chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On unknown dates, improperly stored ZOSTAVAX (2 dose, frequency, route and lot number not provided) were administered to unspecified patients (incorrect product storage). No adverse effects were reported. Names of vaccines involved (including lot/exp): ZOSTAVAX (lot number# reported as L046900, expiration date 23-FEB-2017). Temperature: 12F. Time frame: 72 hours. Was it administered (AE)? Yes. Previous temperature excursion: No. Was call because of a "data logger"? (Y/N): No. Additional information has been requested.
Sex: F
Vaccine: PNC13, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On unknown dates, improperly stored ZOSTAVAX (2 dose, frequency, route and lot number not provided) were administered to unspecified patients (incorrect product storage). No adverse effects were reported. Names of vaccines involved (including lot/exp): ZOSTAVAX (lot number# reported as L046900, expiration date 23-FEB-2017). Temperature: 12F. Time frame: 72 hours. Was it administered (AE)? Yes. Previous temperature excursion: No. Was call because of a "data logger"? (Y/N): No. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning multiple unspecified patients of unknown age or gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates in 2016, the patients received doses of improperly stored M-M-R IK subcutaneous Injection (lot # L026553 with expire date of 16-JUL-2017, dosage and route not provided). The vaccine was stored under was 9 C for 27 hours. The excursion was started on 19-APR-2016. Previous temperature excursion was included in hours assessment. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Local rash and red area at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Injection site erythema, Local swelling, Peripheral swelling, Pruritus
Clinical narrative: Swelling of neck, arm, trouble swallowing, redness at injection site, swelling, itching. Rx for prednisone, ATARAX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling of neck, arm, trouble swallowing, redness at injection site, swelling, itching. Rx for prednisone, ATARAX.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that. on 15-MAY-2013, the patient was vaccinated with a first dose of GARDASIL (lot number, dose, route and anatomical site of injection were not reported). The second dose was received on 28-AUG-2013 and the third dose was received on 11-AUG-2015. Later, on 18-MAY-2016, the patient received a dose of GARDASIL 9 (lot number, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information is not expected, since the reporter did not allow further contact for follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Computerised tomogram normal, Decreased appetite, Disturbance in attention, Erythema
Clinical narrative: Patient states she went to ER b/c of chest pains (which she things was unrelated to vaccine) and was dx with H. pylori. She received 2 antibiotics and a stomach pill. Her arm and face became red and started swelling. She had a loss of appetite and couldn't focus on what she was reading. (Did a CT scan = it was OK). Had shot and Rx of steroids and a breathing tx; saw family MD. Took approximately 1 week for swelling to disappear.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Helicobacter infection, Peripheral swelling, Swelling face
Clinical narrative: Patient states she went to ER b/c of chest pains (which she things was unrelated to vaccine) and was dx with H. pylori. She received 2 antibiotics and a stomach pill. Her arm and face became red and started swelling. She had a loss of appetite and couldn't focus on what she was reading. (Did a CT scan = it was OK). Had shot and Rx of steroids and a breathing tx; saw family MD. Took approximately 1 week for swelling to disappear.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: 3.5 cm x 7 cm area of painful, tender, warm erythema along lateral right upper arm onset this morning.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Right deltoid has a raised red welt measuring 4.5 cm x 4 - Mom advised welt began to form on 5-23-16. Left deltoid has a small red circle measuring 2 cm x 1.5.
Age: 59.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Borrelia test, Chills, Full blood count, Joint swelling
Clinical narrative: She recvd MMR 5/2/16 5/16/16 c/o swelling in bilat knees and hands, chills, joint pain.
Age: 59.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Metabolic function test, Peripheral swelling, Red blood cell sedimentation rate
Clinical narrative: She recvd MMR 5/2/16 5/16/16 c/o swelling in bilat knees and hands, chills, joint pain.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of ERYTHEMA in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, 2 days after receiving DTaP vaccine, the patient experienced ERYTHEMA, inflammation and pain to be related to DTaP vaccine. Additional details were provided as follows: This was all the information the reporter had on this event.
