chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Altered state of consciousness, Body temperature increased, Dysphemia, Headache, Moaning
Clinical narrative: Child suddenly turned sheet white, and started complaining his head hurt. He sat staring into space, seemingly unaware periodically, and moaning between periods of staring into space, which we believe may have been small seizures, for the majority of the rest of the day. Within two hours his temperature had climbed from normal to 104.5 and was still going up. Tylenol was administered and brought the temperature down. His stutter, which had been gradually improving, has become much worse in the days following, and he has begun wetting himself without realizing it has happened, after being reliably toilet trained for over a year and a half.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pallor, Staring, Urinary incontinence
Clinical narrative: Child suddenly turned sheet white, and started complaining his head hurt. He sat staring into space, seemingly unaware periodically, and moaning between periods of staring into space, which we believe may have been small seizures, for the majority of the rest of the day. Within two hours his temperature had climbed from normal to 104.5 and was still going up. Tylenol was administered and brought the temperature down. His stutter, which had been gradually improving, has become much worse in the days following, and he has begun wetting himself without realizing it has happened, after being reliably toilet trained for over a year and a half.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Pt stated he began to itch and swell shortly after injection. The next day Pt came into the clinic: Induration measured 40mm with Pos redness, swelling, and warm to the touch. Pt is Dx with cellulitis and given Rx Keflex. Pt began taking Medication on Fri 17Apr2015. At that point Pt's swelling and redness had lessened but was still warm to the touch. Pt F/U on Tue 21Apr: Redness, swelling, and warmth are no longer present. Induration is still visible and 2cm.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Pt stated he began to itch and swell shortly after injection. The next day Pt came into the clinic: Induration measured 40mm with Pos redness, swelling, and warm to the touch. Pt is Dx with cellulitis and given Rx Keflex. Pt began taking Medication on Fri 17Apr2015. At that point Pt's swelling and redness had lessened but was still warm to the touch. Pt F/U on Tue 21Apr: Redness, swelling, and warmth are no longer present. Induration is still visible and 2cm.
Age: 0.46
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: Patient started vomiting.  She vomited until 11:00 off and on.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Right arm about 3 inches vertically down from shot a large welp. Is shape of a kidney and sz is 12 cm x 2 cm under the skin, raised, red and warm to the touch. patient c/o that is burns, itches and it is tight feeling and is hard to move. She also c/o nausea, dizziness and headache.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Nausea, Skin tightness
Clinical narrative: Right arm about 3 inches vertically down from shot a large welp. Is shape of a kidney and sz is 12 cm x 2 cm under the skin, raised, red and warm to the touch. patient c/o that is burns, itches and it is tight feeling and is hard to move. She also c/o nausea, dizziness and headache.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Right arm about 3 inches vertically down from shot a large welp. Is shape of a kidney and sz is 12 cm x 2 cm under the skin, raised, red and warm to the touch. patient c/o that is burns, itches and it is tight feeling and is hard to move. She also c/o nausea, dizziness and headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Large welt which patient measured to be 3 inches long and 2 inches wide.  Located at injection site of shingles vaccine on left arm that she received on 04/21/15. Patient states that it looks like a large hive. It is not itchy and no red streaks noted. Patient is not sure when this developed but she first noticed it about 0930 today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Soreness, inflammation, redness, and warmth at the injection site. 30mm circle area on the left lateral side of thigh area.
Age: 1.53
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap given instead of Dtap.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site reactoin (red, warm, swollen).
Sex: U
Vaccine: RV5
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to unspecified number of infants of unknown gender. On an unknown date, the patients were vaccinated with ROTATEQ (orally, dose, frequency, lot# and expiration date were not reported). It was stated that the nurse was administering ROTATEQ daily to infants and most of them could drink from dispenser great, but some had unspecified issues on an unknown date. The outcome of adverse event was reported. Causality assessment was not provided. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Tdap given on 4-17-15 (L) deltoid. C/O pain, redness, and itching.
