chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 10-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ with lot # M025568 and expiration date on 07-NOV-2017 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA002269: US-009507513-1706USA002268: US-009507513-1705USA011335: US-009507513-1706USA002267.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Injected limb mobility decreased, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging
Clinical narrative: Pain, burning, weakness, couldn't lift left arm or lay down (slept sitting up for 3 months). 2 Cortisone shots, 1 platelets injection, pain meds. and anti-inflammatory meds and therapy and HYDROGENIE. Still have problem dressing, sleeping, and carrying or lifting more than 5 lbs.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, X-ray
Clinical narrative: Pain, burning, weakness, couldn't lift left arm or lay down (slept sitting up for 3 months). 2 Cortisone shots, 1 platelets injection, pain meds. and anti-inflammatory meds and therapy and HYDROGENIE. Still have problem dressing, sleeping, and carrying or lifting more than 5 lbs.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Pt seen in office 6/02/17 for checkup. Rec'd (11-12yr) vaccines. Reports (LT) arm with mild redness and edema next day. (+) warmth noted. (+) pain on 6/4/17. Less at time of 6/5/17. F.U. OV. (3x3cm pink, SL. Raised/warm area (LT) arm. Tx with TYLENOL or Ibuprofen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Large red localized reaction, right thigh.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Electromyogram normal, Eye pain, Headache, Hyperhidrosis
Clinical narrative: Sometime in the early summer of '99 he began experiencing light-related eye pain and new onset headaches. He remembers headaches which were sharp pains behind the eyes 2-3x/week and severe migraines intermittently. He sought treatment at the clinic and was given Ibuprofen, which he took frequently without significant alleviation of symptoms. He reports he had to "push through the pain" regardless of his training and often tried to rest and use cold compresses on his forehead to alleviate the symptoms. He remembers with each anthrax vaccination he would have an exacerbation of the intensity and duration of headaches for a few days. He always linked his headaches to the anthrax vaccine because he never had significant headaches before, had sustained no head injuries and had no family history of migraines. Symptoms: Vascular headache, rash and oth nonspec skin eruption, generalized hyperhidrosis, unspecified abdominal pain, unsp symp and sign involve ner sysm.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Photophobia, Rash
Clinical narrative: Sometime in the early summer of '99 he began experiencing light-related eye pain and new onset headaches. He remembers headaches which were sharp pains behind the eyes 2-3x/week and severe migraines intermittently. He sought treatment at the clinic and was given Ibuprofen, which he took frequently without significant alleviation of symptoms. He reports he had to "push through the pain" regardless of his training and often tried to rest and use cold compresses on his forehead to alleviate the symptoms. He remembers with each anthrax vaccination he would have an exacerbation of the intensity and duration of headaches for a few days. He always linked his headaches to the anthrax vaccine because he never had significant headaches before, had sustained no head injuries and had no family history of migraines. Symptoms: Vascular headache, rash and oth nonspec skin eruption, generalized hyperhidrosis, unspecified abdominal pain, unsp symp and sign involve ner sysm.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Vascular headache
Clinical narrative: Sometime in the early summer of '99 he began experiencing light-related eye pain and new onset headaches. He remembers headaches which were sharp pains behind the eyes 2-3x/week and severe migraines intermittently. He sought treatment at the clinic and was given Ibuprofen, which he took frequently without significant alleviation of symptoms. He reports he had to "push through the pain" regardless of his training and often tried to rest and use cold compresses on his forehead to alleviate the symptoms. He remembers with each anthrax vaccination he would have an exacerbation of the intensity and duration of headaches for a few days. He always linked his headaches to the anthrax vaccine because he never had significant headaches before, had sustained no head injuries and had no family history of migraines. Symptoms: Vascular headache, rash and oth nonspec skin eruption, generalized hyperhidrosis, unspecified abdominal pain, unsp symp and sign involve ner sysm.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pts leg Rt swelled up to the size of a soft ball was red and hard, warm to touch around injection site.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Back pain, Confusional state, Flank pain, Injection site erythema, Injection site swelling
