chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Pt wait 15min after vacc given. Pt left returned an hour later with hives. Pt seen by provider. Dx with dry skin note states doubt significant allergy or shot reaction. No treatment given.
Sex: U
Vaccine: 6VAX-F
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (dose, unit, route unknown, lot # M006103, expiration date 01-AUG-2017) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, warmth erythema 8cm by 7cm at injection site.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Chest X-ray, Cough, Differential white blood cell count, Drooling, Dyspnoea
Clinical narrative: Vaccines given 8/09/16-developed a gagging cough and drooling later that evening. Episode subsided. Next day 8/10/16 developed the same gagging cough and drooling with fever increased 103.5. Took to Emergency Room mom states had shortness of breath.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Full blood count, Metabolic function test, Pyrexia, Retching, Urine analysis
Clinical narrative: Vaccines given 8/09/16-developed a gagging cough and drooling later that evening. Episode subsided. Next day 8/10/16 developed the same gagging cough and drooling with fever increased 103.5. Took to Emergency Room mom states had shortness of breath.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Pt was given vaccination in office (0950). Mom phoned to say that by that time arrived home (15 mins). Pt was covered in hives. Returned to office in 10-15 min. Hives on back, abdomen, face. Mom gave dose of BENADRYL.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Decreased appetite, Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: (After 2 days right whole swollen elbow, red, couldn't pick up arm, couldn't ear. Pt went to Dr, and got treated with BENADRY cream and Ibuprofen). Pt came back on 8/10/16 and said she was doing fine now.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache
Clinical narrative: Pt received vaccines 8/5/16. He woke up 8/9/16 with severe headache with no additional sx. Pt was seen in office 8/10/16. Phone call to pt's mtr 8/11/16. She states headache somewhat better.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: SEVERE PAIN IN ARM, REDNESS HOT TO TOUCH SWELLING.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Rash
Clinical narrative: Large circular rash and lump on left arm.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Incorrect route of drug administration
Clinical narrative: Vaccine given intradermal instead of intramuscular.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mother called today (8-11-16) to report reaction of child to immunization on 8-8-16.  Mother reports that child received two (2) vaccines in the (R) arm, which is fine and one (1) vaccine in the (L) arm which became red and swollen below the area of injection but in Deltoid area.  She also states that the child ran fever of between 101 & 102 degrees Monday night and Tuesday.  She reports that she took the child to a clinic and was advised to give Benadryl and that no antibiotic was needed at this time.  They also advised for here to report reaction to the Health Department which she did this morning.  Mom reports no further fever or vomiting, only redness, swelling at site and warm to the touch.  I advised mom to continue with the Benadryl as instructed and to give Children's Ibuprofen for pain/inflammation and to apply warm compresses frequently.  She plans to follow-up with me tomorrow to monitor for improvement.
Age: 18.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Head injury, Pallor, Syncope
Clinical narrative: At 12:55 PM-patient noted at doorway of room-patient pale and stated she thought she fainted and hit head against room door-doesn't remember leaving bed to get to door.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came to pharmacy and showed his arm was swollen, red, and warm to the touch.  He stated that he went to the doctor to have them look at it.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Skin discolouration, Swelling
Clinical narrative: Immediate violent pruritis, 8 cm erythema with swelling and 6 cm white center just below site of SQ injection of Proquad MMRV.  No other symptoms noted.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised red skin about 5 cm at injection site with no pain or itching, patient claims dermatitis.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Excessive eye blinking, Muscle twitching, Pyrexia, Screaming
Clinical narrative: Fever recorded after home Tylenol @>103. Seizure-like symptoms (whole body twitching, excessive blinking, screaming cry). Recurrence x5.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Seizure like phenomena
Clinical narrative: Fever recorded after home Tylenol @>103. Seizure-like symptoms (whole body twitching, excessive blinking, screaming cry). Recurrence x5.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around site of injection; marked improvement as of 8/11/2016 approximately 3PM.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: "Swollen, red and warm" left upper thigh-per patient's mother. Cold compress on affected thigh-per mother.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Child had no reported adverse event; varicella vaccine had been in refrigerator for 75 hours; per Merck [manufacturer], because of the lot, this was too long a period out of freezer to be certain vaccine was still full potency.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient stopped in to the pharmacy 8/11/2016 to say that her arm was still sore from her Tdap.