Age: 45.0
Sex: M
Vaccine: HEPAB
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 45-year-old male patient who received TWINRIX adult. On 21st April 2016, the patient received TWINRIX adult 1 ml. On 21st April 2016, less than a day after receiving TWINRIX adult, the patient experienced pain, nausea and vomiting. On an unknown date, the outcome of the pain, nausea and vomiting were not recovered/not resolved. It was unknown if the reporter considered the pain, nausea and vomiting to be related to TWINRIX adult. Additional details were provided as follows: The reporter reported stated that, the patient had undergone a transplant (details not provided). The reporter was unable to provide lot information. No further information was provided.
Sex: F
Vaccine: HEPAB
Symptoms: Accidental exposure to product, Injury associated with device, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of needle injury in a adult female patient who received TWINRIX. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, immediately after receiving the TWINRIX, the patient experienced needle injury and pain in fingers. On an unknown date, the outcome of the needle injury was unknown and the outcome of the pain in fingers was recovered/resolved. It was unknown if the reporter considered the needle injury and pain in fingers to be related to TWINRIX. Additional details were provided as follows: This case was received via Merck National Service Center. About a week ago (before the time of reporting), the patient inadvertently stuck herself with a needle while she was drawing up a dose of TWINRIX. Less than a week after receiving TWINRIX, the patient experienced soreness in the finger she stuck which resolved within an unspecified time frame. No additional information was provided.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2014US094120, is an initial spontaneous report received from the Vaccine Adverse Reporting System (reference number: 515877) website on 24 Jul 2014. This report refers to a 11 year old male patient. On 03 Dec 2013, he was vaccinated with MENVEO (batch number:  M13011) in the left arm with BOOSTRIX (other manufacturer, batch number: 35589) in the right arm. On 04 Dec 2013, he experienced itching, swelling and good redness of left deltoid covering about 30 cm diameter area. The patient visited the emergency room. The events improved (actually resolved) in 24 hours with 2 doses of BENADRYL and within 18 hours of KEFLEX. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: Case number PHHY2014US071326 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525968) website on 08 JUN 2014. This report refers to a 16-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO batch number: M13014) intramuscularly into left arm on an unknown date. On the same after vaccination, at night, she experienced rash, redness and swelling at injection site on left arm which progressively worsened. Then she experienced pain at injection site and increased redness and swelling at injection site. She experienced pain when moved left arm. She was taken to emergency room for medical support. The final outcome was reported as complete recovery. The events was reported as non serious and causality was not reported.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Case number PHHY2014US081339 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 527831) web site on 01 Jul 2014. This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number:  A13015) intramuscularly into right arm on 03 Apr 2013. On the same day, he was also vaccinated with HAVRIX (other manufacturer and batch number: 7C47T) and GARDASIL (other manufacturer and batch number: J006850) both intramuscularly into left arm. On the same day, immediately after vaccinations, his right deltoid became red and swollen at site of MENVEO vaccination. It was also reported that right side of his face became red with some spot. He was treated with BENADRYL and SOLU-MEDROL and was observed. These events were reported as non-serious. Outcome of the events was reported as unknown. Causality of the events was not reported.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site abscess
Clinical narrative: Initial unsolicited report received from a nurse on 15 May 2015. A male (age not reported) patient, whose medical history was none and concomitant medication was not reported, had received intramuscularly a third dose of PENTACEL (batch number: C4742AA, expiration date: 31 May 2016, dose was not reported) in left leg, Hep B (Manufacturer: Unknown, batch number, expiration date, dose, dose cycle and route of administration were not reported) in right leg, PREVENAR (batch number, expiration date, dose, dose cycle and route of administration were not reported) in left leg and also received orally ROTATEQ (batch number, expiration date, dose, dose cycle and route of administration were not reported) on 20 April 2015. Pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination were reported as none. The patient had received two previous dose of PENTACEL. On an unspecified date after vaccination, patient had experienced abscess at injection site on left leg. Patient required ER/doctor visit for the event. Laboratory investigation and corrective treatment were not reported. At the time of this report, patient was not recovered from the event. Upon medical review, company assessed the event of abscess at