chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Pyrexia, Rash, Rash erythematous, Respiratory tract congestion
Clinical narrative: At initial onset mild fever and chest congestion. Next two days were filled with trouble breathing, clear runny nose and fever in the 103 range. Small red bumps started to appear on trunk. On 7/4/16 the fever was in the 104 range, bumps were all over trunk, forehead and thighs.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea, Streptococcus test negative
Clinical narrative: At initial onset mild fever and chest congestion. Next two days were filled with trouble breathing, clear runny nose and fever in the 103 range. Small red bumps started to appear on trunk. On 7/4/16 the fever was in the 104 range, bumps were all over trunk, forehead and thighs.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Migraine, Neck pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of neck pain in a female patient who received BEXSERO. Concomitant products included HAVRIX pediatric. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced neck pain (serious criteria other: as per reporter) and migraine (serious criteria other: as per reporter). On an unknown date, the outcome of the neck pain and migraine were unknown. The reporter considered the neck pain and migraine to be almost certainly related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The physician stated about two female patient that after being administered BEXSERO vaccine, they ended up in the emergency room. Both the patients experienced with severe neck pain and one of the patients had as migraine as well. This case concerned the patient who had experienced severe neck pain and migraine after vaccination. The sales representative had extremely limited information. One female patient was 18 years old and the other female patient was 16 years old. One of the patients were administered HAVRIX with BEXSERO, but the sales representative did not know which patient.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Bacterial test positive, Blood glucose increased, Blood ketone body increased, Diabetes mellitus inadequate control
Clinical narrative: Initial unsolicited report received from a consumer (patient parent) on 23 August 2016. This case involves a 18 -year-old female patient who was vaccinated with a third dose of MENACTRA (batch number, expiry date was not reported) by intramuscularly in right deltoid on 12 August 2016. The patient had previously received Claritin 10mg, olanzapine 10mg and medical history of Type 1 diabetes, LANTUS and humulin Insulin and Hx of head/brain injury March 18 2016. Concomitant medications were not reported. On 18 August 2016, six day following the vaccination, the patient blood sugars went out of control 800-900 with elevated ketones. It was reported that, on an unspecified date the patient has been taken to emergency departments multiple times. The patient required ER. Laboratory investigations included urine culture showed trace of bacteria. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event and released from the emergency department. Upon internal review the case was considered as serious because of important medical event blood sugars went out of control 800-900 with elevated ketones. List of documents held by sender: none. Sender's Comments: This case concerns a 18 years old female with known history of type 1 diabetes, who experienced blood sugars went out of control 800-900 with elevated ketones 5 days after vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is compatible with role of vaccine. However increase of sugar level can be due to many reason as patient is known case of diabetes type 1. Details regarding patients relevant medical history, about life style, patient diets, past vaccination history and tolerance are needed for complete assessment of the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Retinal haemorrhage, Vision blurred
Clinical narrative: Initial unsolicited report received from a consumer on 23 August 2016. This case involves a 67-year-old female patient who was vaccinated with dose of FLUZONE HD (batch number: UI620AB, expiry date: 14-MAR-2017), intramuscularly in the left deltoid on 21 August 2016 in the am (morning). The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as nkda (no known drug allergy), HTN (hypertension). Illness at time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within 4 weeks of vaccinations was not reported. On 21 August 2016, few hours following the vaccination in the evening, the patient had blurred vision, who was seen by an eye doctor and diagnosed bleeding behind the retina. Relevant diagnostic tests/laboratory data was not provided. The patient's corrective treatment was not reported. The patient had not recovered from the event. Upon medical review, the case was considered as serious due to important medical event: bleeding behind the retina. The patient required ER/doctor visit. List of documents held by sender: none. Sender's Comments: Bleeding behind the retina is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Asthma
