chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.66
Sex: M
Vaccine: HEPA, MMR
Symptoms: Irritability, Malaise, Pyrexia, Rash, Rash generalised
Clinical narrative: On 10/13 developed low fever and generally sick-acting, by 10/15 fever rose to 102 degrees F, on 10/16 fever gone but rash appeared on cheeks, 10/17 rash spread all over body and fever back up to 100 degrees.  Both rash and fever gone by 10/19.  Treated with infant Tylenol and fluids.  Dr. recommended ER visit because he claimed it had nothing to do with vaccine, but we kept at home due to information on vaccine insert about exactly this type of reaction. Child remained generally fussy until about 16 days after vaccine.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Significant, localized rash at injection site of High Dose flu shot. no shortness of breath or throat tightness or any other problem.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Nausea, Neck pain, Pain
Clinical narrative: Pain at the injection site that radiated all the way to the neck, fever of 101.0, chills, body aches, nausea.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pain at the injection site that radiated all the way to the neck, fever of 101.0, chills, body aches, nausea.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Ear pain, Epstein-Barr virus test, Eyelid function disorder, Gingival bleeding
Clinical narrative: Ear pain 10/17. Mouth/tongue sore 10/19, bleeding (L) gums 10/22 > resolved 10/22. Inability to wink (R) - 10/24. Bell's Palsy 10/25 - tx sought at urgent care - Dx with Bell's Palsy - placed on prednisone.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Oral pain, VIIth nerve paralysis
Clinical narrative: Ear pain 10/17. Mouth/tongue sore 10/19, bleeding (L) gums 10/22 > resolved 10/22. Inability to wink (R) - 10/24. Bell's Palsy 10/25 - tx sought at urgent care - Dx with Bell's Palsy - placed on prednisone.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oral pruritus
Clinical narrative: C/o itching around her mouth approx 10 min after receiving 1st flu vaccine BENADRYL 50 mg and ZANTAC 150 mg given PO - s/s improved within 30 min.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Pruritus generalised
Clinical narrative: States after receiving flu vaccine 10/23/14 developed generalized itching, voice hoarseness and difficulty breathing.
Age: 14.0
Sex: M
Vaccine: FLUN4, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: (L) deltoid site erythema began 10-24-14. Vesicle appeared 10-25-14. 1 large vesivle - few small at the site. BENADRYL, ibuprofen.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received FLUZONE HD in right arm and PREVNAR 13 in left arm on 10/19/14. She reported that she noticed a warm, red ara around the immunized area on her left arm 10/26/14. Took BENADRYL that day but reports red area grew between 10/26/14 and 10/27/14/
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: The evening after receiving the shot my shoulder was very sore. By morning my entire arm was sore and throbbing. The pain is now constant in my upper arm and shoulder and has a throbbing sore feeling. I can't raise my arm over my head. Also have tingling in hand and wrist. Arm feels a little weak and has not improved over past month.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: The evening after receiving the shot my shoulder was very sore. By morning my entire arm was sore and throbbing. The pain is now constant in my upper arm and shoulder and has a throbbing sore feeling. I can't raise my arm over my head. Also have tingling in hand and wrist. Arm feels a little weak and has not improved over past month.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Two red swollen areas on left forearm. Warm to touch
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Local swelling, Swollen tongue
Clinical narrative: Patient c/o SOB, chest tightness and swelling of hands and tongue. XOPENEX breathing treatment given and ZYRTEC 10 mg po.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Lip swelling, Urticaria
Clinical narrative: Started with lower lip swelling, followed by urticaria arms, legs, hands, then joint pain. Resolved within 24 hours with BENADRYL.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat, chills, fever, headache, cough, nausea. Next day - ache in calves of both legs.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore throat, chills, fever, headache, cough, nausea. Next day - ache in calves of both legs.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza, Pain, Pyrexia
Clinical narrative: Within four hours of shot had severe flu symptoms fever, chills, achy all over. Felt like the worse day of having the flu. Lasted a good 8 hours. Took TYLENOL Q4H helped a little. Have been getting shot for many years never had a problem. Came very close to going to ER.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: No fever - (L) thigh red, swollen and warm to touch. 10 cm x 9 cm.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Drug screen, Dyspnoea, Headache
Clinical narrative: Patient reported back to Employee Health office at approx 15 min after vax. C/O lightheadedness, "shaky", nauseated, SOB, intense headache/head pressure and "like I was having an anxiety attack" vs checked and employee sent to occupational heatlh for evaluation; VS=98'-96-14 - 152/102 @ 100.5 deg (prior to leaving for work eval).
