chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Immediate post-injection reaction, Pain, Peripheral swelling, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a 7-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9PX3H, expiry date 30th June 2017). On 26th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 28th October 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site redness and injection site pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site itching, injection site redness and injection site pain were unknown. It was unknown if the reporter considered the injection site itching, injection site redness and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: After receiving FLUARIX QUADRIVALENT in left deltoid, the patient experienced redness, itching, and pain at the injection site. The redness, pain, and itching had spread past the injection site to underneath the affected arm. The medical staffs were just made aware of the event, on the day of reporting. This case has been linked with US2016159821 reported by same reporter.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a 7-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9PX3H, expiry date 30th June 2017). On 26th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 28th October 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site redness and injection site pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site itching, injection site redness and injection site pain were unknown. It was unknown if the reporter considered the injection site itching, injection site redness and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: After receiving FLUARIX QUADRIVALENT in left deltoid, the patient experienced redness, itching, and pain at the injection site. The redness, pain, and itching had spread past the injection site to underneath the affected arm. The medical staffs were just made aware of the event, on the day of reporting. This case has been linked with US2016159821 reported by same reporter.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 19-year-old female patient of unknown race/ethnicity received on 04Oct2016 4:00 PM first single dose of TRUMENBA, (lot number N11903) intramuscular in the left arm and first dose of INFLUENZA H1N1, (lot number UT5636NA) in the right arm, both for immunization. On 04Oct2016 4:30 PM, the patient had soreness on left arm, were vaccination was administrated, can't lift left arm and pain been on 4 weeks since vaccination. Medical history and concomitant medications were not reported. Outcome was not recovered.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 19-year-old female patient of unknown race/ethnicity received on 04Oct2016 4:00 PM first single dose of TRUMENBA, (lot number N11903) intramuscular in the left arm and first dose of INFLUENZA H1N1, (lot number UT5636NA) in the right arm, both for immunization. On 04Oct2016 4:30 PM, the patient had soreness on left arm, were vaccination was administrated, can't lift left arm and pain been on 4 weeks since vaccination. Medical history and concomitant medications were not reported. Outcome was not recovered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 4-year-old female patient who received KINRIX (batch number 4F49N, expiry date 13th November 2017). Concomitant products included Measles Mumps Rubella and Varicella Vaccine. On 31st October 2016, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving KINRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by a medical assistant. The age at vaccination was not reported. The patient received KINRIX on the left thigh. On the same day, the patient received 2nd dose of MMR vaccine (non-GSK) (batch number L027591, expiry date 23rd July 2017) subcutaneously on left thigh and 2nd dose of varicella vaccine (non-GSK) (batch number L029469, expiry date 6th August 2017) subcutaneously on right thigh. The physician was transferred to medical information for discussion on the product. It is unknown when the cellulitis presented after the vaccination, however the patient was seen by physician on a day before reporting. The patient was seen by the physician. The reporter mentioned that the physician would not be using the same lot of the KINRIX anymore, but there was no mention of QA reported. The reporter's call was transferred to Medical Information System (MIS). This case was linked with US2016163424, reported by the same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 4-year-old female patient who received KINRIX (batch number 4F49N, expiry date 13th November 2017). Concomitant products included Measles Mumps Rubella and Varicella Vaccine. On 31st October 2016, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving KINRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by a medical