chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Erythema, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a consumer refers to a 63 year old female patient who reports on herself. The patient had no allergies. No information regarding the patient's medical history and concomitant medications was provided. In January 2016 (reported as about one month ago), the patient was vaccinated with the dose of ZOSTAVAX injection, in the left arm (dose, route of administration, lot# and expiration date were not reported). In 2016 (2 weeks post vaccination), the patient developed on her left leg red circles, warm to the touch. The circles were the size of a pencil head or smaller. The circles were below the left knee, but above the left ankle. The circles went away 5 or 6 days later by themselves with no treatment (unspecified date in 2016). Then 2 weeks later (approximately in February 2016), the patient developed what she stated looked like bug bites/bumps on the right underarm, at the fatty part. The patient sought medical attention and was seen by her dermatologist. The physician had questioned her if she had gotten the ZOSTAVAX vaccine. When she replied yes, the dermatologist took a scraping biopsy of one of the bumps. The event was treated with HALOG cream. The outcome of bug bites/bumps on the right underarm was reported as not recovered. The outcome of red circles, warm to the touch was assessed as recovered. The causality between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of PNEUMOVAX 23 lot # L019836, exp. 24-MAR-2017 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of ROTATEQ lot # L027719, exp. 28-APR-2017 and lot # L027726, exp. 10-MAY-2017 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of GARDASIL lot # K011562,exp. 08-APR-2017 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of GARDASIL 9 lot # L020015, exp. 16-AUG-2017 and L019297, exp. 18-AUG-2017 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a healthcare worker via a company representative, referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with GARDASIL injection 120 Y (lot#, expiration date, dose and route were not reported). On an unknown date, the patient felt faint. and then recovered from the event on an unknown date. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 6 patients of unknown age and gender. Information about patients' concomitant medication, concurrent condition and medical history was not reported. The physician reported that on unspecified dates ranging from 17-FEB-2016 through 22-FEB-2016, the patients received doses of improperly stored GARDASIL 9 (dose and route not reported, lot # L020015 with expiration date 16-AUG-2017 or lot # reported as L043213 with expiration date 28-AUG-2017), according to a "vaccine for Children (VFC) report of data of 30F for 15 minutes on 17-FEB-2016". The physician also stated that her refrigerator was in correct range and the VFC data was wrong due to the "incorrect placement of a [robe". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with VAQTA stored outside of the recommended temperature range (0.3 degree for 45 minutes with a lot number # L045713 (expiry date: 14-JAN-2017), L023936 (expiry date: 15-MAR-2017), (dosing regimen, strength, route and frequency was unknown). Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from a registered nurse professional regarding unknown number of patients of unknown age and gender. No concurrent conditions and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with the vaccine GARDASIL 9 stored outside the recommended temperature range (0.3 degree for 45 minutes with a lot number # L013429 (expiry date: 08-MAY-2017), L013429 (expiry date: 21-JUN-2017), L020015 (16-AUG-2017), (dosing regimen, strength, route and frequency was unknown). Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with the GARDASIL stored outside the recommended temperature range (0.3 degree for 45 minutes (incorrect product storage) with a lot number # K006124 (expiry date: 02-FEB-2017) (dosing regimen, strength and frequency was unknown. Concomitant medications of the patients were not reported. No adverse event was reported. 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 case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with ROTATEQ stored outside of the recommended temperature range of 0.3 degree for 45 minutes (incorrect product storage) with a lot number # L037924 (expiry date: 22-JUN-2017), L013192 (expiry date: 19-JAN-2017), L013203 (expiry date: 28-JAN-2017). Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 12 month old female patient. Concurrent condition and medical history was not reported. On an unknown date at her 12 month appointment the patient was vaccinated with PROQUAD (Merck) (dose, route and lot# not reported) in additional to VARIVAX (Merck) (dose, route and lot# not reported). The reporter was not aware of an adverse experience. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 4 patients of unknown age and gender. Information about patients' concomitant medication, concurrent condition and medical history was not reported. The physician reported that on unspecified dates ranging from 17-FEB-2016 through 22-FEB-2016, the patients received doses of improperly stored LIQUID PEDVAXHIB (dose and route not reported, lot # J016186 with expiration date 24-OCT-2016), according to a report of data of 30F for 15 minutes on 17-FEB-2016". The physician also stated that her refrigerator was in correct range and the VFC data was wrong due to the "incorrect placement of a probe". No adverse effects were 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: This spontaneous report as received from a medical assistant via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of improperly stored RECOMBIVAX HB (lot# L019298, exp. date:22-JUN-2017) (strength, route and frequency were not reported). The temperature of the storage was 50 Fahrenheit degree for 24 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refer to a patient of unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On 22-FEB-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB of lot # K008988 and expiry date: 04-FEB-2016 (route, dose# and indication not reported). Concomitant therapy was not mentioned by the reporter. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004741, expiration date 04-MAR-2017; lot # L006547, expiration date 04-MAR-2017; lot # L048237, expiration date 08-MAY-2017; lot # L014415, expiration date 25-JUL-2017 and lot # L016429, expiration date 09-AUG-2017) (dosage, strength and route unknown) (temperature: -10 degree Centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles)). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information  has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L038501, expiration date 16-AUG-2018 and lot # L030869, expiration date 08-JUN-2018) (dosage, strength and route unknown) (temperature: -10 degree Centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L018503, expiration date 16-MAR-2017; lot # L022795, expiration date 05-NOV-2016 and lot # L024132, expiration date 21-JAN-2017) (dosage, strength and route unknown) (temperature: -10 degree Centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles)). No adverse effect was 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 healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses of PROQUAD (Merck) (strength, frequency and route unknown), Lot# L010143 with Exp. date 24-SEP-2016, Lot# L005296 with Exp. date 17-AUG-2016, and therapy type HSA). The vaccines were exposed to 30.9F for 11 hours 50 minutes at first excursion; and then exposed to 9 F for 3 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain, Pain in extremity, Skin discolouration
Clinical narrative: My doctor said I need the shingles shot, I have no idea if I ever had the chickenpox or not and have no one to ask if I did. I got the shingles vaccine the Pharmacy on 12/28/15. The next day it had a small pink spot then later it got bigger looked like an ink splatter. I had the pharmacy look at the spot and they said "it was normal but keep an eye on it". 12/30/2015 my arm was sore and it hurt for anything to touch that area and the area was a little warm to the touch. As time went by the area started to get bigger and red. It got sorer and I took a tape measuring and it was 3" across. Jan. 2, 2016 the spot started to get smaller but still hurt. Jan. 3, 2016 was about 1 1/2 inches across and was still pink. Jan 4, 2016 I went to the pharmacy showed them and told them they tell and that the pain was not there now but the mark is there and they said "to write this down and be sure to tell my doctor". Today is Jan. 11, 2016 and I am going to the Doctor office and the mark is still about an 1 1/2" across, there is no pain. Jan 18, 2016 still a mark the doctor said it was like a bruise.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: My doctor said I need the shingles shot, I have no idea if I ever had the chickenpox or not and have no one to ask if I did. I got the shingles vaccine the Pharmacy on 12/28/15. The next day it had a small pink spot then later it got bigger looked like an ink splatter. I had the pharmacy look at the spot and they said "it was normal but keep an eye on it". 12/30/2015 my arm was sore and it hurt for anything to touch that area and the area was a little warm to the touch. As time went by the area started to get bigger and red. It got sorer and I took a tape measuring and it was 3" across. Jan. 2, 2016 the spot started to get smaller but still hurt. Jan. 3, 2016 was about 1 1/2 inches across and was still pink. Jan 4, 2016 I went to the pharmacy showed them and told them they tell and that the pain was not there now but the mark is there and they said "to write this down and be sure to tell my doctor". Today is Jan. 11, 2016 and I am going to the Doctor office and the mark is still about an 1 1/2" across, there is no pain. Jan 18, 2016 still a mark the doctor said it was like a bruise.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medication and drug reaction or allergies reported. On 09-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot# L009213, expiration date, dose anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses of PROQUAD (Merck) (strength, frequency and route unknown, Lot# L024124, Exp. date 30-DEC-2016 and therapy type rHA). The vaccines were expose to 30.9F for 11 hours 50 minutes at first excursion; and then expose to 9 F for 3 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patient was vaccinated with three doses of unidentified Merck HPV vaccine (strength, route of administration, dose, frequency, lot number and expiration date were not reported) (reported as the patient completed GARDASIL series). On an unknown date, the patient was inadvertently vaccinated with the fourth dose of unidentified Merck HPV vaccine (strength, route of administration, dose, frequency, lot number and expiration date were not reported). It was unknown if GARDASIL or GARDASIL 9 was used for completed series and for extra fourth dose. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Product quality issue
