chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. An unspecified number of patients received GARDASIL that was improperly stored by being exposed to 34F for 3 days, 33F for 2 days, 34F for 2.5 days, 32F for 0.5 days, and 30F for 30 minutes. The dates of the temperature excursions were unspecified. The medical assistant stated the vaccines dropped down to 32 F and 30 F for a total of 13 hours on 02-AUG-2012. The temperatures listed for 34 F and 33 F were prior to 02-AUG-2012. GARDASIL (lot number 670049/1261AA, expired date 11-NOV-2013) administered on 06-AUG-2012, 07-AUG-2012, 08-AUG-2012 and 10-AUG-2012. GARDASIL (lot number 671006/1291AA, expired date 12-APR-2014) administered on 15-AUG-2012 and 22-AUG-2012. No known adverse effects. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site is warm, reddish coloured and somewhat sore, ice packs are recommended, TYLENOL & BENADRYL too.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dyskinesia, Feeling hot, Oxygen saturation decreased
Clinical narrative: Pt. received TDAP. Approx 20 min later pt. complained of lightheadness, feeling warmth all over body. Pt. placed on supine position evaluated by 2 physicians, 1 RN. Pt has involuntary movement all over body, with O2 sat of 71%. Placed on 2 liter O2 and transported to ER for further evaluation.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain
Clinical narrative: Pt. state soreness, and redness. RPh - observe redness span 3 inches all direction from injection site.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age. The patient was administered intramuscularly the three doses in the GARDASIL vaccination schedule on 21-OCT-2011; 21-NOV-2011 and 20-FEB-2012 respectively. The outcome was unknown. It was unknown if the patient had sought medical attention. No adverse effect reported. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Feeling hot, Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: 1430 11/06/12 - vaccines given. 1700 11/06/12 - Mother noticed tactile fever. Mother gave ibuprofen every 4hrs - felt warm & irritable all night. 0700 11/07/12 - Mom noticed bulging fontanelle. Mom brought child to ED but left after noticing sunken fontanelle at 8:30 AM. Then at 1000 AM noticed bulging fontanelle.
Age: 1.81
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Today Mom reported that her son developed hives over his body 1/2 hour after he rec'd his 1st HAV on 1-20-2012. They were at home and Mom 1st noticed them during a diaper change. No resp. trouble was noted. Mom did not treat them with any meds. and they resolved. Mom did not report this to us until today. Dr. told this RN "not" to give the HAV #2 today.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Culture, Ear pain, Myringitis bullous, Secretion discharge
Clinical narrative: 3 days after FLUMIST developed bilateral ear pain & serous drainage. Seen 5 days after FLUMIST & has bilateral bullous myringitis with draining bullae.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Blister, Ear pain
Clinical narrative: 3 day after FLUMIST developed severe (R) otalgia. Seen 5th day post vaccine found large bulla (R) TM without any Sx of a URI.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash macular
Clinical narrative: This spontaneous report as received from a 86 years old male patient with colon cancer, breast cancer and drug allergy to naperson refers to himself. The patient was vaccinated with ZOSTAVAX (lot # unknown) subcutaneous 5 years ago (approximately in October 2007). No other co-suspects were reported. Concomitant medications included ZOVIRAX and cephalexin. On 10-OCT-2012 the patient experienced blotch on his left thigh, which was diagnosed by his physician as shingles. The patient had not had shingles prior. There was no treatment information and no lab was given for the event. The outcome of shingles was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 70 year old female patient with no pertinent medical history. Patient current condition included sulfa and naloxone allergy. On 03-OCT-2012, the patient was vaccinated with a dose of 0.65 milliliter ZOSTAVAX, subcutaneously in the left arm. Lot number and expiry date was reported as H011430 and 12-SEP-2013 respectively. No concomitant medications were reported. On 05-OCT-2012, the patient entire left arm was red, itchy, swollen and tender to the touch. The patient called to the pharmacist and visited to her daughter who was a nurse. The patient was treated with hot compress, hydrocortisone and BENADRYL cream. No laboratory studies were performed. The outcome of entire left arm was red, itchy, swollen