chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pain, swelling and rash/redness at injection site. Fever and headache.  All symptoms continued throughout evening and following day.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Pain, swelling and rash/redness at injection site. Fever and headache.  All symptoms continued throughout evening and following day.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, hives within 15-20 minutes after administrartion, Benadryl 25mg given orally x 1 dose. Employee went to ER on 06/29/2016 with hives and was evaluated by MD.
Age: 34.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Urticaria
Clinical narrative: Got the MMR and Hepatitis B vaccines at 0815 on 06/24/2016. That night at midnight I broke up with hives at my upper and lower body - posterior and anterior, wrists, and thighs. I went to the Emergency Department.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Hyperhidrosis, Malaise, Nausea, Pallor
Clinical narrative: Client c/o not feeling well and had nausea, then she said she had chest pressure 5 on a scale of 10. Her heart rate was 54. She was pale and diaphoretic.
Age: 58.0
Sex: F
Vaccine: HEP, MNQ, PPV
Symptoms: Back pain, Feeling abnormal, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: I was given on May 27, 2016 a dose of PNUcn13 (Prevnar 13)(Pneumococcal conjugate, 13 valent and on June 27, 2016 I was given another dose of PNUps (Pneumococcal polysaccharide, pneumonial. I believe it was to soon to be given those similar vaccine. As soon as my secound dose was given I felt pain in my right arm that plain started spreding all the way to my back close to my neck. I could not move or elevate my arm. My arm got so swollen. I felt really thirsty. I did not felt right. I call the advise nurse. They told me to take Tylenol. The pain was so intense I felt like my arm was dislocated. I could not sleep. So I call in the morning to schedule appt to see my doctor. She diagnose that it was a local reaction to the injection. I still feel pain in my right arm. I was given Nabumetone.
Age: 58.0
Sex: F
Vaccine: HEP, MNQ, PPV
Symptoms: Insomnia, Local reaction, Pain in extremity, Peripheral swelling, Thirst
Clinical narrative: I was given on May 27, 2016 a dose of PNUcn13 (Prevnar 13)(Pneumococcal conjugate, 13 valent and on June 27, 2016 I was given another dose of PNUps (Pneumococcal polysaccharide, pneumonial. I believe it was to soon to be given those similar vaccine. As soon as my secound dose was given I felt pain in my right arm that plain started spreding all the way to my back close to my neck. I could not move or elevate my arm. My arm got so swollen. I felt really thirsty. I did not felt right. I call the advise nurse. They told me to take Tylenol. The pain was so intense I felt like my arm was dislocated. I could not sleep. So I call in the morning to schedule appt to see my doctor. She diagnose that it was a local reaction to the injection. I still feel pain in my right arm. I was given Nabumetone.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Fever, chills, fatigue, muscle pain, headache, pain at site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever, chills, fatigue, muscle pain, headache, pain at site.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Syncope
Clinical narrative: Patient experienced a brief episode of syncope. Recovered in a very short period of time (ie: <10 seconds).
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given TDAP on 6/28/16, state she noticed swelling and pain at the injection site around 3:00 the next day. Patient also notices some itching at site. Patient states that discomfort relived by Ibuprofen. Patient returned to Immunization clinic on 6/30/16, where I noted that Right arm (deltoid) was swollen, and warm to touch, 7L x2-3W cm raised area noted. Advised patient to continue Ibuprofen for discomfort.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Full blood count, Mononucleosis heterophile test, Pyrexia, Syncope
Clinical narrative: Syncope X 1; fever 101-103 at least 7 days.
Age: 82.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Balance disorder, C-reactive protein increased, Hypoaesthesia oral, Inflammatory marker increased, Malaise
Clinical narrative: I felt unwell/shaky that evening after receiving the flu vaccine. The next day, my vision was blurry, and the next day after that, I began having severe body aches, accompanied by occasional itching, shakiness, unsteadiness on my feet, and a numb tongue. My physician ordered some tests and said I showed high markers of inflammation. My doctor sent me to see a rheumatologist, who confirmed her diagnosis of polymyalgia rheumatica. As a treatment, I have been taking prednisone since November 2015. To this date, whenever I try to wean off the prednisone, the severe body pain returns.