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, lot#, expiration date and route were unknown). It was reported that the healthcare worker was attempting to report a product complaint with ZOSTAVAX, but due to technically difficulties the call was disconnected before further information could be provided. It cannot be ruled out that an adverse event with ZOSTAVAX was associated with the product complaint. Product quality complaint was filled. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 09-FEB-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB INJ 10 Y, lot # L025738, expiration date- 14-AUG-2017 and oral, ROTATEQ, lot # L013203, expiration date- 28-JAN-2017. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of a unknown age and gender. On 23-FEB-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K015979, expiration date: 23-SEP-2016, dose and route were unknown) (-7.5 degree centigrade for 3 hours). No adverse effects were reported. No previous temperature was excursion. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L034370, expiration date 08-SEP-2017) (dosage, strength and route unknown) (temperature: 42 degree F, time frame: 36 days). No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Pt received his two vaccinations and penicillin injection on 1/7/16. On 1/8/16 he presented with complaints of headaches, chills, and some lightheadedness. He was given acetaminophen for this.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Back pain, Injection site swelling, Injection site warmth, Neck pain, Pain
Clinical narrative: C/o body achy, right arm, neck, back sore, no fever. Right upper arm swollen and warm to touch, Patient states these events started this morning. Mother questioned use of PRN O.T.C. anti inflammatory/pain reliever meds. This RN told mother and patient to take what is recommended by their doctor.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: C/o body achy, right arm, neck, back sore, no fever. Right upper arm swollen and warm to touch, Patient states these events started this morning. Mother questioned use of PRN O.T.C. anti inflammatory/pain reliever meds. This RN told mother and patient to take what is recommended by their doctor.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 12-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II recombinant human albumin (rHA) status (lot# J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history was not reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL lot # K011325, expiration date: 08-APR-2017 (doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Erythema of the thigh area both surrounding the injection site and the rest of the thigh. Papules/patches on the (R) lower ext. within 5 mins of vaccine.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Patient received vaccine (TDAP) 2/18/16. She started with redness at injection site (LD) and 2/21 was dx with cellulitis on 2/22 in ER. Pt on KEFLEX 500 mg 2 BID x 10 days.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Vaccination site reaction
Clinical narrative: 2/22 6 days after vaccination, patient presented with red rash on upper arm below vaccination site. She also had 1 spot below her breasts and an itchy stomach per pt. The next day rash had spread on arm - very red visible spot 2/25 on stomach and cheeks were red - pt went to dr received KENALOG shot and was told to take BENADRYL or ALLEGRA. Dr thought it was a rxn to the PREVNAR.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Child was fine on P.E, 4 yrs, received KINRIX (Dapt and IPV) and PROQUAD (MMR/Varicella) 24 hours before the swelling and redness occurred. There were no CNS, respiratory distress. Infant child was playing well in office. BENADRYL 1 tsp TID for swelling.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: C-reactive protein normal, Full blood count normal, Headache, Induration, Local swelling
Clinical narrative: Onset 2-18-161 severe HA, left neck pain and left upper outer arm 4x5 cm area of pink, warm skin center of this pinkened area 1x2 cm area of firm induration, c/o pain with palpation. T 36.4. Left neck not swollen, pink or warm, no swollen glands noted.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Pain, Pain in extremity, Red blood cell sedimentation rate normal, Skin discolouration
Clinical narrative: Onset 2-18-161 severe HA, left neck pain and left upper outer arm 4x5 cm area of pink, warm skin center of this pinkened area 1x2 cm area of firm induration, c/o pain with palpation. T 36.4. Left neck not swollen, pink or warm, no swollen glands noted.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Skin warm
Clinical narrative: Onset 2-18-161 severe HA, left neck pain and left upper outer arm 4x5 cm area of pink, warm skin center of this pinkened area 1x2 cm area of firm induration, c/o pain with palpation. T 36.4. Left neck not swollen, pink or warm, no swollen glands noted.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Skin warm
Clinical narrative: Shoulder to elbow red and hot, chills and fever times 2 days.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Vaccine admin on 2/14/16. C/0 progressive red, itching/burning rash over both arms, trunk and legs within 12 hours of PCV-13 vaccination.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Injection site pain, Mobility decreased, Neck pain
