chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Peripheral swelling, Sensory loss
Clinical narrative: A contactable consumer reporting on behalf of her mother reported that a 82-year-old female patient received PREVNAR 13 on 21Dec2015, in right arm, at single dose. Medical history included heart problem. The patient concomitant medications were not reported. the patient experienced immobile right arm on 21Dec2015 with outcome of not recovered, could not move her arm past her head on 21Dec2015 with outcome of not recovered, she occasionally had spasms on an unspecified date with outcome of unknown, swollen arm on 21Dec2015 with outcome of not recovered, muscle contraction on an  unspecified date with outcome of not recovered, did not have any feeling in her right arm on an unspecified date with outcome of unknown, she could not use her right arm since then on 21Dec2015 with outcome of not recovered. She was still having pain at injection site since 21Dec2015. Treatment received included BENADRYL 75 mg  tablet, steroids, pain medications, muscle relaxers. the pain medication and muscle relaxers were not doing any good. Some fluid was withdrawn twice out of the big knot (swelled part) but did not find any bacteria in that. the patient went back to the doctor who gave the vaccine. She had also been to the orthopaedic doctor and cardiologist.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Peau d'orange
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 64-year-old male patient of an unspecified ethnicity, on 17Aug2016 received PREVENAR 13 (Lot# N05077) via an unspecified route at single dose. The patient medical history included diabetic, respiratory disease and hypertension. Concomitant medications were not reported. Begin 48 hrs after administration, the patient experienced left arm cellulites. The patient was hospitalized for the event for 1 week. The outcome of the event was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. There was no information about concomitant medication, medical history or drug reactions/allergies. On 29-AUG-2016, the patient was inadvertently vaccinated with an expired (Oka/Merck) VARIVAX (lot # K010437 with expiration date 22-JUL-2016; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Induration, Musculoskeletal stiffness, Peripheral swelling, Pyrexia
Clinical narrative: Fever 102. Arm injected became swollen, red, firm, stiff.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ, HEPA, MENB, MNQ
Symptoms: Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of faint in a 16-year-old female patient who received BEXSERO. Co-suspect products included Hepatitis A vaccine and MENACTRA. On 1st September 2016, the patient received BEXSERO (intramuscular), Hepatitis A vaccine and MENACTRA. On 1st September 2016, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced faint. On an unknown date, the outcome of the faint was not recovered/not resolved. It was unknown if the reporter considered the faint to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: the patient received BEXSERO and Hepatitis A vaccines on her arm. the patient also received a dose of MENACTRA concomitantly on her arm. the manufacturer of co-suspect vaccine Hepatitis A was unknown. the lot number and expiration date of the vaccines were unknown. the sales representative noted that the office had filed a VAERS report. This case has been linked with US2016128112 (twin's case), reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of redness in a 17-year-old female patient who received MENVEO (batch number M15122, expiry date 30th May 2017). On 19th August 2016, the patient received MENVEO .5 ml. On 19th August 2016, unknown time after receiving MENVEO, the patient experienced inappropriate preparation of medication. On an unknown date, the patient experienced redness and induration. On an unknown date, the outcome of the redness, induration and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the redness and induration to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received just the liquid conjugate of the MENVEO vaccine, which led to an inappropriate preparation of medication. After being vaccinated with MENVEO, she experienced a red hardness on the arm. No other details of the reaction were obtained and it was not known how long the redness and hardness persisted.