chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Hyperacusis, Malaise, Musculoskeletal stiffness
Clinical narrative: THE PATIENT RECEIVED THE 11 YEAR SHOTS, TDAP IN THIS CASE BOOSTRIX BY GSK AND MCV, MENVEO ALSO FOM GSK. EACH ONE IN EACH ARM. SHE STATED THAT SHE FELT DIZZY AT THE ELEVATOR OF THE OFFICE'S BUILDING. TWO HOURS LATER SHE FELT SICK VOMITING AND WITH HIGH FEVERS. HER MOM TOOK HER TO THE HOSPITAL LATE AT NIGHT BECAUSE THE FEVER WON'T LOWER AND THE VOMIT DID NOT STOP. THEY RUN SOME LAB TEST AND HER BLOOD PLATELET SEEM LOW. THEY GAVE HER ANTIACIDS AND AN IV. HER MOM TOOK TO HER PEDIATRICIAN AND RUN SOME LABS AGAIN AND EVERYTHING SHOWS NORMAL. BUT THE PATIENT STILL FEELS WEAK AND STIFFNESS IN HER NECK. SOUNDS AND LIGHT SEEMS UPSET HER TOO. THEY WILL TAKE HER AGAIN TO HER PEDIATRICIAN NEXT WEEK.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Photophobia, Platelet count decreased, Pyrexia, Vomiting
Clinical narrative: THE PATIENT RECEIVED THE 11 YEAR SHOTS, TDAP IN THIS CASE BOOSTRIX BY GSK AND MCV, MENVEO ALSO FOM GSK. EACH ONE IN EACH ARM. SHE STATED THAT SHE FELT DIZZY AT THE ELEVATOR OF THE OFFICE'S BUILDING. TWO HOURS LATER SHE FELT SICK VOMITING AND WITH HIGH FEVERS. HER MOM TOOK HER TO THE HOSPITAL LATE AT NIGHT BECAUSE THE FEVER WON'T LOWER AND THE VOMIT DID NOT STOP. THEY RUN SOME LAB TEST AND HER BLOOD PLATELET SEEM LOW. THEY GAVE HER ANTIACIDS AND AN IV. HER MOM TOOK TO HER PEDIATRICIAN AND RUN SOME LABS AGAIN AND EVERYTHING SHOWS NORMAL. BUT THE PATIENT STILL FEELS WEAK AND STIFFNESS IN HER NECK. SOUNDS AND LIGHT SEEMS UPSET HER TOO. THEY WILL TAKE HER AGAIN TO HER PEDIATRICIAN NEXT WEEK.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Blood glucose increased, C-reactive protein normal, Extra dose administered, Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to the ED with redness, warmth and swelling of his L arm. He was diagnosed as possible cellulitis vs adverse vaccine reaction. He was admitted to the pediatric floor and given IV clindamycin. He was discharged one day later on oral clindamycin.   Of note, patient inadvertently received an extra set of kindergarten vaccines. The patient had received his kindergarten vaccines 5 months prior in another state.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site warmth, Metabolic function test normal, White blood cell count normal
Clinical narrative: Patient presented to the ED with redness, warmth and swelling of his L arm. He was diagnosed as possible cellulitis vs adverse vaccine reaction. He was admitted to the pediatric floor and given IV clindamycin. He was discharged one day later on oral clindamycin.   Of note, patient inadvertently received an extra set of kindergarten vaccines. The patient had received his kindergarten vaccines 5 months prior in another state.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Erythema, Headache
Clinical narrative: Pain in R arm, redness, hot to touch, fever, chills, no appetite, weakness, headache.  Pt put on antibiotics on 3/16/16.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Pain in R arm, redness, hot to touch, fever, chills, no appetite, weakness, headache.  Pt put on antibiotics on 3/16/16.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth to touch at injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red and raised area the size of a golf ball. Some itching present.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Blindness transient, Blood glucose decreased, Mydriasis, Pallor
Clinical narrative: Sudden loss of vision, pupil dilated, skin became pale a minute or two after Gardasil shot, pt is alert and oriented. Patient regained vision within a few minutes.  Paramedics came and took blood pressure: 95/57.  1 bag of fluid given and sent home with parents.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MEN, TDAP
Symptoms: Influenza virus test, Injection site swelling, Pyrexia, Rash generalised
Clinical narrative: Swelling to site, fever, rash to body.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at site of injection, increased in size to aprox 8 X 8 cm.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Choking, Feeling cold, Heart rate increased, Peripheral swelling
Clinical narrative: Choking symptoms 20 min after receiving; coldness in her whole body; increased heart rate; swelling of R arm (size of ping pong for 3 days).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Autism, Autoimmune disorder, Crying, Encephalopathy, Lethargy
Clinical narrative: High fever, lethargy to the point of complete non-responsiveness.  Gave him Tylenol per doctor's orders, but took him to ER after 4 days because fever continued to spike to extremely high levels. Fever and crying persisted for days.  ER doctor stated it was a probable vaccine reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Mental retardation, Metabolic disorder, Metal poisoning, Mitochondrial cytopathy, Pyrexia
Clinical narrative: High fever, lethargy to the point of complete non-responsiveness.  Gave him Tylenol per doctor's orders, but took him to ER after 4 days because fever continued to spike to extremely high levels. Fever and crying persisted for days.  ER doctor stated it was a probable vaccine reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Unresponsive to stimuli, Vaccination complication
