chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a healthcare professional (vaccine provider) on 12 July 2016. This case involves a 15-year-old male patient who was vaccinated with a first dose of MENACTRA (batch number: U5282CB, expiration date not provided) intramuscularly in right deltoid and second dose of VARIVAX (batch number: L049536, expiration date, site and route of administration were not reported) on 11 July 2016. Patient's Illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects and medical conditions was reported as no known allergy (NKA). Concomitant medications were not reported. On 11 July 2016, one hour following the vaccination, the patient experienced fever, chills and aches. It was reported that the patient required ER or doctor visit. Lab data and corrective treatment were not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: It appears to be an allergic reaction.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Erythema, Swelling
Clinical narrative: Initial unsolicited report received from a HCP via other company (Pfizer) (Manufacturer Report Number: 2016009819) on 06-Jul-2016. This case involves a 53-year-old male patient who was vaccinated with a dose of TDAP VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) (batch number, expiration date route and site of administration and dose were not reported) on 07-Nov-2011. The patient's medical history included Allergies to AUGMENTIN, PHENERGAN, VIOXX noted on 03-Nov-2011. It was reported that the patient was a smoker since 42 years and consequently was suffering from emphysma further expressing his desire to quit smoking nicotine spray 10mg from 05-Oct-2015 nasally 1-5 times per hour for 8 weeks and Nicotrol 10 mg inhaler 6-16 cartridges per day for up to 3 months, end date 06-Jan-2016. Concomitant medications included XANAX 1 mg tablet orally 3 times a day for anxiety, aspirin 81 mg EC tablet orally daily, CYMBALTA 60 mg capsule orally twice daily, NORCO 10-325 mg tablet orally for pain every six hours, LAMICTAL 200 mg oral tablet twice daily, PRILOSEC capsule 40 mg orally, MIRAPEX 0.25 mg Tablet orally from 19-May-2015 in night as needed, route: none and Zocor 20 mg tablet orally in night from 19-May-2015 to 18-May-2016. On an unspecified date, following the vaccination, the patient experienced redness, swelling and allergy to Tdap vaccine. Laboratory investigations was reported none. Corrective treatment was not reported. The outcome for all the events was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) on 08 July 2016. Manufacturer report number: 2016269330 This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergy to influenza vaccine split (not specified). The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Death
Clinical narrative: Initial unsolicited report received from consumer via social media in on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131486, 2016SA131491 (same vaccine, same reporter). This case involves a patient (age and gender: not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after getting the vaccination the patient died. It was unknown whether autopsy was performed and cause of death was unknown. Documents held by sender: none. Sender's Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient's age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: death.
Sex: U
Vaccine: MEN
Symptoms: Death
Clinical narrative: Initial unsolicited report received from consumer via social media on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131479, 2016SA131491 (same vaccine, same reporter). This case involves a patient (age and gender: not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after getting the vaccination the patient died. It was unknown whether autopsy was performed. Documents held by sender: none.; Sender's Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient's age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: death.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt received her PREVNAR vaccine @ 12:05 pm. That night during her sleep Her L arm swelled up and when she awoke it was noticed it was red as well. The redness started at @ 5cm and spread to 14cm over the course of 2 days. She used ice the 1st 24 hrs the heat and ibuprofen.   She came in to see Dr. on 07/21 and the redness and swelling are regressing.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Concurrent or historical condition was not provided. On unknown dates the patients were vaccinated with inappropriately stored PROQUAD (therapy type, dose and route were unknown). Concomitant therapy was not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash 10 days after MMR, VAR, Hep A administered.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Myalgia
Clinical narrative: (1) Muscle and joint pain (hip, legs, feet) (2) (L) foot numbness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: Fatigue, nausea, loss of appetite, tenderness at injection site - started ay of injection, soreness/tenderness and swelling under the (R) arm and outside of (R) breast started 3 days later, resolved 7 days after shot.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling, Tenderness
