chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness, Muscle tightness, Nausea, Pain, Posture abnormal
Clinical narrative: I am recounting this as best as my wife can remember as I was not present: At about 3:15 pm my son was given two vaccines, the HPV (type unknown to us) and the MCV4P Meningococcal vaccines. Both were injected into his right arm. Within about 10 - 15 seconds my wife noticed his eyes looked sleepy, and he began to slouch forward toward the floor. My wife pushed him back onto the examining table and noticed he began to shake and his skin color was a pale yellow. He appeared to her to be unconscious but shaking with all his muscles tense. The nurse immediately left to get a doctor. My wife went after a several seconds to see if they were coming. Once they returned to the room was still shaking but coming to. He was very startled and wanted to know what was going on.  The medical staff put him on oxygen and monitored him for several minutes. After another examination pt said he was feeling better was comfortable to leave. This morning patient awoke tired, dizzy, and nauseous. He did not have much to eat; just some chicken soup. He was very lethargic and was running a mild fever or 100 degrees. We called the ask a nurse line provided by my healthcare provider and spoke with the nurse who had patient try to touch his chin to his chest. Patient's head tilted forward about 45 degrees and he jerked it back up in pain. Patient was also complaining of a headache. The nurse suggested patient drink plenty of fluids and we provided him some Tylenol. My wife intends on contacting the clinic again in the morning to follow up.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pyrexia, Somnolence, Tremor, Yellow skin
Clinical narrative: I am recounting this as best as my wife can remember as I was not present: At about 3:15 pm my son was given two vaccines, the HPV (type unknown to us) and the MCV4P Meningococcal vaccines. Both were injected into his right arm. Within about 10 - 15 seconds my wife noticed his eyes looked sleepy, and he began to slouch forward toward the floor. My wife pushed him back onto the examining table and noticed he began to shake and his skin color was a pale yellow. He appeared to her to be unconscious but shaking with all his muscles tense. The nurse immediately left to get a doctor. My wife went after a several seconds to see if they were coming. Once they returned to the room was still shaking but coming to. He was very startled and wanted to know what was going on.  The medical staff put him on oxygen and monitored him for several minutes. After another examination pt said he was feeling better was comfortable to leave. This morning patient awoke tired, dizzy, and nauseous. He did not have much to eat; just some chicken soup. He was very lethargic and was running a mild fever or 100 degrees. We called the ask a nurse line provided by my healthcare provider and spoke with the nurse who had patient try to touch his chin to his chest. Patient's head tilted forward about 45 degrees and he jerked it back up in pain. Patient was also complaining of a headache. The nurse suggested patient drink plenty of fluids and we provided him some Tylenol. My wife intends on contacting the clinic again in the morning to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Patient was taking daily CLARITIN for seasonal allergies when he received the vaccine. The KINRIX vaccine was given Monday at 4:00PM. Within 24 hours patient complained of general itchiness over his body and intense itching and discomfort at the injection site. The area around the injection site became red and swollen. By Wednesday evening the redness was 6" in diameter and swelling was from below his shoulder to just above his elbow. BENADRYL was given in addition to the CLARITIN to help relieve itching. Patient was scheduled for a food challenge at his allergist Monday so all antihistamines were discontinued Thursday evening. Symptoms remained stable Friday. Saturday morning patient work with hives covering his body. Hives were coalesced around the injections site and on the underside of his arm where he received the injection. Hives spread down his back and torso and onto his legs. A dose of BENADRYL was given to help, but the hives and arm swelling progressed. My family was traveling for the weekend so I called patient's allergist and discussed patient's symptoms and texted her numerous pictures of his reaction. Patient was prescribed ZYRTEC and 20 mg of Prednisone PO x 5 days. Symptoms started to improve within 24 hours of treatment, and significantly improved after 36 to 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Peripheral swelling, Pruritus generalised, Urticaria