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016389690) on 23-Aug-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed asthma (allergy to Fluzone). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: Initial unsolicited report received from a pharmacist on 24 August 2016. This case involves a 44-year-old female patient who was vaccinated with a first dose of ADACEL batch number: U5318AA, (expiry date: 28-Apr-2018, dose, dose in series, route of administration were not reported), in the left deltoid on 06 August 2016. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions as none. Patient's medical history was reported as none and concomitant medications were not reported. Any other vaccinations within 4 weeks of vaccinations was reported as none. On 22 August 2016, sixteen days following the vaccination, the patient developed palpable lump in her left deltoid at the injection site. It's not warm discolored or painful. Lab data was reported as none and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Brain injury, Encephalopathy, Learning disability, Loss of consciousness
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) via social media on 22 August 2016. This case is linked with case 2016SA157319 and 2016SA157340 (same social medica report). This case involves a 30-month-old (reported as 2 and half year old) male patient who was vaccinated with a fourth dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT) (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, within 6 hours of receiving the shot, patient went into a state of developed encephalopathy and then became unconscious. It was reported that patient was a gifted child, he was speaking full sentences, knew his alphabet and numbers. After receiving the shot he did not. On an unspecified date, patient developed multiple learning disabilities and had permanent brain damage. Laboratory investigations and corrective treatment were not reported. The outcomes of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical events encephalopathy, unconscious, multiple learning disabilities and permanent brain damage. List of documents held by sender: none. Sender's Comments: This is very poorly documented social medical case where patient had encephalopathy, unconscious, multiple learning disabilities and permanent brain damage after administration of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Unknown manufacturer). However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Activities of daily living impaired, Dizziness, Erythema, Feeling abnormal, Headache
Clinical narrative: Patient felt lightheaded immediately after vaccines received.  Color of skin was pale.  Patient was accompanied by mother and they waited in the waiting room for a few minutes before leaving.  Mother reports son said "I don't feel right and was nauseous" returned to school and reported a headache and some dizziness. Vomited once before 6 pm, but still went to work.  He worked a 3 hour shift and vomited a couple of times while at work.  Came home and skipped supper and went to bed.  Mom states he vomited off and on throughout the night.  Stayed home from school the following day.  Redness and a bump under the skin on right arm.  No more vomiting at this time.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Immediate post-injection reaction, Nausea, Pallor, Upper extremity mass, Vomiting
Clinical narrative: Patient felt lightheaded immediately after vaccines received.  Color of skin was pale.  Patient was accompanied by mother and they waited in the waiting room for a few minutes before leaving.  Mother reports son said "I don't feel right and was nauseous" returned to school and reported a headache and some dizziness. Vomited once before 6 pm, but still went to work.  He worked a 3 hour shift and vomited a couple of times while at work.  Came home and skipped supper and went to bed.  Mom states he vomited off and on throughout the night.  Stayed home from school the following day.  Redness and a bump under the skin on right arm.  No more vomiting at this time.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: "Violently ill". chills, aches, fever.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nausea, Vomiting
Clinical narrative: Child reported feeling nauseated and had episode of vomiting on 8/25/16 in the AM (the morning following vaccination). Reported redness, warmth and pain at injection site. Symptoms self resolved and child presented to clinic on 8/29/16 for follow up and evaluation. Did not contact clinic prior to this date for evaluation of vaccine side effect/reaction.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in extremities.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever up to 102 and hives for 2 days.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired vaccine TRUMENBA tolerate well no reaction.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Insomnia, Nausea
Clinical narrative: Pt experienced swelling (baseball sized) redness spreading from injection site (left shoulder), sleeplessness, nausea, the night of receiving Pneumovax 23 and Fluzone HD...pt took ibuprofen 8/30/16 which relieved swelling but redness remains over entire shoulder area as of 8/31/16 AM, also takes daily Claritin.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Nasal congestion, Nausea, Pyrexia, Skin warm
Clinical narrative: Patient described swelling in nasal passages shortly after receiving vaccine, which made it hard to breathe. He then started to feel warm in his head and upper chest with continued shortness of breath. Later that evening he felt nauseous but was not able to vomit. He checked his temperature and had a slight fever this morning. He called the poison control center that evening but they did not instruct him to take any action.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on left deltoid area.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Seizure, Syncope, Vomiting
Clinical narrative: Fainting seizure severe vomiting.