Clinical narrative: Fatigue, nausea, loss of appetite, tenderness at injection site - started ay of injection, soreness/tenderness and swelling under the (R) arm and outside of (R) breast started 3 days later, resolved 7 days after shot.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 03-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Broke out in "hives all over" at 3:00 AM. Was given Benadryl with good effect.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported; indication provided as "vaccination"). Concomitant therapy was not reported. On an unknown date the patient experienced unknown rash on an unknown area of the body after receiving a dose of ZOSTAVAX. The outcome of the rash was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from 2 pharmacists referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 07-JUL-2016, the patient was vaccinated with a dose of expired PNEUMOVAX23 (lot # K023328, expiration date 23-JUN-2016, route not reported). No adverse effect was reported. 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 and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-MAY-2016 and 13-JUN-2016, the patient was vaccinated with improperly stored doses of M-M-R II 0.5 ml injection, lot# L027432, expiry date: 22-JUL-2016 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Pyrexia
Clinical narrative: Severe lower and mid back pain staring the following day also had fever 101 relieved by ALEVE. Resolved after 2 days.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Streptococcus test positive, White blood cells urine positive
Clinical narrative: Severe lower and mid-back pain. Urine dip mod leukocyte via 6-10 WBC. Urine C/S 10,000 Grp B Strep.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Welt developed approx size 2" tall x 3" wide at injection site. No hot, itchy, painful.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot# L032181, expiry date: 25-AUG-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding medical history, concurrent condition and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011717 with expire date 07-DEC-2017, lot # M003659 with expire date 20-SEP-2017, lot # M0041116 with expire date 12-OCT-2017, lot # L018351 with expire date 11-AUG-2017, dose and route unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Lot # M011717 and lot # M0041116 are invalid lot numbers for hpv rl 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). 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 and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-APR-2016, the patient was vaccinated with improperly stored dose of MMR II 0.5 ml injection, lot# L027432, expiry date: 22-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort
Clinical narrative: Discomfort at inj. x 1 week. No swelling, redness, not warm to touch.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Patient called to report had reaction of small bump at site with discomfort. Reported by Patient 7-20-16.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Nausea, Pharyngeal oedema, Pyrexia, Tremor
Clinical narrative: Fever, nausea, vomiting, shaking - blacked out x 3, CP, throat swelling - ER was give ZOFRAN, SOLU-MEDROL, BENADRYL, TACLONEX, PEPCID.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Fever, nausea, vomiting, shaking - blacked out x 3, CP, throat swelling - ER was give ZOFRAN, SOLU-MEDROL, BENADRYL, TACLONEX, PEPCID.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site erythema, Injection site oedema, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Patient admits that he did not realize the reaction until the next day with loss of appetite fever, nausea and edema redness and tenderness at site of left deltoid.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient admits that he did not realize the reaction until the next day with loss of appetite fever, nausea and edema redness and tenderness at site of left deltoid.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood test, Cough, Diarrhoea, Lymph node pain, Lymphadenopathy
Clinical narrative: Intermittent coughing, swollen painful lymph nodes in groin, achiness in testicles, nausea, diarrhea.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Nausea, Testicular pain, Ultrasound scan
Clinical narrative: Intermittent coughing, swollen painful lymph nodes in groin, achiness in testicles, nausea, diarrhea.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Patient complained of not feeling well after vaccines were administered 7/20/16. Vomited 5 x's between 12:30 AM - 4:00 AM 7/21/16. Fever 101.7.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: DIAGNOSED WITH TIA.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vaccination complication
Clinical narrative: High fever for 4 days 102.60 / nauseated lightheaded / headache.  Only needed tetanus booster but County only had Tdap, so had to get that vaccine.  She was trying to get over major injury an then also had to deal with additional stress of the vaccine/adverse reaction.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Contusion, Erythema, Pain in extremity, Vaccination site bruising, Vaccination site pain
Clinical narrative: Upper left arm, originating from vaccination site, initially became severely reddened and painful and patches of bruising occurred approximately 48hrs later.  Affected area included entire medial bicep, ultimately extending to medial forearm just below elbow.  Treatment with ibuprofen and diphenhydramine were ineffective.  Medical treatment was sought on July 12, 2016.  Seven week course of Cephalexin & Sulfamethoxazole/Trimethoprim were prescribed.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site reaction
Clinical narrative: Upper left arm, originating from vaccination site, initially became severely reddened and painful and patches of bruising occurred approximately 48hrs later.  Affected area included entire medial bicep, ultimately extending to medial forearm just below elbow.  Treatment with ibuprofen and diphenhydramine were ineffective.  Medical treatment was sought on July 12, 2016.  Seven week course of Cephalexin & Sulfamethoxazole/Trimethoprim were prescribed.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt C/O Bright redness to site, warm to touch, states very painful, and some swelling to site.
