chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Diarrhoea, Intussusception, X-ray abnormal
Clinical narrative: This spontaneous report as received from a physician and a nurse via a company representative refers to a 4 month old female patient. The patient had no pertinent medical history and no drug reactions or allergies. Concomitant therapies included PREVNAR 13. On an unknown date, the patient received the first dose of ROTATEQ (administered orally in an unspecified dose, lot # and expiration date were not provided). On 07-APR-2016, the patient was vaccinated with the second dose of ROTATEQ (administered orally in an unspecified dose, lot # and expiration date were not provided). On an unspecified date in April-2016, the patient experienced vomiting and diarrhea. On 10-APR-2016, the patient was taken to the regional medical center emergency room due to these events. However, the staff there deemed that the patient should be admitted to a hospital for a better care. The hospital, that the patient was transferred to, was unknown to the reporter. The patient was admitted and stayed in the hospital for three days. The patient received an unspecified treatment for the events. The outcome of vomiting and diarrhea was reported as recovering/resolving. The vaccination schedule with ROTATEQ was continued. The relationship between ROTATEQ and the adverse events was not provided. The reporter considered vomiting and nausea to be disabling and life-threatening events. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a physician and a nurse via a company representative refers to a 4 month old female patient. The patient had no pertinent medical history and no drug reactions or allergies. Concomitant therapies included PREVNAR 13. On an unknown date, the patient received the first dose of ROTATEQ (administered orally in an unspecified dose, lot # and expiration date were not provided). On 07-APR-2016, the patient was vaccinated with the second dose of ROTATEQ (administered orally in an unspecified dose, lot # and expiration date were not provided). On an unspecified date in April-2016, the patient experienced vomiting and diarrhea. On 10-APR-2016, the patient was taken to the regional medical center emergency room due to these events. However, the staff there deemed that the patient should be admitted to a hospital for a better care. The hospital, that the patient was transferred to, was unknown to the reporter. The patient was admitted and stayed in the hospital for three days. The patient received an unspecified treatment for the events. The outcome of vomiting and diarrhea was reported as recovering/resolving. The vaccination schedule with ROTATEQ was continued. The relationship between ROTATEQ and the adverse events was not provided. The reporter considered vomiting and nausea to be disabling and life-threatening events. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Contusion, Genital herpes, Rash, Skin discolouration
Clinical narrative: Patient received Hepatitis B vaccine 3/25/16 per company request for starting job in housekeeping environmental services. Returned 4/11/16 about 11:00 AM with complaint of discoloration of inner thighs/rash bilateral lower, inner thighs 1 day after injection. Resurgence of her Herpes - genital. Reports bruise developed 4/6/16 to anterior left upper arm. This bruise appears new approx. 2" in diameter. At time of visit no rash apparent, discoloration of inner thighs appears normal, bruise appears newer than 5 days old. TC 5/11/16 to GSK to talk with scientist. No relationship to symptoms presented.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had vaccine - within several hours had pain and by 800 AM had redness in the (R) arm near the elbow - redness continued to spread and mother took her to ER - diagnosed with cellulitis.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Pt had vaccine - within several hours had pain and by 800 AM had redness in the (R) arm near the elbow - redness continued to spread and mother took her to ER - diagnosed with cellulitis.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Pt had vaccine - within several hours had pain and by 800 AM had redness in the (R) arm near the elbow - redness continued to spread and mother took her to ER - diagnosed with cellulitis.