Clinical narrative: Patient was taking daily CLARITIN for seasonal allergies when he received the vaccine. The KINRIX vaccine was given Monday at 4:00PM. Within 24 hours patient complained of general itchiness over his body and intense itching and discomfort at the injection site. The area around the injection site became red and swollen. By Wednesday evening the redness was 6" in diameter and swelling was from below his shoulder to just above his elbow. BENADRYL was given in addition to the CLARITIN to help relieve itching. Patient was scheduled for a food challenge at his allergist Monday so all antihistamines were discontinued Thursday evening. Symptoms remained stable Friday. Saturday morning patient work with hives covering his body. Hives were coalesced around the injections site and on the underside of his arm where he received the injection. Hives spread down his back and torso and onto his legs. A dose of BENADRYL was given to help, but the hives and arm swelling progressed. My family was traveling for the weekend so I called patient's allergist and discussed patient's symptoms and texted her numerous pictures of his reaction. Patient was prescribed ZYRTEC and 20 mg of Prednisone PO x 5 days. Symptoms started to improve within 24 hours of treatment, and significantly improved after 36 to 48 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Administration site induration, Administration site pain, Administration site swelling, Chills, Emotional distress
Clinical narrative: PATIENT CAME TO PHARMACY TODAY TO PICK UP HER MEDICINE AND TOLD US THAT THE PREVNAR SHOT SHE GOT IN JULY GOT HER REAL SICK: SYMPTOMS STARTED IN THE EVENING OF THE DAY SHE RECEIVED THE SHOT: ADMINISTRATION SITE ON THE LEFT ARM GOT SWOLLEN, BIGGER AND FELT ON FIRE AND HARD, COLOR WAS DEEP RED. SHE SAID SHE HAD CHILLS. SHE APPLIED ICE PACKS AND USED ORAL BENADRYL. SHE SAID HER JOINTS WERE SWOLLEN AND FORMED ENLARGED KNOTS THAT WERE HURTING. SHE WAS NOT FEELING GOOD IN GENERAL AND EASILY MAD, DISTURBED AND UPSET. SHE SAID IT TOOK HER AROUND 2 WEEKS FOR THE ADMINISTRATION SITE SWELLING TO GO DOWN LITTLE BY LITTLE UNTIL GOT BACK TO NORMAL NOW. SHE SAID SHE IS FEELING NORMAL NOW EXCEPT FOR THE KNOTS IN HER WRIST JOINTS ARE SORT OF STILL THERE. I ADVISED HER TO SEE THE DOCTOR FOR THAT AND SHE WILL DO.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Joint swelling, Malaise, Nodule
Clinical narrative: PATIENT CAME TO PHARMACY TODAY TO PICK UP HER MEDICINE AND TOLD US THAT THE PREVNAR SHOT SHE GOT IN JULY GOT HER REAL SICK: SYMPTOMS STARTED IN THE EVENING OF THE DAY SHE RECEIVED THE SHOT: ADMINISTRATION SITE ON THE LEFT ARM GOT SWOLLEN, BIGGER AND FELT ON FIRE AND HARD, COLOR WAS DEEP RED. SHE SAID SHE HAD CHILLS. SHE APPLIED ICE PACKS AND USED ORAL BENADRYL. SHE SAID HER JOINTS WERE SWOLLEN AND FORMED ENLARGED KNOTS THAT WERE HURTING. SHE WAS NOT FEELING GOOD IN GENERAL AND EASILY MAD, DISTURBED AND UPSET. SHE SAID IT TOOK HER AROUND 2 WEEKS FOR THE ADMINISTRATION SITE SWELLING TO GO DOWN LITTLE BY LITTLE UNTIL GOT BACK TO NORMAL NOW. SHE SAID SHE IS FEELING NORMAL NOW EXCEPT FOR THE KNOTS IN HER WRIST JOINTS ARE SORT OF STILL THERE. I ADVISED HER TO SEE THE DOCTOR FOR THAT AND SHE WILL DO.
Age: 25.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood test, Cerebral disorder, Computerised tomogram, Dizziness, Echocardiogram
Clinical narrative: Lightheadedness, dizziness, insomnia, brain fog, brain zaps.
Age: 25.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Feeling abnormal, Insomnia
Clinical narrative: Lightheadedness, dizziness, insomnia, brain fog, brain zaps.
