chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Enema administration, Intussusception, Irritability
Clinical narrative: The mother was in with the child for vaccines 3/3/15 and at that time, she reported the child had intussusception with 1st (and only) dose of ROTATEQ 4-1-14. Starting approx. 4/2/14 had temp. which continued to be elevated, fussy, thought maybe spit up blood. Went to ER at hospital - then was transferred to another hospital - 4/7-4/9. Had procedure where air in colonoscope corrected the intussusception. No surgery required.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received improperly stored doses of ROTATEQ orally (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F or 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures <77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (06-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Chills, Injection site rash, Pharyngeal oedema, Pyrexia
Clinical narrative: Approx 6 hrs following vaccine he developed rash over upper chest and upper arms.  Approx 10 hrs after receiving vaccine he developed chest pain that progressed over 2 hrs to become quite severe. At the time the chest pain had become severe pt also developed chills.  PT also noted fever at the same time as rash occurred. PT noted restlessness throughout the night. Around 6-7 hrs after receiving vaccine he developed what he felt was throat swelling.
Age: 45.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Restlessness
Clinical narrative: Approx 6 hrs following vaccine he developed rash over upper chest and upper arms.  Approx 10 hrs after receiving vaccine he developed chest pain that progressed over 2 hrs to become quite severe. At the time the chest pain had become severe pt also developed chills.  PT also noted fever at the same time as rash occurred. PT noted restlessness throughout the night. Around 6-7 hrs after receiving vaccine he developed what he felt was throat swelling.
Age: 11.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Decreased appetite, Dyskinesia, Eye movement disorder, Fall, Fatigue
Clinical narrative: Tired, sleeping at day care, not eating, eyes rolled back, one arm jerking, fell and hit his head.
Age: 11.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Head injury, Somnolence
Clinical narrative: Tired, sleeping at day care, not eating, eyes rolled back, one arm jerking, fell and hit his head.
Age: 30.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Muscle pain. patient called pharmacy on 3/13/2015 stating that she has difficulty moving her left arm.
Age: 0.15
Sex: M
Vaccine: 6VAX-F, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: FEVER HIGH PITCHED SCREAMING UNTIL ABOUT 4:00 AM.  TYLENOL GIVEN PER DOCTORS INSTRUCTIONS.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: SWELLING AND INFLAMMATION AROUND THE INJECTION SITE.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Electroencephalogram abnormal, Epilepsy, Memory impairment, Seizure
Clinical narrative: I'm not sure if this is related to the vaccine at all, but I find it strange, I never had seizure before. But about a month after (date approximate) I had what seemed like a small seizure upon waking. This progressed to happening more and more over the last few months with a declining memory till I finally saw a neurologist and was had an abnormal EEG. I think I am basically diagnosed with epilepsy and I have to start seizure meds and I was starting to think maybe it was triggered by the vaccine since it started a month later and I never ever had them before.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 45-year-old female patient who received BOOSTRIX. On 27th February 2015, the patient received BOOSTRIX (intramuscular) .5 ml. In March 2015, less than a week after receiving BOOSTRIX, the patient experienced injection site swelling, injection site nodule, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site nodule, injection site warmth and injection site erythema were not recovered/not resolved. The reporter considered the injection site swelling, injection site nodule, injection site warmth and injection site erythema to be probably related to BOOSTRIX. Additional information: The patient experienced swelling, redness, and a knot under the skin at the injection site. It is also warm to the touch. The events were all ongoing at the time of reporting.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Patient received PENTACEL. Immediately had a large amount of swelling. Right vastas lateralis.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Patient developed hives on lower part of body, no other reaction noted by Dr.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Hypoaesthesia, Influenza, Nervous system disorder
Clinical narrative: Two days after having the vaccine broke out with the flu. Started experiencing numbness in my legs and toes. Felt like mercury was in the body. Did chiro and acupuncture therapy for nerve issues.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Injection site discomfort, Injection site swelling, Vision blurred