Clinical narrative: Arm where vaccination injected started to be in severe pain within 3 hours. To this day arm still sore at point of vaccination and pain more felt in back and neck - it is hard to raise my right arm.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Pt called on call physician and reported hives so pt was sent to ER and not seen in office for the complaint.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Maculopapular rash developed w/in 24 hrs of injections. Low grade fever x 12 hrs. Resolved 5 days later.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chromaturia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, fatigue and local cellulitis muscle pain and dark yellow urine. Tx: extra fluids/hydration and rest; Improving as of flu visit 12/11/15 resolved by mid-Dec.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Bone scan, Chest X-ray, Injection site pain, Mobility decreased
Clinical narrative: Soreness at injection site next day. Migrated  to upper left arm, across shoulder into other arm, extreme pain, lost mobility in lifting etc. Progressively got worse saw M.D. - called pharmacy and Merck to report. Given steroids. some relief. Manifested into a type of rheumatoid arthritis still being treated w/meds!! Steroid, meloxicam and methotrexate.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmological examination, Pain in extremity, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Soreness at injection site next day. Migrated  to upper left arm, across shoulder into other arm, extreme pain, lost mobility in lifting etc. Progressively got worse saw M.D. - called pharmacy and Merck to report. Given steroids. some relief. Manifested into a type of rheumatoid arthritis still being treated w/meds!! Steroid, meloxicam and methotrexate.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site infection
Clinical narrative: Case number PHHY2016US008215 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604711) on 18 Jan 2016. This report refers to a 25 years old female patient. Medical history was none. The patient had no current illness. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158301) intramuscularly into left arm on 21 Oct 2015. On the same day after vaccination the patient's injection site had become infected. Further red area on patient's arm was noted. Two days later the patient returned to pharmacy due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "vaccination site infection" was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 158301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from quality assurance department (QA reference nr. 1011547) on 28 Jan 2016: Updated QA reference number only. Follow-up information received from quality assurance department on 23 Feb 2016: Updated batch review report.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Adverse event, Bone disorder, Computerised tomogram, Gait disturbance, Hemiplegia
Clinical narrative: My body continued to ache, swell, my immune system depleted, my ankle completely with serious pain, I felt like I had the flu again, my acne continued to get worse and other signs of rheumatoid arthritis, thyroid problems, etc. I have health records for view.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immune system disorder, Impaired driving ability, Laboratory test, Mobility decreased, Muscle disorder
Clinical narrative: My body continued to ache, swell, my immune system depleted, my ankle completely with serious pain, I felt like I had the flu again, my acne continued to get worse and other signs of rheumatoid arthritis, thyroid problems, etc. I have health records for view.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray
Clinical narrative: My body continued to ache, swell, my immune system depleted, my ankle completely with serious pain, I felt like I had the flu again, my acne continued to get worse and other signs of rheumatoid arthritis, thyroid problems, etc. I have health records for view.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Arthralgia, Atrophy, Blood test, Computerised tomogram
Clinical narrative: My body continued to ache, swell, my immune system depleted, my ankle completely with serious pain, I felt like I had the flu again, my acne continued to get worse and other signs of rheumatoid arthritis, thyroid problems, etc. I have health records for view.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Immune system disorder, Influenza like illness, Laboratory test, Mobility decreased
Clinical narrative: My body continued to ache, swell, my immune system depleted, my ankle completely with serious pain, I felt like I had the flu again, my acne continued to get worse and other signs of rheumatoid arthritis, thyroid problems, etc. I have health records for view.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Quality of life decreased, Rheumatoid arthritis, Swelling, Thyroid disorder