Age: 70.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Cognitive disorder, Computerised tomogram, Condition aggravated, Decreased appetite, Diarrhoea
Clinical narrative: Within a few minutes of receiving vaccine Pt. became ill, feeling shaky, nauseated, headache. Pt. disoriented, kept taking wrong way home - symptoms got worse,  projectile vomiting, diarrhea, severe headache, Blood Pressure very high, then very low, little to no appetite - finally resulted in hallucinations and seizures, Parkinson type movements - stopped breathing - respiratory arrest - had to be on life support - in ICU 4 days - Left with permanent seizure disorder, memory & cognitive issues - skin lesions that are big purple splotches at slightest impact to skin.
Age: 70.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Disorientation, Electrocardiogram, Electroencephalogram, Hallucination, Headache
Clinical narrative: Within a few minutes of receiving vaccine Pt. became ill, feeling shaky, nauseated, headache. Pt. disoriented, kept taking wrong way home - symptoms got worse,  projectile vomiting, diarrhea, severe headache, Blood Pressure very high, then very low, little to no appetite - finally resulted in hallucinations and seizures, Parkinson type movements - stopped breathing - respiratory arrest - had to be on life support - in ICU 4 days - Left with permanent seizure disorder, memory & cognitive issues - skin lesions that are big purple splotches at slightest impact to skin.
Age: 70.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hypertension, Intensive care, Laboratory test, Life support, Lumbar puncture
Clinical narrative: Within a few minutes of receiving vaccine Pt. became ill, feeling shaky, nauseated, headache. Pt. disoriented, kept taking wrong way home - symptoms got worse,  projectile vomiting, diarrhea, severe headache, Blood Pressure very high, then very low, little to no appetite - finally resulted in hallucinations and seizures, Parkinson type movements - stopped breathing - respiratory arrest - had to be on life support - in ICU 4 days - Left with permanent seizure disorder, memory & cognitive issues - skin lesions that are big purple splotches at slightest impact to skin.
Age: 70.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Malaise, Memory impairment, Nausea, Nervousness, Nuclear magnetic resonance imaging
Clinical narrative: Within a few minutes of receiving vaccine Pt. became ill, feeling shaky, nauseated, headache. Pt. disoriented, kept taking wrong way home - symptoms got worse,  projectile vomiting, diarrhea, severe headache, Blood Pressure very high, then very low, little to no appetite - finally resulted in hallucinations and seizures, Parkinson type movements - stopped breathing - respiratory arrest - had to be on life support - in ICU 4 days - Left with permanent seizure disorder, memory & cognitive issues - skin lesions that are big purple splotches at slightest impact to skin.
Age: 70.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Rash macular, Respiratory arrest, Seizure, Skin discolouration, Skin lesion
Clinical narrative: Within a few minutes of receiving vaccine Pt. became ill, feeling shaky, nauseated, headache. Pt. disoriented, kept taking wrong way home - symptoms got worse,  projectile vomiting, diarrhea, severe headache, Blood Pressure very high, then very low, little to no appetite - finally resulted in hallucinations and seizures, Parkinson type movements - stopped breathing - respiratory arrest - had to be on life support - in ICU 4 days - Left with permanent seizure disorder, memory & cognitive issues - skin lesions that are big purple splotches at slightest impact to skin.
Age: 70.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Tremor, Vomiting projectile
Clinical narrative: Within a few minutes of receiving vaccine Pt. became ill, feeling shaky, nauseated, headache. Pt. disoriented, kept taking wrong way home - symptoms got worse,  projectile vomiting, diarrhea, severe headache, Blood Pressure very high, then very low, little to no appetite - finally resulted in hallucinations and seizures, Parkinson type movements - stopped breathing - respiratory arrest - had to be on life support - in ICU 4 days - Left with permanent seizure disorder, memory & cognitive issues - skin lesions that are big purple splotches at slightest impact to skin.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Balance disorder, Decreased appetite
Clinical narrative: Nausea followed by intense vomiting and diarrhea, muscle and joint aches, headache, stomach ache, extreme weakness, extreme fatigue, unsteadiness when standing. Complete loss of appetite for more than 36 hours.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea followed by intense vomiting and diarrhea, muscle and joint aches, headache, stomach ache, extreme weakness, extreme fatigue, unsteadiness when standing. Complete loss of appetite for more than 36 hours.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Nausea followed by intense vomiting and diarrhea, muscle and joint aches, headache, stomach ache, extreme weakness, extreme fatigue, unsteadiness when standing. Complete loss of appetite for more than 36 hours.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: Patient states that from 7-4-16 to 7-11-16 they had a skin rash all over their back, chest, thighs, and arms. Patient states that they had an intense scratching/ burning sensation on their skin and that their skin was bumpy. Patient reported on 7/20/16 that they may have an allergy to a certain IV medication but they did not know what the product was. It could be a potential latex allergy, however the vials of Havrix do not have any Latex.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red swollen and warm right arm. treated with clindamycin for cellulitis but possibility of reaction is still there.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Bladder discomfort, Cystitis interstitial, Dysuria, Pollakiuria