Age: 31.0
Sex: F
Vaccine: DTP
Symptoms: Diarrhoea, Dyspnoea, Headache, Nasal congestion, Sinus headache
Clinical narrative: Headache, severe and repeated diarrhea, vomiting, burning sinuses clogging the nose making it difficult to breathe.
Age: 31.0
Sex: F
Vaccine: DTP
Symptoms: Vomiting
Clinical narrative: Headache, severe and repeated diarrhea, vomiting, burning sinuses clogging the nose making it difficult to breathe.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV
Symptoms: Crying, Lethargy, Pain, Vomiting
Clinical narrative: Pain, crying, vomiting, lethargy.
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Laboratory test, Muscular weakness, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old female patient. The patient's concurrent conditions included dementia Alzheimer's type, aphasia, anxiety, libido decreased, depression, micturition urgency, cough and seasonal allergy. The patient's medical history included biopsy thyroid gland and colloid brain cyst. The patient was enrolled in the clinical trial (captured in MARRS # 1608USA014647). On 15-AUG-2016, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, route, lot # and expiration date were not reported). Concomitant therapies included montelukast (manufacturer unknown) and IOPHEN C NR. On 16-AUG-2016 (reported as the following morning), she developed a high fever, low blood pressure and muscle weakness and was brought into the hospital, the events were considered to be severe shingles vaccine adverse reaction. The patient was treated for fever, hypotension and generalized muscle weakness. She was tested for tick born infections (results unspecified) and was given intravenous (IV) fluids overnight. The patient felt at baseline following one overnight in the hospital. Her vital signs were stable. She was instructed to follow up with her primary care physician within one week of discharge. On 17-AUG-2016, the patient recovered from the events. The reporter considered pyrexia, muscular weakness and hypotension to be related to Zoster Vaccine Live (manufacturer unknown). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Cyanosis, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Numbness, pain and blue left arm. (L) deltoid presents with paresthesia, hyperemia, numbness down entire arm. Today 8/25/16 has numbness from elbow to hand.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Numbness, pain and blue left arm. (L) deltoid presents with paresthesia, hyperemia, numbness down entire arm. Today 8/25/16 has numbness from elbow to hand.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Occult blood, Vomiting
Clinical narrative: Bloody stools, diarrhea, vomiting 4-5x a day.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever up to 105, body aches.  Tylenol helped.  Vaccine given on Saturday, pt feeling better by Monday.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Large rash on injection site, approx 3" x 5", itchy left deltoid.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Influenza like illness, Injection site erythema, Injection site reaction
Clinical narrative: 24 hours following injection, experienced two welts- one at injection site, once below injection site. Described affected areas as red, swollen, warm to the touch and tight-feeling. Also described flu-like symptoms following injection: fatigue, cough, sneezing.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Sneezing, Urticaria
Clinical narrative: 24 hours following injection, experienced two welts- one at injection site, once below injection site. Described affected areas as red, swollen, warm to the touch and tight-feeling. Also described flu-like symptoms following injection: fatigue, cough, sneezing.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Arm swelling, itching, pain at injection site.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Pyrexia, Throat irritation
Clinical narrative: After 10 min sitting checked on pt who stated throat felt tight and itchy. At that time assessed the patient's breathing and gave option of Epi. Pt refused stating she could still breathe and offered oral diphenhydramine to pt at that time, after which we would reassess need for epi. Pt took 50mg diphenhydramine w/water at 4:51 pm. Checked BP 114/80 mmHg. Stated nervous about getting vaccine when given shot. Pt monitored and started feeling better, after taking diphenhydramine monitored regularly. Pt left at 5:25 pm stating felt ok to go home (walking). Pt came into store 8/19 stating fever, chills, diarrhea. 8/20 stated headache x 3 days.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: After 10 min sitting checked on pt who stated throat felt tight and itchy. At that time assessed the patient's breathing and gave option of Epi. Pt refused stating she could still breathe and offered oral diphenhydramine to pt at that time, after which we would reassess need for epi. Pt took 50mg diphenhydramine w/water at 4:51 pm. Checked BP 114/80 mmHg. Stated nervous about getting vaccine when given shot. Pt monitored and started feeling better, after taking diphenhydramine monitored regularly. Pt left at 5:25 pm stating felt ok to go home (walking). Pt came into store 8/19 stating fever, chills, diarrhea. 8/20 stated headache x 3 days.