Age: 0.18
Sex: M
Vaccine: DTAP, RVX
Symptoms: Muscle twitching, Pyrexia, Rash, Vomiting
Clinical narrative: Mild vomiting, rash from neck to bottom, ears, and face, twitching, fever.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site bruising
Clinical narrative: Bruising larger than size of a quarter around site of injection.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Very sore shoulder, neck, hard to lift arm up. Noticeable swelling under armpit. Pain and swelling in arm.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: Very sore shoulder, neck, hard to lift arm up. Noticeable swelling under armpit. Pain and swelling in arm.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 06 Apr 2016. This case involves a 44-year-old "45-year-old" female patient who was vaccinated with a dose of ADACEL (batch number U5288BA, expiry date not reported) intramuscularly in the left deltoid on 23 December 2015. Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications was not reported. On an unspecified date, one week following the vaccination "first week after vaccination", the patient had pain and redness at the injection site. The pain sometimes shoots down the arm, and it can limit the patient range of motion (ROM) in the arm at times. It was reported that, symptoms had been ongoing from time of vaccination, four months ago. It was reported that patient required emergency room/doctor visit. Patient's lab data and corrective treatment were not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer, 2016185665) on 06 April 2016. This case involves a male (age not reported) patient who was vaccinated with a dose of Tetanus Toxoid (batch number, expiry date, route and site of administration were not reported)on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient was allergic to Tetanus Toxoid. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Sore/painful and could not move the left arm well where vaccine was administered.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Altered state of consciousness, Dyspnoea, Flushing, Hyperhidrosis, Swollen tongue
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 61 year old female patient. The patient's concurrent conditions and medical history included hypothyroidism, Basedow's disease, gastrooesophageal reflux disease, spinal osteoarthritis and allergy to penicillin. On 19-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular, lot#: L035882, expiration date on 19-APR-2017 (dose number and anatomical location were not provided). Concomitant therapies included methimazole (manufacturer unknown), PEPCID AC and clobetasol propionate. On 19-APR-2016, about one minute after the dose was administered, patient experienced difficulty breathing, flushed, visibly sweating and her tongue started swelling. Additionally, the patient stated she felt like she was going to pass out. The patient was transported via ambulance to an emergency room at a medical center, but it was unknown whether she was admitted. DEPO-MEDROL, EPIPEN and BENADRYL were administered in the ambulance. The outcome of dyspnea, swollen tongue, hyperhidrosis, flushing and feeling abnormal was unknown. The reporter did not assess the relatedness between the adverse events and suspect therapy. There was no PQC involved. Upon internal review the adverse events were considered as medically significant, as EPIPEN were administered. The reporter considered the events to be life threatening. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Fatigue, Pain, Pruritus, Vaccination site swelling
Clinical narrative: Extreme fatigue, body aches and pain, swelling in left arm where vaccines were given, itching of face and neck, patient states that swelling and itching are still occurring today 4/20/2016. Patient visited doctor and was prescribed prendnisone and Benadryl.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 75 year old female patient. The patient's concurrent conditions and medical history were not reported. On 08-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, anatomical location, lot number and expiration date not reported) subcutaneously. There was no concomitant medication reported. Subsequently, on an unspecified date in April 2016 the patient experienced "redness, swelling, warmth and a knot" at the injection site. Therefore, the patient sought medical attention and was seen in office visit, but no treatment was given for the above mentioned adverse events. At the reporting time, the outcome of the events was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Injection site swelling, Local swelling, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no drug reactions or allergies. The patient's other pertinent medical history and concomitant medications were not reported. On 08-APR-2016, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX lot # L039096, expiration date 08-JAN-2017 for prevention of shingles. On the same day, within the first hour of getting the vaccine the patient experienced swelling at the injection site which progressed to "swelling in the armpit and shooting pain down the arm and into the site of her chest." The patient reported to the pharmacist that she was having "bad pain over the weekend". The reporter stated that the patient self-applied an ice pack to the arm. The patient did not have any laboratory diagnostic test performed. The patient sought medical attention by calling the pharmacist. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot #: L044526, expiration date on 09-NOV-2017; lot #: L049535, expiration date on 18-DEC-2017 and lot #: L048468, expiration date on 02-DEC-2017 (dose number, strength and anatomical location were not provided). The vaccines were stored in a temperature of 6F during 72 hours. