chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). The nurse reported that doses of improperly stored (Merck) PROQUAD had been administered to an unspecified number of patients on unspecified dates (dosages and route of administration not provided). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Syncope, Tremor
Clinical narrative: This spontaneous report as received from office manager via company representative refers to a 18 year old male patient who on an unknown date was vaccinated with GARDASIL, intramuscular (dose, lot # and expiration date not reported). On an unknown date (reported as within the past few days) the patient started sweating and shaking then fainted immediately after receiving a dose of GARDASIL. When the patient fainted he wounded his forehead and received four stiches in his wound. Blood pressure was measured but result was not provided. The paramedics were called at an unspecified time after the patient fainted. The outcome of the events was recovered/resolved on unknown date. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014, unspecified number of patients were vaccinated with a dose of VAQTA (lot number, Expiry Date, dose, route were not reported), that was improperly stored in April 2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients of unknown age and gender. Two doses of ZOSTAVAX (Lot number, dose and frequency was unknown) were improperly stored and administered to patients. After 25-NOV-2014, temperature range was 10.8 Fahrenheit degrees (F). The time frame was 48 minutes. No adverse events were reported. The outcome of the event was not reported. Follow up information has been received from the same nurse on 17-DEC-2014. The nurse reported that "several" doses (unspecified of how many doses and unspecified if it was the VARIVAX (Merck) or ZOSTAVAX or both) were administered after the temperature excursion. No adverse effect reported. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected because the nurse requested not to receive any additional follow-up.
Sex: U
Vaccine: RV5
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. On 03-DEC-2014 the patient was vaccinated with a dose of ROTATEQ (oral dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.27
Sex: M
Vaccine: RVX
Symptoms: Abdominal pain, Abnormal faeces, Constipation, Crying, Flatulence
Clinical narrative: Screaming, crying, hitting stomach, problems sleeping, would wake up in pain-screaming, constipation, very sudden crying-like stabbing pains that would come and go, straining to poop but unable. This continues for about 6 weeks and slowly got better. Before the vaccination he used to poop 2-3 times a day. Patient required suppositories in order to poop for about 3 months proceeding the vaccination. Patient was exclusively breastfed and after receiving the vaccination his gas and poop smelled horrible-it never returned to normal.
Age: 0.27
Sex: M
Vaccine: RVX
Symptoms: Insomnia, Rectal tenesmus, Screaming, Ultrasound abdomen
Clinical narrative: Screaming, crying, hitting stomach, problems sleeping, would wake up in pain-screaming, constipation, very sudden crying-like stabbing pains that would come and go, straining to poop but unable. This continues for about 6 weeks and slowly got better. Before the vaccination he used to poop 2-3 times a day. Patient required suppositories in order to poop for about 3 months proceeding the vaccination. Patient was exclusively breastfed and after receiving the vaccination his gas and poop smelled horrible-it never returned to normal.
Age: 0.81
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Kinrix administered to 9 month old pt. Manufacturer recommendations ages 4-6 years old. Dose correct for pt.'s age but was given in combined vaccine instead of individual injections.
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13
Symptoms: Rash
Clinical narrative: Mom noticed that pt developed a rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Local rash about 1 inch square at injection site.  Patient showed it to her doctor who recommended no treatment necessary.
