chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Feeling abnormal, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Patient tolerated the vaccine administration well initially. However, a few moments following administration, she experienced a brief fainting spell with jerking and seizure like movements. Per Vaccine information sheet, this is normal. I held on to her (so she wouldn't fall out of the chair) and talked to her during the spell. She did come to and sat back up after about 30 seconds. She felt okay, "just weird." I offered her to lay down but she declined. I stayed with her a few minutes. She was okay with me leaving the room at that time to find staff to get ice water for her. Dr. briefly assessed her and there were no immediate concerns, he reccommended she sit in a chair for 15 minutes before being excused. After she started drinking the water, she complained of feeling nauseous. I gave her an emesis bag. She then stated she felt very hot and sweaty. She appeared diaphoretic. I offered her to lay down again and she did agree this time. I assisted her to lay down in order to prevent injury. I placed a cold rag on her forehead. There was a pool of sweat on the chair where she sat. After a minute or so of lying down she stated she felt much better. However, I did have her lay there for another 10 minutes or so. For the duration of this episode, she denied chest pain, difficulty breathing, swelling of the face/throat, fast heartbeat, dizziness, or weakness. She knows that these are signs of a serious allergic reaction and should she develop any of those signs within the next few hours, she should go to the ER. I sent her home with the meningococcal VIS and told her to be mindful of the signs of mild/serious/allergic reactions listed on the sheet. I offered to call her mom for her and she declined. She sat up and stated she felt much better, that all her symptoms were resolved, and capable of driving herself home. She did say she would tell me if she felt otherwise. I walked her out to the lobby, where she again stated she was okay, and proceeded to go home.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Patient tolerated the vaccine administration well initially. However, a few moments following administration, she experienced a brief fainting spell with jerking and seizure like movements. Per Vaccine information sheet, this is normal. I held on to her (so she wouldn't fall out of the chair) and talked to her during the spell. She did come to and sat back up after about 30 seconds. She felt okay, "just weird." I offered her to lay down but she declined. I stayed with her a few minutes. She was okay with me leaving the room at that time to find staff to get ice water for her. Dr. briefly assessed her and there were no immediate concerns, he reccommended she sit in a chair for 15 minutes before being excused. After she started drinking the water, she complained of feeling nauseous. I gave her an emesis bag. She then stated she felt very hot and sweaty. She appeared diaphoretic. I offered her to lay down again and she did agree this time. I assisted her to lay down in order to prevent injury. I placed a cold rag on her forehead. There was a pool of sweat on the chair where she sat. After a minute or so of lying down she stated she felt much better. However, I did have her lay there for another 10 minutes or so. For the duration of this episode, she denied chest pain, difficulty breathing, swelling of the face/throat, fast heartbeat, dizziness, or weakness. She knows that these are signs of a serious allergic reaction and should she develop any of those signs within the next few hours, she should go to the ER. I sent her home with the meningococcal VIS and told her to be mindful of the signs of mild/serious/allergic reactions listed on the sheet. I offered to call her mom for her and she declined. She sat up and stated she felt much better, that all her symptoms were resolved, and capable of driving herself home. She did say she would tell me if she felt otherwise. I walked her out to the lobby, where she again stated she was okay, and proceeded to go home.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Peripheral swelling
Clinical narrative: Swelling of the arm and warmth at the injection site.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patients arm got red and hot with some swelling.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Back pain, Body temperature increased, Headache, Malaise, Neck pain
