chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician referring to an unspecified number of 11-18 years old female patients, 1 in 30 who were enrolled in a patient support program. There was no information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with first dose of GARDASIL (strength, dosage, frequency and route unspecified). Patients fainted when they received GARDASIL. Pediatrician would then have them elevate legs, recovered, and watch the patients for 15-20 mins before letting them go. The physician reminded patients to eat before vaccine and had them sit in office for 15(unit unspecified). The physician did not prevent administration of 2, 3 doses due to event. The outcome of syncope was reported as recovering/resolving. The causality was not reported. This is one of two cases received from the same reported. Additional information is not expected as there was no consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative concerning the physician's wife of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with 1 shot of ZOSTAVAX (strength, lot # and expiration date not reported) subcutaneously. On an unknown date after receiving the ZOSTAVAX, the patient experienced injection site reaction. Her husband examined the injection site. No lab diagnostics studies were performed. The reaction was treated with a course of unspecified steroids to deal with the inflammation and swelling. With the treatments, the events improved and on an unspecified date, the patient was recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patient's medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a doses of GARDASIL 9 lot number: L043213, expiration date: 28-AUG-2017, lot number: L040164, expiration date: 28-FEB-2018 (dates, doses and routes not reported), that were improperly stored. The vaccine was stored in temperature of 1.7 Celsius degree (C) for two hours and 5 minutes and in  1.7 C for 2 hours and 15 minutes. There was no previous temperature excursion. The excursion was captured with the use of Digital Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: (R) axillary lymphadenopathy 6 cm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Contusion, Erythema, Skin warm, Tenderness
Clinical narrative: 3.5cm x 4cm round, pink, warm tender area with central bruise.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # reported as L043214; expiration date 28-AUG-2017, dose and route of administration were unspecified. The vaccines had been exposed to 32 degrees Fahrenheit for 11 hours. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Laboratory test normal, Unevaluable event
Clinical narrative: None.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: On the day of the shots patient stated it was sore and hurt with some burning. Improved with rubbing the area. The next day it stopped hurting but it itched. On the 14th the area was slightly swollen with a red rash all around the area where the shot was given. Ice pack given and improved now.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Giardiasis, Herpes zoster, Immune system disorder, Malaise, Stool analysis
Clinical narrative: Pt. states Monday 3/7/16 started to feel ill. By Wed 3/9 she broke out in welts from top of shoulders to hips (bright red large welts). Used CORTAID on Thursday and Friday they were almost gone. States it knocked out her immune system. Also caused break out of herpes zoster. Was diagnosed with giardia.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Streptococcus test, Urticaria
Clinical narrative: Pt. states Monday 3/7/16 started to feel ill. By Wed 3/9 she broke out in welts from top of shoulders to hips (bright red large welts). Used CORTAID on Thursday and Friday they were almost gone. States it knocked out her immune system. Also caused break out of herpes zoster. Was diagnosed with giardia.
Age: 38.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Delirium, Fatigue, Headache, Heart rate increased
Clinical narrative: Leg weakness, fever, chills, body aches, extreme tiredness, headache, delirium, large warm red area at location of shot on upper left arm. Still experiencing symptoms. Rapid pulse.
Age: 38.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Muscular weakness, Pain, Pyrexia
Clinical narrative: Leg weakness, fever, chills, body aches, extreme tiredness, headache, delirium, large warm red area at location of shot on upper left arm. Still experiencing symptoms. Rapid pulse.
