chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood glucose increased, Blood pressure increased, Blood test normal, Computerised tomogram normal
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner reporting on behalf of her mother. A 75-years-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on 30Apr2015. Medical history included diabetic and hypertension. Concomitant medication included glipizide 2.5mg once a day in the morning with a meal, topiramate 50mg at bedtime, amlodipine 50mg at bedtime, chlorthalidone 25mg, take 1/2 tablet once a day, LIPITOR once a day, aspirin 81mg daily, alendronate once a week to prevent osteoporosis. On 01May2015, the patient became very confused that required hospitalization from 01May2015 to 02May2015 with outcome of unknown. On 30Apr2015, the patient developed redness with outcome of recovering, tenderness with outcome of recovering, joint pain with outcome of not recovered, blood glucose elevated on an unspecified date with outcome of unknown, left arm deltoid where it's puffy almost looks like a nasty blister with outcome of not recovered. Also, she experienced blood pressure elevated on 01May2015 with outcome of recovering. Reporter added that she noted on 06May2015 that her mother had a blister that was oozing located approximately one half inch distal to her elbow on the lateral side. She mentioned that this was not near the injection site for the PREVNAR 13 but was on the same arm. She stated that she washed it with antibacterial soap and used Neosporin, with outcome of unknown. The patient underwent lab tests and procedures which included Blood glucose (fasting) Low: High; Date: 06May2015 Results: 129; Blood glucose (non-fasting) Low: High; Date: 06May2015 Results: 157; Blood glucose; Date: 02May2015 Results: 259; Blood glucose; Date: 01May2015 Results: 159 or 179; CT Scan; Date: May2015 Results: Normal; EKG; Date: May2015 Results: Normal; Blood work; Date: May2015 Results: Normal. The nurse described the clinical course as follows: After receiving PREVNAR 13 injection patient started to experience adverse events. On Friday 01May2015 patient became very confused and was taken to the emergency room. Confusion came first on Friday and noticed blood glucose was elevated, either 159 or 179. Friday morning it was within normal range 70-75. Normal range for patient is 70-75 range, in the 70s. Every so often 79. In the hospital BG was 259. Discharged from hospital and blood glucose was still elevated. Upper 100s, which is high for her. Also concerned with how area looks. Left arm deltoid, where it is puffy looks like a blister. Nurse who administered saying it is not the injection site. The puffiness is 2 inches below injection site and it is the diameter of a dime looks like a nasty blister.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Confusional state, Electrocardiogram normal, Erythema, Injection site reaction, Injection site vesicles
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner reporting on behalf of her mother. A 75-years-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on 30Apr2015. Medical history included diabetic and hypertension. Concomitant medication included glipizide 2.5mg once a day in the morning with a meal, topiramate 50mg at bedtime, amlodipine 50mg at bedtime, chlorthalidone 25mg, take 1/2 tablet once a day, LIPITOR once a day, aspirin 81mg daily, alendronate once a week to prevent osteoporosis. On 01May2015, the patient became very confused that required hospitalization from 01May2015 to 02May2015 with outcome of unknown. On 30Apr2015, the patient developed redness with outcome of recovering, tenderness with outcome of recovering, joint pain with outcome of not recovered, blood glucose elevated on an unspecified date with outcome of unknown, left arm deltoid where it's puffy almost looks like a nasty blister with outcome of not recovered. Also, she experienced blood pressure elevated on 01May2015 with outcome of recovering. Reporter added that she noted on 06May2015 that her mother had a blister that was oozing located approximately one half inch distal to her elbow on the lateral side. She mentioned that this was not near the injection site for the PREVNAR 13 but was on the same arm. She stated that she washed it with antibacterial soap and used Neosporin, with outcome of unknown. The patient underwent lab tests and procedures which included Blood glucose (fasting) Low: High; Date: 06May2015 Results: 129; Blood glucose (non-fasting) Low: High; Date: 06May2015 Results: 157; Blood glucose; Date: 02May2015 Results: 259; Blood glucose; Date: 01May2015 Results: 159 or 179; CT Scan; Date: May2015 Results: Normal; EKG; Date: May2015 Results: Normal; Blood work; Date: May2015 Results: Normal. The nurse described the clinical course as follows: After receiving PREVNAR 13 injection patient started to experience adverse events. On Friday 01May2015 patient became very confused and was taken to the emergency room. Confusion came first on Friday and noticed blood glucose was elevated, either 159 or 179. Friday morning it was within normal range 70-75. Normal range for patient is 70-75 range, in the 70s. Every so often 79. In the hospital BG was 259. Discharged from hospital and blood glucose was still elevated. Upper 100s, which is high for her. Also concerned with how area looks. Left arm deltoid, where it is puffy looks like a blister. Nurse who administered saying it is not the injection site. The puffiness is 2 inches below injection site and it is the diameter of a dime looks like a nasty blister.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling, Tenderness, Wound secretion