and tender to the touch was reported as resolving as the swelling and itching went down and localized at injection site. The relatedness for entire left arm was red, itchy, swollen and tender to the touch was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 70 year old female patient with no pertinent medical history. Patient current condition included sulfa and naloxone allergy. On 03-OCT-2012, the patient was vaccinated with a dose of 0.65 milliliter ZOSTAVAX, subcutaneously in the left arm. Lot number and expiry date was reported as H011430 and 12-SEP-2013 respectively. No concomitant medications were reported. On 05-OCT-2012, the patient entire left arm was red, itchy, swollen and tender to the touch. The patient called to the pharmacist and visited to her daughter who was a nurse. The patient was treated with hot compress, hydrocortisone and BENADRYL cream. No laboratory studies were performed. The outcome of entire left arm was red, itchy, swollen and tender to the touch was reported as resolving as the swelling and itching went down and localized at injection site. The relatedness for entire left arm was red, itchy, swollen and tender to the touch was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old female patient. The patient was vaccinated with ZOSTAVAX on 09-OCT-2012, subcutaneously in the left arm (dose and Lot # were not reported). No other co-suspects were reported. No concomitant medications were reported. At the end of October 2012 (reported as "in the last few days") the patient developed persisting, tingling left arm pain radiating to the fingers. The patient has noticed decreased grip strength in the left hand. No treatment was provided for the AEs. The outcome of decreased grip strength in the left hand, has developed persistent, tingling left arm pain radiating to the fingers, decreased grip strength in the left hand and tingling left arm was not reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unknown number of patients of unknown age and gender. The patients were vaccinated with PEDVAXHIB (lot # dose and route not reported). No concomitant medications were reported. The nurse reported that unknown number of patients received improperly stored PEDVAXHIB. The vaccine was exposed to 0 degree centigrade (0 C) for 60 days. No adverse effects reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient, with drug reaction/allergy to sulfa and who is prone to skin cancer, and sees a dermatologist every 6 moths. The patient was vaccinated with lot # 0366AE (exp date 23-MAR-2013), 0.65 ml ZOSTAVAX on 14-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. ON 24-AUG-2012 (approximately 10 days post vaccination) the patient developed itchy blisters on the right arm. The patient was treated with Calamine Lotion and Cortisone. Three weeks after getting vaccinated with ZOSTAVAX the patient got vaccinated with an unspecified flu vaccine, it was unknown in which arm. The outcome of itchy blisters on the right arm was reported as not recovered/not resolved. The relatedness for itchy blisters on the right arm was not reported for ZOSTAVAX. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 years old male patient. The primary reporter is pharmacist. Pharmacist called to report that an unspecified patient received ZOSTAVAX vaccination at an unspecified healthcare facility by an unspecified healthcare provider on 01-NOV-2012 and developed a round oval rash 3 inches in diameter at the injection site a couple of days later after vaccination. No further information is available. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection site pruritus. No treatment information was reported. The relatedness for injection site pruritus is unknown for ZOSTAVAX. {Additional information has been requested./Additional information is not expected.}
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report as received from a bachelor of science in nursing (nurse) refers to a 79-year-old female patient. The patient had drug reactions/allergies to penicillin and hydrochlorothiazide (manufacturer unknown). On 27-SEP-2012 the patient was vaccinated with, 0.5 millilitre (ml) PNEUMOVAX 23 (lot # reported as H13581 in validation process, expiration date 15-MAR-2014) (reported as 10 vials of 1) intramuscularly in her left arm. Concomitant medications included FLUOXETINE, ATENOLOL, LIPITOR, PROTONIX, SYNTHROID, MECLIZINE and TRANXENE. Nurse reported that the patient had severe local reactions. The patient came back to the office on 28-SEP-2012 (reported as next day) with erythema, mild swelling towards her bicep and warmth around injection