chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Neuralgic amyotrophy
Clinical narrative: Symptoms started Friday, 11-23-2012, Stiffness to right side of neck- by Saturday pain in left neck radiated to elbow; shoulders very painful. Took Ibuprofen and alternated with acetaminophen, took left over hydrocodone-dulled, never took away. Had appt -ENT gave oxycodone-made appt for neurologist. Scheduled for MRI's 13th/14th if December. Called it Brachial Neuritis or Parsonage Turner.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination, Radiculitis brachial
Clinical narrative: Symptoms started Friday, 11-23-2012, Stiffness to right side of neck- by Saturday pain in left neck radiated to elbow; shoulders very painful. Took Ibuprofen and alternated with acetaminophen, took left over hydrocodone-dulled, never took away. Had appt -ENT gave oxycodone-made appt for neurologist. Scheduled for MRI's 13th/14th if December. Called it Brachial Neuritis or Parsonage Turner.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Antinuclear antibody positive, Arthralgia, Complement factor C3 decreased, Complement factor C4 decreased, Double stranded DNA antibody
Clinical narrative: Rash and joint pain.  Subsequently diagnosed as serum sickeness.  Currently on steroid therapy and with joint pain.  Most likely had same adverse event in 2011 - misdiagnosed at that time as JIR vs JRA vs Strep induced arthritis. Pt completely recovered after tonsillectomy and case of serum sickness with Omnicef.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Full blood count normal, Laboratory test normal, Metabolic function test normal, Rash, Rheumatoid factor negative
Clinical narrative: Rash and joint pain.  Subsequently diagnosed as serum sickeness.  Currently on steroid therapy and with joint pain.  Most likely had same adverse event in 2011 - misdiagnosed at that time as JIR vs JRA vs Strep induced arthritis. Pt completely recovered after tonsillectomy and case of serum sickness with Omnicef.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Serum sickness, Tonsillectomy, Urine analysis normal
Clinical narrative: Rash and joint pain.  Subsequently diagnosed as serum sickeness.  Currently on steroid therapy and with joint pain.  Most likely had same adverse event in 2011 - misdiagnosed at that time as JIR vs JRA vs Strep induced arthritis. Pt completely recovered after tonsillectomy and case of serum sickness with Omnicef.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness to injection site.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt. states had burning pain down upper arm to elbow at time injection given.  Over the last 6 weeks she states she is having increasing weakness, decreasing ROM of left arm/shoulder and pain in left arm.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Patient has pain in the Left Deltoid Muscle.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Orthosis user
Clinical narrative: Headache, diarrhea, tired, body aches, pain and soreness in elbow of arm shot was administered.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Headache, diarrhea, tired, body aches, pain and soreness in elbow of arm shot was administered.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes abnormal, Diarrhoea, Headache, Vaccination complication, Vomiting
Clinical narrative: That nite started having diarrhea and vomiting and headache. This has continued and she does not seem to be better. Doctor said she was having a severe reaction to the flu shot. Put on Zofran.
Age: 24.0
Sex: M
Vaccine: BCG
Symptoms: Cold sweat, Dizziness, Feeling hot, Hypoaesthesia, Injection site erythema
Clinical narrative: Redness around vaccine area itchiness, hot and cold sweats light headed and dizziness, vomiting and complete numbness in hand and thumb area no feelings.
Age: 24.0
Sex: M
Vaccine: BCG
Symptoms: Injection site pruritus, Vomiting
Clinical narrative: Redness around vaccine area itchiness, hot and cold sweats light headed and dizziness, vomiting and complete numbness in hand and thumb area no feelings.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Swollen, sore, hard, red, hot for 7 days following.  Used ice pack & ibuprofen.
Age: 23.0
Sex: F
Vaccine: FLU3, HEPAB, MNQ, TDAP
Symptoms: Diarrhoea
Clinical narrative: Started with diarrhea the following day and has continued with diarrhea since.  This has been about 3 weeks ago.  She has tried anti-diarrhea meds and it works for awhile and the diarrhea returns.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching started on arms and then moved to back about 45 minutes after shot. Hives and itching spread to neck, shoulders and scalp.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Insomnia, Pruritus, Rash erythematous
Clinical narrative: Large red rash (12 X 5 inches); itching, headache, very fast heartbeat - could not sleep.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, chills & red swollen arm - at site of PNEUMOVAX injection (arthus type).