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Product quality issue, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult patient who received ENGERIX B (batch number 79ZS7, expiry date unknown). Co-suspect products included ENGERIX B (batch number A9LB7, expiry date unknown) and ENGERIX B (batch number ZR2M5, expiry date unknown). On 29th February 2016, the patient received the 1st dose of ENGERIX B. On 28th March 2016, the patient received the 2nd dose of ENGERIX B. On 28th June 2016, the patient received the 3rd dose of ENGERIX B. On 28th June 2016, not applicable after receiving ENGERIX B and ENGERIX B, not applicable after receiving ENGERIX B and ENGERIX B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapy non-responder and pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too short and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The reporting pharmacist was the dispensing pharmacist. The age at vaccination was not reported. The regimen used was 3 doses on a schedule of 0, 4 weeks and 12 weeks later. On 28th June 2016, the patient received 3rd dose of ENGERIX B, which led to shortening of the vaccination schedule. The patient who was a healthcare worker at the facility received 3 doses of ENGERIX B with an anti-HBsAg level less than 10 mlU/ml 1 to 2 months after receiving 3rd dose. The patient was then given three more doses of ENGERIX B and a titer would be measured in 1 to 2 weeks after the reporting date. The reported batch numbers (792S7, A9LBZ) of ENGERIX B did not exist and was updated to 79ZS7 and A9LB7 as per sales database. There were 2 more healthcare workers at the facility (US2016GSK131990 and US2016GSK131990), who had experienced the same outcome after three doses of ENGERIX B.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received the 2nd dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: the age at vaccination of the patients was not reported. the sales representative reported that multiple patients in the healthcare professional's office reported pain in their arm after receiving 2nd dose of BEXSERO vaccine. No further information was provided.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapeutic response decrease. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not provided. The reporter did not have the patient's initials, date of birth or batch number and expiry dates of the vaccine. The reporter stated that the patient received a full 3 dose series of ENGERIX-B. On an unknown date, the titers values were tested (it was unknown when the titers were pulled with regard to the 3rd dose in the series) and the patient did not have a proper immune response. So, the patient had received an additional dose of ENGERIX-B. The reporter wanted to check if she should give the 2nd dose in the series or not. She wanted to know the proper next steps in that situation. The reporter was not sure if the patient was a health care professional or not and why titers were pulled.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 14-year-old female patent who received BEXSERO. On 25th May 2016, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: the age at vaccination was not reported. the lot numbers were unknown. the reporter would like to be contacted. This is 1 of the 3 cases reported by same reporter.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 62 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-APR-2016, the patient received dose of improperly stored ZOSTAVAX lot number L035283, expiry date: 15-DEC-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 60 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JAN-2016, the patient received dose of improperly stored ZOSTAVAX lot number L029484, expiry date: 06-NOV-2016; (dose, dosage number, and anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Patient received HPV and MENACTRA vaccines at the same time. Patient's body stiffened and eyes rolled back, for 5 seconds. Patient then felt dizzy. She was asked to lay down and vitals were taken.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, X-ray normal
Clinical narrative: Pt have pain (R) upper arm continue. 2mo.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Pain, Paraesthesia, Swelling
Clinical narrative: Swelling, redness at injection sight, numbness and tingling in hand; treated with ice and BENADRYL and ibuprofen, large welt 2 inch in diameter, swollen/sore for 4 days.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Swelling, redness at injection sight, numbness and tingling in hand; treated with ice and BENADRYL and ibuprofen, large welt 2 inch in diameter, swollen/sore for 4 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt. came back to pharmacy 2 days after administration with a 2 in. red, hot circle at site of injection. Pt. was told to put hydrocortisone/BENADRYL on it and call MD if gets worse.
