chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC, VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Pt had a light red rash upper back of arm around injection site.  She said it was warm to touch and hard nodule under skin.  She came to the pharmacy on 5-26-16 and said it was looking much better and not as warm any longer.  I informed her if the redness spread, became more warm or looked worse to go to the doctor.  I also told her to put a cold pack or frozen veggies on the site to help with the warmth.
Age: 2.0
Sex: F
Vaccine: DPP, HEP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Bladder catheterisation, Chills, Hypersomnia, Injection site induration, Injection site movement impairment
Clinical narrative: Started with fever the first couple of days, was walking normal but soon had stiff legs would not bend at knees and her thighs were hard swollen and hot to the touch. Fever broke and then had high fever for 3-4 days with no break and would shiver/tremble while sleeping. She slept a lot and her heart would be racing. On the 10th day she broke out with a measle like rash and had 104.8 fever which I took her to the ER. She had no infection or UTI. Because of this she had a catheter put in due to her not being able to urinate. She had NO UTI. A few days later still malaise I took her back to health services which ended up her having a UTI. Because of catheter. And injured URETHRA. This is all noted in her record.
Age: 2.0
Sex: F
Vaccine: DPP, HEP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Malaise, Palpitations, Pyrexia
Clinical narrative: Started with fever the first couple of days, was walking normal but soon had stiff legs would not bend at knees and her thighs were hard swollen and hot to the touch. Fever broke and then had high fever for 3-4 days with no break and would shiver/tremble while sleeping. She slept a lot and her heart would be racing. On the 10th day she broke out with a measle like rash and had 104.8 fever which I took her to the ER. She had no infection or UTI. Because of this she had a catheter put in due to her not being able to urinate. She had NO UTI. A few days later still malaise I took her back to health services which ended up her having a UTI. Because of catheter. And injured URETHRA. This is all noted in her record.
Age: 2.0
Sex: F
Vaccine: DPP, HEP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Rash morbilliform, Tremor, Urethral injury, Urinary retention, Urinary tract infection
Clinical narrative: Started with fever the first couple of days, was walking normal but soon had stiff legs would not bend at knees and her thighs were hard swollen and hot to the touch. Fever broke and then had high fever for 3-4 days with no break and would shiver/tremble while sleeping. She slept a lot and her heart would be racing. On the 10th day she broke out with a measle like rash and had 104.8 fever which I took her to the ER. She had no infection or UTI. Because of this she had a catheter put in due to her not being able to urinate. She had NO UTI. A few days later still malaise I took her back to health services which ended up her having a UTI. Because of catheter. And injured URETHRA. This is all noted in her record.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Pneumonia, X-ray
Clinical narrative: Got pneumonia and was hospitalized.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Tenderness, Vaccination complication
Clinical narrative: Patient noticed follow day that his arm was red, slightly swollen, and pain to the touch. He waited until 05/25/16 and when it still wasn't any better he came in the pharmacy and let us know he was experiencing a reaction. The pharmacist working told him to contact his physician so they could chart his reaction.
Age: 15.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling, warmth. Beyond what would be a normal reaction to vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site, pt experiencing hot, red, hard, painful spot. Saw MD yesterday, they prescribed only Hydrocortisone, per patient. Per pt, they didn't believe the site was infected at this time.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MEN, MENB
Symptoms: Syncope
Clinical narrative: Pt fainted after receiving vaccines.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left arm injection site with approx 4 cm round area of erythema, warmth & firmness. Started approx 24 hours after injection. Pt states red area is slightly increasing in size. No treatment.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Fatigue, Gait disturbance, Joint swelling, Rash
Clinical narrative: Major knee swelling, could not walk on leg, fatigue, feet turned purple, rashes on legs.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Skin discolouration, Urine analysis, X-ray limb
Clinical narrative: Major knee swelling, could not walk on leg, fatigue, feet turned purple, rashes on legs.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area is red, very tender to touch and slightly swollen. She does not complain of itching or fever. She used a heating pad yesterday, today she will ice the area and take ibuprofen or NAPROSYN.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Arthralgia, Chills, Gastrooesophageal reflux disease, Injection site pain