Age: 60.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Back pain, Feeding disorder, Nausea, Weight decreased
Clinical narrative: I received two shots on March 30, 2016 at the V.A. Clinic. One was TDAP and the other PREVNAR. I would also imply: I hadn't accepted but a few of these types of shots for years except for the PREVNAR. Yet when I arrived home I began to have increased pain in my back. As well I continually became increasingly nauseous. And during the course of time this pain became too intense and my ability to eat also diminished so much I presently can't eat. Yes the only differences regarding my everyday life and habits and my present condition had been after I received these two shots! And as of today (4/18/16 I've also lost at least 16 pounds! And if this can help anyone else who initially had Pancreatic Cancer along with all the residual occurring symptoms and effects then I'm certainly appreciative to provide this information has well.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: 4/12/16 Received PNEUMOVAX 5:00 PM; at 7 PM had severe pain left shoulder and arm (rate as 10); fever 99.6; 4/13/16 left arm edema/red shoulder -> elbow; made MD visit - given ZYRTEC and ZANTAC. 4/14/16 - MD visit edema, redness, warmth (L) shoulder -> elbow; LEVAQUIN x 5 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: 4/12/16 Received PNEUMOVAX 5:00 PM; at 7 PM had severe pain left shoulder and arm (rate as 10); fever 99.6; 4/13/16 left arm edema/red shoulder -> elbow; made MD visit - given ZYRTEC and ZANTAC. 4/14/16 - MD visit edema, redness, warmth (L) shoulder -> elbow; LEVAQUIN x 5 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not specified. On 01-APR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX lot # L029466, expiry date: 06-AUG-2017 (dose, strength, dose number, vaccination site, route not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Lymph node pain, Lymphadenopathy
Clinical narrative: Client developed sharp stomach pain 4/7/16 that was intermittent. On 4/8/16, client developed swollen (L) armpit nodes, size of a kidney bean. States very tender and unable to wash the area. Saw the physician 4/8/16 and prescribed CLARITIN and BENADRYL daily. 4/19/16 client called area still swollen, no stomach pain.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Patient given flu shot in left arm at work. Recalls it was given high in arm and pain immediately. Pain increased in shoulder w/limited ROM. Orthopedic evaluation revealed vaccine given into bursa. The patient is experiencing left shoulder pain that radiated down the back of his arm to the elbow. He stated that he had a flu shot about 5 weeks ago which caused some soreness in his arm and since then there has been an increase in pain and reduced range of motion. The patient is having trouble getting dressed and has been avoiding sleeping on that side at night.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient given flu shot in left arm at work. Recalls it was given high in arm and pain immediately. Pain increased in shoulder w/limited ROM. Orthopedic evaluation revealed vaccine given into bursa. The patient is experiencing left shoulder pain that radiated down the back of his arm to the elbow. He stated that he had a flu shot about 5 weeks ago which caused some soreness in his arm and since then there has been an increase in pain and reduced range of motion. The patient is having trouble getting dressed and has been avoiding sleeping on that side at night.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a physician via field employee regarding a male patient, above 70 years of age. Concurrent condition and medical history was not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dosing regimen unspecified) for prevention of shingles. The physician reported that "2-3 months" after receiving ZOSTAVAX the patient broke out in "full blown shingles" and "acute pain". He also reported that "the pain could also have been postherpetic neuralgia". The patient did not seek medical attention but did not know if the patient called the physician or was actually seen in the physician's office due to the reaction. VZV packet sent to the physician. The outcome of the events was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on neck, back, front of trunk and forearms. Not hives.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAR-2016, an adult patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (exact dose, lot # and expiration date were not reported, intramuscular). This was the first dose in the series of three, and the patient received the appropriate adult second dose of RECOMBIVAX HB on 16-APR-2016. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Tenderness
Clinical narrative: Erythema and tenderness.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Erythema, Lethargy, Muscle twitching, Peripheral swelling, Pyrexia
Clinical narrative: Pt awoke Kw/swollen arm, fever, emesis and involuntary twitching. Lethargy next day but much improved by 48 hours though arm still red and swollen.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Swelling, Vomiting
Clinical narrative: Pt awoke Kw/swollen arm, fever, emesis and involuntary twitching. Lethargy next day but much improved by 48 hours though arm still red and swollen.