injection site on left leg as serious and important medical event. List of documents held by sender: none. Follow-up report received from a physician on 22 June 2015. A six months old patient was received third intramuscular dose of Recombivax (batch number-KZ9ZC, manufacturer- Merck) and third 0.5 ml intramuscular dose of PREVENAR 13 (batch number- L0491Z, expiration date July 2016) in left leg on 20 April 2015. It was reported that the patient did not receive IMM again. The patient had previously received PREVENAR 13 on 15 December 2014 and 17 February 2015. The patient was hospitalized for two days. At the time of this report, the patient was recovered from the event. Causal relationship with PREVENAR 13 was unknown. List of documents held by sender: none. Sender's Comments: Follow up received on 23-JUN-2015, dose not changes the assessment. Injection site abscess is unlisted with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Dysgeusia, Local swelling, Vomiting
Clinical narrative: Vomiting, metal taste in mouth, joints are sore. Right side where the shot was given is swollen.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Activated partial thromboplastin time normal, Aspartate aminotransferase increased, Burning sensation, Full blood count normal, Haematuria
Clinical narrative: Pt seen in Family Health Clinic for c/o progressive bilateral lower leg "burning" sensation rash with diffuse petechiae x 2 days. Also, c/o headaches. Afebrile.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Headache, International normalised ratio normal, Petechiae, Prothrombin time normal, Rash
Clinical narrative: Pt seen in Family Health Clinic for c/o progressive bilateral lower leg "burning" sensation rash with diffuse petechiae x 2 days. Also, c/o headaches. Afebrile.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Urine analysis abnormal
Clinical narrative: Pt seen in Family Health Clinic for c/o progressive bilateral lower leg "burning" sensation rash with diffuse petechiae x 2 days. Also, c/o headaches. Afebrile.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Aspartate aminotransferase increased, Blood count normal, Blood thromboplastin normal, Burning sensation, Headache
Clinical narrative: Pt seen in Family Health Clinic for c/o progressive bilateral lower leg "burning" sensation rash with diffuse petechiae x 2 days. Also, c/o headaches. Afebrile.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: International normalised ratio normal, Petechiae, Prothrombin level normal, Urine analysis abnormal
Clinical narrative: Pt seen in Family Health Clinic for c/o progressive bilateral lower leg "burning" sensation rash with diffuse petechiae x 2 days. Also, c/o headaches. Afebrile.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Chest pain, Headache
Clinical narrative: Chest pain, mild fever, increased heart rate, headache, increased blood pressure prompted call to pediatricians office and subsequent visit to ER.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Pyrexia, Ultrasound scan, Urine analysis
Clinical narrative: Chest pain, mild fever, increased heart rate, headache, increased blood pressure prompted call to pediatricians office and subsequent visit to ER.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Initial unsolicited report received from a nurse on 11 May 2015. A male patient, whose medical history and concomitant medications were not reported, had received a third dose of PENTACEL (batch number: C4871AB, expiry date: 12 September 2015 and dose not reported) intramuscularly in right thigh and also received a dose of HEP A (batch number, expiry date, dose, dose number, route of administration were not reported) in left thigh, both administered on 06 May 2015. It was reported that, on 08 May (unspecified year) patient mother brought the patient to doctor office with the red rash on the abdomen and right leg. On 11 May (unspecified year) during second examination, rash was reported to have decreased but was still present. It was reported that, patient required emergency room/doctor visit. Patient had no Illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient was recovering from the event. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Laceration, Occupational exposure to product, Product quality issue
Clinical narrative: Initial unsolicited misuse report received from a nurse (consumer) on 16 June 2015. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of PENTACEL (batch number C4879AB, expiry date 10 September 2016, dose, dose number, route and site of administration were not reported) on 16 June 2015. On an unspecified date, nurse was removing ACTHIB component vial of PENTACEL from box and upon removing vial from box she sustained several small lacerations to the palm of her right hand. It was reported that patient had performed first aid measures of cleaning area to remove glass shards. Patient had no excessive bleeding and her hand was fine and stated that she did not require bandaging or any other treatment. Product complaint PC 291071 filed for broken vial of PENTACEL, thus there was a product physical issues and it was also a case of occupational exposure to drug. Laboratory investigations were not reported. At the time of this report, patient had recovered. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Injection site paraesthesia, Irritability, Peripheral swelling