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 05-APR-2016, the patient was vaccinated with second dose of ROTARIX suspension (dosing details, route, lot# and expiry were not reported) rather than ROTATEQ (dosing details, route, lot# and expiry were not reported) due to misdocumentation. No adverse reaction reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored (Merck) VARIVAX (lot # L006383 and expiration date 25-FEB-2017, dose and route of administration were not reported). Concomitant medications were not reported. The temperature of the excursion was 7 Celsius degrees and the time frame was 1 hour. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 14-APR-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # J015063, expiry date 24-OCT-2015; exact dose was not reported). There were no concomitant therapies reported. The reporter stated that the dose of ROTATEQ administered to the patient did not have any previous temperature excursion. No adverse symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 9 week old patient of unknown gender. The pertinent medical history, allergic history and concomitant medications were unspecified. On 22-MAR-2016, the patient was vaccinated with one dose of improperly stored RECOMBIVAX HB (lot # L004754, Expiry: 10-NOV-2016) 0.5 ml, intramuscular in the right thigh. The vaccine was stored at a temperature of 32 F for 19 hours. There was no previous temperature excursion. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 20 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (dose and route not reported, lot # L023385 with expiration date 25-JUN-2017 and therapy type rHA). No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-MAR-2016, the patient was vaccinated with the dose of PROQUAD (Merck) injection, lot # L046506, expiration date 17-MAY-2017 (dose and route of administration were not reported) that was improperly stored. No adverse effects were reported. The vaccine was exposed to temperature of -13 Celsius for 24 hours. There was no previous excursion. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 10 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose and route not reported and lot # L033690 with expiration date 14-JUN-2018). The vaccines were exposed to 0 degrees Celsius for 8 hours. All the vaccines were gone through a second temperature excursion of 13.4 degrees Celsius for 1 hour 50 minutes. It was unspecified if the improperly stored doses of LIQUID PEDVAXHIB were administered after the first excursion (0 degrees Celsius for 8 hours) or after the second excursion (13.4 degrees Celsius for 1 hour 50 minutes). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning three unspecified patients of unknown gender and age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11-APR-2016, these patients were vaccinated with doses of improperly stored (Merck) VARIVAX (strength, dose and route not reported, lot # L043619 with expiration date 02-NOV-2017 and lot # 48467 with expiration date 02-DEC-2017). The vaccines were exposed to 11 degree Celsius for 48 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: This spontaneous report was received from a 54 year old female patient who was a pharmacist and was reporting on herself. The patient did not have concomitant medications, pertinent medical history and any drug reactions or allergies. On 11-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, via subcutaneous route, lot # L040445, expiration date 15-JAN-2017). On 11-APR-2016, the patient experienced burning sensation, redness and a welt at the injection site immediately following the administration of ZOSTAVAX. The patient sought unspecified medical attention. There was no lab diagnostics and studies performed. The patient's outcome was reported as recovering/resolving. The relatedness between the events and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Rash, Scar
Clinical narrative: Information has been received from a male consumer of unknown age referring to himself. There was no concurrent condition or medical history reported. On 02-DEC-2015 the patient was vaccinated with ZOSTAVAX (dosage and lot # unknown) subcutaneously for prevention of herpes zoster. There was no concomitant medication reported. The patient reported, on 25-JAN-2016 he starting having light pain in upper right thigh making him unable to sleep. He also reported, on 28-JAN-2016 he experienced rash broke out on back of right leg thigh and on buttocks. The patient visited the physician's office. He was treated with prednisone, acyclovir and NEURONTIN. The patient reported that he was fully recovered but with scars remaining from rash on an unknown date in 2016. Additional information is not expected as no contacted detail was provided.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to a female patient of unknown age. In 2014, the patient received her first two doses of GARDASIL (dose, route, lot# and expiration date were unknown). On 19-APR-2016, the patient received her third dose of GARDASIL (dose, route, lot# and expiration date were unknown) in the reporter's office. No adverse symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash 3" wide x 10" long extending from 2" red diameter injection site (R) upper arm to elbow.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. The unspecified patient received two doses of pneumonia vaccine, PNEUMOVAX 23 could not be ruled out, strength, dose, route and lot number not provided within one week. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Information regarding the patient's current condition was not provided. On 31-DEC-2012 the patient was vaccinated with VAQTA (25/0.5) lot # 0628AE, expiry date- 26-JAN-2016, dose 1, 0.5 ml, intramuscular. On 07-MAY-2013 the patient was vaccinated with VAQTA (25/0.5) lot # H010145, expiry date-27-FEB-2015, dose 2, 0.5 ml, intramuscular (inappropriate schedule of drug administration). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Rash, Varicella post vaccine
Clinical narrative: Patient developed varicella disease after he had received 2 doses of the vaccine. He was seen in our office 4/11/16 with pruritic spreading, scabbing rash on face, neck, abdomen, and extremities x 4 days. New lesions continue to develop.