Clinical narrative: Child develop severe low back pain within several hours of first rabies imm. 16 hrs after imm. transient confusion LBPx2 days. 3rd shot within minutes developed flank and low back pain, nausea, penile pain lasted x24 hrs. 2nd shot-severe LBP and flank pain. Doubled him over lasted x24hrs. 3rd injection redness and swelling at injection site.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Penile pain
Clinical narrative: Child develop severe low back pain within several hours of first rabies imm. 16 hrs after imm. transient confusion LBPx2 days. 3rd shot within minutes developed flank and low back pain, nausea, penile pain lasted x24 hrs. 2nd shot-severe LBP and flank pain. Doubled him over lasted x24hrs. 3rd injection redness and swelling at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large amount of erythema, warmth, and tenderness surrounding injection site. Treated with cephalexin for cellulitis.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, HIBV, PNC13, RV1
Symptoms: Haematochezia, Pyrexia, Vomiting
Clinical narrative: Fever, emesis, hematochezia.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Blood culture negative, Culture stool negative, Haematochezia, Haematocrit normal
Clinical narrative: Fever, emesis, hematochezia.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haemoglobin normal, Leukocytosis, Platelet count normal, Polymerase chain reaction, Pyrexia
Clinical narrative: Fever, emesis, hematochezia.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rotavirus test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased, X-ray normal
Clinical narrative: Fever, emesis, hematochezia.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: RIGHT THIGH RED, SWOLLEN, 13MM KNOT ON THIGH, TEMP. 100.0 RECTALLY.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Blood glucose normal, Incoherent, Syncope
Clinical narrative: Syncopal episode, patient lowered to the floor, patient became coherent after approximately 20 seconds. Patient alert and oriented, BP and HR stable. EMS was called and arrived on scene to check VS and blood glucose, which were stable. Mother declined going to hospital as child was stable.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Culture stool negative, Full blood count normal, Haematochezia, Pyrexia, Vomiting
Clinical narrative: Fever, emesis, hematochezia.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Haematochezia, Pyrexia, Vomiting
Clinical narrative: Fever, emesis, hematochezia.
Age: 28.0
Sex: F
Vaccine: MMR, PPV, TDAP
Symptoms: Anxiety, Dizziness, Feeling hot, Nausea, Pain in extremity
Clinical narrative: Patient felt pain in arm, nauseous, light headed, warm and anxious 2 hours after receiving vaccinations. Patient went to ER and was given lorazepam, Ibuprofen, and zofran during ER visit.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Rash generalised
Clinical narrative: PATIENT DEVELOPED GENERALZIED RASH, WAS ADMINISTERED STEROID INJECTION BY ORDERING PROVIDER.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site with "redness and feels hot" along with itching. Area involved is the size of a "fist".
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in May 2017 (reported as one month before the second dose), the patient was vaccinated with GARDASIL 9 (dose 1) (route, lot number and expiration date unknown) for prophylaxis. On 02-JUN-2017, the patient was vaccinated with GARDASIL 9 (dose 2) (route, lot number and expiration date unknown) for prophylaxis. The patient's second dose in the human papilloma virus (HPV) vaccine series with GARDASIL 9 was only 1 month (date unspecified) after she received her first dose of GARDASIL 9. Pharmacist stated that the second dose of GARDASIL 9 should have been administered two months after the first dose. 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 Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number M040267, expiration date 14-MAY-2018 (dose was not reported) for prophylaxis. The temperature reported was 33 grades Fahrenheit for 22 hours. It was not prior temperature excursion, and a data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002363: Original Case: 1706USA002271.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient states she developed a lump/redness below injection site along with redness.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Patient voices that she has developed a localized, raised rash at the injection site that runs from the top of her shoulder to the elbow, denies blistering, heat, or itching. Denies fever.