site. Physician recommended TYLENOL and BENADRYL for symptomatic relief. No lab studies were performed. The outcome of the events were unknown at the time of this report. The patient sought medical attention at office visit. This is one of the several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Full blood count, Herpes simplex serology positive, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a 60-year-old female patient regarding herself. Current conditions included rosacea and high blood pressure. Patient was allergic to penicillin, morphine and unspecified antibiotics, patient experienced a rash due to these drugs. On 19-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) dose and route not reported. Concomitant medications included: spironolactone for rosacea (reported as roseasea) and high blood pressure. On 18-AUG-2012 patient underwent tuberculosis (TB) skin test, results were unknown. Patient explained that approximately on 21-SEP-2012 (reported as 2 days later) she developed a large bruise on the back of her arm that was very feverish and painful, like being shot with a paint ball. She explained that the bruise lasted 3-4 days approximately till an unknown date in September 2012 and healed on its own. She explained that on 10-SEP-2012 she underwent STD (Sexually transmitted diseases) testing and showed positive antibodies for herpes 2. She explained that she had no other effects other than the abnormal test results and the initial bruising. No treatment was given for the events. Herpes Simplex Zoster (HSZ) 2 testing had been conducted within a full blood panel. New testing will be taken on 09-NOV-2012 or 10-NOV-2012. Medical attention was sought for the events. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tuberculin test
Clinical narrative: This spontaneous report was received from a 60-year-old female patient regarding herself. Current conditions included rosacea and high blood pressure. Patient was allergic to penicillin, morphine and unspecified antibiotics, patient experienced a rash due to these drugs. On 19-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) dose and route not reported. Concomitant medications included: spironolactone for rosacea (reported as roseasea) and high blood pressure. On 18-AUG-2012 patient underwent tuberculosis (TB) skin test, results were unknown. Patient explained that approximately on 21-SEP-2012 (reported as 2 days later) she developed a large bruise on the back of her arm that was very feverish and painful, like being shot with a paint ball. She explained that the bruise lasted 3-4 days approximately till an unknown date in September 2012 and healed on its own. She explained that on 10-SEP-2012 she underwent STD (Sexually transmitted diseases) testing and showed positive antibodies for herpes 2. She explained that she had no other effects other than the abnormal test results and the initial bruising. No treatment was given for the events. Herpes Simplex Zoster (HSZ) 2 testing had been conducted within a full blood panel. New testing will be taken on 09-NOV-2012 or 10-NOV-2012. Medical attention was sought for the events. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. An unspecified number of patients received either VAQTA that was improperly stored by being exposed to 34F for 3 days, 33F for 2 days, 34F for 2.5 days, 32F for 0.5 days, and 30F for 30 minutes. The medical assistant stated the vaccines dropped down to 32 F and 30 F for a total of 13 hours on 02-AUG-2012. The temperatures listed for 34 F and 33 F were prior to 02-AUG-2012. VAQTA (lot number reported as 1228AA, expired date 16-JUN-2014) administered on 10-AUG-2012, 20-AUG-2012, 24-AUG-2012 and 31-AUG-2012. The dates of the temperature excursions were unspecified. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patient of unknown age. An unspecified number of patients received RECOMBIVAX HB that was improperly stored by being exposed to 34F for 3 days, 33F for 2 days, 34F for 2.5 days, 32F for 0.5 days, and 30F for 30 minutes. The medical assistant stated the vaccines dropped down to 32 F and 30 F for a total of 13 hours on 02-AUG-2012. The temperatures listed for 34 F and 33 F were prior to 02-AUG-2012. RECOMBIVAX HB (lot number reported as 0020AE, expired date 10-JUN-2014) administered on 03-AUG-2012, 06-AUG-2012, 07-AUG-2012, 08-AUG-2012, 09-AUG-2012, 15-AUG-2012, 20-AUG-2012, 22-AUG-2012, 27-AUG-2012, 28-AUG-2012and 29-AUG-2012. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a pediatric patient of unknown age. The pediatric patient received the third dose of RECOMBIVAX HB (dose and lot # were unknown) today (on 08-OCT-2012) which was early. The second dose was given on 06-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. 