Clinical narrative: ELEVATED TEMP, HEADACHE, NECK PAIN, BACK PAIN, VOMITING, GENERAL MALAISE. ON 07/08/2016, PATIENT WAS EVALUATED IN THE CLINIC AND HER TEMP WAS 101.4 F. SHE WAS HAVING MILD HEADACHE, BUT NECK PAIN AND BACK PAIN WERE GONE. PHYSICAL EXAM WAS NEGATIVE FOR ACUTE INFECTION, THEN SHE RECEIVED BENADRYL 25MG INJECTION AND ORAL TYLENOL. SHE WAS DISCHARGED HOME WITH A PRESCRIPTION OF ORAL PREDNISONE 10MG TO TAKE FOR FIVE DAYS AND INSTRUCTIONS TO CONTINUE BENADRYL 25MG EVERY 8 HRS FOR 3 DAYS.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: ELEVATED TEMP, HEADACHE, NECK PAIN, BACK PAIN, VOMITING, GENERAL MALAISE. ON 07/08/2016, PATIENT WAS EVALUATED IN THE CLINIC AND HER TEMP WAS 101.4 F. SHE WAS HAVING MILD HEADACHE, BUT NECK PAIN AND BACK PAIN WERE GONE. PHYSICAL EXAM WAS NEGATIVE FOR ACUTE INFECTION, THEN SHE RECEIVED BENADRYL 25MG INJECTION AND ORAL TYLENOL. SHE WAS DISCHARGED HOME WITH A PRESCRIPTION OF ORAL PREDNISONE 10MG TO TAKE FOR FIVE DAYS AND INSTRUCTIONS TO CONTINUE BENADRYL 25MG EVERY 8 HRS FOR 3 DAYS.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (orally; dose, dose number, lot # and expiration date were not reported). The nurse was not sure what specific vaccines were give, date of administration or to what patients. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 injection (dose, route, anatomical location, lot# and expiration date were not reported). The nurse was not sure what specific vaccines were given, date of administration or to what patients. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB, injection (dose, route, anatomical location, lot # and expiration date were not reported). The nurse was not sure what specific vaccines were given, date of administration or what patients. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored doses of VAQTA injection (dose, route, anatomical location, lot # and expiration date were not reported). The nurse was not sure what specified vaccines were given, date of administration or to what patients. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to 2 patients of unknown age and gender. On 22-JUN-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # L033707 and expiration date 18-MAY-2017), (route and dose were not provided). No adverse effect reported. The vaccines were exposed to 59.5F for 15 hours, 55 min (Data logger: yes). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date, starting on or after 13-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L050560, expiry date: 14-DEC-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 10.67F for 12 hours. There was no previous temperature excursion. No product quality complaint was filed. This is ne of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a registered nurse referring to a currently 4 years old male patient. The patient has none medical history or drug reactions/allergies or concomitant therapies. On 10-JUN-2013, the patient was vaccinated with the first dose of PROQUAD subcutaneous (dosage, anatomical location, lot number and expiration date were not provided). No other suspect therapies were reported. On an unknown date, the patient was diagnosed with Pneumonia in an urgent care center however, the reporter stated that the patient did not hospitalization. It was also reported that the patient was currently on an unspecified antibiotic to treat Pneumonia. Additionally, the reporter also stated that the patient was scheduled "next week" to have an unspecified dental surgery for an unspecified reason. The outcome of pneumonia was reported as recovering. The relatedness between pneumonia and PROQUAD was not reported. Upon internal review, Pneumonia was considered as medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (Lot # L007230 with expiration date 03-SEP-2016; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # K021487, with expiration date 03-NOV-2017, lot # L024250 with expiration date 30-JUN-2017 and lot # L042266 with expiration date 27-OCT-2017; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (lot # L029266 with expiration date 04-AUG-2017, lot# K011188 with expiration date 12-AUG-2016 and lot # L011528 with expiration date 03-APR-2017 and albumin status rHA, 0.5 ml; dose number, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to multiple unspecified patients with unknown demographics. Information about the patients' pertinent medical history, drug reactions, allergies and concomitant medications was not reported. On an unspecified date in 2016 (reported as from 01-MAR-2016 through 08-MAY-2016), the patients were vaccinated with doses of improperly stored GARDASIL 9, lot # L044475 with expiration date 12-MAY-2017, (dose and route of administration were not reported). No adverse effects were reported. The vaccine experienced the following temperature excursion: 7.2 F, on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to multiple unspecified patients with unknown demographics. Information about the patients; pertinent medical history, drug reactions allergies and concomitant medications was not reported. On an unspecified date in 2016 (reported as from 01-MAR-2016 through 08-MAY-2016), the patients were vaccinated with doses of improperly stored RECOMBIVAX HB, lot # L018501 with expiration date 22-JUN-2017, (dose and route of administration were not reported). No adverse effects were reported. The vaccine experienced the following temperature excursion: 7.2 F, on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection (lot # L019835 with expiration date 23-MAR-2017 and lot # reported as L098265 with expiration date 10-JUN-2017; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patient sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L033693 with expiration date 31-MAY-2017, orally; dose and dose number were not reported. No adverse effects were reported and a product quality complaint (PQC) was not involved. IT