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nervousness
Clinical narrative: Patient reported back to Employee Health office at approx 15 min after vax. C/O lightheadedness, "shaky", nauseated, SOB, intense headache/head pressure and "like I was having an anxiety attack" vs checked and employee sent to occupational heatlh for evaluation; VS=98'-96-14 - 152/102 @ 100.5 deg (prior to leaving for work eval).
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Flushing, Injection site erythema, Injection site urticaria, Pruritus
Clinical narrative: Redness that spread from shoulder to jawline - right arm. Hives were present on shoulder and neck. Experienced itching and some flushing. Patient took some BENADRYL to treat itching and hives. Last almost 24 hours.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Redness that spread from shoulder to jawline - right arm. Hives were present on shoulder and neck. Experienced itching and some flushing. Patient took some BENADRYL to treat itching and hives. Last almost 24 hours.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin discolouration
Clinical narrative: Patient called and then came into store to show a bruise the size of about an inch. The bruise was purplish and surrounded by a yellow circle. The bruise is on right arm the same arm that FLUVIRIN was given.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Discomfort, Erythema, Local swelling, Pain
Clinical narrative: Patient was administered HPV #1, right deltoid on 10/15/2014 3:50. Patient had local redness, swelling, pain at 6:00 pm. The reaction grew in size over 2 day to the size of a baseball. Mom iced area and ibuprofen for discomfort.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient now has numbness and tingling in arm.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Pt got flu shot Mon evening and pt experiencing nausea and vomiting on Wed AM. Pt's daughter called and reported adverse effects. Pt's doctor notified by daughter.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Pt said arms sore even after 3 weeks pt started having soreness in the right upper arm since the shot. And pt said still has pain while lifting arm and sleeping per pt.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pruritus, Throat tightness
Clinical narrative: Pt's eyes were red and her throat felt like they were closing up. Took a BENADRYL. (Itching)
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: 10 days post immunization pt. began to have pain at injection site. She has been using ADVIL and heating pads with little to no relief. I referred her to her PCP for follow-up.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis, Scab
Clinical narrative: As soon as first half of intranasal FLUMIST administered, patient moderate nosebleed. Suspect scab came off/picks nose.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: On 10/13/14 patient received AFLURIA - on 10/15/14 she presented with a rash on her arm from shoulder to elbow covering about 30%.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Headache, Metabolic function test normal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Achy body, headache. Aches and pains pronounced in areas of prior injections.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Client was vaccinated at flu clinic/school with FLUARIX (L) arm. She came back to clinic area after recess c/o "tingling" in her hand (L) and part of (L) FA. Exam WNL - pink, (+) radial pulse, equal strong grasp both hands. Both hands cold "I just came in from recess". Wearing nail polish - cuticles/pads pink - with blanching/refilling WNL. Able to use (L) hand/arm without difficulty. Reexamined x 2 - sx remain. Fa contacted via pc. - told to take her to PCP if no relief - he decided not to pick her up at this time since she had her cell and could call him if sx worsen.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Local swelling, Pruritus, Rash
Clinical narrative: Approx. 4:55pm pt. came back to flu shot area and asked what was in shot. Stated hands were swelling and itching, SOB, chest tightness, rash around waist band.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on legs noted 5 hours after flu vaccination; resolved spontaneously after 1 hour.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Erythema, Sinusitis, Swelling face
Clinical narrative: Within 12 hours of receiving vaccine patient experienced swelling and redness in left side of face. Resulted in sinus infection. Skin red and blistered on forehead.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient received the vaccine on 10/13/14. On 10/14/14 patient noticed the injection site was becoming red, but it was minor. On 10/15/14 the patient said the area became red, warm, swollen, and a lump was forming. She estimates the area is about 3-4 cm in diameter and tender/uncomfortable. Patient was advised to ice the area and take BENADRYL.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient received the vaccine on 10/13/14. On 10/14/14 patient noticed the injection site was becoming red, but it was minor. On 10/15/14 the patient said the area became red, warm, swollen, and a lump was forming. She estimates the area is about 3-4 cm in diameter and tender/uncomfortable. Patient was advised to ice the area and take BENADRYL.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Pt was given Flu vaccine in (L) deltoid on 10/9/14. On 10/11/14 went to ER was dx with cellulitis of (L) arm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Computerised tomogram abdomen, Enterocolitis infectious, Pyrexia
Clinical narrative: 1 day after vaccination, she developed fever, episodic abdominal pain - no local pain. After 3 days fever dx infectious colitis.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle spasms
Clinical narrative: 2 days after administration I experienced severe muscle spasms from mid-thoracic region radiating down through lower limbs. This severity lasted 72 hours then lessening intensity daily. I have experienced this before years ago so perhaps coincidence?
