chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Urine analysis normal
Clinical narrative: My daughter had a low grade fever on july 2nd. She awoke that night (about 1 am) and had a seizure which lasted at least 3 minutes. We called 911 and she was taken to the emergency room. We were told that she had a febrile seizure, which had never happened before. I asked if it could be related to the vaccines she received a few days earlier and was told no, it was too long afterward (it had been about 4 days). She continued to run a fever above 100 degrees for the next 3 days. I took her to the pediatrician for a follow-up on July 4th since the fever had not broken. I asked again if it could be a vaccine reaction and again was told no. They screened her for a urinary tract infection (negative) and examined her for other signs of viral infection. None were found. They next day (7/5) she woke up with a red rash covering her entire torso. By evening it had spread to her face and bottom and became very itchy/uncomfortable for her. I took her in for a second follow up and stated that I was frustrated that this was pretty clearly a reaction to the vaccine (all of her symptoms from seizure to rash can be linked to the mmr vaccine per online sources). Again the doctor said it was possible but unlikely and that perhaps she had contracted rosacea (??!) At this time she has been fever free for about 36 hours and has had a rash for 48 hours. The rash now covers her entire body from head to toe and is itchy to the point that she is uncomfortable in clothes or a diaper and has difficulty sleeping.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Pain at injection,Sore, red arm area 2 1/2" diameter, chills, fever , achy, interfered with sleep and work continuing. The severity of the shot will be a factor as to whether I go to get the second shot. Also as an aside, the shots are expensive and not much covered by primary or my secondary. Into second day and not recovered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Pain at injection,Sore, red arm area 2 1/2" diameter, chills, fever , achy, interfered with sleep and work continuing. The severity of the shot will be a factor as to whether I go to get the second shot. Also as an aside, the shots are expensive and not much covered by primary or my secondary. Into second day and not recovered.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Night sweats
Clinical narrative: Same day: diarrhea (2 events); headache, chills, sleepiness, feverish feeling.  Following day and night: joint aches, severe nighttime sweating, fever (temperature not taken)
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: Same day: diarrhea (2 events); headache, chills, sleepiness, feverish feeling.  Following day and night: joint aches, severe nighttime sweating, fever (temperature not taken)
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Nausea, Urticaria
Clinical narrative: Patient called on 7/7/19 10:15 am to report symptoms of headache, hives, nausea, and chills persisting for 2 days after vaccination with the Shingrix. Symptoms have resolved some after 2 days, but patient still wanted to have the reaction reported.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Headache, Nausea, Urticaria
Clinical narrative: Patient called on 7/7/19 10:15 am to report symptoms of headache, hives, nausea, and chills persisting for 2 days after vaccination with the Shingrix. Symptoms have resolved some after 2 days, but patient still wanted to have the reaction reported.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Night sweats, Pain, Pyrexia
Clinical narrative: Patient experienced fever with night sweats first day. Then achy and arm turned red for one week. Patient has since recovered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Reaction:   Headache, muscle aches, nausea,   Treatment: None Outcome:  Symptoms improved after 1-2 days
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, hot around injection site
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Sunburn
Clinical narrative: The patients presented to me 4 days after receiving the vaccine with a red strip along her pant line on her back that spanned the entire distance from left hip to right hip. It was not raised. It was about 1-2 inches from top to bottom and was not raised. It appeared just like a sun burn.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Axillary pain, Burning sensation, Chills, Erythema