assistant. The age at vaccination was not reported. The patient received KINRIX on the left thigh. On the same day, the patient received 2nd dose of MMR vaccine (non-GSK) (batch number L027591, expiry date 23rd July 2017) subcutaneously on left thigh and 2nd dose of varicella vaccine (non-GSK) (batch number L029469, expiry date 6th August 2017) subcutaneously on right thigh. The physician was transferred to medical information for discussion on the product. It is unknown when the cellulitis presented after the vaccination, however the patient was seen by physician on a day before reporting. The patient was seen by the physician. The reporter mentioned that the physician would not be using the same lot of the KINRIX anymore, but there was no mention of QA reported. The reporter's call was transferred to Medical Information System (MIS). This case was linked with US2016163424, reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 4-year-old male patient who received KINRIX (batch number 4F49N, expiry date 13th November 2017). Concomitant products included Measles Mumps Rubella and Varicella Vaccine. On 1st November 2016, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving KINRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by a medical assistant. The patient received KINRIX on the left thigh. On the same day, the patient received 2nd dose of MMR vaccine (non-GSK) (batch number L027591, expiry date 23rd July 2017) on right thigh and 2nd dose of varicella vaccine (non-GSK) (batch number L029469, expiry date 6th August 2017) on right thigh. The physician was transferred to medical information for discussion on the product. It is unknown when the cellulitis presented after the vaccination, however the patient was seen by physician on a day before reporting. The patient was seen by the physician. The reporter mentioned that the physician would not be using the same lot of the KINRIX anymore, but there was no mention of QA reported. The reporter's call was transferred to Medical Information System (MIS). This case was linked with US2016163423, as reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 4-year-old male patient who received KINRIX (batch number 4F49N, expiry date 13th November 2017). Concomitant products included Measles Mumps Rubella and Varicella Vaccine. On 1st November 2016, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving KINRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by a medical assistant. The patient received KINRIX on the left thigh. On the same day, the patient received 2nd dose of MMR vaccine (non-GSK) (batch number L027591, expiry date 23rd July 2017) on right thigh and 2nd dose of varicella vaccine (non-GSK) (batch number L029469, expiry date 6th August 2017) on right thigh. The physician was transferred to medical information for discussion on the product. It is unknown when the cellulitis presented after the vaccination, however the patient was seen by physician on a day before reporting. The patient was seen by the physician. The reporter mentioned that the physician would not be using the same lot of the KINRIX anymore, but there was no mention of QA reported. The reporter's call was transferred to Medical Information System (MIS). This case was linked with US2016163423, as reported by the same reporter.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Insomnia, Pain, Pain in extremity
Clinical narrative: Shoulder and bursa pain ongoing.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Rotator cuff syndrome, X-ray limb
Clinical narrative: Shoulder and bursa pain ongoing.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder and bursa pain ongoing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Condition aggravated, Injection site erythema, Mood altered, Pyrexia
Clinical narrative: Patient has a diagnosis of autism. Received vaccines on: 10/28/16. Mom called on 10/29/16regarding redness around injection site. Then she called 10/31/16 about fever occurring from vaccines. Today she states vaccines- fever/redness/soreness-caused relapse in autisms worsening behavior.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Autism, Condition aggravated, Injection site erythema, Pyrexia
Clinical narrative: Patient has a diagnosis of autism. Received vaccines on: 10/28/16. Mom called on 10/29/16regarding redness around injection site. Then she called 10/31/16 about fever occurring from vaccines. Today she states vaccines- fever/redness/soreness-caused relapse in autisms worsening behavior.
Age: 9.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Rash, Urticaria
Clinical narrative: Broke out in hives down left arm, left side of rib cage, across back of neck, and upper part of right arm.  Given 25mg of Benadryl as soon as symptoms noticed.  Hives were almost unnoticeable after 90 minutes.
