chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHEH2014US021342, is an initial spontaneous report received from pharmacist on 21 Oct 2014 with a follow up information received from a pharmacist on 22 Jan 2015. This report refers to a 61 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of FLUVIRIN (batch number: not reported) which were tolerated in the past. She was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly at a dose of 0.5 ml on 07 Oct 2014. On an unspecified date post vaccination she complained that she could not raise arm over her head and she had bad pain in her shoulder and arm. The outcome of pain in shoulder and arm was reported as condition unchanged and that of could not raise arm over head was not reported. The events were reported as disabling. The causality assessment was not reported. No further information was provided. Follow up information received from a pharmacist on 22 Jan 2015: Updated patient demographics (initials, date of birth, age, height and weight), vaccination history, suspect vaccine, batch number, dose, route and date of vaccination, event (pain in shoulder and arm), outcome and seriousness.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with oral, ROTATEQ (dose, lot number and frequency was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from same source. No further information provided. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Around 1:30 PM, my right arm started burning at the injection site. Then my right bicep became very sore. Within an hour, I couldn't lift my arm, it was stiff and sore. By 7:00 PM, the stiffness and pain had spread to my neck and right shoulder blade. The stiffness reached all the way down to my lower back. I had a fever of 100 degrees. The pain got worse, a deep ache in my arm and shoulder blade. Even my collarbone hurt. At 6:30 AM on 1/27/15, the pain and stiffness had left my neck and back. At 10:00 AM, some of the pain and stiffness had subsided in my right arm. I can raise my right arm slowly now. The right bicep is still sore and stiff, at 1:00 PM.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Around 1:30 PM, my right arm started burning at the injection site. Then my right bicep became very sore. Within an hour, I couldn't lift my arm, it was stiff and sore. By 7:00 PM, the stiffness and pain had spread to my neck and right shoulder blade. The stiffness reached all the way down to my lower back. I had a fever of 100 degrees. The pain got worse, a deep ache in my arm and shoulder blade. Even my collarbone hurt. At 6:30 AM on 1/27/15, the pain and stiffness had left my neck and back. At 10:00 AM, some of the pain and stiffness had subsided in my right arm. I can raise my right arm slowly now. The right bicep is still sore and stiff, at 1:00 PM.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Condition aggravated, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Paralysis
Clinical narrative: Case number PHEH2015US001456, is an initial spontaneous report from a consumer (also patient) received on 16 Jan 2015. This report refers to a 47-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) in 1999 and experienced Guillain-Barre syndrome (see case: PHHY2015US006721). She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 02 Dec 2014. On 03 Dec 2014, the patient experienced paralysis from down the waist and in her arms. She was sent to the emergency room and the patient was hospitalized for six days. In the hospital, the patient was treated with intravenous immunoglobulin (IVIG) for Guillain-Barre syndrome (GBS). The patient still had numbness down the shins and was undergoing physical therapy. The symptoms of the GBS improved. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US006721, is an initial spontaneous report from a consumer (also patient) received on 16 Jan 2015. This report refers to an adult female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date in 1999. On an unknown date after the vaccination, the patient experienced Guillain-Barre syndrome (GBS). The outcome, seriousness and causality were not reported. Seriousness assessment of Guillain-Barre syndrome was upgraded based on NVS-IME list. The patient was further vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 02 Dec 2014 and experienced Guillain-Barre syndrome (see case: PHEH2015US001456).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: Initial unsolicited case received from a physician on 19 January 2015. A 16-year-old male patient, with no reported medical history, received an injection of MENACTRA (lot number not reported) on an unspecified date, and later experienced ITP (idiopathic thrombocytopenic purpura). Outcome was unknown. Documents held by sender: None.