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Hypertension, Pollakiuria, Rhinorrhoea, Sneezing
Clinical narrative: This case was reported by a pharmacist and described the occurrence of urinary frequency in a adult male patient who received FLULAVAL (batch number MJ7A9, expiry date June 2015). Co-suspects products included BOOSTRIX (batch number 95L3P, expiry date 11th April 2016). On an unknown date, the patient received FLULAVAL and BOOSTRIX. On 28th January 2015, an unknown time after receiving FLULAVAL and BOOSTRIX, the patient experienced urinary frequency, blood pressure high, runny nose and sneezing. On an unknown date, the outcome of the urinary frequency, blood pressure high, runny nose and sneezing were unknown. It was unkonwn if the reporter considered the urinary frequency, blood pressure high, runny nose and sneezing to be related to FLULAVAL and BOOSTRIX. Additional information was provided: This case was reported by a pharmacist via a claim from the consumer who experienced the adverse events.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Ear pain, Eye irritation, Headache, Lacrimation increased
Clinical narrative: Itching both arms, abdomen, some on legs, earache, watery eyes, runny nose. Chills started in the evening. Used Benadryl at HS. Itching increased 4-22-2015, to include chest and head, continued earache, irritated throat, irritated- watery eyes, headache and chills.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus generalised, Rhinorrhoea, Throat irritation
Clinical narrative: Itching both arms, abdomen, some on legs, earache, watery eyes, runny nose. Chills started in the evening. Used Benadryl at HS. Itching increased 4-22-2015, to include chest and head, continued earache, irritated throat, irritated- watery eyes, headache and chills.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 7.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness at Tdap injection site.  9cm x 5cm area of erythema and tenderness at time of exam on 4/22/15.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever and seizure.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: LARGE AREA OF REDNESS W/ WITH WARM AND SWELLING 4 INCHES x 3 INCHES.  SOME ITCHINESS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Rash erythematous
Clinical narrative: 7 x 11cm erythematous rash.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Eye discharge, Hypersensitivity, Insomnia, Productive cough, Rash
Clinical narrative: 59 year old male patient comes into the Urgent Care with complaints of an allergic reaction to measles vaccine with rash on the ankle and back extending to the upper buttocks, eye discharge, runny nose, and productive coughing with green sputum interfering with sleep x28 days, onset one month after measles vaccine on 2/20/2015. Symptoms moderate and constant. Pt noted that the symptoms began approximately at the time he should have returned for the second MMR vaccine. Pt has been self-medicating with ciprofloxacin from past prescription, starting yesterday.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Rhinorrhoea, Sputum discoloured
Clinical narrative: 59 year old male patient comes into the Urgent Care with complaints of an allergic reaction to measles vaccine with rash on the ankle and back extending to the upper buttocks, eye discharge, runny nose, and productive coughing with green sputum interfering with sleep x28 days, onset one month after measles vaccine on 2/20/2015. Symptoms moderate and constant. Pt noted that the symptoms began approximately at the time he should have returned for the second MMR vaccine. Pt has been self-medicating with ciprofloxacin from past prescription, starting yesterday.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Eye infection, Headache, Ocular hyperaemia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: 59 year old male patient comes into the Urgent Care with complaints of an allergic reaction to measles vaccine with rash on the ankle and back extending to the upper buttocks, eye discharge, runny nose, and productive coughing with green sputum interfering with sleep x28 days, onset one month after measles vaccine on 2/20/2015. Symptoms moderate and constant. Pt noted that the symptoms began approximately at the time he should have returned for the second MMR vaccine. Pt has been self-medicating with ciprofloxacin from past prescription, starting yesterday.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Productive cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 59 year old male patient comes into the Urgent Care with complaints of an allergic reaction to measles vaccine with rash on the ankle and back extending to the upper buttocks, eye discharge, runny nose, and productive coughing with green sputum interfering with sleep x28 days, onset one month after measles vaccine on 2/20/2015. Symptoms moderate and constant. Pt noted that the symptoms began approximately at the time he should have returned for the second MMR vaccine. Pt has been self-medicating with ciprofloxacin from past prescription, starting yesterday.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Conjunctivitis, Eye discharge, Headache, Oropharyngeal pain, Productive cough