Clinical narrative: Initial unsolicited report received from non-healthcare professional (office staff) on 15 June 2015. Five patients (approximately) (age and gender not reported), whose medical history and concomitant medication were not reported, had received a dose of  PENTACEL (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On unspecified date post-vaccination, the patients experienced red, swollen leg down to the ankle, reddish rash, the injection site seems to be very sensitive to the touch, and also the patients were incredibly irritable; more than usual. It was reported that, all the patients received Pentacel vaccine from the same lot number.  Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none. Follow up information received from a non-healthcare professional on 4 August 2015. Case is linked to case 2015SA117517, 2015SA117518, 2015SA117519 and 2015SA117520 (same reporter). Coding of event swollen leg down to the ankle was updated. Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Initial unsolicited report received from a nurse on 21-Sep-2015. This case involves a 6-month-old male patient who was vaccinated with second dose of PENTACEL (batch number- C4840AA, expiry date: 02-Sep-2016) in right anterolateral thigh, a dose of PREVENAR (manufacturer: Wyeth, batch number, dose and route of administration was not reported) in left anterolateral thigh and a dose of HEPATITIS B VACCINE (manufacturer: Merck, batch number, dose and route of administration was not reported) left anterolateral thigh in all on 14-Sep-2015. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions, medical history and concomitant medications were not reported. Patient had no known allergies. On 15-Sep-2015, one day after vaccination, the patient experienced injection site red and hard to touch, rash at site and rash all down right leg. Patient required ER/ Doctor Visit. Laboratory investigations and corrective treatments were not reported. At the time of this report, no other symptoms were reported rash was still present and patient had not recovered from the events. Documents held by sender: none. Follow up information received from a physician on 09 November 2015. Lot number of Hepatitis B updated as L009155. It was reported that, patient did not receive PREVNAR (in initial report it was reported). Illness at the time of vaccination was reported as none. On 29 September 2015, patient was reevaluated and it was found that patient still had rash.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Agitation, Crying, Dyskinesia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 19 October 2015. This case involves a 2-month-old female patient who was vaccinated with a dose of PENTACEL (batch number, dose, dose in series were not reported) intramuscularly on thigh and also received a dose of ROTATEQ (batch number, route and site of administration were not reported), a dose of Hep B (batch number, route and site of administration were not reported) and a dose of PREVNAR (batch number, route and site of administration were not reported) on 12 August 2015. The patient's medical history of pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at time of vaccination were reported as none and concomitant medications were not reported. On 12 August 2015, few hours following the vaccination at 9:00 pm , the patient started crying and became very agitated she began throwing her head back and forth in a flexion extension motion but, the patient was conscious and afebrile. This episode had lasted for 10 minutes. Laboratory data was reported as none and corrective treatment were not reported. The patient was recovered from the events. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Headache, joint pain/stiffness, low grade fever (101.4
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Completed suicide, Death
Clinical narrative: Death by Suicide.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Feeling abnormal, Hypoaesthesia oral, Nausea, Paraesthesia oral
Clinical narrative: Fever of 101 degrees Fahrenheit, numbness and tingling of tongue, nausea, abdominal pain, "weird" sensations all over body.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Streptococcus test
Clinical narrative: Fever of 101 degrees Fahrenheit, numbness and tingling of tongue, nausea, abdominal pain, "weird" sensations all over body.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Back pain, Blood culture, Blood test, Chest X-ray, Chills
Clinical narrative: I awakened with teeth chattering chills and was incontinent on the way to the bathroom to void. When I awoke around 7:15 I was feverish. I took Acetaminophen. My back ached left of middle back; ER on 05/08/2016 diagnosed UTI, ER on 05/09/2016 admitted due to sepsis; ran several tests to find source of staph infection; 05/12/2016 diagnosed MSSA pneumonia; discharged 05/15/2016; continue to have back aches- wearing Fentanyl patch  and taking Aceteminophen to manage pain.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Computerised tomogram thorax, Echocardiogram, Nuclear magnetic resonance imaging, Pneumonia staphylococcal, Pyrexia