Age: 1.54
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Crying, Gait disturbance, Injection site erythema, Injection site pain
Clinical narrative: Patient had 15 month shots on 1/22/15. Mom noted that child was limping a little today and he cried when she touched his right thigh; mom then saw the redness on his thigh. Pt has been afebrile. Follow-up appt 1/29/15.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: Notice swelling in clavical area on left side Saturday. Hurts to touch. Swelling at vaccine site of left deltoid.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Pain and swelling for 4 months. Bruising intermittently over 4 months. Saw doctor - no treatment provided.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of the left thigh.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 1 week after flu shot, patient states leg pain unlike any she has had before, which started as once a week, but has increased to be more frequent.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: Patient received vaccine on 12/7/14. Two days later she began to have pain at the injection site that radiated up through her shoulder and shoulder blade on her right side. It also caused a tingling sensation in her right hand. She went to the E.R. on 1-3-14 for treatment.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reported day of (2 hours after) immunization that he had pain radiating down the vaccinated arm. He called again 1-19-15 complaining of continued pain.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus
Clinical narrative: Initial itch at dosing; fine for six days; On day 7 noticed 2" vertical and 3/4" at widest width a deeply pink bright "shot-glow" shaped area at dose site but not itchy or painful. Removing sweater made site less pink as el cooled off to change for night time. On day 8, felt momentary itch at site followed by quick flash of HOT pain at site-then nothing ever again at site, but pink noticeable shot flow shaped area took weeks to fade. It is still evident (no big deal) but I hope it goes away over time. (I had chicken pox as a toddler).
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Severe (R) arm pain. Limiting activities including combing hair, cooking. Treated with steroids and pain meds. Has an appointment with an orthopedic doctor wk of 1/26/15.
Age: 64.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Burning sensation, Joint range of motion decreased, Muscle tightness, Pain
Clinical narrative: Persistent pain in left deltoid following vaccine very limited range of movement with abduction, pain, burning, weakness, deltoid tightness that at times radiates in muscle to elbow. Symptoms remain from administration to date.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Persistent pain in left deltoid following vaccine very limited range of movement with abduction, pain, burning, weakness, deltoid tightness that at times radiates in muscle to elbow. Symptoms remain from administration to date.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site injury, Injection site pain, Injection site reaction, Muscle tightness
Clinical narrative: Persistent pain in left deltoid following vaccine very limited range of movement with abduction, pain, burning, weakness, deltoid tightness that at times radiates in muscle to elbow. Symptoms remain from administration to date.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness
Clinical narrative: Persistent pain in left deltoid following vaccine very limited range of movement with abduction, pain, burning, weakness, deltoid tightness that at times radiates in muscle to elbow. Symptoms remain from administration to date.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 05 December 2013. A 25-year-old female patient, who had asthma as medical history, no illness at the time of vaccination and concomitant medication were not reported had received an intradermal dose of FLUZONE ID vaccine (lot number: UT4466AA, dose number was not reported) in the right arm on 15 November 2012. On 16 November 2012, One day after vaccination, the patient developed swelling, redness, pain, and itching at the left deltoid. By the next morning the redness covered the whole upper left arm. Later in the day the patient began to having difficulty breathing. Laboratory investigation were not reported. She received nebulizer treatments thrice as corrective treatment. On an unspecified date, the patient had recovered from events. Documents held by sender: none. Follow-up information received from a healthcare professional on 10-Feb-2014: The patient's asthma was well-controlled. She had concomitant therapies with VENTOLIN, ZYRTEC, PULMICORT. The patient received "Klexbol", "Gincg" and "Ipolarly" as doses of PULMICORT. The patient had in fact received the FLUZONE vaccine in the left arm.
Sex: M
Vaccine: RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of intussusception in a infant male patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, several days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional information received: Sales Representative called into Medical Information to report that a male infant patient experienced intussusception after receiving a dose of ROTARIX. The patient was hospitalized and the HCP stated, "He's fine". This was all the information that the sales representative was given. She did not have the lot number, expiration date, vaccination date, date of onset of intussusception, etc.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Death.
Age: 25.0
Sex: F
Vaccine: HEPA, HPV4, TD
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Local itching & swelling to injection site, 1 day post vaccination. Client visited clinic with concerns. Client was instructed by RN to continue antiinflammatories and to seek medical follow-up if swelling does not subside by next day. Client stated that she initially applied alcohol based perfume to cool skin. Instructions given not to place alcohol or perfume to affected area. Client stated understanding.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Erythema multiforme, Injection site rash, Rash generalised, Rash papular, Vaccination complication
Clinical narrative: S: here with mom and dad for follow-up of Urgent care visit. Patient was taken to Urgent Care because of emergence of rash (reddish hive-like papules of varying sizes) a day after given vaccines (CPV and Pentacel). No fever. No change in appetite and eating habits. Patient was prescribed prednisolone and so far has had 2 doses. Also being given Benadryl every 6 hours. Parents showed pictures taken during the 1st 2 days  Showing rash of varying sizes on the body, prominent on the leg; noted few target lesions on legs and thighs.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Cough, Influenza like illness, Malaise, Pyrexia
Clinical narrative: I felt slightly under the weather at the time I received the vaccination for pneumonia. By the time I arrived home, I felt quite ill and fluey. My symptoms got worse, I developed a cough and wheeziness. Eventually a high fever (102) sent me to the doctor. My symptoms didn't abate for nearly 4 weeks.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: I felt slightly under the weather at the time I received the vaccination for pneumonia. By the time I arrived home, I felt quite ill and fluey. My symptoms got worse, I developed a cough and wheeziness. Eventually a high fever (102) sent me to the doctor. My symptoms didn't abate for nearly 4 weeks.