Age: 18.0
Sex: F
Vaccine: FLU3, MMR, MNQ
Symptoms: Blood pressure decreased, Presyncope, Syncope
Clinical narrative: Pt fainted (vagal response) after receiving the 3rd shot. She had a drop in BP 55/35 and paramedics were called. Pt refused transport but followed up w/MD.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Insomnia, Tenderness
Clinical narrative: Could not sleep on at bedtime. Next day better but still tender. On 8/26 hot to touch and red circle golf ball size at injection site.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Bedridden, Chills, Fatigue, Grip strength decreased, Headache
Clinical narrative: FEVER; POUNDING HEADACHE (LIKE A MIGRAINE); TIREDNESS; NAUSEA; CHILLS; SEVERE BODY ACHES THROUGHOUT ARMS, LEGS, BACK, NECK AND MUSCLE WEAKNESS (ARMS AND LEGS).
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Nausea, Pain, Pyrexia
Clinical narrative: FEVER; POUNDING HEADACHE (LIKE A MIGRAINE); TIREDNESS; NAUSEA; CHILLS; SEVERE BODY ACHES THROUGHOUT ARMS, LEGS, BACK, NECK AND MUSCLE WEAKNESS (ARMS AND LEGS).
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Student received vaccine of Tdap in the morning.  Later in the day noticed swelling (40-50mm) and pain at site of Left Deltoid.  Returned to clinic on 8/25/16 with compaint of pain.  Swelling had abated but still slightly sore.  Saw Dr., prescribed acetaminophen and heat therapy. Patient stated that she felt better than she did several days before.  Policy is for students to return to clinic if they have any problems with vaccinations. Advised to come back if pain continues.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Rash and blisters developed on injection arm.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Exact time of onset unknown, above time it was reported to us by pt. Fever 101 and sore arm at site of injection day 1,  Fever 102 on day 2 with general body aches, slight swelling at injection site.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient developed a red bump at injection site approximately 2 inches in diameter. Patient has not developed any additional symptoms.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt reported to pharmacy.  She had red, raised swelling about the size of a softball on her arm. The pharmacist on duty told the pt to ice it and return if it did no resolve.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given Hep B Pediatric vaccine 2 weeks early.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Full body rash requiring steroids to resolve.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Neurological examination normal, Tinnitus
Clinical narrative: Headache and ringing ears.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Tinnitus
Clinical narrative: Headache and ringing ears.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Felt faint/dizzy.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, Skin discolouration
Clinical narrative: ~ 5 minutes after vaccination, became diaphoretic, c/o light headedness,skin color appeared grey.  States he hadn't eaten since breakfast (now 2:30 pm).  Had just been doing hard work outdoors in the heat.  Took water, raisins & crackers with relief. BP 130/80 after snack. Observed for 20 minutes.  Called at home at 5pm, "feeling fine" per mom.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Fever 100 F, abdominal pain, nausea, vomiting, and tremors. Diphenhydramine and famotidine.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV, PPV, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a double dose of IPV. Received Pediarix and IPV. No adverse reaction reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Culture cervix, Culture urine, Dysuria, Headache, Laboratory test
Clinical narrative: Pt went to bed with a headache and woke up the next AM with a 103 fever. Her vaginal area was really swollen and painful. She also had some dysuria.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Urine analysis, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: Pt went to bed with a headache and woke up the next AM with a 103 fever. Her vaginal area was really swollen and painful. She also had some dysuria.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Pruritus