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner reporting on behalf of her mother. A 75-years-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on 30Apr2015. Medical history included diabetic and hypertension. Concomitant medication included glipizide 2.5mg once a day in the morning with a meal, topiramate 50mg at bedtime, amlodipine 50mg at bedtime, chlorthalidone 25mg, take 1/2 tablet once a day, LIPITOR once a day, aspirin 81mg daily, alendronate once a week to prevent osteoporosis. On 01May2015, the patient became very confused that required hospitalization from 01May2015 to 02May2015 with outcome of unknown. On 30Apr2015, the patient developed redness with outcome of recovering, tenderness with outcome of recovering, joint pain with outcome of not recovered, blood glucose elevated on an unspecified date with outcome of unknown, left arm deltoid where it's puffy almost looks like a nasty blister with outcome of not recovered. Also, she experienced blood pressure elevated on 01May2015 with outcome of recovering. Reporter added that she noted on 06May2015 that her mother had a blister that was oozing located approximately one half inch distal to her elbow on the lateral side. She mentioned that this was not near the injection site for the PREVNAR 13 but was on the same arm. She stated that she washed it with antibacterial soap and used Neosporin, with outcome of unknown. The patient underwent lab tests and procedures which included Blood glucose (fasting) Low: High; Date: 06May2015 Results: 129; Blood glucose (non-fasting) Low: High; Date: 06May2015 Results: 157; Blood glucose; Date: 02May2015 Results: 259; Blood glucose; Date: 01May2015 Results: 159 or 179; CT Scan; Date: May2015 Results: Normal; EKG; Date: May2015 Results: Normal; Blood work; Date: May2015 Results: Normal. The nurse described the clinical course as follows: After receiving PREVNAR 13 injection patient started to experience adverse events. On Friday 01May2015 patient became very confused and was taken to the emergency room. Confusion came first on Friday and noticed blood glucose was elevated, either 159 or 179. Friday morning it was within normal range 70-75. Normal range for patient is 70-75 range, in the 70s. Every so often 79. In the hospital BG was 259. Discharged from hospital and blood glucose was still elevated. Upper 100s, which is high for her. Also concerned with how area looks. Left arm deltoid, where it is puffy looks like a blister. Nurse who administered saying it is not the injection site. The puffiness is 2 inches below injection site and it is the diameter of a dime looks like a nasty blister.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Increased redness, swollen and itchy feeling and pain at the area of the tetanus shot upper left arm, achy feeling in general.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Animal bite, Headache, Muscle rigidity, Posture abnormal, Seizure
Clinical narrative: My symptoms began with a headache 2/25. By 3/1/2015 I was having trembling in body at 1:32 (dawn) two hours later 3:36 am, tremors in head by morning 10:34 am right hand became rigid and gnarled. Head would sometimes go down. More trembling later days. 3/2/2015 a lot of seizures beginning around 9 pm. 3/3/2015 several seizures (trembling) around 10 pm. This vaccine should not have been given to me. I was 68 and became 69. A blonde female doctor with long hair came for a few minutes and she said I should not have rabies vaccine who made decision for Tdap. After being vaccinated I was given a printout with adverse effects but I should have been warned first. Throughout my ordeal (I had hoped to marry) now I don't know if I can marry. I had a witness whose name I will respect if someone phones me can leave a message on voicemail which will give my mother's name. No text messaging; we don't know how to retrieve text messages. In regards to the adverse effects the weekend of my birthday I had trembling in my body while lying down twice each night 3 different nights. On 4/26 both my body and head were shaking twice (2 episodes). Last night, it was just brief, but both my body and head shook around 2:20 am (dawn) other dates 3/8/2015 around 1:15 (dawn), 3/26 8:08 pm, 3/27/2015 10:20 pm, 4/2/2015 1:25, 4/12 and 4/16, 4/23. My hand has not become gnarled and rigid temporarily again since 3/1/2015 but I did have pain at cat bite site March 14 when I began to have several episodes of trembling in my body I went to clinic. The day of 2/23/2015 when I was vaccinated, I went with my friend and witness to clinic; there, a receptionist told us to go to the next town, where I had been 9/16/2014. There a receptionist sitting on right sent us to the emergency and to yet another town. I have been so upset about the trembling in my body that I went to find out the name of the receptionist who told us to go to the ER because the receptionist said I needed a rabies vaccine and the ER doctor said no rabies vaccine. In fact, I could have had the tetanus or Tdap vaccine at clinic I learned when I was trying to find out the name of the woman who sent us on what became a more expensive billing for insurance and a horrible problem of body tremors for me. I phoned an advocacy group and have received papers to file with the dept of licensing and regulatory affairs. I have not filled papers because the remaining doctor in this area might be told not to have me as patient.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Wound complication