Age: 1.81
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom states patient had redness, pain and some swellling  to the (left) anterior mid-thigh that progressively worsened.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Swelling, redness, itching, hot, hard lump. Symptoms increased and grew from localized injection site to include medial aspect of the elbow to the arm pit and the entire posterior aspect of the upper arm. Doctors office called on 2nd day and instructed by nurse to take Benadryl. Took for 3 days and stopped when there was about 1 inch of normal color to posterior of upper arm. Symptoms existed for 7-9 days and remained extremely uncomfortable. The area continues to be sensitive but has decreased as the days have gone by. The sensitivity is similar to the SHINGLES I had in 1999.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, itching, hot, hard lump. Symptoms increased and grew from localized injection site to include medial aspect of the elbow to the arm pit and the entire posterior aspect of the upper arm. Doctors office called on 2nd day and instructed by nurse to take Benadryl. Took for 3 days and stopped when there was about 1 inch of normal color to posterior of upper arm. Symptoms existed for 7-9 days and remained extremely uncomfortable. The area continues to be sensitive but has decreased as the days have gone by. The sensitivity is similar to the SHINGLES I had in 1999.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat and swelling with site pain... level 4 out of 10 per patient.  By the next day 12/23/14 all symptoms increased with pain at 6 of 10. By 12/24/2014 13:30pm slight swelling noted by myself, some heat noted, 4"x3" are of redness over L deltoid. Patient stated pain level at 2.  Patient also stated it was getting better. I gave her a cold pack to ease her symptoms topically.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden hearing loss, unilateral. Minimally improved after two months and intratympanic steroid injection.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Started with a fever. It followed with a rash that started at the injection site has spread from the legs to the arms to the head.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Lacrimation increased, Oropharyngeal pain, Pain, Paranasal sinus hypersecretion
Clinical narrative: FEVER UP TO 102; SEVERE COUGH/ SORE THROAT/WATERY EYES/BODY ACHES/SINUS DRAIN/SORE THROAT. STILL SOME SAME SYMPTOMS BUT REDUCING AS OF 12/22/2014.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: FEVER UP TO 102; SEVERE COUGH/ SORE THROAT/WATERY EYES/BODY ACHES/SINUS DRAIN/SORE THROAT. STILL SOME SAME SYMPTOMS BUT REDUCING AS OF 12/22/2014.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tic
Clinical narrative: Patient has a "tic" since receiving Tdap and MENACTRA on 9-26-2014. Symptoms started 10-20-14 mom questions relationship to MENACTRA or Tdap.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Angioedema, Psoriasis, Swelling face
Clinical narrative: Angioedema x 2 mos. 33 y/o with chronic psoriasis got FLUMIST for the first time 10/13/14. Within 12 hrs developed bilateral swollen face. Treated with steroids with improvement but patient missed a dose and symptoms returned.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Overdose
Clinical narrative: A spontaneous report was received on 17DEC2014 from the father of twins (age not provided) (see MARRS case # 1412USA009006 for second case) regarding a dose of PEDVAXHIB. The father reported "my twins were scheduled to receive their second dose of PEDVAX today but they were given both the second and third dose during the same visit and not with 2 month in between like the product literature says." No adverse effects were reported. The father made no mention of the first dose of PEDVAXHIB. The father reported he spoke with the physician. The father did not wish to provide specific information. No further information was provided. Additional information is expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown ages and genders. On an unknown date the unknown number of patients were vaccinated with a dose of (Merck) PROQUAD (lot #, expiration date, strength, dose and frequency were not reported) which were improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HIBV, HPV4, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician refers to a 11 year old female patient. On 15-DEC-2014 the patient was vaccinated with GARDASIL, intramuscular in the leg (dose, frequency, lot # and expiry date not reported). Other suspect therapies included DTaP (manufacturer unknown) and LIQUID PEDVAXHIB. It was reported that DTaP (manufacturer unknown) was administered in one leg, and GARDASIL and LIQUID PEDVAXHIB was administered in the other leg, about one inch apart, at different injection sites. On 15-DEC-2014, after a few hours the patient had redness and swelling of 3 inches in diameter, and grew to size of 6 inches on morning of 18-DEC-2014, and was still red. It was unspecified that the reaction occurred in which leg. Patient did not had fever. It was reported that the parent did not know which vaccine out of the two, caused the reaction. Patient was advised not to be given TYLENOL or BENADRYL, but parent already administered both to the patient. Outcome of the events were not reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