Age: 64.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchiness and a little swelling, redness for 6 days.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Pain
Clinical narrative: (L) upper arm cellulitis - fever, redness at site, achy all over.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Ageusia
Clinical narrative: Loss of taste, likely due to other medications.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever 102 degrees started day after shot. Treated with TYLENOL. Temp did go down to 100 degrees.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Muscle tightness, Nausea, Throat irritation
Clinical narrative: Woke up from nap feeling nauseous, faint, cheeks and jaw tight and throat uncomfortable.  Presented to ER around 2 PM and was given Benadryl, Zofran and an IV.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Fall, Gait disturbance, Joint swelling, Pyrexia, Urticaria
Clinical narrative: Fever, hives/spots that eventually covered entire body, pain, stumbling/falling from what seemed like swollen joints.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache, Immediate post-injection reaction, Urticaria, Vaccination site swelling
Clinical narrative: Immediate swollen area,3 inches round, hot in the area of vaccination, shortness of breath, headache within the hour, hives - still swollen and warm to the touch after 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site warmth
Clinical narrative: Immediate swollen area,3 inches round, hot in the area of vaccination, shortness of breath, headache within the hour, hives - still swollen and warm to the touch after 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis allergic, Injection site warmth, Urticaria
Clinical narrative: Immediate swollen area,3 inches round, hot in the area of vaccination, shortness of breath, headache within the hour, hives - still swollen and warm to the touch after 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache, Immediate post-injection reaction, Urticaria, Vaccination site swelling
Clinical narrative: Patient had allergic rash, warm at site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site warmth
Clinical narrative: Patient had allergic rash, warm at site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis allergic, Injection site warmth, Urticaria
Clinical narrative: Patient had allergic rash, warm at site of injection.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site mass, Vaccination site induration, Vaccination site warmth
Clinical narrative: Noted a hard, red, warm lump in the area where he was vaccinated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Dyspnoea, Pruritus
Clinical narrative: Shortness of breath, itching about 20 minutes after flu shot. Patient has asthma and used inhaler which helped. Blood pressure and pulse were normal (120/80 and 77bpm), but paramedics took to hospital just in case.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Head discomfort, Swelling face
Clinical narrative: Puffy face, heavy headed, heaviness in arm and dull. Administered BENADRYL 12.5mg 3 tsp. Felt better with above meds.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Pt had swelling (no redness) and warmth to (R) Deltoid area on 9-9-16, Reported by school nurse. Instructed to take ibuprofen and place ice pack to area. Mom later reported same as above. Offered appointment in afternoon-mom unsure if could bring her. Instructed to have seen if no improvement and/or shows signs and symptoms of infection-mom took her to ER 9-9-16 evening. Was told in ER had allergic reaction. (Mom did report had redness to area when went to ER.)
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, swelling at site that continued to worsen over the next 5 days. Patient states that the swelling, redness, and heat at the site that spread from her "shoulder bone to elbow." She was advised to use cool compresses and take diphenhydramine and to seek medical treatment if anything changes.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Patient stated pain and discomfort at injection site immediately following administration of the Pneumovax 23 vaccine.  She returned to the pharmacy 10 days later stating pain at injection site is persistant and it is causing her discomfort and limited use of her arm because of the soreness.  She stated that she may have to make an appointment with her doctor to see why her arm is still painful, but has not yet confirmed she was seen for an appointment as of the time of this report.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient stated there arm is sore, swollen, red, and warm to touch.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Anxiety, Confusional state, Crying, Headache, Muscle rigidity