Clinical narrative: Severe abdominal pain, acid reflux, vomiting stomach acids, fever, chills, whole body muscle and joint pain, pain and swelling at injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Myalgia, Pyrexia, Vomiting
Clinical narrative: Severe abdominal pain, acid reflux, vomiting stomach acids, fever, chills, whole body muscle and joint pain, pain and swelling at injection site.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Arthralgia, Fatigue, Headache, Loss of consciousness
Clinical narrative: Throat feels like its closing, then he passes out. Severe headaches and muscle and joint pain. He now has seizures. He constantly tired and some days he cant get out of bed. He can't play sports he was involved in or even go to school.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Mobility decreased, Myalgia, Seizure, Throat tightness
Clinical narrative: Throat feels like its closing, then he passes out. Severe headaches and muscle and joint pain. He now has seizures. He constantly tired and some days he cant get out of bed. He can't play sports he was involved in or even go to school.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Swelling face
Clinical narrative: Feeling of fever then feeling of swollen face when she woke up in the morning of May 26 2016.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Abasia, Activities of daily living impaired, Arthralgia, Contusion, Diarrhoea
Clinical narrative: Throat closing could not breath, passing out, seizures, vomiting, diarrhea, unexplained bruising, extreme fatigue resulting in sleep for 12 hours plus. Severe joint pain, sometimes can't even walk. Can't attend school or play sports anymore.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Fatigue, Hypersomnia, Loss of consciousness, Seizure
Clinical narrative: Throat closing could not breath, passing out, seizures, vomiting, diarrhea, unexplained bruising, extreme fatigue resulting in sleep for 12 hours plus. Severe joint pain, sometimes can't even walk. Can't attend school or play sports anymore.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Throat tightness, Vomiting
Clinical narrative: Throat closing could not breath, passing out, seizures, vomiting, diarrhea, unexplained bruising, extreme fatigue resulting in sleep for 12 hours plus. Severe joint pain, sometimes can't even walk. Can't attend school or play sports anymore.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 50-year-old female patient who received FLUARIX QUADRIVALENT (batch number L94EX, expiry date 30th June 2016). On 16th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the report considered the pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced sore arm after vaccination. This case was created on follow up of case US2016019415 and was reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt developed Reddish/tender rash around injection site that a physician deemed "allergic" on 1 day after administration.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site. Fever, HA, bodyaches, diarrhea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Redness, swelling, pain at injection site. Fever, HA, bodyaches, diarrhea.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling and severe itching for 24+ hours with ZOSTAVAX shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Throbbing, severe pain approximately 2 hours after vaccination. Pain in neck and down arm. Took TYLENOL but little improvement. Spoke with pt 5-25-16 8 am and she reported it was 80% better.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt. called in AM of 5-25-16 and stated that she had gotten PNEUMOVAX 23 on 5-24-16, and her arm was hurting and swollen. Advised her to use cold compress and if symptoms persist or get worse to check with her MD. Came in Pharmacy later in day for me to check her arm and it was swollen, red and warm from top of shoulder midway down arm. After talking with her she went to urgent care to get her arm checked. Diagnosis was cellulitis and they prescribed clindamycin 300 mg - 1 capsule four times a day for 10 days. She later when to ER and they prescribed prednisone 10 mg Dospak and BENADRYL 25 mg - 1 capsule every 6 hours as needed, and she picked these up at 10:32 am on 5-26-2016. I tried several times today to contact her, but I not heard anything.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Rt arm - 2-2 1/2 inch, 4-6 erythema, soreness and redness 4 6 inches.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Red arm, swollen, and slightly stiff. Pt went to hospital. Prednisone and BENADRYL from urgent care.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Syncope
Clinical narrative: Pt received DTAP injection approx 10AM 5/24/16. Parent stated child fainted 6 hr's later for 30 seconds.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PROQUAD - Red/raised area at injection 1/2 mL BENADRYL given per Dr order.