Age: 9.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Urticaria
Clinical narrative: Broke out in hives down left arm, left side of rib cage, across back of neck, and upper part of right arm.  Given 25mg of Benadryl as soon as symptoms noticed.  Hives were almost unnoticeable after 90 minutes.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Balance disorder, Clumsiness, Cytogenetic analysis, Discomfort
Clinical narrative: Child received the MMRV Proquad around 10:00 AM on 7/11/2016. The next day, 7/12/2016, he began to run a low grade fever and was terribly crabby, uncomfortable and not himself.  He was noticeably more clumsy as well.  We took him to Dr's office on 7/13/2016 and we were given an "all clear" at the doctors office that visit.  The days following he was still not himself. Crabby, uncomfortable and unhappy.  Then on 07/24/2016 bumps showed up on child's right leg, a cluster at the injection site and another on the outside of his knee.  The bumps got larger, firm and more red over the next few days.  On 07/27/2016 he woke up with multiple bumps on his face.  Over the next few days they appeared on his arms and hands.  We were advised by our pediatrician, to come in and be seen.  At this visit she confirmed that he was having a reaction to the MMRV and we were given a hand out which stated that the reaction was likely caused by the "wild type VZV" used in the MMRV Proquad.  This entire time my son was still not his usual self.  Again, crabby and uncomfortable and still seemed noticeably more unbalanced on his feet.  We were advised to stay out of the public until the bumps quit appearing so not to infect immune compromised individuals.  The bumps took about two months to completely diminish. We are currently seeing a more holistic minded doctor to evaluate my son.  Correcting any issues that this vaccine and the compilation of vaccines since birth may of caused.  We are awaiting the results from his MTHFR testing as well.  This genetic mutation could of hindered his body from properly flushing out toxins and caused his reaction due to a build up of toxins from vaccines.  This is a test that I feel strongly every chid should be tested for before just ASSUMING every child can tolerate ALL the recommended vaccines ALL the time.  Just like not everyone can tolerate penicillin, not everyone can tolerate ALL the vaccines. There needs to be safety measures put into place for the sake of our children.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Child received the MMRV Proquad around 10:00 AM on 7/11/2016. The next day, 7/12/2016, he began to run a low grade fever and was terribly crabby, uncomfortable and not himself.  He was noticeably more clumsy as well.  We took him to Dr's office on 7/13/2016 and we were given an "all clear" at the doctors office that visit.  The days following he was still not himself. Crabby, uncomfortable and unhappy.  Then on 07/24/2016 bumps showed up on child's right leg, a cluster at the injection site and another on the outside of his knee.  The bumps got larger, firm and more red over the next few days.  On 07/27/2016 he woke up with multiple bumps on his face.  Over the next few days they appeared on his arms and hands.  We were advised by our pediatrician, to come in and be seen.  At this visit she confirmed that he was having a reaction to the MMRV and we were given a hand out which stated that the reaction was likely caused by the "wild type VZV" used in the MMRV Proquad.  This entire time my son was still not his usual self.  Again, crabby and uncomfortable and still seemed noticeably more unbalanced on his feet.  We were advised to stay out of the public until the bumps quit appearing so not to infect immune compromised individuals.  The bumps took about two months to completely diminish. We are currently seeing a more holistic minded doctor to evaluate my son.  Correcting any issues that this vaccine and the compilation of vaccines since birth may of caused.  We are awaiting the results from his MTHFR testing as well.  This genetic mutation could of hindered his body from properly flushing out toxins and caused his reaction due to a build up of toxins from vaccines.  This is a test that I feel strongly every chid should be tested for before just ASSUMING every child can tolerate ALL the recommended vaccines ALL the time.  Just like not everyone can tolerate penicillin, not everyone can tolerate ALL the vaccines. There needs to be safety measures put into place for the sake of our children.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Vaccination complication
Clinical narrative: Child received the MMRV Proquad around 10:00 AM on 7/11/2016. The next day, 7/12/2016, he began to run a low grade fever and was terribly crabby, uncomfortable and not himself.  He was noticeably more clumsy as well.  We took him to Dr's office on 7/13/2016 and we were given an "all clear" at the doctors office that visit.  The days following he was still not himself. Crabby, uncomfortable and unhappy.  Then on 07/24/2016 bumps showed up on child's right leg, a cluster at the injection site and another on the outside of his knee.  The bumps got larger, firm and more red over the next few days.  On 07/27/2016 he woke up with multiple bumps on his face.  Over the next few days they appeared on his arms and hands.  We were advised by our pediatrician, to come in and be seen.  