Age: 0.44
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Fatigue, Peripheral swelling
Clinical narrative: Patient's thigh red and swollen, tired. No fever, no pain.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blister, Erythema, Local swelling
Clinical narrative: Patient has large raised lied down with few blister like areas. Patient outlined areas and cool compress and IBU 400mg. Temp 98.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient received ZOSTAVAX (shingles vaccine) on 4/6/16 6 pm. Developed a rash surrounding injection site the morning after injection. The rash spread across arm up to 3 inch length, subsided after taking BENADRYL.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Diarrhoea, Dizziness, Flushing, Headache, Influenza A virus test negative
Clinical narrative: Injection administered in clinic at 1400. Patient awoke in the night with headache, dizziness, fever, body aches. Fever 102.5. Had facial flushing and one episode of diarrhea. Presented to clinic for evaluation. No local reaction observed by PA-C.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Influenza B virus test, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Injection administered in clinic at 1400. Patient awoke in the night with headache, dizziness, fever, body aches. Fever 102.5. Had facial flushing and one episode of diarrhea. Presented to clinic for evaluation. No local reaction observed by PA-C.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Influenza B virus test, Laboratory test normal, Middle insomnia, Pain, Pyrexia
Clinical narrative: Injection administered in clinic at 1400. Patient awoke in the night with headache, dizziness, fever, body aches. Fever 102.5. Had facial flushing and one episode of diarrhea. Presented to clinic for evaluation. No local reaction observed by PA-C.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Redness, swelling and pain at injection site. Dizzy, stomach cramps and nausea. Both upper legs are sore.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Redness, swelling and pain at injection site. Dizzy, stomach cramps and nausea. Both upper legs are sore.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area on right arm was warm to touch. No temp was noted. Area was red and outlined in ink. Area had a bulls eye appearance.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, TYP
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Apprx. 10 min after receiving vaccines. Hep A (peds), Typhoid, MENVEO, and Influenza pt c/o vision change (seeing black) and ringing in the ears. Symptoms lasting less than one minute.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer, referring to a 66 year old male patient. The patient's medical history or concurrent conditions were not reported. On approximately 2013, (reported as received the first vaccine at 63 years old), the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported). The patient's concomitant medication was not reported. On 08-APR-2016, the patient was vaccinated with a second PNEUMOVAX 23 (strength, lot number and expiration date were not reported) 0.5 ml, in the upper arm. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a adult female patient who received FLUARIX. Co-suspect products included Amoxicillin unknown for an unknown indication and lisinopril for an unknown indication. Concurrent medical conditions included egg allergy. Concomitant products included LYRICA, PROTONIX and NITROSTAT. On an unknown date, the patient received FLUARIX at an unknown dose, Amoxicillin at an unknown dose and frequency and lisinopril at an unknown dose and frequency. On an unknown date, an unknown time after receiving FLUARIX and Amoxicillin, the patient experienced allergic reaction. The action taken with Amoxicillin was unknown. The action taken with lisinopril was unknown. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLUARIX and Amoxicillin. Additional details provided were as follows: The concomitant medicinal products included Aspirin (81 mg OD), Vitamin E (100 unit OD), Multivitamin (OD), Doxepin HCl (100 mg OD at bedtime). PAXIL (for depression, 30 mg OD), Hydrochlorothiazide (for blood pressure, 25 mg OD), Fenofibrate (for cholesterol, 160 mg OD). Levothyroxine (for thyroid, 125 mcg OD), Clonidine HCl (for blood pressure, 0.1 mg), Metformin (for diabetes, 1000 mg BD), PLAVIX (as blood thinner, 75 mg every other day), Promethazine HCl (for nausea, 25 mg PRN), SOMA (pain, 350 mg PRN), Garcina Camboia (for weight, 60 percent HCA BD), Fiber supplement (for IBS, BD), Probiotics (IBS OD) and Dicyclomine (for IBS, 20 mg PRN). The patient experienced an allergic reaction after reaction after receiving FLUARIX vaccine (unspecified season). Amoxicillin and Lisinopril. The age at vaccination was not provided.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Condition aggravated, Seizure, Tremor
Clinical narrative: Child went to bed and mom heard shaking, seizure lasted about 90 seconds, Night nurse called one of our doctors, and he spoke to mom. Child was not seen at our office or any other medical facility after the seizure. Child does have seizure disorder but has been quiet for a while.