Clinical narrative: Within hours of administration to left deltoid, developed blurred vision right eye, fatigue with generalized weakness, and massive swelling and discomfort at injection site. Pt declined eval initially. Presented 7 days later for eval.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Received the multi dose flu vaccine (QUAD) on Nov 3 subsequently developed a swelling at the site which progressed.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 09-MAR-2015, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (dose, route and lot# were not reported) instead of ZOSTAVAX. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. 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 pharmacist refers to a patient of unknown age and gender. On 26-FEB-2015 the patient was vaccinated with expired ZOSTAVAX (dose and route of administration were not provided; lot # H021459 with expiration date: 30-APR-2014). No adverse effects were noted. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Ear infection, Injection site erythema, Injection site warmth
Clinical narrative: Patient with local erythema and warmth and circular patch overlying both injection sites. Currently on CEFZIL to treat ear infection. Treated with MOTRIN and antihistamine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient who was physician. There were no medical history, no concomitant medication and no drug reactions or allergies. On 05-MAR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020185, expiration date 27-JAN-2015, 0.65 ml, subcutaneous. On 06-MAR-2015, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. There was no labs diagnostics studies performed. The patient took AUGMENTIN as a treatment for adverse events. The patient sought medical attention via contacted with pharmacist. The outcome of injection site erythema, injection site pain, injection site warmth and injection site swelling was unknown. Relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 72-year-old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. The patient received doses of PNEUMOVAX 23 in 2003 (dose, route of administration, anatomical location, lot# and exp. date were not reported) and in 2007 (dose, route of administration, anatomical location, lot# and exp. date were not reported). Concomitant therapies were not reported. No adverse effect was reported. 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 Vocational Nurse (LVN) refers to a patient of unknown age and gender. It was reported that on 12-FEB-2015, improperly stored VARIVAX (Merck) (lot # K008820, dose, route of administration and expiration date were not provided) has been administered to unspecified patient. No adverse effects were reported. No further information was provided. 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 patient of unknown age. On 11-MAR-2015 the patient was vaccinated with a dose of VARIVAX (Merck) that was improperly stored. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a Registered Nurse who was a male patient of unknown age. On unknown dates the patient had 4 or 5 doses of unspecified Hepatitis B vaccines (manufacturer unknown) dose, route and indication was not specified). All of which the patient failed to seroconvert. The outcome of event was unknown. Causality assessment was not provided. This is one of several reports 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 healthcare worker refers to a patient of unknown age and gender. On 11-MAR-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously, lot # not reported) that underwent a supported temperature excursion. No adverse experience reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Dry skin, Erythema, Rash, Rash erythematous, Rash macular
Clinical narrative: According to parent removed Band Aid 2 days after vaccine admin, skin was dry and red, since then "rash" has spread up hip to belly to armpit and arm, gradual spreading of rash - recommended follow up with PCP, blotchy red rash.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Epistaxis, Haemoptysis, Mass, Migraine, Nausea
Clinical narrative: MMR #1 given 13Feb2015. On 24 Feb pt developed blood fr. nasopharynx "coughed up blood", also nausea, decreased focus and migraine and a lump under chin, seen in urgent care on 25 Feb pt had fever 102 intermittent until about 27 Feb and rash over trunk, extremities. 3 and 4 March pt reports flare up of rash.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash, Vision blurred
Clinical narrative: MMR #1 given 13Feb2015. On 24 Feb pt developed blood fr. nasopharynx "coughed up blood", also nausea, decreased focus and migraine and a lump under chin, seen in urgent care on 25 Feb pt had fever 102 intermittent until about 27 Feb and rash over trunk, extremities. 3 and 4 March pt reports flare up of rash.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Adverse event
Clinical narrative: MMR #1 given 13Feb2015. On 24 Feb pt developed blood fr. nasopharynx "coughed up blood", also nausea, decreased focus and migraine and a lump under chin, seen in urgent care on 25 Feb pt had fever 102 intermittent until about 27 Feb and rash over trunk, extremities. 3 and 4 March pt reports flare up of rash.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a Registered nurse who was a 46 year old male patient. The patient's medical history included bacterial spinal meningitis and chickenpox (varicella). No drug allergy was reported. The patient historically had 4 or 5 doses of unspecified Hepatitis B vaccines (manufacturer unknown) on an unspecified dates, to all which he failed to seroconvert (case# 1503USA0068430). Approximately on an unknown date in August 2012, the patient as vaccinated with RECOMBIVAX HB first dose, (dose, route, indication and lot number were not specified). Then the patient had blood titers Hepatitis B surface antibodies drawn on 22-AUG-2012, which were negative. On 09-SEP-2012, which was about a month after the previous dose of RECOMBIVAX HB, nurse then received another dose of RECOMBIVAX HB (dose and route were not reproted) (lot # 1572AA with the expiration date of 26-MAY-2014) dose 2. Other suspect therapies included PROPECIA 1 mg split in to half (start date, route and frequency was not reported) (case #1503USA006842) and ZOCOR (dose, frequency, route were unspecified). The nurse's serostatus was unspecified after the second dose of RECOMBIVAX HB. Action taken with simvastatin and finasteride was continued. The outcome of event was unknown. Causality assessment was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Areas erythema involving most of back, left arm and (R) anterior chest. Itching developed rash 3/5-3/6- Pt applied Witch Hazel.