chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: Patient had some inflammation at injection site. I instructed patient to start taking BENADRYL 25 mg every 6 hours routinely. I told her to continue to monitor site and to call us or her primary care physician if it gets worse.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. The medical assistant reported that, on 17-MAR-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date were not provided) and, on 25-MAR-2015, received the second dose of GARDASIL (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Headache, Night sweats, Pyrexia
Clinical narrative: 2 hours after vaccine, patient felt dizzy, tremulous, short of breath, fever to 102 degrees, had night sweats, emesis twice, headache.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Vomiting
Clinical narrative: 2 hours after vaccine, patient felt dizzy, tremulous, short of breath, fever to 102 degrees, had night sweats, emesis twice, headache.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: S-felt dizzy, nauseated and noted diaphoretic minutes after the shot HR in the 50s, BP 80/60 per Nurse. Seen in the exam room supine, O2 sat 96% in RA. States I feel now not pale, clamminess resolved says felt fine this am. States no previous reaction to vaccines. Needle sticks or blood drawing no chest pain or SOB. BP rechecked by my 120/80 supine, HR 70 O2 sat 97% in RA chest clear abd soft,, no text, not pale, good capillary return CNS non focal. A and P Vasovagal reaction to PREVNAR 13. Transient, temporary, resolved. EKG check Accucheck observe in clinic for 30 minutes check BP and HR supine, sitting and standing, before release from clinic. Allergy to PREVNAR noted.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: S-felt dizzy, nauseated and noted diaphoretic minutes after the shot HR in the 50s, BP 80/60 per Nurse. Seen in the exam room supine, O2 sat 96% in RA. States I feel now not pale, clamminess resolved says felt fine this am. States no previous reaction to vaccines. Needle sticks or blood drawing no chest pain or SOB. BP rechecked by my 120/80 supine, HR 70 O2 sat 97% in RA chest clear abd soft,, no text, not pale, good capillary return CNS non focal. A and P Vasovagal reaction to PREVNAR 13. Transient, temporary, resolved. EKG check Accucheck observe in clinic for 30 minutes check BP and HR supine, sitting and standing, before release from clinic. Allergy to PREVNAR noted.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Dermatitis allergic, Pruritus, Rash, Rash erythematous
Clinical narrative: Triage - presents with red rash onset 1/17/15 - back/chest - arms, ankles - c/o itching - pt antib ointment and triamcinolone cream- with no results - seen 1/9/15 with URI - given AUGMENTIN and prednisone taper - no change in soaps/detergents/no new foods. SOLUMEDROL 125 mg IM right D.G. without problems - instructed to use Aveeno bath and baking soda for itching - but OTC BENADRYL 50 every 6 hrs as needed for itching - do no drive- will make sleepy - verb understanding.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen, red lateral arm shoulder to elbow.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Presented in office with progresssively worsening pain and redness at injection site six days post administration.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Dermatitis, Erythema
Clinical narrative: Skin red and inflamed cellulitis placed on KEFLEX x10d 500mg bid.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Conjunctivitis, Eye pruritus, Lacrimation increased, Upper respiratory tract infection, Upper-airway cough syndrome
Clinical narrative: No local injection site reaction. Patient states she had itchy watery eyes 6 hours after injection on 3/11. Was treated 3/13 for conjunctivitis and upper respiratory infection. Patient returned to clinic on 3/20 stated she was better but still had post nasal drip - she wanted reaction reported.
