chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.47
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Optic nerve disorder, VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 27 August 2015. This case involves a female patient who was vaccinated with a dose of PENTACEL; a dose of ROTATEQ and a dose of PREVNAR ([dose, dose in series, expiry date, route and site of administration were not reported for all the vaccines) (batch number reported as C4772AA, C4855AA, K020183, L62072]) all on 12 July 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced fussiness (for 2 weeks), bulging fontanel and optic nerve palsy (went to ophthalmologist). Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from fussiness and optic nerve palsy. The outcome of the event bulging fontanel was unknown. Upon internal medical review, the seriousness of the event of optic nerve palsy was considered as other - important medical event. List of documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site nodule
Clinical narrative: Patient called HD informing nurse she had received flu shot at apt on Wednesday and noticed raised knot type area near injection site.
Age: 80.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Cough, Pyrexia
Clinical narrative: Fever. (TYLENOL). Cough.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Infection, Injection site pain, Rash
Clinical narrative: Rash, pain at injection site cellulitis infection.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness followed by severe headache.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Fatigue, Grip strength decreased, Influenza like illness, Pain
Clinical narrative: Pt called on 9/11/15 to report some side effects that onset 9/8/15. Feeling pronounced flu-like symptoms (fatigued, achy), but also tingling in hands and fingers. This comes and goes, sometimes just in the thumbs, sometimes all over the hands, but only there. He reports being strangely weak, his grip is difficult to maintain sometimes.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Paraesthesia
Clinical narrative: Pt called on 9/11/15 to report some side effects that onset 9/8/15. Feeling pronounced flu-like symptoms (fatigued, achy), but also tingling in hands and fingers. This comes and goes, sometimes just in the thumbs, sometimes all over the hands, but only there. He reports being strangely weak, his grip is difficult to maintain sometimes.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received the influenza vaccination on 9/08 when she woke up on 9/09 area where Influenza vaccination was given was red, swollen, and sore.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash generalised, Skin warm
Clinical narrative: Symptoms: rash - diffuse, full body rash (trunk and extremities), from the neck down to the toes, red, circular, flat and raised, itches, warm, rash is slowly improving, (9-14-15 - less red and itching). Treatment: Benadryl, Calamine Lotion, Medrol Steroid Dose Pack.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Echocardiogram, Electrocardiogram, Electroencephalogram, Eye movement disorder, Hypopnoea
Clinical narrative: Multiple episodes of pallor, shallow breathing, eyes rolling up, and tachycardia.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Laboratory test, Lumbar puncture, Pallor, Tachycardia
Clinical narrative: Multiple episodes of pallor, shallow breathing, eyes rolling up, and tachycardia.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chest X-ray abnormal, Headache, Laboratory test normal, Myalgia, Pleural effusion
Clinical narrative: Patient had onset of fever, myalgias & headache within several hours of vaccine. Temp has persisted up to 103 - subsequently diagnosed with left lower lobe pneumonia - failed outpatient antibiotics - admitted x 24 hrs for IV antibiotics.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pneumonia, Pyrexia, Respiratory viral panel
Clinical narrative: Patient had onset of fever, myalgias & headache within several hours of vaccine. Temp has persisted up to 103 - subsequently diagnosed with left lower lobe pneumonia - failed outpatient antibiotics - admitted x 24 hrs for IV antibiotics.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Headache, Myalgia, Pneumonia, Pyrexia
Clinical narrative: Patient had onset of fever, myalgias & headache within several hours of vaccine. Temp has persisted up to 103 - subsequently diagnosed with left lower lobe pneumonia - failed outpatient antibiotics - admitted x 24 hrs for IV antibiotics.
