chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Dizziness, Dyskinesia, Fall, Loss of consciousness, Muscle tightness
Clinical narrative: Felt faint, laid head on desk.  Lower extremities tightened, progressing up torso.  Raised upper body up and back in an involuntary movement and began to fall out of chair. She was lowered to the floor so as not to injure her.  Head was tilted back to insure open airway.  She maintained breathing the entire time. Appeared to be unconscious for approx. 2 min.  She responded to her spoken name and began to become lucid.  She knew what had happened. 911 was called by a neighboring office suite and EMTs arrived within 10 to 12 min.  P 90 to 100, R 18 to 20, BP 110/80. She stood up and walked to the gurney and was taken by EMTs to a nearby ER.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash, Skin warm, Urticaria
Clinical narrative: MY SON HAD A BOWEL MOVEMENT 2 IN 30 MINS AND THEN STARTED SCRATCHING PROFUSELY. HE'S NON VERBAL SO I DID A PHYSICAL CHECK & NOTICED HUGE BUMPS ON HIS BACK, ARMS & LEGS THAT WERE VERY HOT TO THE TOUCH. RESEMBLING HIVES. CONTACTED THE DR. OFFICE AND ANSWERING SERVICE NURSE TOLD ME TO ADMINISTER BENADRYL EVERY 2 HRS AND SEE THE DR. THE NEXT DAY.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site. Approximately 1-2 inch diameter. Still having symptoms at 5pm 4/13/2016. Have not seen clinician regarding adverse affect.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Immediately after administration patient had extreme pain in upper arm at the site of the injection. The pain was immediate and has lasted for months.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, sore, warm, pink where shot was given.  Swollen to an oval about 3 in long. Diagnosed with cellulitis.  Treated with antibiotic for 10 days.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Diarrhoea, Discomfort, Eczema, Milk allergy
Clinical narrative: Patient began to run a high fever (102 F). I have him Tylenol to reduce the fever, but it only got worse. At one point he had a 103 fever. Usually a very easy going baby, he screamed for two hours that evening. I nursed him all night long and if he moved he would start to cry again. This continued for two days, fever and crying over everything. He developed eczema two days later, severe. All over his little body. He now is constantly covered in excema and is allergic to cows milk. When he has cows milk through my breast milk, he vomits, has diarrhea, and is very uncomfortable.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pain, Pyrexia, Screaming, Vomiting
Clinical narrative: Patient began to run a high fever (102 F). I have him Tylenol to reduce the fever, but it only got worse. At one point he had a 103 fever. Usually a very easy going baby, he screamed for two hours that evening. I nursed him all night long and if he moved he would start to cry again. This continued for two days, fever and crying over everything. He developed eczema two days later, severe. All over his little body. He now is constantly covered in excema and is allergic to cows milk. When he has cows milk through my breast milk, he vomits, has diarrhea, and is very uncomfortable.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Asthenia, Consciousness fluctuating, Somnolence, Vomiting
Clinical narrative: Pt. was administered a varicella vaccine at approx 3:00pm. Approx 15 min. after the vaccine, the pt. had vomiting, drowsiness, weakness. Performed BP - 96/60 and O2 sat 88%. Pt. in and out. Dr checked pt. and called ED to admit.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Intensive care, Loss of consciousness, Mechanical ventilation, Medical induction of coma, Oropharyngeal pain
Clinical narrative: Pt. was administered a varicella vaccine at approx 3:00pm. Approx 15 min. after the vaccine, the pt. had vomiting, drowsiness, weakness. Performed BP - 96/60 and O2 sat 88%. Pt. in and out. Dr checked pt. and called ED to admit.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Respiratory arrest, Seizure, Vomiting
Clinical narrative: Pt. was administered a varicella vaccine at approx 3:00pm. Approx 15 min. after the vaccine, the pt. had vomiting, drowsiness, weakness. Performed BP - 96/60 and O2 sat 88%. Pt. in and out. Dr checked pt. and called ED to admit.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash pruritic
Clinical narrative: Redness and itchy rash.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. In 2016, between 15-MAR-2016 and 05-APR-2016, the patients' were vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD lot # L050908 with expiration date of 14-JUN-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported due to vaccination with (Oka-Merck) PROQUAD. No product quality issue was involved. The Certified Medical Assistant (C.M.A), also reported that (Oka-Merck) PROQUAD was exposed to a temperature of 11.7 F for 9 hours and 7 minutes and no other temperature excursion was reported for the vaccine. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. There were no concurrent condition, medical history and concomitant therapy reported. On an unknown date, one dose of improperly stored ZOSTAVAX (lot # L027322, Expiration Date 21-OCT-2016) (strength, dose and route not provided) was administered. The vaccine was exposed to 27 F for 1 hour and to 15 F for 1 hours and 35 minutes. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. There were no concurrent condition, medical history and concomitant therapy reported. On an unknown date, one dose of improperly stored (Oka-Merck) PROQUAD (lot # L023111, Expiration Date 24-DEC-2016) (strength, dose and route not provided) was administered. The vaccine was exposed to 27 F for 1 hour to 15 F for 1 hours and 35 minutes. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. In 2016, between 15-MAR-2016, the patients' were vaccinated with and improperly stored dose of VARIVAX (Merck) lot # L004653 with expiration date of 11-FEB-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported due to vaccination with VARIVAX (Merck). No product quality issue was involved. The Certified Medical Assistant (C.M.A), also reported that VARIVAX (Merck) was exposed to a temperature of 11.7 degrees F for 9 hours and 7 minutes and no other temperature excursion was reported for the vaccine. This is one of several received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female patient with iodine allergy. No medical history was reported. On 08-APR-2016 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L028282, Expiration Date 28-OCT-2016) subcutaneous in the left deltoid. Concomitant therapies included progesterone (manufacturer unknown) and estrogens (unspecified). On 10-APR-2016, the patient called the pharmacy back to report that she developed pain in her right leg and right hip on 10-APR-2016. The pharmacist stated that she advised the patient to "take TYLENOL and ice the affected area." No lab diagnostics studies were performed. At the time of reporting, the patient had not recovered from adverse events. The causality between adverse events and the vaccine was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #: K023863, expiration date on 03-APR-2016 and lot #: L045117, expiration date on 06-OCT-2018 (route, dose and anatomical location were not reported) which were stored in a temperature of 31F during 60 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The Patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL lot # L010596, expiration date on 05-MAY-2017 (route, dose and anatomical location were not reported) which were stored in a temperature of 31F during 60 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) regarding a 12 month old female patient. The patient's medical history or concurrent conditions were not provided. On 12-APR-2016, the patient was vaccinated with an expired dose of PEDVAX HIB (which had lot # J006418; however dose, dosage number, route of administration and expiration date were not reported). Concomitant medications were not provided. The L.P.N. stated that there was no adverse effects to report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The Patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot #: K018528, expiration date on 04-APR-2016) (route, dose and anatomical location were not provided) which were stored in a temperature of 31 F during 60 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning unspecified number of patients of unknown age and gender. There were no concurrent condition, medical history and concomitant therapy reported. On an unknown date, two doses of improperly stored (Merck) VARIVAX (lot # K010337, Expiration Date 22-JUL-2016) (strength, dose and route not provided) were administered. The vaccines were exposed to 27 F for 1 hour and to 15 F for 1 hours and 35 minutes. No adverse symptoms 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: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD lot # L030592 with an expiration date of 12-FEB-2017, lot # L040415 with expiration date of 13-APR-2017 and lot # L044056 with expiration date of 12-FEB-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported after vaccination with (Oka-Merck) PROQUAD and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013064 with expiration date of 14-APR-2017, lot # L024251 with expiration date of 30-JUN-2017, lot # L035124 with expiration date of 14-SEP-2017 and lot # L0141207 with expiration date 20-OCT-2017 (anatomical route of vaccination and dose number were not provided. No adverse event was reported due to vaccination with (Oka/Merck) VARIVAX and no product quality issue was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The Patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally lot #: L020859, expiration date on 09-JAN-2017 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 60 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL (dose, route of administration, lot # and expiration date were not reported). Then, on an unknown date, the reporting physician stated that the patient received a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported) to finish the vaccination series. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Groin pain, Pain in extremity
Clinical narrative: Pt came into pharmacy and stated that she thinks she got left arm and some time (R) arm pain, as well as left and (R) knee joint pain, and pain in her groin in (R) side, after getting pneumonia shot. She says the pain is still there thru now since she got the shot.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient was given a 0.5 ml pediatric dose of Hepatitis A vaccine by human error. RN administered a second 0.5 ml pediatric Hepatitis A vaccine dose.