Age: 37.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Diarrhoea, Disorientation, Loss of consciousness, Malaise, Vomiting
Clinical narrative: Dispensed VIVOTIF prior to travel-within 24 hours of 1st dose pt. became violently ill with vomiting, diarrhea, periods of disorientation and black out-slowly recovered-refused to go to ER.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Register Nurse refers to unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with VAQTA (dose, strength, frequency and lot number were not reported), which since 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Register Nurse refers to unspecified patient of unknown age and gender. On an unknown date, the patients were vaccinated with PEDVAXHIB (dose, strength, frequency and lot number were not reported), which since 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Register Nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with M-M-R II (dose, strength, frequency and lot number were not reported), which on 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age who on unknown date completed her three-dose series of GARDASIL (dose, lot# and expiration date were not reported), intramuscular. On unknown date reported as "2-3 months ago", the patient had Pap smear which came back with a positive HPV result. Genotype testing was performed in order to determine which strain of HPV the patient was diagnosed with but no results were available at the time of the report. On unknown date the patient sought medical attention by office visit with obstetric and gynecologist. At the time of the report, the outcome of human papilloma virus test positive was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to 4 patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the 4 doses of improperly stored PNEUMOVAX 23  due to being "in transit for 7 days" were administered to 4 unspecified patients. No adverse effects reported. The outcome of reported events is unknown. No product quality complaint was involved. This case is linked to the case 1503USA013841 via same reporter link. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60-year-old female patient. The patient's medical history included shingles (date reported as prior to ZOSTAVAX). There was no concurrent condition reported. There were any drug reaction and allergies. On 15-MAR-2015 the patient was vaccinated with ZOSTAVAX lot # K016320, 0.65 ml, expiration date 24-DEC-2015. The pharmacist stated that she was unsure if ZOSTAVAX was administered subcutaneously, because the injection site is located on the "inner part of the patient's unspecified arm". Concomitant therapies included spironolactone 50 mg. On 15-MAR-2015, "that night" that the patient received ZOSTAVAX, she developed "hot" at the injection side. On 17-MAR-2015 the patient experienced itchiness at the injection site and the itchiness was worse at the next day. The patient sought medical attention. On 18-MAR-2015 the patient went into the pharmacy and informed the pharmacist of her symptoms. The pharmacist informed the patient to apply over the counter hydrocortisone cream (manufacturer unspecified) to the injection side and to take ibuprofen as needed. 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: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via field employee refers to unspecified patients of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (dose, frequency and indication were not reported). Other suspect therapy was GARDASIL 9 (dose, frequency and indication were not reported). Patients who started the HPV series with GARDASIL vaccine were administered either 1 or 2 doses of GARDASIL 9 to complete the series. No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 56 year old male patient with no drug reactions or allergies who was reporting on himself. On an unknown date, on Saturday, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiry date were not reported) for prevention of shingles. On an unknown date, by Sunday afternoon, the patient got shingles in the left side of his face. The patient sought medical attention (went to the physician). The physician gave him a steroid shot and a dose of steroids in pills as well (did not specify the name of the steroids). The patient's outcome was not reported. The relatedness between the therapy with ZOSTAVAX and the adverse event was reported as related. The patient reported that he felt that the vaccine gave him shingles. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker (certified medical assistant) referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. On 04-MAR-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# not provided, 0.5ml, subcutaneous), which had been improperly stored. No adverse effects were reported. It was unspecified if the patient had sought any medical attention. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician and a nurse practitioner via a company representative refers to am unspecified (reported as a "few") number of patients of unknown age. It was reported that when GARDASIL first came out on the market (reported as many years ago) the doctor and a working with her nurse practitioner had a "few" unspecified patients faint after receiving a doses of GARDASIL (dose, route not reported) on unspecified dates. It was unspecified at which dose within the series the patients experienced the fainting. The outcome of the faintings was unknown. The relatedness between the faintings and GARDASIL was not reported. Additional information is not expected, because the reporters stated that it was so many years ago that they do not remember the details.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored GARDASIL. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a 68 year old female patient. On an unknown date the patient was vaccinated with one dose of ZOSTAVAX (dose, route and lot# unknown). On an unknown date the patient was diagnosed with a mild case of shingles after receiving ZOSTAVAX. The patient made office visit on an unspecified date and received acyclovir (unspecified dose/frequency and manufacturer) as treatment. Outcome of shingles was reported as recovered on an unknown date. This is one of two reports received from the same reporter. Additional information is not expected as the physician refused to be contacted.