Age: 1.6
Sex: U
Vaccine: MMR
Symptoms: Blood immunoglobulin M increased, Measles, Measles antibody positive, Polymerase chain reaction positive, Pyrexia
Clinical narrative: Information has been received from the authors in a published literature article regarding a 19 month old patient of unknown gender. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, in approximately September 2013, when the patient was 12 months old, the patient was vaccinated with 1 dose of MMR (Manufacturer unknown), (Lot #, exp date, strength and dose were not provided). There was no concomitant medication reported. On 17-APR-2014, the child was febrile and developed a rash while on an international flight. The child's illness was clinically compatible with measles, which was confirmed by polymerase chain reaction and immunoglobulin M serology, on an unknown date in April 2014. The case was genotyped as D8 (endemic where the child evidently acquired measles). The child was admitted for 3 days at the hospital and was fully recovered without complications, on an unknown date in April 2014. Although primary vaccine failure was not laboratory confirmed in this case, the child's highly elevated acute immunoglobulin M serology result and classic clinical presentation were consistent with immunologic naivete before infection, on an unknown date. The outcome of vaccine failure was not reported. The reporter authors considered vaccination failure and measles to be related to MMR (Manufacturer unknown). Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: MMR
Symptoms: Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article regarding a 19 month old patient of unknown gender. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, in approximately September 2013, when the patient was 12 months old, the patient was vaccinated with 1 dose of MMR (Manufacturer unknown), (Lot #, exp date, strength and dose were not provided). There was no concomitant medication reported. On 17-APR-2014, the child was febrile and developed a rash while on an international flight. The child's illness was clinically compatible with measles, which was confirmed by polymerase chain reaction and immunoglobulin M serology, on an unknown date in April 2014. The case was genotyped as D8 (endemic where the child evidently acquired measles). The child was admitted for 3 days at the hospital and was fully recovered without complications, on an unknown date in April 2014. Although primary vaccine failure was not laboratory confirmed in this case, the child's highly elevated acute immunoglobulin M serology result and classic clinical presentation were consistent with immunologic naivete before infection, on an unknown date. The outcome of vaccine failure was not reported. The reporter authors considered vaccination failure and measles to be related to MMR (Manufacturer unknown). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient called 11:38 am 9/4/15 stating that his arm was slightly swollen and he had a low grade fever after getting a PREVNAR 13 and AFLURIA flu shot on 9/3/15 at 6:00 pm pharmacist on duty told patient to take ibuprofen and call MD if worsens.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pneumonia
Clinical narrative: Patient call me on 9-11-15 Friday afternoon and said his whole body ache. I call his primary doctor and I told the patient to go to the hospital. Patient was admitted with pneumonia. Patient was released from hosp on 9-14-15.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Bursa disorder, Inflammation, Movement disorder, Pain
Clinical narrative: Severe pain, limited ROM-immediately that evening (Sept. 17, 2015) Dr. visits, prescriptions, x ray- physical therapies.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Grapefruit sized bruise on arm recommended physician examine to rule out infection.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Bone pain, Diarrhoea
Clinical narrative: Patient stopped into store on 9-4-15 and informed me that 12 hours after receiving HIGH DOSE flu shot she developed an upset stomach, aching bones, & diarrhea. She is fine now.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: 9/5/15-pt. came into rx with redness and raise skin at and around site of injection (L) arm- approx. 4"x3" and 2x2"-under that. Patient complained of SOB and soreness of the back upper middle. Patient states that she has asthma and was pulling plants the day after shot. She was told to go to ER should she have ant difficulty breathing.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Heart rate increased, Pyrexia, Rash
Clinical narrative: 9/4 Fever, rash -> on left arm, dizziness, patient said wife noticed an increase heart rate. 9/5 Patient reported was doing fine now.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscle spasms, Pain
Clinical narrative: 8/27/15 woke up with generalized achiness & neck spasms on same side as shot. Applied ice. 8/30/15 couldn't turn head from side to side. 9/2 called doctor who call 6 day MEDROL Dose pack into pharmacy-9/4 feeling much better.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Delirium, Pyrexia
Clinical narrative: Fever (103.4 degrees F by 3:00 am) & 102 degrees F. Pt took ASA 325 mg, then fever subsided and delirious, holding on to bed, couldn't follow directions. Temp 97 degrees in am next morning
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Confusional state, Dizziness, Pruritus, Pyrexia
Clinical narrative: Patient stated she went home and 4 hours later she became very sleepy. She then took a nap. When she woke up she felt dizzy, feverish, confused, itchy, and could not walk. All side effects have subsided except the itchiness at this point. She has been treating herself with Benadryl and a topical anti itch lotion.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: Patient stated she went home and 4 hours later she became very sleepy. She then took a nap. When she woke up she felt dizzy, feverish, confused, itchy, and could not walk. All side effects have subsided except the itchiness at this point. She has been treating herself with Benadryl and a topical anti itch lotion.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Per pt: Moderately severe reaction to Prevnar 13.  Large injection sight swelling, redness, itching.  Red rash covering chest.  Body aches, joint & muscle pain.  No respiratory issues.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash, Rash erythematous, Vaccination complication
Clinical narrative: Per pt: Moderately severe reaction to Prevnar 13.  Large injection sight swelling, redness, itching.  Red rash covering chest.  Body aches, joint & muscle pain.  No respiratory issues.
