chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable nurse. A currently 58-year-old female patient of an unspecified ethnicity started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunisation. The patient's medical history, concomitant medications, and details regarding vaccinations were not reported. The patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. The clinical outcome of event, allergy to vaccine, was unknown.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Feeling cold, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous PREVNAR 13 on 02Dec2016 at single dose  for immunisation. Medical history included high blood pressure, narcolepsy, apnoea. The patient's concomitant medications were not reported. On 02Dec2016 few hours after vaccination, the patient experienced headache, was feeling tired, had generalized muscle pain throughout the body and was feverish (no temperature) with chills. Patient was treated with ADVIL on 02Dec2016 and 03Dec2016. On 03Dec2016 he was still tired and had a slight headache (which was relieved by ibuprofen), other symptoms are gone. Final outcome of feeling tired was not recovered, outcome of the other events was recovered on an unknown date.
Sex: F
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program "Pfizer First Connect". A non-contactable consumer reported for a female patient (daughter). A female patient of an unspecified age and race received, on an unknown date, TRUMENBA single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced nausea. Clinical outcome of the event was unknown at time of this report. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. An elderly male patient of an unspecified age (above 65 years), race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date post vaccination the patient experienced redness and swelling around the vaccination site. Outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016574245 Same reporter, suspect product, events, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. An elderly female patient of an unspecified age (above 65 years), race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date post vaccination the patient experienced redness and swelling around the vaccination site. Outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016574242 Same reporter, suspect product, events, different patient.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Depressed mood, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 16 year old female patient received the first dose of TRUMENBA on an unknown date at single dose for healthy adolescents age 16-23 years old (Immunisation) then went to school. The next day the patient did not feel good, had a fever of 101 degrees. She was starting to feel sick described as she felt hot, tired, and a little down. The patient was out of school the next day and then the third day following the vaccine felt better and went back to school. After the meningococcal group B RLP2086 second dose, she had a slight fever of 101 degrees. She received the vaccine on a Friday and went back to school the following Monday. No other details provided.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 16 year old female patient received the first dose of TRUMENBA on an unknown date at single dose for healthy adolescents age 16-23 years old (Immunisation) then went to school. The next day the patient did not feel good, had a fever of 101 degrees. She was starting to feel sick described as she felt hot, tired, and a little down. The patient was out of school the next day and then the third day following the vaccine felt better and went back to school. After the meningococcal group B RLP2086 second dose, she had a slight fever of 101 degrees. She received the vaccine on a Friday and went back to school the following Monday. No other details provided.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced swelling around injection site on an unspecified date for about a week post vaccination with outcome of unknown. Pfizer Sales Representative mentioned that pharmacist believed that it was because of Prevnar13.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Breast pain, Painful respiration
Clinical narrative: I received the vaccine in my left arm, and late in the evening, my left breast became VERY painful, and breathing hurt on that side. I took two TYLENOL and went to bed. The breast pain lessened by morning, but 36 hours later, deep breathing is still painful on that side.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: She stated arm was swollen and there was a red ring around injection site.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Whole Arm was sore immediately after injection. Eventually I was unable to use my arm. Shoulder pain when moving my arm, unable to lift my arm, and sharp pain when sleeping and not even moving my arm. I went to the nurse's office at my place of work about a week after getting the shot at the school's clinic and she told me that it wasn't normal and to go see a doctor if it didn't go away. I finally couldn't take the pain anymore and I went to a clinic on 11/30. They prescribed ibuprofen and a muscle relaxer for 8 days. I did feel some relief but still unable to move my arm without pain. I went to my PCP on 12/14. She referred me to an orthopedic doctor and my visit is tomorrow 12/15.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Pruritus, Pyrexia, Rash
Clinical narrative: Oonset of rash over anterior and posterior trunk; associated with itching, fever prior to rash flare,  tightness in chest without SOB prior to flare of rash .