Clinical narrative: My symptoms began with a headache 2/25. By 3/1/2015 I was having trembling in body at 1:32 (dawn) two hours later 3:36 am, tremors in head by morning 10:34 am right hand became rigid and gnarled. Head would sometimes go down. More trembling later days. 3/2/2015 a lot of seizures beginning around 9 pm. 3/3/2015 several seizures (trembling) around 10 pm. This vaccine should not have been given to me. I was 68 and became 69. A blonde female doctor with long hair came for a few minutes and she said I should not have rabies vaccine who made decision for Tdap. After being vaccinated I was given a printout with adverse effects but I should have been warned first. Throughout my ordeal (I had hoped to marry) now I don't know if I can marry. I had a witness whose name I will respect if someone phones me can leave a message on voicemail which will give my mother's name. No text messaging; we don't know how to retrieve text messages. In regards to the adverse effects the weekend of my birthday I had trembling in my body while lying down twice each night 3 different nights. On 4/26 both my body and head were shaking twice (2 episodes). Last night, it was just brief, but both my body and head shook around 2:20 am (dawn) other dates 3/8/2015 around 1:15 (dawn), 3/26 8:08 pm, 3/27/2015 10:20 pm, 4/2/2015 1:25, 4/12 and 4/16, 4/23. My hand has not become gnarled and rigid temporarily again since 3/1/2015 but I did have pain at cat bite site March 14 when I began to have several episodes of trembling in my body I went to clinic. The day of 2/23/2015 when I was vaccinated, I went with my friend and witness to clinic; there, a receptionist told us to go to the next town, where I had been 9/16/2014. There a receptionist sitting on right sent us to the emergency and to yet another town. I have been so upset about the trembling in my body that I went to find out the name of the receptionist who told us to go to the ER because the receptionist said I needed a rabies vaccine and the ER doctor said no rabies vaccine. In fact, I could have had the tetanus or Tdap vaccine at clinic I learned when I was trying to find out the name of the woman who sent us on what became a more expensive billing for insurance and a horrible problem of body tremors for me. I phoned an advocacy group and have received papers to file with the dept of licensing and regulatory affairs. I have not filled papers because the remaining doctor in this area might be told not to have me as patient.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Inflammation, Pain, Tenderness
Clinical narrative: Redness, inflammation, tender to palp., pain.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Constipation, Dizziness, Erythema
Clinical narrative: Fever, headache, nausea, redness, swelling and pain in the upper arm, chills, faster heartbeat, dizziness, constipation, felt weak, for 10 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Heart rate increased, Localised infection, Nausea, Pain in extremity
Clinical narrative: Fever, headache, nausea, redness, swelling and pain in the upper arm, chills, faster heartbeat, dizziness, constipation, felt weak, for 10 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fever, headache, nausea, redness, swelling and pain in the upper arm, chills, faster heartbeat, dizziness, constipation, felt weak, for 10 days.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Red, raised welt to right thigh. Pt medicated with BENADRYL 25 mg PO.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 64 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5 ml, intramuscular, lot # K004281, expiration date 22-MAR-2015). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored ROTATEQ, product lot# K007246, expiry date: 17-MAR-2016. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events were unknown. This is one of the several reports from the same source. 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 medical assistant refers to six patients of unknown age and gender. The patient's medical histories, concurrent condirions and concomitant medications were not reported. On unknown dates six patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, route of adminsitration, lot number were not reported). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to three patients of unkown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unknown dates three patients were vaccinated with doses of improperly stored GARDASIL (dose, route of administration, lot number were not reported). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 demographics. The patient's concurrent conditions and medical history was not provided. On 21-APR-2015, the patients was vaccinated with (Oka/Merck) VARIVAX lot # J003541, that had expired on 25-MAR-2015, 0.5 ml, subcutaneous. No adverse experience reported. No product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored VAQTA, product lot# K005958, expiry date: 09-FEB-2017. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events were unknown. This is one of the several 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 demography. Patient's concurrent conditions and relevant medical history was not reported. On 13-APR-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K007983 with expiration date of 03-JUN-2016), 0.5 ml, subcutaneous. Concomitant medications were not reported. No adverse events were reported. The outcome of the events were unknown. The causality of the events with (Oka/Merck) was not reported. Product quality issue was not involved. This case is linked to # 1504USA021167 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored RECOMBIVAX HB, product lot# K006262, expiry date: 17-DEC-2015. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events were unknown. This is one of the several 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 demographics. Patient's concrurent conditions and relevant medical history was not reported. On 13-APR-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K007983 with expiration date of 03-JUN-2016), 0.5 ml, subcutaneous. Concomitant medications were not reported. No adverse events were reported. The outcome of the events were unknown. The causality of the events with (Oka/Merck) was not reported. Product quality issue was not involved. This case is linked to # 1505USA007262 via same reporter link. 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 regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored GARDASIL, product lot # K005881, expiry date reported as 14-JAN-2017. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events were unknown. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored COMVAX, product batch/lot# reported as J009691, expiry date reported as 29-DEC-2015. No adverse effects were reported. There was no product qualtity complaint involved. The outcome of the events were unknown. This is one of the several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX, (lot number and expiry date was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reportetd. On an unknown date in February 2013, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date in October 2014 the patient was vaccinated with second dose and on December 2014, the patient was vaccinated with third dose of GARDASIL. No adverse effects were reported. The outcome of the events were unknown. The causality of the events with GARDASIL vaccine was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy, Neck pain
Clinical narrative: Swollen warm injection site. Pt. c/o hurting into (R) neck and swollen glands in (R) neck and under (R) arm. Received Tdap booster in the right upper arm three days ago and since then has developed swelling and pain in that area with the pain extending to the top of her shoulder and adjacent right upper chest as well as armpit and back of upper shoulder. She does have an area measuring 7 x 6 cm of subcutaneous fullness that is not hard, but is tender to palpation, as well as the adjacent areas where she's having pain. The area of fullness is warm to touch, but the overlaying skin is not inflamed. She's able to fully range her right shoulder compared to left and her grip strength is equal bilaterally. She not have any numbness. I advised her to use over-the-counter ZYRTEC for the antihistaminic effect as well as apply intermittent heat. If she does not gradually improve she's to return to clinic. We will complete a vaccine adverse reactions form regarding this.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tenderness
Clinical narrative: Swollen warm injection site. Pt. c/o hurting into (R) neck and swollen glands in (R) neck and under (R) arm. Received Tdap booster in the right upper arm three days ago and since then has developed swelling and pain in that area with the pain extending to the top of her shoulder and adjacent right upper chest as well as armpit and back of upper shoulder. She does have an area measuring 7 x 6 cm of subcutaneous fullness that is not hard, but is tender to palpation, as well as the adjacent areas where she's having pain. The area of fullness is warm to touch, but the overlaying skin is not inflamed. She's able to fully range her right shoulder compared to left and her grip strength is equal bilaterally. She not have any numbness. I advised her to use over-the-counter ZYRTEC for the antihistaminic effect as well as apply intermittent heat. If she does not gradually improve she's to return to clinic. We will complete a vaccine adverse reactions form regarding this.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with ROTATEQ orally (dose, Lot# and expiration date not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Multisite myalgias, worsening over the course of days.