Age: 74.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash
Clinical narrative: Skin break-out in 3 different locations and at site of vaccination (left arm). Doctor visit. Mometasone Furoate Cream USP 0.1%.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Head injury, Hyperhidrosis, Malaise, Pallor, Syncope
Clinical narrative: She walked out to the waiting room with her mother - was standing and started not to feel good. Told her mom she didn't feel good and collapsed hitting the back of her head on the floor. No LOC. Was immediately awake and interactive, noted to be slightly pale and sweaty. Taken to the treatment room - VS 113/83, hr 76, rr 16, o2 96% on room air. This set of vital signs were taken after drinking some gatoraide, lying back. Felt better and departed from the clinic on her own volition.
Age: 22.0
Sex: M
Vaccine: HPV9, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Severe Right Shoulder Pain at injection site, unable to use right arm and difficulty sleeping due to pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling (4 fingers long by 3 fingers wide) at site of injection; presented with a white speck at center of the shot. Pt saw an MD and was given oral cephalexin and a topical antibiotic ointment.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Abasia, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Laboratory test normal
Clinical narrative: Patient woke up on the morning on July 8 and could no longer walk.  He was unable to walk for exactly 28 days.  On August 4th he began walking again.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Red blood cell sedimentation rate normal, X-ray of pelvis and hip normal
Clinical narrative: Patient woke up on the morning on July 8 and could no longer walk.  He was unable to walk for exactly 28 days.  On August 4th he began walking again.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Injection site hypoaesthesia
Clinical narrative: Patient woke up on the morning on July 8 and could no longer walk.  He was unable to walk for exactly 28 days.  On August 4th he began walking again.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Pain, Pyrexia
Clinical narrative: Patient complains of fever, aches all over, and chest tightness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swollen and hardened at area of injection.  Swelling encircles arm. area is hot to the touch.  No fevers, chill, or pain.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Escalated from onset. Started with pain in arm, tiredness, headaches, dizziness, nausea. She is cold to the touch at 8:00 PM on 8/11/2016.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral coldness
Clinical narrative: Escalated from onset. Started with pain in arm, tiredness, headaches, dizziness, nausea. She is cold to the touch at 8:00 PM on 8/11/2016.
Age: 36.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dysgraphia, Feeling abnormal, Headache, Memory impairment
Clinical narrative: Self reported (6 months after occurrence) Severe Headache lasting 3 days, problems with memory after, problems writing his name initially after the event and feeling of "feeling cloudy" like something in his brain w/o other neurologic deficits, depression/anxiety other MH issue, fevers or local reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal discomfort, Emotional distress, Erythema, Eye pain, Pain
Clinical narrative: APPROXIMATELY 10 MINUTES AFTER VACCINATION, MY SON BEGAN TO ACT EMOTIONALLY UPSET, COMPLAINING THAT HIS EYES HURT AND THEN SCREAMING IN PAIN AND GRABBING HIS BELLY.  WE WENT BACK INSIDE THE CLINIC AND REPORTED THAT HE WAS POSSIBLY HAVING A REACTION.  A NURSE CAME OUT TO ASSESS HIM AND THEN LEFT TO SPEAK WITH THE DR. IMMEDIATLEY FOLLOWING THAT, MY SON BEGAN TO VOMIT. WE RUSHED HIM INTO AN EXAM ROOM AND A DR CAME TO ASSESS HIM.  WE NOTICED A COUPLE HIVES ON HIS BACK/TRUNK.  A NURSE GAVE HIM PO BENADRYL PER THE DR.'S REQUEST. THE DR THEN SAID WE COULD WATCH HIM.  MY CHILD WAS SCREAMING THE ENTIRE TIME.  UPON THE DR.'S EXIT FROM THE ROOM, I NOTICED HE WAS TURNING RED ALL OVER HIS BODY.  I CALLED THE DR. BACK IN AND SHE AGREED WE NEEDED TO GIVE HIM HIS EPI PEN.  I ADMINISTERED THE EPI PEN. SYMPTOMS IMPROVED WITHIN 3-5 MINUTES. I THEN TOOK HIM TO THE ER FOR OBSERVATION.  THEY TREATED HIM WITH ZYRTEC AND PREDNISOLONE.  WE WERE SENT HOME WITH PREDNISOLONE TO BE CONTINUED FOR 4 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Screaming, Urticaria, Vomiting