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a health professional via field representative refers to an 11 year old male patient. Patient's pertinent medical history and drug allergies were not reported. On 23-MAR-2015 the patient received his first dose of GARDASIL, .5 ml, intramuscular in the arm. Concomitant therapies included DTAP (unspecified) and MENACTRA. Within six hours of receiving the vaccination with GARDASIL, the patient experienced pain, warmth and swelling the size of a softball at the injection site. During the same office visit, he also received DTAP (unspecified), and MENACTRA in the opposite arm and experienced the same reaction at the injection site. Patient sought medical attention and visited physician's office on 23-MAR-2015. After assessing the patient, physician decided to discontinue the GARDASIL vaccination series and the therapy was not reintroduced. Outcome of the events were unknown. Causality assessment was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a health professional via field representative refers to an 11 year old male patient. Patient's pertinent medical history and drug allergies were not reported. On 23-MAR-2015 the patient received his first dose of GARDASIL, .5 ml, intramuscular in the arm. Concomitant therapies included DTAP (unspecified) and MENACTRA. Within six hours of receiving the vaccination with GARDASIL, the patient experienced pain, warmth and swelling the size of a softball at the injection site. During the same office visit, he also received DTAP (unspecified), and MENACTRA in the opposite arm and experienced the same reaction at the injection site. Patient sought medical attention and visited physician's office on 23-MAR-2015. After assessing the patient, physician decided to discontinue the GARDASIL vaccination series and the therapy was not reintroduced. Outcome of the events were unknown. Causality assessment was not provided. 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 health professional refers to an unspecified patient (reported as at least 1 patient) of unknown demographics. On an unspecified date the patient was inadvertently administered with an improperly stored dose of VARIVAX (Merck). No adverse effect was reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to VARIVAX (Merck). Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Rash vesicular, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to her son - a 19 month old male patient with no pertinent medical history and no drug allergies. On 23-FEB-2015, the patient was vaccinated with his first dose of VARIVAX (Merck) (lot #, dose, route and site of administration were not reported). There was no concomitant medication. On 27-MAR-2015, in the morning, the patient experienced diarrhoea. Later in the day, the patient experienced vomiting and broke out into a rash that looked like chickenpox. The chickenpox-like rash was on various parts of the patient's body. No treatment was given for the adverse events. Therapy with VARIVAX (Merck) was not discontinued. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 25-MAR-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J004271, expiry date 12-JUL-2014, 0.65 ml, subcutaneous. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student refers to a patient of unknown demographics. On 26-MAR-2015 the patient was administered with an expired dose of PNEUMOVAX 23 (lot # unspecified, expiry date: November 2014). No adverse effects were reported. Outcome of the event was unknown. Reporting healthcare student considered the event to be not related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from the pharmacy technician refers to a patient of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, lot/batch#, expiration date were not reported) 6 months after receiving the first dose of GARDASIL. No adverse experience was reported. It was reported that the patient was not from the reporter's pharmacy. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Diarrhoea, White blood cell count increased
Clinical narrative: 1/30/15 he received 4 mo vaccines including ROTATEQ. That evening he a had a temp. 1/31/15-afebrile but loose stool. 2/3 frothy liquid stools with temp to 103.2 to 104 rectal. Sepsis workup done due to high white blood count. All cultures, urine and blood negative.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a male patient of unknown age. Concurrent conditions and medical history were not reported. On an unknown date, the patient was inadvertently administered a dose of VAQTA (lot# H012642; expiration date: 16-APR-2015, 0.5 ml, intramuscular). Concomitant therapies were not reported. The CMA stated that this VAQTA had been improperly stored. No adverse effects were reported and product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history, co-suspect or concomitant medications was not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). No symptoms were reported. No PQC (product quality complaint) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an immunization official healthcare worker referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with RECOMBIVAX HB (dose, frequency, route and lot# were not reported), which were stored improperly. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain (R) arm, down to 3rd finger, hurts to raise it - since her injection.
Age: 12.0
Sex: F
Vaccine: HPV4, IPV, MMRV, MNQ
Symptoms: Blood test, Electrocardiogram normal, Loss of consciousness, Syncope
Clinical narrative: Patient had a syncopal episode around 12:00 pm to about 2011. Patient was positioned on he back on examining table then she came conscious. VS were taken and were normal. She was A/O 3x. She was sent to urgent care for evaluation.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Patient experienced itching starting 3/21/15. Redness visible around area of vaccine and itching still present as of 3/23/15.
Age: 0.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Breath holding, Crying, Erythema, Hypotonia, Immediate post-injection reaction
Clinical narrative: Upon administration of vaccines, infant cried very forcefully, immediately, and then abruptly held breath and became flaccid with facial redness and then duskiness for a few seconds. Recovered entirely immediately.