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness of left deltoid injection site after receiving (TIV flu) vaccine 11/26/12. Redness did not begin until 11/27/12.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Skin warm, Vaccination site induration
Clinical narrative: Received VARIVAX vaccine #2 on 11-30-12. On 12-3-12 patient stated, "My arm is red, hard and hot. That started on 12-1-12." Golf ball sized area of redness and induration around vaccine site. No fever or rash.
Age: 17.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Had an upset stomach & vomited x 1 several hours after vaccination.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: 3cm x 3cm redness at injection site with 5 1/2 cm x 5 1/2 cm lump underneath redness - observe - F/U if worsening. May give BENADRYL.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patient received vaccine 11/30/12 at pharmacy. Patient returned to pharmacy on 12/2/12 with large, red, round wheal at injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient received vaccine 11/30/12 at pharmacy. Patient returned to pharmacy on 12/2/12 with large, red, round wheal at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Vaccine given 11-28, symptoms started evening 11-29 presented to clinic 11-30. Area distal to vaccine administration site warm, pink, indurated.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Red, raised, hard, 3" in diameter. Gave TYLENOL and put ice pack on leg.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at injection site where received Tdap vaccine. Also some itching at site from deltoid to elbow.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Noted local reactions at the injection site but no flu like symptoms. ((L) deltoid).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Had severe "bursitis" type reaction in shoulder. Resolved after 1 mo.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm x approximately 2 months post injection. Denies fever, swelling. Did not seek medical attention. Sx resolved on their own without tx.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Pt developed a rash in the nasal area across to the left ear & down the neck started the day after immunization & was itchy. Pt saw Dr & Diphenhydramine was recommended.
Age: 1.37
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site erythema
Clinical narrative: 7 x 5 cm area redness (Lt) thigh; no warmth or tenderness to touch; afebrile; activity WNL.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Fever & rash & pain at injection site 10 cm firm, red, warm reaction at site.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Diarrhoea, Headache, Injection site pruritus, Musculoskeletal discomfort
Clinical narrative: Headache, chest tightness, c/o slight pruritus left shoulder & neck discomfort. Nausea, 4 hours - vomited/diarrhea. Headache 90 min after vaccine. Given BENADRYL, FIORICET, PEPCID, Prednisone.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, chest tightness, c/o slight pruritus left shoulder & neck discomfort. Nausea, 4 hours - vomited/diarrhea. Headache 90 min after vaccine. Given BENADRYL, FIORICET, PEPCID, Prednisone.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Significant redness and swelling at injection site on right arm, known site of pneumonia vaccine. Fever up to 102, arm painful with activity.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Within 2 days pain began in both hands and got worse until referred to specialist.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Developed Herpes zoster. Pt was part of varicella exposure at work. Had (+) h/o varicella dz, negative titer. VARIVAX vaccine given pt. developed Herpes Zoster.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Dizziness, Extraocular muscle paresis, Immediate post-injection reaction, Inflammation
Clinical narrative: Redness, soreness and swelling at injection site. Dizzy and light head (immediate0 within 24 hours left leg pain, left arm inflammation, muscle in eye weak - double vision.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Redness, soreness and swelling at injection site. Dizzy and light head (immediate0 within 24 hours left leg pain, left arm inflammation, muscle in eye weak - double vision.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Induration, Injection site induration, Injection site pain, Injection site warmth, Rash
Clinical narrative: Firm & rash. Pain at injection site 1.0 cm firm red warm at reaction site.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Fever & rash & pain at injection site 10 cm firm, red, warm reaction at site.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever & rash & pain at injection site 10 cm firm, red, warm reaction at site.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site swelling, Paraesthesia
Clinical narrative: Unable to rotate left arm (vaccinated arm). Injection site also slightly swollen. Tingly finger (left arm).