Clinical narrative: This is the second shot of the pair, into left deltoid.  Pain in arm at administration.  Morning after administration had headache, esp. sinus area and behind eyes, strong ache in underarms (lymph glands I believe).  By mid-day had chills and body aches, very slight abdominal upset.  Strong fatigue by 3 pm.  By end of day had fever above 100.4 and called health providers. (Fever was 101.3, and I felt really bad.)  Got to speak to a pharmacist.  He advised alternating tylonol and advil.  This helped quite a lot.  Second morning still needed to take the fever, aches medicine.  Left arm has large red spot, and it is burning hot.  Have visited clinic, but they said it seems "normal" strong reaction - and that this may continue for one more day.  I report it, as I have had all the symptoms possible, except for tingling in extremities and those listed as life-threatening.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: This is the second shot of the pair, into left deltoid.  Pain in arm at administration.  Morning after administration had headache, esp. sinus area and behind eyes, strong ache in underarms (lymph glands I believe).  By mid-day had chills and body aches, very slight abdominal upset.  Strong fatigue by 3 pm.  By end of day had fever above 100.4 and called health providers. (Fever was 101.3, and I felt really bad.)  Got to speak to a pharmacist.  He advised alternating tylonol and advil.  This helped quite a lot.  Second morning still needed to take the fever, aches medicine.  Left arm has large red spot, and it is burning hot.  Have visited clinic, but they said it seems "normal" strong reaction - and that this may continue for one more day.  I report it, as I have had all the symptoms possible, except for tingling in extremities and those listed as life-threatening.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sinus headache
Clinical narrative: This is the second shot of the pair, into left deltoid.  Pain in arm at administration.  Morning after administration had headache, esp. sinus area and behind eyes, strong ache in underarms (lymph glands I believe).  By mid-day had chills and body aches, very slight abdominal upset.  Strong fatigue by 3 pm.  By end of day had fever above 100.4 and called health providers. (Fever was 101.3, and I felt really bad.)  Got to speak to a pharmacist.  He advised alternating tylonol and advil.  This helped quite a lot.  Second morning still needed to take the fever, aches medicine.  Left arm has large red spot, and it is burning hot.  Have visited clinic, but they said it seems "normal" strong reaction - and that this may continue for one more day.  I report it, as I have had all the symptoms possible, except for tingling in extremities and those listed as life-threatening.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Frequent bowel movements
Clinical narrative: Increased bowel movement, stomach upset. Increased fatigue occurring a day after vaccination
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient complains of redness and itching at site of injection.  She continues to use hydrocortisone cream and oral zyrtec but still complains of itching 10 days post vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema of eyelid, Hypersensitivity, Swelling of eyelid
Clinical narrative: Pt reported the morning after receiving Shingrix she experienced red, swollen eyelids. The swelling went down over the day but the next morning her eyelids were again swollen and to a greater extreme than the previous day. She does not recall if her eyelids were swollen the day of the vaccination. The eyelids were puffy and red and she felt she could not open her eyes fully. She denies wheezing, difficulty breathing, or swelling in other parts of the body. She denies a history of allergies. Patient was counseled to go to urgent care for assessment. After going to urgent care, pt reported she was diagnosed with a probable allergic reaction to a vaccine component and was given Benadryl and oral and injected steroids.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: patient described severe flu like symptoms and said she would not get the second shot
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient described severe flu like symptoms for 2 days.  Also injection site swelling, redness and hot to the touch.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fine the day of the shot. Woke up next morning feeling awful - severe aching all over - screwed up vision - severe headache - fever reached 101 degrees - arm somewhat sore and hot but no swelling or redness. Felt terrible all day and evening but woke up next morning feeling much, much better.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Visual impairment
Clinical narrative: Fine the day of the shot. Woke up next morning feeling awful - severe aching all over - screwed up vision - severe headache - fever reached 101 degrees - arm somewhat sore and hot but no swelling or redness. Felt terrible all day and evening but woke up next morning feeling much, much better.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Chills, Contusion, Diarrhoea, Erythema
Clinical narrative: Day one:pain, bruisiing, redness, swelling, headache, bloating painthen severe diarrhea, extreme exhaustion, fever, chills with shivering.  Day 2 : Pain, redness, swelling, tiredness.  Eay 3: Pain, redness swelling.  Day 4: redness and swelling starting to leave with itching.  Today I still have some tenderness and skin discoloring.    Everythin I have read say all symptom sould be gone by day 3.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pruritus, Pyrexia