Clinical narrative: Patient was at clinic for WCC given 3 vaccines ( HPV, MCV, Tdap). Stable/normal during exam. Provider left room after exam, MA administered 3 vaccines. Within 1( one) minute pt described headache, clutched sides of his head, closed his eyes and became stiff while collapsing. MA called provider who came in from room next door. Patient was tonic in all limbs, neck and jaw. Eyes open. Whole tonic state lasted approximately 30-40 seconds. Patient body relaxed, he appeared confused, then anxious/started crying/ trying to run from room. We convinced patient him to sit, took vitals. Pt remained stable until EMS arrived approximately 2-3 minutes post end of seizure. Pt reported severe headache, then no memory, then confusion. Denies incontinence during episode. Had mild-moderate headache after episode. Reports fall yesterday with no head injury or loss of consciousness. Never had previous seizure per mom. Pt transferred to ER for evaluation via ambulance.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Musculoskeletal stiffness, Seizure, Syncope
Clinical narrative: Patient was at clinic for WCC given 3 vaccines ( HPV, MCV, Tdap). Stable/normal during exam. Provider left room after exam, MA administered 3 vaccines. Within 1( one) minute pt described headache, clutched sides of his head, closed his eyes and became stiff while collapsing. MA called provider who came in from room next door. Patient was tonic in all limbs, neck and jaw. Eyes open. Whole tonic state lasted approximately 30-40 seconds. Patient body relaxed, he appeared confused, then anxious/started crying/ trying to run from room. We convinced patient him to sit, took vitals. Pt remained stable until EMS arrived approximately 2-3 minutes post end of seizure. Pt reported severe headache, then no memory, then confusion. Denies incontinence during episode. Had mild-moderate headache after episode. Reports fall yesterday with no head injury or loss of consciousness. Never had previous seizure per mom. Pt transferred to ER for evaluation via ambulance.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Chest X-ray normal, Influenza virus test negative, Malaise, Myalgia
Clinical narrative: Awoke feeling as if I had been hit in the neck lower back and knees-bad muscle pain. that evening developed fever 102, took Tylenol, had malaise, generalized feeling of being unwell. Muscle pain grew worse. Saturday night fever went to 104-visit Emergency room on Sunday. No evidence of any infection, had blood work, chest xray, flu test, all negative. Received fluids and this was called severe post vaccination reaction.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Awoke feeling as if I had been hit in the neck lower back and knees-bad muscle pain. that evening developed fever 102, took Tylenol, had malaise, generalized feeling of being unwell. Muscle pain grew worse. Saturday night fever went to 104-visit Emergency room on Sunday. No evidence of any infection, had blood work, chest xray, flu test, all negative. Received fluids and this was called severe post vaccination reaction.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Back pain, Fatigue, Injection site mass, Musculoskeletal pain, Neck pain
Clinical narrative: Patient states that following her ZOSTAVAX and BOOSTRIX immunizations on 9/7/16 she developed a lump where her shingles shot was administered. The area is not red or warm. She notes that she has a very sore arm, fatigue, and significant pain in her shoulder/ scapula, neck, arm and back. She has been using Tylenol and Ibuprofen to help with the pain.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states that following her ZOSTAVAX and BOOSTRIX immunizations on 9/7/16 she developed a lump where her shingles shot was administered. The area is not red or warm. She notes that she has a very sore arm, fatigue, and significant pain in her shoulder/ scapula, neck, arm and back. She has been using Tylenol and Ibuprofen to help with the pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Thigh swelling to knee. Greater day 3 no redness, normal gait. 5th DTaP. No fever. TX cool compresses. Follow up call swelling resolved 09/09/16.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right upper arm developed redness, warmth and induration, started day after vaccines and increased redness today mildly itchy. Given Cephalexin Rx for possibly secondary infection.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Induration, Myalgia, Skin warm
Clinical narrative: Erythema left arm, induration, hot.  With myalgias and temp 99-100.2 F. Patient seen I clinic on 9.12.2016 and treated with 800 mg Motrin.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Red, swollen lower half of bicep/tricep extending to just below elbow of arm.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Reported by husband who had same reaction that I saw: red, swollen lower bicep/tricep extending to just below elbow.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever with Febrile seizure.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Sandpaper itchy rash all over body, including mouth, bottoms of feet. Also broke out in a pimple like rash on body. Pimple rash is resolving, sand paper rash has not improved.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Abdominal pain, Appendicectomy, Appendicitis perforated, Crying, Diet refusal