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Daughter complained of extreme pain in leg a couple hours after the shot. I checked the site of injection and felt that her entire thigh was swollen, rock hard and extremely hot. I was worried and called the doctor when they opened the next morning. They said to give her an epsom salt bath with lavendar essential oil, and if it didn't improve by morning, to schedule a chiropractor visit for a mudding treatment to draw out the irritation. I did as instructed, but there was no improvement, and my daughter was limping from the pain. This was her third DTaP shot. I don't remember the others giving such a bad reaction. The chiropractor adjusted her and sent us home with bontonite clay and spagyric greens. We gave the greens in her juice for the next few days and applied the bentonite clay topically to the site. There was a 75% improvement by morning the next day, and it continued to improve with the clay treatment and greens. She was probably 100% better 6 days after shot.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with (Oka/Merck) VARIVAX (route, dose, Lot# and expirationd date not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. 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: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with (Oka-Merck) PROQUAD (route and dose not reported, Lot# L002419 and expiration date 23-JUL-2016), which were exposed to temperatures outside of the recommended range. No adverse effect had been 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: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (lot#, expiration date, dose and route were unknown). No adverse events were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with improperly stored GARDASIL. No adverse effects were reported. No product quality complaint was reported for GARDASIL. This is one of the several reports 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 a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with improperly stored ROTATEQ. No adverse effects were reported. No product quality complaint was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse who is a patient (age unspecified). The patient's concurrent condition and medical history was not provided. On 05-DEC-1991, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 07-JAN-1992 with the second dose and on 09-JUN-1992 the patient was vaccinated with the third dose of RECOMBIVAX HB. The patient sought medical attention from unspecified healthcare providers to have her hepatitis B surface antibodies obtained. The result of a titer for hepatitis B surface antibodies drawn on 27-NOV-1992 was positive. The result of testing for hepatitis B surface antibodies obtained on 09-APR-2015 was non-reactive. No further information was provided. No treatment was given for the event. The outcome of the event of hepatitis B surface antibodies was non-reactive was not recovered. The casuality was not provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient's pertinent medical history was not reported. She had none drug reactions or allergies. Concomitant therapies included zonisamide, lamotrigine, LYRICA, BETIMOL and vitamin d (unspecified). On 01-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose was unknown) subcutaneous, lot # K020186, expiration date 27-JAN-2016. On approximately 02-MAY-2015 (reported as "on either 02-MAY-2015 or 03-MAY-2015"), the patient began to develop a rash at the site of ZOSTAVAX injection. The patient sought medical attention - she called the pharmacist. None lab diagnostics studies were performed. The outcome of injection site rash was reported as not recovered. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 42 year old male patient. The patient's medical history, concurrentt conditions and concomitant medications were not reported. The nurse reported to the pharmacist that on 22-APR-2015 (also reported as "three weeks ago") the patient was vaccinated with PNEUMOVAX 23 lot # K012424, expiry date: 05-JUN-2016, in the unspecified arm. On the following day (estimated date: 23-APR-2015) the patient range the medical office and reported the upper arm swelling, redness and tenderness extending from the shoulder to the elbow of the arm where he received the vaccine. He was advised to seek a medical atttention at the emergency room in the hospital where he received an unspecified injection as a treatment. The patient was discharged from the emergency room to home with no further issues. Lot check of the PNEUMOVAX 23 was requested by the physician. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to a pediatric patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date in 2012, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route unspecified). On 22-APR-2015, the patient was vaccinated with second dose of GARDASIL. The reporter was enquiring whether the patient can be give third dose in 4 months or should not count the first dose. The outcome of the event was unknown. The causality of the event with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about patient's medical history was not provided. On 15-MAY-2015, the patient was vaccinated with a dose of improperly stored MMR II (therapy type: unknown) (dose, frequency and route of administration were not specified, lot # K020188, expiration date: 22-OCT-2016). Concomitant medications was not reported. No adverse event was reported. No product quality complaintt 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 two patient of unknown age. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, (lot number and expiry date was not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a company representative concerning three patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, route, lot# and expiration date unknown). It was reported that three patients fainted in the office after receipt of GARDASIL. The physician noted that these patients (names unspecified) recovered shortly after fainting. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haemorrhage, Wound