Age: 25.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Lightheadedness, dizziness, insomnia, brain fog, brain zaps.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: 8/11 (L) arm sore, swollen and tender to touch. 8/14 spoke w/mother and she states arm better in 24 hours.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: Patient received vaccine 8-13-2017. Patient came in to pick up KEFLEX (antibiotic) to prevent infection. Patient reported a red swollen red. Rash from deltoid to elbow.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site induration, Injection site rash, Injection site swelling, Malaise
Clinical narrative: Couple hours after receiving BEXSERO vaccine, patient reported feeling "sick" with headache. ("Severe") rash and induration/swelling at the injection site. The rash spread out more the following day and muscle pain continued for over a week. Patient applied ice, massage and took Ibuprofen.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia
Clinical narrative: Couple hours after receiving BEXSERO vaccine, patient reported feeling "sick" with headache. ("Severe") rash and induration/swelling at the injection site. The rash spread out more the following day and muscle pain continued for over a week. Patient applied ice, massage and took Ibuprofen.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Dizziness, Hypoaesthesia, Limb discomfort, Pregnancy test urine negative
Clinical narrative: Patient was given HPV9 vaccine and checked for S/S of RXN after 15 min. Pt. denied. Pt. left clinic with parent and returned 15 min. later C/O (L) side of body "numb" from head to knee. C/O lightheadedness and dizziness. After 30 min. states numbness to chest and arms and legs "heavy". Sent to Hospital ER.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Urine analysis normal
Clinical narrative: Patient was given HPV9 vaccine and checked for S/S of RXN after 15 min. Pt. denied. Pt. left clinic with parent and returned 15 min. later C/O (L) side of body "numb" from head to knee. C/O lightheadedness and dizziness. After 30 min. states numbness to chest and arms and legs "heavy". Sent to Hospital ER.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: (L) arm pain, pain in injection site, pain travelling up (L) arm into neck.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Peripheral swelling
Clinical narrative: Patient was administered vaccine at the pharmacy around 1pm and there was no reaction immediately. Patient called around 5:30 pm to report that their left arm(arm of vaccination) is swollen and feels hot around injection site. They did take ibuprofen and Benadryl but no change. Advised patient to contact PCP/911 or visit ER if condition worsens. No trouble breathing.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Pt. was administered the MENACTRA vaccine on: left deltoid. A minute after administration pt. fainted. In less than two minutes, pt. regained consciousness and stated that he felt dizzy, all vitals were stable.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red welt-like increased in size, itching. OTC Hydrocortisone 1% cream did not help itch. Current size: 3inches in diameter. Change from circle to oval. Pt says 1st appear 2 hr after shot. 1-2 days later increasing to quarter sized and now 3 inches in diameter. (Pt also on PLAVIX). Pt complaining of Left arm shot-PREVNAR.
Age: 70.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Blood glucose normal, Full blood count normal, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediate feeling unwell: diaphoretic, nausea, profound weakness. He had the same reaction with the second oral tablet.
Age: 70.0
Sex: M
Vaccine: TYP
Symptoms: Liver function test normal, Malaise, Metabolic function test normal, Nausea
Clinical narrative: Immediate feeling unwell: diaphoretic, nausea, profound weakness. He had the same reaction with the second oral tablet.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unknown amount of improperly stored doses of VARIVAX lot numbers: M047660, N000682, M038857 and M040137, reconstituted with properly stored diluent. No adverse events reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004482:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from office manager and refers to unspecified patients of unknown demographics. Information on concomitant medication, medical history, concurrent condition, drug allergies/reactions were not provided.  It was reported that, on an unknown dates, an unspecified amount of patients were administered improperly stored PROQUAD (rHA) (lot# N000677, expiration 05-JUL-2018 ; lot M044719, expiration 07-MAY-2018)( incorrect product storage) reconstituted with properly stored STERILE WATER DILUENT (unknown lot, unknown expiration). Concomitant medication included sterile diluent. Administered vaccine experienced the temperature excursion of 9°C to 8°C for 1 Hour; -14°C to-10°C for 1 Hour 30 Minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. The outcome of incorrect product storage and no adverse event were unknown. No product quality complaint(PQC) was involved. No further details provided. Lot number [N000677] (rHA) has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA004058:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX from lot# N008827 with expiry: 16-MAR-2019 (dosing details not reported) for prophylaxis. Concomitant medication included sterile diluent (MERCK). The vaccine stored at  9 degree Celsius to 8 degree Celsius for 38 minutes. The vaccine had no previous temperature excursion and the temperature excursion was detected by data logger. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA003205.