Age: 45.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injection site erythema, Injection site exfoliation, Injection site swelling
Clinical narrative: Patient reports "tennis ball sized, swollen and red area" at injection site of pneumococcal vaccine with superficial skin peeling beginning over 24 hours after vaccine administration. No physician treatment has used.
Age: 28.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Diarrhoea, Headache, Nausea, Polymerase chain reaction positive, Pyrexia
Clinical narrative: 3/13/16 - diarrhea x12, nausea, vomiting 3/14/16 - low grade fever 99.5 degrees F 3/15/16 - abdominal rash resolved on 3/16/16 3/15/` - headache.
Age: 28.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Rash, Salmonella test positive, Vomiting
Clinical narrative: 3/13/16 - diarrhea x12, nausea, vomiting 3/14/16 - low grade fever 99.5 degrees F 3/15/16 - abdominal rash resolved on 3/16/16 3/15/` - headache.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever-104. Stiffness-4 extremities. Swollen upper thigh (left LV).
Sex: U
Vaccine: MENB
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of lethargy in unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced lethargy and tiredness. On an unknown date, the outcome of the lethargy and tiredness were recovered/resolved. It was unknown if the reporter considered the lethargy and tiredness to be related to BEXSERO. Additional details received were as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days (see case US2016046410). Office manager then mentioned that another patient (see case US2016GSK049200) who received also BEXSERO and experienced a soft-ball like swelling at the injection site. Also mentioned about some other patients concerned in this case who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test urine negative
Clinical narrative: Case number PHHY2016US042061, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 619259) website on 29 Mar 2016. This report refers to a 34 years old female patient. The patient had been pregnant before with no miscarriage. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 04 Dec 2015 when she was 4 weeks and 5 days pregnant. The patient had miscarriage the morning after she received the vaccine. It was reported that, pregnancy was early and there was no sign of impending miscarriage. Home urinary pregnancy test one week following onset of miscarriage confirmed end of pregnancy. The patient conceived immediately after the miscarriage. Outcome of the event miscarriage was reported as complete recovery. Seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the event abortion spontaneous was upgraded based on the Novartis Important medical event list. Since the batch number was not reported, the batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non significant follow up report received from a Quality Assurance department (QA reference number: 1013883) on 31 Mar 2016: Added QA reference number. Significant follow up report received from a Quality Assurance department (QA reference number: 1013883) on 12 Apr 2016: Annual Product Review added.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Immediate post-injection reaction, Pregnancy test urine negative
Clinical narrative: Case number PHHY2016US042061, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 619259) website on 29 Mar 2016. This report refers to a 34 years old female patient. The patient had been pregnant before with no miscarriage. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 04 Dec 2015 when she was 4 weeks and 5 days pregnant. The patient had miscarriage the morning after she received the vaccine. It was reported that, pregnancy was early and there was no sign of impending miscarriage. Home urinary pregnancy test one week following onset of miscarriage confirmed end of pregnancy. The patient conceived immediately after the miscarriage. Outcome of the event miscarriage was reported as complete recovery. Seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the event abortion spontaneous was upgraded based on the Novartis Important medical event list. Since the batch number was not reported, the batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non significant follow up report received from a Quality Assurance department (QA reference number: 1013883) on 31 Mar 2016: Added QA reference number. Significant follow up report received from a Quality Assurance department (QA reference number: 1013883) on 12 Apr 2016: Annual Product Review added.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Fatigue, Malaise, Pain