Age: 0.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Skin discolouration
Clinical narrative: Upon administration of vaccines, infant cried very forcefully, immediately, and then abruptly held breath and became flaccid with facial redness and then duskiness for a few seconds. Recovered entirely immediately.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site irritation, Injection site swelling
Clinical narrative: Patient was given PREVNAR and a few days later developed irritation and swelling on site (Left arm).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Pt's mother phoned in on 3/19/15 stating that the pt. developed a red hive looking rash directly below the inj. site of her (L) leg. The mother did send me pictures of the rash which they were shown to Dr. Dr. rec. Hydrocortisone cream and BENADRYL.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity
Clinical narrative: Sharp pain in arm (L) pain varies from 3-6/10. Patient is two weeks out from getting vaccine. Patient was sent to his primary care doctor for possible X-ray/MRI.
Age: 30.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Chills, Decreased appetite, Fatigue, Impaired work ability, Malaise
Clinical narrative: Vaccine administered 1/26/2015. Discussed events with patient on 3/16/2015 following inquiry about whether to get a second dose of MMR. Patient recovered at the time of report. On 1/27/15, following 1/26/2015, patient reported having very sore arms, high fever and chills; unable to go to work for 3 days due to symptoms. Also reported fatigue, lack of appetite. Improvement for 'several days' then experienced onset of extreme fatigue and rash development. "Rash was all over body and very itchy", and "started on chest." Rash resolved after three days. Total course of "not feeling well" approx. two weeks. No doctor visits or assessment of rash at time of symptoms. Wife with previous record of MMR vaccination, reported a small rash following patient rash onset, 3 days later.
Age: 30.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Pain in extremity, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Vaccine administered 1/26/2015. Discussed events with patient on 3/16/2015 following inquiry about whether to get a second dose of MMR. Patient recovered at the time of report. On 1/27/15, following 1/26/2015, patient reported having very sore arms, high fever and chills; unable to go to work for 3 days due to symptoms. Also reported fatigue, lack of appetite. Improvement for 'several days' then experienced onset of extreme fatigue and rash development. "Rash was all over body and very itchy", and "started on chest." Rash resolved after three days. Total course of "not feeling well" approx. two weeks. No doctor visits or assessment of rash at time of symptoms. Wife with previous record of MMR vaccination, reported a small rash following patient rash onset, 3 days later.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 10-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as J009788, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This is a prospective pregnancy case. This 29-year-old female subject was enrolled in a study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during  pregnancy or within 28 days preceding conception. The subject received BOOSTRIX on 5th March 2015. Concomitant products included LOVENOX and prenatal vitamin. The subject's estimated date of delivery was 19th April 2015. The subject received BOOSTRIX at week 35 of the pregnancy and during the third trimester of pregnancy. On 5th March 2015, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included intramuscular formulation administered by other route on 5th March 2015, injection site erythema and injection site swelling. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included injection site erythema (unknown), injection site swelling (unknown) and intramuscular formulation administered by other route (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy and intramuscular formulation administered by other route to be related to BOOSTRIX. The investigator considered that there was reasonable possibility that the injection site erythema and injection site swelling may have been caused by BOOSTRIX. Additional details provided as follows: The reporting nurse reported that after review of site it appears the vaccination was given further down on the arm and anterior to the deltoid. so she believed it may have been given subcutaneously. The nurse was not able to determine the onset of the redness and swelling. She also added that the patient was at 35 weeks 4 days gestation.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-MAR-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 0.5 ml, intramuscularly, lot # K004207, expiration date: 13-MAR-2015 (exp. date also reported as 15-MAR-2015). The dose of PNEUMOVAX 23 was supported. No adverse effects reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: MEA
Symptoms: Haematochezia, Platelet count decreased, Thrombocytopenia