Clinical narrative: 8.5cm x 8cm red, warm, swollen local reaction in left upper leg.  Non tender, slight itchy, no fever, nausea, vomiting, shortness of breath. Used childrens Benadryl and ice on the site.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph node.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal discomfort, Myalgia
Clinical narrative: Muscle pain discomfort started in legs/calves. Muscle aches moved up to upper body (arms/neck). Patient used a diclofenac 75mg tablet and that helped. He contacted dr who renewed medication on 8/29. He has been on this twice daily and feeling better at least 60-70% per patient. He uses diclofenac as needed for arthritis.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Diarrhoea, Injection site swelling, Myalgia
Clinical narrative: Diarrhea, muscle ache, chills, swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Fatigue, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Several hours after vaccine, pt was tired and lethargic. Next morning left upper arm /shoulder swollen and warm to the touch. 08/19/16 mom called and reported that swelling and warmth was gone and pt was back to himself.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Experienced slight soreness and swelling at site of injection on the day I received the first shot of the hpv vaccine (08/22/2016). The symptoms subsided on the same day, but I went on to develop significant pain and swelling (about 8.5 cm in length) at the injection site on 08/28/2016.  The swelling and soreness are still present as of 08/31/2016 albeit less than on 08/28.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Computerised tomogram abdomen, Diarrhoea, Enema administration, Intussusception, Vomiting
Clinical narrative: Vomiting, loose stools, found to have intussusception.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: X-ray
Clinical narrative: Vomiting, loose stools, found to have intussusception.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fatigue, Gait disturbance, Laboratory test, Mobility decreased, Nausea
Clinical narrative: Nausea, extreme vomiting, a few days later facial rash, extreme fatigue, inability to move head and legs, difficulty walking.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Rash, Vomiting
Clinical narrative: Nausea, extreme vomiting, a few days later facial rash, extreme fatigue, inability to move head and legs, difficulty walking.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced swelling, redness, and discomfort in a 2-3 inch radius oblong area on her left arm surrounding the injection site.  The area was inflammed and she stated it was sensitive to the touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed a red oblong mark near the injection site that was about 1.5in x 1in.  It does not itch, hurt, feel hot, and it is not raised.  She noticed this the next morning when she woke up.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: PATIENT WAS GIVEN VACCINE IN THE AM AND WAS IN THE ER LATER THAT AFTERNOON AS PATIENT DEVELOPED A SWOLLEN FACE, SOB, AND DEVELOPED HIVES. PATIENT WAS TREATED WITH STEROIDS AND BENADRYL.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Burning sensation, Hypoaesthesia, Neuralgia, Rash, Rash erythematous
Clinical narrative: Numbness in NON-vaccine arm that readiated to her neck/back. Red bumps (rash) that appears on the arms and burns, but then goes away. Very intense nerve pain.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal distension, Abdominal pain, Colitis ulcerative, Colonoscopy, Culture stool
Clinical narrative: Blood and mucus from rectum, abdominal cramping, bloating and pain.  Diagnosed with ulcerative colitis and is currently on hydrocortisone enemas qd, Melamine rectal suspension qd and Pentasa 500mg two capsules by mouth three times daily.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Enema administration, Full blood count, Laboratory test, Nuclear magnetic resonance imaging abdominal, Rectal discharge