Age: 9.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Fall, Presyncope
Clinical narrative: Vasovagal response with fall.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: Large bump that takes up majority of deltoid, redness, heat, tingling from shoulder to finger tips.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Noticed swelling when changing diaper after patient woke up in the morning. Swelling was worst after 2 days where the entire upper leg was swollen and discolored. It began going away on the fourth day after the shot. This was her third DTaP shot since she was born.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Pt has a red and swollen area on her left shoulder it is warm. She also is having some nausea.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX, PNC13
Symptoms: Eyelid rash, Rash
Clinical narrative: Patient got a rash on her face and eyes.  No irritation at injection site.  She had also received a Pneumovax immunization at her dr's office before coming to the pharmacy.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX, PNC13
Symptoms: Erythema, Erythema of eyelid, Eye discharge, Eye pruritus, Eyelid irritation
Clinical narrative: Patient got a rash on her face and eyes.  No irritation at injection site.  She had also received a Pneumovax immunization at her dr's office before coming to the pharmacy.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX, PNC13
Symptoms: Eyelid margin crusting, Eyelid oedema, Lacrimation increased, Pruritus, Skin irritation
Clinical narrative: Patient got a rash on her face and eyes.  No irritation at injection site.  She had also received a Pneumovax immunization at her dr's office before coming to the pharmacy.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: Crying, Faecal volume decreased, Feeling hot, Irritability, Pain
Clinical narrative: Patient seemed to have a bad reaction to the shots he received on Friday 1/23. He started screaming at 3:30 am Sunday morning and it continued ALL day. He was abnormally fussy and crying and screaming like he was in so much pain. He was shaky as he screamed. He got really hot as well. He was also waking up every 30 to 45 minutes (instead of the usual 2 hours) after the first screaming session at 3:30 am. He didn't sleep the same Sunday night either, he would usually be awake after I changed him in the middle of the night. This time he was out solid, not budging or moving much either.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: Screaming, Tremor
Clinical narrative: Patient seemed to have a bad reaction to the shots he received on Friday 1/23. He started screaming at 3:30 am Sunday morning and it continued ALL day. He was abnormally fussy and crying and screaming like he was in so much pain. He was shaky as he screamed. He got really hot as well. He was also waking up every 30 to 45 minutes (instead of the usual 2 hours) after the first screaming session at 3:30 am. He didn't sleep the same Sunday night either, he would usually be awake after I changed him in the middle of the night. This time he was out solid, not budging or moving much either.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Crying, Irritability
Clinical narrative: Crying inconsolably for 3 hours, as per pt's mother. When pt returned to our office in the afternoon the pt was fussy but consolable. No continuous crying. Normal PE. AFOSF.
Age: 1.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Band neutrophil count decreased, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased
Clinical narrative: Generalized tonic-clonic febrile seizure lasting 3-5 minutes.
Age: 1.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Chest X-ray normal
Clinical narrative: Generalized tonic-clonic febrile seizure lasting 3-5 minutes.
Age: 1.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Haemoglobin normal, Lymphocyte percentage, Neutrophil percentage
Clinical narrative: Generalized tonic-clonic febrile seizure lasting 3-5 minutes.