At this visit she confirmed that he was having a reaction to the MMRV and we were given a hand out which stated that the reaction was likely caused by the "wild type VZV" used in the MMRV Proquad.  This entire time my son was still not his usual self.  Again, crabby and uncomfortable and still seemed noticeably more unbalanced on his feet.  We were advised to stay out of the public until the bumps quit appearing so not to infect immune compromised individuals.  The bumps took about two months to completely diminish. We are currently seeing a more holistic minded doctor to evaluate my son.  Correcting any issues that this vaccine and the compilation of vaccines since birth may of caused.  We are awaiting the results from his MTHFR testing as well.  This genetic mutation could of hindered his body from properly flushing out toxins and caused his reaction due to a build up of toxins from vaccines.  This is a test that I feel strongly every chid should be tested for before just ASSUMING every child can tolerate ALL the recommended vaccines ALL the time.  Just like not everyone can tolerate penicillin, not everyone can tolerate ALL the vaccines. There needs to be safety measures put into place for the sake of our children.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Activities of daily living impaired, Allergy test, Blood test, Chills, Clumsiness
Clinical narrative: Beginning on 09/01/2015 patient began vomiting and I brought her home early from daycare.  09/02/2015 her fever would not go down even with Tylenol. She was sitting in her highchair.  I was giving her rice baby cereal, she had not eaten in 24 hours.  She turned her body to the right, looked up, clenched hands, legs stiff, toes pointed and her body shivered. Her eyes fluttered.  This lasted approximately 30 seconds.  I text my husband and as soon as he could come home from work, I took her to the E.R. I took her temperature and it was 105.3.  When we got to E.R it was 103.6 Since this febrile seizure patient has had a varicella type rash.  Her pediatrician at this time can not diagnose the cause of rash.  She has been treated for scabies, suspected bed bug bites or allergic reaction (house was inspected and we are not infested by any bugs), eczema and steroid creams, antifungal creams and Benadryl.  Nothing has worked. Rash last from one week, fades, reappears looking different and now we have come full circle back to this varicella type rash.  Some rashes looked like infant yeast, others looked liked hives.  Child seems clumsy, falls more than normal, very irritable, very itchy, reoccuring cough with these rashes, and now after so many weeks she is beginning to breakdown and just whimper and cry.  She is very uncomfortable. She is having trouble sleeping and will wake in the night screaming, but not fully conscious. The doctor ordered more blood work today 11/0/10/2016.  We are suppose to have the results in one week, but I suspect it may take two weeks.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Computerised tomogram, Cough, Crying, Discomfort, Electroencephalogram
Clinical narrative: Beginning on 09/01/2015 patient began vomiting and I brought her home early from daycare.  09/02/2015 her fever would not go down even with Tylenol. She was sitting in her highchair.  I was giving her rice baby cereal, she had not eaten in 24 hours.  She turned her body to the right, looked up, clenched hands, legs stiff, toes pointed and her body shivered. Her eyes fluttered.  This lasted approximately 30 seconds.  I text my husband and as soon as he could come home from work, I took her to the E.R. I took her temperature and it was 105.3.  When we got to E.R it was 103.6 Since this febrile seizure patient has had a varicella type rash.  Her pediatrician at this time can not diagnose the cause of rash.  She has been treated for scabies, suspected bed bug bites or allergic reaction (house was inspected and we are not infested by any bugs), eczema and steroid creams, antifungal creams and Benadryl.  Nothing has worked. Rash last from one week, fades, reappears looking different and now we have come full circle back to this varicella type rash.  Some rashes looked like infant yeast, others looked liked hives.  Child seems clumsy, falls more than normal, very irritable, very itchy, reoccuring cough with these rashes, and now after so many weeks she is beginning to breakdown and just whimper and cry.  She is very uncomfortable. She is having trouble sleeping and will wake in the night screaming, but not fully conscious. The doctor ordered more blood work today 11/0/10/2016.  We are suppose to have the results in one week, but I suspect it may take two weeks.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Eyelid disorder, Fall, Febrile convulsion, Gaze palsy, Insomnia