Clinical narrative: Patient came in with bloody open wound on arm. She says that it has been bleeding since receiving flu shot. Recommended that she see her doctor.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There was no information on patient's concurrent conditions, medical history or concomitant therapies reported. On an unknown date, the patient was administered two doses of MMR II (albumin status unknown) (lot #, expiration date, route of administration and indication were not provided). No adverse effect was reported. Additional information is not expected.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 12 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 13-MAY-2015 the patient was inadvertently vaccinated with a 1 ml dose of VAQTA, as their second dose in the series, intramuscularly (lot # and application site were not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 26 year old female patient. Information regarding concurrent conditions and medical history was not provided. On 04-MAY-2015 the patient was vaccinated with her third dose of GARDASIL, 0.5 ml, intramuscularly (lot # and application site were not reported). Concomitant therapy was not reported. Nurse reported patient had received the second dose of GARDASIL, in late August 2014. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Glossodynia, Oral herpes, Rash erythematous, Stomatitis, Swollen tongue
Clinical narrative: This spontaneous report as received from a female consumer of unknown age regarding herself. The patient's concurrent condition and medical history was not provided. The patient's drug reactions/allergies included penicillin and codeine. On an unknown date in January 2015 (reported as second week of January 2015), the patient was vaccinated with ZOSTAVAX 1 single shot, injection (route and dose unspecified). On an unknown date in January 2015 (reported as one hour after receiving ZOSTAVAX), the patient experienced a long red rash on her arm that lasted 7-8 days. After the rash went away, the patient experienced cold sore on her bottom lip that lasted for 5-6 days on an unknown date in January 2015. On an unknown date in January 2015 (reported as lasted for 5-6 days), the cold sores went away. On an unknown date in 2015, the patient developed a cluster of white sores on the inside of her mouth that spread to her tongue. Patient stated that the sores had healed (Recovered/Resolved with Sequelae) but the left side of her tongue remains sore and swollen. The outcome of the event left side of her tongue remains sore and swollen was reported as not recovered. The patient sought medical attention reported as visited the physician. The reporter causality was not provided. No product quality complaint was reported. No further AE information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Tongue ulceration
Clinical narrative: This spontaneous report as received from a female consumer of unknown age regarding herself. The patient's concurrent condition and medical history was not provided. The patient's drug reactions/allergies included penicillin and codeine. On an unknown date in January 2015 (reported as second week of January 2015), the patient was vaccinated with ZOSTAVAX 1 single shot, injection (route and dose unspecified). On an unknown date in January 2015 (reported as one hour after receiving ZOSTAVAX), the patient experienced a long red rash on her arm that lasted 7-8 days. After the rash went away, the patient experienced cold sore on her bottom lip that lasted for 5-6 days on an unknown date in January 2015. On an unknown date in January 2015 (reported as lasted for 5-6 days), the cold sores went away. On an unknown date in 2015, the patient developed a cluster of white sores on the inside of her mouth that spread to her tongue. Patient stated that the sores had healed (Recovered/Resolved with Sequelae) but the left side of her tongue remains sore and swollen. The outcome of the event left side of her tongue remains sore and swollen was reported as not recovered. The patient sought medical attention reported as visited the physician. The reporter causality was not provided. No product quality complaint was reported. No further AE information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to an unspecified patient. Patient medical history and current condition was not reported. On 08-MAY-2015 the patient was vaccinated with improperly stored dose of VAQTA (unspecified strength, dose and frequency). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as recevied from a physician and healthcare worker regarding an unspecified patients of unknown age and demographics. The patients' concurrent condition and medical history was not reported. On an unknown date, the unspecified patients were vaccinated with ROTATEQ lot # K007911; expiry date 29-MAR-2016 (dose and route of administration was unspecified) which was inadvertently and improperly stored at 52 Fahrenheit for 2 hours. No adverse effects were reported. No product quality complaint was reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal eruption