Age: 26.0
Sex: F
Vaccine: HEP, HPV9, MMR
Symptoms: Dizziness, Fall, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: After receiving 3 vaccines (ENGERIX, MMR II, and GARDASIL), the patient went to consultation window. She had received all these vaccines previously. She began to look pale and slouch over. I (pharmacist) asked if she was feeling alright. She replied, "I am okay" then passed out/fell backwards onto her buttocks then further onto her back. She quickly got back up and I helped her to a chair. She said she felt dizzy before passing out but that she felt fine now. She drank some water and then felt she was able to go. She did not require medical attention.
Age: 89.0
Sex: M
Vaccine: FLU4, PNC, VARZOS
Symptoms: Asthenia, Cough, Gait disturbance, Malaise, Productive cough
Clinical narrative: As per daughter, client developed heavy phlegm, cough and frequent fevers of 99.6 degrees. On December 8, 2016 he was taken to MD because he was very weak and had difficulty walking. As per daughter client continues to be ill with all previously mentioned symptoms.
Age: 89.0
Sex: M
Vaccine: FLU4, PNC, VARZOS
Symptoms: Pyrexia
Clinical narrative: As per daughter, client developed heavy phlegm, cough and frequent fevers of 99.6 degrees. On December 8, 2016 he was taken to MD because he was very weak and had difficulty walking. As per daughter client continues to be ill with all previously mentioned symptoms.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event
Clinical narrative: Vaccine was administered time and date above, but there were No adverse Events.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Had MMR and chickenpox vaccine on Feb 20. On Feb 27 had PCV13 vaccine. Same evening had fever of 106. Used ibuprofen in combination with tylenol to lower temperature. Fever lasted 3 days. Would go down in the morning but would come back at night.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling, Swelling, Tenderness
Clinical narrative: Warmth, erythema, mild swelling, sore to touch beginning 4 hrs after vaccination. Following day, reports minor swelling around deltoid, erythema, sore to touch. Denies fever or other myalgias.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Fatigue, Local reaction, Swelling
Clinical narrative: Localized reaction, redness, swelling, fatigue from ZOSTAVAX.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling, pain left elbow to left wrist.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Migraine
Clinical narrative: Patient stated 15 hrs after vaccine was given that he was experiencing a migraine and chills.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, discomfort at injection site.
Age: 18.0
Sex: M
Vaccine: DTAP, HPVX
Symptoms: Dizziness, Dyskinesia, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Immediately after injection patient stated sharp pain and lightheaded. Was laid back on table and patient fainted and had jerking movements in arms/legs lasting about a minute. Patient came to and didn't know what had happened. Told to stay laying down and ice pack placed behind neck. After 15 minutes sat up slowly and given water after 5 minutes helped to standing, patient stated feeling better. Slight dizziness remained for around 15 minutes. Normal arm soreness also reported.
Age: 18.0
Sex: M
Vaccine: DTAP, HPVX
Symptoms: Syncope
Clinical narrative: Immediately after injection patient stated sharp pain and lightheaded. Was laid back on table and patient fainted and had jerking movements in arms/legs lasting about a minute. Patient came to and didn't know what had happened. Told to stay laying down and ice pack placed behind neck. After 15 minutes sat up slowly and given water after 5 minutes helped to standing, patient stated feeling better. Slight dizziness remained for around 15 minutes. Normal arm soreness also reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swollen, red, and itching arm. Blisters present. Patient is using Bendaryl.
Age: 0.08
Sex: M
Vaccine: MENB
Symptoms: Somnolence
Clinical narrative: Drowsy, possible jaundice.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Cough, Laryngitis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Congestion, cough, severe sore throat (sharp,stabbing pain), laryngitis (lost voice completely for 3 days). Had to take a Medrol(steroid)dose pack for a week to get over pain & inflammation in throat & larnyx.
Age: 19.0
Sex: M
Vaccine: HEP, MMR, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted while waiting in line to pay for vaccinations.