Clinical narrative: Blood and mucus from rectum, abdominal cramping, bloating and pain.  Diagnosed with ulcerative colitis and is currently on hydrocortisone enemas qd, Melamine rectal suspension qd and Pentasa 500mg two capsules by mouth three times daily.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Rectal haemorrhage, Stool analysis
Clinical narrative: Blood and mucus from rectum, abdominal cramping, bloating and pain.  Diagnosed with ulcerative colitis and is currently on hydrocortisone enemas qd, Melamine rectal suspension qd and Pentasa 500mg two capsules by mouth three times daily.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Angina pectoris, Blood test, Chest X-ray, Cold sweat
Clinical narrative: Severe abdominal cramping, rapid heartbeat, shallow breathing,cramping, clammmy and sweaty, nausea, faint  Called 911 and went via ambulance. Suspected angina, but heart was ok. Released at 4:00 AM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Heart rate increased, Hyperhidrosis, Hypopnoea, Muscle spasms
Clinical narrative: Severe abdominal cramping, rapid heartbeat, shallow breathing,cramping, clammmy and sweaty, nausea, faint  Called 911 and went via ambulance. Suspected angina, but heart was ok. Released at 4:00 AM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Syncope
Clinical narrative: Severe abdominal cramping, rapid heartbeat, shallow breathing,cramping, clammmy and sweaty, nausea, faint  Called 911 and went via ambulance. Suspected angina, but heart was ok. Released at 4:00 AM.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 25.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Lethargy, Vomiting
Clinical narrative: Vomiting and Lethargy.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine was administered out of indications for the age range per CDC guidelines.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: Pt reported site was red after immunization when she went home that night on 8/29. Stated next day it was red and larger. 8/31 at around 5 PM she came with husband to the pharmacy. Are at vaccination site was large, red, had two dime size blisters, and many tiny white spots around the area. Told pt if the area continues to get worse or doesn't get better soon to contact her Dr. Told pt to try an astringent on it to pull fluid out(Domeboro). Pt also reported a low grade fever. Told pt to take ibuprofen or Tylenol to keep fever under control.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Sharp pain from left shoulder down to elbow at time of injection. Unable to lift arm up or outwards. Pain continued to increase throughout the evening. Placed call to doctor's office following morning. Told to ice and use ibuprofen. Pain continued into Thursday and contacted doctor's office for appt. which was scheduled for 6:30 p.m. on Aug 25, 2016. Doctor checked with infectious disease to see if there were any reports of similar symptoms and none had been reported. We were instructed to use ALEVE starting the next morning 8/26/16. The ALEVE was used for a full day and did not help. Went back to 3 doses of ADVIL each day and continued with ice. On Monday a call was placed to the doctor's office to report the continued symptoms and were referred to Pediatric Neurology for an appt. on 8/30/16. Following appt with Neurology it was determined there was no nerve damage and that patient should receive Physical Therapy and be placed on a non-steroid anti-inflammatory med Diclofenac for 10 days. PT was scheduled for 8/31/16 and the new medication was taken on 8/30/16.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: PATIENT CAME IN TODAY 8/31/16 IN THE AM AND HAD A SMALL REDNESS AT LOCATION OF VACCINATION. I ADVISED PATIENT TO TAKE BENADRYL FOR REACTION AND TO MARK PERIMETER OF REDNESS TO SEE IF IT PROGRESSIVELY GETS WORSE OR BETTER. PATIENT CALLED ME BACK IN THE EVENING AT 8:30 PM STATING THAT IT HAD "TRIPLED IN SIZE". I ADVISED PATIENT TO SEEK IMMEDIATE MEDICAL ATTENTION TO TREAT REACTION.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Urticaria
Clinical narrative: Had reaction to the last oral dose of four. Dizziness and hives. Taking Benadryl.