Age: 0.19
Sex: M
Vaccine: PNC13, RV1
Symptoms: Apnoea, Cold sweat, Confusional state, Crying, Hyperhidrosis
Clinical narrative: After the injection, he was crying and then momentarily stopped breathing and went completely limp. He did not move or breathe for at least 20 seconds and when he woke up, he was drenched in sweat, clammy, and confused. We are discontinuing the shots.
Age: 0.19
Sex: M
Vaccine: PNC13, RV1
Symptoms: Hypotonia, Incomplete course of vaccination, Mobility decreased
Clinical narrative: After the injection, he was crying and then momentarily stopped breathing and went completely limp. He did not move or breathe for at least 20 seconds and when he woke up, he was drenched in sweat, clammy, and confused. We are discontinuing the shots.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Patient called to report that she was pregnant when MMR vaccine was administered. Vaccination was given on 3/18/16; patient reported LMP as 2/24/16.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose of KINRIX and PROQUAD given erroneously. No AE reported by patient.
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Discomfort, Erythema, Injection site bruising, Skin discolouration, Swelling
Clinical narrative: Started with swelling and redness, over night area turned purple. Was very swollen and uncomfortable. Bruising extended down arm from injection site and some bruising still remains today 04/25/2016.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Pt presents to the clinic today with her mother for an ER follow up for a reaction to immunizations. Requesting referral to allergist. She is currently taking an oral antibiotic (SEPTRA and Antibiotic Cream (BACTROBAN). Received immunizations: KINRIX left thigh and Hep B right thigh on 4/14/16. Seen in ER 4 days ago (4/15/16) with local redness and swelling left thigh, painful and itchy. Diagnosis: cellulitis. (Small red spot rt thigh without spreading).The patient was seen again in the ER 2 days ago (4/17/16) for spreading redness in the left thigh. Thigh U/S no abscess. Diagnosis: reaction to KINRIX. Similar incident involving both thighs 2 yrs ago after Hib, IPV, Hep(B), PCV immunizations. No hives or breathing problems. Patient is well today (4/19/16) except for a lump in both thighs.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Injection site swelling, Ultrasound scan normal, Vaccination complication
Clinical narrative: Pt presents to the clinic today with her mother for an ER follow up for a reaction to immunizations. Requesting referral to allergist. She is currently taking an oral antibiotic (SEPTRA and Antibiotic Cream (BACTROBAN). Received immunizations: KINRIX left thigh and Hep B right thigh on 4/14/16. Seen in ER 4 days ago (4/15/16) with local redness and swelling left thigh, painful and itchy. Diagnosis: cellulitis. (Small red spot rt thigh without spreading).The patient was seen again in the ER 2 days ago (4/17/16) for spreading redness in the left thigh. Thigh U/S no abscess. Diagnosis: reaction to KINRIX. Similar incident involving both thighs 2 yrs ago after Hib, IPV, Hep(B), PCV immunizations. No hives or breathing problems. Patient is well today (4/19/16) except for a lump in both thighs.
Age: 1.62
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Neutrophil count decreased, Pyrexia, Rash
Clinical narrative: Redness and swelling at injection site day after injection (in left arm) and lasting 3 days. Starting on 4/22/2016: Fever of 103.4. Next morning rash started on face and spread to belly. Neutrophil count dropped to 1. WBC decreased.