Clinical narrative: Initially there Global body pain and severe fatigue, Subsequently the following are the persisting symptoms: The worst symptoms are: 1. While I had been able to walk vigorously and even to do some interval training, running interspersed with walking, before the vaccination, now I cannot even walk briskly or do any other relatively brisk exertion without my chest tightening up and being overwhelmed by an inner shakiness.  That combination quickly stops me in my tracks and the shakiness reverberates for awhile after I stop.  2.  I feel like I am moving and thinking in slow motion.  3. The fibromyalgia pain that I previously had has become much worse and more widespread throughout my body.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Blood cholesterol abnormal, Blood glucose abnormal, Blood thyroid stimulating hormone normal
Clinical narrative: Initially there Global body pain and severe fatigue, Subsequently the following are the persisting symptoms: The worst symptoms are: 1. While I had been able to walk vigorously and even to do some interval training, running interspersed with walking, before the vaccination, now I cannot even walk briskly or do any other relatively brisk exertion without my chest tightening up and being overwhelmed by an inner shakiness.  That combination quickly stops me in my tracks and the shakiness reverberates for awhile after I stop.  2.  I feel like I am moving and thinking in slow motion.  3. The fibromyalgia pain that I previously had has become much worse and more widespread throughout my body.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bradyphrenia, C-reactive protein normal, Chest discomfort, Electrocardiogram normal, Fatigue
Clinical narrative: Initially there Global body pain and severe fatigue, Subsequently the following are the persisting symptoms: The worst symptoms are: 1. While I had been able to walk vigorously and even to do some interval training, running interspersed with walking, before the vaccination, now I cannot even walk briskly or do any other relatively brisk exertion without my chest tightening up and being overwhelmed by an inner shakiness.  That combination quickly stops me in my tracks and the shakiness reverberates for awhile after I stop.  2.  I feel like I am moving and thinking in slow motion.  3. The fibromyalgia pain that I previously had has become much worse and more widespread throughout my body.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fibromyalgia, Full blood count normal, Gait disturbance, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initially there Global body pain and severe fatigue, Subsequently the following are the persisting symptoms: The worst symptoms are: 1. While I had been able to walk vigorously and even to do some interval training, running interspersed with walking, before the vaccination, now I cannot even walk briskly or do any other relatively brisk exertion without my chest tightening up and being overwhelmed by an inner shakiness.  That combination quickly stops me in my tracks and the shakiness reverberates for awhile after I stop.  2.  I feel like I am moving and thinking in slow motion.  3. The fibromyalgia pain that I previously had has become much worse and more widespread throughout my body.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Red blood cell sedimentation rate normal, Thyroid function test normal, Thyroxine free normal, Tremor
Clinical narrative: Initially there Global body pain and severe fatigue, Subsequently the following are the persisting symptoms: The worst symptoms are: 1. While I had been able to walk vigorously and even to do some interval training, running interspersed with walking, before the vaccination, now I cannot even walk briskly or do any other relatively brisk exertion without my chest tightening up and being overwhelmed by an inner shakiness.  That combination quickly stops me in my tracks and the shakiness reverberates for awhile after I stop.  2.  I feel like I am moving and thinking in slow motion.  3. The fibromyalgia pain that I previously had has become much worse and more widespread throughout my body.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Blister, Contusion, Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year old female patient. The patient's had no pertinent medical history or drug reactions/allergies. On 05-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 which had a lot# L013429 and expiration date 21-JUL-2017 and 05-APR-2016, she was vaccinated with the second dose of GARDASIL 9 which had a lot# L044475 and expiration date 12-MAY-2017 both intramuscularly, in her left arm for prevention of GARDASIL 9. The patient was not taking any concomitant medications. On 09-APR-2016, the patient developed bruising (vaccination site bruising), described as "purplish discoloration", and redness (vaccination site erythema) at the injection site. Later, the same date, the patient developed blisters around the injection site (application site vesicles). The patient