Clinical narrative: Beginning on 09/01/2015 patient began vomiting and I brought her home early from daycare.  09/02/2015 her fever would not go down even with Tylenol. She was sitting in her highchair.  I was giving her rice baby cereal, she had not eaten in 24 hours.  She turned her body to the right, looked up, clenched hands, legs stiff, toes pointed and her body shivered. Her eyes fluttered.  This lasted approximately 30 seconds.  I text my husband and as soon as he could come home from work, I took her to the E.R. I took her temperature and it was 105.3.  When we got to E.R it was 103.6 Since this febrile seizure patient has had a varicella type rash.  Her pediatrician at this time can not diagnose the cause of rash.  She has been treated for scabies, suspected bed bug bites or allergic reaction (house was inspected and we are not infested by any bugs), eczema and steroid creams, antifungal creams and Benadryl.  Nothing has worked. Rash last from one week, fades, reappears looking different and now we have come full circle back to this varicella type rash.  Some rashes looked like infant yeast, others looked liked hives.  Child seems clumsy, falls more than normal, very irritable, very itchy, reoccuring cough with these rashes, and now after so many weeks she is beginning to breakdown and just whimper and cry.  She is very uncomfortable. She is having trouble sleeping and will wake in the night screaming, but not fully conscious. The doctor ordered more blood work today 11/0/10/2016.  We are suppose to have the results in one week, but I suspect it may take two weeks.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Middle insomnia, Muscle contractions involuntary, Musculoskeletal stiffness, Pruritus
Clinical narrative: Beginning on 09/01/2015 patient began vomiting and I brought her home early from daycare.  09/02/2015 her fever would not go down even with Tylenol. She was sitting in her highchair.  I was giving her rice baby cereal, she had not eaten in 24 hours.  She turned her body to the right, looked up, clenched hands, legs stiff, toes pointed and her body shivered. Her eyes fluttered.  This lasted approximately 30 seconds.  I text my husband and as soon as he could come home from work, I took her to the E.R. I took her temperature and it was 105.3.  When we got to E.R it was 103.6 Since this febrile seizure patient has had a varicella type rash.  Her pediatrician at this time can not diagnose the cause of rash.  She has been treated for scabies, suspected bed bug bites or allergic reaction (house was inspected and we are not infested by any bugs), eczema and steroid creams, antifungal creams and Benadryl.  Nothing has worked. Rash last from one week, fades, reappears looking different and now we have come full circle back to this varicella type rash.  Some rashes looked like infant yeast, others looked liked hives.  Child seems clumsy, falls more than normal, very irritable, very itchy, reoccuring cough with these rashes, and now after so many weeks she is beginning to breakdown and just whimper and cry.  She is very uncomfortable. She is having trouble sleeping and will wake in the night screaming, but not fully conscious. The doctor ordered more blood work today 11/0/10/2016.  We are suppose to have the results in one week, but I suspect it may take two weeks.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash vesicular, Screaming, Skull X-ray, Vomiting
Clinical narrative: Beginning on 09/01/2015 patient began vomiting and I brought her home early from daycare.  09/02/2015 her fever would not go down even with Tylenol. She was sitting in her highchair.  I was giving her rice baby cereal, she had not eaten in 24 hours.  She turned her body to the right, looked up, clenched hands, legs stiff, toes pointed and her body shivered. Her eyes fluttered.  This lasted approximately 30 seconds.  I text my husband and as soon as he could come home from work, I took her to the E.R. I took her temperature and it was 105.3.  When we got to E.R it was 103.6 Since this febrile seizure patient has had a varicella type rash.  Her pediatrician at this time can not diagnose the cause of rash.  She has been treated for scabies, suspected bed bug bites or allergic reaction (house was inspected and we are not infested by any bugs), eczema and steroid creams, antifungal creams and Benadryl.  Nothing has worked. Rash last from one week, fades, reappears looking different and now we have come full circle back to this varicella type rash.  Some rashes looked like infant yeast, others looked liked hives.  Child seems clumsy, falls more than normal, very irritable, very itchy, reoccuring cough with these rashes, and now after so many weeks she is beginning to breakdown and just whimper and cry.  She is very uncomfortable. She is having trouble sleeping and will wake in the night screaming, but not fully conscious. The doctor ordered more blood work today 11/0/10/2016.  We are suppose to have the results in one week, but I suspect it may take two weeks.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Myositis, Pain, Pain in extremity
Clinical narrative: The first two days after my flu shot and pneumonia shot, I experienced the typical sore arm and thought nothing of it. I had some concern the next day when the pain became significantly greater, especially when lifting or moving my arm. I went to a local urgent care on day 4 when my arm and shoulder began to really bother me. I was told it was probably a muscle inflammation and given a sling and told to use warm compresses and take Tylenol #3 1 table up to 4 times a day. The pain has now settled in my inner shoulder especially. It is now very difficult for me to lift that arm without the help of my other arm, It is very painful to dress myself or do anything that I must raise my arm for or reach behind me like put my coat on. This is especially distressing to me because my husband had a stroke 3 years ago affecting his left arm and I am the person who helps him. This has become challenging.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016479847) in on 31 October 2016. This case involves a 67-year-old female patient who was vaccinated with a dose of Flu shot and PNEUMONIA SHOT (batch number, expiration date and dose, dose in series, route of administration and site of administration were not reported for both vaccines) on an unspecified date. The patients' previous medications and medical history were not reported. On an unspecified date, following vaccination, the patient felt as patient was in a fog, like patient's pressure was up, cloud over patient's head was not feeling well. Laboratory investigations and corrective treatment was not reported. The patient outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) on 31 Oct 2016. Manufacturer report number: 2016464455. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergy to tetanus vaccines and toxoids (not specified). The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, PNC13