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, aches, chills > 24 hrs post.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient received High dose vaccine and developed a rash on her left arm. Redness and itching.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Pruritus, Vision blurred
Clinical narrative: About 30 sec after receiving vaccination and blurred vision, anxiety and increased HR then facial itching and some shortness of breath. Took BENADRYL and TYLENOL.
Age: 36.0
Sex: U
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Patient with seizure disorder, who has received flu vaccination previously had a seizure.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Pt notice a blister at the injection site 4 days from the date of vaccination.
Age: 19.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Left arm pain, redness, and swelling.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Ear infection, Erythema infectiosum, Pyrexia, Streptococcal infection
Clinical narrative: Mother reported child has had fever ranging up to 102.  Was seen at hospital several times since 10/15/2014 and mother reports child was diagnosed with "strep infection", "ear infection" and "fifths disease".  Mother child improving and has only had fever once in last 5 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Mass, Swelling
Clinical narrative: Redness, swelling, hard lump.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Flu shot (L) deltoid 10-23-14. 2 days later; redness, warm (L) arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain during injection that has persisted since.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Client's father stated that child started out with a rash on the arm where she got the shot, raised area about the size of a quarter and it itiched.  Father reported that client had not taken any Benadryl or medication for the rash.  No temp reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness in administered arm.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Client complains of rash to left arm, spots the size of quarters down her arm, states it itiches.  Has taken Benadryl and it has helped but is not better.  Encouraged mother to take child to PCP.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 10/16 pt. presented with inflammation from mid upper arm to mid lower arm on inside of arm. Stated that injection site had been warm and swollen and spreading down arm. Injection site clear but itchy as it continued to move down arm warm and bright red. At this point recommended Diphenhydramine oral. That evening swelling going down but redness continues to move down arm. 10/17 pt arrived around 10AM. Lower arm swollen, red and slightly warm. No pain, still just itching. 10/18 noon, less swollen and improving from previous day. 10/20 1000 AM. Can see an outline of areas that have been affected. Pt's only complaint of internal itching at site.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Local swelling, Skin warm
Clinical narrative: 10/16 pt. presented with inflammation from mid upper arm to mid lower arm on inside of arm. Stated that injection site had been warm and swollen and spreading down arm. Injection site clear but itchy as it continued to move down arm warm and bright red. At this point recommended Diphenhydramine oral. That evening swelling going down but redness continues to move down arm. 10/17 pt arrived around 10AM. Lower arm swollen, red and slightly warm. No pain, still just itching. 10/18 noon, less swollen and improving from previous day. 10/20 1000 AM. Can see an outline of areas that have been affected. Pt's only complaint of internal itching at site.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Feeling hot, Laboratory test, Skin burning sensation, Vaccination complication
Clinical narrative: Pt called pharmacy on 10/27/2014 to report that she had a reaction 10 days ago and went to ER. Stated that she felt hot all over, skin burning all over, and vomited. Stated that she took a Klonopin to make her feel better, but that it didn't help and she went to ER and they said that it was definitely a reaction to the flu shot. Pt could not recall what all ER did to treat her. Stated that they did EKG and xrays and a lot of other tests. She did not know what kind of meds they gave her. She did not have to stay in ER over night.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: Pt called pharmacy on 10/27/2014 to report that she had a reaction 10 days ago and went to ER. Stated that she felt hot all over, skin burning all over, and vomited. Stated that she took a Klonopin to make her feel better, but that it didn't help and she went to ER and they said that it was definitely a reaction to the flu shot. Pt could not recall what all ER did to treat her. Stated that they did EKG and xrays and a lot of other tests. She did not know what kind of meds they gave her. She did not have to stay in ER over night.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Feeling hot, Swelling face