Clinical narrative: 59 year old male patient comes into the Urgent Care with complaints of an allergic reaction to measles vaccine with rash on the ankle and back extending to the upper buttocks, eye discharge, runny nose, and productive coughing with green sputum interfering with sleep x28 days, onset one month after measles vaccine on 2/20/2015. Symptoms moderate and constant. Pt noted that the symptoms began approximately at the time he should have returned for the second MMR vaccine. Pt has been self-medicating with ciprofloxacin from past prescription, starting yesterday.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Rash generalised
Clinical narrative: 59 year old male patient comes into the Urgent Care with complaints of an allergic reaction to measles vaccine with rash on the ankle and back extending to the upper buttocks, eye discharge, runny nose, and productive coughing with green sputum interfering with sleep x28 days, onset one month after measles vaccine on 2/20/2015. Symptoms moderate and constant. Pt noted that the symptoms began approximately at the time he should have returned for the second MMR vaccine. Pt has been self-medicating with ciprofloxacin from past prescription, starting yesterday.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pruritus generalised, Rash
Clinical narrative: Itching all over body and developed rash afterwards.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Mild Rash started from arms to chest legs and face.  No treatment. Symptoms resolving.
Age: 12.0
Sex: M
Vaccine: HPV2, MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: REDNESS, SWELLING, PAIN.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Haematoma, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had a swollen arm with hematoma on the day after the injection.  She states that ever since, her arm has been progressively painful and she is now experiencing arm immobilization from elbow to the upper arm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site haematoma, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Patient had a swollen arm with hematoma on the day after the injection.  She states that ever since, her arm has been progressively painful and she is now experiencing arm immobilization from elbow to the upper arm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Skin discolouration
Clinical narrative: Patient had a swollen arm with hematoma on the day after the injection.  She states that ever since, her arm has been progressively painful and she is now experiencing arm immobilization from elbow to the upper arm.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Skin discolouration, Unresponsive to stimuli
Clinical narrative: Vaccines given around 10:00 AM on April 22, 2015.  Parents brought patient to ED at 9:45 PM on April 2, 2015 for unresponsiveness and dusky color.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Anaemia, Apnoea neonatal, Blood gases abnormal, Blood glucose decreased, Cardiac arrest
Clinical narrative: Vaccines given around 10:00 AM on April 22, 2015.  Parents brought patient to ED at 9:45 PM on April 2, 2015 for unresponsiveness and dusky color.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Chest X-ray normal, Culture, Death, Echocardiogram normal, Endotracheal intubation
Clinical narrative: Vaccines given around 10:00 AM on April 22, 2015.  Parents brought patient to ED at 9:45 PM on April 2, 2015 for unresponsiveness and dusky color.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count abnormal, Haemoglobin decreased, Hypotension, Laboratory test, Leukocytosis
Clinical narrative: Vaccines given around 10:00 AM on April 22, 2015.  Parents brought patient to ED at 9:45 PM on April 2, 2015 for unresponsiveness and dusky color.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Metabolic acidosis, Pulse absent, Resuscitation, Thrombocytopenia, Unresponsive to stimuli
Clinical narrative: Vaccines given around 10:00 AM on April 22, 2015.  Parents brought patient to ED at 9:45 PM on April 2, 2015 for unresponsiveness and dusky color.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient received FLUZONE High Dose on 11-2-14. When she was in pharamcy today (4-22-15), she said that she still has some pain and numbness in the arm that vaccine was administered that has lingered since vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure
Clinical narrative: Patient had a seizure, paramedic responded to call and then sent her home.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) biceps 10x10 cm erythematous warm area noted near inject site.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Persistent injection site pain in left shoulder. Also numbness/tingling in left arm.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site reaction, Laboratory test
Clinical narrative: Persistent injection site pain in left shoulder. Also numbness/tingling in left arm.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Limb discomfort, Musculoskeletal pain, Myalgia, Paraesthesia