Age: 1.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Platelet count increased, White blood cell count increased
Clinical narrative: Generalized tonic-clonic febrile seizure lasting 3-5 minutes.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Blood test abnormal, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: 2 hours after shot site swollen large grapfruit size, redness swelling went to side of left neck by ear. Tongue fuzzy swollen edema went to elbow left arm and forearm.  911 to ER.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Oedema, Oedema peripheral, Paraesthesia oral, Peripheral swelling
Clinical narrative: 2 hours after shot site swollen large grapfruit size, redness swelling went to side of left neck by ear. Tongue fuzzy swollen edema went to elbow left arm and forearm.  911 to ER.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Swollen tongue
Clinical narrative: 2 hours after shot site swollen large grapfruit size, redness swelling went to side of left neck by ear. Tongue fuzzy swollen edema went to elbow left arm and forearm.  911 to ER.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Influenza like illness, Pyrexia, Rash
Clinical narrative: Patient was diagnosed with Shingles on 1/26. On 1/18 she developed a fever which persisted through 1/20 and she showed general flu like symptoms. On 1/21 we noticed a red rash on her lower back which became progressively worse over the next four days spreading down her left leg with new blisters forming each day. We took her to the pediatrician on 1/26 and she was diagnosed with shingles impacting her L4 dermatome (hence the progression down her left leg. She was prescribed acyclovir which we began on 1/27. She has not had the chicken pox nor has her sibling (DOB 9/4/11 1 dose of the varicella vx @ 1 yr). She does not attend daycare or participate in any other activities where she would be in close contact with potentially contagious children.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Patient was diagnosed with Shingles on 1/26. On 1/18 she developed a fever which persisted through 1/20 and she showed general flu like symptoms. On 1/21 we noticed a red rash on her lower back which became progressively worse over the next four days spreading down her left leg with new blisters forming each day. We took her to the pediatrician on 1/26 and she was diagnosed with shingles impacting her L4 dermatome (hence the progression down her left leg. She was prescribed acyclovir which we began on 1/27. She has not had the chicken pox nor has her sibling (DOB 9/4/11 1 dose of the varicella vx @ 1 yr). She does not attend daycare or participate in any other activities where she would be in close contact with potentially contagious children.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac pacemaker insertion, Heart rate decreased
Clinical narrative: Initial unsolicited case received from a pharmacist on 19 January 2015. A 67-year-old male patient, with no reported medical history and no known allergies received an injection of FLUZONE HD (lot number not reported) on 06 October 2014. On an unspecified date, the patient experienced a "reduced" heart rate, which did not come up after exertion. He had been seen by a cardiologist, and a pacemaker was inserted. Outcome was reported as not recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient got shot 11/26/2014, came in on 01/18/2015 stated she had pain in muscle in arm and trouble lifting arm.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site rash, Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site rash in a 47-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7329G, expiry date 30th June 2015). Previously administered products included flu vaccine (no reactions at previous vaccination). Concomitant products included PNEUMOVAX. On 1st November 2014, the patient received FLUARIX QUADRIVALENT (injection). On 2nd November 2014, less than 24 hours after receiving FLUARIX QUADRIVALENT, the patient experienced injection site rash, fever, chills and general body pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site rash, fever, chills and general body pain were recovering/resolving. The reporter considered the injection site rash, fever, chills and general body pain to be probably related to FLUARIX QUADRIVALENT. Additional information received: RPh called to report that their patient received FLUARIX QIV on 11/1/2014 and less than 24 hours later developed fever, chills, body ache, and "apple" sized rash at the injection site. The patient received FLUARIX QIV on the right arm and the rash is also at that injection site on the right arm. The patient also received PNEUMOVAX on that day as well this was given in the left arm. After the onset of symptoms the patient took ibuprofen and the symptoms have improved but has not completely resolved.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Diarrhoea, Dysphagia, Nausea
Clinical narrative: Nausea, vomiting, diarrhea, difficulty swallowing water, weakness, fever. Symptoms lasted 10 days. Pt was hospitalized due to elevated blood pressure.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, difficulty swallowing water, weakness, fever. Symptoms lasted 10 days. Pt was hospitalized due to elevated blood pressure.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dysphagia, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, diarrhea, difficulty swallowing water, weakness, fever. Symptoms lasted 10 days. Pt went to emergency room.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, difficulty swallowing water, weakness, fever. Symptoms lasted 10 days. Pt went to emergency room.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: After receiving IZ, family noted that patient was splotchy and covered with a rash on face and neck. RN and MA obtained vitals and MD was notified immediately. Vitals stable, red splotchy rash gradually vanished.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU3, HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received INFANRIX. Co-suspect products included PEDIARIX, ENGERIX B, FLUARIX and KINRIX. On an unknown date, the patient received INFANRIX at an unknown dose, PEDIARIX at an unknown dose, ENGERIX B at an unknown dose, FLUARIX at an unknown dose and KINRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, PEDIARIX, ENGERIX B, FLUARIX and KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information.