Age: 1.62
Sex: F
Vaccine: DTAP, MMR
Symptoms: White blood cell count decreased
Clinical narrative: Redness and swelling at injection site day after injection (in left arm) and lasting 3 days. Starting on 4/22/2016: Fever of 103.4. Next morning rash started on face and spread to belly. Neutrophil count dropped to 1. WBC decreased.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Induration, Inflammation, Oedema
Clinical narrative: Pt returned to clinic with raised red area 9cm x 12 cm well defined borders oval in shape, edematous, indurated, (mildly no fluctuation) inflamed warm tender. Diagnosed with cellulitis.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Pt returned to clinic with raised red area 9cm x 12 cm well defined borders oval in shape, edematous, indurated, (mildly no fluctuation) inflamed warm tender. Diagnosed with cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Dyspnoea, Lethargy, Urticaria, Vomiting
Clinical narrative: Pt received KINRIX, Varicella, MMR vaccines 1545, pt tolerated well, cried, mom pt and brother left. Mom left office made it to elevator pt vomited, became lethargic, hives. Mom returned with pt. Dr. evaluated, EPIPEN Jr given immediately 1550 due to increased work of breathing, wheezing and lethargy. O2 93% on room air. Given blow by O2, saturation 99-100%. Pt alert at this time. Transport team for Hospital notified and in route. Return of wheezing and lethargy 1608, EPIPEN Jr repeated by Dr. Pt alert and transported to hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Pt received KINRIX, Varicella, MMR vaccines 1545, pt tolerated well, cried, mom pt and brother left. Mom left office made it to elevator pt vomited, became lethargic, hives. Mom returned with pt. Dr. evaluated, EPIPEN Jr given immediately 1550 due to increased work of breathing, wheezing and lethargy. O2 93% on room air. Given blow by O2, saturation 99-100%. Pt alert at this time. Transport team for Hospital notified and in route. Return of wheezing and lethargy 1608, EPIPEN Jr repeated by Dr. Pt alert and transported to hospital.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, redness, and pain near sight of injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nodule, Pruritus, Skin warm
Clinical narrative: HAS A HARD KNOT WITH REDNESS. ITCHY AND WARM TO TOUCH.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Rash- confluent red rash on face and flat macular rash on rest of body.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever for 3 days. Mild rash on back, neck and face, arms.....red spots.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Cardio-respiratory arrest
Clinical narrative: Cardiopulmonary arrest.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site vesicles, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: On 4/25/16 0945 patient reported a "tennis ball size bulls eye" on (L) upper outer arm after taking a shower. She reports site hard and hot with questionable early blister at injection site. Arm is sore with pain rated 2-3 (on 0-10 scale) and vague itching. Pain was rated 4-5 the previous 2 days. Patient unable to check temperature.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Laboratory test, Oral mucosal eruption, Platelet count normal, Pyrexia
Clinical narrative: Fever and rash on legs on 4/7/16, resolved. Developed new rash/low grade fevers on 4/17. Rash was "blistery" and spread to legs, arms, buttocks, hands/feet, around mouth. Seen on 4/18 for papular rash.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash papular, White blood cell count normal
Clinical narrative: Fever and rash on legs on 4/7/16, resolved. Developed new rash/low grade fevers on 4/17. Rash was "blistery" and spread to legs, arms, buttocks, hands/feet, around mouth. Seen on 4/18 for papular rash.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Papule, Rash macular, Rash papular
Clinical narrative: Multiple erythematous macules with central small papules and papulovesicles on trunk, none on arms, rare on upper legs, none on hands or feet, palms or soles.