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: CHILD WAS GIVEN ADULT DOSE HEP B INSTEAD OF CHILD DOSE HEP B. NO NOTED ADVERSE REACTION UPON RECEVING VACCINES.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: RD remained sore for at least one month after vaccine administration. Right arm is sore, she cannot lay on the right side, and she cannot raise her right arm all the way.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Pain
Clinical narrative: Patient's left arm became harden with pain. He rate it at pain scale of 9. The area was red according to patient but lessen the next day.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Disorientation, Dyskinesia, Incorrect dose administered, Loss of consciousness, Pallor
Clinical narrative: CHILD WAS GIVEN ADULT DOSE HEP B INSTEAD OF CHILD DOSE HEP B. UPON RECEIVING VACCINE, CHILD EXPERIENCED JERKY, SHAKY MOVEMENT FOR 5 SEC. CHILD WAS PALE AND DISORIENTED. CLIENT WAS SAFELY LAID ON A COT UNTIL REGAIN CONCIOUSNESS. ABLE TO VERBALIZE TIME, DATE, PLACE, AND SELF. 911 WAS CALLED AND ARRIVED TO TRANSPORT CHILD TO HOSPITAL.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: CHILD WAS GIVEN ADULT DOSE HEP B INSTEAD OF CHILD DOSE HEP B. UPON RECEIVING VACCINE, CHILD EXPERIENCED JERKY, SHAKY MOVEMENT FOR 5 SEC. CHILD WAS PALE AND DISORIENTED. CLIENT WAS SAFELY LAID ON A COT UNTIL REGAIN CONCIOUSNESS. ABLE TO VERBALIZE TIME, DATE, PLACE, AND SELF. 911 WAS CALLED AND ARRIVED TO TRANSPORT CHILD TO HOSPITAL.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Deafness, Ear pain, Fall
Clinical narrative: I had a 100 degree temperature. Sinus congestion with mucous and feeling very tired. I fell from my bed. Coughing. Sharp pain in my left ear and hearing loss. Treated with antibiotics about a week later.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Secretion discharge, Sinus congestion
Clinical narrative: I had a 100 degree temperature. Sinus congestion with mucous and feeling very tired. I fell from my bed. Coughing. Sharp pain in my left ear and hearing loss. Treated with antibiotics about a week later.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Work provided flu shot. Shot was giving high in the shoulder, no pain at the time. By the end of the evening my shoulder was in a lot of pain and loss a lot of my range of motion. Went to the Dr. several time, been taking anti-inflammatory pills, had physical therapy and a steroid shot. Last visit to Doctor's resulted in scheduling surgery. None of the medication has helped.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2016-11-17.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This spontaneous report has been received from the MR moderator referring to 2 patients of unknown age and gender both of them sons of a 50 year old male that was enrolled in a market research. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL 9 (dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. Also, he said that he got his vaccinated off schedule (reported as "did not follow the prescribed 3 dose schedule"). On an unknown date, the patients experienced pain while the vaccine was being administered. Additionally, it was reported that the patients' father got the patients vaccinated off-schedule (reported as "did not follow the prescribed 3 dose schedule"). At the time of reporting, the outcome of vaccination site pain was unknown. The relationship between pain at vaccination site and the administered dose of GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of GARDASIL (lot # K009482, expiration date 06-MAR-2017) which were exposed to temperatures outside of the recommended range, were administered orally to the patients. No adverse experience had been reported. Temperature and time frame were: 1.2 degrees Celsius (C) for 22 minutes; 1.3C for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 331min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009625: US-009507513-1611USA009626: US-009507513-1611USA008904.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. No information about medical histories, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (doses, routes and sites of vaccinations were not reported, lot number K011081, expiry date 08-AUG-2016). It was reported that all of the vaccinations were administered prior to the expiration date. Digital Data Logger was involved. Doses of vaccines underwent temperature excursion of -14.2 degrees Celsius for 2 hours. Previous temperature excursions were reported as follows: -14.2 degrees Celsius for 2 hours, -11.5 degrees Celsius for 3 hours, -11.0 degrees Celsius for 3 hours and 30 minutes, -12.4 degrees Celsius for 3 hours, -12.4 degrees Celsius for 3 hours, -12.6 degrees Celsius for 2 hours 30 minutes, -14.2 degrees Celsius for 30 minutes and -5.7 degrees Celsius for 13 hours and 30 minutes. Additional information has been requested.