Clinical narrative: Wouldn't be able to drink his formula, kept projecting it. Kept crying and drawing his knees to his chest. This was intervals of pain. That would come and go. We believed it was the flu or the vaccines that he had recieved on December 17, 2015. Since he that same day and up until that night of the 21st of December was very ill. That day that he recieved the vaccine. He was very calm and refused to eat as usual. But well we understood that happens sometimes after receiving a vaccine. Yet the following day on December 18th, 2015 he started crying and projecting his formula, up until the 21st of December that I as a mom had a gut feeling that it was not just a flu symptom that this went beyond a simple flu or cold. I since day 1 felt that it had something to do with the vaccines he had recieved the day of the 17th. On the night of December 21st, 2015 I couldn't take it anymore seeing my baby cry and not feed. I took him in to the hospital.  There doctors did an ultrasound and the room immediately filled with physicians and nurses. They then told me he had a condition named intussusception. That required an immediate enema or surgery. They flew him to another hospital and treated him there. He got an enema done and it failed..it actually worsened the situation and ruptured his instestines and I believe his appendix ruptured too as they removed it. He was hospitalized for approximately 5 to 6 days. Need to look at records to know exactly. Sorry. We moved on January 2016 and in May he had an appt and they refused to put any rotavirus vaccine.  They almost assured me it was the vaccine that caused all that ordeal and almost death.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Enema administration, Intestinal perforation, Intussusception, Pain, Ultrasound abdomen
Clinical narrative: Wouldn't be able to drink his formula, kept projecting it. Kept crying and drawing his knees to his chest. This was intervals of pain. That would come and go. We believed it was the flu or the vaccines that he had recieved on December 17, 2015. Since he that same day and up until that night of the 21st of December was very ill. That day that he recieved the vaccine. He was very calm and refused to eat as usual. But well we understood that happens sometimes after receiving a vaccine. Yet the following day on December 18th, 2015 he started crying and projecting his formula, up until the 21st of December that I as a mom had a gut feeling that it was not just a flu symptom that this went beyond a simple flu or cold. I since day 1 felt that it had something to do with the vaccines he had recieved the day of the 17th. On the night of December 21st, 2015 I couldn't take it anymore seeing my baby cry and not feed. I took him in to the hospital.  There doctors did an ultrasound and the room immediately filled with physicians and nurses. They then told me he had a condition named intussusception. That required an immediate enema or surgery. They flew him to another hospital and treated him there. He got an enema done and it failed..it actually worsened the situation and ruptured his instestines and I believe his appendix ruptured too as they removed it. He was hospitalized for approximately 5 to 6 days. Need to look at records to know exactly. Sorry. We moved on January 2016 and in May he had an appt and they refused to put any rotavirus vaccine.  They almost assured me it was the vaccine that caused all that ordeal and almost death.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Vomiting projectile
Clinical narrative: Wouldn't be able to drink his formula, kept projecting it. Kept crying and drawing his knees to his chest. This was intervals of pain. That would come and go. We believed it was the flu or the vaccines that he had recieved on December 17, 2015. Since he that same day and up until that night of the 21st of December was very ill. That day that he recieved the vaccine. He was very calm and refused to eat as usual. But well we understood that happens sometimes after receiving a vaccine. Yet the following day on December 18th, 2015 he started crying and projecting his formula, up until the 21st of December that I as a mom had a gut feeling that it was not just a flu symptom that this went beyond a simple flu or cold. I since day 1 felt that it had something to do with the vaccines he had recieved the day of the 17th. On the night of December 21st, 2015 I couldn't take it anymore seeing my baby cry and not feed. I took him in to the hospital.  