was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to multiple unspecified patients with unknown demographics. Information about the patients' pertinent medical history, drug reactions allergies and concomitant medications was not reported. On an unspecified date in 2016 (reported as from 01-MAR-2016 through 08-MAY-2016), the patients were vaccinated with doses of improperly stored ROTATEQ, orally, lot # K019370 with expiration date 16-JUL-2016 and lot # L029618 with expiration date 20-MAY-2017. No adverse effects were reported. The vaccine experienced the following temperature excursion: 7.2F on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (Lot # M003659 with expiration date 20-SEP-2017; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (Lot# K008931 with expiration date 04-MAR-2017; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a pharmacist, via Pfizer, referring to a patient of unknown age and gender. Medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration and lot number were not provided).  On an unknown date, the patient had a localized allergic reaction the size of a football after receiving the PNEUMOVAX23. The reporter also asked if there was any information regarding administration of the PREVNAR13 or any known cross-reactivity with PNEUMOVAX23. No Product Quality Complaint was involved. The outcome of the event was unknown. The casual relationship between the event and the PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Cold sweat, Erythema, Feeling abnormal, Feeling hot, Injection site erythema
Clinical narrative: Very hot, but skin cold and clammy to touch. 7/2-joints very stiff all over, injection site very hot, swollen, sore. Additional congestion in chest. Continued feeling bad. 7/6 injection site red, swollen and red welts going around the arm and down in side underarms and left side of body.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Joint stiffness
Clinical narrative: Very hot, but skin cold and clammy to touch. 7/2-joints very stiff all over, injection site very hot, swollen, sore. Additional congestion in chest. Continued feeling bad. 7/6 injection site red, swollen and red welts going around the arm and down in side underarms and left side of body.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Respiratory tract congestion, Urticaria
Clinical narrative: Very hot, but skin cold and clammy to touch. 7/2-joints very stiff all over, injection site very hot, swollen, sore. Additional congestion in chest. Continued feeling bad. 7/6 injection site red, swollen and red welts going around the arm and down in side underarms and left side of body.
Age: 29.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site rash, Pain, Swelling
Clinical narrative: After receiving the immunization, patient complained of swelling and pain. The next day, rash development on right arm around injection site.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Inflammation, Myalgia, Peripheral swelling
Clinical narrative: Swelling, Redness, sore muscle, inflammation. By Thursday, redness and swelling were spreading past my elbow. Diagnosed as Cellulitis. I am on antibiotics and prednisone.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling, Redness, sore muscle, inflammation. By Thursday, redness and swelling were spreading past my elbow. Diagnosed as Cellulitis. I am on antibiotics and prednisone.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Asthenia, Lethargy, Pain
Clinical narrative: Lethargic, body aches, low energy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Localised infection, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT CAME TO SHOW US HER ARM WHICH WAS SWOLLEN. HER PRIMARY SENT HER TO ER BECAUSE HE THOUGHT IT WAS INFECTED BAD. ER GAVE PATIENT ANTIBIOTIC FOR THE INFECTION. PT SAID SHE IS FELLING FINE JUST HER ARM HURTS.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: 8 inch wide x 9 inch length bright red area, with 4x3 inch hard knot under injection site. Warm to the touch and tender at injection site with itching at injection site.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: 8 inch wide x 9 inch length bright red area, with 4x3 inch hard knot under injection site. Warm to the touch and tender at injection site with itching at injection site.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chest discomfort, Fatigue, Feeling abnormal, Formication
Clinical narrative: Patient reported "I felt tingling under her left arm and mild rash on back at first. This progressed to throbbing under both arms (my heartbeat) and my left armpit was hot and swollen. I experienced lower back pain, tightness in my upper chest and waist areas." Day two 2/13/2016 "this developed into extreme itching under my left arm and swelling and it felt like ants were crawling under my left arm; they walked up and down my arm, across to the middle of my chest and back to my shoulder blades. My left rotator cup became inflamed along with my left shoulder blade right up to the back of my head. I had tremendous headache...and stabbing pain that hit on one spot on the right side of my head. The entire shoulder above and under was swollen and hot. I felt like someone knocked the wind out of me, I was exhausted."