Age: 50.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: The day after vaccine, the patient had fever and felt sick. Through the week the injection site area became red, raised, swollen, and hot to the touch. By 8/31, the raised red area was approximately 3-4 inches in diameter.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Pt called complaining of chills & hands shaking. Suggested he go to ER & he didn't want to. Suggested he take Tylenol, he had no fever or soreness or swelling at injection site. He finally decided to try to go to the ER.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Gait disturbance
Clinical narrative: After receiving PREVNAR 13 intramuscularlly in the left arm on 07/16/2016 pt experienced redness on torso, right arm, and right leg in the days following the immunization. The husband reported on 08/30/2016 pt has experienced difficulty in walking since 07/16/2016. Pt was seen locally by Dr. Pt was referred to Neurologist. (08/31/2016) Husband states Dr. indicated the immunization was the source of the patient's difficulty. Dr. opinion was the patient is in the process of recovery, which may take some time.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage #1.
Age: 74.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Cheilitis, Dysgeusia, Glossodynia, Lip swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of burning tongue in a 74-year-old male patient who received BOOSTRIX (batch number TX34X, expiry date 14th May 2017). Concomitant products included ZOSTAVAX. On 2nd August 2016, the patient received BOOSTRIX (intramuscular) .5 ml. In August 2016, 2 days after receiving BOOSTRIX, the patient experienced burning tongue (serious criteria GSK medically significant), lip swelling, taste altered and lip redness. In August 2016, the outcome of the lip redness was recovered/resolved. On an unknown date, the outcome of the burning tongue and taste altered were unchanged and the outcome of the lip swelling was recovering/resolving. It was unknown if the reporter considered the burning tongue, lip swelling, taste altered and lip redness to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX on the right deltoid. The patient received concomitant medication ZOSTAVAX (batch number M010486 expiry date 25th May 2017) subcutaneously on the left arm. The patient received ZOSTAVAX vaccine same time as BOOSTRIX. The reporting pharmacist administered the BOOSTRIX vaccine to the patient. On 18th August 2016, in the morning, the reporter came into the  pharmacy and reported that two days after receiving the BOOSTRIX, the patient's lips became swollen and red, tongue feels scorched, and food does not taste the same as it did prior to the vaccination. It was also reported that the patient's taste buds were affected. The upper lip was still swollen in the left corner. The reporter commented that the manufacturer of the ZOSTAVAX was Merck. This was the first time this was reported to the response center.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging abnormal, Tendon disorder
Clinical narrative: Immediate pain after injection followed by severe intense pain. Went to doctor and got a cortisone shot and x-ray and was given pain medication. Almost a year later still having pain went to doctor got a MRI.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Immediate pain after injection followed by severe intense pain. Went to doctor and got a cortisone shot and x-ray and was given pain medication. Almost a year later still having pain went to doctor got a MRI.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, minor swelling and warmth noted on (L) upper arm surrounding injection site of flu vaccine.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Palpitations, Pyrexia
Clinical narrative: Pt called Wed 8/31 w/complaint of: low grade fever, brain fog, heart palpitations. PCP is aware of RXN and told patient to continue to monitor; did not express concern. Self reported by patient. Patient stated that she has been run down lately.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Fatigue, Fever, Bodyache, Dizziness. Severe soreness at injection site(pain) w/swelling. Fever 103.5 highest myalgia (severe) whole body. 16-year-old female presents with mother for fever. Fever began earlier today. At rest. No exacerbating factors. Constant since onset. Moderate severity. MAXIMUM TEMPERATURE 103. Associated with malaise and myalgias and body aches. Patient with mild pain over the left deltoid where vaccine was given yesterday. Patient took TYLENOL for symptoms. Mild improvement. Called PMD, within for evaluation today told viral syndrome, told that if symptoms continue to go to the emergency department. No other sick contacts. No recent travel to foreign countries.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain, Pyrexia, Viral infection
Clinical narrative: Fatigue, Fever, Bodyache, Dizziness. Severe soreness at injection site(pain) w/swelling. Fever 103.5 highest myalgia (severe) whole body. 16-year-old female presents with mother for fever. Fever began earlier today. At rest. No exacerbating factors. Constant since onset. Moderate severity. MAXIMUM TEMPERATURE 103. Associated with malaise and myalgias and body aches. Patient with mild pain over the left deltoid where vaccine was given yesterday. Patient took TYLENOL for symptoms. Mild improvement. Called PMD, within for evaluation today told viral syndrome, told that if symptoms continue to go to the emergency department. No other sick contacts. No recent travel to foreign countries.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: After vaccination pt. fainted. Pt. layed on floor for a few minutes then felt okay.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Few papulovesicular rashes on ant (R) thigh where VARIVAX and PCV were administered the next day after vaccines were given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: None. Pt given PROQUAD IM instead of SQ.