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Influenza like illness, Injection site mass, Medication error, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient with chemotherapy. The patient's medical history included herpes zoster. On 28-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # N012614, subcutaneous for prophylaxis. Other suspect therapies included everolimus (AFINITOR), sterile diluent (STERILE DILUENT) and lenvatinib mesylate (LENVIMA). On 28-JUL-2017, the patient experienced medication error. On approximately 31-JUL-2017, the patient experienced influenza like illness, pain in extremity, burning sensation and injection site mass. The outcome of injection site mass, medication error, pain in extremity and burning sensation was unknown. The outcome of influenza like illness was reported as recovered/resolved. The reporter considered medication error to be not related to sterile diluent (STERILE DILUENT) and ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 26-JUN-2017 at 17:14, the patient was vaccinated with improperly stored VARIVAX, in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018; second dose, exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The patient was concomitantly vaccinated with a dose of VAQTA. No adverse event was reported. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1706USA009938:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product use in unapproved indication, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with skin papilloma. On an unknown date the patient was vaccinated with GARDASIL 9 for skin papilloma. On an unknown date the patient experienced product use in unapproved indication, therapeutic response unexpected and no adverse event. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # N000237, expiration date 25-OCT-2019 and N001348, expiration date 31-OCT-2019 (strength,dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 32 degree fahrenheit to 35 degree fahrenheit for 480 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Lot number N001348 has been verified to be a valid lot number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate).; Sender's Comments: US-009507513-1708USA004188: US-009507513-1708USA004176: US-009507513-1708USA004187:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age.     In July 2015, the patient was vaccinated with GARDASIL, and on 09-AUG-2017, the patient was vaccinated with GARDASIL 9 both for prophylaxis (interchange of vaccine products and inappropriate schedule of drug administration). No adverse reactions were reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Head injury, Interchange of vaccine products, Syncope
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old female patient. On 08-AUG-2017, the patient was vaccinated with GARDASIL 9 dose 1, .5 ml, intramuscular for prophylaxis. Other suspect therapies included GARDASIL.  On 09-AUG-2017, 2 days after onset of therapy, the patient experienced syncope and head injury.  On an unknown date, the patient experienced interchange of vaccine products. The outcome of head injury, interchange of vaccine products and syncope was unknown.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture negative, Incisional drainage, Injection site pain, Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding a 58 year old female patient. Her medical history, concurrent conditions and concomitant medications were unknown. On 31-JUL-2017, the patient was vaccinated with ZOSTAVAX subcutaneous injection (0.65 ml, subcutaneous) (lot# and expiration date unknown) for prevention of shingles. On 04-AUG-2017, 5 days after onset of therapy, the patient experienced a 2 inch painful blister at the injection site (injection site vesicles and injection site pain) and contacted the office. On the same day, the patient was seen, the blister was lanced and culture was taken. The culture was reported to be negative for infection. The outcome of injection site vesicles and injection site pain was reported as recovered/resolved on an unknown date in August 2017. The causal relationship of injection site vesicles and injection site pain was unknown with ZOSTAVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to 4 patient of unknown age and gender. No medical history and concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M024683, expiry date: 18-MAY-2018) for prophylaxis. Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -11.7 °C for 40 hours 28 minutes. Previous temperature excursion was reported to have occurred on an unknown date. This case was reported because of a data logger. No product quality complaint (PQC) was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA006109.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M022407 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA005844: US-009507513-1708USA005843.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M037770 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: US-009507513-1708USA005844: US-009507513-1708USA005822:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042821 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: US-009507513-1708USA005822: US-009507513-1708USA005843:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to 4 patient of unknown age and gender. No medical history and concurrent conditions were reported. On unknown dates, the patient was vaccinated with improperly stored PROQUAD (lot # M031944, expiry date: 27-DEC-2017; lot number: M041083, expiry date:04-APR-2018) for prophylaxis. Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -11.7 °C for 40 hours 28 minutes. Previous temperature excursion was reported to have occurred on an unknown date. This case was reported because of a data logger. No product quality complaint (PQC) was reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005581:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA lot # N008823 for prophylaxis. No adverse events reported.