Clinical narrative: Day one:pain, bruisiing, redness, swelling, headache, bloating painthen severe diarrhea, extreme exhaustion, fever, chills with shivering.  Day 2 : Pain, redness, swelling, tiredness.  Eay 3: Pain, redness swelling.  Day 4: redness and swelling starting to leave with itching.  Today I still have some tenderness and skin discoloring.    Everythin I have read say all symptom sould be gone by day 3.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration, Swelling, Tenderness
Clinical narrative: Day one:pain, bruisiing, redness, swelling, headache, bloating painthen severe diarrhea, extreme exhaustion, fever, chills with shivering.  Day 2 : Pain, redness, swelling, tiredness.  Eay 3: Pain, redness swelling.  Day 4: redness and swelling starting to leave with itching.  Today I still have some tenderness and skin discoloring.    Everythin I have read say all symptom sould be gone by day 3.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Patient complained of redness, swelling, itching, very painful sore on her right arm.  It produced a softball size red welt that was warm to the touch. Patient stated she did ice the arm but it did not improve the redness. After a few days the soreness has improved but it is still red and itchy. Pt will try hydrocortisone for the itchiness and continue to ice. Patient was advised to seek medical care if the red area became any larger or showed signs of infection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient complained of redness, swelling, itching, very painful sore on her right arm.  It produced a softball size red welt that was warm to the touch. Patient stated she did ice the arm but it did not improve the redness. After a few days the soreness has improved but it is still red and itchy. Pt will try hydrocortisone for the itchiness and continue to ice. Patient was advised to seek medical care if the red area became any larger or showed signs of infection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The site is red, hot, puffy, and itchy. It is getting larger
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Chills, Confusional state, Delirium, Feeling abnormal, Laboratory test normal
Clinical narrative: PATIENT WOKE IN THE MIDDLE OF THE NIGHT WITH A FEVER, CHILLS, NAUSEA, AND CONFUSION/DELIRIUM (GENERALLY NOT FEELING RIGHT). HER HUSBAND CALLED AN AMBULANCE FOR HER AT 4AM AND SHE WAS TAKEN TO THE ER WHERE THEY RAN TESTS THAT WERE INCONCLUSIVE. SHE RECEIVED A DOSE OF ZOFRAN FOR NAUSEA AND TYLENOL FOR FEVER. SHE REPORTS THAT SHE FEELS FINE TODAY AND THAT THE SIDE EFFECTS HAVE RESOLVED.
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: PATIENT WOKE IN THE MIDDLE OF THE NIGHT WITH A FEVER, CHILLS, NAUSEA, AND CONFUSION/DELIRIUM (GENERALLY NOT FEELING RIGHT). HER HUSBAND CALLED AN AMBULANCE FOR HER AT 4AM AND SHE WAS TAKEN TO THE ER WHERE THEY RAN TESTS THAT WERE INCONCLUSIVE. SHE RECEIVED A DOSE OF ZOFRAN FOR NAUSEA AND TYLENOL FOR FEVER. SHE REPORTS THAT SHE FEELS FINE TODAY AND THAT THE SIDE EFFECTS HAVE RESOLVED.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Erythema, Pain, Swelling
Clinical narrative: Redness, Sourness, Swelling, loss of appetite, thrust, weakness 9:00am 7-7-19
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Weight bearing difficulty
Clinical narrative: I have been experiencing pain in the upper left arm  for a few months now. When I researched about it, I came across some links which suggested that it could be due to flu vaccine. The symptoms include pain when I move my left arm in certain directions. I also feel my arm has lost some load-bearing capacity.  I cannot think of any other cause for this pain. I have not been given any other injection in my left arm since vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation, from a lawyer, concerning a decedent patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  In 2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX), due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided).  On an unknown date, the decedent was diagnosed with herpes zoster. On an unknown date, the patient was treated for herpes zoster. At the time of report, the outcome of the event was unknown.   The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Arthralgia, Discomfort, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Peripheral swelling, Sinus disorder
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Tenderness, Toothache, X-ray dental abnormal
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Diarrhoea
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Back pain, Injected limb mobility decreased, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Myalgia, Nerve conduction studies normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Periarthritis, Peripheral swelling, Tooth disorder, X-ray dental normal
Clinical narrative: Possible vaccination failure; shingles; This case was reported by a consumer via other and described the occurrence of vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that some friends received Shingrix(unspecified manufacturer and dates) and experienced shingles. No additional information was provided. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked with the case US2019AMR118871 reported by the same reporter.