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 physician refers to a patient of unknown age. The patient received the first dose of GARDASIL on 16-MAY-2008 and the second dose on 04-OCT-2012. No adverse effect reported. The outcome was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months old female patient. The patient had no relevant medical history and used no concomitant medication. Past drug history included ZANTAC. The patient was vaccinated orally with a dose ROTATEQ (reported lot number 1033AA; expiry date 22-OCT-2012) on 29-OCT-2012. The patient was administered expired ROTATEQ. The case was reported a few minutes after expired vaccines was given. It was unknown whether the infant would have another dose of ROTATEQ. Patient outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abasia, Arthralgia, Joint swelling, Oedema peripheral, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 60 years old male patient with hypertension, hepatitis C, type II diabetes and heartburn. The patient had no known drug allergies. The patient was vaccinated with dose 1 of ZOSTAVAX (lot number not specified) in his left arm on 08-JUL-2012. Route was unknown. No other co-suspects were reported. Concomitant medications included carvedilol, metformin, EDECRIN, amlodipine, lisinopril and ZANTAC. On 10-JUL-2012 the patient began experiencing left foot swelling, left ankle swelling, left foot pain, "could not walk" and "hurting". These events subsided in August 2012 and then he began having right foot swelling, right foot pain, right ankle pain, "could not walk" and "hurting". The patient was started on gabapentin 300 mg, 2 tabs twice daily, as treatment for these events. The patient did not have any results of labs that have been done. As of 29-OCT-2012, all events except the right foot swelling had resolved. The patient's physician was aware of the events. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 60 years old male patient with hypertension, hepatitis C, type II diabetes and heartburn. The patient had no known drug allergies. The patient was vaccinated with dose 1 of ZOSTAVAX (lot number not specified) in his left arm on 08-JUL-2012. Route was unknown. No other co-suspects were reported. Concomitant medications included carvedilol, metformin, EDECRIN, amlodipine, lisinopril and ZANTAC. On 10-JUL-2012 the patient began experiencing left foot swelling, left ankle swelling, left foot pain, "could not walk" and "hurting". These events subsided in August 2012 and then he began having right foot swelling, right foot pain, right ankle pain, "could not walk" and "hurting". The patient was started on gabapentin 300 mg, 2 tabs twice daily, as treatment for these events. The patient did not have any results of labs that have been done. As of 29-OCT-2012, all events except the right foot swelling had resolved. The patient's physician was aware of the events. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 58 years old female patient with rheumatoid arthritis. The patient's medical history included chickenpox in her childhood. The patient's relevant past drug history was unknown. The patient was vaccinated with a dose of VARIVAX (reported lot number 0048AE; expiry date 20-DEC-2013) on 29-OCT-2012. Route was unknown. No other co-suspects were reported. Concomitant medications included acid and methotrexate. On 29-OCT-2012 the patient was accidentally administered VARIVAX (merck) instead of the prescribed ZOSTAVAX (Merck). The status of the patient after accidental administration of VARIVAX (merck) was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that on approximately 05-OCT-2012 the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. No laboratory diagnostic test were performed. The patient sought medical attention by notifying the physician. The physician was inquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. There were no laboratories diagnostic test performed. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX23 and was it possible that this lot of PNEUMOVAX23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with PNEUMOVAX 23 (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, RECOMBIVAX HB, PEDVAXHB and VAQTA that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 for 15 minutes is also reported. This information is processed in the linked cases: 1210USA007111, 1211USA001296, 1211USA001297 and 1211USA001298. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with MMR II. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired vaccine used. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to MMR II. (Lot # 0496AE) on 10/27/2012 that expired on 10/26/2012. NO adverse effect has been observed or reported. No additional information currently available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 25-OCT-2012, the patient received a dose of intramuscular VARIVAX (Merck) (lot#, dose and frequency not provided) instead of ZOSTAVAX. No adverse symptoms reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. A patient who received first 0.5 mL dose of an unspecified hepatitis B vaccine on 04-AUG-2009, and received his second dose of an unspecified hepatitis B vaccine on 04-NOV-2009, would receive his third dose of RECOMBIVAX HB on 22-OCT-2012. No adverse effect reported. No other information was available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. When reconstituting ZOSTAVAX refrigerated the solution became foamy. The pharmacist was unable to draw the full 0.65 mL, and administered only about 0.5 mL to an unspecified number of patients. No adverse effects were reported. No additional information provided. PQC filled. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 64 years old patient with vaccine for shingles. The patient was vaccinated with ZOSTAVAX on 02-NOV-2012. No other co-suspects were reported.  No concomitant medications were reported. On an unknown date the patient experienced expired drug administered. No treatment information was reported. The outcome of expired drug administration is unknown. Expired drug administered is not related to ZOSTAVAX. Lot # 1199AA, expiry date 10/25/2012. No further information available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 75-year-old male patient with no drug reactions/allergies. Current conditions included diabetes and high cholesterol. On 22-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #0423AE in verification process, expiration date 02-APR-2013) dose and route not reported. Concomitant medications included unspecified medication for diabetes and high cholesterol. The physician reported that the patient developed shingles following vaccination with ZOSTAVAX on 31-OCT-2012. Treatment was not given for the event. No laboratory diagnostic studies were performed. The patient sought medical attention by contacting the office. The event did not resolve at the time of this report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 05-NOV-2012, was vaccinated with a dose of PNEUMOVAX23 (lot number 667695/1028Z) (route and dose not reported) that was expired. The vaccine expired on 28-JAN-2012. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 age. The patient was vaccinated with dose 1 ZOSTAVAX in 2009. No other co-suspects were reported. No concomitant medications were reported. On 02-NOV-2012 the patient received a 2nd dose of ZOSTAVAX. The patient is not experiencing any known symptoms. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: This patient was given a subcutaneous injection of Merck brand varicella zoster vaccine -ZOSTAVAX- in the right deltoid area in the early afternoon of 10/16/2012. The reaction began as a vague soreness at the area of injection in the evening. The patient reported that the reaction reached its peak the next day with a tennis ball sized lump at the site of injection accompanied by redness, warmth and was sore to the touch. She also reported body aches and headache. The patient had read the literature provided and correctly applied ice and took acetaminophen for her symptoms. On the second day, the above symptoms were still present but had diminished. Today she reports that symptoms of soreness at the site of injection are still present but slight. The lump has disappeared along with the systemic symptoms described above.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This patient was given a subcutaneous injection of Merck brand varicella zoster vaccine -ZOSTAVAX- in the right deltoid area in the early afternoon of 10/16/2012. The reaction began as a vague soreness at the area of injection in the evening. The patient reported that the reaction reached its peak the next day with a tennis ball sized lump at the site of injection accompanied by redness, warmth and was sore to the touch. She also reported body aches and headache. The patient had read the literature provided and correctly applied ice and took acetaminophen for her symptoms. On the second day, the above symptoms were still present but had diminished. Today she reports that symptoms of soreness at the site of injection are still present but slight. The lump has disappeared along with the systemic symptoms described above.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin reaction, Skin warm, Swelling