There doctors did an ultrasound and the room immediately filled with physicians and nurses. They then told me he had a condition named intussusception. That required an immediate enema or surgery. They flew him to another hospital and treated him there. He got an enema done and it failed..it actually worsened the situation and ruptured his instestines and I believe his appendix ruptured too as they removed it. He was hospitalized for approximately 5 to 6 days. Need to look at records to know exactly. Sorry. We moved on January 2016 and in May he had an appt and they refused to put any rotavirus vaccine.  They almost assured me it was the vaccine that caused all that ordeal and almost death.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: RASH, FEVER.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient has a quarter sized bruise around the injection site on his left arm occurring a couple days after the injection. Patient claimed it was very painful more so than in previous years.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: REDNESS, ITCHING 1 WEEK LATER.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Slight redness and minimal swelling at injection site.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Per patient, she is being treated for cellulitis by her MD. Reaction on same arm as pneumovax given.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Malaise, Migraine, Pain in extremity
Clinical narrative: Patient mentioned he was not feeling well due to having pain in his one arm (right arm) and Migraine.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Activities of daily living impaired, Musculoskeletal pain
Clinical narrative: Severe shoulder pain ->difficult to perform daily activities.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported having headaches on the same day after the vaccine was given.  The next day she noticed pain, redness, and swelling of the right arm (where the vaccine was given).  On the following day, she went to see her doctor, who prescribed a pain medication (Tramadol), and using an antihistamine and an ice pack.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pruritus, Rash generalised, Swelling
Clinical narrative: Began with rash on front and back torso. Spread over entire body (head to toe) within 2 days; Extreme itching, burning and swelling. Went to dr twice; Had 2 DECADRON Shots, 1 KENALOG shot, 1 ZANTAC shot, oral MEDROL, SINGULAIR, and multiple antihistamines;  Also topical sarna, BENADRYL, AND AVEENO bath.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Activities of daily living impaired, Asthenia, Cough, Dermatitis, Erythema
Clinical narrative: Symptoms started with low grade fever (about 99 degrees); vomiting in crib early AM Aug 26. Patient continued to have side effects over 19 days. She also continued with low-grade fever for 3 nights. She developed a runny nose, with sore throat, congestion in throat/phlegm, and developed a strong wet cough that was active during day and most evenings. She exhibited low energy, low interest in normal activities with somnolence for the first 7 days. The cough continued for 19 days even though her normal daily activities improved or resumed. The cough has been most bothersome in the evenings and my child has been unable to resume sleep after waking up with coughing episodes most evenings since the vaccine event. Notably, she has had external skin rashes (appears like Measles, Rubella or Varicella photos for mild case) on her skin for about 12-24 hours duration within 1 week of vaccine date: face and chest. There was noteably a red and inflamed area on the side of her nose which appears to be painful. She also had a rash that was red, round and pustule-filled where she had extreme itchiness in the diaper area and caused her distress. Appointment with pediatrician made on 9/12/16. Otitis media was confirmed with impetigo diagnosis. Waiting for culture result of the diaper area swab.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Impetigo, Oropharyngeal pain, Otitis media, Pain, Productive cough
Clinical narrative: Symptoms started with low grade fever (about 99 degrees); vomiting in crib early AM Aug 26. Patient continued to have side effects over 19 days. She also continued with low-grade fever for 3 nights. She developed a runny nose, with sore throat, congestion in throat/phlegm, and developed a strong wet cough that was active during day and most evenings. She exhibited low energy, low interest in normal activities with somnolence for the first 7 days. The cough continued for 19 days even though her normal daily activities improved or resumed. The cough has been most bothersome in the evenings and my child has been unable to resume sleep after waking up with coughing episodes most evenings since the vaccine event. Notably, she has had external skin rashes (appears like Measles, Rubella or Varicella photos for mild case) on her skin for about 12-24 hours duration within 1 week of vaccine date: face and chest. There was noteably a red and inflamed area on the side of her nose which appears to be painful. She also had a rash that was red, round and pustule-filled where she had extreme itchiness in the diaper area and caused her distress. Appointment with pediatrician made on 9/12/16. Otitis media was confirmed with impetigo diagnosis. Waiting for culture result of the diaper area swab.