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Infection, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: At 1800 on 3/3/2015 I felt pain in left armpit. Looked in mirror 2 red streaks outer aspect of left arm where shot given going into armpit. Armpit completely swollen - pink and painful. Dr. closed. Put warm pack on for 20 minutes took it off looked entire left side of body pink. Abdomen pink expanded from armpit all the way down left side after warm pack - even outlining my ribs on left side to belly button. Next day saw Dr at 10:15 am he felt it was infection. Dr prescribed cefadroxil 500mg capsule 2 x's a day x's 7 days. Redness all gone on 3/7/2015 at 700.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Infection, Injection site erythema, Injection site pain
Clinical narrative: At 1800 on 3/3/2015 I felt pain in left armpit. Looked in mirror 2 red streaks outer aspect of left arm where shot given going into armpit. Armpit completely swollen - pink and painful. Dr. closed. Put warm pack on for 20 minutes took it off looked entire left side of body pink. Abdomen pink expanded from armpit all the way down left side after warm pack - even outlining my ribs on left side to belly button. Next day saw Dr at 10:15 am he felt it was infection. Dr prescribed cefadroxil 500mg capsule 2 x's a day x's 7 days. Redness all gone on 3/7/2015 at 700.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one o several 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 a healthcare worker refers to an unspecified number of unspecified patients of unknown age. The healthcare worker reported the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (dose, route and lot# not reported). No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of the several reports with the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Product label confusion
Clinical narrative: This spontaneous report was received from a nurse. The nurse reported that PROQUAD (Merck) (lot# K023363, exp. date: 20-MAY-2016) was placed in the refrigerator because another nurse saw M-M-R II on the PROQUAD (Merck) cartoon and confused the product with M-M-R II. The reporter stated that the boxes of both vaccines were of the same color. No patients received any doses of PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a patient of unknown age and gender. No pertinent medical history was reported. On 23-FEB-2015, the patient was vaccinated with expired dose of ZOSTAVAX (lot # J004269 and expiration date 12-JUL-2014) (strength, dose and route were not reported). No adverse effects reported. No product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial information has been received from a nurse referring to a patient of unknown age and gender. The nurse reported that an unspecified patient was administered a dose of (Oka-Merck) PROQUAD (dose, route and lot number not provided) on 23-FEB-2015, which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a medical assistant referring to a 41 year old male patient who had no pertinent medical history or drug reactions/allergies. On 29-JUL-2013, 26-AUG-2013 and 24-FEB-2014, the patient was separately vaccinated with a dose of RECOMBIVAX HB (strength:2.5/0.5, dose: 1.0 ml), (lot# separately reported as 190AA with expiration date 11-MAR-2013, 148AB with expiration date 06-SEP-204 and 209AB with expiration date 07-MAR-2015), intramuscularly. The patient had no concomitant medication. On 12-JAN-2015, hepatitis B titer was drawn and the result was below3.1. The patient had a low hepatitis B titer (hepatitis b surface antibody negative). The patient did not seek medical attention. There was no treatment given to the patient. The outcome and causality of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to an the patient of unknown age. The healthcare worker reported the patient were administered an unspecified number of improperly stored doses of VAQTA (dose, route and lot# not reported). No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of the several reports with the same reporter. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a 21 year old patient. On 27-FEB-2015, the patient was wrongly vaccinated with two doses of VAQTA (1 ml, strength: 50U/1.0 ml, K002744, expiration date: 19-SEP-2015) in error. The patient had not reported an adverse effect. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Infromation about concurrent conditions and medical history were not provided. On 03-MAR-2015 the patient was vaccinated with GARDASIL (lot # K006191, expiration date 02-FEB-2017, dose, dose# and route not provided) after it was improperly stored (incorrect product storage). No adverse effects reported. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. On 02-MAR-2015 the patient was vaccinated with GARDASIL (lot # K006191, expiration date 02-FEB-2017, dose, dose# and route not provided) after it was improperly stored (incorrect product storage). No adverse effects reported. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous report was received from a health professional refers to a female patient of unknown age. Patient's pertinent medical history was reported as asthma. Patient had an unspecified reaction on sulfa drug. Patient was administered with the first dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016) on 04-NOV-2014 and with the second dose (Lot # K023435, expiration date: 05-NOV-2016) on 06-JAN-2015. Concomitant therapies included VENTOLIN. On 27-FEB-2015 patient sought medical attention at the office of healthcare provider for rechecking of a pre-existing diagnosis of asthma which had not changed or worsened since the administration of GARDASIL. At the office visit on 27-FEB-2015 patient's mother stated that since an unspecified date the patient experienced floating outside of her body while lying in the bed at an unspecified frequency after the administration of GARDASIL. No treatment was given for the adverse event. No lab diagnostic studies were performed. Outcome of the adverse event was unknown. Causality assessment was not provided. 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 an unspecified number of patients of unknown age and gender. On an unspecified date, the patients received improperly stored doses of RECOMBIVAX HB (dose and lot number were not reported). There was no adverse effects reported. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients received improperly stored doses of PNEUMOVAX 23 (dose and lot number were not reported). There was no adverse effects reported. This is one of several reports received 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 as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received improperly stored doses of VAQTA intramuscularly (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F for 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures <77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (on 06-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports received 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 as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received improperly stored doses of GARDASIL intramuscularly (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F for 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures <77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (on 06-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as recovered from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received improperly stored od PEDVAXHIB intramuscularly (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F for 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures <77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (on-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Pruritus
Clinical narrative: Information has been received from the nurse referring to a 15 year old male patient with asthma and none drug allergies. The patient's medical history included acne. The reporter reported the patient was inadvertently administered a total of 5 doses of GARDASIL. The first dose (lot and expiration unspecified) was administered on 01-AUG-2011. The second and third doses (lot and expiration unspecified) were administered on unspecified dates. The fourth dose (lot/expiration unspecified) was administered on 21-OCT-2014. The fifth dose (lot K006960, expiration 19-FEB-2017) was administered on 24-FEB-2015. There was no concomitant medications. On an unspecified date between the fourth and fifth dose, patient developed scalp itching, which was ongoing at the reporting time. The patient did not seek medical attention. None lab was performed and no treatment was given. The outcome of the scalp itching was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. It was reported that one dose improperly stored (Oka/Merck) VARIVAX (injection, strength, dose, lot# and route were unspecified) was administered to the patient on unknown date. No adverse effects were reported. 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 physician refers to a patient of unknown demographics. The pertinent medical history was not reported. On 16-FEB-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck). No adverse event was reported. No product quality complaint was involved. 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 healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of GARDASIL (strength, dose and lot# were not reported) intramuscular. No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports from the 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 Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. 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 a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date at unspecified times in January 2015, the patients were vaccinated with PEDVAXHIB 0.5 ml once, intramuscular which was improperly stored. No adverse effect reported. No Product Quality Complaint (PQC) was involved. 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 adult patient of 60 or 61 years old (gender was not reported). Concurrent or medical conditions were not reported. On an unknown date, the patient received an improperly stored dose of ZOSTAVAX (dose, strength, route and lot number were not reported). No adverse effects reported. No product quality complain was reported. This is one of two reports from the 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 pharmacist refers to a child of less than 12 years old (gender was not reported). Concurrent or medical conditions were not reported. On an unknown date, the patient received an improperly stored dose of VARIVAX (Merck) (dose, strength, route and lot number were not reported). No adverse effects reported. No product quality complaint ws reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood glucose, C-reactive protein, Culture urine, Cyanosis, Differential white blood cell count