Clinical narrative: High fever, lethargy to the point of complete non-responsiveness.  Gave him Tylenol per doctor's orders, but took him to ER after 4 days because fever continued to spike to extremely high levels. Fever and crying persisted for days.  ER doctor stated it was a probable vaccine reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 09-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L037563, expiration date (exp) 29-SEP-2016), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock: Lot #L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: Lot 3 L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases 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 nurse referring to a patient of unknown age and gender The patient's concurrent and historical conditions were not reported. On 08-MAR-2016, the patient was vaccinated an improperly stored dose of (Oka/Merck) VARIVAX (Lot number L037563, expiration date (exp) 29-SEP-2016, dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in (Oka/Merck) VARIVAX immunization series were improperly stored in a temperature of -5.9C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccine involved included (Oka/Merck) VARIVAX private stock: Lot #L035124 exp 14-SEP-2017 and (Oka/Merck) VARIVAX VFC stock: Lot #L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases 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 nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 10-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L035124, expiration date (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock: L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases 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 nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (Lot number L037563, expiration date (exp) 29-SEP-2016), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses if (Oka/Merck) VARIVAX immunization series were improperly stored in a temperature of -5.9C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included (Oka/Merck) VARIVAX private stock: Lot # L035124 exp 14-SEP-2017 and (Oka/Merck) VARIVAX VFC stock: Lot #L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received form 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 nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 16-MAR-2016, the patient was vaccinated an improperly stored dose of ROTATEQ (Lot number L027070, expiration date 30-APR-2016), dose, route and anatomical location were not provided and the patient was also vaccinated with an improperly dose of PEDVAXHIB), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses of ROTATEQ and PEDVAXHIB were improperly stored in a temperature of -1.4 degrees C, the time frame was 1 hour. There was no previous temperature excursion reported. The vaccines involved included ROTATEQ Lot # L027070 (exp 30-APR-2017) and Lot # M002252 (exp 28-FEB-2017), and PEDVAXHIB Lot # L033690 (exp 28-FEB-2017). No adverse effects were reported, no product quality complaint was involved. This is one of several case received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: (L) arm pain from shoulder to hand, aggravated by ROM of wrist and fingers - no skin irritation, nodules or warmth at site of injection. Pt reports pain 8/10.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-SEP-2015, the patient was vaccinated with the first dose of GARDASIL lot # L010596 and expiry date in 06-APR-2017, and then on 15-MAR-2016, the patient received the second dose of GARDASIL lot # K010215 and expiry date in 05-MAR-2017, both doses were administered intramuscularly (strength, dose and frequency were not reported). No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 22 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 06-MAR-2016, the patient was vaccinated with an expired dose of VAQTA lot # K001296, expiry date 15-JAN-2016, 1 ml, intramuscularly in the right arm (reported as right deltoid). No adverse event and no product quality complaint (PQC) were reported. Additional information is not expected as the reporter did not wish any further contact.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Pain, warmth and edema to site. (R) deltoid.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Patient rec'd Tdap 3-16-16 on 3-18-16 presents to the clinic with a small red, warm lump at the injection site.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Headache, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date 30th June 2016). Concomitant products included B12 injection. On 7th March 2016, the patient received FLULAVAL QUADRIVALENT .5 ml. On 7th March 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced headache. On 8th March 2016, the patient experienced injection site pain, axillary pain and rash. On an unknown date, the outcome of the injection site pain, axillary pain and rash were recovering/resolving and the outcome of the headache was recovered/resolved. The reporter considered the injection site pain and axillary pain to be probably related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the headache to be related to FLULAVAL QUADRIVALENT. The reporter considered the rash to be possibly related to FLULAVAL QUADRIVALENT. Additional details were received as follows: This case was previously reported to a doctor. On 8th March 2016, 1 day after vaccination, the patient experienced sore left arm and left axillary area, rash 3 inches below the injection site. The reporter stated that the patient's date of birth was not available.