Clinical narrative: On 10/10/14 FLUMIST was given to patient, patient appears to have no adverse reaction to vaccine while in clinic. On 10/11/14 patient was seen at ED for complaints of facial swelling and felt warm. Mom gave ZYRTEC at home. Dr reported no swelling or difficulty breathing on exam.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site urticaria
Clinical narrative: 1 hive to left thigh, redness at injection site closer to flu injection, redness on left side of forehead, given 4ml of Children's BENADRYL.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Shortness of breath, throat tightness.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Skin warm
Clinical narrative: 10-1-14 - Rt. arm started to swell and got hot; 10-2-14 - Swelling from shoulder to elbow; 10-3-14 - Saw my dr and received prescription for antibiotic - daily - one 500 mg Cephalexin 500 mg Caplupi
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt fainting after influenza injection. Passed out approximately five times within a 20 minute period. Called 911 and paramedics took patient to hospital.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: After I gave the patient the injection, patient said she felt warmth at injection site and had a little redness. I monitored the site every 5 minutes for 15 minutes and the red area lessened. She said it did not feel worse.  I told her that if her symptoms persisted or worsened to let me know. On 10/27/14 she returned and showed me she still had a little redness.  The area measured about the same as it had on 10/23/14, about 2 inches long and one-half inch wide.  She said it felt warm and she felt a slight burning sensation at times.  I contacted Merck and the rep said it could last 3.7-9.7 days.  I told her she could take an antihistamine, apply cool compresses or apply some Benadryl cream if needed. I asked her to contact me or come by the pharmacy again on 10/30/14 if her symptoms did not resolve.  I also advised her to seek medical treament if symtoms persisted, worsened or were bothersome.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: After I gave the patient the injection, patient said she felt warmth at injection site and had a little redness. I monitored the site every 5 minutes for 15 minutes and the red area lessened. She said it did not feel worse.  I told her that if her symptoms persisted or worsened to let me know. On 10/27/14 she returned and showed me she still had a little redness.  The area measured about the same as it had on 10/23/14, about 2 inches long and one-half inch wide.  She said it felt warm and she felt a slight burning sensation at times.  I contacted Merck and the rep said it could last 3.7-9.7 days.  I told her she could take an antihistamine, apply cool compresses or apply some Benadryl cream if needed. I asked her to contact me or come by the pharmacy again on 10/30/14 if her symptoms did not resolve.  I also advised her to seek medical treament if symtoms persisted, worsened or were bothersome.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Dull, aching pain in the left arm and shoulder.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Local swelling, Pain
Clinical narrative: Swollen, red upper arm from shoulder to elbow. Chills and bodyaches.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Middle insomnia
Clinical narrative: Pain at injection site x24 hours with radiation down arm 2-3 days later.  Pain worse at night- awakens her from sleep.  Injection given high in deltoid.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Decreased appetite, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Shooting pain down arm & into chest, pain, swollen, red at injection site for approx 6 days. Also fatigue & loss of appetite. Injection site upper shoulder area, noted liquid spray & air sound during injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Pain in extremity, Syringe issue
Clinical narrative: Shooting pain down arm & into chest, pain, swollen, red at injection site for approx 6 days. Also fatigue & loss of appetite. Injection site upper shoulder area, noted liquid spray & air sound during injection.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Immediate post-injection reaction, Pruritus generalised
Clinical narrative: Case stated noted some immediate flushing "by the time I got to my car". reported flushing resolved but then noticed upper body generalized itching. Denied any past allergy to flu shots or eggs. Reported it was her first time getting the intradermal injections. Reports she takes daily allergy medication but nothing additional for itching. Reported no difficulty breathing or swelling. States she is "just itchy".