Age: 28.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 20 June 2013. A 28-year-old female patient, had received an intramuscular dose 1 of ADACEL vaccine (lot number C4327AA) in right deltoid on 20 June 2013. The patient was pregnant at the time of vaccination. last menstrual period date was unknown. The estimated date of delivery was 05 September 2013. The patient's health during pregnancy, risk factors (e.g. alcohol, tobacco or recreational drugs) and treatment for infertility were unknown. Concomitant medications were not reported. At the time of the report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Exposure during pregnancy
Clinical narrative: Initial report received from a healthcare professional on 20 June 2013. A 28-year-old female patient, had received an intramuscular dose 1 of ADACEL vaccine (lot number C4327AA) in right deltoid on 20 June 2013. The patient was pregnant at the time of vaccination. last menstrual period date was unknown. The estimated date of delivery was 05 September 2013. The patient's health during pregnancy, risk factors (e.g. alcohol, tobacco or recreational drugs) and treatment for infertility were unknown. Concomitant medications were not reported. At the time of the report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Pt whom is prone to headaches got a very bad headache several hours after receiving the HPV vaccine headache lasted several days.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Hypoaesthesia, Injection site induration, Pain in extremity, Skin warm
Clinical narrative: Two days ago (01/25) arm was more sore/numb at some points. Injection site itself became hard; Patient increased arm movement. The arm soreness increased warm and red. Injection site mild, told him to see primary.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count, Pyrexia
Clinical narrative: Patient developed and kept low grade fever x 1 week past administration of MMR vaccine. CBC was done.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified patients of unknown ages and genders who on unknown date in January 2015 (reported as since 21-JAN-2015) were vaccinated with a dose of PNEUMOVAX 23, intramuscular (dose, lot # and expiration date were not reported) which underwent a supported temperature excursion. No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 08 April 2013. A 29-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (Lot number: U4612AA, expiry date: 9/15, dose number was not reported) on left deltoid on 8 April 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period (LMP) date was on 5 September 2012 and estimated delivery date was reported as 12 June 2013. The patient's health during pregnancy and risk factors were not reported. As of 08 April 2013, the patient had not experienced any adverse event. Documents held by sender; none.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Vision blurred
Clinical narrative: This spontaneous report was received from a 24 year old female pharmacist reporting on herself. Pertinent medical history and drug reactions or allergies were not reported. At the time of the report the pharmacist was not pregnant. On 15-JAN-2015 the pharmacist experienced accidental exposure to product, described as she was exposed to ZOSTAVAX 19400 PFU suspension (lot number K018173, expiry date reported as 10-JAN-2016) on the skin around her left eye and possibly in her left eye, during the administration of the ZOSTAVAX to a consumer. Concomitant medication included Niastrin. On the same date the pharmacist experienced vision blurred (described as blurriness) in her left eye which resolved the same day. It was reported that this event was treated with an eye wash with water on left eye and the skin around the left eye was washed with soap and water. There were no lab diagnostics studies performed. It was reported that the pharmacist did not seek medical attention and no disability, incapacity or hospitalization were reported. There was no product quality complaint involved. The reporter did not rate the relatedness between ZOSTAVAX and vision blurred. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1 (strength, route, lot # were not reported). Her second dose was 4 months after the first dose and the third dose was 10 months after the first dose. The patient received 3 doses of GARDASIL but they were not given on the recommended schedule. Concomitant therapy was not reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Injection site mass, Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: Fever and red itchy rash around injection site started 36 hours after vaccination. Fever resolved in 2 days rash continued. Lump under injection site and heat at site started 1/26/15. Seen today with continued rash. Itching and lump at injection site. Prescribed ZYRTEC and BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Fever and red itchy rash around injection site started 36 hours after vaccination. Fever resolved in 2 days rash continued. Lump under injection site and heat at site started 1/26/15. Seen today with continued rash. Itching and lump at injection site. Prescribed ZYRTEC and BENADRYL.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Shot given in rt arm-within 12 hrs inj site started to itch and a little redness. Then swelling started in upper arm (abt 1 1/2 size of norm) kept swelling lower clear to hand-abt 3 wks swelling and itching gone and arm fine.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a 25 year old female patient. Medical history and concurrent conditions were not reported. The physician informed that on 26-DEC-2014 the patient was vaccinated with the first dose GARDASIL lot # K006960, 0.5 ml, intramuscular, when the patient was pregnant "approximately 18 weeks gestation". No adverse effects reported, the patient sought medical attention with her physician, there was not treatment given for the event. The Last menstrual period (LMP) was approximately 22-AUG-2014, and the estimated date of delivery (EDD) was 29-MAY-2015. The pregnancy outcome was outcome pending. The fetal outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse who stated that on 26-JAN-2015, she inadvertently administered a dose of PNEUMOVAX 23, intramuscular that had expired on 25-JAN-2015 to a patient of unknown age and gender. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV1