Clinical narrative: Persistent injection site pain in left shoulder. Also numbness/tingling in left arm.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: On 3rd vaccine of Hepatitis-B, ENGERIX-B 20 mcg (adult dose) given VS ENGERIX-B 10 mcg. No adverse reaction at this time.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient called and stated that her arms/shoulders are still painful from when vaccinations were given several mths prior. Patient stated that it hurts to raise arms over head.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Bone disorder, Injection site reaction, Injection site swelling, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a consumer via a company representative referring to the consumer's daughter, a 2 year old female patient. In 2004 the patient was vaccinated with a first dose of MMR (manufacturer unknown) and in approximately 2006 was vaccinated with the second dose (dose, route and lot# were not reported for both doses). The consumer reported that the patient experienced extreme swelling at the injection site of her left leg after administration of her first dose of MMR (manufacturer unknown), when she was aged 2 years. The patient also lost some speech ability as well as her memory of the alphabet and numbers on unknown dates. The swelling at the injection site resolved after several months and the speech and memory difficulties resolved after 2 years. In approximately 2006, when the patient was aged 4 years, she also experienced swelling at the injection site after administration of her second dose. In 2006, an magnetic resonance imaging (MRI) revealed a growth on the left femur near the same location as the site of the MMR (manufacturer unknown) injection. The outcome of the second injection site swelling and "a growth on the left femur" was unknown. The relationship between these events and MMR (manufacturer unknown) was not reported. Upon internal review, the event "lost some speech ability" was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dyskinesia, Fall, Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: Shortly after vaccine given, while still seated in chair, had 2-3 small jerks and passed out. Fell while in chair and hit side of head on desk. Slightly dazed but appropriate. Observed x 1/2 hr. Went home in stable condition.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a health care worker refers to a currently 14 years old female patient with no pertinent medical history and no drug reactions or allergies. On 22-JAN-2001, the patient was vaccinated with the first dose, on 26-MAR-2003 with the second dose and on 06-AUG-2003 with the third dose of RECOMBIVAX HB, intramuscular, 5/0.5 microgram/ml (dose, lot # therapy type, expiration date were not reported). No concomitant therapy was reported. On an unknown date, the patient failed to produce antibodies following the administration of the RECOMBIVAX HB series. Unspecified "infectious disease serologic testing" was performed on an unspecified date in December 2014 and the results showed no immunity to hepatitis B (no specified lab values were provided). Due to the failure to produce antibodies after receiving the first RECOMBIVAX HB series, the patient received a fourth dose of RECOMBIVAX HB on unspecified dates. The outcome of the event was not reported. Relatedness between the vent and vaccination with RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 53 year old male patient with hypertension and depression and with no drug reactions or allergies. On 27-MAR-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # reported as K020186 exp date 27-JAN-2016) subcutaneously. Concomitant therapies included atenolol and CELEXA. The nurse reported that on 28-MAR-2015, the patient experienced a two red circle with minor irritation and itching at the site of injection after being administered with ZOSTAVAX. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. On 31-MAR-2015, the patient recovered from the adverse events. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Pt c/o redness, swelling, and much itchiness x 1 day on left upper arm after receiving shingles vaccine on 2/17/2015. Area of reaction is about 2 inches in diameter. Has not taken anything to try to reduce the symptoms - ie BENADRYL because it makes her sleepy. Skin rash, rash and urticaria pruritus
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt c/o redness, swelling, and much itchiness x 1 day on left upper arm after receiving shingles vaccine on 2/17/2015. Area of reaction is about 2 inches in diameter. Has not taken anything to try to reduce the symptoms - ie BENADRYL because it makes her sleepy. Skin rash, rash and urticaria pruritus
Age: 75.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via GSK market research programs and described the occurrence of sickness in a 75-year-old female patient who received Flu Seasonal TIV. Concomitant products included ADVAIR. On an unknown date, the patient received Flu Seasonal TIV at an unkonwn dose. On an unknown date, an unknown time after receiving Flu Seasonal TIV, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Flu seasonal TIV. Additional information was provided: The patient was ill for 2 days. She stayed in bed and drank plenty of fluids and in 2 days felt fine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-APR-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # J013728, expiration date 30-OCT-2015 (dose and route were not reported). No adverse symptoms. No co-suspect and concomitant therapies were reported. This is one of several reports from the same souce. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of an unknown age and an unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PROQUAD which was exposed to 12F for 40 minutes. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several repots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified patients of unknown ages and genders who between 06-MAR-2015 and 15-APR-2015 were inadvertently vaccinated with an improperly stored of LIQUID PEDVAXHIB (lot # reported as K011077, expiration date 30-MAR-2017) (dose and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and concurrent conditions were not reported. On 12-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, lot # L000450, expiration date 09-MAR-2016, in the left arm (dose and route was not reported). No co-suspect and concomitant therapies were reported. In April 2015, "on or two days later" of vaccination, the patient experienced redness and swelling at injection site. The patient sought medical attention, called the pharmacist. The outcome of injection site swelling and injection site erythema was reported as recovering. No treatment was given for the adverse events. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 09-APR-2015 the patient was vaccinated with an expired dose of MMR II which was administered subcutaneously (dose and lot # was not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was administered a dose of ROTATEQ (2 ml, via oral route of administration, lot # J012954, expiration date: 31-MAR-2015) post temperature excursion. Excursion was supported. No adverse events were reported. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 17-APR-2015, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (lot # K015310; expiration date reported as 17-DEC-2015) (dose and route not provided) in error, instead of (Merck) VARIVAX. At the time of the report, the patient had not demonstrated any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-APR-2015, the patient was vaccinated with improperly stored PROQUAD lot # K018142, expiration date 10-APR-2016 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown ages and genders. Concurrent conditions, medical history and allergies were not reported. On an unknown dated, the unspecified patients were vaccinated with series of hepatitis b vaccine (manufacturer unknown), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The reporter stated that the unspecified patients were not considered to be immune to Hepatitis B at a later time when titers were measured on an unknown date. The outcome of hepatitis b surface antibody negative was unknown. The relatedness between hepatitis b surface antibody negative and therapy with hepatitis b vaccine (manufacturer unknown) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a clinical medical assistant regarding a currently 11 year old non pregnant female patient with an allergy to OMNICEF. The patient did not have pertinent medical history and concomitant medications. On 30-OCT-2003, the patient was vaccinated with the first dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported) for prevention of hepatitis B. On 05-JAN-2004, the patient was vaccinated with the second dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported) for prevention of hepatitis B. On 27-MAR-2004, the patient was vaccinated with the third dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported) for prevention of hepatitis B. On an unspecified day in December 2014, unspecified infectious disease serologic testing was performed and showed no immunity to hepatitis B. Due to the failure to produce antibodies after receiving the first RECOMBIVAX HB series, the patient received a fourth and a fifth dose of RECOMBIVAX HB on an unspecified dates. The patient's outcome was unknown. The relatedness between the events and therapy with RECOMBIVAX HB was not provide. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via GlaxoSmithKline, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # K025766, expiration date: 08-JUN-2016) dose and route were not reported. No adverse events were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a non medical healthcare worker refers to three unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date in March 2015, the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # K009759 and expiration date 09-JUL-2016) (dose and route were not reported). No adverse events were reported. This is one of the two reports from the same source. 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 refers to 2 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-APR-2015, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # J013728, expiration date 30-OCT-2015 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. 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 refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-APR-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX lot# J013728, expiration date 30-OCT-2015 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 51-year-oold female patient who received FLUARIX. On an unknown date, the patient received FLUARIX (injection) .5 ml. On 1st October 2014, unknown after receiving FLUARIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovering/resolving. The reporter considered the pain in arm and mobility decreased to be possibly related to FLUARIX. Additional information received: A nurse reported adverse events for 3 patients. Each patient was a female adult patient between 30 and 40 years of age. The patients all received the Flu vaccine from the same lot number. Each patient experienced extreme arm pain and limited arm mobility. The patients are recovering. The dose given was 0.5 mL for each patient. The field rep had no other information about the event. Additional information received on 07 April 2015: This case was reported for a 51-year-old female patient. On 01 October 2014, the patient experienced extreme arm pain and limited mobility in the arm. DOB was added.