Clinical narrative: I awakened with teeth chattering chills and was incontinent on the way to the bathroom to void. When I awoke around 7:15 I was feverish. I took Acetaminophen. My back ached left of middle back; ER on 05/08/2016 diagnosed UTI, ER on 05/09/2016 admitted due to sepsis; ran several tests to find source of staph infection; 05/12/2016 diagnosed MSSA pneumonia; discharged 05/15/2016; continue to have back aches- wearing Fentanyl patch  and taking Aceteminophen to manage pain.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Radioisotope scan, Sepsis, Staphylococcal infection, Staphylococcus test positive, Urinary incontinence
Clinical narrative: I awakened with teeth chattering chills and was incontinent on the way to the bathroom to void. When I awoke around 7:15 I was feverish. I took Acetaminophen. My back ached left of middle back; ER on 05/08/2016 diagnosed UTI, ER on 05/09/2016 admitted due to sepsis; ran several tests to find source of staph infection; 05/12/2016 diagnosed MSSA pneumonia; discharged 05/15/2016; continue to have back aches- wearing Fentanyl patch  and taking Aceteminophen to manage pain.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Urinary tract infection
Clinical narrative: I awakened with teeth chattering chills and was incontinent on the way to the bathroom to void. When I awoke around 7:15 I was feverish. I took Acetaminophen. My back ached left of middle back; ER on 05/08/2016 diagnosed UTI, ER on 05/09/2016 admitted due to sepsis; ran several tests to find source of staph infection; 05/12/2016 diagnosed MSSA pneumonia; discharged 05/15/2016; continue to have back aches- wearing Fentanyl patch  and taking Aceteminophen to manage pain.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Facial paralysis, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: Face droop left side. Left eye watering. Lip numbness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling and redness, warm to touch, pain, steroids and antihistamine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site on Right leg from his 4 year well child vaccines.
Age: 77.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: Rash all over arms and legs.
Age: 77.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Rash all over arms and legs.
Age: 0.17
Sex: F
Vaccine: PNC13, RVX
Symptoms: Brain oedema, Crying, Diet refusal, Dyskinesia, Lethargy
Clinical narrative: Uncontrolled crying, arm and legs flailing, lethargic, refusal to nurse, brain swelling.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash, Rash generalised
Clinical narrative: Fever started on 5/24/16 and has continued to date.  She got a mild rash on her face and neck that started on 5/25/16.  The rash has spread to her entire body today, and appears to be itchy.  The doctor's office advised us to give her Benadryl, which we just started, and that we'll need to bring her in for a check up if any of the symptoms last more than 72 hours.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Echocardiogram, Injection site reaction
Clinical narrative: Patient states local injection site reaction after Smallpox vaccination. Presents 5/26/16 to ER with complaint of chest pain, SOB, and chills. Chest pain worsening with exertion or recumbent. Diagnosed with pericarditis and admitted to the hospital.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Local reaction, Pericarditis
Clinical narrative: Patient states local injection site reaction after Smallpox vaccination. Presents 5/26/16 to ER with complaint of chest pain, SOB, and chills. Chest pain worsening with exertion or recumbent. Diagnosed with pericarditis and admitted to the hospital.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest X-ray, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Patient states local injection site reaction after Smallpox vaccination. Presents 5/26/16 to ER with complaint of chest pain, SOB, and chills. Chest pain worsening with exertion or recumbent. Diagnosed with pericarditis and admitted to the hospital.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram, Electrocardiogram, Intensive care, Painful respiration, Paraesthesia
Clinical narrative: Patient states local injection site reaction after Smallpox vaccination. Presents 5/26/16 to ER with complaint of chest pain, SOB, and chills. Chest pain worsening with exertion or recumbent. Diagnosed with pericarditis and admitted to the hospital.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin
Clinical narrative: Patient states local injection site reaction after Smallpox vaccination. Presents 5/26/16 to ER with complaint of chest pain, SOB, and chills. Chest pain worsening with exertion or recumbent. Diagnosed with pericarditis and admitted to the hospital.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: Mid left upper arm swelling, mild erythema and warmth, no pain, arms feels a bit heavy and uncomfortable. No violaceous discoloration. Sites of immunization normal.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: 7x5 cm erythematous patch on Lt upper arm at injection site. No raised papilla, red streaks or swelling.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Swelling, redness, fever.
Age: 25.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Emotional distress, Face injury, Fall, Loss of consciousness, Swelling face
Clinical narrative: Client suddenly lost consciousness, falling face forward onto the tile.  She regained consciousness quickly, but was shaken up and tearful.  She had a large goose egg sized lump above her left eye.  Client was examined by our physician and was able to drive herself home after resting for approximately half an hour.