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Joint range of motion decreased, Musculoskeletal pain, Periarthritis, X-ray
Clinical narrative: The next day I noticed swelling at the injection site and then developed increasing pain in shoulder. By Tuesday, two days later, my shoulder was completely immobilized. I went to a late clinic, and was referred for X rays on 10/21. I was referred to orthopedist who diagnosed frozen shoulder and referred to Physical Therapy. By Monday, before PT assessment my shoulder was moving more freely and I can now raise my arms over my head. I suspect SIRVA.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in jaw, Tenderness
Clinical narrative: Pain at injection site and progressive arm tenderness that radiated into her shoulder, scapula, left sde of her neck and her head until she developed pain in her jaw on 9/30/14.
Age: 39.0
Sex: F
Vaccine: FLUC3
Symptoms: Blister, Erythema, Pain in extremity, Pruritus, Scab
Clinical narrative: Arm pain "entire day" after vaccination.  At bedtime, noticed 2 fluid-filled "blisters" near injection site. Mild erythema around blisters.  No warmth noted.  No itching. Follow up on 10/24/2014-itching, blisters ruptured and crusted over.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Diarrhoea, Hypotension, Syncope, Urine analysis
Clinical narrative: Vomiting, diarrhea, very low blood pressure, fainting...
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: Vomiting, diarrhea, very low blood pressure, fainting...
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia
Clinical narrative: PAINFUL/SORE SHOULDER, NUMBNESS AND TINGLING THROUGHOUT ARM AND HAND.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Reports had soreness in right arm 30 minutes after vaccination. States that 3 hours after vaccination felt sharp pain that radiated down arm to fingers. Woke up on morning of 10/17/14 with pain in right index, middle and ring fingers. No redness, swelling or heat noted at (R) deltoid area. States arm pain is less often "few" "not like last week".
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Pt received FLULAVAL and when finished, immediately looked pale, fainted and had a small seizure. We made her comfortable and helped her rest and get water after she was ok (approx 5 min). Mother reported a few similar seizures in the past.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Uncontrollable shaking for short period.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Burning sensation, Chest discomfort, Electromyogram normal, Electrophoresis protein normal
Clinical narrative: Progressive numbness, tingling, burning, and pain in hands, legs, hips, back, right shoulder and feet. Difficulty walking. Developed bladder incontinence. Chest heaviness.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Hypoaesthesia, Nuclear magnetic resonance imaging spinal abnormal, Pain, Paraesthesia
Clinical narrative: Progressive numbness, tingling, burning, and pain in hands, legs, hips, back, right shoulder and feet. Difficulty walking. Developed bladder incontinence. Chest heaviness.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Red blood cells CSF positive, Urinary incontinence
Clinical narrative: Progressive numbness, tingling, burning, and pain in hands, legs, hips, back, right shoulder and feet. Difficulty walking. Developed bladder incontinence. Chest heaviness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Patient said she experienced facial swelling 3 hours after the Flu shot around the left side by the eye area. It has gone down since then. There was no swelling at the site of the injection. She feels ok otherwise. Just wanted to notify us.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Received flu shot at around 9:30 am on Sept 26, 2014. Shot was given by employee in her left arm. She has been having pain ever since from shoulder to elbow and limited range of motion. Taking MOTRIN 800 mg QD to ease the pain. Pt takes the flu shot every year.
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: I was given flu shot on 10.04/14 and have had severe pain and a fist-sized hematoma where the injection was given. On 10/17/14 I went to Hospital seeking assistance. I have been taking Ibuprofen as prescribed but pain persists.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Headache
Clinical narrative: Patient has experienced a headache and dry mouth which has occurred 3 days after the administration.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness swelling and itching to site where vaccine given.