Symptoms: Incorrect product formulation administered, No adverse event, Wrong technique in drug usage process
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a unk patient who received ROTARIX (batch number A41CB4464, expiry date 30th January 2016). On 14th October 2014, the patient received ROTARIX (oral). On 14th October 2014, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: RN reported to Account Manager that 5 patients had inadvertently received only the diluent portion of the ROTARIX vaccine. All five patients returned to the physician office that day to receive the vaccine and diluent product. No AE's were reported. It is thought that one child may have been 2 months old, it is unknown if any had received ROTATEQ previously as the office was changing over vaccine manufacturers.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a health professional and described the occurrence of vaccine exposure during pregnancy on a 26-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Prenatal vitamins (Prenatal vitamin). On 16 June 2014, the subject received an unspecified dose of BOOSTRIX (intramuscular, administration site unknown). The last menstrual period was on 17 November 2013 and estimated date of delivery was 31 August 2014. The subject was exposed to the vaccine during 3rd trimester (29 1/7 gestation weeks). At the time of reporting the pregnancy was ongoing. Follow-up information received on 01 October 2014 from nurse: On 5th September 2014 after 41 weeks, the subject gave birth to a male neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate weighed 3925 grams (8lbs 10oz) at birth, a height of 53 cm, a cranial circumference of 37.5 cm. APGAR scores were 8 and 9.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's past medical history was not reported. No concurrent medication was reported. On 25 June 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 28 October 2013 and estimated date of delivery was on 4 August 2014. The subject was exposed to the vaccine at 34 weeks and 2 days gestation. No adverse event was reported. At the time of reporting, the pregnancy was still ongoing. The nurse reported another case of vaccination with BOOSTRIX during pregnancy. See case A1078835A. Follow-up information received on 20 October 2014 from the nurse: The patient gave birth to a male infant at 38 weeks gestation by vaginal delivery. Birth weight was 6 lbs and APGAR scores at 1 minute and 5 minutes were 08 and 09. VAERS details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician (contradicting information, also reported as a patient) as part of a marketing research program refers to unspecified number of patients older than 26 years of age of unknown gender. On an unknown date, the patients were vaccinated with doses of GARDASIL9 (dose, route and lot # not reported). Additional information is not expected. There is no contact information.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 09 April 2013. A 29-year-old female patient had received first intramuscular dose of ADACEL vaccine (lot number U4431AA, anatomical site of vaccination was not reported) on 09 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 07 July 2012 and the expected date of delivery is 30 April 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "not applicable". As per reporter, the patient did not experience any adverse event. List of documents held by the sender: None.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's past medical history was not reported. No concurrent medication was reported. On 25 June 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 28 November 2013 and estimated date of delivery was on 4 September 2014. The subject was exposed to the vaccine at 29 weeks and 4 days gestation. No adverse event was reported. At the time of reporting, the pregnancy was still ongoing. The nurse reported another case of vaccination with BOOSTRIX during pregnancy. See case A1078833A. Follow-up information received on 20 October 2014 from the health professional: The patient gave birth to female live infant at 40 weeks gestation by vaginal delivery. Birth weight was 8 lbs and APGAR scores at 1 minute and 5 minutes were 09 and 09. VAERS details were provided.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a health care professional and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included 1 previous full-term pregnancy. On 21 May 2014, the subject received an unspecified dose of BOOSTRIX (Intramuscular, administration site unknown). The last menstrual period was on 26 October 2013 and estimated date of delivery was on 2 August 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 4 August 2014: Subject's details and report details were provided. Follow-up information received on 30 October 2014: On 29 July 2014, the patient gave birth to a female infant at 39 3/7 weeks of gestation by cesarean section. Birth weight was 8 lbs and APGAR scores at 1 minute and 5 minutes were 08 and 09.