Symptoms: Chills, Injection site swelling, Tachycardia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 01 November 2016. This case involves a 69-year-old female patient who was vaccinated with a Fluzone HD (batch number: UI654AE, expiry date: 07-APR-2017, dose, dose in series and route of administration were not reported) in the left deltoid on 25 October 2016. The patient denied any medical issues and any known allergies. No other information about the patient's medical history was reported. Concomitant medications were reported as unknown. On 25 October 2016, the night of vaccination (time unspecified), the patient had swelling at the injection site, chills and tachycardia. The patient needed ER visit. Lab data was not reported. The patient received corrective treatment with Zyrtec and hydrocortisone cream. The outcome of the events was not recovered. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 01 November 2016. This case involves a 69-year-old female patient who was vaccinated with a Fluzone HD (batch number: UI654AE, expiry date: 07-APR-2017, dose, dose in series and route of administration were not reported) in the left deltoid on 25 October 2016. The patient denied any medical issues and any known allergies. No other information about the patient's medical history was reported. Concomitant medications were reported as unknown. On 25 October 2016, the night of vaccination (time unspecified), the patient had swelling at the injection site, chills and tachycardia. The patient needed ER visit. Lab data was not reported. The patient received corrective treatment with Zyrtec and hydrocortisone cream. The outcome of the events was not recovered. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, PNC13
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 01 November 2016. This case involves a 69-year-old female patient who was vaccinated with a Fluzone HD (batch number: UI654AE, expiry date: 07-APR-2017, dose, dose in series and route of administration were not reported) in the left deltoid on 25 October 2016. The patient denied any medical issues and any known allergies. No other information about the patient's medical history was reported. Concomitant medications were reported as unknown. On 25 October 2016, the night of vaccination (time unspecified), the patient had swelling at the injection site, chills and tachycardia. The patient needed ER visit. Lab data was not reported. The patient received corrective treatment with Zyrtec and hydrocortisone cream. The outcome of the events was not recovered. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016465696) on 31-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient had swollen arm. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Coeliac disease, Condition aggravated, Diarrhoea, Dizziness
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 03 Nov 2016. This case involves a 15-year-old female patient who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose and dose in series were not reported) intramuscularly in the deltoid on 01 Nov 16. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as celiac disease, asthma and Gastro esophageal Reflux Disease (GERD). Illness at the time of vaccination was reported as not acutely ill. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 02 Nov 2016, one day following the vaccination, the patient experienced a flare up of her celiac disease symptoms and dizziness. The patient experienced abdominal cramping, diarrhea and fatigue. Parent stated no plans to have her daughter evaluated by physician. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 03 Nov 2016. This case involves a 15-year-old female patient who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose and dose in series were not reported) intramuscularly in the deltoid on 01 Nov 16. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as celiac disease, asthma and Gastro esophageal Reflux Disease (GERD). Illness at the time of vaccination was reported as not acutely ill. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 02 Nov 2016, one day following the vaccination, the patient experienced a flare up of her celiac disease symptoms and dizziness. The patient experienced abdominal cramping, diarrhea and fatigue. Parent stated no plans to have her daughter evaluated by physician. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: EE received influenza vaccine at 1012. At approximately 10:30 she notified staff that she was experiencing numbness in the right arm. Describes as numbness and tingling down the entire arm into her hand. Saw PCP. In consultation with Infectious Disease was diagnosed with atypical Guillain Barre syndrome. No specific treatment recommended at this time.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Diffuse urticaria.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Autopsy, Bladder cancer, Death, General physical health deterioration, Haemorrhage