Age: 0.2
Sex: U
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of diarrhea in a 2-month-old patient who received ROTARIX. On an unknown date, the patient received the 1st dose of ROTARIX. On an unknown date, less than a day after receiving ROTARIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the diarrhea to be related to ROTARIX. Additional details were provided as follows: The patient received a dose of ROTARIX during his 2 month vaccination visit and had diarrhea for 14 days following administration of the vaccine. The sales representative did not have any patient or vaccine information and believed that the patient was a male but was unsure. He also said that he believed the diarrhea began the same day after vaccination. The reporter was unsure of what other vaccines were given concomitantly.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Product preparation error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 11 year-old male patient who received MENVEO. Concomitant products included ADACEL. On 9th March 2016, the patient received the 1st dose of MENVEO. On 9th March 2016, immediately after receiving MENVEO, the patient experienced injection site pain and inappropriate preparation of medication. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the inappropriate preparation of medication was unknown. The reporter considered the injection site pain to be possibly related to MENVEO. The reporter considered the inappropriate preparation of medication to be unrelated to MENVEO. Additional details were received as follows: This case was previously reported to a doctor. This case was reported by the patient's father. The patient only received the liquid portion of the MENVEO and not the lyophilized powder portion, which led to an inappropriate preparation of medication. The reporter stated that the physician office called and let him know about the maladministration. The reporter noted his sone also received ADACEL in the opposite arm but did not known which product was given in which arm. The reporter noted his son also had pain at the time of injection as any 11 years old would experience.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Movement disorder, Pain in extremity, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Information has been received from a 68 year old female referring to herself. The patient's pertinent medical history and concurrent conditions were not reported. On 22-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported). No concomitant medications were reported. The patient reported on 22-FEB-2016, after receiving PNEUMOVAX 233 in her left arm, her arm was "very sore and swollen, hot to the touch, with red blotchy bumbs that looked like hives". Patient also experienced difficulty moving her left arm. Patient sought medical attention by visiting physician's office. The outcome of the events pain in extremity, urticarial, rash macular, peripheral swelling, movement disorder and skin warm was reported as recovered/resolved. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a 68 year old female referring to herself. The patient's pertinent medical history and concurrent conditions were not reported. On 22-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported). No concomitant medications were reported. The patient reported on 22-FEB-2016, after receiving PNEUMOVAX 233 in her left arm, her arm was "very sore and swollen, hot to the touch, with red blotchy bumbs that looked like hives". Patient also experienced difficulty moving her left arm. Patient sought medical attention by visiting physician's office. The outcome of the events pain in extremity, urticarial, rash macular, peripheral swelling, movement disorder and skin warm was reported as recovered/resolved. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: RAB
Symptoms: Amylase increased, Musculoskeletal chest pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of amylase increased in a adult female patient who received RABAVERT. The patient's past medical history included rib pain (prior to vaccination). On an unknown date, the patient received RABAVERT. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced amylase increased. On an unknown date, the outcome of the amylase increased was unknown. It was unknown if the reporter considered the amylase increased to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. The patient did not want to provide additional information as she was not sure it was the RABAVERT vaccine or a different rabies vaccine. The patient wanted to know in general, if a patient has the last shot in a series of a rabies vaccine then immediately has blood drawn for a pancreas test, could it result in elevated amylase. The patient had amylase level as 40 points above the high end of normal. The test was ordered, because the patient had been having pain under her left side rib cage prior to taking  the vaccine and mentioned it to the nurse who had the test ordered.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2016118803 for PREVNAR 13. This was originally reported by a physician regarding a 71 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot and expiration date were not reported). Other suspect therapy included PREVNAR 13 which the patient was vaccinated on 17-FEB-2016. The patient's concomitant therapies were not reported. On 17-FEB-2016, the patient developed a low grade fever that escalated to 104 F degrees at still had the fever at the morning at the time of the report. On 24-FEB-2016, the patient experienced extreme redness and swelling at the injection site. On an unknown date, the patient had a neomycin allergy which had come up with ZOSTAVAX and the physician was concerned about an allergic reaction. At the time of the report, the outcome of the patient developed a low grade fever was reported as not recovered and the outcome of the patient experienced extreme and at the injection was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Local swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of local swelling in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown. It was unknown if the reporter considered the local swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by a Certified Medical Assistant (CMA). This case was reported by other healthcare professional, who herself was the patient's mother. The patient experienced a lump (huge swollen spot) on her arm after receiving BEXSERO. The sales representative did not have further information regarding patient identifiers, product details or information regarding the event. Attempt to contact the other healthcare professional was unsuccessful and a voicemail was left to return call back to GlaxoSmithKline Medical information for follow up reporting purposes.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU3, HPV9, MENB, MNQ, FLU3, HPV4, MENB, MNQ