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old male patient. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis.  On an unknown date the patient experienced pain in extremity. The outcome of pain in extremity was unknown.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 03-AUG-2017 the patient was vaccinated with RECOMBIVAX HB lot # M040422 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for contact the reporter. Sender's Comments: US-009507513-1708USA006417.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of PROQUAD lot # M044020 for prophylaxis. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676: US-009507513-1707USA006507:
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product
Clinical narrative: This spontaneous report was received from a female patient of an unknown age who was also a pharmacist reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date in November or December 2016, while the pharmacist administered a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with its sterile diluent (manufacturer unknown) (lot #, expiration date, dose, route of administration or anatomical location were not reported for both); some of the vaccine could have gotten on her person (Occupational exposure to product/ Accidental exposure to product). No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA006421.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to two unspecified patients of unknown age. On 08-AUG-2017 the patients were vaccinated with GARDASIL 9 lot # N007931 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for contact the reporter.; Sender's Comments:  US-009507513-1708USA006387:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Rash
Clinical narrative: This spontaneous report was received from a pharmacist who was also the patient's wife, concerning a 48 years-old male patient. The patient's concurrent conditions included allergy to sulfa drugs. The patient did not have medical history or concomitant medications. On an unspecified date in November or December 2016, while the patient's wife administered a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with its sterile diluent (manufacturer unknown) (lot #, expiration date, dose, route of administration or anatomical location were not reported for both); some of the vaccine could have gotten on her person, which caused shingles rash in the patient about 2-3 days after (Herpes zoster/Secondary transmission). Subsequently, he was diagnosed with shingles by his primary care physician, who prescribed him an unspecified antiviral medication and unspecified pain medication. No laboratory diagnostics studies were performed. The pharmacist reported that the shingles caused a significant incapacity, as the patient was unable to attend work for 2 weeks. The patient fully recovered from the events 3 weeks after the symptoms began on an unspecified date in 2016, and he did not have any residual symptoms. The causal relationship between the ZOSTAVAX and the events was not provided. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA006411.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medication were not reported. On 06-AUG-2017, the patient was vaccinated with improperly stored ZOSTAVAX lot # M042850 and expiry date: 18-JAN-2018 (dose and route were not reported) for prophylaxis. The pharmacist was unable to provide the lot number and expiration date for the properly stored sterile diluent that were used to reconstitute the vaccines. The vaccine was exposed to a temperature frame of 15 Fahrenheit to 46 Fahrenheit for 11 hours and 2 minutes. There were no previous temperature excursions. The call was because of a digital data logger. No adverse effects were reported. No additional information is available. No product quality complaint involved. This is one of the two reports from the same reporter.; Sender's Comments: US-009507513-1708USA006544:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unspecified number of patients of unknown ages and genders. On an unknown dates,the patients were vaccinated with an unspecified amount of improperly stored doses of PNEUMOVAX 23 lot # N004564, expiration date:22 AUG-2018 for prophylaxis. The sterile diluent (unknown lot, unknown expiration date) used for reconstitution did not undergo a temperature excursion. No adverse effects reported. The vaccines were exposed to temperature ofemperature: 9°C to 25°C (8.6C),time frame: 48 Hours.No previous excursions were reported.The reason of the call was  not temperature alarm received via Digital Data Logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regardinga patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M040267 and expiry date: 14-MAY-2018 (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 35 Fahrenheit to a time frame of 15 hours. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (lot #, expiration date and dose were not reported), subcutaneously for prophylaxis instead of VARIVAX (wrong drug administered). No adverse effects were reported in the patient. No other information was available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medication were not reported. On 06-AUG-2017, the patient was vaccinated with improperly stored ZOSTAVAX lot # M042850 and expiry date: 18-JAN-2018 (dose and route were not reported) for prophylaxis. The pharmacist was unable to provide the lot number and expiration date for the properly stored sterile diluent that were used to reconstitute the vaccines. The vaccine was exposed to a temperature frame of 15 Fahrenheit to 46 Fahrenheit for 11 hours and 2 minutes. There were no previous temperature excursions. The call was because of a digital data logger. No adverse effects were reported. No additional information is available. No product quality complaint involved. This is one of the two reports from the same reporter.; Sender's Comments: US-009507513-1708USA006430:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to two unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD from lot # M029599 with expiry: 10-DEC-2017, for prophylaxis, which was reconstituted with properly stored sterile diluent (MERCK). No adverse effects reported. The vaccine was exposed to a temperature of 6°F to 14°F for 3 hours. The vaccine had no previous temperature excursion and the excursion was detected by digital data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with VARIVAX (strength, dose and route of administration were not reported) lot # M019643, expiration date 20-APR-2018, and lot# M038857, expiration date 14-SEP-2018, for prophylaxis. The vaccine was exposed to 6 degree fahrenheit to 14 degree fahrenheit for 300 hours. There was no previous temperature excursion.Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with first dose of GARDASIL (dosing details not reported), for prophylaxis. Subsequently, on 14-AUG-2017, received a second dose of GARDASIL 9 (interchange of vaccine products, wrong drug administered and inappropriate schedule of drug administration). No adverse symptoms reported and no further information provided
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Paraesthesia