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Inflammation, Oedema peripheral, Pain, Paraesthesia
Clinical narrative: Patient reported "I felt tingling under her left arm and mild rash on back at first. This progressed to throbbing under both arms (my heartbeat) and my left armpit was hot and swollen. I experienced lower back pain, tightness in my upper chest and waist areas." Day two 2/13/2016 "this developed into extreme itching under my left arm and swelling and it felt like ants were crawling under my left arm; they walked up and down my arm, across to the middle of my chest and back to my shoulder blades. My left rotator cup became inflamed along with my left shoulder blade right up to the back of my head. I had tremendous headache...and stabbing pain that hit on one spot on the right side of my head. The entire shoulder above and under was swollen and hot. I felt like someone knocked the wind out of me, I was exhausted."
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Patient reported "I felt tingling under her left arm and mild rash on back at first. This progressed to throbbing under both arms (my heartbeat) and my left armpit was hot and swollen. I experienced lower back pain, tightness in my upper chest and waist areas." Day two 2/13/2016 "this developed into extreme itching under my left arm and swelling and it felt like ants were crawling under my left arm; they walked up and down my arm, across to the middle of my chest and back to my shoulder blades. My left rotator cup became inflamed along with my left shoulder blade right up to the back of my head. I had tremendous headache...and stabbing pain that hit on one spot on the right side of my head. The entire shoulder above and under was swollen and hot. I felt like someone knocked the wind out of me, I was exhausted."
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Big red spot with a bruise in center... hot to touch on 7/8.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Vaccination site pain
Clinical narrative: Extreme pain at the site of vaccine application. The shoulder pain and lack of hand mobility has continued after 3 months with no improvement.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache
Clinical narrative: Headache, severe dizziness, stomachache continuing into evening.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: Patient had a very large injection site reaction that night lasting for 3 days. It was very swollen and inflamed. She did not seek medical treatment. She stopped in pharmacy a week later to report and by then it was resolved.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: Left arm slight hand swelling, pain in upper arm, unable to fully extend.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: Adverse events-DTaP-HepB-IPV (PEDIARIX) HIB PREVNAR 13 ROTARIX given 5/17/16 and again on  6/1/16.
Age: 0.61
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting 5-10 mins after giving the vaccine. BENADRYL was given in the clinic. Child was stable, active and playful.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Disturbance in social behaviour, Hyporesponsive to stimuli, Lethargy
Clinical narrative: Child became less responsive within 4 hrs of vaccine but by the next morning, baby was lethargic with marked decrease in interaction with others. Seemed 'drugged'.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Oedema
Clinical narrative: 50 x 50 mm red area on RT arm. Edema.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient received TDAP vaccine in left medial deltoid (into the muscle after palpation). Next day, patient reported soreness at site. Told ice and APAP. Pain still 30d after vaccine administration.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: One day later, had pink skin, mild warmth, swelling just distal to biceps of same arm. Encouraged ice, acetaminophen for some stiffness and elevation if any sysx of infection return. If itchy, antihistamine.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. It was reported that on 21-JUN-2016 or 22-JUN-2016, the patients received improperly stored doses of VARIVAX lot # L046888, expiration date 23-NOV-2017 (dose, dose number and anatomical location not reported) or PROQUAD lot # L051100, expiration date 17-JUN-2017 (dose, dose number and anatomical location not reported). The temperature was -7.4 C and the time frame was less than 1 hour. Concomitant medications were not reported. It was unspecified as to which product was received on which date. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Urticaria
Clinical narrative: Red welt size of palm - approx. 4" x 3" with heat. Said the spot is hard. Noticed on same evening of injection.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Drug administered at inappropriate site
Clinical narrative: None stated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site inflammation, Injection site swelling
Clinical narrative: Patient came to the pharmacy today with a very large surface area surrounding site injection that was swollen and inflamed. She also had an area/patch of blistering. I advised patient to see her PCP.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Hyperhidrosis, Nausea, Pallor
Clinical narrative: 5 minutes after vaccine administration pt. complained of dizziness, nausea, pt was sweaty and pal. Called emergency service. Pt was taken to hospital.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Foaming at mouth, Gaze palsy, Seizure, Unresponsive to stimuli
Clinical narrative: Mother told that baby was with father and he noted jerking movements of baby upper limbs and rest of baby, he had froth around mouth and tongue. Eyes rolled upward and he was unresponsive like.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vital dye staining cornea present