Clinical narrative: APPROXIMATELY 10 MINUTES AFTER VACCINATION, MY SON BEGAN TO ACT EMOTIONALLY UPSET, COMPLAINING THAT HIS EYES HURT AND THEN SCREAMING IN PAIN AND GRABBING HIS BELLY.  WE WENT BACK INSIDE THE CLINIC AND REPORTED THAT HE WAS POSSIBLY HAVING A REACTION.  A NURSE CAME OUT TO ASSESS HIM AND THEN LEFT TO SPEAK WITH THE DR. IMMEDIATLEY FOLLOWING THAT, MY SON BEGAN TO VOMIT. WE RUSHED HIM INTO AN EXAM ROOM AND A DR CAME TO ASSESS HIM.  WE NOTICED A COUPLE HIVES ON HIS BACK/TRUNK.  A NURSE GAVE HIM PO BENADRYL PER THE DR.'S REQUEST. THE DR THEN SAID WE COULD WATCH HIM.  MY CHILD WAS SCREAMING THE ENTIRE TIME.  UPON THE DR.'S EXIT FROM THE ROOM, I NOTICED HE WAS TURNING RED ALL OVER HIS BODY.  I CALLED THE DR. BACK IN AND SHE AGREED WE NEEDED TO GIVE HIM HIS EPI PEN.  I ADMINISTERED THE EPI PEN. SYMPTOMS IMPROVED WITHIN 3-5 MINUTES. I THEN TOOK HIM TO THE ER FOR OBSERVATION.  THEY TREATED HIM WITH ZYRTEC AND PREDNISOLONE.  WE WERE SENT HOME WITH PREDNISOLONE TO BE CONTINUED FOR 4 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal pain upper, Agitation, Eye pain, Eye swelling, Ocular hyperaemia
Clinical narrative: APPROXIMATELY 10 MINUTES AFTER VACCINATION, MY SON BEGAN TO ACT EMOTIONALLY UPSET, COMPLAINING THAT HIS EYES HURT AND THEN SCREAMING IN PAIN AND GRABBING HIS BELLY.  WE WENT BACK INSIDE THE CLINIC AND REPORTED THAT HE WAS POSSIBLY HAVING A REACTION.  A NURSE CAME OUT TO ASSESS HIM AND THEN LEFT TO SPEAK WITH THE DR. IMMEDIATLEY FOLLOWING THAT, MY SON BEGAN TO VOMIT. WE RUSHED HIM INTO AN EXAM ROOM AND A DR CAME TO ASSESS HIM.  WE NOTICED A COUPLE HIVES ON HIS BACK/TRUNK.  A NURSE GAVE HIM PO BENADRYL PER THE DR.'S REQUEST. THE DR THEN SAID WE COULD WATCH HIM.  MY CHILD WAS SCREAMING THE ENTIRE TIME.  UPON THE DR.'S EXIT FROM THE ROOM, I NOTICED HE WAS TURNING RED ALL OVER HIS BODY.  I CALLED THE DR. BACK IN AND SHE AGREED WE NEEDED TO GIVE HIM HIS EPI PEN.  I ADMINISTERED THE EPI PEN. SYMPTOMS IMPROVED WITHIN 3-5 MINUTES. I THEN TOOK HIM TO THE ER FOR OBSERVATION.  THEY TREATED HIM WITH ZYRTEC AND PREDNISOLONE.  WE WERE SENT HOME WITH PREDNISOLONE TO BE CONTINUED FOR 4 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Pain, Rash erythematous, Screaming, Swelling, Urticaria
Clinical narrative: APPROXIMATELY 10 MINUTES AFTER VACCINATION, MY SON BEGAN TO ACT EMOTIONALLY UPSET, COMPLAINING THAT HIS EYES HURT AND THEN SCREAMING IN PAIN AND GRABBING HIS BELLY.  WE WENT BACK INSIDE THE CLINIC AND REPORTED THAT HE WAS POSSIBLY HAVING A REACTION.  A NURSE CAME OUT TO ASSESS HIM AND THEN LEFT TO SPEAK WITH THE DR. IMMEDIATLEY FOLLOWING THAT, MY SON BEGAN TO VOMIT. WE RUSHED HIM INTO AN EXAM ROOM AND A DR CAME TO ASSESS HIM.  WE NOTICED A COUPLE HIVES ON HIS BACK/TRUNK.  A NURSE GAVE HIM PO BENADRYL PER THE DR.'S REQUEST. THE DR THEN SAID WE COULD WATCH HIM.  MY CHILD WAS SCREAMING THE ENTIRE TIME.  UPON THE DR.'S EXIT FROM THE ROOM, I NOTICED HE WAS TURNING RED ALL OVER HIS BODY.  I CALLED THE DR. BACK IN AND SHE AGREED WE NEEDED TO GIVE HIM HIS EPI PEN.  I ADMINISTERED THE EPI PEN. SYMPTOMS IMPROVED WITHIN 3-5 MINUTES. I THEN TOOK HIM TO THE ER FOR OBSERVATION.  THEY TREATED HIM WITH ZYRTEC AND PREDNISOLONE.  WE WERE SENT HOME WITH PREDNISOLONE TO BE CONTINUED FOR 4 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Vomiting
Clinical narrative: APPROXIMATELY 10 MINUTES AFTER VACCINATION, MY SON BEGAN TO ACT EMOTIONALLY UPSET, COMPLAINING THAT HIS EYES HURT AND THEN SCREAMING IN PAIN AND GRABBING HIS BELLY.  WE WENT BACK INSIDE THE CLINIC AND REPORTED THAT HE WAS POSSIBLY HAVING A REACTION.  A NURSE CAME OUT TO ASSESS HIM AND THEN LEFT TO SPEAK WITH THE DR. IMMEDIATLEY FOLLOWING THAT, MY SON BEGAN TO VOMIT. WE RUSHED HIM INTO AN EXAM ROOM AND A DR CAME TO ASSESS HIM.  WE NOTICED A COUPLE HIVES ON HIS BACK/TRUNK.  A NURSE GAVE HIM PO BENADRYL PER THE DR.'S REQUEST. THE DR THEN SAID WE COULD WATCH HIM.  MY CHILD WAS SCREAMING THE ENTIRE TIME.  UPON THE DR.'S EXIT FROM THE ROOM, I NOTICED HE WAS TURNING RED ALL OVER HIS BODY.  I CALLED THE DR. BACK IN AND SHE AGREED WE NEEDED TO GIVE HIM HIS EPI PEN.  I ADMINISTERED THE EPI PEN. SYMPTOMS IMPROVED WITHIN 3-5 MINUTES. I THEN TOOK HIM TO THE ER FOR OBSERVATION.  THEY TREATED HIM WITH ZYRTEC AND PREDNISOLONE.  WE WERE SENT HOME WITH PREDNISOLONE TO BE CONTINUED FOR 4 DAYS.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Biopsy brain, Blood test, Echocardiogram