Age: 21.0
Sex: F
Vaccine: FLUC3, YF
Symptoms: Hallucination, auditory, Hallucination, tactile
Clinical narrative: Tactile and auditory hallucinations, just at bedtime.  Have recurred several nights now.  Not sure if related to her depression or vaccine. No other signs/symptoms of encephalitis.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site joint pain, Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, fever, pain at injection site, joint pain in injected arm.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Neuralgia, Pain
Clinical narrative: At first sight was a little sore. No visible bruising just sore and painful but then the pain began radiating to arms more like nerve pain. I figured it was normal until it began getting worse instead of getting better. Today I called the pharmacy and they said it could have hit a nerve. I can not bend my arm behind my back to unbutton bra and over my head to move my arm hurts. This feels like a sharp pain which isn't like a muscle pain. It doesn't feel normal. I will be following up with my doctor's office and have made an appointment.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports red, itchy, raised, swollen skin at area of injection and vicinity, roughly 3-4 inch area of left deltoid. Vaccine given 4/5/2016, patient reports 4/12/2016.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Syncope at 2-3 minutes after immunization. HPV #1, MCV (MENACTRA), ADACEL were the vaccines given. No hx of previous reaction to any vaccine.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient had warm red area down arm and up towards shoulder.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient called to state she had been admitted for Guillain-Barre Syndrome.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Syncope within 5 minutes of HPV 9 and MENACTRA. Recovered on own without intervention. Exam at our office and not referred to ED.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Immediate post-injection reaction, Intussusception, Surgery, Vomiting
Clinical narrative: Vomiting and diarrhea immediately following vaccine administration. Seen in office day after, transported directly to Medical Center. Diagnosed with intussusception, 2 surgeries performed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre diagnosed 1/18/16 at hospital by Dr. Treated with intravenous immunoglobulin.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Mass, Pain
Clinical narrative: Received HPV #2 on 3-28-16. No unusual problem initially. Began to be hurtful 4/11/16, palpable painful lump, painful to move arm. Sl. red overlaying skin. Afebrile otherwise well.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Redness, Induration and hot to the touch.
Age: 28.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Redness, inflammation, hot to touch.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash to bilateral forearms 1-8 days post vaccine. Rash to injection site 9 days post vaccine. Raised, pruritic, erythema.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Myalgia
Clinical narrative: By next day, my arm had a red ring around site of needle. it was hard and itchy and lasted over a week. Also, from that day on, I had pain, sometimes intense, coming from the muscle of left arm.