Age: 1.25
Sex: M
Vaccine: DTAPIPV, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction occurred - Pt rec'd KINRIX (Dtap and Polio) instead of INFANRIX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Ultrasound scan normal
Clinical narrative: Vaccines received 8/23/16 - seen in ED 8/24 for "lt upper thigh erythema, swelling, warmth and redness"-dx "post vaccine rash due to DTAP." U/S done - negative. Treated empirically with antibiotic. Follow up on 8/26/16 - recovering.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local reaction
Clinical narrative: Vaccines received 8/25/16 - seen in ED 8/28/16 for "5 cm x 6 cm mild erythema, localized reaction to vaccine." Follow up on 8/30/16 - recovering.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Infant at DM house next day 8/16/16. GM report rash on buttocks, end day all over, small bumps. Took to pediatrician 8/16/16 gave shot. Went away. Rash came back 3 days later. Took yesterday 8/21 Rx given, not with mom at present. No need to bring infant into clinic.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Nerve pain down left arm, where Tdap administered. No prev adverse event of w/any immunizations.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Right upper arm redness, warmth, itchiness, pain 8/10 x 2 days. Redness progressively spread down to elbow area.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching 2 days after administration. 8/23 - Administered. 8/25 - Noticed redness and itching. 8/31 - Reported to pharmacy seems to be getting better.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Since shots yesterday-pt. increased N/V and dizziness. Mother reports child has vomited and has severe headache.
Age: 30.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Malaise, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, malaise. Arm pain and swelling (left). Red demarcated rash below the injection site.
Age: 30.0
Sex: U
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Fever, chills, malaise. Arm pain and swelling (left). Red demarcated rash below the injection site.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe L arm pain (rated 10 out of 10). Refusal to move L arm away from body more than a few inches.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Injection site pain, Neck pain, Swelling
Clinical narrative: Pt. began having injection site arm hurting at area of injection. Pain radiated up thru neck to top of head. There was also swelling/redness 1 in. below injection site. No previous sxs. Pt took 2 TYLENOL that pm but no other doses. Pt. did not use any compresses on area. Contacted pt. on 8-25-16 all sxs gone except mild swelling and soreness.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Gave immunization too early. No adverse event took place. 2nd Hep A dose was received 3 months too early.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Swelling and redness from elbow to top of shoulder-felt warm to patient. Over weekend had fever, chills, body aches.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Swelling and redness from elbow to top of shoulder-felt warm to patient. Over weekend had fever, chills, body aches.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (Temp 102 F), body aches, chills.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Local reaction.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 32 unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored dose of ROTATEQ (lot # M019708, expiration date: 25-OCT-2017, oral, dose was unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-MAY-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical condition. On 29-AUG-2016 the patient was vaccinated with expired dose of GARDASIL lot # K008335/ expiration date- 23-JUN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of event was unknown. No PQC(product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 26 unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M010440, expiration date:09-DEC-2018, dose and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 17-AUG-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot # K010442 and expiration date 22-JUL-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 09-AUG-2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (exact dose and route not reported) lot # L003228 which expired on 30-JUL-2016. It was reported that this was supported. No adverse effects were reported. Additional information has been requested.