Clinical narrative: Feeling tired; Feeling dizzy; Arm tingling moving towards patient's back. Patient feeling "shocks" in arms and legs.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Dyspnoea
Clinical narrative: TROUBLE BREATHING.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Mild redness and swelling at injection site. Swollen lymph nodes in neck.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, injection, via subcutaneous route, lot # M003440 with expiration date of 20-JAN-2018 (dose was not reported), reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of vaccines experienced temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 72 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no product quality complaint. This is one of two reports received from the same reporter. Follow-up information was received on 08-AUG-2017. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007811:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M049125 and N007930 for prophylaxis with sterile diluent (STERILE DILUENT). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: 1708USA002826-1708USA002091:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 20-OCT-2016 the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis. On an unknown date the patient experienced vaccination error and no adverse event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 16-JUN-2017, the patient was vaccinated with first dose of ROTATEQ orally, lot # M044396, expiration date 19-MAR-2019, and on 16-JUN-2017 the patient was vaccinated with a second dose of ROTATEQ orally, lot # M044396, expiration date 19-MAR-2018. No adverse effects were reported. 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 pharmacist and refers to a patient of unknown demographics. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 23-JUL-1998, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (dose, lot number and expiration date were not reported). The patient subsequently received the second dose of RECOMBIVAX HB on 25-AUG-1998. On 10-AUG-2017, the patient visited the reporting pharmacist's office to receive the third dose of RECOMBIVAX HB. There were no adverse symptoms reported. It was not reported if the patient received the third dose of the vaccine. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M041085, expiration date on 03-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the unspecifie temperature excursion. Data logger was involved in recording of the temperature excursions. There were unspecified previous excursions reported. Properly stored doses of sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot number and expiration date were not reported) were used to reconstitute the doses of the vaccine. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA006767:
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old patient. On 11-AUG-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On 11-AUG-2017, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-JUL-2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # M020101 for prophylaxis. On 31-JUL-2017, the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site irritation, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a 62 year old female patient. On 09-AUG-2017 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot number and expiration date were unspecified) for prophylaxis. In August 2017, the patient experienced injection site discolouration, injection site irritation and injection site swelling. The outcome of injection site discolouration, injection site swelling and injection site irritation was reported as not recovered/not resolved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant via a physician refers to a unspecified amount of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient were vaccinated with improperly stored LIQUID PEDVAXHIB (lot N007749, expiration date 29-NOV-2019; lot N003700, expiration date 01-NOV-2019)(incorrect product storage) for prophylaxis. Temperature was reported as 47°F to 77°F and Time frame was reported as 2 Hours 30 Minutes. Previous temperature excursion was involved. The call was because of a "data logger".  No adverse effects reported. No PQC involved. No further details provided. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1708USA005419: US-009507513-1708USA006276:
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 22 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter stated that "the patient blood work showed that she needed a booster shot of RECOMBIVAX HB 2.5/0.5 (date of test unspecified). The reporter could not specify which hepatitis B vaccine was previously administered to the patient. On an unknown date the patient was inadvertently  vaccinated with pediatric dose of RECOMBIVAX HB 2.5/0.5  lot # L016959 expiry date 12-MAR-2018 (drug administered to patient of inappropriate age) for prophylaxis and no adverse effects were reported. Unspecified treatmetnt was given to the patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M028553, expiration date on 07-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the unspecifie temperature excursion. Data logger was involved in recording of the temperature excursions. There were unspecified previous excursions reported. Properly stored doses of sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot number and expiration date were not reported) were used to reconstitute the doses of the vaccine. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005237:
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dyspnoea, Vomiting
Clinical narrative: Patient began vomiting and having difficulty breathing.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: 7-25-17 Returned to Hospital for Day 14 injection, my final injection in my right arm (dominate arm). This injection was incredible painful, given higher up than the other injections, I felt immediate radiating pain up my neck, down my arm and into my back shoulder region. Every day after that pain became greater and greater. I lost a great deal of mobility and function in the arm.  I have to have aid dressing, preparing food and can accomplish no chores around the house such as laundry, changing bed sheets and dishes. I had to stop my daily workouts that involved weights and only use the recumbent bike. My rowing machine in not useful to me anymore.I took large quantities of Tylenol and Motrin, hoping
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: 7-25-17 Returned to Hospital for Day 14 injection, my final injection in my right arm (dominate arm). This injection was incredible painful, given higher up than the other injections, I felt immediate radiating pain up my neck, down my arm and into my back shoulder region. Every day after that pain became greater and greater. I lost a great deal of mobility and function in the arm.  I have to have aid dressing, preparing food and can accomplish no chores around the house such as laundry, changing bed sheets and dishes. I had to stop my daily workouts that involved weights and only use the recumbent bike. My rowing machine in not useful to me anymore.I took large quantities of Tylenol and Motrin, hoping
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Per phone call from father has red rash from shoulder to elbow.