Age: 35.0
Sex: F
Vaccine: MMR, TD
Symptoms: Erythema, Injection site mass, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. returned today 4-25-16 for MMR #2 - She stated that after her last MMR her arm swelled to size of a "football" was red and painful. She went to her primary MD on 3/28/16 where he treated her w/Diphenhydramine and Ibuprofen and inst. her to ice it. RN noted that there is still a walnut sized lump at inj site. No other s/s.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Pain.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Headache, Pyrexia
Clinical narrative: Approximately 2 hours after receiving PNEMOVAX 23 she began having severe HA, abdominal pain, fever = 39C, diarrhea and severe dizziness. Called 5 hrs after receiving vaccine with above symptoms; sent to ED.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a 63 year old female patient, referring on herself. The patient's concurrent conditions and medical history were not reported. On 05-APR-2016, the patient was vaccinated with one dose (also reported as "1 shot") of PNEUMOVAX 23 (route, dose, dose number, anatomical place of vaccination, lot # and expiration date were not provided). Information regarding concomitant therapies was not reported. On the same date, the patient experienced injection site reaction. However, she did not seek for medical attention. Additionally, no product quality complaint was involved. At the time of reporting, the outcome of the injection site reaction was unknown. Also, the causality assessment between PNEUMOVAX 23 and the event was not provided. 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 Registered Nurse referring to an unspecified number of patients of unknown ages and genders. The patient's concurrent conditions and medical history were not provided. On an unknown date the patients were vaccinated with doses of improperly stored (Merck) VARIVAX (doses, routes and anatomical locations were not provided). The lot numbers used were: L005299, expiration date: 17-FEB-2017 and L037562, expiration date: 29-SEP-2017. It was reported that the vaccines had an excursion of -10.6 Celsius degrees for 30 minutes. There were no previous temperature excursions. No adverse symptoms were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On an unknown date the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (doses, routes and anatomical locations were not provided). The lot numbers used were: K020751, expiration date: APR-2016; L007231, expiration date: 03-SEP-2016; L004007, expiration date: 05-AUG-2016; L044056, expiration date: 02-MAY-2017 and lot number L0501098, expiration date 17-JUN-2017. it was reported that the vaccines had an excursion of -10 celsius degrees for 30 minutes. There were no previous temperature excursions. No adverse symptoms were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Tdap administered 4/20/16 - developed redness and swelling 4-23-16 - came back to clinic 4-25-16. Treated for localized reaction to immunization. Cannot R/O cellulitis.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Vaccine administered 4/23/16. Same day patient started feeling pain and noticed swelling and redness later on that day. Patient noticed it worse on Sunday 4/24/16. Pt. seen on 4/25/16 and cephalexin and BENADRYL was prescribed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient states she developed a 4" x 2" red localized reaction by the injection site. Non painful, not itching; just red and warm to touch. No other symptoms. I had patient come in and show me reaction and advised patient to keep in touch Kw/PCP. I will also call and monitor patient over next few days.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient called 57 minutes after receiving ZOSTAVAX subcutaneously complaining of numbness in left arm opposite of the arm he got the shot. Pt was heading to ER.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Patient called 57 minutes after receiving ZOSTAVAX subcutaneously complaining of numbness in left arm opposite of the arm he got the shot. Pt was heading to ER.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Echocardiogram
Clinical narrative: Patient called 57 minutes after receiving ZOSTAVAX subcutaneously complaining of numbness in left arm opposite of the arm he got the shot. Pt was heading to ER.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Headache, Hemiparesis, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: Patient called 57 minutes after receiving ZOSTAVAX subcutaneously complaining of numbness in left arm opposite of the arm he got the shot. Pt was heading to ER.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Feeling abnormal, Headache, Pain
Clinical narrative: Night of vaccine very painful, 9 out of 10 pain. Achy, headachey, chills 4/12/16, felt as though she was "coming down with something", fine 4/13/16.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative, referring to a 11 year old female patient. The patient's medical history or concurrent conditions were not reported. On 30-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot number and expiration date were not reported). The second dose was received on 29-JAN-2016 and the 3rd dose was received on 12-APR-2016, which was a schedule different than what was recommended in the prescribing information. The patient's concomitant medication was not reported. Additionally, no symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, referring to her son, a male patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL, either, GARDASIL 9 (it was unspecified which one)(dose, strength, route, lot number and expiration date were not reported). The patient's concomitant medication was not reported. Subsequently, on the same date of vaccination, the patient fainted. At the time reporting, the outcome of fainted was unknown. Additional