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a physician and described the occurrence of injection site nodule in a 18-month-old male patient who received INFANRIX. Concurrent medical conditions included aluminum (nodule caused by aluminium allergy). On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced injection site nodule. On an unknown date, the outocme of the inejction site nodule was unknown. It was unknown if the reporter considered the injection site nodule to be related to INFANRIX. Additional information received: INFANRIX was given to a chils at 18 months of age. The developed a nodule at the injection site that lasted for several year. The HCP states that the nodule was caused by an Aluminum allergy. HCP states that the patient is now 4 years of age and wants to know what information we have on this topic. The HCP who called is an allergist, the vaccine was given at a different HCPs office. The allergist HCP is calling to determine if another vaccine can be given to the child.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever Started 3 hours post injection. Localized welts on arm where injection was administered.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Prenatal screening test
Clinical narrative: Initial pregnancy report received from a healthcare professional on 10 April 2013. A 39-year-old female patient, had received the first dose of ADACEL vaccine (batch number: C4344AA, expiry date: 06/04/2015, site of administration was not reported) intramuscularly on 09 April 2013. The patient's medical history and concomitant medications were not reported. The patient was 17 weeks pregnant with twins. The patient had no specific risk factors. The patient's date of last menstrual period and estimated delivery date were not reported. At the time of this report, the patient had not experienced any adverse events. Document held by sender: none. Follow up information received from healthcare professional on 20 June 2013. The patient had received vaccine on right arm. The patient received KEFLEX, Prenatal kit and Iron as concomitant medications. The patient's LMP date was December 2012 (date was unspecified) and EDD date was reported as 25 August 2013. The patient had unspecified prenatal tests on an unspecified date in May 2013.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Herpes zoster, Musculoskeletal pain, X-ray limb abnormal
Clinical narrative: Pt developed severe pain in left shoulder. Went to Dr who felt it was arthritis after X-ray. She followed up with another Dr who felt pt had developed shingles and ordered prednisone and valacyclovir.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 10 April 2013. A female patient (age not specified), had received an intramuscular dose of ADACEL vaccine (batch number: U4612AA, dose number and site of administration were not reported) on an unspecified date. The patient was pregnant. The patient's medical history, health during pregnancy, risk factors and concomitant mediations were not reported. The patient's date of last menstrual period was 10 July 2012 and the estimated delivery date was 27 April 2013. Laboratory investigations were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 23-JAN-2015 the patient was inadvertently administered, with a single dose of ZOSTAVAX, subcutaneous, that was improperly stored (dose, dose number, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the event was unknown. Additional information is not expected because the reporter refused additional contact.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 20 March 2013. A 37-year-old pregnant female patient had received first intramuscular dose of ADACEL vaccine (Lot number U4586AA, anatomical site of vaccination was not reported) on 20 March 2013. The last menstrual period date was 21 June 2012 and the expected date of delivery was 28 March 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "not applicable". As per reporter, the patient did not experience any adverse event. List of documents held by the sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female consumer of unknown age reporting herself. Medical history and concurrent conditions were not provided. On an unknown date reported as "five days before she conceived", the consumer was vaccinated with a dose of GARDASIL (dose, route, lot number and expiry date were not reported). The consumer did not specify which dose she received in the GARDASIL series, and it was not confirmed if the consumer received any subsequent doses, after conception. On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) was not known. The pregnancy outcome was pending. Additional information is not expected because no demographics were provided for the patient or physician.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 25 march 2013. A 37-year old female patient had received first intramuscular dose of ADACEL vaccine (Lot number U4586AA, anatomical site of vaccinations was not reported on 25 March 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 16 July 2012 and the expected date of delivery was 22 April 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. As per reporter, the patient did not experience any adverse event. List of documents held by the sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse, via company representative, refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were unspecified by reporter. On an unknown date the patient was vaccinated with GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies were unspecified by reporter. On an unknown date, just after the administration of GARDASIL, the patient fainted. The patient recovered while in the office, without requiring medical treatment. The relatedness between GARDASIL and syncope was not reported. Additional information is not expected because the reporter refused additional contact.