Sex: U
Vaccine: HEP, MMR
Symptoms: Anxiety
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On an unknown dates, the patient was vaccinated with a dose of M-M-R II and RECOMBIVAX HB (dosage information, lot numbers and expiration dates were not informed) both for prophylaxis. Information regarding concomitant medication was not provided. It was reported that the patient developed increased anxiety lasting for an unspecified duration of time. The reporter did not indicate if the increased anxiety had resolved. There was no product quality complaint involved. At the time of reporting, the outcome of anxiety was unknown. The causality assessment between anxiety and therapy with M-M-R II and RECOMBIVAX HB was not provided. Additional information is not expected, since the physician cannot be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 22-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 (which had the lot # L002310, expiration date July 2016) (dosage information was not informed) intramuscular route, for prophylaxis. Information regarding concomitant medication was not provided. It was also informed that no adverse effects were reported and there was no product quality complaint involved. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse, referring to a 38 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently administered a dose of PROQUAD, subcutaneous (dose, anatomical location of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2016-12-08.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Feeding disorder, Headache, Hypersensitivity, Malaise
Clinical narrative: High fever, nausea, vomiting until 06:00 AM of Dec. 1st. Transfered to ER to Hospital put on fluid and medication released at 4:00 PM on Dec. 1st.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: High fever, nausea, vomiting until 06:00 AM of Dec. 1st. Transfered to ER to Hospital put on fluid and medication released at 4:00 PM on Dec. 1st.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-11-22.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out while checking out of office.
Age: 44.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Nasal congestion, Painful respiration, Pleuritic pain, Rhinorrhoea
Clinical narrative: Pleuritic pain in the flank on both sides, worse with inspiration.  Better with ibuprofen.  Mild nasal congestionand drainage began about 2 hours after the dose.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: CLIENT WAS GIVEN A PEDIATRIC DOSE OF HEP A VACCINE. HE THEN NEEDED TO BE CONTACTED TO COME BACK TO THE OFFICE TO GIVE A SECOND PEDIATRIC DOSE TO = ADULT DOSING FOR VACCINE SCHEDULE.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Red Hives all over body but face. Severe looking. Also fever, chills, intense itching.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: Mom said that her daughter really complained about the Gardasil being really painful when she got it. After mom stated that she developed a weird rash on her arm where the shot was given. That has resolved and there is no swelling now. Since then she has experienced pain going down her arm, to the point where mom says that she can't even move it due to pain. She is experiencing shooting pains in her 1-3 fingers fingers.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Dysphemia, Nuclear magnetic resonance imaging brain, Regressive behaviour
Clinical narrative: Mid-day on Saturday October 1st I noticed that my son began to stutter not thinking much into it and just thinking that he got excited. About one week later his caregivers at daycare/school, Grandparents, Aunts, and Uncle noticed it. Patient also at this point started to get very aggravated with himself and say "I can't talk Mommy". It progressively got worse I then contacted his pediatrician and they told me that it was normal for him to stutter like this at his age. I disagreed with this because I feel that he should have progressed rather than regressed, they then told me that I could make an appointment for an evaluation. I made the appointment with his doctor and I was given a referral to a speech pathologist. I made the appointment and they recommended a Neurologist. I've made an appointment with a Neurologist but required a referral. I contacted his pediatrician and it took them days to get back to me regarding this. They finally contacted me and I was able to schedule him the appointment, 12/12/16. They are suggesting an MRI and told me to report this incident and to see Speech Pathologist to evaluate if this is permanent or treatable. I am to have my son follow up with neurologist after testing and they will be in contact with us.
Age: 7.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Abnormal behaviour, Feeling abnormal, Injection site erythema, Injection site pain, Lethargy
Clinical narrative: Localized pain and redness to left deltoid area; fever 101.2 per father taken by school nurse today at approximately 1PM. Per the father described "lethargic" and was "foggy"-child just not himself; advised recovered other than quiet at time of exam in doctors office 12/14/16 at 3PM today vital signs oral temperature 100.0; heartrate 104; respiratory rate 22; b/p 100/66.
Age: 7.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Localized pain and redness to left deltoid area; fever 101.2 per father taken by school nurse today at approximately 1PM. Per the father described "lethargic" and was "foggy"-child just not himself; advised recovered other than quiet at time of exam in doctors office 12/14/16 at 3PM today vital signs oral temperature 100.0; heartrate 104; respiratory rate 22; b/p 100/66.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Eye contusion, Lethargy, Pyrexia, Rash generalised
Clinical narrative: High fever spiked on day 6 post vaccine administration. Fever didn't break till a week later. Was consequently high for 6 days straight with no aid. Rash on whole body from forehead to toes. Yellowing of the skin all over and black and blues under the eyes. Lethargic state.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Yellow skin
Clinical narrative: High fever spiked on day 6 post vaccine administration. Fever didn't break till a week later. Was consequently high for 6 days straight with no aid. Rash on whole body from forehead to toes. Yellowing of the skin all over and black and blues under the eyes. Lethargic state.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Chest X-ray, Febrile convulsion
Clinical narrative: PATIENT HAD A FEBRILE SEIZURE.