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-APR-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # J013728, expiration date 30-OCT-2015 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a health worker (medical assistant) concerning a patient of unknown age and gender. On 03-APR-2015 the patient was vaccinated with a dose of expired (Merck) VARIVAX (0.5 ml, once, lot # J003228, expiration date: 15-MAR-2015, subcutaneous). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (exposed to 33F for 0.5 hours) ROTATEQ (lot # K010224, expiration date 13-MAY-2016, dose was unknown, orally) (Incorrect product storage). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with an improperly stored doses of PROQUAD (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. Additional information is not expected as there is no consent to follow up contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with an improperly stored dose of MMR II (dose, route and lot# were not reported). No symptoms were reported. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on 10-APR-2105 was inadvertently vaccinated with an expired dose (expired product administered) of ZOSTAVAX 19400 PFU (expiration date 18-FEB-2015) (dose, lot # and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with an improperly stored dose of MMR II (dose, route and lot# were not reported). No symptoms were reported. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 16-APR-2015 the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (strength, route, lot# and dose were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (strength, route, lot# and dose were unkonwn). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dyspnoea, Hypersensitivity, Immune system disorder, Lip swelling
Clinical narrative: Initial unsolicited case received from a healthcare professional from a local Department of Health on 04 and 05 February 2015. An 83-year-old female patient received an intramuscular left arm injection of FLUZONE (lot number UI197AA) on 30 September 2014 at 9:00 am. The patient denied pre-existing conditions or illness at time of vaccination. According to the patient's daughter, who reported the event to the healthcare professional, the patient developed a fever, cough, and shortness of breath on 01 October 2014 at 9:00 am (i.e. 24 hours post-vaccination). She was seen by her physician and prescribed an antibiotic which she had taken in the past. From November through February, the patient experienced 5 episodes of facial and lip swelling, hives, and severe itching. During each episode, the patient was treated in the emergency room with steroids, and was currently taking BENADRYL as needed. The patient's daughter had reported that "since flu vaccine mom appears to have a weakened immunity, highly sensitive to various things (peanuts, dust, fabric softener) which she had been exposed to in the past and never had a reaction". The patient was scheduled to see her physician on 06 February 2015. Outcome was unknown. Follow-up information received for this unsolicited case on 23 February 2015 from a healthcare professional. On 20 February 2015, the reporter spoke to the patient. No final diagnosis was made. The patient denied any illness at time of vaccination and any pre-existing physician-diagnosed allergies, birth defects and medical conditions. She had a full cardiac workup, X-ray, Doppler studies (results not provided). She did not have any allergy testing. The patient stated she was admitted to the hospital in October for 5 days (date provided: 30 October 2014, but unclear whether it was the admission or discharge date). She was also seen in the emergency room a few times since September. She was presently taking BENADRYL and PEPCID, and using cortisone cream PRN. She has never been seen by an allergist, and was under the care of an internist. Daughter had stated patient was initially prescribed an antibiotic, but patient denied taking any antibiotic. Patient was due to call the internist's office for an appointment. She was improving slowly. Documents held by sender: None. Follow-up information received from a physician on 13 April 2015 and on 14 April 2015. It was reported that patient was admitted on 30 October 2014 for chest pain and discharged on 03 November 2014. The reporter stated that he did not think the patient had any weakened immunity or other side effect from flu shot. The outcome of the event chest pain was unknown and patient was recovering from other events. Documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Pyrexia, Swelling face, Urticaria