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Full blood count, Metabolic function test, Pyrexia, Stridor, Tachycardia
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Urine analysis, Vomiting
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chest X-ray normal, Chills, Crying, Cyanosis, Decreased appetite
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyspnoea, Grunting, Hypersensitivity, Hypotonia, Laboratory test normal
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Middle insomnia, Peripheral swelling, Pyrexia, Retching, Skin discolouration
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Skin warm, Sleep disorder, Sluggishness, Somnolence, Stridor
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 0.83
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Tremor, Vomiting
Clinical narrative: Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Herpes zoster, Nipple pain, Rash
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 63 year old female patient with hypertension and blood cholesterol increased. The patient's medical history included colon cancer and herpes zoster. The patient had no known drug reactions or allergies. On 14-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # J007210, expiration date 20-SEP-2014, 0.65 ml, subcutaneous. Concomitant therapies included SYNTHROID, lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 25-FEB-2015, the patient experienced herpes zoster as since this date, the patient developed pain under the left axilla and over the left breast and his left nipple became tender. Then on 28-FEB-2015, the patient developed rash in 3 different areas on his left side. On 05-MAR-2015, the patient was seen by the physician in regards to the symptoms. The physician diagnosed the patient with herpes zoster and prescribed acyclovir and tramadol hydrochloride for treatment. There were no laboratory diagnostics studies performed. Regarding the patient present status it was reported that the patient was not as bad as it was, the herpes zoster was still there but the rash was starting to crust over, so the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: HEPAB
Symptoms: Blood pressure increased, Heart rate increased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a male patient who received TWINRIX adult (batch number 3EX72, expiry date 22nd March 2016). On 3rd March 2015 09:30, the patient received TWINRIX adult (injection) 1 ml. On 5th March 2015, 2 days after receiving TWINRIX adult, the patient experienced pain and pins and needles. On an unknown date, the outcome of the pain and pins and needles were unknown. The reporter considered the pain and pins and needles to be related to TWINRIX adult. Additional information: The patient's right arm was sore, he felt like he had pins and needles in his right pectoral muscle and he had an elevated blood pressure and pulse.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient with cardiac disorder and no known drug reactions or allergies. On 07-MAR-2015, the patient was vaccinated with ZOSTAVAX, lot # K016326, expiration date 24-DEC-2015. Concomitant therapy information was not provided. On 08-MAR-2015, the patient appeared to have experienced herpes zoster as he developed shooting pains, tingling and numbness on the left side of his face and head, so the pharmacist mentioned that she believed it was a small herpes zoster outbreak. No treatment was given to the patient. There were no laboratory diagnostics studies performed. The patient contacted the pharmacist. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Ear discomfort, Facial pain, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient with cardiac disorder and no known drug reactions or allergies. On 07-MAR-2015, the patient was vaccinated with ZOSTAVAX, lot # K016326, expiration date 24-DEC-2015. Concomitant therapy information was not provided. On 08-MAR-2015, the patient appeared to have experienced herpes zoster as he developed shooting pains, tingling and numbness on the left side of his face and head, so the pharmacist mentioned that she believed it was a small herpes zoster outbreak. No treatment was given to the patient. There were no laboratory diagnostics studies performed. The patient contacted the pharmacist. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number: K004204 and expiry date: 12-JAN-2017), which was improperly stored by exposing to 52F for 12 hours on 06-SEP-2014, 33.5F for 2 hours on 19-JAN-2015 and 31.5F for 29 hours (date unspecified). No adverse effects were reported from the time of administration of the vaccine. 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: Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. On 13-FEB-2015 the patients were vaccinated with an unspecified number of improperly stored doses of ZOSTAVAX (lot # was reported as K010336, expiration date 22-JUL-2016; another lot# was reported as K019388, expiration date 20-JAN-2016; dose, route were not reported). No adverse effect was reported. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Cardioversion