Age: 25.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Tearfulness
Clinical narrative: Client suddenly lost consciousness, falling face forward onto the tile.  She regained consciousness quickly, but was shaken up and tearful.  She had a large goose egg sized lump above her left eye.  Client was examined by our physician and was able to drive herself home after resting for approximately half an hour.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Accidental exposure to product packaging, Laceration, Product packaging issue
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 20 May 2015. A female patient (age not reported) had occupational exposure while administering product PENTACEL (batch number C4879AB, expiry date not reported) on 20 May 2015. The patient's medical history and concomitant medications were not reported. On 20 May 2015, when removing ACTHIB component vial of PENTACEL from the box the patient received a small, finger laceration due to broken vial. Laceration was treated with first aid measures and no stitches were required. Laboratory investigations and corrective treatment were not reported. The event outcome was unknown. Documents held by sender: none. Addendum: 23/June/2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the event coding and drug/Vaccine PTC box checked.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Pain in extremity, Peripheral swelling
Clinical narrative: Based on the additional information received on 03 September 2015, this case is medically confirmed. Initial unsolicited report received from a non-healthcare professional on 4 August 2015. Case is linked to case 2015SA088110, 2015SA117518, 2015SA117519 and 2015SA117520 (same reporter). A two-month-old female patient, had received a 0.5 ml dose of PENTACEL (batch number C4767AD, expiry date, dose number and site of administration were not reported) intramuscularly on 08 June 2015 (1:40 PM). Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination was reported as none. Patient had no other vaccine within four weeks of vaccinations. Patient had no other medications. On 08 June 2015 (07:30 PM), i.e. five hour fifty minutes after vaccination patient had experienced swollen thigh not whole limb, painful to touch and irritable. Laboratory investigations was not performed Corrective treatments was not reported. On an unspecified date, patient had recovered. Follow-up information received from a Physician on 03 September 2015. The patient had received a first dose of 0.5 ml of PENTACEL in right thigh on 08 June 2015 and received a dose of HEPATITIS B VACCINE (Manufacture: unknown), a dose of PREVENAR, (Manufacture: Other) and a dose of ROTAVIRUS VACCINE (Manufacture: Other) batch number, expiry date, dose, dose in series, route and site of administration were not reported on an unspecified date. Patient has no illness at the time of vaccination. No vaccine was given four weeks before vaccination. The patient had no reaction after receiving Hepatitis B, PREVENAR and Rotavirus. Documents held by sender: none.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Injection site swelling, Irritability, Rash, Skin warm
Clinical narrative: Based on additional information received on 3 September 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 4 August 2015. This case linked to 2015SA088110, 2015SA117517, 2015SA117518 and 2015SA117520 (same reported, different patient). A two-month-old female patient, whose concomitant medications were reported as none, had received a 0.5 ml intramuscular dose of PENTACEL (batch number C4917AB, site of administration was not reported) on 10 June 2015 at 12:17 pm. Illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects and medical conditions were reported as none. It was also reported that patient did not receive any other medication. On 10 June 2015 at 1:50 pm, 93 minutes after vaccination, the patient experienced swollen thigh, redness and hot, irritable, very fussy, painful to touch and rash. Laboratory investigations were not performed and corrective treatments were not reported. On an unspecified date, the patient was recovered from the event. Documents held by sender: none. Follow-up information received from a physician on 03 September 2015. This case involves a patient who was vaccinated with first dose of 0.5 ml of PENTACEL via intramuscular route in right thigh. The patient had also received a dose of HEPATITIS B VACCINE, PREVENAR and ROTAVIRUS VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's had not received any vaccine four weeks before vaccination and illness at the time of vaccination reported as none. The patient had no reaction after receiving Hepatitis B, PREVENAR and Rotavirus. The patient had not recovered from rash. Documents held by sender: none.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Tenderness