Age: 0.79
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site nodule, Pyrexia
Clinical narrative: Mom called 5/13/16 and reported that pt got 4 month old vaccines on 5-11-16 and the next morning had a fever until that evening. (Did not know what temp was). Also, the upper left leg was red and knot size of quarter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hyperaesthesia, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Local redness and swelling of site. Symptoms of body aches, nausea and increased sensitivity of skin.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 49-year-old female patient who received FLUARIX QUADRIVALENT (batch number L94EX, expiry date 30th June 2016). On 16th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced sore arm after vaccination. This case was created on follow up of case US2016019415 and was reported by the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # L023870 Expiry: 20-APR-2017). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a pharmacist via a company representative referring to the pharmacist himself, a male patient of unknown age. On an unknown date the patient was vaccinated with unspecified hepatitis vaccine (manufacturer unknown) VAQTA or RECOMBIVAX HB (dose and frequency were not reported). The pharmacist had "titers drawn" on an unspecified date which showed "he had no hepatitis titers". The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to various unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 03-MAY-2015, doses of VARIVAX (lot # L040421 with expiration date of 15-OCT-2017; lot # L040423 with expiration date of 15-OCT-2017 and lot # L043623 with expiration date of 02-NOV-2017 (lot # L043623 is an invalid lot number for VARIVAX), dose frequency and route unknown) were exposed to a temperature excursion at 0.2 degrees Celsius for 4.5 hours and back in range then. Subsequently the vaccines were exposed at minus 4.9 degrees Celsius for 1 hour and 42 minutes and back in range after that. Since 03-MAY-2016, the vaccines were administered to unspecified patients. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to various unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 03-MAY-2015, doses of PROQUAD (Merck) (lot # M003436 with expiration date of 19-JUL-2017 (therapy type: rHA); lot # L050910 with expiration date of 14-JUN-2017; lot # L046506 with expiration date of 17-MAY-2017 and lot # L051098 with expiration date of 17-JUN-2017, dose, frequency and route unknown) were exposed to a temperature excursion at 0.2 degrees Celsius for 4.5 hours and back in range then. Subsequently the vaccines were exposed at minus 4.9 degrees Celsius for 1 hour and 42 minutes and back in range after that (incorrect product storage). Since 03-MAY-2016, the vaccines were administered to unspecified patients. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 77 year old female patient. The patient had no history of drug reaction or allergies. On 03-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX Lot # L035504 with expiration date of 16-DEC-2016 (dose was unspecified), subcutaneously on the inside of her left arm near the elbow. On 04-MAY-2016, the patient developed a 4 inch area of redness and warmth at the injection site. The patient came to pharmacy to seek medical attention. No treatment was given. No lab diagnostics study was performed. At the time of reporting, the patient was not recovered from the events. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative referring to a 2 months old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with ROTATEQ (Lot# and Expiration date not reported) 1 dose orally. The patient had also been administered a dose of PREVNAR 13, PENTACEL and an unspecified hepatitis B vaccine (manufacturer unknown) (dose, lot#, expiration date and route not reported) at the same visit. The physician assistant reported that on an unknown date the patient presented with a full body rash including the face within 8 hours of receipt of the ROTATEQ. The adverse event was treated with BENADRYL, and the rash resolved within 24 hours. Reporter's causality was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a male pharmacist of unknown age referring to himself via a field employee. Pertinent medical history, drug allergy or concomitant medication was unspecified. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unspecified date, the patient developed pain, tenderness and swelling at the injection site. At the time of reporting, the outcome of the events was not reported. The relationship between the events and the ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist via a field employee concerning 1-2 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 ZOSTAVAX (lot # and expiration date not reported) subcutaneously. On unknown dates, after being administered ZOSTAVAX, the patients developed shingles. It was not specified how long after receiving the ZOSTAVAX the patients  developed shingles. The outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was not provided. Additional information is not expected, as there is no consent to contact the pharmacist.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. In August 2014, the patient was vaccinated with first dose of ZOSTAVAX (lot number, dose and route were unknown). Then in May 2016, the patient was vaccinated with a second dose of ZOSTAVAX (lot number, dose and route were unknown). No adverse effects were reported. 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 referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly store (13.9 degree centigrade for 17 hours) doses of ROTATEQ (lot # L008031, expiration date: 03-AUG-2016 and lot# L023866 with expiration date: 24-MAR-2017, oral, dose was unknown). No adverse effects were reported. No previous temperature was excursion. 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 referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored (13.9 degree centigrade for 17 hours) doses of PEDVAXHIB (lot # L014429, expiration date: 15-MAR-2018 and Lot# L028501 with expiration date: 16-AUG-2018, dose was unknown). No adverse effects were reported. No previous temperature was excursion. 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 health professional referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M001813, expiration date 14-OCT-2018, dose and route unknown). The vaccine was stored under 55 F for 15 hours. It was back in range. There was no previous temperature excursion. It was called because of a data logger. No adverse effects were reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Malaise, Menstruation irregular, Muscle spasms, Myalgia