Age: 33.0
Sex: F
Vaccine: FLUX, PER, PPV, TD
Symptoms: Contusion, Erythema, Injection site pain, Local swelling, Mobility decreased
Clinical narrative: Long stabbing when given shot. Unable to lift arm. Used ice and heat on arm with no effects. Arm is red and swollen after shot. Huge bruise on arm and red puffy streaks. Went to hospital and received Anaprox DS.
Age: 33.0
Sex: F
Vaccine: FLUX, PER, PPV, TD
Symptoms: Ultrasound scan abnormal
Clinical narrative: Long stabbing when given shot. Unable to lift arm. Used ice and heat on arm with no effects. Arm is red and swollen after shot. Huge bruise on arm and red puffy streaks. Went to hospital and received Anaprox DS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient complained of a red, sore, and swollen arm for duration of 1 week.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Headache, Pain, Pruritus
Clinical narrative: SEVERE HEAD PAIN ITCHING SHOOTING PAIN. BURNING STINGING EXCRUCIATING pain cant even touch hair. Left side only.
Age: 36.0
Sex: F
Vaccine: FLUC3
Symptoms: Lip swelling, Pruritus, Rash generalised
Clinical narrative: BECAME ITCHY & FELT SWELLING TO LIPS; HAD RASH ALL OVER BODY; EPI-PEN ADMINISTERED & 25 MG BENADRYL (IM & PO DOSES).
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: SORENESS, REDNESS (AREA MEASURED APPROXIMATELY 3 INCHES IN DIAMETER), SWELLING, ITCHING AT INJECTION SITE. ALL OF THE ABOVE LASTED FOR 4 DAYS. PATIENT HAD NEVER HAD AN ADVERSE REACTION TO INJECTIONS.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Generalised erythema, Pruritus generalised
Clinical narrative: REDNESS & ITCHING THROUGHOUT BODY...STARTED ON LOWER ABDOMEN BUT THEN SPREAD THROUH BODY.
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling
Clinical narrative: ACHING & SWELLING IN JOINTS (HANDS/ELBOWS/KNEES) WITHOUT RASH, REDNESS OR FEVER LASTING APPROX 7 DAYS. TOOK ONLY OTC MEDS FOR SYMPTOMS.
Age: 23.0
Sex: F
Vaccine: DTPIPV
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Hives and slightly swollen throat.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Woke up aching all over,extre mely sore upper arm, temperature of 102.5, chills, vomited twice during the next 15 hours. Low grade temperature as late as Sunday afternoon. On Friday 10/24 I woke up to find my arm was very red down as far as the inside of the elbow, and injection area was still very sore. Redness spread the next day (10/25) to the underside of the arm with a large welt, still very sore  but starting to itch. Next day (10-/26) redness was starting to improve.  10/27 most of the redness is gone, but upper arm still itches.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pain, Pain in extremity, Urticaria, Vomiting
Clinical narrative: Woke up aching all over,extre mely sore upper arm, temperature of 102.5, chills, vomited twice during the next 15 hours. Low grade temperature as late as Sunday afternoon. On Friday 10/24 I woke up to find my arm was very red down as far as the inside of the elbow, and injection area was still very sore. Redness spread the next day (10/25) to the underside of the arm with a large welt, still very sore  but starting to itch. Next day (10-/26) redness was starting to improve.  10/27 most of the redness is gone, but upper arm still itches.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: 5 inch x 3 inch patch of swelling and redness at the site of administration of the vaccine. The skin was hot to the touch. Waited 8 hours for the reaction to go away by itself. Reaction grew worst and administered Benadryl at 6 p.m.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Vascular injury
Clinical narrative: Extensive blue/purple bruising spreading from shoulder to elbow, extending around arm.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MEA, VARCEL
Symptoms: Hypoaesthesia, Rash, Urticaria
Clinical narrative: Numbness in arm, locallized rash/hives. Given ibruprofen at clinic. Still has rash/hives a week later.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Malaise, Migraine, Pain
Clinical narrative: Fatigue, Rash, itching starting on arm of flu shot, progressing to both arms, then over body. Diarrhea, body aches, migraine ill x 9 days. Given CLARITIN - no relief SOLU-MEDROL - minimal relief.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: Fatigue, Rash, itching starting on arm of flu shot, progressing to both arms, then over body. Diarrhea, body aches, migraine ill x 9 days. Given CLARITIN - no relief SOLU-MEDROL - minimal relief.