Sex: F
Vaccine: MENB
Symptoms: Crying, Injection site pain, Malaise
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, feeling unwell and crying. On an unknown date, the outcome of the injection site pain, feeling unwell and crying were recovered/resolved. The reporter considered the injection site pain, feeling unwell and crying to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was not reported previously to anyone. The injection site pain was severe and made the patient cry. The patient required emergency room visit. The patient needed to be seen in the doctor's office. The physician recommended observation and if the events did not resolve the patient was asked to return. At the time of reporting, the patient did not come back to the office. The field representative had limited information.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSER, the patient experienced pain and fainting. On an unknown date, the outcome of the pain and fainting were unknown. It was unknown if the reporter considered the pain and fainting to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. Medical liaison reported that she had a "matrix connect call" with a physician and a local representative. The physician said that one of their patient's fainted after receiving BEXSERO because of the pain. The physician did not clarify what the pain was. The medical liaison attempted to collect details and the physician said that they needed permission from the patient to answer additional questions and declined answering questions. The physician said that she did not want to report even through the medical liaison. That the physician would get permission from the patient and then report it. It was possible that the physician would send an additional report about this case.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 20-year-old female patient who received BEXSERO (batch number 166701, expiry date May 2018). The patient's past medical history included exposure to communicable disease (the patient's mother had meningitis in the past and the patient may have been exposed to it and developed antibodies which may have contributed to the reaction). Concurrent medical conditions included allergic reaction to antibiotics (caused nausea and vomiting). On 9th May 2017, the patient received the 1st dose of BEXSERO (intramuscular). On 9th May 2017, several hours after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb and injection site vesicles. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site vesicles were not recovered/not resolved. Additional details provided as follows: The patient received vaccination with BEXSERO on left deltoid, later in the evening after several hours she developed raised reaction with vesicles on the left deltoid. The raised reaction with vesicles was 10 by 8 cm in size. The physician was unaware of the time of the reaction or how long had transpired since the administration of vaccine to the start of the reaction. The physician did not know what type of meningitis the mother had.
Sex: U
Vaccine: MENB
Symptoms: Adverse event, Laboratory test normal, Musculoskeletal stiffness, Pyrexia, Somnolence
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of stiff neck in a adolescent patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 2nd dose of BEXSERO .5 ml. On an unknown date several weeks after receiving BEXSERO and BEXSERO, the patient experienced stiff neck, fever, drowsiness and adverse event. On an unknown date, the outcome of the stiff neck and drowsiness were recovered/resolved and the outcome of the fever was not recovered/not resolved and the outcome of the adverse event was unknown. It was unknown if the reporter considered the stiff neck, fever, drowsiness and adverse event to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced side effects after 1st dose or 2nd dose of BEXSERO. The healthcare professional was concerned that the side effects resembled symptoms of the disease so the patient was referred to the hospital to have lab work and the lab work came back and everything was negative. The healthcare professional also reported that several side effects occurred approximately 16 days after the vaccine was administered.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received BOOSTRIX (batch number J2NH5, expiry date 11th May 2018). On 1st May 2017, the patient received BOOSTRIX .5 ml. On 1st May 2017, immediately after receiving BOOSTRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unchanged. It was unknown if the reporter considered the injection site swelling to be related to BOOSTRIX. Additional details were provided as follows: The nurse stated that it had been 10 days post-vaccination and the swelling had not resolved.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Peripheral swelling, Pruritus, Rash, Vaccination site discharge