Clinical narrative: Interstitial cystitis (frequent/painful urination, bladder discomfort, abdominal pain) treated with Elmiron and UTA.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain and Loss of movement in arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: Dizziness, weakness, clammy, sweaty.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal discomfort, Headache, Injection site rash
Clinical narrative: Headache, upset stomach, localized rash at injection site.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, RV5
Symptoms: Haematochezia
Clinical narrative: Bloody streaks in stool.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: ITCHING AT THE SITE OF INJECTION FOR 10 MIN.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Pt's arm has a wide rash around the injection site that appeared 3 days after the injection and is till present 8 days later.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling, Tenderness
Clinical narrative: Slight swelling. Crippling pain.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Decreased appetite, Pyrexia, Urine analysis normal, Vomiting
Clinical narrative: High fever, started within 2 hours of receiving vaccine. Increased above 105 degrees (105.3) and lasted 60 hours. Vomiting and prolonged crying, reduced appetite, would eat very little until 3 days after vaccine administered.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-JUN-2016, the patient was vaccinated with improperly stored dose of MMR II 0.5 ml injection, lot# L032181, expiry date: 25-AUG-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms  were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-MAY-2016, the patient was vaccinated with improperly stored dose of MMR II 0.5 ml injection, lot# L027432, expiry date: 22-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot# L032181, expiry date: 25-AUG-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. 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: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients medical history, and concurrent condition and concomitant therapy were not provided. On 12-JUL-2016 the patients were vaccinated with improperly stored GARDASIL (lot # M014929, expiration date 29-MAY-2017, dose and route were not reported). There was no previous temperature excursion and data logger was not involved. The vaccine had been improperly stored under temperature dof 1 degree Celsius for 48 hours. No adverse effects were reported. This is one of several reports that received from the same source. Additional information is not expected as no consent to contact the healthcare professional.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse event
Clinical narrative: Patient son informed pharmacist that patient was hospitalized on 7-19-16 due to receiving PREVNAR on 6-21-16.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-APR-2016, the patient was vaccinated with an improperly stored dose M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ (dose, lot # and expiry date were not reported). The reporter stated that maximum time out of range for the vaccines was minutes only when door was being opened and closed. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patient's were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiry date were not reported). The reporter stated that maximum time out of range for the vaccines was minutes only when door was being opened and closed. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Eyelid function disorder, Eyelid oedema, Headache, Herpes zoster
Clinical narrative: This spontaneous report as received from a 90 year old male patient reporting on himself, with allergy to Sulfazine, diabetes mellitus and hypertension, colitis ulcerative and prostate cancer. Approximately, in 2008 (reported as "8 years ago") the patient was vaccinated with ZOSTAVAX 1 shot, subcutaneous. Dose, lot number and expiration date were not provided. Concomitant therapies included ALTACE, finasteride(manufacturer unknown), ACTOS, tamsulosin hydrochloride(manufacturer unknown, OXBYBUTYNIN and simvastatin(manufacturer unknown). Approximately, on 20-APR-2016 ("reported as two and a half months ago") the patient experienced an outbreak of Shingles. The patient had blisters developed around the eyelid and on the right side of his face, as well as the area around the eye socket an don his right temple. On an unknown date, in 2016, the  blistered area was also swollen, which had an effect on his eyelid opening and closing (eyelid function disorder). Also, the patient stated that on the first 48 hours of the Shingles experienced a extreme headaches, which prevented him from sleeping (sleeping disorder). The outcome of Shingles, eyelid function disorder, sleep disorder and headache was reported as recovering. The causality between the events and the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Swelling
Clinical narrative: This spontaneous report as received from a 90 year old male patient reporting on himself, with allergy to Sulfazine, diabetes mellitus and hypertension, colitis ulcerative and prostate cancer. Approximately, in 2008 (reported as "8 years ago") the patient was vaccinated with ZOSTAVAX 1 shot, subcutaneous. Dose, lot number and expiration date were not provided. Concomitant therapies included ALTACE, finasteride(manufacturer unknown), ACTOS, tamsulosin hydrochloride(manufacturer unknown, OXBYBUTYNIN and simvastatin(manufacturer unknown). Approximately, on 20-APR-2016 ("reported as two and a half months ago") the patient experienced an outbreak of Shingles. The patient had blisters developed around the eyelid and on the right side of his face, as well as the area around the eye socket an don his right temple. On an unknown date, in 2016, the  blistered area was also swollen, which had an effect on his eyelid opening and closing (eyelid function disorder). Also, the patient stated that on the first 48 hours of the Shingles experienced a extreme