Clinical narrative: This spontaneous report was received from a 74 year old female consumer with allergy to sulfa, reporting on herself. The patient's medical history included skin cancer, cataract operation and a mild case of shingles on the auditory nerve on the left side of her face. In approximately 2007, (reported as "9 years ago"), the consumer stated that in this time the rash appeared did not blister and it looked like an allergic reaction and after two weeks she recovered from it. In June 2016 (reported as "about one month ago"), the patient was vaccinated with ZOSTAVAX 1 shot, subcutaneous (strength, lot # and expiration date were not reported). Concomitant therapies included SINGULAIR.. The consumer reported that on 29-JUN-2016 (reported as "last Wednesday"), she developed another rash on the cheekbone, she described it as looking like a bug bite. However, on 04-JUL-2016 (reported as "yesterday"), developed another bump around her eye, after which she visited her physician The physician performed an eye stain after confirming shingles (herpes zoster) and stated that the optic never and eye was not infected. Furthermore, the patient added that the rash was milder than her previous case, and that it did not hurt or feel inflamed, but rather the spots themselves were sore. The patient was given Acyclovir and was recovering. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 21-JUN-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (dose, route, and Lot# not provided) instead of an intended dose of M-M-M II, concomitantly with a dose of VARIVAX (dose, route, Lot# not provided). Nurse was uncertain why the error occurred but did not felt it was due to product confusion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient received improperly stored GARDASIL (strength, dose, frequency and route unknown). Reporter reported GARDASIL with Lot # L024993 and expired date 17-AUG-2017 which was not valid for GARDASIL. However, Lot # L024993 was valid for GARDASIL 9. Concomitant therapy was not provided. The vaccines was stored under 30F for 15 minutes. There was no previous temperature excursion. Digital logger was not involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient received improperly stored GARDASIL (strength, dose, frequency and route unknown). Reporter reported GARDASIL with Lot # L024993 and expired 17-AUG-2017 which was not valid for GARDASIL. However, Lot # L024993 was valid for GARDASIL 9. Concomitant therapy was not provided. The vaccine was stored under 30F for 15 minutes. There was no previous temperature excursion. Digital logger was not involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient received improperly stored GARDASIL (strength, dose, frequency and route unknown). Reporter reported GARDASIL with Lot # L024993 and expired date 17-AUG-2017 which was not valid for GARDASIL. However, Lot # L024993 was valid for GARDASIL 9. Concomitant therapy was not provided. The vaccine was stored under 30F for 15 minutes. There was no previous temperature excursion. Digital logger was not involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to an unknown number of patients of unknown ages and genders. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (lot number M003440 expiration date 20-JAN-2018). Dose, route and frequency were not provided. No other suspect or concomitant therapy was reported. The doses were stored at 15.6 F for 1800 hours. The reporter stated that their office was not aware of any adverse effects from these administrations. This is one of two reports received from the same reporter (1607USA001830). Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX, subcutaneously (dose, dose number, lot # and anatomical locations were not reported), 21 days after the administration of M-M-R II)(dose, dose number, lot # and anatomical locations were not reported). (Drug use for unapproved schedule). No adverse effects were reported. Additional information is not expected since the patient cannot be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from other reporter referring to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 14-JUN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K016589)(Not a valid Merck lot number, as verified by Merck vaccines contact. Additionally, dose, dosage number, route of administration and anatomical location were not reported). It was also stated by the reporter that PNEUMOVAX23 lot # K012424 expiration date 05-JUN-2015 was the only stock currently in the office. No concomitant medication was reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Hyporesponsive to stimuli, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 6 month old female patient. It was reported that the patient had none medical history or concomitant medication or drug reaction. On 16-MAY-2016, the patient was vaccinated with ROTATEQ Orally (lot number and expiration date were not reported); PENTACEL lot # C5075AA and PREVNAR 13 (lot number and expiration date were not reported). The reporter stated that this last two vaccines were given separate in separate sights (lot number, expiration date, dosage and route of administration were not specified for all vaccines). ON 27-MAY-2016 (also reported as 27-JUN-2016), the reporter stated that the patient was less responsive to sound and also had a minor fever of 99.6, furthermore it was reported that the patient was acting strangely, as well as the next morning, it was reported that the patient was not interacting and talking. Nevertheless, the reporter referred on that same day in the afternoon the patient was doing much better. It was also reported that the patient sought medical attention by taking the patient for an exam, though the clinician's exam was normal, the patient was arrange to get hearing test. However, the mother decided not to take the patient to hearing specialist, since the baby was only 6 month. At the time of the report, the outcome of less responsive to sound, minor fever and abnormal