chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Dyspnoea, Lip swelling, Urticaria
Clinical narrative: Hives, lip swelling, difficulty breathing; treated in ER with steroids and Benadryl.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Burning sensation, Dizziness, Skin warm
Clinical narrative: Started feeling extremely hot-warm or burning inside of her body and light headed sensation 5 minutes after FluMist administration.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Left arm induration, red and warm to the touch. Instructed to give patient Benadryl and put cold packs.
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Bladder catheterisation, Blood test, Computerised tomogram, Gait disturbance, Lumbar puncture
Clinical narrative: Patient woke up and was unable to walk right.
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Nuclear magnetic resonance imaging, Urine analysis
Clinical narrative: Patient woke up and was unable to walk right.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Sharp, searing pain down my arm at shot time.  For half a day severe aching on left side of body.  Range of motion and pain with moving arm from onset-current.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site. No treatment needed.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Bradycardia, Cold sweat, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Syncopal episode after receiving vaccine, hypotensive, bradycardic, diaphoretic, clammy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient was administered the shingles vaccine and returned to the pharmacy to report developing a rash.  Patient was advised to see his doctor who diagnosed him with the shingles.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Eye movement disorder, Hyperhidrosis, Hypotonia, Rhinorrhoea
Clinical narrative: Notes: Pt had adverse vaccine reaction about 1-2 minutes after injections of menactra and Tdap (in separate arms). Per mother, she blew her nose, then asked mom to "hold" her. When mother was giving hug, patient went "limp" in her arms, then leaned back with "convulsions" and "eyes rolled back." This lasted 5-6 seconds as mother laid her on table then called for help. Pt recalls asking mother to hold her, then the room going dark, then hearing mother call out of room. No loss of bowel or bladder control. She may have hit head slightly against mirror as she was being placed in reclining position. Patient observed to be very shaky and sweaty after event but was coherent and responding to questions appropriately.  She was observed in office for >30 minutes after immunization reaction with BP, pulse checked and remained stable.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Notes: Pt had adverse vaccine reaction about 1-2 minutes after injections of menactra and Tdap (in separate arms). Per mother, she blew her nose, then asked mom to "hold" her. When mother was giving hug, patient went "limp" in her arms, then leaned back with "convulsions" and "eyes rolled back." This lasted 5-6 seconds as mother laid her on table then called for help. Pt recalls asking mother to hold her, then the room going dark, then hearing mother call out of room. No loss of bowel or bladder control. She may have hit head slightly against mirror as she was being placed in reclining position. Patient observed to be very shaky and sweaty after event but was coherent and responding to questions appropriately.  She was observed in office for >30 minutes after immunization reaction with BP, pulse checked and remained stable.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Local warmth and erythema at injection site with associated itching.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Joint range of motion decreased, Musculoskeletal pain, Nausea, Pain
Clinical narrative: Intense pain in the right shoulder.  Pain was more intense towards the back of the shoulder/arm.  This was two hours after the shot.  No, on 11-20-2014, I have limited range of mobility with soarness to a shooting pain.  I feel fatigued and nausea.
Age: 34.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Pain in extremity
Clinical narrative: The patient said that their arm was sore after getting the vaccine on the 16th and the soreness has got worse instead of better as of the 20th.  He said the soreness radiates from his deltoid to his thumb on that arm.  The pain gets better with the administration of ibuprofen.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Pain
Clinical narrative: Left arm swollen/injected at site and large area around injection, tenderness at site of injection and upper left arm, bubbly almost vesicular/linear reaction at site and also pt feels achy all over.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Left arm swollen/injected at site and large area around injection, tenderness at site of injection and upper left arm, bubbly almost vesicular/linear reaction at site and also pt feels achy all over.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: Left arm swollen/injected at site and large area around injection, tenderness at site of injection and upper left arm, bubbly almost vesicular/linear reaction at site and also pt feels achy all over.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Left arm swollen/injected at site and large area around injection, tenderness at site of injection and upper left arm, bubbly almost vesicular/linear reaction at site and also pt feels achy all over.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Left arm swollen/injected at site and large area around injection, tenderness at site of injection and upper left arm, bubbly almost vesicular/linear reaction at site and also pt feels achy all over.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Endoscopy, Oesophageal disorder
Clinical narrative: Shortness of breath, chest pain, air in throat.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: Oesophageal motility test, Pulmonary function test, X-ray
Clinical narrative: Shortness of breath, chest pain, air in throat.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: Barium swallow, Chest X-ray normal, Computerised tomogram normal, Dysphagia, Dyspnoea
Clinical narrative: Shortness of breath, chest pain, air in throat.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Shortness of breath, chest pain, air in throat.