Clinical narrative: Based on additional information received on 3 September 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 4 August 2015. This case linked to 2015SA088110, 2015SA117517, 2015SA117518 and 2015SA117520 (same reported, different patient). A two-month-old female patient, whose concomitant medications were reported as none, had received a 0.5 ml intramuscular dose of PENTACEL (batch number C4917AB, site of administration was not reported) on 10 June 2015 at 12:17 pm. Illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects and medical conditions were reported as none. It was also reported that patient did not receive any other medication. On 10 June 2015 at 1:50 pm, 93 minutes after vaccination, the patient experienced swollen thigh, redness and hot, irritable, very fussy, painful to touch and rash. Laboratory investigations were not performed and corrective treatments were not reported. On an unspecified date, the patient was recovered from the event. Documents held by sender: none. Follow-up information received from a physician on 03 September 2015. This case involves a patient who was vaccinated with first dose of 0.5 ml of PENTACEL via intramuscular route in right thigh. The patient had also received a dose of HEPATITIS B VACCINE, PREVENAR and ROTAVIRUS VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's had not received any vaccine four weeks before vaccination and illness at the time of vaccination reported as none. The patient had no reaction after receiving Hepatitis B, PREVENAR and Rotavirus. The patient had not recovered from rash. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Laceration
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 12 December 2015. This case involves a female patient who was vaccinated with a dose of PENTACEL (batch number: C4937AA, expiration date:29 January 2017, dose, dose number, route and site not reported) on 17 December 2015. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not available. On 17 December 2015, same day following the vaccination, the patient was taking the flip cap off the DTaP- IPV vial of PENTACEL, the neck snapped off and cut her finger. It was a minor cut that patient consulted Occupational health at her facility and patient has had no further issues. Laboratory investigations were reported none. The patient's wound was clean and band aid was applied. Outcome of the event was recovered. List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Antibody test negative
Clinical narrative: Initial unsolicited report received from the literature on 22 April 2016. The following is verbatim from the article: Infections are a leading cause of morbidity in children following transplantation. It is therefore imperative to ensure that children are immunized before a transplant. Contrary to this recommendation, it has long been suggested that children with congenital nephrotic syndrome (CNS) not receive immunizations due to their perceived lack of response. We report a child with CNS who was immunized before transplantation per the routine pediatric immunization protocol and responded appropriately. The intent of this report is to encourage health care providers to immunize children with CNS, as the practice of withholding immunizations in these patients may have adverse health implications. At 33 week gestation to a 21-year-old (patient's mother) who had been noted to have an elevated serum and amniotic fluid alpha-fetoprotein level and carried a prenatal diagnosis of CNS. This case involves a 16-year-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had a medical history of congenital nephrotic syndrome. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed Antibody test abnormal. Lab data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Blood test, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a Consumer on 11 May 2016. This case involves a 52-year-old female patient who was vaccinated with a dose of Tetanus vaccine (batch number, expiry date not reported) intramuscularly in left arm on 10 May 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included reflex sympathetic dystrophy syndrome on right leg and seasonal allergies and illness at time of vaccination included pain and swelling in leg and right arm. Concomitant medications were not reported. On 10 May 2016 (by the evening), same day following the vaccination, the patient had experienced soreness at the injection site. Patient's left arm, above the injection site was swollen and the swelling wraps around to the back of the arm and the shoulder. Patient could not approximate the size of the swelling and pain when she lifts the left arm. No redness noted by patient. No other symptoms reported. Relevant diagnostic tests/laboratory data included blood work was done in the office, result was pending. Corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Patient presented to Clinic at 09:31 AM for possible allergic reaction to a TWINRIX vaccination that was administered on 05/23/2016.  Patient was seen by NP who noted the following symptoms: Itchy red raised rash to left (anterior and posterior) torso, and bilateral lip swelling with numbness, no fever, no chills, no recent weight loss, no HA, no chest pain or discomfort, no dyspnea and no cough, no tightness of throat, no SOB, No DOE or wheeze. Patient stated he received a TWINRIX vaccine on 05/23/16 at 15:03 PM and ate dinner that evening.  No other new known environmental contacts/exposures in past week.  Patient prescribed Methylprednisolne 4m dosepack 21 tabs - follow directions in package #21 RFO and Diphenhydramine 25mg oral cap - take 1 capsule by mouth every 6hrs as needed for allergy #28 RFO and to hydrate well (more than usual) and to seek immediate care for any airway/throat symptoms and to avoid scratching.  Patient diagnosis: Allergy, unspecified, initial encounter possible to TWINRIX injection (was paient's last), however could have other dietary or environmental component/etiology.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Myalgia