Clinical narrative: POTS, brain fog, numbness in legs feet and hands, bad head ache, every time she eats she feels nauseous, she stays tired. Has no energy and that's not patient she has always been very out going and athletic she has cheered and played softball all her life until she got the vaccine and wasn't able to play do to being sick and being put on home bound due to POTS.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram, Fatigue, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: POTS, brain fog, numbness in legs feet and hands, bad head ache, every time she eats she feels nauseous, she stays tired. Has no energy and that's not patient she has always been very out going and athletic she has cheered and played softball all her life until she got the vaccine and wasn't able to play do to being sick and being put on home bound due to POTS.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nuclear magnetic resonance imaging, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS, brain fog, numbness in legs feet and hands, bad head ache, every time she eats she feels nauseous, she stays tired. Has no energy and that's not patient she has always been very out going and athletic she has cheered and played softball all her life until she got the vaccine and wasn't able to play do to being sick and being put on home bound due to POTS.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 19-JUL-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plaque forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016; dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months. There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a nurse referring to 2 patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were unknown. On unknown dates the patients were vaccinated with doses of PNEMOVAX23 (lot#, route and dose not reported). The nurse indicated that each dose of PNEUMOVAX23 administered was different lot number. On unspecified dates after the administration, both patients developed pain, warmth and redness that traveled to the inner arm, lasting for an unspecified duration of time. The nurse did not indicate the present status of either patient. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via company representative referring to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in the past, the patients were vaccinated with GARDASIL (dose, route, lot # and expiry date not reported). Then, on an unknown date, both the patients fainted. The outcome of the event was not known at the time of report. Causality assessment was not provided. No product quality complaint (PQC) involved. No further information provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 41.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 41 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-JUL-2016, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (lot # L040458, expiration date, exact dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received form a respiratory therapist (R.T.) concerning to an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurred conditions were not reported. On an unknown date the patient was inadvertently vaccinated with a dose of PROQUAD (lot #, expiration date, concentration, dose and therapy route were not reported) and with a dose of VARIVAX (lot #, expiration date, concentration, dose and therapy route were not provided), at the same office visit. Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Pain, Rash macular
Clinical narrative: Left shoulder tenderness with splotchy rash. Pain with movement in left shoulder.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Pain in extremity, Rash
Clinical narrative: Pt developed a rash on both arms, tops of shoulders, and collar bone and complained of soreness to left arm. Pt was given BENADRYL and rash resolved after one day.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Tearfulness, Tremor
Clinical narrative: Fever, shakiness, tearful.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema multiforme
Clinical narrative: Diffuse erythema multiforme rash 4-5 days after vaccine.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dysarthria, Headache, Hyperhidrosis, Hypersomnia, Urinary incontinence
Clinical narrative: Had vaccine on Wednesday evening and Friday am had slurred speech and sweating and headache. Patient had urinated on himself while sleeping. Slept all day on Friday.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: MMR given rt thigh SQ 4:30 pm shortly after began swelling and hot to touch. Having child stay in clinic for 20-30 min.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Induration, Swelling