Clinical narrative: This spontaneous report was received from a physician regarding an approximately 4 month old male infant. No medical history was reported. On an unknown date approximately in 2011, the patient was vaccinated with measles virus vaccine (manufacturer unknown) (dose not provided) at 2 months of age, 3 months of age and 4 months of age. Other suspect therapies included DTaP. No concomitant therapy was reported. On an unknown date approximately in 2011, after 3rd dose of the suspect vaccine, the patient experienced thrombocytopenia and bloody stools. The patient was hospitalized for 7 days. The outcome of the events was reported as recovered (unknown date). The relatedness of the event to the therapy with measles virus vaccine was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Asplenia, Dyspnoea, Hypersensitivity, Rash generalised, Splenectomy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 52 year old female patient. Pertinent medical history included: angioedema and allergy to yeast. Concomitant medication included: hormone therapy, sleeping agent, antianxiety medication (names of medications were unspecified). On an unspecified day (reported as over five years ago), the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route, lot # and expiration date were not reported). The pharmacist reported that the patient was asplenic (reported as now) and it was not known whether the patient's spleen was removed prior or after receipt of the dose of pneumococcal vaccine (manufacturer unknown). On 03-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (route intramuscular, lot # K010465, expiration date 23-MAR-2016, dose not reported). On 03-MAR-2015 (reported as within 2 hours), the patient experienced hypersensitivity reaction which was described as a swollen face, body rash and trouble breathing. The patient was treated with BENADRYL. The patient sought for medical attention via calling a pharmacist. There was no lab diagnostics and studies performed. The outcome of spleen removal was unknown. The outcome of hypersensitivity reaction described as swollen face, body rash and trouble breathing was recovered/resolved (reported as within 24-48 hours, on an approximately 05-MAR-2015). The relatedness between the events and PNEUMOVAX 23 and pneumococcal vaccine (manufacturer unknown) was not provided. Upon internal review, the event of spleen removal was considered to be medically significant. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 52 year old female patient. Pertinent medical history included: angioedema and allergy to yeast. Concomitant medication included: hormone therapy, sleeping agent, antianxiety medication (names of medications were unspecified). On an unspecified day (reported as over five years ago), the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route, lot # and expiration date were not reported). The pharmacist reported that the patient was asplenic (reported as now) and it was not known whether the patient's spleen was removed prior or after receipt of the dose of pneumococcal vaccine (manufacturer unknown). On 03-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (route intramuscular, lot # K010465, expiration date 23-MAR-2016, dose not reported). On 03-MAR-2015 (reported as within 2 hours), the patient experienced hypersensitivity reaction which was described as a swollen face, body rash and trouble breathing. The patient was treated with BENADRYL. The patient sought for medical attention via calling a pharmacist. There was no lab diagnostics and studies performed. The outcome of spleen removal was unknown. The outcome of hypersensitivity reaction described as swollen face, body rash and trouble breathing was recovered/resolved (reported as within 24-48 hours, on an approximately 05-MAR-2015). The relatedness between the events and PNEUMOVAX 23 and pneumococcal vaccine (manufacturer unknown) was not provided. Upon internal review, the event of spleen removal was considered to be medically significant. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: Patient called the pharmacy the morning of 3/30/15 to report event to pharmacist. Onset time unknown; patient reported AE as the inability to lift his arm and classified it as severe.  The patient had spoken to a nurse and had tried to be seen by his PCP whose office is closed until early April.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Death, Dyskinesia, Fall, Headache, Resuscitation
Clinical narrative: After receiving vaccination, pt asked for ibuprofen for headache, then he went to church, then saw his attorney. When he came back, he sat down at a table, put his head down and reportedly had some spastic movements and fell over. They did CPR and used the AED without results. He coded at 3:25, was sent to the ED at 3:40 and passed at 4:10.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Headache, Malaise, Nausea, Pain
Clinical narrative: Nausea, headache, body aches. Drank some ginger tea. Lasted until 3/27/2015. Felt sick and crummy.