Clinical narrative: Pt was administered vaccine 11/03/2012 (ZOSTAVAX). Pt came back Monday 11/05/12 with area red, swollen and warm. Pt was recommended BENADRYL & ibuprofen.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On 29-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly (also reported as unknown route) (dose and lot number unspecified) that had expired on 18-AUG-2012. No concomitant medications were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Food poisoning, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old male patient with penicillin allergy and septra allergy and no medical history. The patient was intramuscularly vaccinated with PNEUMOVAX 23 (lot # H010661/exp 02-FEB-2014 as reported) on 12-OCT-2012 for revaccination (patient had vaccine 6 years ago). There was no concomitant medications. On 12-OCT-2012 the patient developed pain, redness, swelling and itching at the injection site and also having food poisoning after receiving the vaccine. The patient sought medical attention. TYLENOL and ice were given for the treatment and no lab test was performed. The outcome of the adverse events was reported as not recovered/ not resolved. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient. The patient had no pertinent medical history and no drug reaction. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number reported as H011052, expire date 05-SEP-2013) subcutaneously on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned the patient received ZOSTAVAX around 1:30pm on 16-OCT-2012 and the patient called 1 hour later to report cramps in the left ankle that was pretty painful and radiating from the site. No treatment was given for adverse event. No laboratory diagnostics studies were performed. The outcome of adverse events was reported as not recovered. The patient had sought medical attention via phone call to pharmacist. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Cellulitis, Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report as received from a physician refers to a 21 years old female patient with asthma and allergies. The patient was vaccinated with PNEUMOVAX23 (lot# reported as 1947aa, expire date 20-OCT-2013) subcutaneous injection in left arm on 24-JUL-2012. No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and albuterol. On 24-JUL-2012 the patient experienced a localized severe reaction. Injection site started out as a red swollen quarter size area on patient left arm and by day three(on approximately 26-JUL-2012) patient's entire upper arm from her left armpit down to her elbow was swollen, itchy, red and in pain. (No anaphylaxis) Patient also experienced a fever (no shortness of breath) with this site reaction. Patient was hospitalized for 4 days as treatment information and sought medical attention. Name of hospital, city are unknown. The patient had completed unknown labs at hospital. The outcome was reported as recovered on 30-JUL-2012. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Rash macular
Clinical narrative: This spontaneous report as received from a physician refers to a 21 years old female patient with asthma and allergies. The patient was vaccinated with PNEUMOVAX23 (lot# reported as 1947aa, expire date 20-OCT-2013) subcutaneous injection in left arm on 24-JUL-2012. No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and albuterol. On 24-JUL-2012 the patient experienced a localized severe reaction. Injection site started out as a red swollen quarter size area on patient left arm and by day three(on approximately 26-JUL-2012) patient's entire upper arm from her left armpit down to her elbow was swollen, itchy, red and in pain. (No anaphylaxis) Patient also experienced a fever (no shortness of breath) with this site reaction. Patient was hospitalized for 4 days as treatment information and sought medical attention. Name of hospital, city are unknown. The patient had completed unknown labs at hospital. The outcome was reported as recovered on 30-JUL-2012. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Laboratory test