called the physician for medical attention and received treatment with topical bacitracin and oral cephalexin. None laboratory tests were performed. There was no product quality complaint involved. At the time of reporting, the patient had not recovered from application site vesicles, vaccination site erythema and vaccination site bruising. The reporter did not assess the relatedness of the events of GARDASIL 9. This is one of several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year old female patient. The patient's had no pertinent medical history or drug reactions/allergies. On 05-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 which had a lot# L013429 and expiration date 21-JUL-2017 and 05-APR-2016, she was vaccinated with the second dose of GARDASIL 9 which had a lot# L044475 and expiration date 12-MAY-2017 both intramuscularly, in her left arm for prevention of GARDASIL 9. The patient was not taking any concomitant medications. On 09-APR-2016, the patient developed bruising (vaccination site bruising), described as "purplish discoloration", and redness (vaccination site erythema) at the injection site. Later, the same date, the patient developed blisters around the injection site (application site vesicles). The patient called the physician for medical attention and received treatment with topical bacitracin and oral cephalexin. None laboratory tests were performed. There was no product quality complaint involved. At the time of reporting, the patient had not recovered from application site vesicles, vaccination site erythema and vaccination site bruising. The reporter did not assess the relatedness of the events of GARDASIL 9. This is one of several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pain
Clinical narrative: Pain/limitation of movement in arm where vaccine given that night. Patient's wife reported patient saw MD and took ibuprofen.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain/limitation of movement in arm where vaccine given that night. Patient's wife reported patient saw MD and took ibuprofen.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via field representative, refers to several patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unspecified by the reporter. On an unknown dates, the patients were vaccinated with GARDASIL 9 injection, for prevention of HPV disease, (dose, frequency and route of administration not reported). Physician reported that several patients experienced adverse reaction to vaccinated with GARDASIL 9 therapy. Physician also stated that several patient experienced 'fainting' spells directly following vaccinated with GARDASIL 9 injection therapy. The outcome of the events was unknown. Causality assessment was not provided. Patient did not seek medical attention. No product quality complaint (PQC) was involved. No other adverse event information was given. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Aphasia, Decreased eye contact
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1-year-old male patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 16-MAR-2016, the patient was vaccinated with the first dose of PROQUAD human serum albumin (HSA) lot # L004007, expiration date: 05-AUG-2016 (dose and route of administration were not reported). The patient had no concomitant medications. On 26-MAR-2016 (reported as exactly 10 days after vaccination), the patient stopped babbling, smiling and making eye contact. The patient did not receive any treatment for the event. The outcome of the event was not recovered. The causality assessment between the event and (Oka-Merck) PROQUAD was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 01-APR-2016 the patient was vaccinated with expired dose of RECOMBIVAX HB injection 2.5/0.5, lot # J007946; expiry: 24-MAR-2016, dose: 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effect was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates in 2016 the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, dose# and route unknown, lot# L044527, expiration date 09-NOV-2017; lot# L042367 (invalid lot#), expiration date 27-OCT-2017). The vaccines were stored under -11.9 degree for 2 hours and 38 minutes on 09-MAR-2016 and -10.8 degree for 2 hours and 47 minutes on 10-MAR-2016. There was no previous temperature excursion. It was called because of a data logger. Cumulative Excursion was -10.8 degree for 5 hours and 25 minutes. No adverse effects were reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Mom first noticed rash yesterday (04/12/16) afternoon, then noticed patient rubbing (R) side of face this morning (04/13/16). Rash isolated on groin and trunk area yesterday (04/12/16) that had spread to (R) hand today (04/13/16). TYLENOL was given at 0800 on 04/13/16 at home by mom and BENADRYL 2.5 mL at 1230 in office.