Age: 64.0
Sex: U
Vaccine: TDAP
Symptoms: Lymphadenopathy, Peripheral swelling, Pyrexia, Somnolence, Swelling face
Clinical narrative: Pt c/o swollen neck glands fever of 101 degrees facial swelling, sore puffy rt arm, sleepiness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Patient returned to pharmacy with an injection site reaction. Per pharmacist on duty the site looked infected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Decreased appetite, Dizziness
Clinical narrative: The day after the GARDASIL vaccine, patient was very pale and extremely tired. She began complaining of headaches, dizziness, stomach pain, lack of appetite, extreme fatigue, weakness, numbness and tingling in her extremities, and trouble sleeping immediately after and in the weeks/months following vaccine. She was a honor student and star athlete. Overnight she changed. She no longer had the strength or energy to pursue sports, and now she struggles with her school work.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hypoaesthesia, Immediate post-injection reaction, Insomnia
Clinical narrative: The day after the GARDASIL vaccine, patient was very pale and extremely tired. She began complaining of headaches, dizziness, stomach pain, lack of appetite, extreme fatigue, weakness, numbness and tingling in her extremities, and trouble sleeping immediately after and in the weeks/months following vaccine. She was a honor student and star athlete. Overnight she changed. She no longer had the strength or energy to pursue sports, and now she struggles with her school work.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Paraesthesia
Clinical narrative: The day after the GARDASIL vaccine, patient was very pale and extremely tired. She began complaining of headaches, dizziness, stomach pain, lack of appetite, extreme fatigue, weakness, numbness and tingling in her extremities, and trouble sleeping immediately after and in the weeks/months following vaccine. She was a honor student and star athlete. Overnight she changed. She no longer had the strength or energy to pursue sports, and now she struggles with her school work.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Electromyogram normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia, X-ray normal
Clinical narrative: Experienced paresthesia bilaterally within one week of injection. Occurred a second time a week to 10 days later and last episode was to date 6 weeks after vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. It was reported that from 14-MAR-2016 to 16-MAR-2016, ZOSTAVAX (lot #L029484, expiration date 06-NOV-2016; lot # L029485, expiration date 06-NOV-2016; lot # L034736, expiration date 09-DEC-2016) were improperly exposed to -12.97 centigrade degree for 9.5 hours and -12.59 centigrade degree for 9.75 hours and -10.79 centigrade degree for 14 hours. Then, on unspecified dates after 16-MAR-2016 (in 2016), the patients were vaccinated with the improperly stored vaccine (dose and route not reported). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMVIBAX HB injection (lot # K026666 with expiry date: 22-OCT-2016; strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 53 degree Fahrenheit during 12 hours and 15 minutes. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician and refers to a 2 month old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of MMR II (lot#, expiration date, dose and route were not reported). On an unknown date, the patient experienced low grade fever. The patient did not seek medical attention and no treatment was given. The outcome of the event was not reported. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin infection, Swelling
Clinical narrative: Patient developed redness and swelling, saw doctor, diagnosed as skin infection.
Age: 17.0
Sex: F
Vaccine: HEPA, MMR, MNQ, VARCEL
Symptoms: Burning sensation, Hypoaesthesia, Rash, Rash macular, Skin warm
Clinical narrative: Burning and numbness of the hands and swelling of the face. No erythema at sites. Slight increased warmth. Neurologic exam is intake. Minimal swelling of the face. Slight erythematous macular rash of the arms. No wheezing. Treated with Atarax.
Age: 17.0
Sex: F
Vaccine: HEPA, MMR, MNQ, VARCEL
Symptoms: Swelling face
Clinical narrative: Burning and numbness of the hands and swelling of the face. No erythema at sites. Slight increased warmth. Neurologic exam is intake. Minimal swelling of the face. Slight erythematous macular rash of the arms. No wheezing. Treated with Atarax.