Age: 49.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Inflammation, Pain in extremity, Swelling
Clinical narrative: Swelling and inflammation about 2 1/5 cm diameter. Pain extending to elbow.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative  refers 3 or 4  patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patients developed an irritation about the size of a palm around the injection site. Two of the patients took diphenhydramine hydrochloride(BENADRYL) or an unspecified antihistamine to treat the adverse event. The injection site irritation went away after a couple days (unknown date). No product quality complaint was involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unspecified date, the patient received GARDASIL (dose, route of administration, lot# and expiration date were not reported) as the first dose in the HPV series. Seven months later, the patient recieved GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) as the second dose in the HPV series. No concomitant therapies were reported. No adverse event was reported. The outcome of the event and the relatedness between the event and the vaccines were not reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1607USA011966.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, (reported as "before 12-AUG-2016"), the patients were vaccinated with improperly stored M-M-R II, lot number K011188, expiration date 12-AUG-2016, and lot number L003858, expiration date 05-FEB-2017, (route, anatomical location and frequency were not reported), for prophylaxis. The temperature was 8.7 Celsius degrees, time frame 1.5 hours without previous temperature excursions. Digital data logger was involved. No adverse effects were reported and no product quality complain was involved. No other suspect or concomitant therapies were reported. This is on of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014046.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable Physician. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, (Lot # N11902, Expiry Date 31Jul2017) injection and FLU VACCINE, (GSK, Lot # C54L5, Expiry Date 30Jun2017), both via an unspecified route of administration at injection on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient cannot lift arms on an unspecified date with outcome of unknown. The patient's parent called the physician thinking her child had a reaction to Trumenba and a flu vaccine. The parent thought the vaccine was given too high up in the bone and the medicine went between the muscle and the bone and now the patient can't lift her arms. The physician wished to know of any reports related to excavation of vaccines outside the deltoid.
Age: 3.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Per parent patient had fever of 103F and vomited 2 times on 12/12/2016 night.
Age: 59.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Myalgia, Pain in extremity, Rhinorrhoea
Clinical narrative: Soreness in arm and joints running nose constant muscle pains.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain
Clinical narrative: Soreness in the back initially, but eventually had some soreness in her hip.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Dyspnoea, Laboratory test, Lip swelling, Urticaria
Clinical narrative: Pt awoke at 1 AM, about 30 hr after vaccination, with hives, diarrhea, vomiting, shortness of breath, lip swelling, and wheezing. Given Epipen and Benadryl at home, taken by ambulance to ED, had Epipen, Benadryl, prednisone and Zantac. Admitted to hospital for 2 days.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting, Wheezing
Clinical narrative: Pt awoke at 1 AM, about 30 hr after vaccination, with hives, diarrhea, vomiting, shortness of breath, lip swelling, and wheezing. Given Epipen and Benadryl at home, taken by ambulance to ED, had Epipen, Benadryl, prednisone and Zantac. Admitted to hospital for 2 days.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Hib administered out of age guidelines.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: No adverse signs or symptoms.
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Burning sensation, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported severe pain in shoulder, burning sensation, and difficulty/inability to move arm a few hours following vaccination. Patient visited ER and was treated with TYLENOL w/ codeine no.3 and ice compress. Patient reported still having pain a day later, but it was not as bad. Primary care continued RX for TYLENOL w/ codeine no. 3 for pain.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Mouth swelling, Pruritus generalised, Rash, Urticaria
Clinical narrative: Patient states she developed rash/hives about three hours after receiving vaccine and is still bothered by it over three weeks later. States has intense itching, "all over" which is worse at night. She mentioned that there was two times during the night "her lips and mouth" had swollen up. She has been treating herself with OTC BENADRYL with only some mild relief.
Age: 32.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site pain, Insomnia
Clinical narrative: I received this shot on October 31, 2016 at 1:30 PM, tetanus shots are painful however, it is now December 14, 2016 and I am still having the same pain in my left arm where the shot was injected.  I cannot sleep on that side and it continues to bother me with pain.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: SWELLING, REDNESS AND PAIN IN THE ARM.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Soreness in left arm that won't go away. Reduced mobility...difficulty raising arm above shoulder or across the body. Sharp pain.