Age: 1.17
Sex: M
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: 9:19pm 6/13 mom called after hrs-crying baby x15 min. gave 2.5ml Infant Tylenol for fussiness. 6/14 called - red spots on legs (noted 330A 1st one) now spreading - seen in office urticaria arms + legs given - diphenhydramine Hcl 3mg @ 12:30p Allergist dept advised ER -> steroid (ORAPRED-cont x2 days) 6/15 HIVES BACK - to ER again - hives worse on face, trunk + extremities 6/17 scattered hives on legs per allergist Pentacel exp. date: 9/19/2020 Prevnar exp date: 1/31/2021 Rotate exp date: 9/11/2020
Age: 1.17
Sex: M
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site urticaria, Irritability, Urticaria
Clinical narrative: 9:19pm 6/13 mom called after hrs-crying baby x15 min. gave 2.5ml Infant Tylenol for fussiness. 6/14 called - red spots on legs (noted 330A 1st one) now spreading - seen in office urticaria arms + legs given - diphenhydramine Hcl 3mg @ 12:30p Allergist dept advised ER -> steroid (ORAPRED-cont x2 days) 6/15 HIVES BACK - to ER again - hives worse on face, trunk + extremities 6/17 scattered hives on legs per allergist Pentacel exp. date: 9/19/2020 Prevnar exp date: 1/31/2021 Rotate exp date: 9/11/2020
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: Swelling in mouth causing breathing  concerns. Injection point still not healed and continues to hurt
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Injection site pain, Mouth swelling
Clinical narrative: Swelling in mouth causing breathing  concerns. Injection point still not healed and continues to hurt
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blister rupture, Chills, Injection site erythema, Migraine
Clinical narrative: Chills; Fever; Pain below injection site; Redness below injection site; Blisters below injection site; migraine; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2019) for prophylaxis.   Concurrent medical conditions included allergy to plants (aloe vera plant). Concomitant products included Herpes zoster (Shingrix).   On 26th June 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, less than a day after receiving Shingrix, the patient experienced migraine. On 27th June 2019, the patient experienced chills, fever, injection site pain, injection site erythema and blister. On an unknown date, the outcome of the migraine, chills, fever, injection site pain, injection site erythema and blister were recovering/resolving.   It was unknown if the reporter considered the migraine, chills, fever, injection site pain, injection site erythema and blister to be related to Shingrix.  Additional details were provided as follows: The patient recived 2nd dose of Shingrix on left deltoid. The patient experienced migrain, chills, pain below injection site, redness below injection site and blister below injection site which was medically located towards chest area after receiving 2nd dose of Shingrix. For tolerance of the 1st dose of Shingrix vaccine, refer case US2019117677.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia, Secretion discharge, Skin exfoliation, Sleep disorder
Clinical narrative: Chills; Fever; Pain below injection site; Redness below injection site; Blisters below injection site; migraine; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2019) for prophylaxis.   Concurrent medical conditions included allergy to plants (aloe vera plant). Concomitant products included Herpes zoster (Shingrix).   On 26th June 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, less than a day after receiving Shingrix, the patient experienced migraine. On 27th June 2019, the patient experienced chills, fever, injection site pain, injection site erythema and blister. On an unknown date, the outcome of the migraine, chills, fever, injection site pain, injection site erythema and blister were recovering/resolving.   It was unknown if the reporter considered the migraine, chills, fever, injection site pain, injection site erythema and blister to be related to Shingrix.  Additional details were provided as follows: The patient recived 2nd dose of Shingrix on left deltoid. The patient experienced migrain, chills, pain below injection site, redness below injection site and blister below injection site which was medically located towards chest area after receiving 2nd dose of Shingrix. For tolerance of the 1st dose of Shingrix vaccine, refer case US2019117677.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence, Tremor, Wound treatment
Clinical narrative: Chills; Fever; Pain below injection site; Redness below injection site; Blisters below injection site; migraine; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2019) for prophylaxis.   Concurrent medical conditions included allergy to plants (aloe vera plant). Concomitant products included Herpes zoster (Shingrix).   On 26th June 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, less than a day after receiving Shingrix, the patient experienced migraine. On 27th June 2019, the patient experienced chills, fever, injection site pain, injection site erythema and blister. On an unknown date, the outcome of the migraine, chills, fever, injection site pain, injection site erythema and blister were recovering/resolving.   It was unknown if the reporter considered the migraine, chills, fever, injection site pain, injection site erythema and blister to be related to Shingrix.  Additional details were provided as follows: The patient recived 2nd dose of Shingrix on left deltoid. The patient experienced migrain, chills, pain below injection site, redness below injection site and blister below injection site which was medically located towards chest area after receiving 2nd dose of Shingrix. For tolerance of the 1st dose of Shingrix vaccine, refer case US2019117677.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chills, Injection site erythema, Injection site pain, Migraine