Age: 1.92
Sex: M
Vaccine: FLUN3
Symptoms: Pneumonia
Clinical narrative: A physician report from a medical representative concerns a 24 month old male. The patient had history of seizures and cerebral palsy since he was born. Concomitant medications were not provided. On 03-Nov-2009 the physician administered FLUMIST (intranasal) to the patient. On 10-Nov-2009 the patient was hospitalized for pneumonia. After a couple of weeks patient recovered from pneumonia but remained hospitalized due to complications with underlying condition. The physician was being sued by the parent. The reporter assessed the event as non-serious with additional criteria of required emergency room/ doctor visit. The company physician upgraded the event to serious due to hospitalization.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, MMRV
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash on abdomen, face, back, arms and legs. Macular and papular erythematous rash-10 days after vaccine-resolving in about 2 days.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Ataxia, Cardiac arrest, Diarrhoea, Dysarthria, Dysphagia
Clinical narrative: Per medical records. Per mother, child saw PCP and received FLUMIST on 10/17/14. By the time they arrived home the child developed watery diarrhea and vomiting. Next day child had droopy eyelids and rhinorrhea. Over the course of a few days this progressed to truncal ataxia, dysphagia, ptosis and slurred speech. The child progressed to respiratory failure and cardiac arrest. No treatment, aside from supportive fluids and tube feeding provided.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Enterovirus test positive, Eyelid ptosis, Gastrointestinal tube insertion, Influenza B virus test positive, Polymerase chain reaction
Clinical narrative: Per medical records. Per mother, child saw PCP and received FLUMIST on 10/17/14. By the time they arrived home the child developed watery diarrhea and vomiting. Next day child had droopy eyelids and rhinorrhea. Over the course of a few days this progressed to truncal ataxia, dysphagia, ptosis and slurred speech. The child progressed to respiratory failure and cardiac arrest. No treatment, aside from supportive fluids and tube feeding provided.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Respiratory failure, Rhinorrhoea, Vomiting
Clinical narrative: Per medical records. Per mother, child saw PCP and received FLUMIST on 10/17/14. By the time they arrived home the child developed watery diarrhea and vomiting. Next day child had droopy eyelids and rhinorrhea. Over the course of a few days this progressed to truncal ataxia, dysphagia, ptosis and slurred speech. The child progressed to respiratory failure and cardiac arrest. No treatment, aside from supportive fluids and tube feeding provided.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Local swelling, Pyrexia
Clinical narrative: The day after receiving immunizations, the patient developed swelling of the upper arm and a 105 degree F fever. The patient went to his doctor and was referred to the hospital. The patient was kept in the hospital for 3 days until the symptoms subsided.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain in extremity, Tenderness, Upper extremity mass
Clinical narrative: Pt. got vaccination on 8/21/14, and is still complaining of arm soreness and tenderness. She claims there is something in there that feels like a clot. Pt. is calling complain today 11/20/14.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site pain
Clinical narrative: Pt. got vaccination on 8/21/14, and is still complaining of arm soreness and tenderness. She claims there is something in there that feels like a clot. Pt. is calling complain today 11/20/14.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: 11-18-14 Developed urticaria (lg had rash with welts over entire body) day after receiving immunization. 11-20-14 Mom called and stated rash has resolved.
Age: 47.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Injection site rash
Clinical narrative: Pt had headache 1 hour after injection that lasted 2 weeks, and rash on left arm where vaccine was administered.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Received vaccine 11-17-14. Developed warm, red rash at site Rt. upper thigh overnight. No fever. Erythema 7 x 6", (R) upper outer thigh. Vaccine to Rt thigh-influenza, varicella.