Age: 82.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain, Polymyalgia rheumatica, Pruritus, Red blood cell sedimentation rate increased, Tremor
Clinical narrative: I felt unwell/shaky that evening after receiving the flu vaccine. The next day, my vision was blurry, and the next day after that, I began having severe body aches, accompanied by occasional itching, shakiness, unsteadiness on my feet, and a numb tongue. My physician ordered some tests and said I showed high markers of inflammation. My doctor sent me to see a rheumatologist, who confirmed her diagnosis of polymyalgia rheumatica. As a treatment, I have been taking prednisone since November 2015. To this date, whenever I try to wean off the prednisone, the severe body pain returns.
Age: 82.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Vision blurred
Clinical narrative: I felt unwell/shaky that evening after receiving the flu vaccine. The next day, my vision was blurry, and the next day after that, I began having severe body aches, accompanied by occasional itching, shakiness, unsteadiness on my feet, and a numb tongue. My physician ordered some tests and said I showed high markers of inflammation. My doctor sent me to see a rheumatologist, who confirmed her diagnosis of polymyalgia rheumatica. As a treatment, I have been taking prednisone since November 2015. To this date, whenever I try to wean off the prednisone, the severe body pain returns.
Age: 82.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza like illness
Clinical narrative: I felt unwell/shaky that evening after receiving the flu vaccine. The next day, my vision was blurry, and the next day after that, I began having severe body aches, accompanied by occasional itching, shakiness, unsteadiness on my feet, and a numb tongue. My physician ordered some tests and said I showed high markers of inflammation. My doctor sent me to see a rheumatologist, who confirmed her diagnosis of polymyalgia rheumatica. As a treatment, I have been taking prednisone since November 2015. To this date, whenever I try to wean off the prednisone, the severe body pain returns.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Fall, Head injury, Swelling face, Unresponsive to stimuli
Clinical narrative: After receiving shots, patient was walking out the door and fell to the floor, hit her head on the floor.  Quarter size nodular area protruded from forehead.  Mom stated child was unresponsive for 30 -60 seconds.  As nurse entered room child was awake and oriented.
Age: 0.42
Sex: M
Vaccine: DTAP
Symptoms: Crying, Diarrhoea, Emotional distress, Head banging, Screaming
Clinical narrative: Patient began screaming unconsolably and it lasted all night, then off and on for the next few days. It was a high pitched cry/scream. He started banging his head on his crib and that continued periodically for months. He also had loose stools starting that night which continued forever 2 years.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: PATIENT DEVELOPED A RASH AT SITE OF INJECTION.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site hypersensitivity, Injection site reaction, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Patient had light swelling and a rash extending from the injecting arm around the tricep wrapping around to the front of the arm, none on the deltoid, rash was itchy and mildly red. Reported this to her doctor who gave her a prescription for Keflex just incase it was an infection however he said it was probably an allergic reaction and told her to get Benadryl. Doctor told her to report it to the pharmacy so we could report it to VAERS.
Age: 59.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Nausea, Peripheral swelling, Skin warm, Vomiting
Clinical narrative: ARM WAS HOT, AND HAD A BIG LUMP. SHE WAS NAUSEOUS AND VOMITED.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dermatitis bullous, Rash
Clinical narrative: This spontaneous report as received from a 67 year old male patient, reporting on himself, with asthma. No other medical history or concurrent conditions of the patient were reported. In January 2016 the patient was vaccinated with ZOSTAVAX, subcutaneous. The strength, dose, frequency, lot # and expiration date were not provided. Concomitant therapies included cortisone acetate (manufacturer unknown). In March 2016 the patient developed a blistering rash on both wrists and up both arms (dermatitis bullous). The patient saw his physician and acyclovir was prescribed. The patient stated that after about 10 days the rash appeared to dissipate for few weeks. Recently, in June 2016, the blistering rash had reappeared. At the time of reporting the outcome of blistering rash on both wrists and up both arms (dermatitis bullous) was reported as not recovered. The causality between blistering rash on both wrists and up both arms (dermatitis bullous) and ZOSTAVAX was unknown. Upon internal review the event of blistering rash on both wrists and up both arms (dermatitis bullous) was considered medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Migraine, Mycobacterium tuberculosis complex test, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of migraine in a 16-year-old female patient who received MENVEO (batch number M15036, expiry date July 2016). Concomitant products included Tdap vaccine. On 22nd June 2016, the patient received the 1st dose of MENVEO .5 ml. On 22nd June 2016, less than a day after receiving MENVEO, the patient experienced migraine (serious criteria other: as per reporter) and fever. The action taken with MENVEO was unknown. On an unknown date, the outcome of the migraine and fever were not recovered/not resolved. The reporter considered the migraine and fever to be possibly related to MENVEO. Additional details were provided as follows: This case was previously reported to a doctor. The field representative stated that the nurse reported that the patient experienced severe migraine with fever of 101 degree F after receiving MENVEO injection. The patient had TB test at the same time as the MENVEO vaccination. The patient required visit to the emergency room. The patient's initials and the manufacturer of the concomitant vaccine were unknown.