headaches, which prevented him from sleeping (sleeping disorder). The outcome of Shingles, eyelid function disorder, sleep disorder and headache was reported as recovering. The causality between the events and the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from an unspecified reporter from the billing office of a physician's office referring to a 17 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 11-JUL-2016, the patient was vaccinated with an unspecified dose in the series of GARDASIL (lot# K010215, expiration date 5-MAY-2017, route not reported). There was no concomitant therapy. On 12-JUL-2016, the patient woke up in the morning with an unspecified rash on an unspecified location on her body. The patient sought medical attention via calling the physician. No laboratory test was performed. The patient received unspecified treatment. As of the time of this report, the patient was "doing better". The causality between GARDASIL and event was not provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient's medical history included coeliac disease and previous history shingles. On 09-JUL-2016 the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU lot # L040442 expiration date 15-JAN-2017, subcutaneous. No other suspect or concomitant therapies were reported. On follow up call placed to the patient on 10-JUL-2016 she stated that she had a quarter sized red area at the injection site. It was unknown if the event began on 09-JUL-2016 or 10-JUL-2016. A second phone call was placed to the patient on 12-JUL-2016, she stated that the red area had grown to 3-4 inches, was hard in the middle, warm to the touch, and itchy. The outcome of the events was reported as not recovered. The causality between the therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization coordinator referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of ZOSTAVAX Lot#: L011529, expiration date on 03-JUL-2016, lot# L024999, expiration date on 06-OCT-2016 and lot# M001746, expiration date on 07-APR-2017 (strength, dose number, route of administration and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were previous excursions reported as 13.1 degrees Fahrenheit for 3 hours 10 minutes and 7 degrees Fahrenheit for 2 hours, 50 minutes. It was reported total cumulative time out of range 6 hours 30 minutes. 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 as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose, route, lot # and expiry date were not reported). The reporter stated that maximum time out of range for the vaccines was minutes only when door was being opened and closed. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-APR-2016, the patient was vaccinated with an improperly stored does of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital logger was involved. No adverse symptoms were 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 an administrator refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route, lot # and expiry date were not reported). The reporter stated that maximum time out of range for the vaccines was minutes only when door was being opened and closed. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received form a consumer and refers to her husband. The report was received via Pfizer. The patient's age, medical history and concurrent conditions were not reported. On an unknown date (reported as "a couple of years ago"), the patient was vaccinated with unspecified shingles shot (manufacturer unknown) (dose, lot #, expiration date and route of administration were not provided). Concomitant therapies were not reported. On an unknown date, the patient developed shingles despite the vaccination. The shingles were described as "not as bad as he would have" by his physician. The patient was taking LYRICA for about 3 months (unspecified start date, approximately in April 2016) for shingles pain. The outcome of the event was unknown. The relatedness between the events and suspect vaccine was not reported. Additional information had been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 4 doses of improperly stored ROTATEQ lot# reported as L046320 with expiration date: 29-SEP-2017 and 1 dose of improperly stored ROTATEQ lot# L038534 with expiration date: 19-AUG-2017 (dose was not reported; orally) were administered to the patients. Administered doses of ROTATEQ underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On 12-JUL-2016 the patients were vaccinated with improperly stored GARDASIL 9 (lot # M005714, expiration date 30-OCT-2017, dose and route were not reported). There was no previous temperature excursion. The vaccine was stored under temperature of 1 degree Celsius for 48 hours. No adverse effects were reported. Additional information is not expected as the reporter did not consent to be contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot # L027432, expiry date: 22-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dermatitis contact
Clinical narrative: Information has been received from a licensed practical nurse referring to a 12 year old male patient. The patient had no pertinent medical history, drug reactions/allergies or concomitant medication. On 07-MAY-2016, the patient was vaccinated with a first dose of GARDASIL 9 (frequency and route were not reported). On 03-JUL-2016, the patient developed a rash from coming into contact with poison sumac. Unspecified treatment was given for the event. No lab diagnostic studies were performed. The patient's present status was reported as not recovered. The causality between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding medical history, concurrent condition and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L051125 with expire date 14-OCT-2018, lot # M006710 with expire date 06-DEC-2018, dose and route unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Lot# L051125 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). Additional information has been requested.