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever started. Peaked at 104 on 9/13/15. Today 9/14/15 fever currently 101. Per mother, diarrhea/loose stools off and on since receiving vaccines.
Age: 1.27
Sex: M
Vaccine: DTAP
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, Conjunctival hyperaemia, Diarrhoea, Fatigue
Clinical narrative: Generalized red, raised rash consistent with hives; 2+ tonsils, increased fatigue, mild diarrhea, mild conjunctiva injection, & bilateral anterior cervical lymphadenopathy.
Age: 1.27
Sex: M
Vaccine: DTAP
Symptoms: Full blood count normal, Lymphadenopathy, Rash erythematous, Rash generalised, Streptococcus test negative
Clinical narrative: Generalized red, raised rash consistent with hives; 2+ tonsils, increased fatigue, mild diarrhea, mild conjunctiva injection, & bilateral anterior cervical lymphadenopathy.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain, restricted arm movement.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Muscle twitching, Tremor
Clinical narrative: Apro 5 mins after vaccines were administered, child became very dizzy and was shaking. He was then placed to lie supine BP93/53 P74. After lying for about 2-3mins he no longer felt dizzy but complained of being hungry so was given sips of apple juice. At 9:40AM BP 109/69 P76 client in sitting position denies any dizziness or nausea but still shaking, however the shaking looks more like frequent uncontrollable twitching. Client alert and oriented so was allowed to have breakfast. At 10:02AM  BP107/59 P 83. Client states that he feels fine after having his breakfast. Body still shaking/twitching but less frequently and not as strong as before. Client continues to be oriented and speaking to mom clearly. After a few moments he is allowed to stand and walk around office with no trouble but twitch continues to be noted occasionally. At 1010AM Client was taken to clinic pediatrician for evaluation prior to being discharged from the clinic. Pediatrician cleared him and client left the office with his mom alert and oriented with mild occasional twitching at 10:21AM.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever to 102.6, nausea with vomiting.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscle twitching, Tremor
Clinical narrative: Aprox 2mins after vaccines were administered child began to visibly shake/twitch a little. She admitted to be a little nervous but felt fine. Denied any dizziness, nausea, or feeling light headed. Ate breakfast this morning. Oriented and alert but can feel her body twitching more strongly after after aprox another 2mins. Client continued to sit upright and talk with Grandmother and staff. Twitching decreased significantly but still occurring. Client continues to be alert and oriented allowed to walk around in office and did so without issue. Discharged from office at 12:03pm with very mild occasional twitch. Advised to f/u with ER if symptoms returned.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Balance disorder, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site rash
Clinical narrative: Extreme drowsiness, rash at injection site, itching, swelling, knot at injection site, light headed, unsteady, redness at injection site, weaknesss. Symptoms lasted four days. Treated with ice pak, Benadryl cream. Unaware at the time, that an injection? was the cause until a return visit to physician's office to ask questions, followed by my own research into the booster (no vaccine?) as PREVNAR. This was first attempt to secure a vaccine against pneumonia. Am I going to seek a "real" vaccination whenever- emphatically NO.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Somnolence
Clinical narrative: Extreme drowsiness, rash at injection site, itching, swelling, knot at injection site, light headed, unsteady, redness at injection site, weaknesss. Symptoms lasted four days. Treated with ice pak, Benadryl cream. Unaware at the time, that an injection? was the cause until a return visit to physician's office to ask questions, followed by my own research into the booster (no vaccine?) as PREVNAR. This was first attempt to secure a vaccine against pneumonia. Am I going to seek a "real" vaccination whenever- emphatically NO.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Activated partial thromboplastin time, Full blood count, Prothrombin time, Purpura
Clinical narrative: Purpuras in left and right forearms, not tender, not blanching, not raised, not itchy, lasting for 7 days in right arm, left arm pupura still present but smaller size refers mom. No treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: C-reactive protein increased, Erythema, Fibrin D dimer increased, Full blood count, Metabolic function test
Clinical narrative: Bilateral feet pain with redness and swelling. No known injury.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate increased, Ultrasound scan normal
Clinical narrative: Bilateral feet pain with redness and swelling. No known injury.