Sex: U
Vaccine: DTAPIPV
Symptoms: Abscess limb, Cough, Hypersensitivity, Pruritus, Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of abscess leg in a patient who received KINRIX (batch number D592C, expiry date 29th September 2017). On an unknown date, the patient received KINRIX. On an unknown date, less than a day after receiving KINRIX, the patient experienced abscess leg (serious criteria GSK medically significant), allergic reaction, throat irritation, generalized rash, cough and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the abscess leg, allergic reaction, throat irritation, generalized rash, cough and pruritus were unknown. It was unknown if the reporter considered the abscess leg, allergic reaction, throat irritation, generalized rash, cough and pruritus to be related to KINRIX. Additional details were provided as follows: The reporter stated that 2 patients received KINRIX and experienced allergic reactions. The patient experienced scratching of throat, abscess on right leg, rash on entire body and coughing. The patient was kept in clinic for 3 hours until side effects subsided. The patient was treated with BENADRYL 5 ml. The reporter had minimal information. These were reports from other offices. She believed even though they were indeed KINRIX. She felt as though there was a mistake and this was not KINRIX. This case was linked to case US2016GSK093516 as reported by the same reporter.
Sex: U
Vaccine: DTAPIPV
Symptoms: Throat irritation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of abscess leg in a patient who received KINRIX (batch number D592C, expiry date 29th September 2017). On an unknown date, the patient received KINRIX. On an unknown date, less than a day after receiving KINRIX, the patient experienced abscess leg (serious criteria GSK medically significant), allergic reaction, throat irritation, generalized rash, cough and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the abscess leg, allergic reaction, throat irritation, generalized rash, cough and pruritus were unknown. It was unknown if the reporter considered the abscess leg, allergic reaction, throat irritation, generalized rash, cough and pruritus to be related to KINRIX. Additional details were provided as follows: The reporter stated that 2 patients received KINRIX and experienced allergic reactions. The patient experienced scratching of throat, abscess on right leg, rash on entire body and coughing. The patient was kept in clinic for 3 hours until side effects subsided. The patient was treated with BENADRYL 5 ml. The reporter had minimal information. These were reports from other offices. She believed even though they were indeed KINRIX. She felt as though there was a mistake and this was not KINRIX. This case was linked to case US2016GSK093516 as reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cough, Pneumonia, Productive cough
Clinical narrative: This spontaneous report was received from a 78 year old female patient referring to herself. The patient's concurrent conditions included Diabetes Mellitus, artificial heart valve, immunodeficiency, Stage 4 kidney disease, Arthritis and drug hypersensitivity (reported as allergic to Sulfa and KEFLEX). On an unknown date in 2014 (reported as about two years ago), the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dosage, frequency and route of administration were not provided). This information was reported accordingly to the patient's chart record, however, the patient stated that she did not recall ever being administered with the vaccine. No other suspect or concomitants therapies were reported. In March 2016, the patient developed pneumonia described as she was coughing several times a day and each coughing episode would last up to 10 minutes at a time. Then she was twice admitted to the Hospital because of pneumonia complications for about 4 days in both hospitalizations. Additionally, the reporter stated that pneumonia was treated with unspecified antibiotics and an unspecified nebulizer. It was also reported that Blood work test was performed, however, the result was not provided. At the time of the report, the outcome of pneumonia was recovering as the patient stated that she was almost recovered but she still had some residual coughing and phlegm occurring. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. Upon internal review, the event of pneumonia was considered to be medically significant. No product quality complain was involved. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: FLU3, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult Tdap given Lot # B2435 exp 4/3/18. GlaxoSmithKline - Manufacturer. Site - LD.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: Lightheadedness.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Pt. had no adverse events. Reporting that KINRIX was given instead of PEDIARIX: The KINRIX was not age appropriate - but pt has had the IPV and DTaP previously.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's other concurrent or historical condition was not provided. On 12-APR-2016 the patient received dose 1 of GARDASIL (strength, dose, frequency, route and lot # unknown). Then on 17-JUN-2016 the patient received a dose of GARDASIL 9 (strength, dose, frequency, route and lot # unknown). No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant to multiple, unspecified 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 were vaccinated with doses of improperly stored VAQTA (strength, frequency and route not reported, lot # L015460 and Expiration date 20-JUL-2017). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were 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: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L000456, expiration date 06-JAN-2017, dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: Patient reported swelling at the site the size of a grapefruit a few hours after administration, cetirizine was given with improvement 4-22. Further notes on the reaction not found. Pain, Swelling. Cetirizine 10 mg once.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ (lot # L008053 and expiry date: 30-NOV-2016) following a temperature excursion. No adverse effects were reported. The vaccine was stored at a temperature of 1.1 Celsius for 15 minutes (3 cycles). There was no previous temperature excursion and data logger was reported as yes. No product quality complaint (PQC) was reported for ROTATEQ. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer and refers to a 67 year old male patient. The reporter did not provided the patient or physician demographics. The patient's medical history, concomitant therapy and concurrent conditions were not reported. On an unknown date, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX injection (lot #, expiration date, dose and anatomical location were not reported). On an unknown date, the patient was diagnosed with shingles. The outcome of the event was reported as improved. The relatedness between the event and the therapy with ZOSTAVAX was not reported. Additional information is not expected, as the consumer did not wish to disclose her identity.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was reported. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II with lot # L029266, expiry date: 04-AUG-2016 (route and dose not provided). The vaccine was exposed to temperature excursion of 47 F for 9 hours on 13-JUN-2016. It was reported that the vaccine was exposed to 47 F for a total of 22 hours. The nurse stated that the refrigerator back in range. No adverse effects were reported. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Expired product administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a patient of unknown age and gender. Information regarding concurrent condition, medical history and concomitant therapy was not reported. It was reported that an expired dose of VARIVAX (dose, route, and lot# not reported, expired date 16-OCT-2015) was inadvertently administered on 17-JUN-2016 instead of ZOSTAVAX. The reporter confirmed that there was no medication confusion involved; however, it was given in error. Also, it was confirmed by the reporter that ZOSTAVAX was not administered to the patient. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received medical assistant refers to unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On 16-JUN-2016, an unspecified patients were vaccinated with six improperly stored doses of VAQTA, with lot # M009377, expiry date: 17-JUN-2017 (dose and route not reported), which were exposed to temperature excursion of 47 F for 9 hours . Then, on 23-JUN-2016, an unspecified patient was vaccinated with an improperly stored dose of VAQTA, lot # L015460, expiry date: 20-JUL-2017 (dose and route not reported), which was exposed to temperature excursion of 47 F for 9 hours on 13-JUN-2016, 47 F for 8 hours on 17-JUN-2016 and 47 F for unknown number of hours on 23-JUN-2016. No adverse effects were reported. The nurse stated that the refrigerator back in range. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received medical assistant refers to unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On 16-JUN-2016, an unspecified patient was vaccinated with an improperly stored dose of ROTATEQ with lot # L028645, expiry date: 25-MAY-2017 (dose and route not reported), which was exposed to temperature excursion of 47 F for 9 hours. Then, on 23-JUN-2016, an unspecified patients were vaccinated with two improperly stored doses of ROTATEQ, with lot# L028645, expiry date: 25-MAY-2017 (dose and route not reported), which were exposed to temperature excursion of 47 F for 9 hours on 13-JUN-2016, 47 F for 8 hours on 17-JUN-2016, and 47 F for unknown number of hours on 23-JUN-2016. No adverse effects were reported. The nurse stated that the refrigerator back in range. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 18-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in June 2016 (reported also as "last monday"), the patient was vaccinated with a dose of GARDASIL 9 (dose, lot#, expiration date, route of administration and vaccination site were not reported). On the same day, the patient received an unspecified meningococcal vaccine (dose, route of administration and vaccination site were not reported). Immediately after vaccination (reported also as "on saturday"), the patient felt very nauseated and had vomiting. The patient received PHENERGAN for nausea. The symptoms subsided 30 hours later (recovered on an unknown date in approximately 2016). The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant to multiple, unspecified 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 were vaccinated with doses of improperly stored GARDASIL 9 (strength, frequency and route not reported, lot # M004116 and Expiration date 12-OCT-2017). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant to multiple, unspecified 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 were vaccinated with doses of improperly stored ROTATEQ (strength, frequency and route not reported, lot # L033693 and Expiration date 31-MAY-2017. The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant to multiple, unspecified 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 were vaccinated with doses of improperly PEDVAXHIB (strength, frequency and route not reported, lot # L038501 and Expiration date 16-AUG-2018). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of pediatric patients of unknown age and gender. The patients' medical history and concurrent condition were not reported. On an unknown date the patients were administered with PEDVAXHIB (Lot# L051122, expiration date 12-OCT-2018, dose, route and frequency not reported). The vaccine was undergoing a possible (but not verifiable) second temperature excursion at 30.8 degree Fahrenheit for 15 hours. It was noted that the reading of "30.8" was based on a handwritten record that was not clear. It was strongly believed by the reported that the vaccines instead remained in range at 38.8 degree Fahrenheit and that the reading of "30.8" was based on a clerical error (handwriting legibility issue). The vaccines involved previously underwent an excursion. No adverse effects were reported. This is one of several reports received from the same reporter. No additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 19-JUN-2016 at around 18:05 the patient was vaccinated with a dose of M-M-R II (lot# M001200, expiration date 28-AUG-2016, therapy type rHA) subcutaneously. No adverse effects were reported. Temperature information was as follows: Last known time in correct storage range was on 19-JUN-2016 at 14:00 (24-hour clock). The refrigerator reached a high of 49 degrees Fahrenheit at the time that the dose of M-M-R II was removed from the refrigerator, which was on 19-JUN-2016 "around 18:00" (24 hour clock). The dose was administered to the patient "5 minutes later" (room temperature where the dose was administered was estimated to be at "around 73 degrees Fahrenheit"). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. information regarding relevant medical history and concurrent condition were not reported. On 28-JUN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L031272, expiration date 19-NOV-2016, dosage and route not specified). No adverse effect reported. 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 healthcare worker refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-APR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB 5/0.5 microgram/ml, lot # L033343 with expiration date: 13-SEP-2017, via intramuscular route (dose was not reported). Administered dose of RECOMBIVAX HB underwent temperature excursion at 31.1 Fahrenheit degrees, for 82 hours. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates, the patient was vaccinated with the first and second dose of VAQTA (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient was inadvertently vaccinated in the left deltoid with the third dose of VAQTA (dose, route of administration, lot number reported as M003618 and expiration date 18-NOV-2017) instead of an intended dose of RECOMBIVAX HB. When the error was noticed, the patient was vaccinated in the right deltoid with RECOMBIVAX HB (lot number L038499 and expiration date 26-JUN-2017, dose and route of administration were not reported) on the same date as well. The reporter stated that there was no confusion on the labeling but that both products were in the same container, and the reporter just picked the wrong one. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB of lot# L051122, expiry date: 12-OCT-2018. Concomitant medication was not mentioned by the reporter. No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 1.36
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Decreased appetite, Dehydration, Influenza, Influenza like illness, Influenza virus test negative
Clinical narrative: 04/15/2016 16 months toddler who developed a fever yesterday temperature was 100.8 AX, URI symptoms, HX of vomiting X 6 times, no diarrhea, mom gave MORTIN and TYLENOL, unsure if anything hurts, decreased appetite. 04/19/2016 Patient was seen in the office for well visit on April 13, 2016 for well visit. Patient received that the hepatitis A vaccine and Haemophilus influenza type b vaccine. Mother states that within a day of receiving the vaccines he developed fever. He was seen in our office on April 15, 2016 with a history of fever from the day before. URI symptoms, vomiting without diarrhea. Patient was found to be tachycardic to about 170 bpm with a temperature of 102.6 axillary. Patient was sent to the pediatric emergency room for further management due to the persistent vomiting and tachycardia. According to the mother that temperature at there when as high as 105.5 F. And the heart rate was over 200. Also upon arriving to the hospital patient had developed some hives. According to the mother the patient received IV fluids. Final diagnosis was fever, influenza-like illness and dehydration. The influenza test and RSV test came back negative. According to the mother the patient received one dose of TAMIFLU in the emergency room for suspected influenza. Upon leaving the emergency room the mother states that he developed hives on the face and also started having some swelling of the tongue. Mother gave the patient BENADRYL and did not take her back to the emergency room. Patient did improve with the treatment. Mother continued giving antipyretics to the patient until the day prior to the visit. Not further fever documented according to the mother since discharge from the emergency room but she was given the antipyretics around the clock. Mother also notice a faint rash appearing 1 day ago that is clearing now. Does not seem to be bothering her.