Age: 28.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site swelling, Swelling
Clinical narrative: After receiving Tdap patient had swelling at injection site which spread to shoulder/back. Reaction happened within 5 mins of receiving vaccine. Given 25 mg of BENADRYL. Sxs began to resolve while being monitored in office. Prednisone 40 mg given to hold in case of systemic reaction.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: On 11-12-14 Mother brought her daughter, age 11, into HD for immunizations. Nurse administered Hep A, Hep B and FLUMIST. Mother later that day said to receptionist, that her daughter had a flu vaccine 8 days ago.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Pt had immediate localized swelling above (R) forearm injection site. Firm, sl tender, no fluctuance. Pt able to do full AROM (R) arm ice applied 10 min. Decreased swelling 10" with some residual. Saw pt 2 weeks or more later-area w/o swelling, pain.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiform, resolved. Seen allergiist. Allergist referred diagnosed.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Myositis
Clinical narrative: Myositis (L) arm at time of injection. Also occured in 2013 per pt, but not evaluated medically.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site nodule, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Per pt; she felt pain shooting down her arm and upper back shoulder. After 2 wks, she noticed about 25% loss of range of motion of her arm and she still noticed a knot on the injection site.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Per pt; she felt pain shooting down her arm and upper back shoulder. After 2 wks, she noticed about 25% loss of range of motion of her arm and she still noticed a knot on the injection site.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: Per pt; she felt pain shooting down her arm and upper back shoulder. After 2 wks, she noticed about 25% loss of range of motion of her arm and she still noticed a knot on the injection site.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Appt on 11-18-14. Received MCV4 shot in right deltoid, IM. Patient started having swelling next day and seen at our office on 11-20-14-red, swollen, hot to touch. Treated w/KEFLEX 500 mg BID, elevation BENADRYL. R/C appt on 11-21-14.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient complained of itching at the injection site. Redness was noted at the injection site. The event occurred approx 10 minutes after the patient received the vaccine. The MD evaluated the patient.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Muscle soreness at site of injection since 10/22/14 injection.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Patient has experienced "sharp persistent pain" in shoulder of the arm the shot was given. Stiffness occurs upon waking. The stiffness goes away after several hours but the pain stays. This has happened daily since 11/1/14.
Age: 97.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient woke up with fluid filled raised area on her left arm where she received her immunization. She complains of persistent pain in that area. It hasn't gotten any worse since the onset, but it hasn't gone away either. Went to the doctor several days later and given antibiotic KEFLEX 10 days, but condition did not improve.
Sex: F
Vaccine: FLU4
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a female patient who received FLUARIX QUADRIVALENT (batch number XE294, expiry date 30th June 2014). On 30th September 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX QUADRIVALENT. Additional information received: Nurse reported she gave 4 female adult patients an expired dose of flu vaccine. Additional information was either unavailable or not provided at time of report.
Age: 0.9
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received FLUARIX QUADRIVALENT (batch number 2A2KX, expiry date 26th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLUARIX QUADRIVALENT. Additional information received: A 10 months old was inadvertently given a dose of FLUARIX QUADRIVALENT.
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a health professional and described the occurrence of expired vaccine used in a adult female patient who received FLUARIX (batch number XE294, expiry date 30th June 2014). On 30th September 2014, the patient received FLUARIX. On an unkonwn date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to bee related to FLUARIX. Additional information received: Nurse reported she gave 4 female adult patients an expired dose of flu vaccine. Additional information was either unavailable or not provided at time of report.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching
Clinical narrative: This case was reported by a other health professional and described the occurrence of thumb twitching in a 18-year-old female patient who received FLUARIX (batch number LM55C, expiry date 23rd June 2015). On 8th October 2014, the patient received FLUARIX .5 ml. On 8th October 2014, 10 min after receiving FLUARIX, the patient experienced thumb twitching. On an unknown date, the outcome of the thumb twitching was not recovered/not resolved. The reporter considered the thumb twitching to be possibly related to FLUARIX. Additional information: The pharmacist reported that a patient received Flu vaccine 10-15 minutes ago. The patient's thumb on her opposite arm (of where she received the vaccine) started to twitch almost immediately after receiving the vaccine. It only twitches when the patient is in a relaxed position, otherwise if she used the thumb, it did not twitch.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccination in a 2-year-old female patient who received FLUARIX QIV (batch number 5J9E9, expiry date 20th May 2015). On an unknown date, the patient received FLUARIX. On an unkonwn date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to FLUARIX. Additional information: FLUARIX QIV was inadvertently given to a 2 years old patient which led to maladministration. FLUARIX QIV was approved for use in persons 3 years of age and older. No adverse event reported.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Nervousness, Throat irritation