Age: 23.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Induration, Mobility decreased, Pain in extremity
Clinical narrative: The arm where I received the shot was extremely sore the next morning. I struggled to move my arm at all that day. Around 12 pm, I started to run fever. I ran fever for 2 day of 102. My arm was red, hard, swollen, and the red area spread to my elbow. I was diagnosed with having Cellulitis. The nurse gave me Amoxicillin and a steroid pack. This did not help at all and the redness was still spreading four days after the shot. I went back to the doctor and was given Clindamycin, which finally helped.
Age: 23.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: The arm where I received the shot was extremely sore the next morning. I struggled to move my arm at all that day. Around 12 pm, I started to run fever. I ran fever for 2 day of 102. My arm was red, hard, swollen, and the red area spread to my elbow. I was diagnosed with having Cellulitis. The nurse gave me Amoxicillin and a steroid pack. This did not help at all and the redness was still spreading four days after the shot. I went back to the doctor and was given Clindamycin, which finally helped.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia
Clinical narrative: Case number PHEH2016US031075, is an initial spontaneous report received from a pharmacist on 28 Nov 2016. This report refers to a 59 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 16 Nov 2016. On 18 Nov 2016, the patient experienced numbness, tingling and shoulder pain. Patient cannot lay or lean on it. Patient believes that it is getting worse. The patient is still experiencing reaction. The outcome of the events was reported as condition deteriorated. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Atrial flutter, Cardioversion, Heart rate increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of atrial flutter in a 18-year-old male patient who received BEXSERO (batch number 148901C, expiry date September 2016). The patient's past medical history included cardiac operation (at 16 months to treat heart condition) and premature birth. Concurrent medical conditions included congenital heart disease NOS and heart disease, unspecified (minor residual anatomical heart disease after heart surgery, no interventions or medications needed). On 16th August 2016, the patient received the 1st dose of BEXSERO (intramuscular). On 17th August 2016, 1 days after receiving BEXSERO, the patient experienced atrial flutter (serious criteria hospitalization, disability, life threatening and other: As per reporter) and heart rate increased (serious criteria hospitalization, disability, life threatening and other: As per reporter). The patient was treated with beta blocker NOS. On an unknown date, the outcome of the atrial flutter and heart rate increased were recovered/resolved. The reporter considered the atrial flutter and heart rate increased to be possibly related to BEXSERO. Additional details were provided as follows: On 17th August 2016, the patient was admitted to hospital for approximately 24 hours. The baseline heart rate was around 50, it was increased to 170. The patient required cardioversion. At the time of reporting, the patient was on the maintenance with beta-blocker due to atrial flutter and increased heart rate.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Rash
Clinical narrative: Patient phoned to inform me he has had a painful rash on his face/neck since the day after receiving the vaccine. Also he has had joint pain.
Age: 67.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Balance disorder, Peripheral swelling, Pyrexia
Clinical narrative: Arm swollen up to the neck, imbalance and high fever.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site warmth, Pain, Rash erythematous
Clinical narrative: Admin'd 12/2 - achy on 12/3. Extensive warm red rash noticed on arm where given and under arm on 12/5. Suggested BENADRY/pain reliever. Called her MD.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Severe pain with movement after vaccine given since 11/7/16, seen in ER on 11/28/16. Started MEDROL dose pack. Still having pain.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling pt. waited 10 to 15 min no reaction. VIS was not given.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patients family has not reported any adverse effects (at this time). Patient received a dose of flu when she was supposed to received a varicella vaccine.