Age: 1.36
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Pyrexia, Rash, Respiratory syncytial virus test negative, Swollen tongue, Tachycardia
Clinical narrative: 04/15/2016 16 months toddler who developed a fever yesterday temperature was 100.8 AX, URI symptoms, HX of vomiting X 6 times, no diarrhea, mom gave MORTIN and TYLENOL, unsure if anything hurts, decreased appetite. 04/19/2016 Patient was seen in the office for well visit on April 13, 2016 for well visit. Patient received that the hepatitis A vaccine and Haemophilus influenza type b vaccine. Mother states that within a day of receiving the vaccines he developed fever. He was seen in our office on April 15, 2016 with a history of fever from the day before. URI symptoms, vomiting without diarrhea. Patient was found to be tachycardic to about 170 bpm with a temperature of 102.6 axillary. Patient was sent to the pediatric emergency room for further management due to the persistent vomiting and tachycardia. According to the mother that temperature at there when as high as 105.5 F. And the heart rate was over 200. Also upon arriving to the hospital patient had developed some hives. According to the mother the patient received IV fluids. Final diagnosis was fever, influenza-like illness and dehydration. The influenza test and RSV test came back negative. According to the mother the patient received one dose of TAMIFLU in the emergency room for suspected influenza. Upon leaving the emergency room the mother states that he developed hives on the face and also started having some swelling of the tongue. Mother gave the patient BENADRYL and did not take her back to the emergency room. Patient did improve with the treatment. Mother continued giving antipyretics to the patient until the day prior to the visit. Not further fever documented according to the mother since discharge from the emergency room but she was given the antipyretics around the clock. Mother also notice a faint rash appearing 1 day ago that is clearing now. Does not seem to be bothering her.
Age: 1.36
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Upper respiratory tract infection, Urticaria, Vomiting
Clinical narrative: 04/15/2016 16 months toddler who developed a fever yesterday temperature was 100.8 AX, URI symptoms, HX of vomiting X 6 times, no diarrhea, mom gave MORTIN and TYLENOL, unsure if anything hurts, decreased appetite. 04/19/2016 Patient was seen in the office for well visit on April 13, 2016 for well visit. Patient received that the hepatitis A vaccine and Haemophilus influenza type b vaccine. Mother states that within a day of receiving the vaccines he developed fever. He was seen in our office on April 15, 2016 with a history of fever from the day before. URI symptoms, vomiting without diarrhea. Patient was found to be tachycardic to about 170 bpm with a temperature of 102.6 axillary. Patient was sent to the pediatric emergency room for further management due to the persistent vomiting and tachycardia. According to the mother that temperature at there when as high as 105.5 F. And the heart rate was over 200. Also upon arriving to the hospital patient had developed some hives. According to the mother the patient received IV fluids. Final diagnosis was fever, influenza-like illness and dehydration. The influenza test and RSV test came back negative. According to the mother the patient received one dose of TAMIFLU in the emergency room for suspected influenza. Upon leaving the emergency room the mother states that he developed hives on the face and also started having some swelling of the tongue. Mother gave the patient BENADRYL and did not take her back to the emergency room. Patient did improve with the treatment. Mother continued giving antipyretics to the patient until the day prior to the visit. Not further fever documented according to the mother since discharge from the emergency room but she was given the antipyretics around the clock. Mother also notice a faint rash appearing 1 day ago that is clearing now. Does not seem to be bothering her.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown age and gender. Information on the concurrent condition, pertinent medical history and drug allergies of the patients were not reported. On unspecified dates the patients were vaccinated with improperly stored VAQTA (lot L023936, expiry date 15-MAR-2017, lot/batch # M011839, expiry date 13-SEP-2017, or an unspecified lot and expiry date) (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Urticaria, pruritus and in area of injection 8 cm/6 cm erythema with several small areas of raised skin.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 28-JUN-2016, the patient was inadvertently vaccinated with first dose of ROTATEQ (lot # K023534) that was expired on 22-MAY-2016. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration
Clinical narrative: 8-10 cm area of erythema and induration.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after TYPHIM administration. Patient did not fall, Rph. caught patient before she fell. Patient was conscious and responsive. Called 911 but patient left before they got here.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Presyncope, Seizure like phenomena