Clinical narrative: Chills; Fever; Pain below injection site; Redness below injection site; Blisters below injection site; migraine; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2019) for prophylaxis.   Concurrent medical conditions included allergy to plants (aloe vera plant). Concomitant products included Herpes zoster (Shingrix).   On 26th June 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, less than a day after receiving Shingrix, the patient experienced migraine. On 27th June 2019, the patient experienced chills, fever, injection site pain, injection site erythema and blister. On an unknown date, the outcome of the migraine, chills, fever, injection site pain, injection site erythema and blister were recovering/resolving.   It was unknown if the reporter considered the migraine, chills, fever, injection site pain, injection site erythema and blister to be related to Shingrix.  Additional details were provided as follows: The patient recived 2nd dose of Shingrix on left deltoid. The patient experienced migrain, chills, pain below injection site, redness below injection site and blister below injection site which was medically located towards chest area after receiving 2nd dose of Shingrix. For tolerance of the 1st dose of Shingrix vaccine, refer case US2019117677.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills; Fever; Pain below injection site; Redness below injection site; Blisters below injection site; migraine; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2019) for prophylaxis.   Concurrent medical conditions included allergy to plants (aloe vera plant). Concomitant products included Herpes zoster (Shingrix).   On 26th June 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, less than a day after receiving Shingrix, the patient experienced migraine. On 27th June 2019, the patient experienced chills, fever, injection site pain, injection site erythema and blister. On an unknown date, the outcome of the migraine, chills, fever, injection site pain, injection site erythema and blister were recovering/resolving.   It was unknown if the reporter considered the migraine, chills, fever, injection site pain, injection site erythema and blister to be related to Shingrix.  Additional details were provided as follows: The patient recived 2nd dose of Shingrix on left deltoid. The patient experienced migrain, chills, pain below injection site, redness below injection site and blister below injection site which was medically located towards chest area after receiving 2nd dose of Shingrix. For tolerance of the 1st dose of Shingrix vaccine, refer case US2019117677.
Age: 5.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Bacterial  infection. Swelling of arm at injection site due to Bacterial infection. Painful warm swelling  in the area of deltoid muscle 48 hours after injection.
Age: 5.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Bacterial infection, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Bacterial  infection. Swelling of arm at injection site due to Bacterial infection. Painful warm swelling  in the area of deltoid muscle 48 hours after injection.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: Hours after the shot, I experienced muscle, bone and nerve pain down both legs, intensifying as time went on. I reported this to the Agency on 5/30/2019, 3 weeks after the shot. It is now nine (9) weeks after the shot and there is no improvement. I have gone to see an orthopedic surgeon, Dr. of Hospital, and a neurologist, Dr. to try to find out what has happened. I am in terrible, constant, and debilitating pain that has affected my quality of life that it is a struggle to walk without pain and have great difficulty climbing steps or standing from a chair. I have had X-Rays of bilateral hips and spine and an MRI of the spine on June 21,2019. On June 28 I had EMG/NCV Nerve Testing (Dr.), and I am taking Gabapentin [Neurontin] for the nerve pain. I am in remission from Endometrial cancer since April 2019 until next CT Scans in August 2019. I have never expected that a voluntary Shingles/Shingrix shot would put me in a debilitating position. I am hoping for some easing of the side effects of that shot, and hope that this will serve as a warning that maybe something was wrong with the vaccine or the batch. I don't think I could be the only person to have this experience with the Shingrix vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia, Vaccination complication
Clinical narrative: Hours after the shot, I experienced muscle, bone and nerve pain down both legs, intensifying as time went on. I reported this to the Agency on 5/30/2019, 3 weeks after the shot. It is now nine (9) weeks after the shot and there is no improvement. I have gone to see an orthopedic surgeon, Dr. of Hospital, and a neurologist, Dr. to try to find out what has happened. I am in terrible, constant, and debilitating pain that has affected my quality of life that it is a struggle to walk without pain and have great difficulty climbing steps or standing from a chair. I have had X-Rays of bilateral hips and spine and an MRI of the spine on June 21,2019. On June 28 I had EMG/NCV Nerve Testing (Dr.), and I am taking Gabapentin [Neurontin] for the nerve pain. I am in remission from Endometrial cancer since April 2019 until next CT Scans in August 2019. I have never expected that a voluntary Shingles/Shingrix shot would put me in a debilitating position. I am hoping for some easing of the side effects of that shot, and hope that this will serve as a warning that maybe something was wrong with the vaccine or the batch. I don't think I could be the only person to have this experience with the Shingrix vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Bone pain, Dysstasia, Electromyogram, Gait disturbance