Clinical narrative: Temperature of 100.9 F, muscle pain- almost to tears.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Pneumonia, Productive cough, Pyrexia
Clinical narrative: I was given the PREVNAR 13 vaccine on 4/27/16. By 4/29 I had a horrible cough and was spitting out green phlegm. I started running a fever on 4/30. I have been back to the doctor several times since then. I was put on prednisone, LEVAQUIN and am using a nebulizer twice a day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Sputum discoloured
Clinical narrative: I was given the PREVNAR 13 vaccine on 4/27/16. By 4/29 I had a horrible cough and was spitting out green phlegm. I started running a fever on 4/30. I have been back to the doctor several times since then. I was put on prednisone, LEVAQUIN and am using a nebulizer twice a day.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Fluid intake reduced, Full blood count normal
Clinical narrative: Infant received PEDIARIX on 5/4/2016 and Hemophilus and pneumococcal vaccines on 5/5/2016. On 5/6/2016 at 0045, infant was noted by the nurse caring for her, to have periodic breathing accompanied by decreased oxygen levels, period breathing continued for about 1 hour. At 0145, infant was noted to be lethargic with an elevated temp of 37.7C. Infant had another desaturation to 14% with bottle feeding requiring oxygen to be administered to the infant. The neonatologist was notified and lab testing was ordered. The infant remained lethargic for many hours and did not take her usual amounts of milk. At 0556, infant had another 5-6 minutes of periodic breathing with desaturations to 60%.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Irregular breathing, Lethargy, Oxygen saturation decreased
Clinical narrative: Infant received PEDIARIX on 5/4/2016 and Hemophilus and pneumococcal vaccines on 5/5/2016. On 5/6/2016 at 0045, infant was noted by the nurse caring for her, to have periodic breathing accompanied by decreased oxygen levels, period breathing continued for about 1 hour. At 0145, infant was noted to be lethargic with an elevated temp of 37.7C. Infant had another desaturation to 14% with bottle feeding requiring oxygen to be administered to the infant. The neonatologist was notified and lab testing was ordered. The infant remained lethargic for many hours and did not take her usual amounts of milk. At 0556, infant had another 5-6 minutes of periodic breathing with desaturations to 60%.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Developmental delay, Electroencephalogram, Infantile spasms, Seizure
Clinical narrative: Family requested update to VAERS - on 6/15/2007 patient received MMR, Varicella, Hib, PREVNAR. Patient seen 7/11/2007 for seizures and subsequently diagnosed with infantile spasms. Profound developmental delays.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received FLUARIX QUADRIVALENT (batch number 35F5F, expiry date 30th June 2016). On 16th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient 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 FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced sore arm after vaccination. This case was created on follow up of case US2016019415 and was reported by the same reporter.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discharge, Injection site erythema, Injection site haemorrhage, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Entire upper arm, which vaccine was administered, was very red, hot to touch, very swollen, and the injection site was still bleeding/seeping clear fluid.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: ENTIRE LEFT UPPER ARM WAS RED, HOT TO TOUCH, AND VERY SWOLLEN.  SOME ITCHING ALSO PRESENT.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Immediate post-injection reaction, Presyncope
Clinical narrative: Immediately after receiving Tdap, MCV4, and HPV 9 vaccines, the patient had a vaso-vagal reaction. Initial BP was 90/50 HR 45-50.  After 5 minutes pt was given crackers and water. Final BP 95/61 HR 73.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain at injection site. Trouble lifting arm. Pain radiates around injection site.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Significant redness & inflammation at injection site.
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Dizziness, Hyperglycaemia, Hypotension, Presyncope, Unresponsive to stimuli
Clinical narrative: Patient was administered Prevnar-13 and Zostavax and experienced a vaso-vagal reaction about 30 seconds to 1 minute following administration.  He became unresponsive briefly. He was lightheaded. He did not fall to the floor, but remained upright in the chair. He was alert and talking after about 3 minutes.  911 was called and EMS treated at the pharmacy. He was not transported to the hospital.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Pruritus
Clinical narrative: I broke out with shingle eruptions thats followed my nerves upon my upper chest region.  No other effects from shingles aside from itching.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Tremor
Clinical narrative: Mother noted infant's arms were shaking if he went to grab or eat something. Lasted for about 24 to 48 hours, then lessened in severity.