Clinical narrative: Was given a Tdap booster to immunize against tetanus after a deep knee wound/running accident. I immediately had a sore arm, muscle spasms and aches and felt sick. I got my period the next day approximately 5 days earlier than normal.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Was given a Tdap booster to immunize against tetanus after a deep knee wound/running accident. I immediately had a sore arm, muscle spasms and aches and felt sick. I got my period the next day approximately 5 days earlier than normal.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027076, expiry 25-MAY-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32F Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. This case is one of the 3 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L023936, expiry 15-MAR-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32 F. Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. This case is one of the 3 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age. On an unknown dates, the patients were vaccinated wit ZOSTAVAX lot # L035286, 15-DEC-2016. No adverse effects were reported. Temperature of 2.8 degree centigrade for 6hours 46 minutes and it was administrated previously there was no temperature excursion. This is one of the 3 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 refers to a multiple unspecified patients of unknown age. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L017146, 13-MAY-2017, L017142, 30-MAY-2017, L050560, 14-DEC-2017. No adverse effects were reported. Temperature of 2.8 degree centigrade for 6hours 46 minutes and it was administered, previously there was no temperature excursion. This is one of the 3 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 from a medical assistant refers to an unspecified number of patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unspecified. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K015816, expiry date: 29-MAY-2016 and lot # L013202, expiry date: 27-JAN-2017). Medical assistant reported that the vaccine underwent temperature excursion at 33 degree Fahrenheit for 1 hour. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash erythematous, Rash macular
Clinical narrative: This spontaneous report as received from an unknown reporter via a field representative concerning a 12 month old male patient. No concurrent conditions, medical history or allergy/drug reactions were reported. On 25-APR-2016, the patient was vaccinated with one dose of VARIVAX lot #L025206 (dosing details, expiry date were not reported). On the same day, the patient experienced blisters and splotchy red rash. No treatment was given for the event. The patient did not seek any medical attention. The outcome of blisters and splotchy red rash was reported as recovered/resolved. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M004116, expiry 12-OCT-2017 (dose and route not reported). Temperature: 28 F. Time frame: one hour. No previous temperature excursions reported. Data logger was used. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: PREVNAR 13 administered in (L) deltoid on 5-19-16. Patient reports redness started that PM, most of upper arm became swollen, hot and red. Today 5-25-16 - area below deltoid and above elbow remains red/swollen and warmer to touch c/o being tender and very itchy.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Back pain, Computerised tomogram abnormal, Diarrhoea, Hernia repair
Clinical narrative: In 10 hours, by night, horrible cramping and diarrhea several times a day. Went back to doctor by Christmas did a CT scan. Identified a small hernia and had outpatient surgery. On February 2016. General practitioner recommended CREON for the diarrhea. Had reaction to medication so changed to VIBERZI. Medicine helped settled diarrhea, but horrible stomach cramping continues; pain radiates to back. Has seen 2 gastrointestinal specialist over time and problems still continue. Has been taking VIRBEZI for 2 weeks; got blood work done yesterday to test for pancreatic enzyme levels. In the past the only AE to vaccine experienced has been the common sore arm for a day or so.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Muscle spasms, Pancreatic enzymes
Clinical narrative: In 10 hours, by night, horrible cramping and diarrhea several times a day. Went back to doctor by Christmas did a CT scan. Identified a small hernia and had outpatient surgery. On February 2016. General practitioner recommended CREON for the diarrhea. Had reaction to medication so changed to VIBERZI. Medicine helped settled diarrhea, but horrible stomach cramping continues; pain radiates to back. Has seen 2 gastrointestinal specialist over time and problems still continue. Has been taking VIRBEZI for 2 weeks; got blood work done yesterday to test for pancreatic enzyme levels. In the past the only AE to vaccine experienced has been the common sore arm for a day or so.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # L043213, expiry 28-AUG-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32 F. Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. This case is one of the 3 reports from the same source. Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Tremor