Age: 72.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: Headache, nausea, body aches. Lasted until 3/27/2015. Felt crummy those days. First 3 days went nowhere as felt awful.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy test, Body temperature increased, Pruritus, Rash generalised
Clinical narrative: Pt. describes outbreak of rash all over body that itches.  It comes and goes numerous times a day over different parts of her body.  This is ongoing has have been occurring for five weeks.  She has run a temp for 1 1/2 weeks at start of outbreak. Pt has been given steroids on two occasions.  Once orally and once by injection with no relief.  Is to undergo allergy testing in one week by private provider. Is using Benadryl cream at present with very little relief.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin lesion
Clinical narrative: No symptoms. 2 additional lesions appeared distal to original site.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Angioedema, Eye swelling, Lip swelling, Urticaria
Clinical narrative: Angioedema on 3-26-15 upon waking; epinephrine prednisone and Benadryl. Has had 3 more reactions 3-28-15 lip swelling, 3-30-15 lip and eye swelling upon waking, and 3-31-15 hives upon waking; all treated with Benadryl.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Eyelid oedema, Lip swelling, Swelling face, Urticaria
Clinical narrative: Angioedema on 3-26-15 upon waking; epinephrine prednisone and Benadryl. Has had 3 more reactions 3-28-15 lip swelling, 3-30-15 lip and eye swelling upon waking, and 3-31-15 hives upon waking; all treated with Benadryl.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV2
Symptoms: Angioedema, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Per ER 11/28/2014 r. upper arm redness, warmth, swelling 18cm x 19 cm, clindamycin at ER. Was resolving by discharge. 12/1/2014, totally normal appearance. Never did have a respiratory problem or hives only angioedema of right upper arm.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Allergy to vaccine, Injection site pain, Type III immune complex mediated reaction
Clinical narrative: 3/7/15 HPI from fast track (urgent care): 47 year old female presents complaining of right arm pain in the deltoid after getting immunization to right arm this morning. No fevers, no chills, no N/V. Denies any shortness of breath. Denies chest pain. 3/17/15 HPI from PCP 1) Arthus Reaction:  Classic history and exam for arthus reaction. She is allergic to this (hep B) vaccine so I will not give her #3.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a Pfizer sales representative who reported on behalf of a contactable nurse for three patients This report is the first of the three patients. An elderly female patient of an unspecified ethnicity received PREVNAR 13, on an unspecified date to an unspecified date at single dose. Two of the patients received vaccines were of Lot# J20343 and expiration date 31May2016 and the other dose was of Lot# L13519 and expiration date 01Jun2016. The patient medical history and concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown, injection site was hot to the touch and swollen on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a Pfizer sales representative who reported on behalf of a contactable nurse for three patients. This report is second of the three patients. An elderly female patient of an unspecified ethnicity started to receive PREVNAR 13, on an unspecified date to an unspecified date at single dose. Two of the patients received vaccines were of Lot# J20343 and expiration date 31May2016 and the other dose was of Lot# L13519 and expiration date 01Jun2016. The patient medical history and concomitant medications were not reported. The patient experienced cellulitis, injection site was hot to the touch and swollen on an unspecified date with outcome of unknown.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Insomnia, Malaise, Myalgia, Thirst
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient of unspecified ethnicity received PREVNAR 13, intramuscular, on 17Feb2015, at 0.5 ml single. Relevant medical history included psoriasis treated with methotrexate (unspecified trade name). The patient had no drug allergies and was not an alcohol abuser. Family history was not reported. Concomitant medication included methotrexate (unspecified trade name), via an unspecified route of administration, from 17Feb2015, at 10 mg weekly (4 tablets weekly), for psoriasis. On unspecified date in Feb2015 the patient experienced insomnia, increased thirst, muscle pain, weakness and feeling unwell. The events caused patient's hospitalization for 1 day. Therapeutic measures were taken as a result of the events and included BENADRYL. The patient recovered from the events on 21Feb2015. Follow-up (18Feb2015): New information from the same contactable pharmacist includes: vaccination partial date, events partial onset date, vaccine posology, additional event feeling unwell, patient inquiry. Follow-up (17Mar2015): new information received from the same contactable pharmacist includes: PREVNAR 13 details, events details, concomitant medication, medical history. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from health worker (Certified Medical Assistant) referring to an unspecified number of unspecified patients who on unknown dates received doses of oral, ROTATEQ (lot#, expire date, dose were unspecified), that underwent a supported temperature excursion. No adverse experiences reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Nausea, Vomiting
Clinical narrative: 3/16/150- Redness, heat, edema at site of injection. Employee states c/o nausea and emesis. 3/17/15- Patient contacted office, evaluated by physician and treated with antibiotics.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Right arm pain at injection site; fever; could not raise arm for several days; loss of appetite for several days; headaches for 1-2 days; increased swelling, rash, and redness from shoulder to elbow of right arm.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Mobility decreased, Pyrexia
Clinical narrative: Right arm pain at injection site; fever; could not raise arm for several days; loss of appetite for several days; headaches for 1-2 days; increased swelling, rash, and redness from shoulder to elbow of right arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Neuralgia, Pain
Clinical narrative: 61 y/o female present to clinic c/o left axillary pain since August 2014. Pt. states the pain started after 3 days of receiving her shingles immunization. Pt. describes pain as throbbing and burning.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Local swelling, Peripheral swelling, Urticaria
Clinical narrative: Arm became reddened and swollen and progressively got worse over the course of the next three days.  On March 27, 2015 arm, hand, shoulder, and neck became swollen.  On March 29, 2015 hives on chest, back, and throat.  Patient saw her physician on March 27, 2015 and physician prescribed antibiotics and stated it was cellulitis.  Patient took Benadryl and reactions began to subside; however, she is continuing with the Benadryl at this time.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at the injection site.