Age: 68.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 68-year-old male patient who received Flu Seasonal QIV Dresden (Quadrivalent). Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine). Previously administered products included XTANDI with an associated reaction of adverse event (bruising, depressed, loss of appetite, joint aches, hot flashes, headache, fatigue (in July 2016), fatigue (in October 2016), fatigue (1st episode), soreness in the arm and achiness at the injection site). Concurrent medical conditions included pain. On 7th November 2016, the patient received Influenza vaccine Quadrivalent 2016-2017 season and Pneumococcal vaccine. in November 2016, less than a week after receiving Influenza vaccine Quadrivalent 2016-2017 season and Pneumococcal vaccine, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to Influenza vaccine Quadrivalent 2016-2017 season and Pneumococcal vaccine. Additional details were provided as follows: This case was reported by the patient's wife to other manufacturer on 8th November 2016. No concomitant medication information was provided. The patient experienced various adverse events after receiving a dose of XTANDI (batch number: 1539683PC, 1543982PC, 1553886PC). The patient experienced soreness in arm and achiness at injection site after vaccination with flu and pneumococcal vaccine. No lab test information was provided. The soreness in arm and achiness at injection site were considered to be non-serious and the causal relationship to XTANDI was not related as it can be attributed to flu and pneumonia vaccine. No further information was available.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles diagnosis by PCP on 12/13/16; Treated w/VALACYCLOVIR 1 gm TID x 7 days.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Dizziness, nausea, vomiting and syncope.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of palpitation in a 32-year-old male patient who received RABAVERT (batch number 587011A, expiry date 30th April 2019). Concomitant products included Tetanus vaccine and immunoglobulin. On 20th September 2016, the patient received the 2nd dose of RABAVERT (intramuscular). On 20th September 2016, less than a day after receiving RABAVERT, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was not recovered/not resolved. The reporter considered the palpitation to be almost certainly related to RABAVERT. Additional details were provided as follows: On 16th September 2016, the patient received Tetanus vaccine on an unknown arm. The patient received 2nd dose of RABAVERT in his left arm and experienced heart palpitations in the same night. The patient reported that he had been to the emergency room twice since 20th September 2016. The patient planned to continue follow-up with his physician on an unknown date. The vaccination date was wrongly reported as 16th September 2016 for suspect vaccine, however corrected to 20th September 2016 as per narrative description.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Joint range of motion decreased, Pain
Clinical narrative: Pt complained of pain 2.5-3 hrs after inj. Went to dr on 12-6-16, Dr stated arthritis was triggered in shoulder, was given cortisone shot. Pt states still has limited range of motion.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient came for 2 mo well and Hib was not mixed patient only received the Diluent. Parents were advised and reschedule to give vaccine. No adverse reactions.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Rash
Clinical narrative: 3:45 pm mother complains of rash. Rash noted on right ear and right cheek. Breath sounds clear bilaterally. BENADRYL 5 mL PO given. Frequent checks on pt with no changes within 20 minute time frame. Mother instructed to seek emergency evaluation if difficulty breathing, wheezing, or rash worsens. Continue OTC BENADRYL for next 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Swelling, Tenderness
Clinical narrative: Immediate reaction - redness, tenderness, swelling about 10 cm. Itchy area. Administered BENDARYL, applied ice pack. Observed 20 min. No systemic reaction occurred.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: (R) UE cellulitis, warmth/redness. BENADRYL and KEFLEX (if febrile).
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass
Clinical narrative: Lump in injection site, infection of site. Treated with sulfamet/TMP.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, redness, warm to touch, left upper arm. (Deltoid area). Painful at injection site.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Mom noted onset of rash on chest and neck today. Also noted swelling at site of injections on (L) leg. Dr. today examined the areas and noted redness and swelling at injection sites approximately .5 cm diameter at each site. No specific treatments. Will mon. for improvement.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: No adverse symptoms or signs at this time but patient was given a PROQUAD and a varicella vaccine instead of a MMR and a varicella vaccine that was ordered by the physician.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Pruritus, Skin warm
Clinical narrative: Patient reports symptoms appearing on 12/12/16. Redness at the injection site and spreading up arm approximately 3 inches in diameter. Patient states the arm is hot to touch and itches. A knot has formed at site of injection. Patient had no fever to previously administered PNEUMOVAX 23. No fever or anaphylactic response reported by patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Rec'd 5y IMM. on 12/07/16 at 4 y/o WCE in office fever x 1 Day (12/08/16) -> 101.8 max; seen for S/S on 12/09/16 -> (RT) upper arm with 5x6 cm area erythema. No induration. TX with PRN BENADRYL. Call if S/S increased.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: SX's started 10pm on 12/6/16 - arm hurt at injection site, felt swollen and lumpy. By 7 am the next morning pt. was unable to raise arm easily over or above shoulder area without force. Towards the afternoon patient developed chills, no appetite and all over achiness. 24-30 hours post vaccination - pt developed welts and/or hives starting at injection site and traveled to patient's neck area (Thursday evening). Pt. reported no itch. Pt. reported adverse side effect lasted 3 days in total and by the second day SX's started to dwindle. Pt. treated SX's with ice.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site urticaria, Pain, Urticaria
Clinical narrative: SX's started 10pm on 12/6/16 - arm hurt at injection site, felt swollen and lumpy. By 7 am the next morning pt. was unable to raise arm easily over or above shoulder area without force. Towards the afternoon patient developed chills, no appetite and all over achiness. 24-30 hours post vaccination - pt developed welts and/or hives starting at injection site and traveled to patient's neck area (Thursday evening). Pt. reported no itch. Pt. reported adverse side effect lasted 3 days in total and by the second day SX's started to dwindle. Pt. treated SX's with ice.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fatigue, Headache, Loss of consciousness, Pyrexia, Urticaria
Clinical narrative: Received a spontaneous report on 31OCT2016 from a consumer. A pregnant wife called to report that her 25 year old husband passed out three minutes after being inoculated with anthrax vaccine. She stated shortly after receiving the vaccine her husband experienced headaches, fever, sore muscles, and fatigue. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fatigue, Headache, Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: Received a spontaneous report on 31OCT2016 from a consumer. A pregnant wife called to report that her 25 year old husband passed out three minutes after being inoculated with anthrax vaccine. She stated shortly after receiving the vaccine her husband experienced headaches, fever, sore muscles, and fatigue. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: MMR, MMRV
Symptoms: Computerised tomogram head normal, Febrile convulsion, Full blood count normal
Clinical narrative: Prolonged seizure.
