case was reported by a consumer via call center representative and described the occurrence of localised rash in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On 18th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced localised rash and chest tightness. The patient was treated with methylprednisolone. On an unknown date, the outcome of the localised rash was unknown and the outcome of the chest tightness was recovered/resolved.   It was unknown if the reporter considered the localised rash and chest tightness to be related to Shingrix.  Additional case details were reported as follows: The patient received first dose of Shingrix and experienced rash just below the injection site, in an area about 3.5 by 3.0 inches in size and some chest tightness. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: injection site pain; flu-like symptoms; fev; chills; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, fev, chills and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, fev, chills and injection site pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fev, chills and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms that lasted for 3 days. This case is linked to the case US2020AMR034880 for the 2nd dose of the same patient. This case is linked to the case US2020AMR034881 and US2020AMR034882 husband's case.      Lab Comments: Lab test on an unknown date
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: mild pain injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm and only experienced mild pain at the injection site. This case is linked to the case US2020AMR034844 reported for the 2nd dose.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy test positive, Food allergy, Pain in extremity, Pruritus, Rash
Clinical narrative: hands and palms were also painful, itching; Sensitive to warm water; Itching; red rash on his back, buttocks, arms, hands and palms; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meat allergy. Concomitant products included prednisone.   On 12th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, 7 days after receiving Shingrix, the patient experienced pruritus. In February 2020, the patient experienced red rash, pain in extremity and sensitization. The patient was treated with hydrocortisone (Cortisone Topical Cream) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus and red rash were recovered/resolved and the outcome of the pain in extremity and sensitization were unknown.   It was unknown if the reporter considered the pruritus, red rash, pain in extremity and sensitization to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced itching. The patient also experienced red rash on his back, buttocks, arms, hands and palms. His hands and palms were also painful, itching, and sensitive to warm water. The patient used topical cortisone and prescription cream. When he initially noticed the rash he took Benadryl. The day after he noticed the rash, he visited his physician assistant, and had blood work done for an allergy test. The results showed that he was allergic to alphagalactose. He also saw his allergist and was told to stop eating red meat and carry an EpiPen with him.      Lab Comments: On an unknown date, lab test was performed
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin sensitisation
Clinical narrative: hands and palms were also painful, itching; Sensitive to warm water; Itching; red rash on his back, buttocks, arms, hands and palms; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meat allergy. Concomitant products included prednisone.   On 12th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, 7 days after receiving Shingrix, the patient experienced pruritus. In February 2020, the patient experienced red rash, pain in extremity and sensitization. The patient was treated with hydrocortisone (Cortisone Topical Cream) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus and red rash were recovered/resolved and the outcome of the pain in extremity and sensitization were unknown.   It was unknown if the reporter considered the pruritus, red rash, pain in extremity and sensitization to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced itching. The patient also experienced red rash on his back, buttocks, arms, hands and palms. His hands and palms were also painful, itching, and sensitive to warm water. The patient used topical cortisone and prescription cream. When he initially noticed the rash he took Benadryl. The day after he noticed the rash, he visited his physician assistant, and had blood work done for an allergy test. The results showed that he was allergic to alphagalactose. He also saw his allergist and was told to stop eating red meat and carry an EpiPen with him.      Lab Comments: On an unknown date, lab test was performed
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site redness; Injection site swelling; injection site pain; joint aches; fatigue; body aches; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, joint pain, fatigue and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved and the outcome of the joint pain, fatigue and general body pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, joint pain, fatigue and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Five months before the time of reporting, the patient received the Shingrix vaccine via intramuscular route. One day following the vaccination, the patient developed injection site redness, pain, and swelling accompanied by body aches, joint aches and feeling fatigued. On an unknown date the injection site redness, pain, and swelling resolved. However the body aches, joint aches, and feeling fatigue was reported as ongoing, but improving. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: injection site redness; Injection site swelling; injection site pain; joint aches; fatigue; body aches; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, joint pain, fatigue and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved and the outcome of the joint pain, fatigue and general body pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, joint pain, fatigue and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Five months before the time of reporting, the patient received the Shingrix vaccine via intramuscular route. One day following the vaccination, the patient developed injection site redness, pain, and swelling accompanied by body aches, joint aches and feeling fatigued. On an unknown date the injection site redness, pain, and swelling resolved. However the body aches, joint aches, and feeling fatigue was reported as ongoing, but improving. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash 2 weeks after receiving a dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient developed a rash 2 weeks after receiving a dose of Shingrix. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Feeling cold, Loss of consciousness, Muscle twitching
Clinical narrative: Within 3 min after giving vaccine the patient leaned to his right side and started having a seizure-like symptoms for 5 seconds, eyes rolled back, hands/arms twitching and passed out for 5 minutes. After 10 min the patient was alert, he complained of dizziness and being cold.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Posture abnormal, Seizure like phenomena
Clinical narrative: Within 3 min after giving vaccine the patient leaned to his right side and started having a seizure-like symptoms for 5 seconds, eyes rolled back, hands/arms twitching and passed out for 5 minutes. After 10 min the patient was alert, he complained of dizziness and being cold.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Decreased eye contact, Eczema, Food allergy, Gene mutation identification test
Clinical narrative: she also received Prevnar (CK0838) and Rotavirus (S006050) the same time. Patient started to have severe eczema after vaccinations where her face, forehead, cheeks, chin and scalp are broken out with rashes and raw skins and won't heal. She also suddenly developed allergic reaction to all types of food I eat (I am breastfeeding) - she can no longer tolerate almost all allergens (soy, wheat, sugar, eggs, citrus). She also had behavior change 4 weeks after her shots. She stopped making eye contact, stop smiling and stop responding to sounds.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Impaired healing, Rash, Skin erosion
Clinical narrative: she also received Prevnar (CK0838) and Rotavirus (S006050) the same time. Patient started to have severe eczema after vaccinations where her face, forehead, cheeks, chin and scalp are broken out with rashes and raw skins and won't heal. She also suddenly developed allergic reaction to all types of food I eat (I am breastfeeding) - she can no longer tolerate almost all allergens (soy, wheat, sugar, eggs, citrus). She also had behavior change 4 weeks after her shots. She stopped making eye contact, stop smiling and stop responding to sounds.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: Syncope
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: & ERYTHEMA; SWELLING; INJECTION SITE PAIN ACETAMINOPHEN
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme
Clinical narrative: ErythemaMultiform & ERYTHEMA