Clinical narrative: Initial unsolicited case received from a healthcare professional from a local Department of Health on 04 and 05 February 2015. An 83-year-old female patient received an intramuscular left arm injection of FLUZONE (lot number UI197AA) on 30 September 2014 at 9:00 am. The patient denied pre-existing conditions or illness at time of vaccination. According to the patient's daughter, who reported the event to the healthcare professional, the patient developed a fever, cough, and shortness of breath on 01 October 2014 at 9:00 am (i.e. 24 hours post-vaccination). She was seen by her physician and prescribed an antibiotic which she had taken in the past. From November through February, the patient experienced 5 episodes of facial and lip swelling, hives, and severe itching. During each episode, the patient was treated in the emergency room with steroids, and was currently taking BENADRYL as needed. The patient's daughter had reported that "since flu vaccine mom appears to have a weakened immunity, highly sensitive to various things (peanuts, dust, fabric softener) which she had been exposed to in the past and never had a reaction". The patient was scheduled to see her physician on 06 February 2015. Outcome was unknown. Follow-up information received for this unsolicited case on 23 February 2015 from a healthcare professional. On 20 February 2015, the reporter spoke to the patient. No final diagnosis was made. The patient denied any illness at time of vaccination and any pre-existing physician-diagnosed allergies, birth defects and medical conditions. She had a full cardiac workup, X-ray, Doppler studies (results not provided). She did not have any allergy testing. The patient stated she was admitted to the hospital in October for 5 days (date provided: 30 October 2014, but unclear whether it was the admission or discharge date). She was also seen in the emergency room a few times since September. She was presently taking BENADRYL and PEPCID, and using cortisone cream PRN. She has never been seen by an allergist, and was under the care of an internist. Daughter had stated patient was initially prescribed an antibiotic, but patient denied taking any antibiotic. Patient was due to call the internist's office for an appointment. She was improving slowly. Documents held by sender: None. Follow-up information received from a physician on 13 April 2015 and on 14 April 2015. It was reported that patient was admitted on 30 October 2014 for chest pain and discharged on 03 November 2014. The reporter stated that he did not think the patient had any weakened immunity or other side effect from flu shot. The outcome of the event chest pain was unknown and patient was recovering from other events. Documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cardiovascular evaluation, Chest pain, Cough, Dyspnoea, Food allergy
Clinical narrative: Initial unsolicited case received from a healthcare professional from a local Department of Health on 04 and 05 February 2015. An 83-year-old female patient received an intramuscular left arm injection of FLUZONE (lot number UI197AA) on 30 September 2014 at 9:00 am. The patient denied pre-existing conditions or illness at time of vaccination. According to the patient's daughter, who reported the event to the healthcare professional, the patient developed a fever, cough, and shortness of breath on 01 October 2014 at 9:00 am (i.e. 24 hours post-vaccination). She was seen by her physician and prescribed an antibiotic which she had taken in the past. From November through February, the patient experienced 5 episodes of facial and lip swelling, hives, and severe itching. During each episode, the patient was treated in the emergency room with steroids, and was currently taking BENADRYL as needed. The patient's daughter had reported that "since flu vaccine mom appears to have a weakened immunity, highly sensitive to various things (peanuts, dust, fabric softener) which she had been exposed to in the past and never had a reaction". The patient was scheduled to see her physician on 06 February 2015. Outcome was unknown. Follow-up information received for this unsolicited case on 23 February 2015 from a healthcare professional. On 20 February 2015, the reporter spoke to the patient. No final diagnosis was made. The patient denied any illness at time of vaccination and any pre-existing physician-diagnosed allergies, birth defects and medical conditions. She had a full cardiac workup, X-ray, Doppler studies (results not provided). She did not have any allergy testing. The patient stated she was admitted to the hospital in October for 5 days (date provided: 30 October 2014, but unclear whether it was the admission or discharge date). She was also seen in the emergency room a few times since September. She was presently taking BENADRYL and PEPCID, and using cortisone cream PRN. She has never been seen by an allergist, and was under the care of an internist. Daughter had stated patient was initially prescribed an antibiotic, but patient denied taking any antibiotic. Patient was due to call the internist's office for an appointment. She was improving slowly. Documents held by sender: None. Follow-up information received from a physician on 13 April 2015 and on 14 April 2015. It was reported that patient was admitted on 30 October 2014 for chest pain and discharged on 03 November 2014. The reporter stated that he did not think the patient had any weakened immunity or other side effect from flu shot. The outcome of the event chest pain was unknown and patient was recovering from other events. Documents held by sender: none.