Clinical narrative: Initial  and follow-up information has been received from a healthcare professional and a pharmacist concerning an 85 year old female patient. Information about concurrent condition and medical history was not reported. On an unspecified date the patient was subcutaneously vaccinated with PNEUMOVAX NP injection (vaccination date, lot number, dose and indication not reported). On an unspecified date (from about 35 years ago), the patient had no health issue  originally, she was continuously administrated with FLUITRAN and PERDIPINE as blood pressure medication. On an unspecified date (from about 15 days after vaccination), the patient suffered poor health suddenly. On an unspecified date (within one month after vaccination), the patient developed bleeding suddenly. The patient visited the hospital and found bladder cancer. On an unspecified date (within half a year), the patient died. The cause of death was bladder cancer. Information on autopsy was not reported. Reporter's comment: The cancer primary doctor considered the vaccine was not the cause of death and considered the cause could not be identified. But the patient's family did not agree and considered there was no other reason except the PNEUMOVAX NP. The reporting pharmacist considered that the bladder cancer was serious due to death. The reporting pharmacist did not assess the relationship of bladder cancer to PNEUMOVAX NP. Upon internal review, the event of bladder cancer was considered to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted.  Updated information received on 07-NOV-2016 from the pharmacist has been marked with double caret.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Herpes zoster, Knee arthroplasty
Clinical narrative: This spontaneous report as received from a 69 year old female patient regarding herself. The patient's medical history was not reported. The patient had drug reactions/allergies to a number of antibiotics (unspecified). The concomitant therapies included unspecified over the counter medications, metoprolol and levothyroxine sodium. On an unspecified date in 2010, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot/batch # and expiration date  were not reported) subcutaneously. On an unspecified date in June 2016, the patient had a knee replacement surgery. "Recently, around the beginning of October 2016" the patient experienced a case of shingles. The patient had to reschedule knee replacement surgery in her other knee that was scheduled  for 12-OCT-2016 "because of the shingles".  On an unspecified date, a biopsy was performed which confirmed shingles. The patient sought medical attention by going to the physician. The patient received treatment by the use of VALTREX, gabapentin and clobetasol propionate. As of the date of this report, she has  almost recovered, but still has shingles in her left thumb. The outcome of knee replacement surgery and shingles was recovering. The causality assessment was not provided by the reporter. Upon internal review, the event, knee replacement surgery was considered to be medically significant. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Abscess, Cellulitis, Pain, Secretion discharge, Urticaria
Clinical narrative: More pain than normal starting on day 1. 1 Week later patient developed cellulitis, a 3/4 inch wheal and an abscess with white pus like discharge. Within 3 weeks after vaccination the site was scabbed over. Almost a month later the site has healed. No treatment sought.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site scab
Clinical narrative: More pain than normal starting on day 1. 1 Week later patient developed cellulitis, a 3/4 inch wheal and an abscess with white pus like discharge. Within 3 weeks after vaccination the site was scabbed over. Almost a month later the site has healed. No treatment sought.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in right arm where injection given- pain in shoulder, upper arm, elbow lower arm and hand with numbness and tingling periodically.  Using heat, Tylenol, ASA, Advil for some slight relief.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Client fainted approximately 10 minutes after vaccine administration. Client regained consciousness approximately 2 to 3 seconds after fainting. Vital signs were taken immediately following event. Vitals were WNL and appropriate for client's age. After assessment client stated " I feel normal". No deficits were observed.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: High Fever, Swelling of Injection Sight Weakness, 3x6 Red Swollen Area around the Injection Sight and headaches.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Heart rate increased
Clinical narrative: Fast heartbeat, rigors, went by EMS to hospital on 10/15/16.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Received flu vaccine - 10/12/16 - (R) arm swollen, red, warm by the evening of 10/12/16. 10/13/16 blisters on deltoid area and arm swollen down to elbow.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Patient developed intussusception on 9/14/16 and required surgery. Patient received ROTATEQ on 9/7/16.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: 1 wk later with pink warm circle around area of injection.