Age: 23.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Lethargy, Loss of consciousness, Pain, Pallor, Unresponsive to stimuli
Clinical narrative: PHN administered Typhoid Vi without incident. PHN then administered TDaP and within 3 seconds patient stated "oh that hurt, wait a minute..." then became unconscious, pale and unresponsive for approximately 30 seconds. No respirations for approximately 15 seconds. PHN called for assistance and pt. was placed in supine position on the floor. He then became responsive and was oriented x3 but remained very pale and lethargic. EMS was notified and pt was transferred to local ER for evaluation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Oxygen saturation decreased, Urticaria, Vomiting
Clinical narrative: Pt subsequently developed recurring emesis, diffuse hives, and difficulty breathing.  Patient placed on pulse oximetry and given 5 ml of Children's Benadryl po.  Pt's O2 Sats decreased to 85%.  He was then placed on O2 at 2 L by NC and he was administered 0.15 mg Epinephrine i.m.  Pt showed marked improvement with resolution of his increased WOB.  EMS was contacted to transport patient to the hospital for further evaluation.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Headache
Clinical narrative: Right sided Bell's Palsy. Started on prednisone in the emergency department where she first presented. I added valacyclovir and prolonged steroid dosing. Patient then went on to develop severe right sided headache a week after the Bell's Palsy started. Her facial droop is starting to improve somewhat and the headache is lessening a little as of the time of this report.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient reports arm red, swollen, tender, and painful. Advise to take motrin, over the counter Benadryl and cool compresses.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Type III immune complex mediated reaction
Clinical narrative: Arthus and erythemas  - swelling extended to hand and fingers severe pain for 3 days. Today still has some pain today.
Age: 1.59
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Induration, Injection site erythema, Injection site warmth
Clinical narrative: Patient has a warm, erythematous reaction (L) arm around injection site measuring 8x9 cm. Area of induration 1cm, no fever, patient already on antibiotics (started 4/20/16) for otitis.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature decreased, Respiration abnormal, Streptococcus test, Throat irritation, Viral test
Clinical narrative: Pt complained of pain in (L) arm at site of injection on same day of injection. On the following day, pt felt his stomach was "warm" and vomited at school. Also complains of "scratchy throat". Denies shortness of breath or chest pain although mother treated with Albuterol and ZYRTEC because she thought he was "breathing funny". School nurse reported temp = 96.4. Vitals on exam WNL in clinic on 4-20-2016 at 11:50 AM. Child denies any symptoms other than "scratchy throat". Strep A culture and viral respiratory panel sent on 4-20-2016. Pt to follow up in clinic on 4-21-2016.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Activated partial thromboplastin time, Blood culture, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: Petechial rash on (L) leg - same leg he had PENTACEL 3/28/16 - 20 days. 3/28/16 2 mos well visit - rash developed 4/16/16 and seen in ER 4/18/16 for rash on (L) LE purpuric.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Petechiae, Prothrombin time, Purpura, Red blood cell sedimentation rate
Clinical narrative: Petechial rash on (L) leg - same leg he had PENTACEL 3/28/16 - 20 days. 3/28/16 2 mos well visit - rash developed 4/16/16 and seen in ER 4/18/16 for rash on (L) LE purpuric.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient's arm very sore since 4/12 - called Dr and patient has been taking Ibuprofen - I told her to call Dr. and follow up. Can't move arm very well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5 cm x 5 cm area of erythema and induration on the lateral aspect of left thigh. Give BACTRIM and cephalexin.
Age: 52.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL, VARCEL
Symptoms: Asthenia, Cardiac disorder, Catheterisation cardiac abnormal, Congestive cardiomyopathy, Coronary artery disease
Clinical narrative: The patient is a 54-year old male, who presents to the office via consult from Dr., Cardiology, for further evaluation and recommendations following significant cardiac issues in the setting of recent Smallpox vaccination #3 vaccine received on 22 Jan 2014 (Manufacturer ACAM 2000; 15 jabs percutaneous, left arm, Lot # VV04-003A). The patient denied any immediate symptoms and reports no significant LLR or robust take was noticed with this vaccination (which was his third documented smallpox vaccine). However, from Mar - Jun 2014, he began to note a decline in exertional tolerance. Review of clinical notes show his first visit for such complaint was 1 June 2014. He was evaluated with ECG and echocardiogram which demonstrated decreased LVEF and severe MR. He subsequently had an evaluation at Medical Center, with the key finding of dilated non-ischemic CM with severe MR thought to be secondary to posterior leaflet restriction due to underlying inferolateral wall motion abnormality. He was sent to another Medical Center where cMRI was performed which showed global LV hypokinesis with dilated LV and a focal area of hyper-enhancement of undetermined etiology but thought to perhaps be secondary to his recent SPV. Patient has since had surgical intervention (Mitral valve repair) and cardiac rehabilitation. He is currently followed by Dr. (Cardiologist) and another Cardiology. Patient desires causality assessment. He denies any previous AEFI and specifically denies any previous problems with prior Smallpox Vaccine. No personal or family h/o autoimmune disease. No previous work-up for viral causes of cardiomyopathy. No other complaints.