Clinical narrative: Per mom swelling, hard. Per mom stated symptoms by phone.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Faeces discoloured, Hypophagia, Irritability, Mucous stools
Clinical narrative: Vaccinated on 8/15/16 an d3 days later pt with maculopapular rash on torso that spread to ace/head. Present fussy, decrease PO intake. Temp afebrile but 99 degree F. Present greenish stool w/mucus appearance on 8/10/16 mom instructed to give TYLENON and pt slept better.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash maculo-papular
Clinical narrative: Vaccinated on 8/15/16 an d3 days later pt with maculopapular rash on torso that spread to ace/head. Present fussy, decrease PO intake. Temp afebrile but 99 degree F. Present greenish stool w/mucus appearance on 8/10/16 mom instructed to give TYLENON and pt slept better.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: 15 to 20 minutes after receiving MENACTRA while still laying down developed urticarial rash face, arms, abdomen, back, legs - no difficulty breathing, no swelling of lips, or face, no vomiting - given BENADRYL 50 mg oral, observation for another 30 minutes - no new hives - ok home phone call 4 hrs after no more hives, or any problems.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Cellulitis-itchy swollen red hot injection site reaction. Saw MD for amoxicillin therapy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Pt. received vaccines on 8/10/16. Fever started on 8/10/16 of 102 F and TYLENOL given. Then rash developed and became severe morning of 8/11/16. Mom brought pt. clinic and Rx given for BENADRYL and advised to give TYLENOL.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received immunization on 8/10/2016 at 2:26 PM. Came in next day with redness and swelling around the injection site. Never had reaction in the past to flu shot. Was told to take antihistamine and ibuprofen. Will follow up.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Numbness, pn, tingling, redness with swelling on right arm.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient received flu shot at clinic. Presents with localized swelling and warmth approximately 5-6 cm reaction. Mild redness overlying.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in jaw
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of jaw pain in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, 2 days after receiving BEXSERO, the patient experienced jaw pain. On an unknown date, the outcome of the jaw pain was unknown. The reporter considered the jaw pain to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced severe jaw pain after vaccination with BEXSERO. The patient was referred to the dentist. The status of the event was unknown. The reporter would be on vacation the next week after reporting date and correspondence contact for her practice manager was provided. This case is one of the four cases reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Swelling face
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of facial swelling in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, 30 days after receiving BEXSERO, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. The reporter considered the facial swelling to be probably related to BEXSERO. Additions details were provided as follows. The age of vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced facial swelling after vaccination with BEXSERO. The reporter will be on vacation and correspondence contact (practice manager) was reported. This is one of the four cases reported by the same reporter.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO (batch number 151401, expiry date 30th December 2016). On 25th July 2016, the patient received the 1st dose of BEXSERO .5 ml. On 27th July 2016, 2 days after receiving BEXSERO, the patient experienced injection site pain, tingling of extremity and pain in hand. On an unknown date, the outcome of the injection site pain, tingling of extremity and pain in hand were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, tingling of extremity and pain in hand to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, after administration of BEXSERO the patient experienced pain and tingling in both hands and pain at the injection site, which was persisted till the time of reporting. On a pain scale of 1-10, the pain was at a scale of 3 and annoying.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Left Arm localized redness and itching warm to the touch.