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Symptoms started with low grade fever (about 99 degrees); vomiting in crib early AM Aug 26. Patient continued to have side effects over 19 days. She also continued with low-grade fever for 3 nights. She developed a runny nose, with sore throat, congestion in throat/phlegm, and developed a strong wet cough that was active during day and most evenings. She exhibited low energy, low interest in normal activities with somnolence for the first 7 days. The cough continued for 19 days even though her normal daily activities improved or resumed. The cough has been most bothersome in the evenings and my child has been unable to resume sleep after waking up with coughing episodes most evenings since the vaccine event. Notably, she has had external skin rashes (appears like Measles, Rubella or Varicella photos for mild case) on her skin for about 12-24 hours duration within 1 week of vaccine date: face and chest. There was noteably a red and inflamed area on the side of her nose which appears to be painful. She also had a rash that was red, round and pustule-filled where she had extreme itchiness in the diaper area and caused her distress. Appointment with pediatrician made on 9/12/16. Otitis media was confirmed with impetigo diagnosis. Waiting for culture result of the diaper area swab.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin culture positive, Vomiting
Clinical narrative: Symptoms started with low grade fever (about 99 degrees); vomiting in crib early AM Aug 26. Patient continued to have side effects over 19 days. She also continued with low-grade fever for 3 nights. She developed a runny nose, with sore throat, congestion in throat/phlegm, and developed a strong wet cough that was active during day and most evenings. She exhibited low energy, low interest in normal activities with somnolence for the first 7 days. The cough continued for 19 days even though her normal daily activities improved or resumed. The cough has been most bothersome in the evenings and my child has been unable to resume sleep after waking up with coughing episodes most evenings since the vaccine event. Notably, she has had external skin rashes (appears like Measles, Rubella or Varicella photos for mild case) on her skin for about 12-24 hours duration within 1 week of vaccine date: face and chest. There was noteably a red and inflamed area on the side of her nose which appears to be painful. She also had a rash that was red, round and pustule-filled where she had extreme itchiness in the diaper area and caused her distress. Appointment with pediatrician made on 9/12/16. Otitis media was confirmed with impetigo diagnosis. Waiting for culture result of the diaper area swab.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at site diagnosed as cellulitis, treated with Cephalexin 250mg/5ml 8 ml BID x 7 days seen in office today with improvement.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Blister, Pain, Paraesthesia
Clinical narrative: Patient began having tingling/burning pain along the jaw line (left side). Also started to get blisters/canker sores in the mouth. Resolved on its own in 2-3 days.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling cold, Headache, Nausea, Pain in extremity
Clinical narrative: Headache, nausea, chills, dizziness, very sore arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site mass
Clinical narrative: Left side lump on his upper thigh just noticed yesterday. Here for lump of skin, thinks its only been there a day or so. Lump on left upper thigh. Doesn't seem to be causing pain. No fever, no change in appetite, playful as usual. No other rash or lump. He did have vaccines x 4 at his recent visit for WCC on 7/25/16. No other c/o.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Flushing, Nausea, Presyncope, Tachycardia
Clinical narrative: Sudden onset of tachycardia up to 166 BPM, nausea, pre-syncope, facial flushing, diarrhea, shakiness/tremors. Blood pressure was 101/63. EMS came to assess me and they were going to take me to the hospital, but I refused. Hours later at 7:30 PM I'm feeling better, but still nauseous.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Tremor
Clinical narrative: Sudden onset of tachycardia up to 166 BPM, nausea, pre-syncope, facial flushing, diarrhea, shakiness/tremors. Blood pressure was 101/63. EMS came to assess me and they were going to take me to the hospital, but I refused. Hours later at 7:30 PM I'm feeling better, but still nauseous.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: After giving flu shot arm started to get swelling and bumbping.