Clinical narrative: Mom reports child cannot move without shaking. Has not checked temp but gave TYLENOL. Counseled to give ibuprofen and see PMD.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # M003436, 07-SEP-2017, L024122, 30-DEC-2016, M001152, 15-JUL-2017. No adverse effects were reported. Temperature of 2.8 degree Centigrade for 6 hours 46 minutes and it was administered, previously there was no temperature excursion. This is one of the 3 reported received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed redness, swelling just a few mins after receiving the injections, below the injection site Rt. thigh.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 10-MAY-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot # K009876 with expiration date of 19-MAR-2016, dose and route unknown. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ages and genders. Information regarding their pertinent medical history, drug reactions/allergies or concurrent conditions were not reported. On 23-MAY-2016, the patients were vaccinated with improperly stored doses of VARIVAX (which had a lot # of L048467 and an expiration date of 02-DEC-2017; however, the doses, dosage numbers, anatomical locations and the routes of administration were not reported). No concomitant therapies were reported. The vaccines experienced a temperature excursion of 5.4 F for a time frame of 30 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with an improperly stored vaccine, no adverse effects were reported. Notably, no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 08-JAN-2016, the patient was vaccinated with first dose of RECOMBIVAX HB (lot # K026531, expiry date: unspecified). On 08-MAR-2016, the patient received their second dose of vaccine (lot # K024553, expiry date: unspecified) at a greater than recommended interval (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # M001152, expired date 05-JUL-2017, dose and route were unknown), which was exposed under 37.2 F for 6 hours. No concomitant therapy was reported. There was no previous temperature excursion. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reaction/ allergies were reported. On 11-NOV-2015, the patient was vaccinated with first dose of VAQTA (strength, dosing details, anatomical location, lot# and exp date unknown). On 27-APR-2016 the patient was vaccinated with a booster dose of VAQTA strength 25/0.5 (unspecified unit), (lot # L036300, Expiration date 04-NOV-2016, dose 2) (dosing details and anatomical location unknown), which was earlier than 6 months after the initial dose of VAQTA. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: RUB
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and 70 year old female patient who is also a registered nurse. The patient had no concurrent condition and medical history. The patient was allergic to PERCODAN. On an unknown date in 1981 or 1982 (also reported as 35 years ago), the patient was vaccinated with RUBELLA virus vaccine live (manufacturer unknown). The patient was not on any concomitant medications. On an unknown date, 10 days later, the patient experienced headache, fever and swollen lymph node at the back of the head and neck. As she was working at the hospital at that time she went to the doctor who advised her to take rest and take TYLENOL. No lab tests were performed. The patient recovered from the events after 7 days and she returned to work. The causality was unspecified. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Information regarding concurrent condition, historical condition and concomitant therapy was not reported. During the entire time from 26-AUG-2015 to 13-OCT-2015, doses of M-M-R II (lot # K007108, expired date 16-MAY-2016, rHA) was improperly stored to 9 centigrade. On 12-OCT-2015, the patient received a dose of this improperly stored vaccine, subcutaneously. No known adverse effect was reported This is one of the several reports with 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 referring to unspecified patients of unknown age and gender. On unknown dates since October 2015, an unspecified number of unspecified patients have been administered doses of ZOSTAVAX (dose, frequency and route not provided) which were improperly stored (incorrect product storage). No adverse effects were reported. There was no product quality issue (PQC) involved. Names of vaccines involved: ZOSTAVAX (Lot#L032403 and expiration date 30-NOV-2016). Temperature: 9F. Time frame/date of excursion: 1,440 hours. Date of administration: see above note. Lot and expiration date: see above note. Due to data logger: Yes. Additional information is not expected as the pharmacist did not have access the lot and expiration date.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to various unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 03-MAY-2015, doses of ZOSTAVAX (lot # L029485 with expiration date of 06-NOV-2016; lot # L035286 with expiration date of 15-DEC-2016 and lot # L039094 with expiration date of 08-JAN-2017, dose, frequency and route unknown) were exposed to a temperature excursion at 0.2 degrees Celsius for 4.5 hours and back in range then. Subsequently the vaccines were exposed at minus 4.9 degrees Celsius for 1 hour and 42 minutes and back in range after that (incorrect product storage). Since 03-MAY-2016, the vaccines were administered to unspecified patients. No adverse effects were reported. 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 referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent condition, drug reaction or concomitant medication described. On 03-MAY-2016 the patient was vaccinated with ZOSTAVAX lot # L029485 with expiration date of 06-NOV-2016 (dose and rouge were not reported), which had been stored at 37 degree for over 3 month, since 21-JAN-2016. The vaccine did not have previous temperature excursion. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown gender and age. The patients' pertinent medical history and drug reactions/allergies were not provided. On unspecified dates the patients were vaccinated with M-M-R II (dose, route and lot # were not provided). On multiple unspecified dates the patients experienced redness and swelling at injection site for 3-5 days following the administration of M-M-R II, but no induration had developed. The nurse did not have any further details on any of the patients who experienced only redness or swelling at the injection site. The outcome of the events was considered as recovered/resolved. The causality of the events was not provided. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Injection site induration