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (route, lot# and expiration date unknown). On an unknown date the patient developed an unspecified rash  a month after receiving ZOSTAVAX. The patient said that the rash cleared (recovered) within two days after it appeared. The reporting pharmacist was offered the varicella zoster virus (VZV) information but declined. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with GARDASIL (route, dose, lot# and expiration date not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of 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 concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with RECOMBIVAX HB (route, dose, Lot# and expiration date not reported), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored (Merck) VARIVAX (strength, dosage, frequency and route unspecified) (Lot reported as K015375 with expiration date 18-SEP-2016, Lot reported as K018990 with expiration date 15-OCT-2016, Lot reported as K011317 with expiration date 13-AUG-2016 and Lot reported as K016153 with expiration date 24-SEP-2016) or improperly stored MMR II rHA, (strength, dosage, frequency and route unspecified) (Lot reported as K021930 with expiration date 10-NOV-2016, Lot reported as K021487 with expiration date 03-NOV-2016 and Lot reported as L001329 with expiration date 13-JAN-2017) (incorrect product storage). It was unspecified exactly which the lot % vaccine the patient was given. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Product and narrative were updated.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Lightheadedness.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fatigue, anorexia, fever up to 104.6 for 3-4 days then low grade fever for a few more days as energy slowly came back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Inject site swelling with redness, redness then continued to entire upper arm. Patient said it wasn't painful and had minimal itching. Patient then visited physician for additional relief as the redness continued to spread.
Age: 0.69
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Dyspnoea, Productive cough, Pyrexia, Sputum discoloured
Clinical narrative: Per mom, developed a wet raspy cough with green mucus, fever, and trouble breathing. Mother did not seek medical care and believes it was caused by flu vaccine.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling at the site of injection 2 x 2 cm in diameter. Raised given BENADRYL in office observed for 1 hr. (L) leg MMR/Varicella.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Right side of back, 2 large blisters, 1 small blister. No pain, no itching. Pt F/U MD but no treatment prescribed. Blisters reduced.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site starting in the night on day of administration. Tender to touch 3cm subcutaneous swelling over left deltoid. No fluctuance. PRN Rx of cephalexin 250mg/5ml 5ml QID to be used only if symptoms worsen.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Diarrhoea, Dizziness, Dysuria, Injection site erythema
Clinical narrative: Rec MMR 5-8-15; 5/9/15 experienced nausea, dizziness, pain at inj. site, felt warm. 5-18-15 c/o inc. nausea, loose stools, chills. Also, c/o pain prior to and at end of urination. Still sl. tender/red inj. site.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Mumps antibody test negative, Nausea, Red blood cells urine positive, Skin warm
Clinical narrative: Rec MMR 5-8-15; 5/9/15 experienced nausea, dizziness, pain at inj. site, felt warm. 5-18-15 c/o inc. nausea, loose stools, chills. Also, c/o pain prior to and at end of urination. Still sl. tender/red inj. site.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: White blood cells urine negative
Clinical narrative: Rec MMR 5-8-15; 5/9/15 experienced nausea, dizziness, pain at inj. site, felt warm. 5-18-15 c/o inc. nausea, loose stools, chills. Also, c/o pain prior to and at end of urination. Still sl. tender/red inj. site.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: Pt stated she received the Prevnar shot on Friday, and had diarrhea on Monday morning.  Pt did not seek medical attention as symptoms resolved.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Peripheral swelling, Throat irritation
Clinical narrative: Arm redness and swelling, itchy throat.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site warmth, Malaise, Tremor
Clinical narrative: Didn't feel well and had shakes and chills.  Also had Bright redness, Hot to touch, from injection site to 1 inch above elbow. Patient did not report this for 5 days after injection  Treated with ice and allergy med.