Clinical narrative: This case was reported by a consumer and described the occurrence of catching a cold in a 76-year-old male patient who received FLUARIX. On 23rd September 2014, the patient received the 1st dose of FLUARIX. On 23rd September 2014, less than a day after receiving FLUARIX, the patient experienced catching a cold, tickle in throat and feel shaky. On an unknown date, the outcome of the catching a cold, tickle in throat and feel shaky were not recovered/not resolved. It was unknown if the reporter considered the catching a cold, tickle in throat and feel shaky to be related to FLUARIX. Additional information: The patient planned to follow-up with his pharmacist on 24 September 2014.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence if arm pain at injection site in a 65-year-old female patient who received FLUARIX TETRA. On 26th September 2014, the patient received a dose of FLUARIX TETRA .5 ml. On 27th September 2014, 1 days after receiving FLUARIX TETRA, the patient experienced arm pain at injection site. On an unknown date, the outcome of the arm pain at injection site was not recovered/not resolved. It was unknown if the reporter considered the arm pain at injection site to be related to FLUARIX TETRA. Additional information: Patient reports the entire upper arm that was vaccinated was painful. There was no redness or swelling but it was painful to touch. She stated she had never a reaction that had lasted two weeks from any previous vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccination. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccination were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccination to be related to BOOSTRIX. Additional information received: A patient was given BOOSTRIX instead of PEDIARIX. No other information was given.
Age: 1.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a pharmacist and described the occurrence of inappropriate age at vaccination in a 1-year-old patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to BOOSTRIX. Additional information: A BOOSTRIX dose was inadvertently given to a 1 year old patient. BOOSTRIX was recommended for children of 10 years and more.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccination in a female patient who received FLUARIX TETRA (batch number UI191AA?, expiry date unknown). On an unknown date, the patient received FLUARIX TETRA. On an unknown date, an unknown time after receiving FLUARIX TETRA, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to FLUARIX TETRA. Additional information: A pediatric patient was inadvertently given an adult dose (0.5 mL) of FLUARIX QIV. No adverse event was reported.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 29-month-old male patient who received FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration and wrong administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLUARIX QUADRIVALENT. Additional information received on 26 September 2014: FLUARIX QIV was administered instead of another flu vaccine approved for that age.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child pati4ent and unknown gender. On 09-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several 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 as received from registered nurse refers to a unspecified number of patients of unknown age and gender. Patient medical history and other previous drug allergic reactions were not reported. On an unknown date the patient was vaccinated with PROQUAD (Merck) (dose number, lot number and expiry date unknown). No concomitant therapies were reported. Since 07-NOV-2014 PROQUAD (Merck) have been exposed to additional temperature excursions and additional unspecified number of improperly stored doses of PROQUAD (Merck) have been administered to patients. Action taken with PROQUAD (Merck) was unknown. The outcome of temperatures outside of the proper storage range, exposed to additional temperature excursions and no adverse effect was unknown. The reporter considered temperatures outside of the proper storage range and no adverse effect to be not related to PROQUAD (Merck). This case # 1411USA007174 is linked to case # 1411USA009134 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a unspecified number of patients of unknown age and gender. Patient medical history and other previous drug allergic reactions were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose number, lot number and expiry date unknown) for vaccination. No concomitant therapies were reported. Since 07-NOV-2014 (Oka/Merck) VARIVAX have been exposed to additional temperature excursions and additional unspecified number of improperly stored doses of (Oka/Merck) VARIVAX have been administered to patients. Action taken with (Oka/Merck) VARIVAX was unknown. The outcome of temperatures outside of the proper storage range, exposed to additional temperature excursions and no adverse effect was unknown. The reporter considered temperatures outside of the proper storage range and no adverse effect to be not related to (Oka/Merck) VARIVAX. This case # 1411USA009134 is linked to case # 1411USA007174 via same reporter link. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 14-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 17-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 02-SEP-0214 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 30-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 years old adolescent patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 18 years old adolescent patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with first dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a female physician via a company representative refers to herself. In 1999 (exact date unspecified, reported as 15 years ago) the patient was vaccinated with a first dose and in 2000 (exact date unspecified, reported as a year apart) the patient was vaccinated with second dose of VARIVAX (Merck) (exact dosage, route of administration, anatomical location, lot number were not reported). On an unknown date, the patient's titers came back negative when testing was done. The outcome of event was not reported. The relatedness between event and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 01-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 29-JUL-2014 the patient was vaccinated with a doses of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 11-NOV-2014, the patient was inadvertently vaccinated with an expired dose of MMR II lot # H017027, expiration date: 14-SEP-2014, albumin status: HSA, 0.5 ml, subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no pertinent medical history and no drug reactions/allergies. On 03-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # K000330 (expired date 06-MAR-2015). There was no concomitant medication. A couple of days later, approximately on 05-SEP-2014 the patient experienced redness around injection site and size of redness was about 5 inches in circumference. About 2 weeks after vaccination, approximately on 17-SEP-2014 the patient noticed that glands around her neck were swollen. The patient went to physician's office for these symptoms but physician did not prescribe any treatment and advised the patient to just observe symptom. The pharmacist reported that swollen glands had been resolved but the patient still had little bit of redness around injection site, over 2 months after vaccination. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 05-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 31-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: None-pt received ZOSTAVAX instead of VARIVAX.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-NOV-2014 the patient was vaccinated with an improperly stored dose of GARDASIL (lot#, dose, route not reported). Concomitant medications were not provided. No adverse events were reported. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 25-year-old patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to HAVRIX. Additional information: An expired dose of HAVRIX was given to a patient. No adverse event was reported.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 18 years old adult patient and unknown gender. On 16-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by and described the occurrence of inappropriate age at vaccine administration in a 7-month-old male patient who received HAVRIX pediatric. On an unknown date, the patient received HAVRIX pediatric at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to HAVRIX pediatric. Additional information: A 7 month old patient old was inadvertently administered the first dose of HAVRIX too early. HAVRIX pediatric was recommended for children of 12 months and more.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, lot# and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, an empty carton single dose ZOSTAVAX (lot # K007177,  parenteral, expiration date 21-AUG-2014), for shingles, caused an anonymous patient to miss a dose. No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up information was received from a Licensed Practical Nurse. The nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and date of vaccine administration) available at the reporting time. The nurse also stated she might fax information at a later time. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 17 years old adolescent. The patient was vaccinated with GARDASIL (J015378, expiration date 09-APR-2016) on 22-SEP-2014. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Pt is an insulin dependant female (on an insulin pump) given her 1st varicella vaccine w/o incident after 2nd vaccine she developed a breakthrough mild varicella outbreak and 50 lesions. No fever-mild.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-OCT-2014 the patient was vaccinated with GARDASIL INJ (route, dosage and dose number unknown; lot # J015378 EXP 09-APR-2016). The nurse reported that a patient was administered an improperly stored dose of GARDASIL. No adverse events were reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: (L) arm red swollen warm to touch about five inches long. Sore painful to touch. Took 10 days to totally feel better. Got a little better each day.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received TWINRIX (batch number unknown, expiry date 13th September 2014). On an unknown date, the patient received TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to TWINRIX. Additional information received: A patient was administered an expired vaccine. No more details available due to vaccine given at another facility.
Sex: F
Vaccine: HPV2
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of drug dose interval too long in a female patient who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced drug dose interval too long. On an unknown date, the outcome of the drug dose interval too long was unknown. It was unknown if the reporter considered the drug dose interval too long to be related to CERVARIX. Additional information: A patient was vaccinated with only 2 doses of CERVARIX. Recommended schedule was 3 dose (0, 1 and 6 months).
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse and described the occurrence of accidental overdose in a 4-year-old male patient who received PEDIARIX (batch number 232P5, expiry date 30th August 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. It was unknown if the reporter considered the accidental overdose to be related to PEDIARIX. Additional information: The nurse reported that the patient was accidentally administered both PEDIARIX and INFANRIX during the same day office visit which led to maladministration "accidental overdose". The intended product to be administered was INFANRIX only.