behavior was recovered. Additionally, it was reported that no treatment was given for the adverse events, that no laboratory diagnostics were performed, that no intervention to prevent serious criteria was necessary, that the adverse events was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The relatedness between the adverse event and ROTATEQ was not reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Body temperature increased, Crying, Hypoacusis, Hyporesponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 6 month old female patient. It was reported that the patient had none medical history or concomitant medication or drug reaction. On 16-MAY-2016, the patient was vaccinated with ROTATEQ Orally (lot number and expiration date were not reported); PENTACEL lot # C5075AA and PREVNAR 13 (lot number and expiration date were not reported). The reporter stated that this last two vaccines were given separate in separate sights (lot number, expiration date, dosage and route of administration were not specified for all vaccines). ON 27-MAY-2016 (also reported as 27-JUN-2016), the reporter stated that the patient was less responsive to sound and also had a minor fever of 99.6, furthermore it was reported that the patient was acting strangely, as well as the next morning, it was reported that the patient was not interacting and talking. Nevertheless, the reporter referred on that same day in the afternoon the patient was doing much better. It was also reported that the patient sought medical attention by taking the patient for an exam, though the clinician's exam was normal, the patient was arrange to get hearing test. However, the mother decided not to take the patient to hearing specialist, since the baby was only 6 month. At the time of the report, the outcome of less responsive to sound, minor fever and abnormal behavior was recovered. Additionally, it was reported that no treatment was given for the adverse events, that no laboratory diagnostics were performed, that no intervention to prevent serious criteria was necessary, that the adverse events was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The relatedness between the adverse event and ROTATEQ was not reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Middle insomnia, Speech disorder
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 6 month old female patient. It was reported that the patient had none medical history or concomitant medication or drug reaction. On 16-MAY-2016, the patient was vaccinated with ROTATEQ Orally (lot number and expiration date were not reported); PENTACEL lot # C5075AA and PREVNAR 13 (lot number and expiration date were not reported). The reporter stated that this last two vaccines were given separate in separate sights (lot number, expiration date, dosage and route of administration were not specified for all vaccines). ON 27-MAY-2016 (also reported as 27-JUN-2016), the reporter stated that the patient was less responsive to sound and also had a minor fever of 99.6, furthermore it was reported that the patient was acting strangely, as well as the next morning, it was reported that the patient was not interacting and talking. Nevertheless, the reporter referred on that same day in the afternoon the patient was doing much better. It was also reported that the patient sought medical attention by taking the patient for an exam, though the clinician's exam was normal, the patient was arrange to get hearing test. However, the mother decided not to take the patient to hearing specialist, since the baby was only 6 month. At the time of the report, the outcome of less responsive to sound, minor fever and abnormal behavior was recovered. Additionally, it was reported that no treatment was given for the adverse events, that no laboratory diagnostics were performed, that no intervention to prevent serious criteria was necessary, that the adverse events was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The relatedness between the adverse event and ROTATEQ was not reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Asocial behaviour, Crying, Hypoacusis, Hyporesponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 6 month old female patient. It was reported that the patient had none medical history or concomitant medication or drug reaction. On 16-MAY-2016, the patient was vaccinated with ROTATEQ Orally (lot number and expiration date were not reported); PENTACEL lot # C5075AA and PREVNAR 13 (lot number and expiration date were not reported). The reporter stated that this last two vaccines were given separate in separate sights (lot number, expiration date, dosage and route of administration were not specified for all vaccines). ON 27-MAY-2016 (also reported as 27-JUN-2016), the reporter stated that the patient was less responsive to sound and also had a minor fever of 99.6, furthermore it was reported that the patient was acting strangely, as well as the next morning, it was reported that the patient was not interacting and talking. Nevertheless, the reporter referred on that same day in the afternoon the patient was doing much better. It was also reported that the patient sought medical attention by taking the patient for an exam, though the clinician's exam was normal, the patient was arrange to get hearing test. However, the mother decided not to take the patient to hearing specialist, since the baby was only 6 month. At the time of the report, the outcome of less responsive to sound, minor fever and abnormal behavior was recovered. Additionally, it was reported that no treatment was given for the adverse events, that no laboratory diagnostics were performed, that no intervention to prevent serious criteria was necessary, that the adverse events was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The relatedness between the adverse event and ROTATEQ was not reported. Additional information has been requested.