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. On 24-NOV-2014 the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. 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 Licensed Practical Nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with 0.5 ml VARIVAX (Merck) which was post supported excursion date 24-NOV-2014, lot # J014407, expiry date: 13-NOV-2015, (dose number, route, application site not reported). No adverse effects reported. The outcome of post event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The reporter stated that on 10-DEC-2014 a patient who was indicated for ZOSTAVAX inadvertently received a dose of VARIVAX (Merck), 0.5 ml once, subcutaneous injection, (anatomical location was not reported), lot number J000193, expiration date 07-JAN-2015. Other suspect and concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Information regarding drug reactions and allergies and medical history was not reported. In August 2012 (exact date not reported) the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot#, expiration date were not reported). Patient received her second GARDASIL in June 2014 (exact date not reported) (dose, route of administration, anatomical location, lot#, expiration date were not reported) and her third injection in August 2014 (exact date not reported) (dose, route of administration, anatomical location, lot#, expiration date were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients. On unknown dates the patients were vaccinated with doses of improperly stored doses of VAQTA (lot #, expiration date, dose and route unspecified). No adverse events were reported. No additional information was available at that time. This is one of several reports received from same source. 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 nurse refers to a patient of unknown age and gender. On 16-DEC-2014 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), dose 0.5 ml, subcutaneous which was exposed to a maximum of 27.2F for a total time of 9.5 hours. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-NOV-2014 (exact date unspecified) those patients were vaccinated with an improperly stored dose of ZOSTAVAX (strength, route of administration, dose and lot # were not reported. The reporter was not able to provided a cumulative time from of these excursions, so the total time out of range was not known at the time of the report. Follow-up information has been received from a Licensed Practical Nurse on 15-DEC-2014. The reporter stated that two patients received ZOSTAVAX one male and one female. This report concerns a female patient of unknown demographics. On an unknown date, a female patient received a dose of ZOSTAVAX (lot# J016259, expiry date: 27-FEB-2015, dose, units, route od administration, anatomical location were not reported) which was improperly stored. There had been no reported adverse events since administration and there was no need for revaccination. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Pneumonia
Clinical narrative: This spontaneous report as received from a consumer via Pfizer (MFR # 2014317108) refers to an approximately 76 year old female patient (currently 78 year old). On unknown date in December 2009 (reported as 5 years ago) the patient was vaccinated with PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). There was no concomitant medication reported. On unknown date in December 2012 (reported as 2 years ago) the patient had pneumonia. On an unknown date the patient experienced bronchitis. The outcome of bronchitis and pneumonia was unknown. Additional information is not expected because there is not reporter contact information.
Sex: U
Vaccine: MMR
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. On 01-DEC-2014 the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. 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 medical assistant refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (dose, lot #, expiration date and route were not reported) which was exposed to temperatures outside of recommended condition. No adverse events were reported. The patients did not seek medical condition. This is one of several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse a 62 year old patient of unknown gender. The reporter stated, that in 2012 (exact date unspecified) the patient received a dose of ZOSTAVAX (subcutaneously, dose, units, anatomical location, lot number were not reported) and on 19-DEC-2014 the patient was inadvertently administered another dose of ZOSTAVAX (subcutaneously, dose, units, anatomical location, lot number were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A spontaneous report was received from 17Dec2014 from the father of twins (age not provided) (see MARRS case # 1412USA011108 for second case) regarding a dose of LIQUID PEDVAXHIB. The father reported "my twins were scheduled to receive their second dose of PEDVAX today but they were given both the second and third dose during the same visit and not with 2 months in between like the product literature says." No adverse effects were reported. The father made no mention of the first dose of LIQUID PEDVAXHIB. The father reported he spoke with the physician. The father did not wish to provide specific information. No further information was provided. Additional information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker via Merck Vaccines.com and via company representative refers to a patient of unknown age (reported as: "pediatric") and unknown gender. Information regarding drug reactions or allergies and medical history was not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot#, expiration date were not reported). The second booster dose of GARDASIL (dose, route of administration, anatomical location, lot#, expiration date were not reported) was administered 13 months after the initial dose/first dose. Concomitant medications were not reported. 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 nurse refers to a patients of unknown age and gender. On an unknown date RECOMBIVAX HB (dose, route and site of administration were not reported) vaccines have been administered to multiple patients post supported excursions. No adverse effects reported by any patients. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (dose, lot number, expiration date were not reported) for prophylaxis that were stored improperly. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a consumer of unknown age. About 3 or 4 years ago (estimated as 2010) the patient was vaccinated with ZOSTAVAX (Lot number was unknown) (dose frequency was unknown). The ZOSTAVAX  (Lot number was unknown) was not properly stored prior to administration. No adverse events were reported. Additional information has been requested.