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: The patient states that 2 days ago she received two immunizations, one for the flu and one for pneumonia in her left arm.. Shortly after the injections she notes that she had intense pain and rated it to be a 9/10 in severity. Today, the surrounding area became red, and part of it was swollen as well. She receives flu shots every year and has not had a reaction before. The patient denies fever or vomiting. The patient voices no further concerns at this time. No fever. No numbness. No bites. Skin: Arm visibly swollen-localized to left mid arm, area of erythema is 16 x 7 cm. Area hot to touch.  Not circumferential. No crepitus. No fluctuance. No hives. No necrosis. No petechia, no purpura.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Malaise, Pain, Pyrexia, Restlessness
Clinical narrative: Pt developed fever and chills, leading to restless night and malaise and body aches the following day. Pt received TYLENOLl for fever.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient presented with a itching and a few hives. patient was given oral diphenhydramine. hives cleared. lasted about 15 minutes.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Autism, Autism spectrum disorder, Decreased eye contact
Clinical narrative: After the MMR vaccination, my son woke up a different boy the following morning. He had a fever for two weeks. He lost all eye contact. He wanted to be alone. He started spinning in circles and would flap his arms. He no longer was aware of his surroundings. He no longer clapped, he no longer waved, he no longer vocalized. He ignored people he once loved. He began bolting and never looked for his parents while out in public. He lost all of his skills. He never started talking and received an autism diagnosis.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Dyskinesia, Pyrexia, Social avoidant behaviour
Clinical narrative: After the MMR vaccination, my son woke up a different boy the following morning. He had a fever for two weeks. He lost all eye contact. He wanted to be alone. He started spinning in circles and would flap his arms. He no longer was aware of his surroundings. He no longer clapped, he no longer waved, he no longer vocalized. He ignored people he once loved. He began bolting and never looked for his parents while out in public. He lost all of his skills. He never started talking and received an autism diagnosis.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an unknown reporter referring to a 6 year old female patient. The patient's medical history and concurrent conditions were not reported. On 30-JUN-2016, at 15:57, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K008625, expiration date 16-JUN-2016), 1st dose, subcutaneously in the left deltoid. She was also vaccinated, on the same date, at 15:11 with the 1st dose of INFANRIX, in the left deltoid, intramuscularly. No adverse effects were reported. This is one of four cases from the same reporter source, (linked to MARRS # 1607USA000647, 1609USA005771, AND 1609USA005772). Additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a multiple unspecified number of patients. The patients' concurrent conditions and medical histories were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # L048463, expiration date 02-DEC-2017); (Lot # M008173, expiration date 16-FEB-2018) doses, routes and frequencies were not reported. There was no concomitant medication reported for any patient. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: The day after receiving vaccine the patient's arm and face started swelling. Arm/injection site was warm, red, and raised (size of a baseball) for several days. Also pt. had diarrhea x 4 days.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: The day after receiving vaccine the patient's arm and face started swelling. Arm/injection site was warm, red, and raised (size of a baseball) for several days. Also pt. had diarrhea x 4 days.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Peripheral swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Mom stated patients legs, hands, face and throat started swelling. She gave her a 1/2 of BENADRYL that night and she did good with. She was advised to continue the BENADRYL every 6 hrs for 24 hours, and take her to ER with any signs of troubles breathing.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Product quality issue, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 35-year-old female patient who received ENGERIX B (batch number 79ZS7, expiry date 4th June 2018). Co-suspect products included ENGERIX B (batch number A9LB7, expiry date 7th July 2018) and ENGERIX B (batch number A9LB7, expiry date 7th July 2018). On an unknown date, the patient received the 1st dose of ENGERIX B (intramuscular) and the 2nd dose of ENGERIX B (intramuscular) 1 ml. On 21st June 2016, the patient received the 3rd dose of ENGERIX B (intramuscular) 1 ml. On 21st June 2016, not applicable after received ENGERIX B and ENGERIX B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On 23rd August 2016, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too short and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The reporting pharmacist was the dispensing pharmacist. The age at vaccination was not reported. The regimen used was 3 doses on a schedule of 0, 4 weeks and 12 weeks later. On 21st June 2016, the patient received 3rd dose of ENGERIX B, which led to shortening of the vaccination schedule. The patient who was a healthcare worker at the facility received 3 doses of ENGERIX B in her deltoid. On 23rd August 2016, 63 days after receiving 3rd dose of ENGERIX B, the patient underwent laboratory test, which showed an anti-HBsAg level less than 10 mlU/ml drawn. There were 2 more healthcare workers at the facility (US2016128146 and US2016GSK131990), who had experienced the same outcome after three doses of ENGERIX B.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Injection site pain, Lip swelling
Clinical narrative: Painful LD x 3 days. Pain much more significant in first 3 days. Tender LD x 2 weeks. Pt. reported swollen lymph nodes above (L) clavicle. No other associated symptoms.