Clinical narrative: This case was reported by a consumer call via call center representative and described the occurrence of allergic reaction in a 71-year-old female patient who received BOOSTRIX (batch number 3457Y, expiry date 20th May 2019). The patient's past medical history included Lyme disease. Concurrent medication conditions included penicillin allergy, allergic reaction to antibiotics (in 2002) and allergic reaction to analgesics. Concomitant products included atorvastatin, BENICAR, CYMBALTA, metformin, TRAVATIN Z and Aspirin (Baby).  On 28th April 2017 13:00, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 8th May 2017, 10 days after receiving BOOSTRIX, the patient experienced allergic reaction, pruritus, swelling arm, rash and vaccination site discharge. The patient was treated with prednisone. On an unknown date, the outcome of the allergic reaction, pruritus, swelling arm, rash and vaccination site discharge were not recovered/not resolved. The reporter considered the allergic reaction, pruritus, swelling arm, rash and vaccination site discharge to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The patient had no previous reactions to vaccines and no rubber or latex allergies. The patient received BOOSTRIX in his left arm. The patient went to visit her daughter out of town. Within 10 days of receiving the vaccine, the patient had a rash with some oozing spots. The patient required an emergency room visit. The patient went to a walk-in clinic and was prescribed prednisone and anti-itch and a cream. The condition was improving, but on the day of reporting there was some new spots. The home where the patient was visiting had new bedding, but the patient felt that the vaccine was the cause of the rash. The patient was returning home next day of reporting and would consult with her primary physician.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site discoloration in a 5-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018. On 15th April 2017, the patient received KINRIX .5 ml. On 15th April 2017, immediately after receiving KINRIX, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved. The reporter considered the injection site discoloration to be almost certainly related to KINRIX. Additional details were provided as follows: The case was reported by nurse practitioner student. The patient received KINRIX in the left deltoid and a few seconds after vaccination (immediately) experienced discoloration at injection site. The discoloration had lasted for a month and the patient's parent said that the discoloration was becoming more prevalent.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 5-year-old male patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). On 29th March 2017, the patient received KINRIX (subcutaneous). On 29th march 2017, unknown after receiving KINRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were reported as follows: A dose of KINRIX was inadvertently administered subcutaneously, which led to Incorrect route of drug administration. No further information was available or reported regarding the event. Follow up information was received from the physician via call center representative on 9th May 2017: The patient demographics were updated. It was reported that the patient received KINRIX as 5th DTaP and 4th IPV. It was reported that the vaccine documented was given as intramuscular to right deltoid. The patient returned two days later with localized injection site reaction with no permanent harm along posterior right humeral region and looks to had been given subcutaneous rather than intramuscular. The symptoms included localized redness, warmth, mild itching and some tenderness. No systemic symptoms were reported. The VAERS details were updated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site warmth, Local reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 5-year-old male patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). On 29th March 2017, the patient received KINRIX (subcutaneous). On 29th march 2017, unknown after receiving KINRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were reported as follows: A dose of KINRIX was inadvertently administered subcutaneously, which led to Incorrect route of drug administration. No further information was available or reported regarding the event. Follow up information was received from the physician via call center representative on 9th May 2017: The patient demographics were updated. It was reported that the patient received KINRIX as 5th DTaP and 4th IPV. It was reported that the vaccine documented was given as intramuscular to right deltoid. The patient returned two days later with localized injection site reaction with no permanent harm along posterior right humeral region and looks to had been given subcutaneous rather than intramuscular. The symptoms included localized redness, warmth, mild itching and some tenderness. No systemic symptoms were reported. The VAERS details were updated.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a 17-year-old female patient who received BEXSERO. On 20th March 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. The reporter considered the pain to be probably related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. Concomitant medications were unknown. The patient received BEXSERO on right arm. The patient experienced 4 weeks of pain. The patient received the 2nd dose of BEXSERO on 17th May 2017. No other vaccines were administered. This case was linked to case US2017073554, reported by the same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Injection site bruising, Rash generalised