Clinical narrative: Several hours after vaccination patient had unsustained episodes of defibrillation several times that evening and into the following day that resolved after that. It caused his defibrillator to pace him a couple times. No further symptoms. Has had defibrillator since 2004.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Erythema, Induration, Mass, Mass excision
Clinical narrative: This spontaneous report was received from a 62-year-old female patient reporting on herself. The patient's medical history included the removal of appendix and tonsils on an unknown dates, when she was a child and tubal ligation on an unknown date, many years prior to the date of vaccination with ZOSTAVAX. The patient had no allergies and previous drug reactions. On 29-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # J011828, expiration date: 26-DEC-2014, in the left arm; dose and route of administration were not reported). Concomitant therapies included unspecified vitamins. In October 2014, the patient developed two lumps, one lump which was 1 inch in diameter and a second lump which was 1/2 inch in diameter. The lumps started off sore, red, pussy, then became hardened, and later turned a blackened color. The patient had two outpatient surgeries to remove the lumps, on 11-FEB-2015 and 27-FEB-2015. At the time of the report, the lumps have been removed. The patient had blood work and cultures obtained at outpatient surgery, at the time of the report the results of cultures were pending and no diagnosis were made. The outcome of the event was reported as not recovered. The relatedness between vaccination with ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Purulent discharge, Skin discolouration
Clinical narrative: This spontaneous report was received from a 62-year-old female patient reporting on herself. The patient's medical history included the removal of appendix and tonsils on an unknown dates, when she was a child and tubal ligation on an unknown date, many years prior to the date of vaccination with ZOSTAVAX. The patient had no allergies and previous drug reactions. On 29-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # J011828, expiration date: 26-DEC-2014, in the left arm; dose and route of administration were not reported). Concomitant therapies included unspecified vitamins. In October 2014, the patient developed two lumps, one lump which was 1 inch in diameter and a second lump which was 1/2 inch in diameter. The lumps started off sore, red, pussy, then became hardened, and later turned a blackened color. The patient had two outpatient surgeries to remove the lumps, on 11-FEB-2015 and 27-FEB-2015. At the time of the report, the lumps have been removed. The patient had blood work and cultures obtained at outpatient surgery, at the time of the report the results of cultures were pending and no diagnosis were made. The outcome of the event was reported as not recovered. The relatedness between vaccination with ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Injection site reaction to left upper extremity with redness, pain, and slight induration at injection site. Redness measured approximately 4 in x 3 in.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to an unspecified number of patient of unknown age. The healthcare worker reported the patients were administered an unspecified number of improperly stored doses of PNEUMOVAX 23 (dose, route and lot# not reported). No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of the several reports with the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II, (subcutaneous injection, dose and frequency was not provided). No concomitant therapy was reported. On an unknown date, while the patient was pregnant, the titers were drawn showing that she did not have immunity to suspected vaccine. No adverse effects reported. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Information has been received from a registered nurse regarding 2 female patients of unknown age. No concurrent condition and historical medication was reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose-0.5 ml and route-intramuscular) (lot # and expiration date not provided). No concomitant medication was reported. On an unknown date two unspecified patients called the practice seeking medical recommendations/attention regarding the treatment of injection site reactions of swelling and knot. The condition of both the patient's was unresolved after at least 7 days, post administration of GARDASIL 9. Suggestion was given via telephone to apply warm compress and use ibuprofen. No PQC was involved. The outcome of injection site reaction, injection site swelling and injection site nodule was unknown. Causality between GARDASIL 9 and injection site reactions of swelling and knot was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Angioedema, Mouth swelling, Swollen tongue
Clinical narrative: Symptoms of angioedema, tongue and mouth swelling.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Cellulitis, Pruritus, Swelling
Clinical narrative: (L)-leg cellulitis, itching and swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling w/a small bump.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Vomiting, redness, warmth, swelling and pain to left upper arm. Treatment - MEDROL dose pack, CLARITIN and BENADRYL, ice.
Age: 1.42
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No adverse events noted. Patient receive expired vaccine. Vaccine expired 3/7/15. Was given today 3/13/15.