Age: 1.08
Sex: F
Vaccine: MMR, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Prolonged seizure.
Age: 45.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Erythema, Measles antibody negative, Skin mass, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old female patient. The patient's pertinent medical history. There were no drug reactions or allergies. Concomitant medications included hydrochlorothiazide and PROZAC. On 26-OCT-2016, the patient was vaccinated with the first dose of M-M-R II, lot # L007216, expiration date 03-MAR-2017, administered per subcutaneous route, for prophylaxis. The nurse stated there was no documentation of previous vaccination with this vaccine for this patient. On the same day of vaccination, the patient developed a subcutaneous nodule (Skin mass) after the vaccination with M-M-R II. The nodule was described as 3cm x 3cm in size and tender. The patient was required to receive 2 doses of M-M-R II as required immunization as a nursing student. The patient went to the office on 21-NOV-2016 to report the nodule for the first time and looking for medical attention. No treatment was given for the adverse events nor laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The outcome of skin mass was reported as not recovered at the time of the report. The causal relationship between M-M-R II and the skin mass was not reported. Albumin status rHA is valid for M-M-R II. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Nodule
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old female patient. The patient's pertinent medical history. There were no drug reactions or allergies. Concomitant medications included hydrochlorothiazide and PROZAC. On 26-OCT-2016, the patient was vaccinated with the first dose of M-M-R II, lot # L007216, expiration date 03-MAR-2017, administered per subcutaneous route, for prophylaxis. The nurse stated there was no documentation of previous vaccination with this vaccine for this patient. On the same day of vaccination, the patient developed a subcutaneous nodule (Skin mass) after the vaccination with M-M-R II. The nodule was described as 3cm x 3cm in size and tender. The patient was required to receive 2 doses of M-M-R II as required immunization as a nursing student. The patient went to the office on 21-NOV-2016 to report the nodule for the first time and looking for medical attention. No treatment was given for the adverse events nor laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The outcome of skin mass was reported as not recovered at the time of the report. The causal relationship between M-M-R II and the skin mass was not reported. Albumin status rHA is valid for M-M-R II. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Myalgia, Pain
Clinical narrative: Patient states arm is still sore.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient states arm is still sore.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Insomnia
Clinical narrative: The night of the vaccine I could not sleep due to terrible joint pain. Starting in my knees and eventually working up to my hips and lower back. Symptoms became worse in right hip and lower back where a previous (dormant) injury had occurred 12 years earlier.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Injection site swelling
Clinical narrative: Severe pain in arm, couldn't move it; tiredness; muscle aches; no appetite; fever; joint pain; vomiting; chills, shaking, swelling at injection site; lasted 42 hrs.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: Severe pain in arm, couldn't move it; tiredness; muscle aches; no appetite; fever; joint pain; vomiting; chills, shaking, swelling at injection site; lasted 42 hrs.
Age: 20.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: PT STATED THAT NIGHT AFTER TRAINING AND HIS SHOWER HE NOTICED IT STARTED ITCHING AND A LITTLE SWELLING, THE NEXT MORNING HE HAD MORE SWELLING AND REDNESS.