Age: 1.24
Sex: M
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Movement disorder, Pyrexia, Staring, Vomiting
Clinical narrative: Apparent fever of unknown degree during night of 12/22/14 with episodes of vomiting and Ibuprofen given every 6 hours. About 8:30 AM 12/23/14 child had an episode of blank staring and not moving of unknown length of time. Took to ER where fever was 100.5, one episode of vomiting and benign exam according to nurse.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Ageusia, Amylase normal, Anosmia, Atelectasis
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Chest X-ray abnormal, Chronic sinusitis, Cough, Decreased appetite
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Ear pain, Eczema, Face and mouth X-ray abnormal, Full blood count normal
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Haematocrit decreased, Haemoglobin decreased, Local swelling, Metabolic function test normal, Mumps
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mumps antibody test positive, Nasal congestion, Nasopharyngitis, Neck mass, Neutrophil percentage increased
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Parotid gland enlargement, Productive cough, Pyrexia
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Renal failure acute, Renal function test abnormal, Respiratory tract congestion, Rhinitis allergic, Rhinorrhoea
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis, Sneezing, Upper respiratory tract infection, White blood cell count normal
Clinical narrative: Following receipt of 8/28/2009 influenza vaccine she reported onset of body aches. After receipt of 8/24/2011 and 9/26/2012 flu vaccine she complained of body aches, runny nose, cough, fever and congestion x 2 days. On 9/30/2013 she received annual flu vaccine FLUZONE. She advised she did have a sinus issue with a head cold, nasal fullness and congestion and a runny nose prior to receipt of this vaccination. Approximately 2-3 days later her symptoms worsened with "flu like symptoms" with fever. She presented to medical on 10/18/2013 complaining of nasal congestion, runny nose, sneezing and a sore throat and ear pain x 1 week. She was diagnosed with bronchitis and URI and given Amoxicillin. On 10/30/2013 she returned to medical with a dry cough, scanty mucous production with sinus x-ray showing chronic bilateral maxillary and ethmoid sinusitis. Her CXR had bibasilar atelectasis. She was diagnosed with bronchitis and given LEVAQUIN and CLARITIN. On 11/8/2013 she returned to medical with a neck mass to bilateral parotid gland swelling and diagnosed with mumps, sinusitis, eczema, allergy rhinitis and other health issues. On 11/22/2013 she was seen for bilateral dry eyes, dull full achy abdominal pain to epigastrium with anorexia and fever (100.6 tympanic), neck swelling, and URI. Labs drawn included normal metabolic panel and amylase. Her CBC with diff had normal WBC, but mildly abnormal neutrophils 77, H/H 7.5/24.2, with mumps IgG 5.85. She advised being referred to ENT with normal CT head and more antibiotics for chronic sinusitis and she was started on allergy shots for seasonal allergies/allergic rhinitis. Over the past year (2013-2014) she continues to complain of chronic sinusitis, loss of smell, taste and poor appetites with an episode of acute renal failure that has not fully resolved. She advised her HCP requests no influenza vaccine due to history of acute parotitis and sinusitis, facial swelling and severe dehydration (hx of sickle cell trait-anemia) with renal function studies not back to normal (Nov 2014).
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt reported huge red mark/reaction around injection site, hard, size of orange. No bruising; was not sick; no nausea; was not ill. Resolved, went away.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Patient was found unresponsive by mother on 12/23/14 about 2:30 AM - paramedics took him to ER - transferred to another hosp. Pronounced dead.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Merck) PROQUAD (lot # not reported) that were improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported and doses were administered to patients since 04-SEP-2012. No adverse effect was reported. Follow up information has been received on 17-NOV-2014. It was reported that the healthcare professional contacted during telephone follow-up could not supply the following information: Patients names, dates of birth, date of vaccination, dose number, lot #, date of the event, recovery status, healthcare provider name and contact information. Follow up information has been received on 10-DEC-2014 from the nurse concerning a male patient of 5 years old. On 06-DEC-2013, the patient was vaccinated with (Merck) PROQUAD (lot # H019439 and expiration date was 25-APR-2014) (strength, dose and route were not reported) that were improperly stored. Also reported that there was no adverse events following administration of the vaccinations and there was no need for revaccination. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. On an unknown date, the pregnant patient was vaccinated with a dose of VARIVAX (Merck) (lot#, dose, route and site of administration were not reported). The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. The patient sought medical attention (unspecified). No more details regarding pregnancy were reported. Additional information is not expected because the patient did not want to participate in the adverse event report.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of (Merck) (PROQUAD) (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports 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 was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of M-M-R II (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports 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 Nurse refers to unspecified patients of unknown age and gender. On a unknown date in 2014 (also reported as since 2014) the patient was vaccinated with PNEUMOVAX 23 (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication which was exposed to temperatures below the recommended range. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. No product quality issue was reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if patients sought medical attention. 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 concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of VARIVAX (Merck) (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified amount of patients. The reporter stated that on an unknown date the patients were vaccinated with improperly stored VAQTA (dose, dosage schedule, route, lot number and expiry date not provided). There was no concomitant medication reported. No adverse effects were reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with dose of LIQUID PEDVAXHIB (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) eight (8) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of VAQTA (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender that were vaccinated with a dose of GARDASIL dose, dose number, lot number, expiration date and route were not reported, that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.