Clinical narrative: Administered the vaccine on 5/24/17. Patient called me today: 6/6/17, stating that she has rash all over her body from last Friday 6/2/17. Also bruised at injection site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Loss of consciousness, Muscle twitching, Nausea, Syncope
Clinical narrative: Patient received vaccines at his well child visit. About 1-2 minutes after receiving the last vaccine, patient fainted. The MA assisted patient to a supine position on the exam room table and noticed some brief twitching just after the patient lost consciousness. Patient woke up after about 30-60 seconds. He was confused and nauseated. He has emesis x 1. We continued to assess patient's condition and monitor vital signs for the next 30 minutes. When patient returned to baseline he was sent home with his mother.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Patient received vaccines at his well child visit. About 1-2 minutes after receiving the last vaccine, patient fainted. The MA assisted patient to a supine position on the exam room table and noticed some brief twitching just after the patient lost consciousness. Patient woke up after about 30-60 seconds. He was confused and nauseated. He has emesis x 1. We continued to assess patient's condition and monitor vital signs for the next 30 minutes. When patient returned to baseline he was sent home with his mother.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms after pt. was administered extra dose of VARIVAX. Pt. received 2 previous doses on 10-16-17 and 5-16-08.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt. developed redness and warmth at injection site. Pt visited Doctor who prescribed antibiotic as precaution. Pt notified Pharmacist when picking up Rx.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction, redness, rash around injection site, raised, itchy.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Visual impairment, Vomiting
Clinical narrative: On morning of 6/6/17 while at school, pt. saw "colorful blasts" and then felt lightheaded. Headache then "wrapped around the front" of her head. Ice pack applied which helped and vision. TYLENOL administered by school nurse. Felt better but did vomit x1 around 11:30am. Now, in office at 3:00pm, patient feels "fine",
Age: 68.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Arthralgia, Rash, Rash maculo-papular
Clinical narrative: Pt received vaccine on 5/24/17. The next day maculopapular rash on face and trunk. Face was worse on (L) side. Also with arthralgia's. No fever.
Age: 8.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received via medical records from a licensed practical nurse and refers to an 8 year old White male patient (one of 3 siblings). Information on the patient's concurrent conditions was not reported. The patient's historical drugs included: poliovirus vaccine inactivated (unspecified), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, Hepatitis B Vaccine (Recombinant) (manufacturer unknown), varicella virus vaccine live (Oka/Merck) (manufacturer unknown), PEDIARIX, Hib conj vaccine (tet toxoid), PENTACEL, Hib conj vaccine (unspecified carrier), HPV vaccine (unspecified) (manufacturer unknown), influenza virus vaccine (unspecified), M-M-R II, meningococcal conj vaccine (unspecified), PNEUMOVAX 23, Rotavirus Vaccine, Live, Oral, Pentavalent (manufacturer unknown), VARIVAX and ZOSTAVAX (captured in MARRS# 1706USA002758). On 31-AUG-2016, the patient was vaccinated with a first dose of VAQTA (lot # L043209, expiration date 17-SEP-2017, intramuscularly in the right deltoid), which was stored improperly. The data logger was involved, prior temperature excursion reported: in July 2016 (1 Celsius degree for 69 hours 30 minutes) and in March 2017 (10 Celsius degree for 77 hours 41 minutes). No adverse effects were reported. Concomitant vaccines included poliovirus vaccine inactivated (unspecified), M-M-R II, diphtheria toxoid, pertussis acellular vaccine (unspecified), VARIVAX and RECOMBIVAX HB; all administered on 31-AUG-2016. This is one of 3 reports concerning 1 of 3 siblings. Additional information is not expected as all follow-up information has been received. All available medical records will be provided upon request. Sender's Comments:  US-009507513-1705USA009102: US-009507513-1704USA001524: US-009507513-1706USA002758:
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Arthralgia, Axillary pain, Back pain, Burning sensation, Chills
Clinical narrative: This spontaneous report was received from a physician and refers to a 52-year-old female patient. The patient's concurrent conditions included breast cancer and basal cell skin carcinoma. The patient had no known drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N003997 (in the arm, dose and expiration date were not reported). On the same day, the patient was also vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot # 7Z9Z5 and expiry date were not reported) in the same arm as PNEUMOVAX 23, however at a different injection site. Concomitant therapies included NEURONTIN. On 02-MAY-2017, after receiving the suspect vaccines, the patient experienced serum sickness including fever, diffuse rash, body aches, white blood cell changes and thrombocytopenia. The patient sought medical attention via a physician office visit on an unknown date, in May 2017. The white blood cell changes and thrombocytopenia were the results of complete blood count test performed on an unknown date, in May 2017. The patient had also comprehensive metabolic panel performed but no results were provided. The patient had a complete blood count and comprehensive metabolic panel performed, however the results were not provided. The patient recovered from the event on an unknown date in May 2017. The relatedness between the suspect vaccines and the event were not reported. The event was considered to be disabling, because the patient missed work for one week. Upon internal review, the event of serum sickness was considered to be medically significant, as the symptoms included thrombocytopenia. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Fatigue, Feeling hot, Full blood count, Headache, Injection site erythema