Age: 0.68
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Pain, Rash
Clinical narrative: Patient received vaccines after waiting in room for 10 min. Pt broke out with a rash. Tamp was taken rectal. Dr examined pt and ordered TYLENOL for pain after 80 min rash was gone. Pt was ok.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Pt described rash/blister-like on face, when assessed by Dr was diagnosed as shingles.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Headache, Injection site reaction, Pain, Rash, Rash erythematous
Clinical narrative: Pt described rash/blister-like on face, when assessed by Dr was diagnosed as shingles.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pain, Rash erythematous
Clinical narrative: Pt received vaccine on a Thur - On Fri and Sat developed pain and rash began. Started small, but by Sun rash became bright red and rash grew to the elbow from inj. site. On Sun pain started to diminish. By Mon rash started to lighten and go away. Pt is now recovered.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal dreams, Disturbance in attention, Feeling abnormal, Feeling cold, Heart rate increased
Clinical narrative: Listless, lack of concentration, feeling cold violent shaking, elevated pulse rate, vivid unusual, weird nonsensical dreams. No fever. Did not feel right the next day.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Listless, Tremor
Clinical narrative: Listless, lack of concentration, feeling cold violent shaking, elevated pulse rate, vivid unusual, weird nonsensical dreams. No fever. Did not feel right the next day.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise, Nausea
Clinical narrative: Sick/nausea.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Nausea, Pain in extremity, White blood cell count increased
Clinical narrative: Sore arm visited ER given pain med and antibiotic. Nausea, headache.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Cough, Headache, Pain, Pyrexia
Clinical narrative: Pt. received AFLURIA shot on 10/23/14. On 10/25/14 he developed sx of runny nose, sneezing, coughing, and on 10/26/14 developed fever of 101 degree F with body aches, H/A, stomach ache.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Pt. received AFLURIA shot on 10/23/14. On 10/25/14 he developed sx of runny nose, sneezing, coughing, and on 10/26/14 developed fever of 101 degree F with body aches, H/A, stomach ache.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Malaise, Nausea
Clinical narrative: Visited hospital sick, nausea, claims cellulitis.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Claims to have gotten hives, resolved before being seen by medical practice.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Pt received shot at approximately 8:00 pm. Pt call on 10/27/14 to report the next morning (10/25/14) awakened at 1:00 AM with cheek swollen. Took aspirin at 3:00 AM.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Diffuse rash over upper region of body and treated with OTC BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site swelling
Clinical narrative: Erythemia and swelling L upper arm 7x10 cm; mild right arm flat 1x2 cm; 1 purple, 1 red papule.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 25-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 26th September 2014, the subject received Flu Seasonal QIV Dresden .5 ml. The subject received Flu Seasonal QIV Dresden during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Pharmacist provided limited information. More specific gestational timing was not available. Minimum information collected for asymptomatic adverse event.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Blood gases, Cardiac enzymes, Chest X-ray, Diarrhoea, Dyspnoea
Clinical narrative: Had facial swelling especially of the lips. Respiratory Stridor - Respiratory difficulty. Redness of face and neck, explosive diarrhea. Respiratory Arrest - No pulse - Nonresponsive.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Full blood count, Lip swelling, Metabolic function test, Pulse absent
Clinical narrative: Had facial swelling especially of the lips. Respiratory Stridor - Respiratory difficulty. Redness of face and neck, explosive diarrhea. Respiratory Arrest - No pulse - Nonresponsive.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory arrest, Stridor, Swelling face, Unresponsive to stimuli
Clinical narrative: Had facial swelling especially of the lips. Respiratory Stridor - Respiratory difficulty. Redness of face and neck, explosive diarrhea. Respiratory Arrest - No pulse - Nonresponsive.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 7th October 2014, the subject received Flu Seasonal QIV Dresden. The subject's past medical history included miscarriage (around 5-6 week gestation in early July 2014). The subject's last menstrual period was on 26th May 2014 and estimated date of delivery was 11th April 2015. The subject received FLUARIX at week 13 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX. The patient received a FLUARIX vaccine while pregnant. Gestational age was 13 weeks. Last menstrual period 26 May 2014, but the patient experienced a miscarriage around 5-6 weeks gestation in early July 2014. This current pregnancy occurred before having another menstrual period. The patient had a twin pregnancy.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 10th February 2014, the subject received Flu Seasonal QIV Dresden at week 9 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX. Caller reported that she received a FLUARIX 2014-2015 season vaccine while she was pregnant. No AEs were reported.