Age: 12.0
Sex: M
Vaccine: RAB
Symptoms: Feeling abnormal, Malaise, Pyrexia, Vision blurred
Clinical narrative: Mom reports that around 10:00 PM patient just did not feel well. She gave him some water, put him to bed-he was OK. At 11:30, he awoke with temp of 102, blurry vision and said his arms and legs "felt funny". She gave him Tylenol and took him to ED. (around 1:00 AM 8/5/15) There temp was 34, his neuro sx had resolved, and his P.E. was normal. Sent home with no therapy and with Dx of post- immunization fever.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given the Fluzone HD indicated for patients 65 years of age and older. The patient is only age 54 at time of administration.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Severe muscle pain that progressed to difficulty moving arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: Rash and inflammation from site of injection to elbow on left arm.
Age: 1.03
Sex: F
Vaccine: MMR
Symptoms: Crying
Clinical narrative: Unconsolable crying that lasted 4+ hours. Received first MMR vaccine that morning.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure before pregnancy, Nausea, Vomiting
Clinical narrative: Nausea and vomiting.
Age: 68.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Dizziness, nauseea, fever and chills.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus generalised
Clinical narrative: Began to have itching all over body. No airway compromise. Seen 9/9/15 3:15pm. Give IM Benadryl. Prescription for Medrol dose pak and take OTC Benadryl as needed. Had follow ups qd. Resolved as of 9/14/15. No hospitalization.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Nausea
Clinical narrative: Nausea, patient went to urgent care and received prescription for phenergan 12.5mg.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Seizure like phenomena
Clinical narrative: Sudden onset chills (patient described as seizure like) and high fever. Lasted overnight for about 10 hours. Was gone the next day. No treatment used.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at injections site, swelling. Called MD office to alert them.
Age: 1.74
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever of 102, 2 hours later infant threw up, fever has been ranging from 99-104 with fever reducers.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Muscle spasms
Clinical narrative: Shortly after the patient received vaccinations she complained of back pain and spasm.
Age: 80.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Rash, Rash pruritic, Skin exfoliation
Clinical narrative: AN ITCHY RASH ACROSS POSTERIOR NECK; AN UNUSUAL REDNESS AND PEELING OF SKIN TO HANDS AND FEET. ON 9/10/15, A RAISED, ITCHY RASH APPEARED ON HANDS, ARMS AND WAS SPREADING TOWARDS BODY.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Slight pain on injection. Bump formed quickly. Bump turned to a hot, red swelling area the size about 3 inches in diameter. Bruising and burning at injection site 9/10 through today (9/14).  Patient reports lethergy and diarrhea.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Slight pain on injection. Bump formed quickly. Bump turned to a hot, red swelling area the size about 3 inches in diameter. Bruising and burning at injection site 9/10 through today (9/14).  Patient reports lethergy and diarrhea.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Injection site pain, Local swelling
Clinical narrative: Area just under injection site appeared raised and puffy. Also had a light red/pink color with some slight bruising. Patient said site was painful when being touched. Patient was recommended to put a cold compress on site, and take an oral pain reliever such as Motrin or Tylenol. Also advised to notify physician and pharmacy if anything changes or progresses.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Mobility decreased, Pain, Tremor
Clinical narrative: Severe pain in shoulder joint - unable to move or lift arm without excruciating pain. No redness or swelling.  Severe shaking due to pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb
Clinical narrative: Severe pain in shoulder joint - unable to move or lift arm without excruciating pain. No redness or swelling.  Severe shaking due to pain.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: IMMEDIATELY UPON INJECTION, A FIRM BUMP THE SIZE OF A DIME FORMED AT THE SITE OF INJECTION.  PATIENT DENIED ANY SHORTNESS OF BREATH, DIZZINESS. SHE STATED SHE FELT "FINE." AN ICE PACK WAS PLACED AT INJECTION SITE AND PATIENT WAS ASKED TO BE OBSERVED FOR 15 MINUTES.  AFTER 10 MINUTES OF OBSERVATION, THE BUMP AND REDUCED IN SIZE AND PATIENT INSISTED SHE FELT FINE AND LEFT THE FACILITY AGAINST THE PHARMACIST'S ADVICE.