Clinical narrative: My body continued to ache, swell, my immune system depleted, my ankle completely with serious pain, I felt like I had the flu again, my acne continued to get worse and other signs of rheumatoid arthritis, thyroid problems, etc. I have health records for view.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of Guillain Barre Syndrome in a adult male patient who received FLUARIX. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced Guillain Barre Syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was fatal. The reported cause of death was Guillain Barre Syndrome. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to Influenza vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of Guillain-Barre Syndrome in a male patient of unspecified age who had received an unspecified Influenza vaccine. The authors reported that his daughter was later diagnosed with membranous nephropathy and severe acute kidney injury after been referred to the emergency department with worsening bilateral lower extremity oedema and elevated serum creatinine level 2 weeks after being vaccinated with Influenza vaccine (see case B0713616A). She had developed fever, intermittent nausea and vomiting, and lower extremity oedema soon after being immunized with. She was 60 years old at the time and she had refused Influenza vaccination previously due to what have happened to her father. No information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received a dose of unspecified Influenza vaccine. Dosage unknown; administration route and site unspecified; batch number was not provided. On an unspecified date, an unknown period after the vaccination, the patient developed Guillain-Barre Syndrome and subsequently died from it. Cause of death was Guillain-Barre syndrome. It is unknown if a post-mortem was performed. Treatment was unknown. The authors did not comment on any possible causal relationship between this event and the vaccine, apart from mentioning that exposure to Influenza vaccine had been associated with autoimmune diseases like Guillain-Barre syndrome. The authors concluded (referring to the daughter's case): "we present an interesting case of membranous nephropathy and severe acute kidney injury following the 2009 H1N1 Influenza vaccination. Optimal therapy of Influenza vaccine-associated glomerular diseases including membranous nephropathy is unknown. Our patient remains in clinical remission with normal renal function, five years after completion of corticosteroid therapy. Based on our experience, one can consider corticosteroid therapy in patients with membranous nephropathy and acute interstitial nephritis following Influenza vaccination. However, further studies are required to investigate the exact pathogenesis of Influenza vaccine-induced membranous nephropathy." The article corresponding to this case is not available for submission due to copyright restrictions.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Urticaria
Clinical narrative: Rash broke out at injection site 24 hours after administration.  It continued to spread.  48 hours after initial rash, she went to the ER.  She was given prednisone.  Had intermittent hives for 1 month.  She was followed by occupational health services at work.  They felt the symptoms were caused by the flu shot.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nervousness, Throat tightness
Clinical narrative: Within in the hour of flu vaccination, patient reported feeling nauseous, shaky and throat feeling tight. Administration nurse gave 50mg im Benadryl in vaccination arm.  Ambulance was called and patient was transported to ER.  I attempted to contact the patient on numerous occasions for follow up.  She did not respond to my calls.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Oral papilloma
Clinical narrative: I got the Gardasil vacine and the next morning I woke up with thousands of tiny warts on my lip.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Arthralgia, Chest pain, Chills, Disturbance in attention
Clinical narrative: Shortly after immunization my daughter began to have a multitude of health issues including fatigue, tachycardia, pain in chest, severe headaches, insomnia, dizziness, nausea, light sensitivity, tremors, joint pain, coldness/chills, digestive problems, shooting nerve pain, ear pain and difficulty concentrating. She developed a bad cold then flu bug late Jan early Feb. All the other symptoms above followed and stuck around for several months.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Ear pain, Electrocardiogram ambulatory normal, Electrocardiogram normal, Fatigue
Clinical narrative: Shortly after immunization my daughter began to have a multitude of health issues including fatigue, tachycardia, pain in chest, severe headaches, insomnia, dizziness, nausea, light sensitivity, tremors, joint pain, coldness/chills, digestive problems, shooting nerve pain, ear pain and difficulty concentrating. She developed a bad cold then flu bug late Jan early Feb. All the other symptoms above followed and stuck around for several months.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling cold, Gastrointestinal disorder, Headache, Influenza, Insomnia
Clinical narrative: Shortly after immunization my daughter began to have a multitude of health issues including fatigue, tachycardia, pain in chest, severe headaches, insomnia, dizziness, nausea, light sensitivity, tremors, joint pain, coldness/chills, digestive problems, shooting nerve pain, ear pain and difficulty concentrating. She developed a bad cold then flu bug late Jan early Feb. All the other symptoms above followed and stuck around for several months.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Nasopharyngitis, Nausea, Neuralgia, Photophobia