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Pt. left office and went to bathroom in the hallway, passed out on floor, found by grandmother.  Was brought back to the exam room and kept for monitoring, was said to have had a vasovagal response to immunizations given at appt.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood lactic acid, Body temperature increased, Chest X-ray, Computerised tomogram abdomen
Clinical narrative: Rec'd vaccine while on shift at work. Had reaction nine hours later and went to the ER. C/o heart racing, back soreness, N/V, rapid breathing, oral temp 100.5 F 10/30/16 ER visit diagnosed with Tachycardia. Treating physician couldn't rule out flu shot caused.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram pelvis, Electrocardiogram, Fibrin D dimer, Full blood count, Lipase
Clinical narrative: Rec'd vaccine while on shift at work. Had reaction nine hours later and went to the ER. C/o heart racing, back soreness, N/V, rapid breathing, oral temp 100.5 F 10/30/16 ER visit diagnosed with Tachycardia. Treating physician couldn't rule out flu shot caused.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Liver function test, Metabolic function test, Nausea, Palpitations, Respiratory rate increased
Clinical narrative: Rec'd vaccine while on shift at work. Had reaction nine hours later and went to the ER. C/o heart racing, back soreness, N/V, rapid breathing, oral temp 100.5 F 10/30/16 ER visit diagnosed with Tachycardia. Treating physician couldn't rule out flu shot caused.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Urine analysis, Vomiting
Clinical narrative: Rec'd vaccine while on shift at work. Had reaction nine hours later and went to the ER. C/o heart racing, back soreness, N/V, rapid breathing, oral temp 100.5 F 10/30/16 ER visit diagnosed with Tachycardia. Treating physician couldn't rule out flu shot caused.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: 10/24/16 had flu shot, pt reports "given in subacromial space". 2 hours later had pain with any arm movement rates pain 8/10. ROCEPHIN given IM and placed on oral KEFLEX 500mg BID on 10/27/16 warm moist heat and ZYRTEC also. Today 11/7/16 rates pain 5-6/10. Awaiting MRI schedule.
Age: 42.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain, Blood culture, Full blood count, Injection site pain, Injection site swelling
Clinical narrative: Received PCV-13 vaccine at 3pm on 11/4/16. At 8pm same day experienced mild pain and swelling at injection site. At 3am next day woke up with 10/10 pain, fever 102.2 F. On 11/5 temp max was 104. Took ibuprofen and acetaminophen with good effect. Had abdominal cramping 11/5/16. Fever and abd. cramping resolved 11/5. Continuous site swelling and pain 11/7.
Age: 42.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Received PCV-13 vaccine at 3pm on 11/4/16. At 8pm same day experienced mild pain and swelling at injection site. At 3am next day woke up with 10/10 pain, fever 102.2 F. On 11/5 temp max was 104. Took ibuprofen and acetaminophen with good effect. Had abdominal cramping 11/5/16. Fever and abd. cramping resolved 11/5. Continuous site swelling and pain 11/7.
Age: 33.0
Sex: F
Vaccine: FLUR3
Symptoms: Chest discomfort, Dyspnoea, Throat irritation
Clinical narrative: This is an initial report of an AE, received on 01Nov2016, for Protein Sciences Flublok. A female received Flublok Intramuscular on 01Nov2016 at 10.30 am. The pharmacist observed the patient for 20 minutes with no recorded adverse signs or symptoms and the subject left the pharmacy. On, 01Nov2016, approximately 1.5 hours after receiving Flublok, the subject reported to her employer that she was on her way to the hospital. The subject had texted to her employer that she had symptoms of labored breathing (weight on her chest) and an itchy throat. The patients employer had called the pharmacy where the subject received Flublok to inquire additional information regarding anaphylactic reactions with Flublok, specifically the length of time between the injection and symptoms. The employer appeared to express doubt that this was a genuine medical event. At the time of the report, the outcomes of the events of labored breathing (weight on her chest) and an itchy throat were unknown. Medical or surgical history for the subject included an egg allergy (non descriptive adverse reaction to a previous flu shot from a few years prior). Concomitant medications were not reported. Additional information received on 08Nov2016, pharmacist who provided the Flublok vaccine and the infectious control officer at the hospital where the subject was seen were unable to provide any additional information at this time.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling 2 days after injection. (R) thigh.