Age: 1.59
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Irritability
Clinical narrative: I am a Pediatrician and have a question regarding an erroneous administration, which happened at my office yesterday, as an honest mistake of the 15 mo. set of recommended Vaccines, namely, DtaP, HIB and Prevnar-13 to a child who had already received those at her actual 15 mo. of age in Dec. 2014. The child is an otherwise healthy child and I have spoken to the parents about what happened and will follow on any side-effects during the day tomorrow and am available to them in case of any adverse effect. The baby is doing well as of today as well except for slight fussiness per parents.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Blister, Decreased appetite, Injection site pain, Injection site scab, Injection site vesicles
Clinical narrative: Broke out in blisters to sites of vaccination of MMR and Varicella. Pain at both SQ sites bilat. arms.  Loss of appetite for a few days.  Also had blister on Right lower leg. All sites scabbing over at time of exam on 03/19/2015.  Anti-bacterial ointment to blisters to avoid infection.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Injection site pain, Injection site warmth, Lethargy, Screaming, Skin discolouration
Clinical narrative: About an hour after my son received his vaccinations at his well child check he started becoming lethargic, his skin looked a grey color, the injection site was hot and he wouldn't let you touch it. He also screamed off and on for hours for 24 hours after his vaccinations...we tried spacing the vaccinations out on his next appointment which was 05/13/14 which the doctor suggested to see if he just couldn't handle that many at once or which ones were giving him a reaction and he still had the same reaction again for the second time on 05/13/14.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: CSF culture negative, CSF glucose normal, CSF protein normal, CSF test normal, CSF white blood cell count negative
Clinical narrative: Case number PHHO2015US004372, is an initial report received on 16 Mar 2015, from clinical study. This 18-year-old male subject was enrolled in a study. The subject's medical history included asthma. Concomitant medications were not reported. On 06 Sep 2014 at 09:33, the subject received the study vaccine MenB. It was reported that the subject had just returned from a 5-day camping trip with other college students. Approximately at 18:50 hrs the subject was taken to the ER room due to fever, myalgia, malaise and mild neck stiffness. In the emergency room, the subject recovered from the event neck stiffness. The subject was noted with temperature of 101-102 F. ER physician suspected possible meningitis. On the same day lumbar puncture was performed and CSF analysis was not consistent with meningitis. CSF showed WBC-1, glucose was normal, protein was normal and culture showed no growth. On the same day the subject was admitted to the hospital for overnight observation. The other investigations included WBC: normal with normal differential, platelets: normal, ALT was 71, AST was 46 (mildly elevated), blood culture showed no growth, urine analysis was normal, Lyme disease antibody titre was negative, Wright's stain for Ehrlichia showed negative, Ehrlichia IgG antibody titre was <1:64, blood smear showed normal and West Nile virus IgG and IgM antibodies showed negative. On 07 Sep 2014, the subject was discharged from the hospital with a diagnosis of likely tick borne illness and was prescribed with doxycycline as a treatment. On 07 Nov 2014, a follow up serology for tick-borne illness was performed (considering subject's history of a recent camping trip), which included Lyme EIA test which returned negative, Rickettsia rickettsii IgG showed negative, Ehrlichia chaffeensis IgG showed negative, Anaplasma phagocytophilum IgG was negative and Babesia microti AB IFA was negative. It was reported that these negative antibody results, 8 weeks following symptom onset argue against the earlier presumptive diagnosis of a tick-borne illness and hence the symptoms myalgia, malaise and fever were considered as serious (hospitalization). The event mild neck stiffness was considered as non-serious. It was reported that as per the hospital admission notes that the neck stiffness had resolved in the emergency room and it was not included in the treating physician's assessment as an important factor in the clinical decision making and was not indicated as a reason for the hospital admission. The investigator did suspect a causal relationship between the events and study vaccine. Investigator stated that since all antibody tests for tick-borne illness were negative, this suggests that the subject's symptoms were possibly related to rMenB vaccine based on the timing of onset and the absence of an identified alternative cause. Follow up received on 23 Mar 2015, prior to the circulation of previous report: Clinical information related to the seriousness of the event neck stiffness was updated.