Age: 1.16
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash papular
Clinical narrative: Pt vaccinated w/ routine 12mo vaccines on  8/8/16. She returned to clinic 8/11/16 w/ papular vesicular like rash, approx 20-25 lesions. Afebrile, non-toxic.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Red, inflamed, pain to touch and move, 6-8" radius. Pt is taking BENADRYL and ADVIL. Occurred 8am morning after that they noticed.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to a 71 year old female patient. No pertinent medical history and no drug reactions/allergies. On 19-JUL-2016, the patient was vaccinated with ZOSTAVAX lot # M001746 (07-APR-2017), at a dosage of 0.65 ml once subcutaneously. Concomitant therapies included paroxetine and lorazepam. Approximately on an unknown date and unspecified time in July-2016, the patient developed a "red, swollen area" at the ZOSTAVAX injection site that "might be infected"; no further clarification information was provided. The patient was seen by the pharmacist today (21-JUL-2016), in regards to the reaction. No treatment was given for the events. None lab diagnostics/studies performed. No Product Quality Complaint (PQC) was involved. The outcome of the events was not recovered. The reporter did not provide any causality assessment between events and ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to a 71 year old female patient. No pertinent medical history and no drug reactions/allergies. On 19-JUL-2016, the patient was vaccinated with ZOSTAVAX lot # M001746 (07-APR-2017), at a dosage of 0.65 ml once subcutaneously. Concomitant therapies included paroxetine and lorazepam. Approximately on an unknown date and unspecified time in July-2016, the patient developed a "red, swollen area" at the ZOSTAVAX injection site that "might be infected"; no further clarification information was provided. The patient was seen by the pharmacist today (21-JUL-2016), in regards to the reaction. No treatment was given for the events. None lab diagnostics/studies performed. No Product Quality Complaint (PQC) was involved. The outcome of the events was not recovered. The reporter did not provide any causality assessment between events and ZOSTAVAX. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Computerised tomogram head normal, Electroencephalogram, Full blood count, Metabolic function test normal, Status epilepticus
Clinical narrative: Within 24h of vaccine administration - had prolonged seizure (not febrile). Intubated and hospitalized x 3d.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Electroencephalogram abnormal, Endotracheal intubation, Seizure
Clinical narrative: Within 24h of vaccine administration - had prolonged seizure (not febrile). Intubated and hospitalized x 3d.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Bruxism, Confusional state, Crying, Dyskinesia, Eye movement disorder
Clinical narrative: 8/8/2016-She received GARDASIL-9, Lot# M013636. Mom was checking out. She went to the care upset, as she was trying to open the door, she fell backwards when she passed out. Mom noted her teeth clenched. She tried to open her mouth. Dr came out to help. She was crying hysterically. She was helped to get up and walk back to the office. She cried hysterically for sometime. When she calmed down-arm was normal. She did not have any swelling at the back of her head. Neurostim-normal.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Fall, Respiratory rate increased, Somnolence, Tremor
Clinical narrative: 8/8/2016-She received GARDASIL-9, Lot# M013636. Mom was checking out. She went to the care upset, as she was trying to open the door, she fell backwards when she passed out. Mom noted her teeth clenched. She tried to open her mouth. Dr came out to help. She was crying hysterically. She was helped to get up and walk back to the office. She cried hysterically for sometime. When she calmed down-arm was normal. She did not have any swelling at the back of her head. Neurostim-normal.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Bruxism, Crying, Fall, Loss of consciousness
Clinical narrative: 8/8/2016-She received GARDASIL-9, Lot# M013636. Mom was checking out. She went to the care upset, as she was trying to open the door, she fell backwards when she passed out. Mom noted her teeth clenched. She tried to open her mouth. Dr came out to help. She was crying hysterically. She was helped to get up and walk back to the office. She cried hysterically for sometime. When she calmed down-arm was normal. She did not have any swelling at the back of her head. Neurostim-normal.