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. There was no concomitant medications. On 29-APR-2016 the patient was vaccinated with M-M-R II (dose and lot# were not provided), subcutaneously. On an unspecified date in 2016 the patient experienced induration at the injection site. On 20-MAY-2016 the patient sought medical attention by coming into the office. There was no treatment given for the adverse event and no lab diagnostics studies performed. The outcome of injection site induration and the causality of the event were not reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L019297, Expiry: 18-AUG-2017 and Lot# L043213, Expiry: 28-AUG-2017). The vaccines were stored at a temperature of 54 F for 10.5 hours (digital data logger). There were no previous excursions. No adverse events were reported. This is one of the two 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 nurse refers to two patients of unknown age. On 23-MAY-2016, the patients were vaccinated with an improperly stored PROQUAD (Merck) lot # L051098, 17-JUN-2017 and M002053, 1-JUL-2017. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 23-MAY-2016 the patient was vaccinated with expired dose of PROQUAD (Merck) (lot # K023364 expiry date 20-MAY-2016) (dosing details were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Biopsy skin, Impaired healing, Injection site discharge, Injection site pustule
Clinical narrative: Information has been received from a pharmacist via field representative concerning a male patient of unknown age. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date in February 2015, the patient was administered ZOSTAVAX (Lot #, dosage and route not provided) and developed a pock mark at the injection site shortly after the administration. The patient's pock mark at the injection site continually oozed, crusts over, then eventually the scab fell off and it started oozing again. It never healed. The patient visited several unspecified physicians regarding this issue but none of them were able to assist him. The pock mark had never completely healed. The patient was not recovered from the events at the time of the reporting. The relationship between the events and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site scab, Injection site scar, Pruritus, Skin lesion
Clinical narrative: Information has been received from a pharmacist via field representative concerning a male patient of unknown age. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date in February 2015, the patient was administered ZOSTAVAX (Lot #, dosage and route not provided) and developed a pock mark at the injection site shortly after the administration. The patient's pock mark at the injection site continually oozed, crusts over, then eventually the scab fell off and it started oozing again. It never healed. The patient visited several unspecified physicians regarding this issue but none of them were able to assist him. The pock mark had never completely healed. The patient was not recovered from the events at the time of the reporting. The relationship between the events and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired healing, Injection site discharge, Injection site reaction, Injection site scab, Injection site scar
Clinical narrative: Information has been received from a pharmacist via field representative concerning a male patient of unknown age. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date in February 2015, the patient was administered ZOSTAVAX (Lot #, dosage and route not provided) and developed a pock mark at the injection site shortly after the administration. The patient's pock mark at the injection site continually oozed, crusts over, then eventually the scab fell off and it started oozing again. It never healed. The patient visited several unspecified physicians regarding this issue but none of them were able to assist him. The pock mark had never completely healed. The patient was not recovered from the events at the time of the reporting. The relationship between the events and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scab
Clinical narrative: Information has been received from a pharmacist via field representative concerning a male patient of unknown age. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date in February 2015, the patient was administered ZOSTAVAX (Lot #, dosage and route not provided) and developed a pock mark at the injection site shortly after the administration. The patient's pock mark at the injection site continually oozed, crusts over, then eventually the scab fell off and it started oozing again. It never healed. The patient visited several unspecified physicians regarding this issue but none of them were able to assist him. The pock mark had never completely healed. The patient was not recovered from the events at the time of the reporting. The relationship between the events and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Laboratory test abnormal, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year female patient (regarding his wife). The medical history and concomitant medication were none. There was no known allergies. On 13-MAR-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm. On 14-MAY-2016, the patient experienced right arm and back pain, had no blisters, rash or open areas. On an unspecified date, she saw her primary physician for the right arm and back pain. The physician called on 20-MAY-2016 and stated that the lab work tested positive for shingles. The physician prescribed ACYCLOVIR 800 mg by mouth, 5 times per day for 10days on 20-MAY-2016. The reporter stated that his wife was feeling better since the start of ACYCLOVIR. The reporter accepted VZV packet. The outcome of the events were reported as recovering/resolving. The patient sought medical attention. Additional information has been requested.