information is not expected, since the reporter did not allow further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report regarding to multiple unspecified patients of unknown ages and genders was received from a licensed practical nurse. The patients' concurrent conditions and medical histories were not reported. On multiple unspecified dates, the patients were vaccinated with unspecified and improperly stored doses of GARDASIL 9 which had a lot # reported as L044775 and an expiration date of 12-MAY-2017 (route, dose and anatomical place of vaccination were not reported). The aforementioned doses of vaccine were stored at 23 degrees F for a time frame of 576 hours. Nevertheless, no adverse effect was reported and no product quality complaint was involved. Information regarding concomitant therapies was not reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 12 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 11 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 08-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 11 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 08-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 07-JAN-2016, this patient was vaccinated with a dose of PROQUAD (strength, dose, route, lot # and expiration date not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; route not reported) that were improperly stored (0.6 degree C for 11 hours and 10 minutes and 12.3 degree C for 50 minutes; data logger). No adverse effects were reported. This is 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 was received from a registered nurse and refers to multiple unspecified patients. Information about the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD, lot # L047307 with expiration date 23-MAY-2017; lot # reported as L041267 with expiration date 20-APR-2017 and lot # L019997 with expiration date 02-DEC-2016, (route of administration was not provided). The vaccines were exposed to a temperature of -12F by a time frame of 3 hours. NO adverse effects were noted. 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 registered nurse and refers to multiple unspecified patients. Information about the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX lot # reported as L042266 with expiration date 27-OCT-2017; lot # reported as L04265 with expiration date 25-OCT-2017 and lot # L040419 with expiration date 14-OCT-2017, (route of administration was not provided). The vaccines were exposed to a temperature of -12F by a time frame of 3 hours. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PNEUMOVAX 23 (lot # L019836, expiration date: 24-MAR-2017; route not reported) that were improperly stored (0.6 degree C for 11 hours and 10 minutes and 12.3 degree C for 50 minutes; data logger). No adverse effects were reported. This is the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PEDVAXHIB (lot # L035880, expiration date: 11-AUG-2018; route not reported) that were improperly stored (0.6 degree C for 11 hours and 10 minutes and 12.3 degree C for 50 minutes; data logger). No adverse effects were reported. This is the several reports from the same reporter. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: RV5
Symptoms: Constipation
Clinical narrative: Information has been received from a medical assistant referring to an 8 week female patient. The patient had no medical history or drug allergies. On 29-JAN-2016 the patient was vaccinated with a dose of ROTATEQ (lot#, dose, frequency and strength unknown) orally. The patient experienced lack of bowel movement after administration of ROTATEQ. The patient's mother sought medical attention by contacting the office by phone. No treatment was given for the event and no lab diagnostics studies were performed. The event lasted for 5 days and the patient was recovered on 02-FEB-2016. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of M-M-R II (lot # L024268, expiration date: 01-JUL-2017; route not reported) that were improperly stored (0.6 degree C for 11 hours and 10 minutes and 12.3 degree C for 50 minutes; data logger). No adverse effects were reported. This is the several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 16 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 18-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 17 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 29 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unspecified date in 2008, the patient was vaccinated with hepatitis B vaccine (manufacturer unspecified) (dose number, dose, frequency, lot number, expiration date, frequency and route were not reported). Concomitant medications were not provided. On an unknown date, the patient experienced pyrexia and rash but she did not seek medical attention at that time and no treatment was given for the adverse events. No product quality complaint (PQC) was involved. At the time of the report, the outcome of pyrexia and rash was reported as recovered on an unspecified date. Additional information is not expected as no contact permission was provided.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 13 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Adverse reaction, Mental disorder
Clinical narrative: This spontaneous report was received from a consumer and refers to an unspecified number of male patients (reportedly described as "boys") of unknown ages. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. Subsequently, on unknown dates, the patients presented themselves with "new physical and psychological problems". The outcome of these psychosexual disorders and nonspecific reactions were unknown. The reporter did not explicitly state any causal relationship between the events and vaccination with the suspect vaccine. This is one of the several reports received from the same reporter. Additional information has been requested.