Age: 52.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL, VARCEL
Symptoms: Coxsackie virus test positive, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Exercise tolerance decreased
Clinical narrative: The patient is a 54-year old male, who presents to the office via consult from Dr., Cardiology, for further evaluation and recommendations following significant cardiac issues in the setting of recent Smallpox vaccination #3 vaccine received on 22 Jan 2014 (Manufacturer ACAM 2000; 15 jabs percutaneous, left arm, Lot # VV04-003A). The patient denied any immediate symptoms and reports no significant LLR or robust take was noticed with this vaccination (which was his third documented smallpox vaccine). However, from Mar - Jun 2014, he began to note a decline in exertional tolerance. Review of clinical notes show his first visit for such complaint was 1 June 2014. He was evaluated with ECG and echocardiogram which demonstrated decreased LVEF and severe MR. He subsequently had an evaluation at Medical Center, with the key finding of dilated non-ischemic CM with severe MR thought to be secondary to posterior leaflet restriction due to underlying inferolateral wall motion abnormality. He was sent to another Medical Center where cMRI was performed which showed global LV hypokinesis with dilated LV and a focal area of hyper-enhancement of undetermined etiology but thought to perhaps be secondary to his recent SPV. Patient has since had surgical intervention (Mitral valve repair) and cardiac rehabilitation. He is currently followed by Dr. (Cardiologist) and another Cardiology. Patient desires causality assessment. He denies any previous AEFI and specifically denies any previous problems with prior Smallpox Vaccine. No personal or family h/o autoimmune disease. No previous work-up for viral causes of cardiomyopathy. No other complaints.
Age: 52.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL, VARCEL
Symptoms: Hypokinesia, Mitral valve incompetence, Mitral valve repair, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart
Clinical narrative: The patient is a 54-year old male, who presents to the office via consult from Dr., Cardiology, for further evaluation and recommendations following significant cardiac issues in the setting of recent Smallpox vaccination #3 vaccine received on 22 Jan 2014 (Manufacturer ACAM 2000; 15 jabs percutaneous, left arm, Lot # VV04-003A). The patient denied any immediate symptoms and reports no significant LLR or robust take was noticed with this vaccination (which was his third documented smallpox vaccine). However, from Mar - Jun 2014, he began to note a decline in exertional tolerance. Review of clinical notes show his first visit for such complaint was 1 June 2014. He was evaluated with ECG and echocardiogram which demonstrated decreased LVEF and severe MR. He subsequently had an evaluation at Medical Center, with the key finding of dilated non-ischemic CM with severe MR thought to be secondary to posterior leaflet restriction due to underlying inferolateral wall motion abnormality. He was sent to another Medical Center where cMRI was performed which showed global LV hypokinesis with dilated LV and a focal area of hyper-enhancement of undetermined etiology but thought to perhaps be secondary to his recent SPV. Patient has since had surgical intervention (Mitral valve repair) and cardiac rehabilitation. He is currently followed by Dr. (Cardiologist) and another Cardiology. Patient desires causality assessment. He denies any previous AEFI and specifically denies any previous problems with prior Smallpox Vaccine. No personal or family h/o autoimmune disease. No previous work-up for viral causes of cardiomyopathy. No other complaints.