Age: 1.75
Sex: F
Vaccine: FLUX
Symptoms: Dermatitis diaper, Miliaria, Rash macular, Viral rash
Clinical narrative: Pt developed a rash spreading from the diaper area to the limbs.  The rash is macular, 1-2 mm in diameter, without secondary lesions.  Some coalesence of lesions in the diaper area. Ddx also includes viral exanthem and heat rash.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, soreness, swelling, itching and vesicles formed at the site of injection.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling, itching and vesicles formed at the site of injection.
Age: 36.0
Sex: M
Vaccine: FLUC3, PNC13
Symptoms: Decreased appetite, Erythema, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: The pt. developed noticeable itching and redness at the injection site the same night as the vaccines were administered. upon awakening, the pt. experienced increased swelling, rash, pain, redness, site warm to touch, loss of appetite, and fatigue. Pt. initially tried Ibuprofen and ice to treat symptoms, but offered little relief. The rash continued to spread so pt. sought treatment at the local emergency room, where she was given a prescription for hydroxyzine.
Age: 36.0
Sex: M
Vaccine: FLUC3, PNC13
Symptoms: Injection site warmth, Pain, Rash, Swelling
Clinical narrative: The pt. developed noticeable itching and redness at the injection site the same night as the vaccines were administered. upon awakening, the pt. experienced increased swelling, rash, pain, redness, site warm to touch, loss of appetite, and fatigue. Pt. initially tried Ibuprofen and ice to treat symptoms, but offered little relief. The rash continued to spread so pt. sought treatment at the local emergency room, where she was given a prescription for hydroxyzine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Pain in extremity, Peripheral swelling
Clinical narrative: COUGH, CHEST TIGHTNESS, ARM IS SORE AND SWOLLEN A LITTLE.  CHEST TIGHTNESS IS WORSE WHEN COUGHING.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Pain in arm after flu shot. Stabbing pain. Got pneumonia shot 8 days later, same arm. Now experiencing muscle spasms, limited range of motion, weakness and pain. Pain is 5/10 when sleeping, or attempting to use arm. Has gotten worse with time. ALEVE, TYLENOL, ADVIL do nothing for pain.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient reported a red warm rash going down arm from deltoid down past elbow, noticed at 9/12/15 9:00 pm, saw primary physician on 9/14/15 & was diagnosed w/adverse reaction. Started KEFLEX & prednisone.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased
Clinical narrative: Pt received FLUZONE HD around noon on 9-12-15. At 7 pm her BP read 165/97. She took BP meds; retested later and it decreased to 108/65 at 9:45 pm. AM of 9-13-15 BP=165/97. Took BP meds-retested at 9:45 pm: 108/68. Pt BP usually not above 140/80 not normally is in the 130s at the highest per pt.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: Progressively got worse. Fever. Headache. Chest congestion. Diarrhea. Got shot Tuesday felt better Saturday.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Influenza, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 24 hours after vaccination-rt arm red hot (extended from shoulder to mid torso). Also flu symptoms & slight fever. Worsened symptoms on 2md day. Treated with ibuprofen & APAP. Began to improve on day 2. By am of day 4 symptoms gone.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: 24 hours after vaccination-rt arm red hot (extended from shoulder to mid torso). Also flu symptoms & slight fever. Worsened symptoms on 2md day. Treated with ibuprofen & APAP. Began to improve on day 2. By am of day 4 symptoms gone.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient. Concurrent condition included pain. Past drug history was unknown. Medical history included no conditions weakening her immune system and no vaccines within the last week. On 28-AUG-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # was L020482, expiration date 02-SEP-2016, strength unknown) and FLUVIRIN (Novartis), 0.5ml once intramuscularly (lot # 1514601, expiration date 01-MAY-2016, strength unknown). Her concomitant medication included possibly an unknown pain medication. On 29-AUG-2015, the patient experienced redness, swelling and hot to touch at the injection site, nausea, weakness and round welts. On 30-AUG-2015, she felt worse. On an unknown date, the pharmacist advised her to use a cold compress to alleviate the swelling, but it did not work. There was no lab performed. As of 30-AUG-2015, it was unknown if she would have the ZOSTAVAX or the FLUVIRIN again and the patient continued to experience worsened redness, swelling, and hot to touch at the injection site as well as nausea, weakness, and round welts. Causality between events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient. Concurrent condition included pain. Past drug history was unknown. Medical history included no conditions weakening her immune system and no vaccines within the last week. On 