Clinical narrative: Vasovagal seizure-like episode immediately following vaccine administration
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Rash, fever, chills, sore throat. Rash for 9 days next to where the vaccine was given.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Blood culture negative, Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient went to ER 6/22/16 (R) arm swollen, red and vesicles noted ((R) upper arm). Diag. cellulitis and possible developing abscess. Given KEFLEX x 7 days, BENADRYL, hydrocortisone topical. F/U schedule July 6.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: White blood cell count normal
Clinical narrative: Patient went to ER 6/22/16 (R) arm swollen, red and vesicles noted ((R) upper arm). Diag. cellulitis and possible developing abscess. Given KEFLEX x 7 days, BENADRYL, hydrocortisone topical. F/U schedule July 6.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp of 102.1 evening of imms, no redness or tenderness of site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Imm site warm to touch, slightly tender. Step sibling with same reaction to same imm today.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site warmth
Clinical narrative: Discomfort and warmth at inj site. Step sibling with same reaction to same imm today.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test normal, Papule, Pyrexia, Rash, Varicella virus test
Clinical narrative: Fever, rash - small papules (a few scabbed on 6/8/16). TYLENOL, OTC calamine (symptomatic care).
Age: 25.0
Sex: U
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Billed ins for ADACEL but BOOSTRIX administered.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient came in on 6/23/2016 to get PREVNAR shot.  I/M shot was given. Pt came back on 6/28/16 and her arm was red and swollen, and was prescribed Doxycycline.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Administered MENACTRA B, patient had already received booster on 3-19-2015.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site swelling, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Temperature 101.8. Pain in (L) neck, behind (L) ear, (L) shoulder, (L) arm. Painful to move arm. Swelling at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 24-JUN-2016 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU (lot # L003215, 30-APR-2016) (dosing regimen and frequency unknown) subcutaneously. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 70 year old female patient. The patient had no pertinent medical history and was allergic to CIPRO, doxycycline, erythromycin and sulfa drugs. On 18-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot#L031272, expiration date 19-NOV-2016). Concomitant therapies included sertraline hydrochloride and hydrochlorothiazide, BENICAR HCT. On 16-JUN-2016 (reported as 7 or 8 days ago), the patient developed a rash on her left hip. The patient visited her physician, who diagnosed the rash as shingles. The reporting pharmacist reported there were no blisters present at the site of the rash. No lab diagnostics studies were performed. Acyclovir was given as treatment. At the time of this report the patient had not recovered from the shingles. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash pustular
Clinical narrative: Information has been received from a pharmacist referring to a 70 year old female patient. The patient had no pertinent medical history and was allergic to CIPRO, doxycycline, erythromycin and sulfa drugs. On 18-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot#L031272, expiration date 19-NOV-2016). Concomitant therapies included sertraline hydrochloride and hydrochlorothiazide, BENICAR HCT. On 16-JUN-2016 (reported as 7 or 8 days ago), the patient developed a rash on her left hip. The patient visited her physician, who diagnosed the rash as shingles. The reporting pharmacist reported there were no blisters present at the site of the rash. No lab diagnostics studies were performed. Acyclovir was given as treatment. At the time of this report the patient had not recovered from the shingles. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2016 the patient was vaccinated with first dose of RECOMBIVAX HB (route, dose, frequency, lot # not reported). On 25-JUN-2016, the patient was vaccinated with second dose of RECOMBIVAX HB (inappropriate schedule of drug administration). The patient did not experience adverse event. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 4 month old female patient. On 23-FEB-2016 at 12:35, the patient was orally (inappropriate route of vaccination) vaccinated with improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB (second dose, lot # reported as L013202, dose was unknown). No adverse effect was reported. Lot number L013202 has been verified to be a non-valid lot number for RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.