Age: 52.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL, VARCEL
Symptoms: Scan with contrast abnormal, Ventricular hypokinesia
Clinical narrative: The patient is a 54-year old male, who presents to the office via consult from Dr., Cardiology, for further evaluation and recommendations following significant cardiac issues in the setting of recent Smallpox vaccination #3 vaccine received on 22 Jan 2014 (Manufacturer ACAM 2000; 15 jabs percutaneous, left arm, Lot # VV04-003A). The patient denied any immediate symptoms and reports no significant LLR or robust take was noticed with this vaccination (which was his third documented smallpox vaccine). However, from Mar - Jun 2014, he began to note a decline in exertional tolerance. Review of clinical notes show his first visit for such complaint was 1 June 2014. He was evaluated with ECG and echocardiogram which demonstrated decreased LVEF and severe MR. He subsequently had an evaluation at Medical Center, with the key finding of dilated non-ischemic CM with severe MR thought to be secondary to posterior leaflet restriction due to underlying inferolateral wall motion abnormality. He was sent to another Medical Center where cMRI was performed which showed global LV hypokinesis with dilated LV and a focal area of hyper-enhancement of undetermined etiology but thought to perhaps be secondary to his recent SPV. Patient has since had surgical intervention (Mitral valve repair) and cardiac rehabilitation. He is currently followed by Dr. (Cardiologist) and another Cardiology. Patient desires causality assessment. He denies any previous AEFI and specifically denies any previous problems with prior Smallpox Vaccine. No personal or family h/o autoimmune disease. No previous work-up for viral causes of cardiomyopathy. No other complaints.
Age: 52.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL, VARCEL
Symptoms: Left ventricular dilatation, Mitral valve incompetence, Mitral valve repair, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart
Clinical narrative: The patient is a 54-year old male, who presents to the office via consult from Dr., Cardiology, for further evaluation and recommendations following significant cardiac issues in the setting of recent Smallpox vaccination #3 vaccine received on 22 Jan 2014 (Manufacturer ACAM 2000; 15 jabs percutaneous, left arm, Lot # VV04-003A). The patient denied any immediate symptoms and reports no significant LLR or robust take was noticed with this vaccination (which was his third documented smallpox vaccine). However, from Mar - Jun 2014, he began to note a decline in exertional tolerance. Review of clinical notes show his first visit for such complaint was 1 June 2014. He was evaluated with ECG and echocardiogram which demonstrated decreased LVEF and severe MR. He subsequently had an evaluation at Medical Center, with the key finding of dilated non-ischemic CM with severe MR thought to be secondary to posterior leaflet restriction due to underlying inferolateral wall motion abnormality. He was sent to another Medical Center where cMRI was performed which showed global LV hypokinesis with dilated LV and a focal area of hyper-enhancement of undetermined etiology but thought to perhaps be secondary to his recent SPV. Patient has since had surgical intervention (Mitral valve repair) and cardiac rehabilitation. He is currently followed by Dr. (Cardiologist) and another Cardiology. Patient desires causality assessment. He denies any previous AEFI and specifically denies any previous problems with prior Smallpox Vaccine. No personal or family h/o autoimmune disease. No previous work-up for viral causes of cardiomyopathy. No other complaints.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Patient checked blood sugar that evening and it was over 250.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Pain in extremity
Clinical narrative: Whole arm pain from shoulder to elbow. Difficulty moving arm and chills. No treatment given.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Cellulitis, Erythema, Swelling
Clinical narrative: Redness, swelling, and pain around the elbow. Diagnosed at hospital as cellulitis and treated with antibiotics.
Age: 5.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Dry skin, Pruritus, Rash, Skin exfoliation
Clinical narrative: Itching, and rash with extreme dry, rough, and flaky skin on my sons right wrist.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Fever and malaise and swelling on hand where the PNEUMOVAX 23 was given.