28-AUG-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # was L020482, expiration date 02-SEP-2016, strength unknown) and FLUVIRIN (Novartis), 0.5ml once intramuscularly (lot # 1514601, expiration date 01-MAY-2016, strength unknown). Her concomitant medication included possibly an unknown pain medication. On 29-AUG-2015, the patient experienced redness, swelling and hot to touch at the injection site, nausea, weakness and round welts. On 30-AUG-2015, she felt worse. On an unknown date, the pharmacist advised her to use a cold compress to alleviate the swelling, but it did not work. There was no lab performed. As of 30-AUG-2015, it was unknown if she would have the ZOSTAVAX or the FLUVIRIN again and the patient continued to experience worsened redness, swelling, and hot to touch at the injection site as well as nausea, weakness, and round welts. Causality between events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Feeling hot, Rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. There was no information about the patient's pertinent medical history and concomitant therapies provided. On 08-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On approximately 22-AUG-2015 (reported as "a week ago Saturday morning"), the patient broke out in a rash around eye and hand. The patient sought medical attention. The outcome of the event was unknown. The relatedness between rash around eye and hand and ZOSTAVAX was not reported. Additional information is not expected as there were no healthcare professional contact details provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. There was no information about the patient's pertinent medical history and concomitant therapies provided. On 08-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On approximately 22-AUG-2015 (reported as "a week ago Saturday morning"), the patient broke out in a rash around eye and hand. The patient sought medical attention. The outcome of the event was unknown. The relatedness between rash around eye and hand and ZOSTAVAX was not reported. Additional information is not expected as there were no healthcare professional contact details provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. The patients pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot# K010336 with expiration date 22-JUL-2016 (dose, frequency and route were not reported). Information regarding concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown  age and gender. No pertinent or historical conditions were reported. On 10-SEP-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L009203, expiration date 17-MAR-2017, strength, dose and route unknown) and a dose of (Oka/Merck) PROQUAD (lot # L014401, expiration date 23-OCT-2016, strength, dose and route unknown) (overdose). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (K020181, expiry 24-JUN-2015) (K023537, exp 22-JUN-2016) (K024700 exp. 30-JUL-2016) (dose and route unspecified). Other suspect therapies included GARDASIL (K011562 expiry 08-APR-2017) (dose and route unspecified). No adverse effect reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates in August 2015, these patients were vaccinated with improperly stored (Merck) PROQUAD (Lot# reported as L007320, expiration date: 03-SEP-2016, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Lot# L007320 is an invalid lot number for PROQUAD. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On 19-AUG-2015, the patient was vaccinated subcutaneously in the left upper arm with 0.5 ml doses of MMR II (therapy type was not reported) (lot number K016154 and expiration date 24-SEP-2016). Concomitant therapy was not reported. On 24-AUG-2015 (reported as five days post vaccination), the patient developed rash on her stomach and back. The pharmacist stated that he would recommend cortisone cream as treatment for the event. The outcome of the event was reported as not recovered. The patient sought medical attention, she called pharmacy on 02-SEP-2015 (reported as today). The relatedness between the event and the MMR II was not reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates in August 2015, these patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L006383, expiration ate: 25-FEB-2017 or lot # L017145, expiration date: 13-MAY-2017, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, multiple patients were vaccinated with a dose of improperly stored MMR II lot # K002528, expiry date: 18-FEB-2016, lot # K016153, expiry date: 24-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with a dose of improperly stored RECOMBIVAX HB, lot# reported as1004754, expiry date 10-NOV-2016, dose, site and route of administration were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # K025004, expiration date 22-JUL-2017, dose and route were unknown) (Incorrect product storage). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of COMVAX (lot # J002621, expiration date 29-NOV-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # K023534, expiration date 22-MAY-2016, dose and route were unknown) (Incorrect product storage). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K007982, expiration date 03-JUN-2016, dose, frequency and route were not reported) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of Oral, ROTATEQ lot # K016263, expiration date: 26-JUN-2016. No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K015827, expiration date: 11-MAR-2016, (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of M-M-R II (lot number K010319 and expiration date 22-JUL-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Adverse event