Age: 0.17
Sex: U
Vaccine: DTAP, IPV, RV5
Symptoms: Convulsion, Cytogenetic analysis, Lumbar puncture, Metabolic function test
Clinical narrative: Patient seen by me on 9-27-13 at 9:25 am due to multiple episodes of seizures (at least 10 x). Each episode 20-30 sec of duration. Treated with KEPPRA.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a mother refers to her daughter of unknown age. In August 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route unspecified). In August 2014 the patient was vaccinated with the second dose of GARDASIL (lot#, dose and route unspecified). She called because she noticed how the GARDASIL doses were supposed to be administered and unfortunately her doctor hadn't followed the recommended use. Additional information is not expected as there was no follow up contact information provided.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first and second dose of RECOMBIVAX (strength, dose, route and lot # not reported). It was reported that the patient was late getting third dose of RECOMBIVAX (strength, dose, route and lot # not reported), no adverse symptoms reported. This is one of the 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). On 28-SEP-2104, the patient was vaccinated with first dose of PNEUMOVAX 23 (dose and lot # unknown) intramuscularly. On 02-OCT-2014 the patient was inadvertently administered a second dose of PNEUMOVAX 23 (dose and lot # unknown) intramuscularly. No adverse effects reported. Additional information is not expected as reporter could not be contacted.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a other health professional (registered nurse) refers to a female patient of approximately 29 years old age. Current conditions and medical history were reported as none. On 13-SEP-2014, the patient was vaccinated with (Merck) VARIVAX (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Reporter reported that the patient received (Merck) VARIVAX and later found out she was pregnant. The patient became pregnant with approximated last menstrual period (LMP) of 18-JUL-2014 and estimated date of delivery (EDD) of 24-APR-2015 (calculated as per the gestational age which was reported as 9 weeks and 1 day). Estimated date of conception was 01-AUG-2014. Patient was exposed during first trimester. No lab diagnostics studies performed. No treatment was given. The pregnancy outcome was unknown. Patient sought unspecified medical attention. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients was vaccinated with PNEUMOVAX 23 (route, dose was unknown) which was improperly stored. No adverse effects reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to cases MARRS # 1410USA008635, 1410USA013361, 1410USA013358, 1410USA013359 with same reporter link. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients was vaccinated with VAQTA (route, dose was unknown) which was improperly stored. No adverse effects reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to cases MARRS # 1410USA008635, 1410USA013361, 1410USA013360, 1410USA013359 with the same reporter link. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients was vaccinated with RECOMBIVAX (route, dose was unknown) which was improperly stored. No adverse effects reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to cases MARRS # 1410USA008635, 1410USA013358, 1410USA013360, 1410USA013361. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients was vaccinated with ROTATEQ (route, dose was unknown) which was improperly stored. No adverse effects reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to cases MARRS #  1410USA013361, 1410USA013360, 1410USA013358, 1410USA013359 with the same reporter link. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. "Last month", in September 2014 the patient was administered a first dose of PNEUMOVAX 23 (lot#, dose, route not reported). "Yesterday", on 21-OCT-2014 the patient was inadvertently administered a 2nd dose of PNEUMOVAX 23 (lot#, dose, route not reported). No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient. The patient's medical history was not reported. On 30-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency, route and lot # were not reported). Concomitant medications were not reported. On 17-OCT-2014 the patient was vaccinated with second dose of VAQTA. No adverse effect was reported. No product complaint was reported for VAQTA. This case is linked to case # 1410USA010488 (same patient link). Additional information has been requested.