Age: 26.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: RN at 8/3/2016 3:43 PM Patient is driving home from work yesterday.  She had a pneumococcal vaccine yesterday to her left arm.  Last night, she noticed a tender area under her left armpit.  Arm pit is mildly swollen.  She noticed a red area, near the armpit.  She is unable to assess now because she is driving.  Injection site isn't red. Progress Notes MD at 8/4/2016 7:53 AM She has axillary adenopathy. Left axillary: Pectoral and lateral adenopathy present. On examination of the left hand and elbow show an area, patient does have this localized tenderness present, on the left axillary area, patient does have this tenderness present which is approximately 3-4 cm in diameter, it seems like patient is having axillary lymphadenopathy which is tender to touch.  No significant redness present. Assessment plan Allergic reaction/exhilarated lymphadenopathy: It seems like patient might have had allergic reaction to pneumonia vaccine and now she is having exhilarated lymphadenopathy going on from that.  Decided to call in a prescription of clindamycin 300 mg to be taken 3 times daily for 10 days.  Recommended taking ibuprofen for the pain control, patient can also ice it.
Age: 26.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Tenderness
Clinical narrative: RN at 8/3/2016 3:43 PM Patient is driving home from work yesterday.  She had a pneumococcal vaccine yesterday to her left arm.  Last night, she noticed a tender area under her left armpit.  Arm pit is mildly swollen.  She noticed a red area, near the armpit.  She is unable to assess now because she is driving.  Injection site isn't red. Progress Notes MD at 8/4/2016 7:53 AM She has axillary adenopathy. Left axillary: Pectoral and lateral adenopathy present. On examination of the left hand and elbow show an area, patient does have this localized tenderness present, on the left axillary area, patient does have this tenderness present which is approximately 3-4 cm in diameter, it seems like patient is having axillary lymphadenopathy which is tender to touch.  No significant redness present. Assessment plan Allergic reaction/exhilarated lymphadenopathy: It seems like patient might have had allergic reaction to pneumonia vaccine and now she is having exhilarated lymphadenopathy going on from that.  Decided to call in a prescription of clindamycin 300 mg to be taken 3 times daily for 10 days.  Recommended taking ibuprofen for the pain control, patient can also ice it.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Skin warm, Ultrasound scan
Clinical narrative: Severe upper left extremity pain at injection site, Swollen approximate 5 inch diameter around injection site, Warm/ Slight Redness of skin- Prescribed Kflex 500mg (take 2 capsules by mouth twice daily for 10 days), Prescribed Deltasone 50mg (take 1 tablet by mouth daily).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Diarrhea for several days. At days 5 and 6 after the vaccine, blood showed up in stools.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: DONOR STATED ON 08/09/16 HER ARM FELT SORE, RED ITCHING AND COULD FEEL A BUMP. REPORTED THE INCIDENT ON 08/12/16. MINOR ITCHING, REDNESS (LOCALIZED), MINOR BUMP IN SITE AREA.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Laceration, Product package associated injury
Clinical narrative: Initial unsolicited report received from non-health care professional on 02 Aug 2016. This case involves a female patient (age was not reported) who was exposed to the vial of Pentacel (batch number: C5139AA and expiry date-14 May 2017) on 18 Jun 2016. Product complaint was filed as CO2016-00360 PC 329911. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 18 Jun 2016, same day, patient had finger laceration when she pulled out a vial of Pentacel that had been broken in the box. Lab data and corrective treatment were not reported. There were no issues/complications reported. On unspecified date the laceration healed. List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Malaise, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 04-Aug-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TD VACCINE (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) probably in 1984. The patient's illness at time of vaccination, pre- existing physician diagnosed allergies, birth defects, medical conditions were not reported. Patient reported that she had many reactions to other vaccines and products. Concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced swollen arm, fever and nausea and was sick for one week. Lab data was not reported. Corrective treatment was not reported. On an unspecified date, patient recovered from the event. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis viral, Herpes simplex test positive, Herpes virus infection, Mental status changes