Clinical narrative: This initial spontaneous report was received from the patient's mother referring to her daughter; a female patient of unknown age. There was no pertinent medical history or drug allergies/drug reactions reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL injection (strength, dose, route, lot # and expiration date were not provided). There was no concomitant medication described. The reporter stated that since on an unknown date in September 2010, her daughter had been "out of school" due to developed unspecified symptoms after receiving GARDASIL. At the time of the report, the outcome of adverse event was not recovered. The relatedness between the adverse event to GARDASIL was not reported. Upon internal review adverse event was considered as disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Healthcare Worker refers to an unspecified patients of unknown age and gender. The patient's medical history, drug allergies and concomitant medications were not reported. On unspecified dates since 13-AUG-2015, the patients were vaccinated with VARIVAX (Merck) K006133, exp 29-APR-2016; L002215, exp 21-JAN-2017; L004649, exp 11-FEB-2017 and L012035, exp 07-MAR-2017, (dose, frequency, and route not reported), which were exposed to temperatures outside of the recommended range. No  adverse experience has been reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin ulcer
Clinical narrative: Information has been received from a pharmacist concerning a male patient of unknown age. There was no pertinent medical history or drug reactions/allergies reported. On 04-SEP-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot# and expiration date unspecified). After vaccination the patient experienced an active case of shingles "with open sores on the lower back and the front of his body". VALTREX was given for the adverse events at the time of report. Dates of onset of shingles and therapy of VALTREX were unspecified by the reporter. The reporter also stated that the patient was experiencing a worsening of pain on an unspecified date following the administration of ZOSTAVAX. The patient sought medical attention by making an appointment with a physician. At the time of reporting, the outcome and causality between the events and ZOSTAVAX were not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD lot # L009209, expiration date: 17-SEP-2016 (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office administrator refers to an unspecified number of patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date starting February 2015, the patients were vaccinated with an unspecified number of doses of oral, ROTATEQ (lot # K001453, exp.date 21-NOV-2015 (dose and dose number were not provided). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reporter (MARRS # 1509USA001811). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office administrator refers to an unspecified number of patients of unknown ages and genders. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified dates starting in February 2015, the patients were vaccinated with an unspecified number of doses of GARDASIL (lot # J009243, exp. date 23-APR-2016) (route, dose and dose number were not provided). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reporter (MARRS # 1509USA003613). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a 57 years old female patient with diabetes and fibromyalgia, who was reporting on herself. The patient had no drug reactions or allergies. The patient's medical history was not reported. On 21-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (lot #, expiration date, dose, route of administration and anatomical location were not reported). No concomitant therapies were reported. On 21-AUG-2015, immediately after vaccination, the patient "could feel the vaccine going through her body". The pharmacist told the patient to take ibuprofen to treat his symptom. The patient administered ibuprofen 200 mg and the feeling went away. On an unknown date in 2015 (reported as "a coupled days ago"), the patient developed rash on both legs "that did not look like chickenpox". The patient stated that "the rash was itchy, like a mosquito bite and somewhat painful". The patient had been applying an unspecified analgesic cream and mupirocin 2% to the rash. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, multiple patients were vaccinated with a dose of improperly stored (oral, ROTATEQ) lot# K024700, expiry date 30-JUL-2016, dose was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.