Age: 13.0
Sex: F
Vaccine: HPV9, FLUX
Symptoms: Blood test, Infectious mononucleosis, Platelet count decreased, Weight decreased
Clinical narrative: Information has been received from a physician via company representative referring to a 13 year old female patient. Information about medical history and concurrent condition was unspecified. On 14-SEP-2015 the patient was vaccinated with first dose of GARDASIL 9 (lot number, dose and route were unknown) for prevention of HPV. In January 2015, the patient received an unspecified influenza virus vaccine (unspecified). In January 2016, the patient started to "work out" and lose weight. The patient was seen by an unspecified hematologist on an unspecified date and it was found that she had a low platelet count and mononucleosis. Unspecified blood tests were performed. The outcome and causality of the events was unknown. Additional information is not expected because the reporter did not want to be contacted.
Age: 13.0
Sex: F
Vaccine: HPV9, FLUX
Symptoms: Infectious mononucleosis, Platelet count decreased, Weight decreased
Clinical narrative: Information has been received from a physician via company representative referring to a 13 year old female patient. Information about medical history and concurrent condition was unspecified. On 14-SEP-2015 the patient was vaccinated with first dose of GARDASIL 9 (lot number, dose and route were unknown) for prevention of HPV. In January 2015, the patient received an unspecified influenza virus vaccine (unspecified). In January 2016, the patient started to "work out" and lose weight. The patient was seen by an unspecified hematologist on an unspecified date and it was found that she had a low platelet count and mononucleosis. Unspecified blood tests were performed. The outcome and causality of the events was unknown. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (lot # L030592 with expiration date 12-FEB-2017, lot # L007231 with expiration date 03-SEP-2016 and lot # reported as L051098 with expiration date 17-JUN-2017; dose and route of administration were not reported). No adverse effects were reported. The vaccines were stored in 11F for 24 hours. No previous temperature excursion was 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 was received from a nurse and refers to 17 patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # L038018, expiration date 13-SEP-2017 (dose and route of administration were not reported). The vaccines underwent a temperature excursion at 59.7 degrees Fahrenheit for 17 hours and 40 minutes. No adverse event reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 year old female patient with no pertinent medical history or known drug reactions or allergies. No information regarding the patient's concurrent conditions was provided. On 08-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (lot# and expiry date were not reported), 0.65 ml subcutaneously. Concomitant therapies included MOTRIN (it was also reported that the patient had no concomitant medications). On an unknown date in April 2016, reported as "over the weekend", the patient developed a 3 inch area of redness around the injection site, which was swollen and warm to the touch. She sought medical attention by returning to the pharmacy on 11-APR-2016. No treatment was given for the event and no diagnostic lab studies were performed. The outcome of the event was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old male patient. No medical history and concurrent conditions were reported. On 07-APR-2016 the 5 year old male patient was inadvertently vaccinated with GARDASIL 9 (inappropriate schedule of drug administration) (lot # L026602, expiry date 19-OCT-2017) (dosing regimen and frequency unknown). It was reported that the vaccine was administered due to human error. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K026247, expiration date 29-JAN-2017. On 25-SEP-2015, the patient received the second dose of GARDASIL 9 loot # K026247, expiration date 29-JAN-2017 and on 16-OCT-2015 the third dose of GARDASIL 9 lot # L007560, expiration date 15-JUN-2017 (exact dose and route was not reported for all doses). The patient inadvertently received doses of GARDASIL 9 outside of the recommended series intervals. No adverse events were reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to herself, about 59 years old female patient. It was stated that the patient's pertinent medical history included "fever blisters". The patient had previously received measles and mumps vaccines on an unspecified date (reported as "prior to receiving ZOSTAVAX"). On an unknown date in approximately 2015 (reported as "3-4 months ago"), the patient was vaccinated with a dose of ZOSTAVAX, injection, dose 0.65 ml, subcutaneously, (injection site, lot number and expiration date were not provided). There were no concomitant medications reported. On an unknown date, after receiving ZOSTAVAX, the patient developed soreness at the injection site when touched. The patient did not seek medical attention. No laboratory diagnostic studies were performed. No treatment was given for the event. The outcome of the event was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt rec'd flu vaccine 0n 4/11/16 in AM at doctor appt. on 4/12/16 she noticed arm was more painful, swollen around injection site to about 4-5 inches in diameter, and c/o itching and warmth to touch and painful w/ and w/out touch. Given BENADRYL 1st night.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pruritus, Pruritus generalised