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Incorrect route of drug administration, Oedema peripheral
Clinical narrative: On Nov-30-2012 patient received a varicella in wrong route (Intradermal) pt show up today with left fore arm redness and swelling, pt was evaluated by dr, plan at 4 weeks repeat varicella, MOTRIN.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt reports having shingles 23 days after receiving the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Loss of consciousness, Mass, Oedema peripheral
Clinical narrative: Pt. received vaccine 11/28. Symptoms did not develop until 12/1. Red lump, swollen upper arm, hot rash, pt. passed out taken to ER.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt. received vaccine 11/28. Symptoms did not develop until 12/1. Red lump, swollen upper arm, hot rash, pt. passed out taken to ER.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial infection, Injection site erythema
Clinical narrative: Redness in a ring around injection site, spreading outward. MD diagnosed as bacterial infection & treated with antibiotic.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Headache, Nausea, Visual impairment
Clinical narrative: Weakness; seeing spots; headache; nausea; dizziness; lightheaded. Started later on in the day evening time.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site rash, Injection site vesicles
Clinical narrative: Pt. developed a non-itchy non-painful rash at site of immunization. It covered approx. 2x4 inches w/ blisters. Started w/in 3 days and blisters went down over time. Discoloration remains after 2 1/2 months.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling pain redness. (L) delt.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant who administers vaccines refers to a patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot # reported as H012973; expired on 05-MAR-2015) intramuscularly on 28-NOV-2012 that was exposed to an unsupported temperature excursion (70F for 96 hours). This is the only dose of GARDASIL this patient has received. No other co-suspects were reported. No concomitant medications were reported. It was unknown that if the patient had sought medical attention. NO adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with a 0.5 ml dose of lot # (666121/0597Z; exp date 19-AUG-2012), GARDASIL on 28-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Hyperhidrosis, Oedema peripheral, Pain
Clinical narrative: Received PREVNAR two days ago, left arm became swollen and fever to 101.0 sweaty chills, body aches and headaches.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Received PREVNAR two days ago, left arm became swollen and fever to 101.0 sweaty chills, body aches and headaches.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On19-OCT-2012 11:49, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date (reported as a few years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number unspecified). No concomitant medications were reported. On an unknown date, the patient experienced a mild case of shingles. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. It was unknown if the patient had sought medical attention. Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 at 03:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (gender unknown) patient of unknown age. On 24-OCT-2012 21:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Purulent discharge, Scab
Clinical narrative: This spontaneous report was received from a 74-year-old female patient regarding herself. The patient's medical history included stroke. Current conditions included cancer, allergy to codeine, TOFRANIL and morphine. On an unknown date the patient was vaccinated a dose of with ZOSTAVAX (lot#, expiration date and route not reported). No concomitant medications were reported. The patient reported that after being administered the ZOSTAVAX she noticed a beet red, blister on her left arm and on the lower part of her breast. The blisters turned white and filled with puss and scabbed over. The patient had sought unspecified medical attention. No treatment was given for the events. Biopsy was performed on an unknown date in 2012, results unknown. Outcome of the reported events were unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 12:03, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 06:29, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 21:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 25-OCT-2012 13:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 at 13:04, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 02:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 10:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 09:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 24-OCT-2012 19:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-OCT-2012 at 21:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On20-OCT-2012 00:18, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On19-OCT-2012 14:34, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 at 12:07, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 12:35, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 13:11, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Neuropathy peripheral, Pain, Paraesthesia, Sinusitis
Clinical narrative: This spontaneous report was received from a 72 years old female consumer without any drug allergy or pertinent medical history regarding herself. On 21-NOV-2011, the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot# and expiry not reported). Concomitant medications included unspecified thyroid medication. A week after receiving the ZOSTAVAX approximately on 28-NOV-2011, the patient experienced a sinus infection that took 2 months to go away(recovered in January 2012). Antibiotics were given as treatment. In September 2012 ("Two months ago"), the patient experienced a burning pain, including electric shock sensations at the bottom of her feet. She was told by an healthcare professional (HCP) that she has small fiber neuropathy. A computerized axial tomography(CAT) scan was performed(results not reported). Patient sought medical attention(unspecified). The outcome of small fiber neuropathy was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-NOV-2012 at 08;55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 at 14:52, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 11:25, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 11:56, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-OCT-2012 20:24, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-OCT-2012 11:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-OCT-2012 03:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 25-OCT-2012 10:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-NOV-2012 13:20, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin infection, Skin warm
Clinical narrative: Patient called day after receiving PNEUMOVAX complaining of extreme pain/soreness radiating down past elbow-arm swollen & red & warm to touch shoulder to elbow. Required antibiotics & pain meds - went to ER 12/2 received BACTRIM & cephalexin for skin infection.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-NOV-2012 at 12:45, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 03-NOV-2012 12:49, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 13:07, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 11:17, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 05-NOV-2012 at 08:32, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-NOV-2012 at 00:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 14:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 12:45, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 11:04, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.09
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 32 days old patient. On 26-NOV-2012 the patient was vaccinated with the first dose of ROTATEQ (lot # not reported). No adverse event was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.