Clinical narrative: This spontaneous report as received from a physician refers to a 21 years old female patient with asthma and allergies. The patient was vaccinated with PNEUMOVAX23 (lot# reported as 1947aa, expire date 20-OCT-2013) subcutaneous injection in left arm on 24-JUL-2012. No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and albuterol. On 24-JUL-2012 the patient experienced a localized severe reaction. Injection site started out as a red swollen quarter size area on patient left arm and by day three(on approximately 26-JUL-2012) patient's entire upper arm from her left armpit down to her elbow was swollen, itchy, red and in pain. (No anaphylaxis) Patient also experienced a fever (no shortness of breath) with this site reaction. Patient was hospitalized for 4 days as treatment information and sought medical attention. Name of hospital, city are unknown. The patient had completed unknown labs at hospital. The outcome was reported as recovered on 30-JUL-2012. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Local reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 21 years old female patient with asthma and allergies. The patient was vaccinated with PNEUMOVAX23 (lot# reported as 1947aa, expire date 20-OCT-2013) subcutaneous injection in left arm on 24-JUL-2012. No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and albuterol. On 24-JUL-2012 the patient experienced a localized severe reaction. Injection site started out as a red swollen quarter size area on patient left arm and by day three(on approximately 26-JUL-2012) patient's entire upper arm from her left armpit down to her elbow was swollen, itchy, red and in pain. (No anaphylaxis) Patient also experienced a fever (no shortness of breath) with this site reaction. Patient was hospitalized for 4 days as treatment information and sought medical attention. Name of hospital, city are unknown. The patient had completed unknown labs at hospital. The outcome was reported as recovered on 30-JUL-2012. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 59 years old female patient who was not pregnant at reporting time with no drug reactions/allergies. The patient was vaccinated subcutaneously with 0.5 ml PNEUMOVAX 23 (lot # 669379/0453AA, expiration date 03-AUG-2012) on 12-OCT-2012. The patient received an unspecified flu vaccine (manufacturer unknown) on 27-SEP-2012 in the same arm but it was given intramuscularly and the patient did not have any problems. Concomitant medications included amlodipine, SINGULAIR and LYRICA. On 12-OCT-2012 later that night after vaccination, the patient experienced swelling, redness, hot to touch, and sore elbow. The reaction was the back of the arm surrounding the injection site that went from the elbow to almost the shoulder. The patient visited to pharmacy for medical attention. Ibuprofen was given for treatment. No laboratory diagnostics studies were performed. The outcome of swelling, redness, hot to the touch and sore elbow was reported as recovering/resolving. This had already been reported to VAERS. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired drug administered, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 59 years old female patient who was not pregnant at reporting time with no drug reactions/allergies. The patient was vaccinated subcutaneously with 0.5 ml PNEUMOVAX 23 (lot # 669379/0453AA, expiration date 03-AUG-2012) on 12-OCT-2012. The patient received an unspecified flu vaccine (manufacturer unknown) on 27-SEP-2012 in the same arm but it was given intramuscularly and the patient did not have any problems. Concomitant medications included amlodipine, SINGULAIR and LYRICA. On 12-OCT-2012 later that night after vaccination, the patient experienced swelling, redness, hot to touch, and sore elbow. The reaction was the back of the arm surrounding the injection site that went from the elbow to almost the shoulder. The patient visited to pharmacy for medical attention. Ibuprofen was given for treatment. No laboratory diagnostics studies were performed. The outcome of swelling, redness, hot to the touch and sore elbow was reported as recovering/resolving. This had already been reported to VAERS. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Burning sensation, Chest pain, Cough, Ocular hyperaemia
Clinical narrative: Red eyes, cough, chest pain, loss of voice, throat irritation (burning sensation down throat and into lungs when inhaling).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Red eyes, cough, chest pain, loss of voice, throat irritation (burning sensation down throat and into lungs when inhaling).
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Worst headache (9/10), nausea, vomiting, upset stomach, felt like I had a fever.
Age: 40.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Axillary pain, Injection site pain, Pain, Pyrexia
Clinical narrative: High fever >101 degrees. Shaking. Aching; whole body, especially joints soreness at injection site and under arm on torso. Self Treated with Acetaminophen and Ibuprofen.