Clinical narrative: Pt reported itching at injection site on the day following the injection. By the next day, she had generalized itching. No rash/hives. Pt. reported taking BENADRYL to relieve itching. She also received PREVNAR at another clinic on 4/11/16.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I had headache, fever up to 100.5-101 degree for first 24 hours then 99.5-100.5 degree for next 24 hour. I also had tenderness, redness, and swelling at the injection site, decreased appetite.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: I had headache, fever up to 100.5-101 degree for first 24 hours then 99.5-100.5 degree for next 24 hour. I also had tenderness, redness, and swelling at the injection site, decreased appetite.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a currently 80 year old patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient was vaccinated with doses of PNEUMOVAX 23 (exact dose, route of administration, lot # and expiration date were not reported). It was reported that the patient was receiving PNEUMVOAX 23 every 5 years (it was unspecified when or at what age the patient started receiving the vaccine). No adverse effects were reported. Additional information is not expected as the physician did not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a patient of unknown age regarding himself/herself. Information regarding the patient's current conditions and medical history was not provided. It was reported that the RECOMBIVAX HB (dose, lot number unspecified) was given 0, 1 month and 11 weeks (dates unspecified) (inappropriate schedule of drug administration). No product quality complaint (PQC) was involved. No further information was provide. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 28-MAR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX (dose: 0.5 ml, lot # L040421, expiry date: 15-OCT-2017) via intramuscular route, (incorrect product storage). Nurse reported that the vaccine underwent a temperature excursion of 37 degree Fahrenheit for 96 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: HIBV, MMR
Symptoms: Diarrhoea, Pyrexia, Sleep disorder, Thirst, Vomiting
Clinical narrative: Diarrhea vomiting fever sleep disturbances thirst clinginess.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, warm mass that progressively became more painful and has limited mobility of patient's arm. The area red and swollen is not about 6 inches in diameter. Also complained of itchy, scratchy throat soon after vaccine administration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation, Upper extremity mass
Clinical narrative: Swelling, redness, warm mass that progressively became more painful and has limited mobility of patient's arm. The area red and swollen is not about 6 inches in diameter. Also complained of itchy, scratchy throat soon after vaccine administration.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. Approximately in 2016 (reported as from 24-MAR-2016 to 01-APR-2016) multiple unspecified patients were vaccinated with improperly stored MMR II lot#L027591, expiry: 23-JUL-2017 (dosing details were not reported). The patients sought medical attention. It was reported that the vaccines were exposed to maximum temperature of 9.9C and minimum temperature of 0.8C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Electroencephalogram, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Pain and red at inject. site, flu-like aches and pains. Severe pain, spasms neck, shoulder, arm and hand. Pain down both legs. Loss of function and weakness left arm and hand-fingers. Severe cramping in hands, fingers, leg and feet. Left hand muscle wasting and denervation. Headaches.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle atrophy, Muscle spasms, Muscular weakness, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Pain and red at inject. site, flu-like aches and pains. Severe pain, spasms neck, shoulder, arm and hand. Pain down both legs. Loss of function and weakness left arm and hand-fingers. Severe cramping in hands, fingers, leg and feet. Left hand muscle wasting and denervation. Headaches.