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 64 year old female patient. The patient did not have any medical history and drug reactions or allergies were unknown. On 09-SEP-2015, the patient was vaccinated with a one time injection of ZOSTAVAX (subcutaneously, lot# and expiration date were not reported). No concomitant therapy was reported.  In approximately March 2016, 6 months after vaccination, the patient experienced viral encephalitis which caused her to be in and out of hospital. It was reported that the patient had mental status changes and was positively tested for herpes. Unspecified treatment was given for the event. Patient sought medical attention, she visited a provider on 04-APR-2016. The outcome of the events was not recovered/not resolved, the patient was not doing well. Causality assessment was not reported. The reporter considered the event of viral encephalitis to be disabling. Upon internal review, the event of viral encephalitis was considered to be medically significant. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient received wrong vaccine. Patient had no side effect.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Bilirubin conjugated increased, Blood bilirubin increased, Cough, Differential white blood cell count, Epstein-Barr virus antibody
Clinical narrative: Patient developed a fever that started a few hours after receiving immunizations and lasted for approximately 24 hours. During that time the patient felt thirsty and had a mild cough. On 08/06/2016, patient's mother reported that the patient's eyes looked yellow and he was complaining of fatigue. All of his symptoms resolved by 08/08/2016.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Fatigue, Full blood count, Metabolic function test, Mononucleosis heterophile test, Ocular icterus
Clinical narrative: Patient developed a fever that started a few hours after receiving immunizations and lasted for approximately 24 hours. During that time the patient felt thirsty and had a mild cough. On 08/06/2016, patient's mother reported that the patient's eyes looked yellow and he was complaining of fatigue. All of his symptoms resolved by 08/08/2016.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Pyrexia, Streptococcus test, Thirst, Urine analysis
Clinical narrative: Patient developed a fever that started a few hours after receiving immunizations and lasted for approximately 24 hours. During that time the patient felt thirsty and had a mild cough. On 08/06/2016, patient's mother reported that the patient's eyes looked yellow and he was complaining of fatigue. All of his symptoms resolved by 08/08/2016.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Mobility decreased, Pain in extremity
Clinical narrative: Arm really hurt, and could not lift arm.  This effect went away but redness developed from injection site to elbow.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Nurse, referring to an unknown number of patients of unknown age and gender. No pertinent medical histories, concurrent conditions and concomitant therapies were reported. On 04-AUG-2016, the patients were vaccinated with improperly stored VAQTA. Dose, route, lot #, indication and anatomical location were not reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health professional refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were inadvertently vaccinated with improperly stored M-M-R II (unspecified lots/expirations (incorrect product storage). This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HIBV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 months old patient. Information regarding medical history and drug reactions/allergies was not reported. On 06-MAR-2015, the patient was vaccinated with a dose of ACTHIB (lot # UIO66AAA with expiration date 29-OCT-2019) when he/she was 2 months old. On 07-JUL-2016, the patient was vaccinated with a dose of MENHIBRIX (lot# ACA012A with expiration date 15-JUL-2016) when he/she was 6 months old. On 05-MAY-2015, the 4 months old patient was vaccinated with a dose of PEDVAXHIB (lot # H02059 (invalid) with expiration date 20-SEP-2016, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (strength, dose number, route, anatomical location, lot number and expiration date were not provided). This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 years old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degrees Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.76
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 21 months old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacy intern (also reported as a doctor) referring to a 68 year-old female patient with high blood pressure. She did not have drug/allergy reactions or concomitant medications. On 27-JUL-2016, the patient was vaccinated with ZOSTAVAX. Dose, dose number, route and anatomical location were not reported. On 29-JUL-2016 (reported as within two days), the patient experienced a rash around the injection site as well as muscular pain in the upper arm. The pharmacy intern noted that the patient went to the pharmacy for a check from the pharmacist who recommended to the patient to see her primary care physician. Laboratory test were not performed. At the time of reporting the patient status was reported as ongoing. The causality assessment between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician via Pfizer on 08-AUG-2016, referring to 3 patients of unknown age and gender. The patients' medical history and concurrent condition were not reported. In approximately 2006 (reported as ten years ago), the patients were vaccinated with ROTATEQ orally (dose, dose number and lot# were not reported), which caused intussusception. The outcome of intussusception was not reported. Upon internal review, intussusception was determined to be medical significant event. Additional information has been requested.