Age: 40.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Tremor
Clinical narrative: High fever >101 degrees. Shaking. Aching; whole body, especially joints soreness at injection site and under arm on torso. Self Treated with Acetaminophen and Ibuprofen.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Burning, itching, redness and swelling at vaccination site. No treatment yet.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Urticaria
Clinical narrative: ARM FELT WARM & SLIGHTLY ITCHY ABOUT 2 INCH WELT THIS MORNING 11/08/2012 7:00 AM FEELS MORE PAINFUL & SLIGHTLY ITCHY ABOUT 2 INCH RED WARM WELT.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Pain, hard lump, red, warm, bruising, entire upper arm swelled up, some itching.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: Pain, hard lump, red, warm, bruising, entire upper arm swelled up, some itching.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Contusion, Oedema peripheral, Skin warm
Clinical narrative: Pain, hard lump, red, warm, bruising, entire upper arm swelled up, some itching.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Culture throat positive, Full blood count, Influenza virus test positive, Pain in extremity
Clinical narrative: AFTER RECEIVING THE FLU MIST 30 MIN'S LATER COMPLAINED ABOUT STOMACH HURTING. BY THE TIME WE GOT HOME AT 4:00PM THAT DAY HE HAD TEMP. OF 102% AND CONTINUED THROUGH THE NIGHT CALL THE DR. NEXT DAY.  THEY DID NOT GET BACK WITH ME.  GAVE HIM TYLENOL ALT. WITH ADVIL ALL THAT WEEKEND FEVER 102-103 AND HE WAS COMPLAINING OF ACHES IN LEGS. FEVER CAME DOWN WITH MEDICATION AS SOON AS WORE OFF CAME BACK. TOOK HIM BACK TO DR. MONDAY 11/5/2012 SHE SAID IT WAS ALLERGIES.  GAVE HIM MEDS FOR ALLERGY NASONEX AND CLARITIN.  TUESDAY NO BETTER SLEEP ALL DAY AND STILL HAS FEVER GOING ON 6 DAY'S. WENT BACK TO DR. WEDNESDAY TESTED POSITIVE FOR FLU AND STREP.  TAKING TAMAFLU AND TYLENOL AND ADVIL. SEEMS TO BE DOING BETTER BUT STILL HAS FEVER IF NOT MEDICATED ON TIME BUT NOT AS HIGH. DR. SAID HE WOULD BE BETTER BY THIS MONDAY 11/12/12 AND COULD GO BACK TO SCHOOL. WE ARE SURE HOPING SO.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Streptococcus test positive
Clinical narrative: AFTER RECEIVING THE FLU MIST 30 MIN'S LATER COMPLAINED ABOUT STOMACH HURTING. BY THE TIME WE GOT HOME AT 4:00PM THAT DAY HE HAD TEMP. OF 102% AND CONTINUED THROUGH THE NIGHT CALL THE DR. NEXT DAY.  THEY DID NOT GET BACK WITH ME.  GAVE HIM TYLENOL ALT. WITH ADVIL ALL THAT WEEKEND FEVER 102-103 AND HE WAS COMPLAINING OF ACHES IN LEGS. FEVER CAME DOWN WITH MEDICATION AS SOON AS WORE OFF CAME BACK. TOOK HIM BACK TO DR. MONDAY 11/5/2012 SHE SAID IT WAS ALLERGIES.  GAVE HIM MEDS FOR ALLERGY NASONEX AND CLARITIN.  TUESDAY NO BETTER SLEEP ALL DAY AND STILL HAS FEVER GOING ON 6 DAY'S. WENT BACK TO DR. WEDNESDAY TESTED POSITIVE FOR FLU AND STREP.  TAKING TAMAFLU AND TYLENOL AND ADVIL. SEEMS TO BE DOING BETTER BUT STILL HAS FEVER IF NOT MEDICATED ON TIME BUT NOT AS HIGH. DR. SAID HE WOULD BE BETTER BY THIS MONDAY 11/12/12 AND COULD GO BACK TO SCHOOL. WE ARE SURE HOPING SO.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Became achy and nauseated, and this lasted until approximately 2am.  Denied any fever, or vomiting.  Is feeling fine on 11/08/2012 with just the soreness at injection site.
Age: 1.11
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Computerised tomogram head, Culture urine, Drooling, Electroencephalogram, Full blood count
Clinical narrative: Developed fever 102 R following Hep A and Influenza #2 drooling reported by father, father brought patient to PCP office, where she was noted to be febrile, drooling unresponsive to verbal, tactile and auditory stimuli.
Age: 1.11
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Laboratory test, Lumbar puncture, Pyrexia, Toxicologic test, Unresponsive to stimuli
Clinical narrative: Developed fever 102 R following Hep A and Influenza #2 drooling reported by father, father brought patient to PCP office, where she was noted to be febrile, drooling unresponsive to verbal, tactile and auditory stimuli.
Age: 1.11
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Urine analysis
Clinical narrative: Developed fever 102 R following Hep A and Influenza #2 drooling reported by father, father brought patient to PCP office, where she was noted to be febrile, drooling unresponsive to verbal, tactile and auditory stimuli.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer field representative. A female patient received PREVNAR 13 and experienced rash and swelling at injection site 4cm X 5cm, and cellulitis was suspected.