Clinical narrative: Hours after the shot, I experienced muscle, bone and nerve pain down both legs, intensifying as time went on. I reported this to the Agency on 5/30/2019, 3 weeks after the shot. It is now nine (9) weeks after the shot and there is no improvement. I have gone to see an orthopedic surgeon, Dr. of Hospital, and a neurologist, Dr. to try to find out what has happened. I am in terrible, constant, and debilitating pain that has affected my quality of life that it is a struggle to walk without pain and have great difficulty climbing steps or standing from a chair. I have had X-Rays of bilateral hips and spine and an MRI of the spine on June 21,2019. On June 28 I had EMG/NCV Nerve Testing (Dr.), and I am taking Gabapentin [Neurontin] for the nerve pain. I am in remission from Endometrial cancer since April 2019 until next CT Scans in August 2019. I have never expected that a voluntary Shingles/Shingrix shot would put me in a debilitating position. I am hoping for some easing of the side effects of that shot, and hope that this will serve as a warning that maybe something was wrong with the vaccine or the batch. I don't think I could be the only person to have this experience with the Shingrix vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nerve conduction studies, Neuralgia, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: Hours after the shot, I experienced muscle, bone and nerve pain down both legs, intensifying as time went on. I reported this to the Agency on 5/30/2019, 3 weeks after the shot. It is now nine (9) weeks after the shot and there is no improvement. I have gone to see an orthopedic surgeon, Dr. of Hospital, and a neurologist, Dr. to try to find out what has happened. I am in terrible, constant, and debilitating pain that has affected my quality of life that it is a struggle to walk without pain and have great difficulty climbing steps or standing from a chair. I have had X-Rays of bilateral hips and spine and an MRI of the spine on June 21,2019. On June 28 I had EMG/NCV Nerve Testing (Dr.), and I am taking Gabapentin [Neurontin] for the nerve pain. I am in remission from Endometrial cancer since April 2019 until next CT Scans in August 2019. I have never expected that a voluntary Shingles/Shingrix shot would put me in a debilitating position. I am hoping for some easing of the side effects of that shot, and hope that this will serve as a warning that maybe something was wrong with the vaccine or the batch. I don't think I could be the only person to have this experience with the Shingrix vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Quality of life decreased, Spinal X-ray, X-ray of pelvis and hip
Clinical narrative: Hours after the shot, I experienced muscle, bone and nerve pain down both legs, intensifying as time went on. I reported this to the Agency on 5/30/2019, 3 weeks after the shot. It is now nine (9) weeks after the shot and there is no improvement. I have gone to see an orthopedic surgeon, Dr. of Hospital, and a neurologist, Dr. to try to find out what has happened. I am in terrible, constant, and debilitating pain that has affected my quality of life that it is a struggle to walk without pain and have great difficulty climbing steps or standing from a chair. I have had X-Rays of bilateral hips and spine and an MRI of the spine on June 21,2019. On June 28 I had EMG/NCV Nerve Testing (Dr.), and I am taking Gabapentin [Neurontin] for the nerve pain. I am in remission from Endometrial cancer since April 2019 until next CT Scans in August 2019. I have never expected that a voluntary Shingles/Shingrix shot would put me in a debilitating position. I am hoping for some easing of the side effects of that shot, and hope that this will serve as a warning that maybe something was wrong with the vaccine or the batch. I don't think I could be the only person to have this experience with the Shingrix vaccine.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Aches, slight fever, weakness, fatigue, malaise. Still going on, third day. Took Tylenol.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Condition aggravated, Cytogenetic analysis
Clinical narrative: PFAPA syndrome (excessive tiredness,  swollen lymphnodes,  headache,  stomach aches,  vomiting,  rashes, joint pain, mouth sores, body sores, etc)
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Fatigue, Headache, Lymphadenopathy, PFAPA syndrome, Rash
Clinical narrative: PFAPA syndrome (excessive tiredness,  swollen lymphnodes,  headache,  stomach aches,  vomiting,  rashes, joint pain, mouth sores, body sores, etc)
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Skin ulcer, Stomatitis, Vomiting
Clinical narrative: PFAPA syndrome (excessive tiredness,  swollen lymphnodes,  headache,  stomach aches,  vomiting,  rashes, joint pain, mouth sores, body sores, etc)
Age: 76.0
Sex: M
Vaccine: MMR
Symptoms: Myalgia, Platelet count decreased, Rash generalised, White blood cell count decreased
Clinical narrative: Muscle aches, a rash covering body per patient's spouse, and low white blood cell count, low platelet count per doctor's office.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation, from a lawyer, concerning a decedent patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  In 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX), due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided).  On an unknown date, the decedent was diagnosed with herpes zoster. On an unknown date the patient was treated for the event from the physician. At the time of report, the outcome of the event was unknown. The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 06-OCT-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster.   On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.