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Redness, swelling, itchiness 1 day after getting GARDASIL 9 and TRUMENBA on the right arm. It started with induration and redness but then the redness and swelling progressed 2 days after getting shot. Right arm erythema 17cm x 15cm with some induration. Plan: ice for 20 mins. 3 x day, avoid frost bite. Use steroid cream on lesion. Will temporarily hold off on TRUMENBA doses 2 and 3.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU3, HPV9, MENB, MNQ, FLU3, HPV4, MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling, itchiness 1 day after getting GARDASIL 9 and TRUMENBA on the right arm. It started with induration and redness but then the redness and swelling progressed 2 days after getting shot. Right arm erythema 17cm x 15cm with some induration. Plan: ice for 20 mins. 3 x day, avoid frost bite. Use steroid cream on lesion. Will temporarily hold off on TRUMENBA doses 2 and 3.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Productive cough
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of productive cough in a 58-year-old female patient who received BOOSTRIX (batch number X7DN3, expiry date 31st August 2017. On 16th February 2016, the patient received BOOSTRIX. On 16th February 2016, immediately after receiving BOOSTRIX, the patient experienced productive cough. On an unknown date, the outcome of the productive cough was unchanged. It was unknown if the reporter considered the productive cough to be related to BOOSTRIX.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 15-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L035124, expiration date (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock: Lot #L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: Lot #L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases 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 nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 11-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L035124, expiration date (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock; L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases 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 nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. VARIVAX: On 14-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (lot number L035124, expiration (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-201. The vaccines involved included VARIVAX (Merck) private stock: Lot # L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: Lot # L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Emotional disorder, New daily persistent headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician via a company representative refers to a approximately 20 years old female patient. Concurrent or medical conditions were not reported. Approximately in March 2013 (reported as "2 to 3 years ago"), the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that approximately in March 2015 (reported as "about a year ago"), the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches." The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one normal Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating and the patient was recently demonstrating emotional issues (in approximately March 2016). It was reported that the patient had been hospitalized on an unknown date. It was also reported that the patient had received multiple diagnostic tests, computerized tomography (CT) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant at the time of the report. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not did much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested. This is a corrected report. The serious criteria hospitalization was checked for the events headache and emotional disorder.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician via a company representative refers to a approximately 20 years old female patient. Concurrent or medical conditions were not reported. Approximately in March 2013 (reported as "2 to 3 years ago"), the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that approximately in March 2015 (reported as "about a year ago"), the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches." The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one normal Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating and the patient was recently demonstrating emotional issues (in approximately March 2016). It was reported that the patient had been hospitalized on an unknown date. It was also reported that the patient had received multiple diagnostic tests, computerized tomography (CT) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant at the time of the report. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not did much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested. This is a corrected report. The serious criteria hospitalization was checked for the events headache and emotional disorder.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Blood test, Computerised tomogram, Emotional disorder, Headache
Clinical narrative: Information has been received from a physician via a company representative refers to a approximately 20 years old female patient. Concurrent or medical conditions were not reported. Approximately in March 2013 (reported as "2 to 3 years ago"), the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that approximately in March 2015 (reported as "about a year ago"), the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches." The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one normal Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating and the patient was recently demonstrating emotional issues (in approximately March 2016). It was reported that the patient had been hospitalized on an unknown date. It was also reported that the patient had received multiple diagnostic tests, computerized tomography (CT) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant at the time of the report. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not did much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested. This is a corrected report. The serious criteria hospitalization was checked for the events headache and emotional disorder.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician via a company representative refers to a approximately 20 years old female patient. Concurrent or medical conditions were not reported. Approximately in March 2013 (reported as "2 to 3 years ago"), the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that approximately in March 2015 (reported as "about a year ago"), the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches." The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one normal Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating and the patient was recently demonstrating emotional issues (in approximately March 2016). It was reported that the patient had been hospitalized on an unknown date. It was also reported that the patient had received multiple diagnostic tests, computerized tomography (CT) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant at the time of the report. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not did much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested. This is a corrected report. The serious criteria hospitalization was checked for the events headache and emotional disorder.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles to head and face and eye.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Computerised tomogram, Facial pain, Gait disturbance