Clinical narrative: Shortly after immunization my daughter began to have a multitude of health issues including fatigue, tachycardia, pain in chest, severe headaches, insomnia, dizziness, nausea, light sensitivity, tremors, joint pain, coldness/chills, digestive problems, shooting nerve pain, ear pain and difficulty concentrating. She developed a bad cold then flu bug late Jan early Feb. All the other symptoms above followed and stuck around for several months.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia, Thyroid function test normal, Tremor, Vitamin D deficiency
Clinical narrative: Shortly after immunization my daughter began to have a multitude of health issues including fatigue, tachycardia, pain in chest, severe headaches, insomnia, dizziness, nausea, light sensitivity, tremors, joint pain, coldness/chills, digestive problems, shooting nerve pain, ear pain and difficulty concentrating. She developed a bad cold then flu bug late Jan early Feb. All the other symptoms above followed and stuck around for several months.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain at injection site, somewhat limited range of motion, pain up into shoulder.  Had several thousand dollars of PT, some pain still exists during some motions and positions.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Neck pain, Polymyalgia rheumatica
Clinical narrative: Extreme pain in shoulders, hips, wrists, and neck. Treated with Percocet 5mg, masked pain temporarily. Incapacitated patient. Worsened with time, diagnosed with Polymyalgia Rheumatica, treatment 60mg Prednisone.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Extreme pain in shoulders, hips, wrists, and neck. Treated with Percocet 5mg, masked pain temporarily. Incapacitated patient. Worsened with time, diagnosed with Polymyalgia Rheumatica, treatment 60mg Prednisone.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 58-year-old male patient who received FLULAVAL Quadrivalent (batch number 93T79, expiry date June 2016). On 13th October 2015, the patient received FLULAVAL Quadrivalent (intramuscular). In February 2016, 122 days after receiving FLULAVAL Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria other: serious as per reporter), fever, nausea, vomiting and muscle pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, fever, nausea, vomiting and muscle pain were recovering/resolving. It was unknown if the reporter considered the vaccination failure, influenza, fever, nausea, vomiting and muscle pain to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: Approximately 4 months after vaccination, the patient subsequently contracted influenza, verified by nasal swab which read positive for several strains, including H1N1 2009. The patient was presented to an urgent care clinic with symptoms of fever, nausea, vomiting, and muscle aches.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination failure, Viral test positive, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 58-year-old male patient who received FLULAVAL Quadrivalent (batch number 93T79, expiry date June 2016). On 13th October 2015, the patient received FLULAVAL Quadrivalent (intramuscular). In February 2016, 122 days after receiving FLULAVAL Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria other: serious as per reporter), fever, nausea, vomiting and muscle pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, fever, nausea, vomiting and muscle pain were recovering/resolving. It was unknown if the reporter considered the vaccination failure, influenza, fever, nausea, vomiting and muscle pain to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: Approximately 4 months after vaccination, the patient subsequently contracted influenza, verified by nasal swab which read positive for several strains, including H1N1 2009. The patient was presented to an urgent care clinic with symptoms of fever, nausea, vomiting, and muscle aches.
Sex: U
Vaccine: PPV
Symptoms: Local reaction, Vaccination complication
Clinical narrative: Information has been received from a physician via Pfizer referring to a patient of unknown age and gender. Concurrent condition included HIV infection. There was no concomitant medication reported. The physician reported that the patient had received PNEUMOVAX 23 two times before, the latest time was in 2012. The lot #, dosage information and route were not provided. The patient went to the hospital for 3 days due to a severe local reaction to the vaccine (onset date unknown). The outcome of the event was not reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Balance disorder, Laboratory test normal
Clinical narrative: Off balance - dx with Ataxia. Unsteady on her feet. Will f/u today? Refer to neuro.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Patient felt weak and tired after immunization and extreme tenderness at injection site with erythema, 4 days later there was less tenderness/pain but about a 10 cm diameter red blotch at injection site and felt warm to touch.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Patient felt weak and tired after immunization and extreme tenderness at injection site with erythema, 4 days later there was less tenderness/pain but about a 10 cm diameter red blotch at injection site and felt warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Body temperature increased, Febrile convulsion, Influenza virus test negative, Streptococcus test negative, Urine analysis normal
Clinical narrative: Febrile Seizure, temp 105.6.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: X-ray normal
Clinical narrative: Febrile Seizure, temp 105.6.