Clinical narrative: This spontaneous report was received from a physician and refers to a 52-year-old female patient. The patient's concurrent conditions included breast cancer and basal cell skin carcinoma. The patient had no known drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N003997 (in the arm, dose and expiration date were not reported). On the same day, the patient was also vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot # 7Z9Z5 and expiry date were not reported) in the same arm as PNEUMOVAX 23, however at a different injection site. Concomitant therapies included NEURONTIN. On 02-MAY-2017, after receiving the suspect vaccines, the patient experienced serum sickness including fever, diffuse rash, body aches, white blood cell changes and thrombocytopenia. The patient sought medical attention via a physician office visit on an unknown date, in May 2017. The white blood cell changes and thrombocytopenia were the results of complete blood count test performed on an unknown date, in May 2017. The patient had also comprehensive metabolic panel performed but no results were provided. The patient had a complete blood count and comprehensive metabolic panel performed, however the results were not provided. The patient recovered from the event on an unknown date in May 2017. The relatedness between the suspect vaccines and the event were not reported. The event was considered to be disabling, because the patient missed work for one week. Upon internal review, the event of serum sickness was considered to be medically significant, as the symptoms included thrombocytopenia. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site induration, Joint swelling, Metabolic function test, Neuralgia, Pyrexia
Clinical narrative: This spontaneous report was received from a physician and refers to a 52-year-old female patient. The patient's concurrent conditions included breast cancer and basal cell skin carcinoma. The patient had no known drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N003997 (in the arm, dose and expiration date were not reported). On the same day, the patient was also vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot # 7Z9Z5 and expiry date were not reported) in the same arm as PNEUMOVAX 23, however at a different injection site. Concomitant therapies included NEURONTIN. On 02-MAY-2017, after receiving the suspect vaccines, the patient experienced serum sickness including fever, diffuse rash, body aches, white blood cell changes and thrombocytopenia. The patient sought medical attention via a physician office visit on an unknown date, in May 2017. The white blood cell changes and thrombocytopenia were the results of complete blood count test performed on an unknown date, in May 2017. The patient had also comprehensive metabolic panel performed but no results were provided. The patient had a complete blood count and comprehensive metabolic panel performed, however the results were not provided. The patient recovered from the event on an unknown date in May 2017. The relatedness between the suspect vaccines and the event were not reported. The event was considered to be disabling, because the patient missed work for one week. Upon internal review, the event of serum sickness was considered to be medically significant, as the symptoms included thrombocytopenia. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Rash, Sleep disorder
Clinical narrative: This spontaneous report was received from a physician and refers to a 52-year-old female patient. The patient's concurrent conditions included breast cancer and basal cell skin carcinoma. The patient had no known drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N003997 (in the arm, dose and expiration date were not reported). On the same day, the patient was also vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot # 7Z9Z5 and expiry date were not reported) in the same arm as PNEUMOVAX 23, however at a different injection site. Concomitant therapies included NEURONTIN. On 02-MAY-2017, after receiving the suspect vaccines, the patient experienced serum sickness including fever, diffuse rash, body aches, white blood cell changes and thrombocytopenia. The patient sought medical attention via a physician office visit on an unknown date, in May 2017. The white blood cell changes and thrombocytopenia were the results of complete blood count test performed on an unknown date, in May 2017. The patient had also comprehensive metabolic panel performed but no results were provided. The patient had a complete blood count and comprehensive metabolic panel performed, however the results were not provided. The patient recovered from the event on an unknown date in May 2017. The relatedness between the suspect vaccines and the event were not reported. The event was considered to be disabling, because the patient missed work for one week. Upon internal review, the event of serum sickness was considered to be medically significant, as the symptoms included thrombocytopenia. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Full blood count, Impaired work ability, Metabolic function test, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician and refers to a 52-year-old female patient. The patient's concurrent conditions included breast cancer and basal cell skin carcinoma. The patient had no known drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N003997 (in the arm, dose and expiration date were not reported). On the same day, the patient was also vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot # 7Z9Z5 and expiry date were not reported) in the same arm as PNEUMOVAX 23, however at a different injection site. Concomitant therapies included NEURONTIN. On 02-MAY-2017, after receiving the suspect vaccines, the patient experienced serum sickness including fever, diffuse rash, body aches, white blood cell changes and thrombocytopenia. The patient sought medical attention via a physician office visit on an unknown date, in May 2017. The white blood cell changes and thrombocytopenia were the results of complete blood count test performed on an unknown date, in May 2017. The patient had also comprehensive metabolic panel performed but no results were provided. The patient had a complete blood count and comprehensive metabolic panel performed, however the results were not provided. The patient recovered from the event on an unknown date in May 2017. The relatedness between the suspect vaccines and the event were not reported. The event was considered to be disabling, because the patient missed work for one week. Upon internal review, the event of serum sickness was considered to be medically significant, as the symptoms included thrombocytopenia. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Rash, Serum sickness, Thrombocytopenia, White blood cell disorder
Clinical narrative: This spontaneous report was received from a physician and refers to a 52-year-old female patient. The patient's concurrent conditions included breast cancer and basal cell skin carcinoma. The patient had no known drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N003997 (in the arm, dose and expiration date were not reported). On the same day, the patient was also vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot # 7Z9Z5 and expiry date were not reported) in the same arm as PNEUMOVAX 23, however at a different injection site. Concomitant therapies included NEURONTIN. On 02-MAY-2017, after receiving the suspect vaccines, the patient experienced serum sickness including fever, diffuse rash, body aches, white blood cell changes and thrombocytopenia. The patient sought medical attention via a physician office visit on an unknown date, in May 2017. The white blood cell changes and thrombocytopenia were the results of complete blood count test performed on an unknown date, in May 2017. The patient had also comprehensive metabolic panel performed but no results were provided. The patient had a complete blood count and comprehensive metabolic panel performed, however the results were not provided. The patient recovered from the event on an unknown date in May 2017. The relatedness between the suspect vaccines and the event were not reported. The event was considered to be disabling, because the patient missed work for one week. Upon internal review, the event of serum sickness was considered to be medically significant, as the symptoms included thrombocytopenia. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in 5-year-old male patient who received KINRIX (batch number C5222AA ?, expiry date 20th June 2019) (GSK note: The reported lot number did not match any GSK lot number). Concomitant products included PROQUAD and VAQTA. On 11th May 2017, the patient received KINRIX (intramuscular) .5 ml. In May 2017, less a week after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. In May 2017, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. The reporter considered the extensive swelling vaccinated limb injection site erythema to be almost certainly related to KINRIX. Additional details were provided as follows: The patient's concomitant medication included multivitamin. On 11th May 2017, the patient received 2nd dose of subcutaneous PROQUAD vaccine (batch number M041507, expiry date 9th April 2018) in the right thigh and 3rd dose of intramuscular VAQTA vaccine (batch number M047658, expiry date 28th October 2017) in right thigh. The medical assistant reported that the patient received KINRIX in the left thigh as 5th DTaP and 4th Polio vaccine. Over the weekend, the patient's mother reported that the patient had swelling and redness in the left thigh starting 1 in above the knee and going up through the groin area. The patient's mother reported it was 5 to 7 inches in diameter. The reaction resolved before the patient could be seen at the office.