Clinical narrative: Started with numbness in toes that progressed to numbness in feet, legs, and hands. The numbness then progressed to excruciating pain to extremities, chest, and face. I became extremely weak and could not walk without assistance. I was admitted to the hospital and diagnosed with Guillain Barre Syndrome and received IVIG treatment.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Started with numbness in toes that progressed to numbness in feet, legs, and hands. The numbness then progressed to excruciating pain to extremities, chest, and face. I became extremely weak and could not walk without assistance. I was admitted to the hospital and diagnosed with Guillain Barre Syndrome and received IVIG treatment.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Started with numbness in toes that progressed to numbness in feet, legs, and hands. The numbness then progressed to excruciating pain to extremities, chest, and face. I became extremely weak and could not walk without assistance. I was admitted to the hospital and diagnosed with Guillain Barre Syndrome and received IVIG treatment.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Itchy arm, redness, swelling spreading down the arm.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram normal, Full blood count, Metabolic function test, Seizure
Clinical narrative: Generalized seizure like activity x 45 seconds.  Non-febrile.  Normal video EEG.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site nodule, Pain in extremity
Clinical narrative: PT'S ARM WAS NOT SORE UNTIL 6 DAYS AFTER RECEIVING SHOT; SHE DEVELOPED A KNOT ON HER ARM AT THE INJECTION SITE AND IT WAS HARD; THE KNOT WAS NOT FEVERISH.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness transient, Hyperhidrosis, Hypotension, Nausea, Pallor
Clinical narrative: Nausea, Vomiting, Hypotension BP ~ 96/60, pre syncope, ringing in the ears, transient vision loss, diaphoresis, pallor.  Sx lasted approximately 45 minutes. Sx started to improve after laying down, cool compresses and drinking water.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Tinnitus, Vomiting
Clinical narrative: Nausea, Vomiting, Hypotension BP ~ 96/60, pre syncope, ringing in the ears, transient vision loss, diaphoresis, pallor.  Sx lasted approximately 45 minutes. Sx started to improve after laying down, cool compresses and drinking water.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Small bumps on chest and arms.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Asthma, Dyspnoea
Clinical narrative: Woke up, difficullty breathing, asthma attack... used Xopenex HFA inhaler, drank coffee, walked around a lot...
Age: 34.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient complained of fever, chills, muscle soreness.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint range of motion decreased, Muscle strain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain in arm.  Eventual loss of range of motion/frozen shoulder. Urgent Care visit on 2/6/16 for "cervical strain, acute" and received RX for Cyclobenzaprine HCl 10 MGS and a sling, Urgent Care visit on 2/10 for pain in joint of right shoulder region, received cortisone shot, MRI on 3/7/16, Follow Up Apt with GP on 3/9, received ref. to PT and ORTHO.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Pain in arm.  Eventual loss of range of motion/frozen shoulder. Urgent Care visit on 2/6/16 for "cervical strain, acute" and received RX for Cyclobenzaprine HCl 10 MGS and a sling, Urgent Care visit on 2/10 for pain in joint of right shoulder region, received cortisone shot, MRI on 3/7/16, Follow Up Apt with GP on 3/9, received ref. to PT and ORTHO.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: Chills, extreme swelling, fever.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot skin by side of injection pain. Pt used TYLENOL, BENADRYL, and ice for a straight week after the vaccine and there was no improvement in symptoms.
Age: 21.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Erythema, Syncope
Clinical narrative: Syncope, red-face, treated with cold compress and IV in ambulance. Stated after 2nd vaccine and last for approximately 5-10 minutes.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 3 patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) lot # L029466, expiration date 06-AUG-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as 3 doses of improperly stored VARIVAX (Merck) were administered to unspecified patients. The temperature was  14.3 F during 8 hours and 45 minutes and there was no previous excursion. No adverse event was reported. The patient's status was unknown. Additional information has been requested.
Age: 0.05
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17 day old patient. The patient's pertinent medical history and concomitant conditions were not provided. On 13-FEB-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (route, lot number and expiration date were not provided). Then, on 01-MAR-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (route, lot number and expiration date were not provided) and on 16-MAR-2016, the patient was vaccinated with the third dose of RECOMBIVAX (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On 01-MAR-2016 and 16-MAR-2016, there was an appropriate schedule of drug administration, as the patient was inadvertently administered the series of RECOMBIVAX HB each dose separated by only two week intervals. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. 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 licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 08-MAR-2016, the patient was vaccinated with an improperly stored of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route. lot # L024255 with expiration date 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with ROTATEQ by oral route (dose was not reported), Lot # L013203 with expiration date 28-JAN-2017, that ion an unspecified date were improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports from the same source. Additional information is not expected as the reporter did not wish further contact.